Quality management training for blood transfusion services: facilitator's guide

Quality Management Training for Blood Transfusion Services Facilitator’s Guide EHT/05.03 A Restricted THIS DOCUMENT HAS BEEN DECLASSIFIED DE CL AS SIF IED This publication forms part of a series of training materials developed specifically for use in WHO Quality Management Training courses. Its distribution is restricted to approved QMT training centres, course coordinators, facilitators and participants. © World Health Organization, 2005. All rights reserved. This health information product is intended for a restricted audience only. It may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means. 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DE CL AS SIF IED Contents Preface Acknowledgements FACILITATOR’S GUIDE Introduction 3 The need for quality management WHO Quality Management Programme 3 Components of the QMP Quality Management Training 4 Creating a culture of quality Facilitator’s Toolkit 5 Course contents 6 Curriculum 6 Introduction Part 1: Basic Principles of Quality Part 2: Applying Quality Management in the BTS Curriculum structure Weekly programme of work 8 Presentation notes 8 PowerPoint presentations 9 Using the PowerPoint slides PowerPoint handouts Using the PowerPoint projector Supplementary materials Making your presentation Activities 11 Activity notes: facilitator Activity notes: participants Activity materials Facilitating an activity Group work Role play Quality Status Questionnaire 14 DE CL AS SIF IED Course evaluation form 15 Participant’s final report 15 Glossary 15 Participant’s Workfile 15 CORE COURSE MATERIALS Course contents 19 Curriculum 23 Example of a weekly programme of work 65 Participant’s final report 68 Glossary 71 DE CL AS SIF IED Preface The availability of safe blood and blood products is a public health responsibility that is an essential to modern medical care. Blood safety also plays a crucial role in preventing the transmission of HIV, hepatitis viruses and other bloodborne pathogens through transfusion. The World Health Organization (WHO) advocates the following integrated strategy to national health authorities to promote the safety and accessibility of blood and blood products and reduce the risks associated with transfusion. 1 Establishment of a well-organized, nationally-coordinated blood transfusion service (BTS) that can provide adequate and timely supplies of safe blood and blood products to meet the transfusion requirements of the patient population. 2 Collection of blood only from voluntary non-remunerated blood donors from low-risk populations and the use of stringent criteria for assessing the suitability of donors. 3 Quality-assured testing of all donated blood for transfusion-transmissible infections, including HIV, hepatitis viruses, syphilis and other infectious agents, and blood grouping and compatibility testing. 4 Reduction in unnecessary transfusions through the appropriate clinical use of blood and the safe administration of blood and blood products. 5 Implementation of effective quality systems, covering all aspects of BTS activities, including quality management, the development and implementation of quality standards, effective documentation systems, the training of all staff and regular quality assessment. WHO supports its Member States in implementing each element of this strategy for blood safety through advocacy, training, materials development and technical support. WHO Quality Management Programme Consistent quality and the safety and availability of blood transfusion cannot be achieved without effective quality systems, yet evidence from the WHO Global Database on Blood Safety 2001– 2002 (WHO, 2004) indicates a lack of trained quality management staff in blood transfusion services, particularly in developing countries. An Aide-Mémoire: Quality Systems for Blood Safety (WHO, 2003) outlines the requirements for quality systems for blood transfusion services. To address the challenge of a lack of quality systems, WHO established the Quality Management Programme (QMP) as a cornerstone of its initiatives to support Member States in ensuring the overall safety of the transfusion process, from the recruitment of blood donors to the transfusion of blood and blood products and follow-up of the recipients. The programme was developed to build regional and national capacity in quality management and promote the establishment of quality systems in blood transfusion at all levels of the health system in Member States. Quality Management Training (QMT) lies at the core of the programme. Since the launch of the QMP in 2000, BTS directors and quality managers from over 100 countries have been trained in the basic principles of quality management for blood transfusion services. Initially conducted at regional and inter-regional levels, QMT has now cascaded to national and local levels with post-course follow-up DE CL AS SIF IED and support from WHO, WHO Collaborating Centres and other centres of excellence designated as Regional Quality Training Centres. WHO has also established regional external quality assessment (EQA) schemes in blood group serology and virology and has published Quality Assessment of Transfusion Laboratory Practice: Guidelines on Establishing an EQA Scheme in Blood Group Serology (WHO, 2004) to support the establishment of national EQA schemes. The Quality Management Training Facilitator’s Toolkit has been developed to provide a standardized curriculum and training materials to ensure consistency in teaching in all regions of the world. The curriculum was developed through an process of extensive consultation with experts in quality in blood transfusion services from all regions of the world. The training materials were prepared by a team of international facilitators and quality experts and were further refined following testing in a series of regional, sub-regional and national QMT courses. The interactive course is based on two main components: formal presentations and activities to enable course participants to apply what they have learned. The QMT Facilitator’s Toolkit has been produced in two formats: print and CD-ROM. The printed edition, containing five books, has been produced to assist QMT course coordinators and facilitators in planning and preparing for QMT courses. In addition to a Facilitator’s Guide, it contains the curriculum, presentations in handout form, facilitator notes on presentations and activities and other resource materials. The CD-ROM accompanying the Facilitator’s Guide contains all the materials required for a QMT course, including PowerPoint presentations for use in teaching and materials for activities. For further information on the WHO Quality Management Programme and Quality Management Training, contact Blood Transfusion Safety, Department of Essential Health Technologies at: bloodsafety@who.int. Website: http://www.who.int/bloodsafety. Dr Neelam Dhingra Coordinator, Blood Transfusion Safety Department of Essential Health Technologies World Health Organization DE CL AS SIF IED Acknowledgements The Blood Transfusion Safety team in the WHO Department of Essential Health Technologies wishes to express its thanks to the following experts in quality management in blood transfusion services for their contribution to the development of the Quality Management Training Facilitator’s Toolkit. Project director Dr Neelam Dhingra, Coordinator, Blood Transfusion Safety, Department of Essential Health Technologies, WHO Authors and editorial team Dr Alan Kitchen, Head, National Transfusion Microbiology Reference Laboratory, National Blood Service, England and Wales Mrs Shân Lloyd, former Technical Officer, Blood Transfusion Safety, Department of Essential Health Technologies, WHO Mr Neil Rosen, National Quality Manager, South African National Blood Service, South Africa Profesor Maurice Chassaigne, Delegate, International Cooperation, Etablissement Français du Sang, France Critical readers and other contributors Dr Jean-Baptiste Tapko, Regional Adviser, Blood Safety, WHO Regional Office for Africa Dr José Ramiro Cruz-Lopez, Regional Adviser, Laboratory and Blood Services, WHO Regional Office for the Americas/Pan American Health Organization Dr Nabila Metwalli, Regional Adviser, Blood Safety Laboratory and Imaging, WHO Regional Office for the Eastern Mediterranean Dr Valentina Hafner, Medical Officer, Quality of Health Systems, Division of Country Support, WHO Regional Office for Europe Dr Rajesh Bhatia, Regional Adviser, Blood Safety & Clinical Technology, WHO Regional Office for South-East Asia Dr Yu Junping, Blood Safety Specialist, WHO Regional Office for the Western Pacific Ms Susan Best, General Manager, National Serology Reference Laboratory, Australia Professor Kamel Boukef, Director, National Blood Transfusion Centre, Ministry of Public Health, Tunisia Dr Pimol Chiewsilp, Quality Manager, National Blood Centre, Thai Red Cross Society, Thailand Dr M.E. Chitiyo, Medical Director, National Blood Transfusion Service, Zimbabwe Dr Janiet Merza Niqur, Director, National Blood Bank, Jordan Dr Faten Moftah, Medical Director, National Blood Transfusion Center, Ministry of Health, Egypt Dr Rachanee O’Charoen, Director, National Blood Centre, Thai Red Cross Society, Thailand Mr Patrick Prakash, Senior Laboratory Officer, Centre for Transfusion Medicine, Health Sciences Authority, Singapore Professor Cees Th. Smit Sibinga, Academic Institute for International Development of Transfusion Medicine, University of Groningen, Sanquin Blood Bank Noordoost, Netherlands Dr Liliane Siransy-Bogui, Chief, Laboratory Services, Centre National de Transfusion Sanguine, Côte d’Ivoire Dr Diana Teo, Director, Centre for Transfusion Medicine, Health Sciences Authority, Singapore Dr Lenka Walterova, Head, Department of Clinical Haematology, Regional Hospital Liberec, Czech Republic Dr Neelam Dhingra, Coordinator, Blood Transfusion Safety, Department of Essential Health Technologies, WHO Dr Jean C. Emmanuel, former Director, Department of Blood Safety and Clinical Technology, WHO Ms Jan Fordham, Technical Officer, Blood Transfusion Safety, Department of Essential Health Technologies, WHO DE CL AS SIF IED DE CL AS SIF IED Facilitator's Guide DE CL AS SIF IED DE CL AS SIF IED Introduction The Quality Management Programme (QMP) is a major global initiative developed by the World Health Organization (WHO) to support its Member States in ensuring the overall quality and safety of blood transfusion practice, from the collection of donated blood to the clinical use of blood and blood products. The QMP was launched in 2000 with the objective of helping to build national capacity in the effective quality management of blood transfusion services (BTS), supporting the development of national quality systems and increasing the awareness of BTS staff of the need for quality in all activities related to blood transfusion. WHO has played a major role in supporting countries in ensuring the safety of blood and blood products and their accessibility to all patients requiring transfusion. It works at global, regional and country levels through advocacy at the highest level, supporting the development and implementation of national blood policies and plans, helping to mobilize resources and capacity building at regional and national levels. In support of these activities WHO has developed advocacy, teaching and training materials which have been used widely in workshops, technical training and other activities to support countries in the development of strategies to ensure the safety and adequacy of the blood supply and safe clinical transfusion practice. The need for quality management Blood transfusion is an essential and life-saving support within the health care system but, globally, the safety and availability of transfusion is not assured. Particular threats include: „ An insufficient number of voluntary non-remunerated blood donors to ensure an adequate supply of safe blood and blood products „ Risk of the transmission of infections such as HIV, hepatitis B and C, and syphilis through unsafe transfusion „ Unnecessary transfusions, which needlessly expose patients to the risk of acute or delayed reactions and transfusion-transmitted infection „ Errors in the transfusion of blood and blood products. The focus of WHO initiatives and strategies has been the development of well-organized national blood programmes that can provide timely supplies of safe blood and blood products, collected only from voluntary non-remunerated donors. In order to ensure sustainability, consistency of quality and the overall safety of the entire transfusion process, an effective quality management system is required to provide the framework within which the blood programme functions. There are many definitions of quality, one of the simplest and most appropriate being “fit for purpose”. In the context of blood transfusion, this means the setting and meeting of basic national or international quality standards and then continual quality improvement to ensure the safety of the transfusion process. WHO Quality Management Programme The WHO Quality Management Programme (QMP) is a global programme that is designed to support countries in improving the safety and adequacy of blood transfusion by: 1 Building capacity in quality management in all aspects of blood transfusion through an integrated approach of training and assessment. 2 Supporting the establishment of sustainable national quality systems in blood transfusion services. QMT/Facilitator's Guide 3 DE CL AS S F IED The QMP is a dynamic programme which aims to assist all national blood programmes to reach common minimum standards, whilst offering flexibility to meet the needs of individual countries. It was launched in 2000 and is coordinated at global level by WHO Headquarters. At regional level, the QMP is coordinated by WHO Regional Offices, in partnership with Regional Quality Training Centres, WHO Collaborating Centres, national blood transfusion services, international nongovernmental organizations and experts in quality and transfusion medicine. Components of the QMP The Quality Management Project has six integrated components: „ Quality Management Training (QMT) to train at least two persons from each country in every region as BTS quality managers/officers „ Designation of at least one Regional Quality Training Centre (RQTC) in each region to coordinate regional QMT courses and support national courses „ Post-training support and follow-up of course participants „ Expansion of External Quality Assessment Schemes in blood group serology and transfusion-transmissible infections „ Regional Quality Networks for the exchange of information and experience between Regional Quality Training Centres, course participants and blood transfusion services „ Development of advocacy and training materials to support QMT courses and the establishment of national quality systems. The long-term effectiveness of the QMP lies in the cascading of QMT from regional to national level, with post-training follow-up to identify problems and provide additional support through visits to individual participating countries, further training courses and the involvement of global and regional partners in supporting quality management training at all levels. The success of the QMP depends on the individuals trained in regional QMT courses applying what they have learned in developing quality systems within their own BTSs, initiating and organizing national QMT courses and playing an active role in the development of the regional and national quality networks. These are vital in ensuring continued communication between course participants and providing the support needed for the development of effective and sustainable national quality systems. The expected outcomes of the programme are that the quality, safety and accessibility of blood transfusion will be improved in all countries that have participated in the QMP, including: „ The establishment of a sustainable national quality system in each country, with a quality area in each blood transfusion centre „ An increase in blood donation by regular, voluntary non-remunerated blood donors from low-risk populations „ Quality-assured testing of all donated blood „ A reduction in unnecessary transfusions and safe clinical transfusion practice. Quality Management Training Quality Management Training (QMT) courses are the foundation of the QMP. At regional level, QMT courses are held in blood centres or other institutions designated as Regional Quality Training Centres and are organized and facilitated by Regional Quality Training Teams, comprising the Regional Quality Management Programme (QMP) Coordinator and QMT/Facilitator's Guide 4 DE CL AS SIF IED regional facilitators. A team of international facilitators provides additional technical support, where required. Regional and sub-regional QMT courses are normally attended by at least two participants from each country, usually a person designated as the BTS quality manager and one or more senior laboratory technicians. Prior to QMT courses, regional meetings are held to sensitize directors of blood transfusion services and/or national blood programmes to the need for quality systems to ensure blood safety and availability and to introduce them to the Quality Management Programme. As the number of regional courses has increased, WHO Regional Offices have decentralized training by supporting sub-regional and national QMT courses. Each 18-day course follows a standard curriculum that has been developed by an international team of experts in quality management in blood transfusion services and has been extensively reviewed and tested in QMT courses. It uses core training materials, provided on the CD-ROM, in order to promote consistency in teaching, ensure common understanding of quality terminology and concepts and provide tools that will enable QMT participants to apply quality principles in their own working environments. Each course is interactive in approach, using a combination of formal presentations, for which Microsoft PowerPoint slides are provided, and a series of activities that are designed to enable participants to apply what they have learned. Following an introduction to the QMP and QMT, the course addresses general concepts and basic principles of quality and their application in general manufacturing/service scenarios and then focuses on their application to blood transfusion, including the organization, management and costing of blood transfusion services, donor management and blood collection, laboratory testing, blood component production, the issue of blood and the clinical interface and blood usage. QMT courses focus on quality and quality systems and how they should be applied in all aspects of the blood transfusion service through effective quality management. They are not designed to train participants in technical areas such as blood donor management or laboratory testing. Where a need for training on specific technical issues is identified, additional courses may be planned as part of post-course follow-up and support. Creating a culture of quality A safe and adequate blood supply cannot be assured without quality – and quality comes from the individual. Quality will not happen unless every member of staff, from the medical director to the cleaners, understands that everyone is responsible for quality and that everyone plays a part in developing and maintaining the quality system. A fundamental aim of QMT courses is therefore to instill an understanding in participants that a culture of quality has to be created in BTSs and that all staff need to be fully aware of this culture and play their part in putting it into practice. An important part of the thrust of the QMT course, and a measure of its effectiveness, must therefore be to ensure that course participants are aware of their central role in this process and to stimulate their interest and enthusiasm for quality. One of the fundamental objectives of QMT courses is to help participants to develop a realistic plan of action for establishing an effective quality system in their own BTS and assisting in the development of a national quality system. Facilitator’s Toolkit The five books of printed material comprising the QMT Facilitator's Toolkit are designed for use in course planning by QMT course coordinators and facilitators. Book 1 contains the Facilitator's Guide, overview of course contents, curriculum, example of a weekly programme of work, glossary and the template for the participants' report to be completed at the end of the course. Books 1–5 contain notes for facilitators on handling each session, handouts from QMT/Facilitator's Guide 5 DE CL AS SIF IED the PowerPoint presentations and instructions for conducting activities. They also contain additional resource materials for use in activities. The Facilitator's Toolkit is also provided on an interactive CD-ROM which contains the same materials in .pdf format plus PowerPoint presentations (slide show) and activity notes for participants. The CD-ROM has been designed for use during the course itself. If no CD-ROM has been provided for a QMT course, please request one from the WHO Regional Office for your region or from WHO Headquarters (e-mail: bloodsafety@who.int). QMT materials are described below. Course contents The list of course contents provides a brief overview of a QMT course. It shows the modules in each part of the course and lists the presentations and activities that are included in each module. Curriculum The course curriculum provides a detailed guide to the structure and content of QMT courses. It is a generic curriculum that has been designed for use in all QMT courses in order to maintain a consistent approach to teaching. QMP Coordinators and facilitators should therefore follow the curriculum and not omit any presentations or activities. However, there is some in-built flexibility to allow local adaptation, where appropriate. In addition, where time permits, additional presentations and activities may be included. The curriculum is divided into fifteen modules. You should familiarize yourself with the entire curriculum and its associated presentations and activities so that you can see where your own sessions fit in with those of other facilitators. It is particularly important to look carefully at all the presentations and activities in the modules that you will be involved in teaching in order to avoid any duplication with other facilitators. Since each module builds on previous modules, it is also essential to be aware of how they relate to other modules earlier or later in the course. Modules in Part 1, for example, introduce concepts of quality in a general context; these are expanded on in Part 2 where they are addressed specifically in the context of blood transfusion services. Effective coordination and communication with other facilitators is therefore vital during the course, and preferably also in advance. The course consists of 57 presentations and 69 activities, including assessment. These are organized into 15 modules which are presented as follows: „ Introduction (1 module) „ Part 1: Basic Principles of Quality (7 modules) „ Part 2: Applying Quality Management in the BTS (7 modules). Introduction The Introduction is designed to place the course in context by outlining the WHO strategy for blood safety and the need for quality in all aspects of blood transfusion and to introduce the Quality Management Programme and the QMT course. It contains a single module. Module 1 The WHO Quality Management Project Part 1: Basic Principles of Quality Part 1 explores the basic principles of quality and quality systems. Since many participants will be unfamiliar with quality concepts and terminology, the curriculum is designed to QMT/Facilitator's Guide 6 DE CL AS SIF IED introduce quality in a general context by using familiar examples, including general manufacturing and service scenarios, to illustrate the basic components of a quality system. Part 1 contains the following seven modules. Module 2 Introduction to Quality Module 3 Quality Systems Module 4 Organizational Management Module 5 Standards for Quality Systems Module 6 Documentation Module 7 Training Module 8 Assessment within the Quality System Part 2: Applying Quality Management in the BTS Part 2 focuses on the application of quality principles and systems within the blood transfusion service. It begins by exploring the specific organizational requirements for quality and then addresses the components of a quality system for all aspects of the BTS, from blood donor recruitment to the administration of blood and follow-up of the patient. It focuses particularly on the actions that need to be taken and the role of the quality manager in establishing a quality system. Participants are introduced to the concept of action planning and the final module draws together their work on the course when they finalize an action plan for implementing a quality system in their own blood centre and assisting in the establishment of a national quality system. Part 2 contains the following seven modules. Module 9 Quality Management in the BTS Module 10 Hygiene and Safety in the BTS Module 11 Quality Systems in Donor Management and Blood Collection Module 12 Quality Systems in Laboratory Testing Module 13 Quality Systems in Component Production and the Issue of Blood Module 14 Quality Systems and the Clinical Interface Module 15 Finalization of Participants’ Action Plans and Completion of the Course Curriculum structure The curriculum outlines the following information about each session. 1 Title: the number, title and type of session: i.e. presentation or activity. 2 Teaching aim: the purpose of the session. 3 Core topics: the main topics that will be covered in the session. 4 Key points: a summary of the most important messages that the session is designed to convey and that you expect participants to remember. 5 Teaching focus: brief guidance on the recommended approach to handling this session. 6 Learning outcomes: a brief summary of what participants should be able to do after the presentation or completing the activity: QMT/Facilitator's Guide 7 DE CL A SIF IED „ The learning outcomes for presentations generally specify what participants should be able to describe or explain to demonstrate their knowledge and understanding of topics covered in the presentation „ The learning outcomes for activities focus more on the application of knowledge to practice since the course is designed to assist participants to relate what they have learned directly to their own blood transfusion service. 7 Timespan: the suggested time allocated for the presentation or activity plus discussion, based on experience in field testing. Weekly programme of work The course has been designed to take place over a period of 18 days. Experience from earlier QMT courses has demonstrated that it is not possible to complete the course in a shorter period of time. Participants will be unfamiliar with many of the concepts that will be presented to them during the course and will need time to understand the principles of quality and learn how to apply them. Your QTC should provide you with a copy of the weekly and daily programme of work in advance, including the dates and times of presentations and activities, as well as a list of facilitators for each session. The programme of work should be explained to participants in session QMT 1.3. An example of a weekly programme of work is included in this book and on the CD-ROM. You should be present throughout the days allocated for your involvement as a facilitator and attend presentations made by other facilitators so that you are familiar with the topics that are being covered in other sessions. You should also be present during activities facilitated by other facilitators so that you can assist participants in group work. The QMP Coordinator should organize evening debriefing meetings and brief you on the programme for the following day. You will also find it helpful to talk informally with other facilitators to ensure a coordinated approach to teaching. Presentation notes The PowerPoint presentations provided on the CD-ROM are the core training material. Each PowerPoint presentation is accompanied by notes that provide guidance on how to present the session, identify the key messages in the presentation and suggest ways of ensuring that these messages are understood. It is essential to familiarize yourself with both the presentation notes and the PowerPoint presentation in advance of the session. You may wish to add your own handwritten notes on the handouts showing the slides; these are also provided on the CD-ROM. The presentation notes include the following information, some of which is also included in the curriculum for easy reference. 1 Teaching aim. 2 Core topics. 3 Key points. 4 Teaching focus. 5 Learning outcomes: participants generally find learning outcomes helpful because they specify what each individual should have learned from the session. You should also find learning outcomes useful because they will help you to evaluate the effectiveness of the session and assess whether further teaching is required on particular topics. QMT/Facilitator's Guide 8 DE CL AS SIF IED 6 Materials required: „ Some materials, such as examples of documentation and case studies, are provided on the CD-ROM „ Publications: these should be supplied in advance by the QTC or WHO. Wherever possible, provide examples of documentation from your own region or country. The QTC is responsible for providing copies of any materials that need to be distributed to participants during the session. However, you should check that all materials required are available in sufficient quantities in advance of the session. 7 List of PowerPoint slides in the presentation. 8 Presentation notes: these provide guidance on how to use the PowerPoint slides during the session and suggest points for emphasis or discussion. Where the notes indicate that topics are covered in other sessions, you should simply provide a brief introduction and explain to participants that these topics will be discussed in more depth later in the course or remind them of the sessions in which they have already been covered. 9 Related activities: most presentations are followed by activities that are designed to assist participants to apply what they have learned from the session. Ensure that you are familiar with any activities (and other presentations) related to the sessions that you will be presenting and understand the objectives and the instructions for conducting the activities effectively. Explain how the activities link in with the sessions that precede and follow them and how they are designed to help participants to apply what they have learned from the presentations. 10 Timespan: suggested allocation of time for the session, including discussion. PowerPoint presentations The 57 PowerPoint presentations are the main teaching resource for the course and are designed to strengthen participants’ knowledge and understanding of quality principles and how they can be applied in the BTS. Please note that the copyright of the PowerPoint files belongs to WHO and the files should not be amended without permission. Each presentation has a similar structure and contains the following common slides that have been taken from the curriculum: „ Title „ Teaching aim „ Core topics „ Key points „ Learning outcomes. Using the PowerPoint slides However experienced you are as a teacher, preparation is the key to making an effective presentation. It is essential that you study the slides and the accompanying presentation notes in advance and plan how you will use them to cover the topics allocated to you. While the same presentations will be used by all facilitators, each facilitator will present them in a different way because each of you will draw on your own experience of quality, quality systems and quality management to talk about the points covered by the slides. Remember QMT/Facilitator's Guide 9 DE CL AS SIF IED that you should use all the slides provided but, if you wish, you can prepare an additional PowerPoint file to expand on issues in the presentation, particularly if you wish to add examples or introduce regional or local issues. The slides provide a framework for your teaching, but do not provide the total content of your presentation. In effect, they provide a series of headings for you to expand on during the session. Plan carefully what you will say about each of the topics presented on each slide. Talk to the QMP Coordinator if you find the meaning of any slides unclear or do not feel confident about presenting them. Don’t present a session without being thoroughly familiar with the slides and preparing your talk. PowerPoint handouts For each presentation, a handout is provided which shows the slides in the presentation, three to a page, with space for you to add notes. The handouts should also be photocopied and given to participants to add to their Workfiles. Using the PowerPoint projector PowerPoint presentations are made using a special projector which should be available in the training centre. Check that the file has been loaded onto the hard disk of the computer in advance of the session. If you have not used a PowerPoint projector before, ask one of the staff of the training centre to demonstrate and practise in advance until you feel confident about moving from one slide to the next throughout the presentation. Supplementary materials Before the session, prepare any supplementary materials, such as examples of documentation, that you want to provide for participants. Check that sufficient copies are available before the session starts. Making your presentation While the PowerPoint slides cover the key issues to be covered in the session, they simply provide a framework for your teaching and you must use your own experience to illustrate and expand on the points in the slides. Keep the following principles in mind when making your presentation. 1 Emphasize that the purpose of the course is not to provide training on technical aspects of blood transfusion services, but rather to enable participants to develop the knowledge and skills to establish and maintain an effective quality system in their own BTS. Don’t allow the sessions to be diverted into discussions on technical issues such as the characteristics of anti-HIV screening assays, but keep the focus on the action required to ensure quality in each area of BTS activity. If you identify a need for specific technical training, discuss this with the QMP Coordinator as workshops on specific technical issues in blood transfusion may be organized as part of post-course follow-up. 2 The course is very intensive and participants will be introduced to many new and often complex concepts. Your communication skills and the way in which you make your presentation will therefore play an important part in promoting participants’ interest and understanding and creating an effective learning experience for them. Avoid simply reading the points on the slides and use a lively style of delivery to explain the concepts you are introducing. You may find it helpful to use a flipchart, whiteboard or overhead projector transparencies to illustrate key issues in more depth or to summarize points that have arisen in discussion. QMT/Facilitator's Guide 10 DE CL AS SIF IED 3 Be flexible and creative in your approach and be prepared to adjust the level of your teaching in response to participants’ needs. Check for understanding by questioning and observing participants; you can learn a great deal from their body language. If they look bored or confused, you may need to vary your style or pace of presentation or to address some issues in more depth. If they are unresponsive to questions, they may have found it difficult to understand some of the concepts you have presented or feel that, in practice, it would be difficult to apply them in their own BTS. Whatever the reason, you need to find out whether they have achieved the learning outcomes specified for the presentation or whether any further teaching or discussion is required. 4 Use general examples to introduce new topics and then progress to BTS-specific examples. Participants who have little experience of quality management may be overwhelmed by new ideas and concepts unless these are first introduced in a simple way that they can relate to their own experience. Some of the presentations use simple daily activities to illustrate quality principles, such as making a cup of coffee or general manufacturing processes in food production. Use your own experience to provide additional examples that will be meaningful and will help participants to understand how quality concepts relate to their everyday lives as well as their work. 5 The course is designed to be highly interactive so promote questions and discussion. Some participants may be unfamiliar with an active style of learning and may need encouragement to ask for clarification or express their opinions. Acknowledge that some quality issues may initially be difficult to understand and check that participants have understood the points you have explained. 6 Be prepared for any question and always answer honestly. If you don’t know the answer, use the question as an opportunity to explore the issue with the participants through discussion. 7 Encourage and positively reinforce participants’ learning, but be realistic in your expectations. Some participants may work in BTSs that have not yet established quality systems; don’t criticize them for any current limitations in their BTS or their own experience or expect that they will be able to establish a quality system in a short period of time. Participants who are made to feel inadequate will not learn effectively. Recognize and discuss any constraints they may face in setting up a quality system, such as working within a fragmented, hospital-based blood programme, and focus on helping them to understand how they can begin to apply quality principles in their own work environment. Don’t be too prescriptive: keep reminding participants that there are many ways of doing things. 8 Identify any continuing learning needs of individual participants as well as the group as a whole and discuss these with the QMP Coordinator as feedback from facilitators is essential in: „ Shaping the remainder of the course to the needs of the specific group of participants „ Identifying priorities for post-course follow-up and support. Activities The course is designed not only to enhance participants’ knowledge and understanding of quality principles and concepts, but also to assist them in developing the skills needed to establish a quality system in their own BTS. The course should therefore be as interactive as possible. QMT/Facilitator's Guide 11 DE CL AS SIF IED Most topics are covered by a presentation and one or more activities; the activities are an essential part of the training process because they complement and reinforce the topics covered and enable participants to practise applying what they have learned. In particular, they are designed to encourage participants to explore quality concepts from their own perspectives and give them some experience in planning and developing components of quality systems. The course contains 69 activities. Activity notes: facilitator For each activity, the following information is provided for facilitators. 1 Teaching aim. 2 Core topics. 3 Key points. 4 Teaching focus. 5 Learning outcomes. 6 Type of activity: the majority of activities are conducted in small groups followed by plenary discussion, but some involve role play or individual exercises. 7 Materials required: „ Most activities will require flipcharts (or overhead projector transparencies) and pens for participants to summarize their discussions and report back to the plenary group „ Where additional materials are required, they are provided on the CD-ROM „ You may wish to provide additional materials as examples or to relate the topics more specifically to regional or national issues. 8 Instructions for conducting the activity: ensure that you clearly understand the instructions for the activity and how it relates to the preceding presentation. See below for further guidance on facilitating an activity. 9 Review of the activity: guidance is provided on the main issues to be covered in discussion when the activity has been completed and the participants have reassembled in the plenary group. Ensure that the key points have been addressed and assess whether participants have achieved the learning outcomes. 10 Timespan. Activity notes: participants Instructions on completing each activity are provided for participants on the CD-ROM. These should be printed out and photocopied in advance and distributed to participants at the start of the activity. Activity materials Where applicable, activity sheets are provided on the CD-ROM, including case studies, instructions on role plays and activity work sheets. These should be printed out and photocopied in advance and distributed to participants at the start of the activity. QMT/Facilitator's Guide 12 DE CL AS SIF IED Facilitating an activity It is essential to familiarize yourself with the activities to ensure that you understand what they are designed to achieve and can explain the instructions to participants, some of whom may have little or no experience of group work. You may find it helpful to test out the activity in advance, perhaps with a group of your colleagues. There will normally be a range of different abilities, backgrounds and levels of responsibility among the participants and you will need to take this into account in facilitating the activities. Participants are often unfamiliar with activity-based learning and may need encouragement to participate fully. You will need to be flexible and creative in your approach to conducting activities and to be prepared to steer the discussion back to the core topics and key points if participants stray from them. Group work The majority of activities are conducted in small groups, although assessment and a small number of other activities are undertaken on an individual basis. Group work plays an important part in the course because it provides an opportunity for in-depth discussion and a free exchange of views, enabling participants to learn from each other as well as from the facilitators. It also promotes more active participation by individuals who are hesitant or shy about speaking in the larger plenary group. At the beginning of the course, the QMP Coordinator should already have divided the participants into small groups of 5-8 people, depending on the total number of participants, ensuring a good mix of personalities and experience in the groups. Ideally, there should be a separate room available for each small group but, if this is not possible, arrange the groups in the space available so that they can talk without being distracted by participants in other groups. At least one additional facilitator should be present to assist in facilitating each activity. Where possible, these facilitators should have attended the sessions to which the activities relate so that they are familiar with the issues addressed in the presentations and can reinforce them with examples and ideas from their own experience. When facilitating an activity, keep the following principles in mind. 1 Explain the aim and anticipated learning outcomes for the activity and distribute the instructions. Check that participants have understood them. Ensure that any materials for the activity are distributed to participants at the appropriate time. 2 Instruct each group to designate one person to act as moderator to focus the discussion and another as rapporteur to take notes and report on the discussion to the plenary group at the end of the activity. The roles of the moderator and rapporteur should be rotated throughout each group to prevent the discussions being dominated by more articulate or confident participants and to ensure that each person has the opportunity to report on activities. A flipchart or blank overhead projector transparencies and pens should be provided for each rapporteur to summarize the group’s discussion. 3 Once the group work has started, the facilitators should move between the groups to ensure that they have understood the purpose of the activity and what they are expected to do. Make sure that participants remain focused on the task and do not become diverted from the key issues. Check that all members of the group, particularly the quieter ones, are participating actively and, if necessary, specifically encourage individuals to express their ideas and opinions. 4 Answer any questions raised by participants, but avoid spending all your time with one group or dominating the discussion. Use the review session with the plenary group at QMT/Facilitator's Guide 13 DE CL AS SIF IED the end of the activity to highlight key issues, answer common questions, promote further discussion and summarize the session. 5 Encourage participants to be creative in their thinking and to share their experience in identifying problems, constraints and possible solutions. The groups must develop their own communication dynamics. 6 At the end of the work in small groups, bring all the participants together in the plenary group. Ask the rapporteurs to summarize their groups’ discussion and conclusions. Encourage further discussion of the activity and what participants have learned from it. Use the guidance notes to ensure that the key points have been addressed and check whether participants feel that they have achieved the learning outcomes. 7 Keep in mind that the time allocated for each activity includes time for discussion in the plenary group. Allow approximately five minutes for each rapporteur to make their reports and for questions and answers. Role play Two activities, QMT 8.13 and 8.15, are built around role play, in which participants simulate real-life situations by acting out a scenario, using instructions and player briefs that are provided on the CD-ROM. The role play is followed by plenary discussion. This technique is a lively way of demonstrating key issues and generating insights in a way that is not possible through lectures or discussion and is one of the most effective ways of bringing learning close to real life. Most participants are unlikely to have participated in role play before, so it is essential to give them clear instructions on what they have to do. Encourage them to use their imagination in acting out their roles, but reassure them that their enthusiasm and enjoyment are more important than their performing ability. Role play is intended to be fun, while at the same time illustrating serious points. Explain that the role play will help them in understanding key concepts and that they should use their skills of observation and analysis throughout the activity. The review of the activity is particularly important to highlight issues that have emerged from the scenario. QMT 8.15: Analysing Quality System Failures is a complex role play, called Smartosis Cocoanaemia, which is designed to illustrate the problems that can occur in the absence of an effective quality system. Most participants find it very enjoyable and enlightening, but its success depends on good preparation and skilful facilitation. The role play involves all participants and requires various materials to be prepared in advance and distributed to the correct participants. If you are involved in facilitating this activity and are not fully familiar with the scenario, talk to the QMP Coordinator about how it should be handled and the issues that should be raised in discussion afterwards. Quality Status Questionnaire In QMT 9.7: Quality Status Analysis, each participant is requested to complete a Quality Status Questionnaire (QSQ) for the centre in which he or she works. The QSQ is designed both as an assessment tool as a means of generating baseline information for use at the institutional level in assessing progress in implementing quality systems, evaluating the impact of QMT courses and identifying follow-up requirements. All QMT participants will complete the same questionnaire, regardless of the level of the health system in which they work. QMT/Facilitator's Guide 14 DE CL AS SIF IED The questionnaire will be distributed by the QMP Coordinator to participants before they attend the QMT course in order to give them an opportunity to collect the required information and begin filling in the questionnaire. QMT 9.7 is an individual activity in which participants finish filling in the questionnaire. By this stage of the course, they should be familiar with quality concepts and terminology and should be able to answer all the questions. If you are facilitating this session, check whether participants have any remaining difficulties in completing the questionnaire and provide any clarification or assistance they may require. Assess whether any participants have any difficulty in understanding specific quality concepts since this will indicate a need for further teaching. Each participant’s responses to the questionnaire will indicate their priorities for action when they return to their own countries. Ensure that these priority areas are addressed in the individual action plans that they will begin to prepare in Activity QMT 9.9 and will complete in Module 15. Course evaluation form The course concludes with an evaluation of the course by participants. Ensure that each participant completes the course evaluation form (QMT 15.7) as this will help to identify any modifications that may be needed when the next course is planned. Participant’s final report As you facilitate sessions during the course, you will have a variety of opportunities to observe participants and to talk to them about the course and how they will implement what they have learned from it. An important part of your role as a facilitator is to liaise with the QMP Coordinator and provide feedback at regular intervals on participants’ strengths and weaknesses and, in particular, any areas in which they will require further support, both during and after the course. A final report form for each participant should be completed by the QMP Coordinator and facilitators. Add your comments at the end of each module in which you have facilitated sessions and ensure that you have completed all the forms before your departure. Glossary The Glossary provides definitions of quality terminology used in QMT courses. Where possible, accepted definitions from ISO 9000 are included but, in some cases, the terms used within the course are not defined within the most recent ISO standard. In the absence of any other formal definitions, the most commonly accepted definitions have been used. Participants should find the glossary helpful in defining terms that have similar meanings or new terms with which they are not familiar. Keep in mind that the language of the course may not be the participants’ mother tongue and you may have to be flexible in defining some terms used during the course. When introducing new terms, explain them when they first appear in a presentation or activity and check that participants have understood them before proceeding. Participant’s Workfile At the beginning of the course, each participant will receive a Participant’s Workfile. This consists of a folder to which the following materials will be added: QMT/Facilitator's Guide 15 DE CL AS SIF IED „ Presentation handouts: printouts of the slides in each presentation with space for them to add their own notes „ Activity notes containing instructions on what participants are required to do during each activity „ Resource materials, such as examples of documentation, published material and materials required to complete activities „ Glossary. At the end of the course, participants will be given a copy of the CD-ROM containing the Facilitator’s Toolkit. QMT/Facilitator's Guide 16 DE CL AS SIF IED Core Course Materials DE CL AS SIF IED DE CL AS SIF IED QUALITY MANAGEMENT TRAINING COURSE CONTENTS INTRODUCTION Module 1 The WHO Quality Management Programme QMT 1.1 WHO strategy for blood safety Presentation QMT 1.2 WHO Quality Management Programme (QMP) for blood transfusion services Presentation QMT 1.3 Introduction to the WHO QMT Course Presentation QMT 1.4 Participants’ expectations Activity QMT 1.5 Pre-course assessment Activity PART 1 BASIC PRINCIPLES OF QUALITY Module 2 Introduction to Quality QMT 2.1 The importance of quality in the blood transfusion service Presentation QMT 2.2 The consequences of poor quality in the blood transfusion service Activity QMT 2.3 Introducing quality Presentation QMT 2.4 Quality characteristics Activity QMT 2.5 Tour of the Blood Transfusion Centre (BTC) Activity Module 3 Quality Systems QMT 3.1 Quality systems Presentation QMT 3.2 Processes and procedures Presentation QMT 3.3 Flowcharting as a tool for mapping processes Presentation QMT 3.4 Developing a process flowchart Activity Module 4 Organizational Management QMT 4.1 Management responsibility for quality Presentation QMT 4.2 Developing a quality policy Activity QMT 4.3 Organizational structure and role of the quality manager Presentation QMT 4.4 Developing an organigram Activity QMT 4.5 Job descriptions, responsibility and delegation Presentation QMT 4.6 Writing a job description Activity QMT 4.7 The cost of quality Presentation QMT/Core Course Materials 19 DE CL AS SIF IED Module 5 Standards for Quality Systems QMT 5.1 Introduction to standards for quality systems Presentation QMT 5.2 Principles of good manufacturing practice Presentation Module 6 Documentation QMT 6.1 Documentation in quality systems Presentation QMT 6.2 Standard operating procedures Presentation QMT 6.3 Writing an SOP Activity QMT 6.4 Validating an SOP Activity QMT 6.5 Document control Presentation QMT 6.6 Controlling a document Activity Module 7 Training QMT 7.1 Training in the quality system Presentation QMT 7.2 Training needs and plans Presentation QMT 7.3 Creating a training plan Activity QMT 7.4 Monitoring and evaluation of training Presentation Module 8 Assessment within the Quality System QMT 8.1 Assessment within quality systems Presentation QMT 8.2 Validation Presentation QMT 8.3 Preparing a validation plan Activity QMT 8.4 Maintenance and calibration of equipment Presentation QMT 8.5 Designing a maintenance and calibration plan Activity QMT 8.6 Quality monitoring tools Presentation QMT 8.7 Analysing data and monitoring performance Activity QMT 8.8 Error management Activity QMT 8.9 Preparing an SOP on error reporting Activity QMT 8.10 Audits and auditing Presentation QMT 8.11 The audit process Presentation QMT 8.12 Developing an audit plan Activity QMT 8.13 Identifying non-compliances against a set of standards Activity QMT 8.14 Audit of a work area Activity QMT 8.15 Analysing quality system failures Activity QMT 8.16 Mid-course assessment Activity PART 2 APPLYING QUALITY MANAGEMENT IN THE BTS Module 9 Quality Management in the BTS QMT 9.1 Applying quality management in the BTS Presentation QMT 9.2 Identifying critical control points and preparing flowcharts for BTS activities Activity QMT/Core Course Materials 20 DE CL AS SIF IED QMT 9.3 Steps in developing a quality system in the BTS Presentation QMT 9.4 Costing activities in a blood transfusion service Presentation QMT 9.5 Principles of stock control Presentation QMT 9.6 Quality aspects of contingency planning Presentation QMT 9.7 Quality status analysis Activity QMT 9.8 Preparing an action plan Presentation QMT 9.9 Preparing a draft action plan Activity Module 10 Hygiene and Safety in the BTS QMT 10.1 Introduction to hygiene and safety in the BTS Presentation QMT 10.2 Hygiene in the BTS Presentation QMT 10.3 Biological and chemical safety in the BTS Presentation QMT 10.4 Safety issues and minimizing risks Activity Module 11 Quality Systems in Blood Donor Management QMT 11.1 Introduction to quality systems in blood donor management Presentation QMT 11.2 Donor recruitment and selection Presentation QMT 11.3 Donor recruitment and selection Activity QMT 11.4 Blood collection Presentation QMT 11.5 Blood collection Activity QMT 11.6 Developing a documentation system for blood donor management Presentation QMT 11.7 Donor care, satisfaction and retention Presentation QMT 11.8 Donor satisfaction Activity QMT 11.9 Identifying and monitoring critical control points in blood donor management Activity Module 12 Quality Systems in Laboratory Testing QMT 12.1 Introduction to quality systems in laboratory testing Presentation QMT 12.2 Evaluation and use of immunohaematology reagents Presentation QMT 12.3 Evaluation and use of test kits for transfusion- transmissible infections Presentation QMT 12.4 Selecting reagents and test kits Activity QMT 12.5 Developing a documentation system for the laboratory Presentation QMT 12.6 External quality assessment (EQA) schemes Presentation QMT 12.7 Identifying and monitoring critical control points in laboratory testing Activity Module 13 Quality Systems in Component Production and Management QMT 13.1 Introduction to quality systems in blood component production and management Presentation QMT 13.2 Quality monitoring of blood component production Presentation QMT/Core Course Materials 21 DE CL AS SIF IED QMT 13.3 Evaluation and monitoring of blood component production activities Activity QMT 13.4 Quarantine and release Presentation QMT 13.5 Storage and transportation of blood components Presentation QMT 13.6 Storage and transportation of blood components Activity QMT 13.7 Blood stock management Presentation QMT 13.8 Developing a documentation system for blood component production Presentation QMT 13.9 Identifying and monitoring critical control points in blood component production Activity Module 14 Quality Systems and the Clinical Interface QMT 14.1 Introduction to quality systems at the clinical interface Presentation QMT 14.2 Policy and guidelines on the clinical use of blood Presentation QMT 14.3 Role of the BTS at the clinical interface Activity QMT 14.4 Documentation in the hospital transfusion process Presentation QMT 14.5 Designing a blood request form Activity QMT 14.6 Quality in the hospital transfusion process Presentation QMT 14.7 Quality in the hospital transfusion process Activity QMT 14.8 Monitoring and evaluation of the hospital transfusion process Presentation QMT 14.9 Haemovigilance Presentation QMT 14.10 Identifying and monitoring critical control points for the clinical interface and the administration of blood Activity Module 15 Finalization of Participants’ Action Plans and Completion of the Course QMT 15.1 Review of the course Activity QMT 15.2 Laboratory/clinic visits in BTS Activity QMT 15.3 Completing individual action plans Activity QMT 15.4 Discussion of individual action plans Activity QMT 15.5 Review of quality systems Presentation QMT 15.6 Post-course assessment Activity QMT 15.7 Course evaluation Activity QMT 15.8 Final discussions Activity QMT/Core Course Materials 22 DE CL AS SIF IED Q U A LI TY M A N A GE M EN T TR A IN IN G CU RR IC U LU M O pe ni ng C er em on y In tr od uc ti on M od ul e 1 Th e W H O Q ua lit y M an ag em en t Pr og ra m m e Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 1. 1 W H O s tra te gy fo r bl oo d sa fe ty Pr es en ta ti on To in tro du ce c ou rs e pa rti ci pa nt s to th e W H O st ra te gy fo r b lo od s af et y • W H O s tra te gy fo r g lo ba l bl oo d sa fe ty • Th e W H O s tra te gy fo r bl oo d sa fe ty d ef in es re qu ire m en ts fo r t he sa fe ty , a de qu ac y an d ac ce ss ib ilit y of n at io na l bl oo d su pp lie s • E ns ur e pa rti ci pa nt s un de rs ta nd th e W H O st ra te gy fo r b lo od s af et y Pa rti ci pa nt s sh ou ld b e ab le to : • D es cr ib e th e W H O st ra te gy fo r b lo od s af et y ¼ h ou r Q M T 1. 2 W H O Q ua lit y M an ag em en t P ro gr am m e (Q M P ) fo r B lo od Tr an sf us io n S er vi ce s Pr es en ta ti on To in tro du ce c ou rs e pa rti ci pa nt s to th e W H O Q ua lit y M an ag em en t P ro gr am m e (Q M P ) a nd Q ua lit y M an ag em en t Tr ai ni ng (Q M T) • Q ua lit y M an ag em en t P ro gr am m e • Q ua lit y M an ag em en t Tr ai ni ng • Th e W H O Q M P a im s to as si st M em be r S ta te s in im pr ov in g th e sa fe ty a nd ad eq ua cy o f n at io na l bl oo d su pp lie s • Q M T co ur se s ar e he ld in ea ch re gi on to s up po rt th e es ta bl is hm en t o f qu al ity s ys te m s in b lo od tra ns fu si on s er vi ce s in al l M em be r S ta te s • Q M T co ur se p ar tic ip an ts w ill pl ay a c en tra l r ol e in es ta bl is hi ng n at io na l qu al ity s ys te m s • E ns ur e pa rti ci pa nt s un de rs ta nd th e go al s of th e Q M P • Em ph as iz e th e pr in ci pl es o f a ct iv e le ar ni ng in Q M T co ur se s • Ex pl ai n th e pu rp os e of th e Q M P a nd Q M T ½ h ou r Q M T/ Co re C ou rs e M at er ia ls 23 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 1. 3 In tro du ct io n to th e W H O Q M T co ur se Pr es en ta ti on To in tro du ce th e W H O Q M T co ur se • M od ul ar a pp ro ac h • R ol e of th e fa ci lit at or s • R ol e of th e pa rti ci pa nt s • Th e ov er al l s tru ct ur e of th e co ur se is m od ul ar • Th e co ur se w ill he lp pa rti ci pa nt s to im pl em en t q ua lit y sy st em s in th ei r B TS /b lo od c en tre • Th e ro le o f t he fa ci lit at or s is to e ns ur e th at th er e is a ct iv e le ar ni ng • E ns ur e pa rti ci pa nt s un de rs ta nd th e co ur se ob je ct iv es a nd s tru ct ur e • E ns ur e pa rti ci pa nt s re co gn iz e th e ac tiv e ro le th ey a re e xp ec te d to ta ke in th e le ar ni ng pr oc es s • E nc ou ra ge p ar tic ip an ts to a sk q ue st io ns a bo ut th e co ur se • O ut lin e th e st ru ct ur e an d co nt en t o f t he c ou rs e • Id en tif y th ei r r ol e an d re sp on si bi lit ie s in th e Q M T co ur se ½ h ou r Q M T 1. 4 P ar tic ip an ts ’ ex pe ct at io ns A ct iv it y To fi nd o ut w ha t c ou rs e pa rti ci pa nt s ex pe ct to g ai n fro m th e Q M T co ur se • D is cu ss io n of th e ob je ct iv es a nd s tru ct ur e of th e Q M T co ur se • Id en tif ic at io n of pa rti ci pa nt s’ s pe ci fic in te re st s an d le ar ni ng ne ed s in re la tio n to qu al ity m an ag em en t • Q M T is n ot d es ig ne d to pr ov id e te ch ni ca l t ra in in g • Fo llo w -u p an d su pp or t w ill be p ro vi de d af te r t he co ur se • If id en tif ie d as a n ee d, te ch ni ca l t ra in in g w ill be pr ov id ed a fte r t he co ur se • H el p to k ee p pa rti ci pa nt s’ ex pe ct at io ns re al is tic an d fo cu se d on q ua lit y ra th er th an o n te ch ni ca l is su es • Ex pl ai n ho w th e Q M T co ur se w ill as si st th em in ap pl yi ng th e pr in ci pl es o f qu al ity in th ei r o w n B TS 2 ho ur s Q M T 1. 5 P re -c ou rs e as se ss m en t A ct iv it y To d et er m in e pa rti ci pa nt s’ cu rre nt le ve ls o f k no w le dg e an d un de rs ta nd in g ab ou t qu al ity • A ss es sm en t o f pa rti ci pa nt s’ k no w le dg e an d un de rs ta nd in g of qu al ity • D et er m in at io n of th e ra ng e of k no w le dg e w ith in th e gr ou p in o rd er to p la n an a pp ro pr ia te le ve l o f t ra in in g • Th e pr e- co ur se as se ss m en t a im s to ge ne ra te b as el in e in fo rm at io n ab ou t pa rti ci pa nt s • It w ill he lp fa ci lit at or s to fo cu s th e co ur se o n ar ea s of p ar tic ul ar w ea kn es s or n ee d • E m ph as iz e th at th e pr e- co ur se a ss es sm en t i s no t a n ex am in at io n • A ss es s th ei r o w n le ve l o f kn ow le dg e an d un de rs ta nd in g of q ua lit y is su es ¾ h ou r Q M T/ Co re C ou rs e M at er ia ls 24 DE CL AS SIF IED P ar t 1 BA SI C PR IN CI PL ES O F Q U A LI TY M od ul e 2 In tr od uc ti on t o Q ua lit y Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 2. 1 Th e im po rta nc e of qu al ity in th e bl oo d tra ns fu si on s er vi ce Pr es en ta ti on To in tro du ce th e ov er al l co nc ep t o f q ua lit y in th e bl oo d tra ns fu si on s er vi ce • Th e ne ed fo r q ua lit y in th e B TS • Fa ct or s af fe ct in g qu al ity • R es ul ts o f q ua lit y • Q ua lit y is e ss en tia l t o en su re th at b lo od tra ns fu si on is s af e an d ef fic ac io us • Q ua lit y ap pl ie s to a ll B TS a ct iv iti es • Q ua lit y in vo lv es a ll st af f • Q ua lit y be ne fit s al l • Q ua lit y im pr ov em en t i s ac hi ev ab le , e ve n w he n re so ur ce s ar e lim ite d • E nc ou ra ge p ar tic ip an ts to id en tif y ad di tio na l po si tiv e ou tc om es o f qu al ity • E m ph as iz e th at q ua lit y is ev er yb od y’ s re sp on si bi lit y • Ex pl ai n th e im po rta nc e of q ua lit y in b lo od tra ns fu si on • Id en tif y th e po si tiv e ou tc om es o f q ua lit y in th e B TS ½ h ou r Q M T 2. 2 Th e co ns eq ue nc es of p oo r q ua lit y in th e bl oo d tra ns fu si on s er vi ce A ct iv it y To c on tra st th e co ns eq ue nc es o f p oo r qu al ity w ith th e be ne fit s of go od q ua lit y • Th e co ns eq ue nc es o f po or q ua lit y fo r b lo od do no rs , r ec ip ie nt s, s ta ff an d th e BT S P oo r q ua lit y: • En da ng er s pa tie nt s’ liv es • U nd er m in es th e cr ed ib ilit y of th e B TS • C re at es a n eg at iv e at tit ud e to w ar ds b lo od do na tio n an d tra ns fu si on • C on tri bu te s to p oo r s ta ff m or al e an d jo b in se cu rit y • E nc ou ra ge p ar tic ip an ts to d is cu ss s om e ex am pl es o f p oo r q ua lit y in re la tio n to b lo od tra ns fu si on a nd th e re as on s w hy th ey m ay oc cu r • D o no t f or ce re lu ct an t pa rti ci pa nt s to re ve al de fic ie nc ie s in th ei r o w n B TS a t t hi s ea rly s ta ge of th e co ur se • Ac kn ow le dg e th e pr ob le m s an d co ns tra in ts p os ed b y lim ite d st af f a nd re so ur ce s • E m ph as iz e th at th e Q M T co ur se w ill fo cu s in a pr ac tic al w ay o n ho w ev er y B TS c an w or k to w ar ds q ua lit y • Id en tif y so m e of th e re as on s fo r p oo r q ua lit y in th e tra ns fu si on pr oc es s • Id en tif y th e co ns eq ue nc es o f p oo r qu al ity ¾ h ou r Q M T/ Co re C ou rs e M at er ia ls 25 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 2. 3 In tro du ci ng q ua lit y Pr es en ta ti on To in tro du ce th e co nc ep t o f qu al ity • W ha t i s qu al ity ? • B en ef its o f q ua lit y • Q ua lit y as a p ro ce ss o f co nt in uo us im pr ov em en t • Ba si c qu al ity p rin ci pl es • Ba si c qu al ity d ef in iti on • Fi tn es s fo r p ur po se • Q ua lit y ch ar ac te ris tic s • Q ua lit y is a c on tin ua l pr oc es s of s tri vi ng fo r im pr ov em en t t o en su re co ns is te nt ly h ig h qu al ity • Q ua lit y pr od uc ts a nd se rv ic es a re fi t f or th ei r pu rp os e • E ns ur e al l p ar tic ip an ts ha ve a c le ar un de rs ta nd in g of b as ic pr in ci pl es o f q ua lit y • D em on st ra te a n un de rs ta nd in g of th e br oa d co nc ep ts o f qu al ity • R ec og ni ze th e im po rta nc e of q ua lit y in ev er yd ay li fe a nd in th e B TS ¾ h ou r Q M T 2. 4 Q ua lit y ch ar ac te ris tic s A ct iv it y • To d em on st ra te h ow th e te rm ‘f itn es s fo r p ur po se ’ is a b ro ad d ef in iti on o f qu al ity • To d em on st ra te h ow qu al ity a pp lie s to co m m on , e ve ry da y si tu at io ns • To in tro du ce th e co nc ep t of q ua lit y ch ar ac te ris tic s • Q ua lit y is "f itn es s fo r pu rp os e" • Q ua lit y ex te nd s be yo nd si m pl y pr od uc in g a pr od uc t • Q ua lit y re la te s to pr od uc ts , p ro du ct io n, pa ck ag in g an d se rv ic e • C us to m er s w an t a h ig h qu al ity p ro du ct /s er vi ce • Ev er yt hi ng a bo ut a pr od uc t d ef in es it s qu al ity • E ns ur e th at th e ai m o f th e ac tiv ity is c le ar • En su re a n un de rs ta nd in g of de fin in g an d m ee tin g cu st om er n ee ds • Id en tif y th e qu al ity ch ar ac te ris tic s of a pr od uc t • D em on st ra te a n un de rs ta nd in g of fi tn es s fo r p ur po se a nd cu st om er n ee ds 1 ho ur Q M T 2. 5 To ur o f t he B lo od Tr an sf us io n C en tre (B TC ) A ct iv it y To fa m ilia riz e pa rti ci pa nt s w ith th e la yo ut a nd ac tiv iti es o f t he B TC • Fa m ilia riz at io n w ith th e bu ild in g • O pp or tu ni ty to o bs er ve a w or ki ng b lo od tra ns fu si on c en tre (B TC ) • In tro du ct io n to a w or ki ng qu al ity s ys te m • Q ua lit y is v is ib le • Q ua lit y is a c on tin ui ng pr oc es s • Q ua lit y in vo lv es a ll st af f • P oi nt o ut a re as o f pa rti cu la r i nt er es t i n re la tio n to q ua lit y • D o no t g et d ra w n in to sp ec ifi cs a bo ut th e w ay in w hi ch th e B TS w or ks • Id en tif y el em en ts o f a qu al ity s ys te m th at le ad to c on si st en cy a nd fit ne ss fo r p ur po se 1½ h ou rs Q M T/ Co re C ou rs e M at er ia ls 26 DE CL AS SIF IED M od ul e 3 Q ua lit y Sy st em s Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 3. 1 Q ua lit y S ys te m s Pr es en ta ti on To in tro du ce th e co nc ep t o f qu al ity s ys te m s • Q ua lit y an d qu al ity sy st em s • K ey e le m en ts o f a qu al ity s ys te m : ─ O rg an iz at io na l m an ag em en t ─ S ta nd ar ds fo r q ua lit y sy st em s ─ D oc um en ta tio n ─ T ra in in g ─ A ss es sm en t • Q ua lit y sy st em s ar e de si gn ed to c on tro l pr oc es se s • Th er e ar e fiv e ke y el em en ts in a q ua lit y sy st em : ─ O rg an iz at io na l m an ag em en t ─ S ta nd ar ds fo r q ua lit y sy st em s ─ D oc um en ta tio n ─ T ra in in g ─ A ss es sm en t • U se e xa m pl es o f s im pl e, ge ne ric q ua lit y sy st em s to e ns ur e un de rs ta nd in g • W he re a pp ro pr ia te , en co ur ag e pa rti ci pa nt s to d is cu ss th ei r o w n qu al ity s ys te m s • Li st th e ke y el em en ts o f a qu al ity s ys te m • D em on st ra te a n un de rs ta nd in g of th e in te rre la tio ns hi p be tw ee n th es e ke y el em en ts ½ h ou r Q M T 3. 2 P ro ce ss es a nd pr oc ed ur es Pr es en ta ti on To in tro du ce th e co nc ep t o f pr oc es se s, p ro ce du re s an d th ei r c on tro l • P ro ce ss es • P ro ce du re s • C rit ic al c on tro l p oi nt s • In di ca to rs • A n or ga ni za tio n’ s op er at io ns c on si st o f pr oc es se s an d pr oc ed ur es • C rit ic al c on tro l p oi nt s ne ed to b e id en tif ie d in ea ch p ro ce du re • In di ca to rs fo r m ea su rin g co nt ro l o f t he p ro ce du re m us t b e id en tif ie d an d an al ys ed • C he ck fo r u nd er st an di ng of th e co nc ep ts o f pr oc es se s an d pr oc ed ur es • E m ph as iz e th at th er e ar e cr iti ca l c on tro l p oi nt s in e ve ry p ro ce ss • D ef in e pr oc es se s an d pr oc ed ur es • D ef in e cr iti ca l c on tro l po in ts a nd in di ca to rs • Li st th e ch ar ac te ris tic s of in di ca to rs ½ h ou r Q M T/ Co re C ou rs e M at er ia ls 27 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 3. 3 Fl ow ch ar tin g as a to ol fo r m ap pi ng pr oc es se s Pr es en ta ti on • To in tro du ce th e us e of flo w ch ar ts fo r a na ly si ng pr oc es se s • To il lu st ra te th e us e of flo w ch ar ts fo r i de nt ify in g cr iti ca l c on tro l p oi nt s • M ai n el em en ts o f t he an al ys is o f p ro ce ss es an d pr oc ed ur es • P re pa rin g flo w ch ar ts • P ro ce ss es a nd pr oc ed ur es m us t b e an al ys ed in o rd er to id en tif y cr iti ca l c on tro l po in ts • S ev er al im po rta nt qu es tio ns s ho ul d be as ke d w he n an al yz in g a pr oc es s: ─ I s th e ta sk c rit ic al to th e ou tc om e? ─ C an th e ta sk – o r t he ou tc om e of th e ta sk – be m ea su re d? • Fl ow ch ar tin g pr ov id es a si m pl e pi ct ur e (m ap ) o f th e ov er al l p ro ce ss • U se s im pl e ex am pl es o f pr oc es se s • U se c on ve nt io na l flo w ch ar tin g sy m bo ls an d te rm in ol og y • Li st fa ct or s th at n ee d to be c on si de re d in pr oc es s an al ys is • D es ig n a flo w ch ar t o f a pr oc es s 1 ho ur Q M T 3. 4 D ev el op in g a pr oc es s flo w ch ar t A ct iv it y To d em on st ra te to pa rti ci pa nt s th at th e co nc ep t o f p ro ce ss fl ow ca n be a pp lie d to a ny g iv en si tu at io n • B re ak do w n of a s pe ci fic pr oc es s • A na ly si s of th e pr oc es s us in g a flo w ch ar t • Pr oc es se s ar e m ad e up of in di vi du al p ro ce du re s • Fl ow ch ar ts h el p to c la rif y th e in di vi du al e le m en ts of p ro ce ss es a nd pr oc ed ur es , i nc lu di ng cr iti ca l c on tro l p oi nt s • Fo cu s on th e ba si c pr oc es se s, fr om ra w m at er ia ls to fi na l p ro du ct an d di st rib ut io n • Em ph as iz e th e ne ed fo r si m pl ic ity • Pr ov id e a sp ec im en flo w ch ar t f or th e pr oc es s • Id en tif y th e in di vi du al el em en ts in a s pe ci fic pr oc es s • D ev el op a s im pl e pr oc es s flo w c ha rt 1½ h ou rs Q M T/ Co re C ou rs e M at er ia ls 28 DE CL AS SIF IED M od ul e 4 O rg an iz at io na l M an ag em en t Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 4. 1 M an ag em en t re sp on si bi lit y fo r qu al ity Pr es en ta ti on To in tro du ce m an ag em en t’s re sp on si bi lit ie s fo r t he qu al ity s ys te m • Q ua lit y m an ag em en t te rm in ol og y • O rg an iz at io na l re sp on si bi lit y fo r q ua lit y • Q ua lit y po lic y as a p ar t of th e or ga ni za tio n’ s st ra te gi c pl an • Pl an ni ng a nd im pl em en tin g a qu al ity sy st em • M an ag in g a qu al ity sy st em • C om m itm en t b y m an ag em en t t o qu al ity is e ss en tia l • R es po ns ib ilit y fo r q ua lit y sh ou ld b e ou tli ne d in th e qu al ity p ol ic y an d pl an • Q ua lit y m us t f irs t b e pl an ne d by m an ag em en t • Th e in vo lv em en t a nd co m m itm en t o f a ll st af f i s es se nt ia l t o de ve lo p a "c ul tu re o f q ua lit y" • Em ph as iz e th e im po rta nc e of to p- le ve l su pp or t a nd a ct io n • E m ph as iz e th e ro le o f a ll st af f i n en su rin g qu al ity • D ef in e m an ag em en t’s re sp on si bi lit ie s fo r qu al ity • D ef in e co m m on ly u se d qu al ity m an ag em en t te rm in ol og y • Li st th e ke y el em en ts o f a qu al ity p ol ic y ½ h ou r Q M T 4. 2 D ev el op in g a qu al ity p ol ic y A ct iv it y To c on so lid at e pa rti ci pa nt s’ le ar ni ng a bo ut q ua lit y po lic ie s • Fu ll an d ac tiv e su pp or t fro m s en io r m an ag em en t • Fo rm al a pp ro va l a nd ac ce pt an ce o f t he p ol ic y • Ke y qu al ity p rin ci pl es up on w hi ch th e po lic y is ba se d • Id en tif yi ng a pp ro pr ia te st an da rd s • Th e qu al ity p ol ic y m us t re fle ct th e ne ed s of th e or ga ni za tio n’ s cu st om er s as w el l a s its ow n st ru ct ur e an d ca pa bi lit ie s • W ha te ve r s ta nd ar ds a re ad op te d, th ey m us t b e ap pr op ria te to th e or ga ni za tio n • Th e su pp or t o f s en io r m an ag em en t i s ce nt ra l to s uc ce ss fu l im pl em en ta tio n of th e qu al ity p ol ic y • E ns ur e th at th e po lic ie s re fle ct th e or ga ni za tio n an d its c us to m er s • Fo cu s on s im pl ic ity a nd th e us e of s im pl e w or di ng • E ns ur e th er e is a s ec tio n fo r t op m an ag em en t t o si gn th e po lic y • W rit e a qu al ity p ol ic y fo r a ge ne ric o rg an iz at io n • Ap pl y th e ge ne ra l pr in ci pl es a nd u lti m at el y w rit e a qu al ity p ol ic y fo r th ei r o w n B TS 1½ h ou rs Q M T/ Co re C ou rs e M at er ia ls 29 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 4. 3 O rg an iz at io na l st ru ct ur e an d ro le of th e qu al ity m an ag er Pr es en ta ti on To h ig hl ig ht th e im po rta nc e of a re po rti ng s tru ct ur e in an o rg an iz at io n an d th e ro le o f t he q ua lit y m an ag er • Au th or ity a nd re sp on si bi lit y fo r t he or ga ni za tio n’ s ac tiv iti es • Im po rta nc e of a c le ar de fin iti on o f a ll ac tiv iti es an d re sp on si bi lit ie s in a n or ga ni za tio n • R ol e an d re sp on si bi lit ie s of th e qu al ity m an ag er • Ev er y or ga ni za tio n ne ed s a fo rm al s tru ct ur e • A cl ea r o rg an iz at io na l st ru ct ur e is e ss en tia l f or sm oo th fu nc tio ni ng • Au th or ity a nd re sp on si bi lit y w ith in th e or ga ni za tio n m us t b e de fin ed • S tru ct ur es s ho ul d be de ve lo pe d th at m ai nt ai n an d st re ng th en th e or ga ni za tio n as a w ho le • Th e qu al ity m an ag er is re sp on si bl e fo r t he im pl em en ta tio n an d m ai nt en an ce o f t he qu al ity s ys te m • Th e qu al ity m an ag er m us t b e in de pe nd en t o f op er at io na l a ct iv iti es • Th e qu al ity m an ag er re po rts to th e he ad o f th e or ga ni za tio n or in st itu tio n • E m ph as iz e th at or ga ni za tio na l s tru ct ur es ne ed n ot b e co m pl ex to be e ffe ct iv e • E ns ur e pa rti ci pa nt s un de rs ta nd th e de fin iti on s of a ut ho rit y an d re sp on si bi lit y an d ho w th e tw o ar e re la te d in a n or ga ni za tio n • Ex pl ai n w hy a c le ar or ga ni za tio na l s tru ct ur e is a n im po rta nt p ar t o f a qu al ity s ys te m • Pr ep ar e a ba si c or ga ni za tio na l c ha rt (o rg an ig ra m ) • Li st th e re sp on si bi lit ie s of th e qu al ity m an ag er ½ h ou r Q M T 4. 4 D ev el op in g an or ga ni gr am A ct iv it y To p ro vi de p ra ct ic e in pr ep ar in g a si m pl e or ga ni za tio na l c ha rt (o rg an ig ra m ) • P re pa ra tio n of or ga ni za tio na l c ha rts • C on so lid at io n of th e us e of o rg an ig ra m • O rg an ig ra m s si m pl ify th e pr es en ta tio n of or ga ni za tio na l s tru ct ur es • E ns ur e th e pa rti ci pa nt s ke ep to a s im pl e or ga ni za tio na l s tru ct ur e fo r g en er ic o rg an iz at io n • D ra w a n or ga ni za tio na l ch ar t • D em on st ra te th ei r kn ow le dg e of li ne s of re sp on si bi lit y an d re po rti ng s tru ct ur es 1 ho ur Q M T/ Co re C ou rs e M at er ia ls 30 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 4. 5 Jo b de sc rip tio ns , re sp on si bi lit y an d de le ga tio n Pr es en ta ti on To h ig hl ig ht th e im po rta nc e of jo b de sc rip tio ns th at ou tli ne a ut ho rit y, re sp on si bi lit y an d de le ga tio n • Jo b de sc rip tio ns • P er so n sp ec ifi ca tio ns • C om pe te nc e • A ut ho rit y/ re sp on si bi lit y • E ffe ct iv e pe rs on ne l m an ag em en t • D el eg at io n • A ll or ga ni za tio ns m us t en su re th at th ey e m pl oy th e rig ht p er so n fo r t he rig ht jo b • S ta ff sh ou ld b e w el l- tra in ed a nd c om pe te nt • Jo b de sc rip tio ns a nd pe rs on s pe ci fic at io ns s et ou t p re ci se ly w ha t a jo b in vo lv es a nd th e ki nd o f pe rs on n ee de d • R es po ns ib ilit y m us t co m e w ith a ut ho rit y • D el eg at io n en ab le s m an ag er s to m ak e th e be st u se o f t he ir tim e an d de ve lo p ju ni or s ta ff • D el eg at io n is th e si gn o f a go od m an ag er a nd a go od q ua lit y sy st em • Em ph as iz e th e im po rta nc e of c le ar a nd sp ec ifi c jo b de sc rip tio ns an d pe rs on sp ec ifi ca tio ns • R ei nf or ce th e im po rta nc e of th e de le ga tio n of a ut ho rit y • Li st th e ke y el em en ts o f jo b de sc rip tio ns a nd pe rs on s pe ci fic at io ns • Id en tif y th e im po rta nc e of a ut ho rit y an d re sp on si bi lit y • Ex pl ai n th e im po rta nc e of d el eg at io n 1 ho ur Q M T 4. 6 W rit in g a jo b de sc rip tio n A ct iv it y To p ro vi de p ra ct ic e in pr ep ar in g a jo b de sc rip tio n to a g iv en fo rm at • Th e jo b de sc rip tio n as a st ru ct ur ed d oc um en t • K ey e le m en ts o f a jo b de sc rip tio n • Ap pr op ria te re sp on si bi lit ie s an d du tie s fo r a jo b • Al l j ob d es cr ip tio ns in a n or ga ni za tio n sh ou ld ha ve th e sa m e fo rm at an d sh ou ld in cl ud e th e ke y el em en ts o f t he jo b • E ns ur e ke y el em en ts a re in cl ud ed in th e jo b de sc rip tio ns • Em ph as iz e th e qu al ity m an ag er ’s ro le in en su rin g a st an da rd iz ed ap pr oa ch to th e de ve lo pm en t o f j ob de sc rip tio ns • Pr ep ar e a si m pl e jo b de sc rip tio n an d pe rs on sp ec ifi ca tio n • In cl ud e th e ap pr op ria te du tie s an d re sp on si bi lit ie s in th e jo b de sc rip tio n 1½ h ou rs Q M T 4. 7 Th e co st o f q ua lit y Pr es en ta ti on To d em on st ra te th at a qu al ity -b as ed a pp ro ac h sa ve s m on ey • D ef in iti on o f t he c os t o f qu al ity • C os t o f q ua lit y • E le m en ts o f q ua lit y co st s • P oo r q ua lit y co st s m or e • P oo r q ua lit y le ad s to fa ilu re s an d re je ct ed pr od uc ts • P oo r q ua lit y in cr ea se s op er at io na l c os ts • G iv e a ra ng e of ex am pl es w he re th e ac tu al c os t i s hi gh er th an e xp ec te d du e to po or q ua lit y • An al ys e pr oc es se s an d pr oc ed ur es to id en tif y w he re p oo r q ua lit y in cr ea se s co st s ½ h ou r Q M T/ Co re C ou rs e M at er ia ls 31 DE CL AS SIF IED M od ul e 5 St an da rd s fo r Q ua lit y Sy st em s Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 5. 1 In tro du ct io n to st an da rd s fo r qu al ity s ys te m s Pr es en ta ti on To in tro du ce v ar io us q ua lit y st an da rd s th at m ay b e us ed b y bl oo d tra ns fu si on se rv ic es • Q ua lit y st an da rd s • N at io na l a nd in te rn at io na l s ta nd ar ds • R eg ul at or y st an da rd s • Q ua lit y st an da rd s an d au di ts • Q ua lit y st an da rd s ar e ke y el em en ts o f t he qu al ity s ys te m • Q ua lit y st an da rd s he lp en su re a s ys te m at ic a nd co ns is te nt a pp ro ac h to th e de ve lo pm en t o f qu al ity s ys te m s • Q ua lit y st an da rd s m us t be re le va nt to th e B TS • Ex pl ai n th e us ef ul ne ss of q ua lit y st an da rd s to th e B TS • Em ph as iz e th e im po rta nc e of id en tif yi ng ap pr op ria te s ta nd ar ds fo r t he p ar tic ul ar B TS • Ex pl ai n th e ro le o f qu al ity s ta nd ar ds • D es cr ib e th e be ne fit s to th e B TS o f u si ng q ua lit y st an da rd s • Ex pl ai n th e ro le o f t he qu al ity m an ag er in en su rin g th at re le va nt qu al ity s ta nd ar ds a re id en tif ie d an d im pl em en te d ½ h ou r Q M T 5. 2 P rin ci pl es o f g oo d m an uf ac tu rin g pr ac tic e Pr es en ta ti on To in tro du ce th e pr in ci pl es of G oo d M an uf ac tu rin g P ra ct ic e (G M P ) w ith in th e qu al ity s ys te m • Th e B TS a s a m an uf ac tu re r • G M P a s a pa rt of th e qu al ity s ys te m • K ey e le m en ts o f G M P • B TS s ar e m an uf ac tu re rs of th er ap eu tic p ro du ct s • Im pl em en tin g G M P is es se nt ia l t o as su re g oo d qu al ity p ro du ct s • Fo cu s on th e B TS a s a m an uf ac tu re r • En su re a n un de rs ta nd in g of th e co nc ep t o f m an uf ac tu re ap pl ie d to b lo od /b lo od pr od uc ts • D es cr ib e th e ro le o f G M P w ith in th e qu al ity sy st em • Li st th e el em en ts o f G M P 1 ho ur Q M T/ Co re C ou rs e M at er ia ls 32 DE CL AS SIF IED M od ul e 6 D oc um en ta ti on Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 6. 1 D oc um en ta tio n in qu al ity s ys te m s Pr es en ta ti on To e xp la in th e ke y ro le o f do cu m en ta tio n in q ua lit y sy st em s • D ef in iti on s re la tin g to do cu m en ta tio n • B as ic ty pe s of do cu m en ts • R el at io ns hi p be tw ee n do cu m en ts • D an ge rs o f t oo m uc h do cu m en ta tio n • D oc um en ta tio n is k ey to a qu al ity s ys te m • D oc um en ta tio n he lp s to en su re c on si st en cy o f pr oc es se s an d pr oc ed ur es • D oc um en ta tio n gi ve s tra ce ab ilit y • G oo d do cu m en ta tio n in di ca te s a go od q ua lit y sy st em • Tr ai ni ng is e as ie r i f th er e is g oo d do cu m en ta tio n to tr ai n to • Ill us tra te th e im po rta nc e of d oc um en ta tio n by us in g ex am pl es fr om yo ur o w n ex pe rie nc e • U se s ce na rio s w he re a la ck o f d oc um en ta tio n m ay h av e/ ha s ca us ed pr ob le m s • E ns ur e th at p ar tic ip an ts un de rs ta nd th e va lu e of do cu m en ta tio n • Ex pl ai n th e ro le a nd ne ed fo r d oc um en ta tio n in a q ua lit y sy st em • Li st d iff er en t t yp es o f do cu m en ts u se d in a qu al ity s ys te m ½ h ou r Q M T 6. 2 St an da rd op er at in g pr oc ed ur es Pr es en ta ti on To d es cr ib e ho w to p la n an d w rit e an e ffe ct iv e S O P • Pl an ni ng a nd w rit in g S O P s • V al id at io n of S O P s • U se o f S O P s • S O P s ar e an e ss en tia l pa rt of th e qu al ity sy st em • S O P s sh ou ld b e w rit te n fo r a ll th e ke y pr oc ed ur es in a n or ga ni za tio n • S O P s m us t b e cl ea r, co nc is e an d ea sy to fo llo w • SO Ps s ho ul d be u se d fo r s ta ff tra in in g • S O P s sh ou ld b e va lid at ed • SO Ps s ho ul d be li vi ng do cu m en ts • S ta ff m us t h av e ea sy ac ce ss to th e S O P s • S O P s m us t b e fo llo w ed • Fo cu s on th e va lu e an d us e of S O P s ge ne ric al ly • D o no t b e to o pr es cr ip tiv e ab ou t la yo ut a nd d es ig n of S O P s • Id en tif y ke y ch ar ac te ris tic s of a n ef fe ct iv e S O P • D es cr ib e ho w to p la n S O P s • P re pa re S O P s • Ex pl ai n th e us e of S O P s 1 ho ur Q M T/ Co re C ou rs e M at er ia ls 33 EC LA SS IFI ED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 6. 3 W rit in g an S O P A ct iv it y To p ro vi de p ra ct ic e in pr ep ar in g an S O P fo r a si m pl e, fa m ilia r a ct iv ity • Id en tif yi ng th e co m po ne nt s of th e ac tiv ity • Pr ep ar at io n of a u sa bl e S O P • S O P s de fin e th e w ay in w hi ch a p ro ce du re is to be c ar rie d ou t • S O P s m us t b e w rit te n to be u se d • E ns ur e th e S O P s fo llo w th e pr in ci pl es ta ug ht • K ee p th e S O P s fo cu se d on s im pl y m ak in g th e co ffe e • E ns ur e th at S O P s re fle ct th e ac tu al p ro ce du re • W rit e an S O P o f a si m pl e fa m ilia r a ct iv ity • Li st th e ke y co m po ne nt s of a n S O P 1½ h ou rs Q M T 6. 4 Va lid at in g an S O P A ct iv it y To d em on st ra te h ow S O P s ar e va lid at ed • C re at in g a va lid at io n pr ot oc ol fo r a n S O P • Id en tif yi ng a nd un de rs ta nd in g an y pr ob le m s w ith th e va lid at io n of S O P s • C or re ct in g an y pr ob le m s id en tif ie d • N o SO P sh ou ld b e in tro du ce d w ith ou t f irs t be in g va lid at ed • Th e pr oc ed ur e m us t re su lt in a n ac ce pt ab le ou tc om e • E ns ur e th at th e S O P s ar e fo llo w ed a s w rit te n • E ns ur e th at a ll as pe ct s of th e S O P s ar e re vi ew ed • Va lid at e an S O P • Id en tif y m is si ng s te ps in an S O P th ro ug h th e va lid at io n pr oc es s 1 ho ur Q M T 6. 5 D oc um en t c on tro l Pr es en ta ti on To in tro du ce th e m ec ha ni sm s an d re as on s fo r c on tro l o f do cu m en ts • Th e im po rta nc e of do cu m en t c on tro l • M ec ha ni sm s of do cu m en t c on tro l • D is tri bu tio n of do cu m en ts • D oc um en t r ev is io ns • A ll do cu m en ts re la te d to qu al ity s ho ul d be co nt ro lle d • C on tro l m ec ha ni sm s co ve r: • D is tri bu tio n • R ev ie w • C ha ng e • Em ph as iz e th e ki nd o f pr ob le m s lik el y w ith ou t a do cu m en t c on tro l s ys te m • S tre ss th e ne ed fo r si m pl ic ity in d oc um en t co nt ro l s ys te m s • M ak e cl ea r t he di st in ct io n be tw ee n re vi si on a nd a n ew do cu m en t • Id en tif y th e ke y as pe ct s of d oc um en t c on tro l • S ta te w hi ch d oc um en ts m us t b e co nt ro lle d an d ho w ½ h ou r Q M T 6. 6 C on tro llin g a do cu m en t A ct iv it y To il lu st ra te th e pr oc es s of d oc um en t c on tro l • Id en tif yi ng a s im pl e re vi si on re qu ire d to a n S O P • In co rp or at in g th e re vi si on in to a n ew ve rs io n of th e S O P • C or re ct a nn ot at io n of th e re vi se d S O P • En su rin g do cu m en t co nt ro l p ro ce du re s ha ve be en fo llo w ed • R ev is io n of d oc um en ts is an o ng oi ng a ct iv ity • D oc um en t c on tro l sy st em s en su re th at th e co rre ct d oc um en t i s in us e • R ev is io ns m us t b e va lid at ed b ef or e th e re le as e of th e do cu m en t • E ns ur e th at th e re vi si on is c or re ct ly id en tif ie d • E ns ur e th at th e ke y ch an ge s ne ed ed h av e be en id en tif ie d • E ns ur e th e co nt ro l sy st em is s im pl e an d ea sy to fo llo w • R ev ie w th e di ffe re nc e be tw ee n th e re vi si on o f a do cu m en t a nd n ee d fo r a ne w d oc um en t • Id en tif y th e er ro rs th at re su lt fro m la ck o f do cu m en t c on tro l. • Id en tif y ho w to ta ke co rre ct iv e ac tio n 1½ h ou rs Q M T/ Co re C ou rs e M at er ia ls 34 DE CL AS SIF IED M od ul e 7 Tr ai ni ng Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 7. 1 Tr ai ni ng in th e qu al ity s ys te m Pr es en ta ti on To h ig hl ig ht th e im po rta nc e of tr ai ni ng in th e qu al ity sy st em • Im po rta nc e of tr ai ni ng • O rg an iz at io n’ s re sp on si bi lit y fo r t ra in in g • Ty pe s of tr ai ni ng • S ta ff ar e a m aj or va ria bl e in p ro ce ss es • Tr ai ni ng o f s ta ff is es se nt ia l t o en su re co ns is te nt p er fo rm an ce of d ut ie s • Ev er y or ga ni za tio n sh ou ld ta ke re sp on si bi lit y fo r t he co nt in ui ng tr ai ni ng o f i ts st af f • Th e or ga ni za tio n be ne fit s fro m h av in g a sk ille d an d m ot iv at ed w or kf or ce • E m ph as iz e th at q ua lit y pr ob le m s ar e lik el y if st af f a re n ot tr ai ne d • R ei nf or ce th e va lu e of tra in in g to th e or ga ni za tio n an d th e in di vi du al • Ex pl ai n w hy tr ai ni ng is a re qu ire m en t o f q ua lit y sy st em s • Li st th e be ne fit s of s ta ff tra in in g to th e or ga ni za tio n an d to th e st af f t he m se lv es ½ h ou r Q M T 7. 2 Tr ai ni ng n ee ds an d pl an s Pr es en ta ti on To e xa m in e th e im po rta nc e of a ss es si ng tra in in g ne ed s of a ll ca te go rie s of s ta ff an d pr ep ar in g tra in in g pl an s • Id en tif yi ng th e ne ed fo r jo b- sp ec ifi c tra in in g • Pl an ni ng th e tra in in g • R es ou rc es re qu ire d • Th e tra in er a nd th e tra in ee • Tr ai ni ng m at er ia ls • H ow to im pa rt tra in in g • Th e di st an ce le ar ni ng ap pr oa ch • Tr ai ni ng m us t b e w el l pl an ne d • Th e re qu ire d re so ur ce s m us t b e pr ov id ed : • Fu nd s • A pp ro pr ia te tr ai ne rs • M at er ia ls • Th e tra in er m us t b e ab le to im pa rt hi s/ he r kn ow le dg e to tr ai ne es • H ig hl ig ht th e ne ed to id en tif y al l j ob -s pe ci fic tra in in g • Em ph as iz e th e ne ed to en su re tr ai ni ng p la ns ar e re al is tic • Id en tif y tra in in g ne ed s in th e B TS • D ev el op a p la n to m ee t id en tif ie d tra in in g ne ed s • Id en tif y th e sk ills re qu ire d to tr ai n ot he rs ef fe ct iv el y ½ h ou r Q M T 7. 3 C re at in g a tra in in g pl an A ct iv it y To p ro vi de p ra ct ic e in pr ep ar in g a tra in in g pl an • Id en tif yi ng k ey s ki lls re qu ire d fo r t he jo b • D ev el op in g an ap pr op ria te , e ffe ct iv e an d de liv er ab le tr ai ni ng pr og ra m m e • R ev ie w in g tra in in g pl an s to e ns ur e th at a ll as pe ct s ha ve b ee n co ve re d • Tr ai ni ng p la ns m us t b e de si gn ed to m ee t id en tif ie d ne ed s • R ev ie w a nd as se ss m en t o f t ra in in g pl an s ar e es se nt ia l • C he ck th at tr ai ni ng pl an s ar e ap pr op ria te an d co m pr eh en si ve • E ns ur e th at th ey a re de liv er ab le • C he ck th at tr ai ni ng pl an s ar e ef fe ct iv e an d co m pl et e • Id en tif y sp ec ifi c jo b ne ed s • C re at e a tra in in g pl an fo r B TS s ta ff • C rit ic al ly re vi ew a tra in in g pl an to e ns ur e it is s ui ta bl e an d de liv er ab le 1 ho ur Q M T/ Co re C ou rs e M at er ia ls 35 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 7. 4 M on ito rin g an d ev al ua tio n of tra in in g Pr es en ta ti on To e st ab lis h th e im po rta nc e of do cu m en ta tio n an d re co rd s in tr ai ni ng a nd th e ne ed to m on ito r a nd ev al ua te tr ai ni ng • D oc um en tin g th e tra in in g pr og ra m • Tr ai ni ng re co rd s • M on ito rin g th e ef fe ct iv en es s of tr ai ni ng • Q ua lit y pr in ci pl es a pp ly to tr ai ni ng a s m uc h as an y ot he r B TS p ro ce ss • Al l t ra in in g sh ou ld b e do cu m en te d • Tr ai ni ng p ro ce du re s sh ou ld b e de fin ed , ag re ed o n an d do cu m en te d • Bo th th e ov er al l t ra in in g pl an a nd th e ac tu al tra in in g ne ed to b e m on ito re d an d ev al ua te d • Ev al ua tio n sh ou ld b e us ed to im pr ov e tra in in g in th e fu tu re • Em ph as iz e th e im po rta nc e of tr ai ni ng re co rd s • H ig hl ig ht th e im po rta nc e of re gu la r r ev ie w s of tra in in g an d th ei r do cu m en ta tio n • D em on st ra te a n un de rs ta nd in g of th e ne ed fo r d oc um en ta tio n an d tra in in g re co rd s • P ro du ce e ffe ct iv e do cu m en ta tio n co ve rin g th e tra in in g sy lla bu s an d its d el iv er y • D ev el op a tr ai ni ng pr og ra m m e th at in cl ud es m on ito rin g an d ev al ua tio n ½ h ou r Q M T/ Co re C ou rs e M at er ia ls 36 DE CL AS SIF IED M od ul e 8 A ss es sm en t wi th in t he Q ua lit y Sy st em Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 8. 1 A ss es sm en t w ith in qu al ity s ys te m s Pr es en ta ti on To in tro du ce a ss es sm en t of th e qu al ity s ys te m • Th e ne ed fo r as se ss m en t • E le m en ts o f as se ss m en t ─ E va lu at io n ─ V al id at io n ─ M on ito rin g • Q ua lit y as se ss m en t sc he m es • E rro rs a nd e rro r m an ag em en t • A ud its • C on tin ua l a ss es sm en t is e ss en tia l f or th e m ai nt en an ce a nd im pr ov em en t o f t he qu al ity s ys te m • Th er e ar e a nu m be r o f in te rre la te d to ol s th at sh ou ld b e us ed fo r qu al ity a ss es sm en t • Em ph as iz e th e va lu e an d im po rta nc e of m on ito rin g an d ev al ua tio n in th e m ai nt en an ce o f a qu al ity s ys te m • Li st k ey e le m en ts o f as se ss m en t a nd th ei r us e w ith in q ua lit y sy st em s ½ h ou r Q M T 8. 2 Va lid at io n Pr es en ta ti on To e xp la in th e im po rta nc e of v al id at io n w ith in th e qu al ity s ys te m • B as ic p rin ci pl es o f va lid at io n • P rin ci pl es fo r t he va lid at io n of p ro ce ss es , eq ui pm en t, re ag en ts an d so ftw ar e • Pl an ni ng v al id at io ns • V al id at io n en su re s: ─ E ve ry th in g to b e us ed in a p ro ce ss , in cl ud in g th e pr oc es s its el f, is w or ki ng to do cu m en te d sp ec ifi ca tio ns b ef or e us e ─ E ve ry th in g us ed re m ai ns w ith in sp ec ifi ca tio ns (r e- va lid at io n) • V al id at io n co nt ro ls th e im pa ct o f c ha ng e • E m ph as iz e th e ris ks o f a fa ilu re to v al id at e ne w ac tiv iti es o r c ha ng es • C la rif y th e di st in ct io n be tw ee n va lid at io n an d ev al ua tio n • D es cr ib e th e m ai n pu rp os es o f v al id at io n • D ev el op a v al id at io n pl an 1 ho ur Q M T 8. 3 Pr ep ar in g a va lid at io n pl an A ct iv it y To p ro vi de p ra ct ic e in pr od uc in g an e ffe ct iv e an d ap pr op ria te v al id at io n pl an • Id en tif yi ng c rit ic al va lid at io n po in ts • Ap pr op ria te v al id at io n • Th e di ffe re nc e be tw ee n va lid at io n an d ev al ua tio n • Ex am pl es o f v al id at io n pl an s • Pl an ni ng is e ss en tia l • N o m at te r h ow s m al l t he ch an ge , v al id at io n is ne ed ed • Fo cu s on v al id at io n, n ot ev al ua tio n • E ns ur e pa rti ci pa nt s ke ep v al id at io n pl an s si m pl e • En su re u nd er st an di ng of th e di ffe re nc e be tw ee n va lid at io n an d ev al ua tio n • D es cr ib e th e m ai n ac tiv iti es w he n va lid at in g re ag en ts , pr oc es se s, e qu ip m en t an d so ftw ar e • Id en tif y th e us e of do cu m en ta tio n in va lid at io n pr oc ed ur es 2 ho ur s Q M T/ Co re C ou rs e M at er ia ls 37 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 8. 4 M ai nt en an ce a nd ca lib ra tio n of eq ui pm en t Pr es en ta ti on To in tro du ce th e re as on s fo r a nd th e ba si c pr in ci pl es of m ai nt en an ce a nd ca lib ra tio n of e qu ip m en t • N ee d fo r e qu ip m en t m ai nt en an ce • O rg an iz at io na l a nd u se r re sp on si bi lit ie s • P rin ci pl es o f c al ib ra tio n • A ct io n in th e ev en t o f ca lib ra tio n fa ilu re • R ec or ds a nd do cu m en ta tio n • P re ve nt io n is b et te r th an c ur e • A n ef fe ct iv e m ai nt en an ce a nd ca lib ra tio n pr og ra m m e is re qu ire d fo r a ll eq ui pm en t t ha t h as a ny im pa ct o n th e qu al ity o f th e fin al p ro du ct • M ai nt en an ce a nd ca lib ra tio n sh ou ld b e re gu la r, ap pr op ria te a nd co m pr eh en si ve • S ta ff m us t b e tra in ed in th e co rre ct u se , m ai nt en an ce a nd ca lib ra tio n of e qu ip m en t • Al l m ai nt en an ce a nd ca lib ra tio n m us t b e do cu m en te d • Em ph as iz e th e va lu e of pr ev en tiv e m ai nt en an ce • D is cu ss in d ep th th e ac tio n to b e ta ke n in th e ev en t o f c al ib ra tio n fa ilu re • D is cu ss th e im po rta nc e of th e re lia bi lit y of pr ev io us re su lts ob ta in ed w ith th at eq ui pm en t • Li st th e m ai n re as on s fo r t he m ai nt en an ce a nd ca lib ra tio n of e qu ip m en t • D is cu ss th e va lu e of pr ev en tiv e m ai nt en an ce • O ut lin e th e ba si c pr in ci pl es o f c al ib ra tio n an d ho w to a pp ly th em • D ev el op d oc um en ta tio n fo r t he m ai nt en an ce a nd ca lib ra tio n of e qu ip m en t ¾ h ou r Q M T 8. 5 D es ig ni ng a m ai nt en an ce a nd ca lib ra tio n pl an A ct iv it y To p ro vi de p ra ct ic e in pr od uc in g ap pr op ria te m ai nt en an ce a nd ca lib ra tio n pl an s • Id en tif yi ng th e m ai nt en an ce a nd ca lib ra tio n ne ed s of eq ui pm en t • D et er m in in g ap pr op ria te ca lib ra tio n m et ho ds • Th er e ar e di ffe re nt ap pr oa ch es to m ai nt en an ce a nd ca lib ra tio n • M ai nt en an ce a nd ca lib ra tio n pl an s m us t be s us ta in ab le • Em ph as iz e th e im po rta nc e of d es ig ni ng si m pl e an d ap pr op ria te m ai nt en an ce a nd ca lib ra tio n pl an s • E ns ur e pa rti ci pa nt s un de rs ta nd th e va lu e an d us e of do cu m en ta tio n an d re co rd s fo r m ai nt en an ce an d ca lib ra tio n • Pr od uc e an a pp ro pr ia te m ai nt en an ce a nd ca lib ra tio n sc he du le • Id en tif y ke y do cu m en ta tio n fo r t he m ai nt en an ce a nd ca lib ra tio n of e qu ip m en t 1½ h ou rs Q M T/ Co re C ou rs e M at er ia ls 38 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 8. 6 Q ua lit y m on ito rin g to ol s Pr es en ta ti on To in tro du ce q ua lit y m on ito rin g an d so m e ex am pl es o f q ua lit y m on ito rin g to ol s • M on ito rin g pe rfo rm an ce • M on ito rin g to ol s • Be nc hm ar ki ng • Q ua lit y m on ito rin g is a w ay o f l oo ki ng a t w ha t i s ac tu al ly h ap pe ni ng • Lo ok in g at k ey in di ca to rs c an id en tif y tre nd s an d he lp p re ve nt pr ob le m s oc cu rri ng • M on ito rin g is a n ac tiv e pr oc es s th at re qu ire s ap pr op ria te d at a an al ys is to m ak e be st us e of th e m on ito rin g sy st em • V is ua liz at io n of d at a is on e of th e be st w ay s of lo ok in g at w ha t i s go in g on • E m ph as iz e th at th er e ar e di ffe re nt ap pr oa ch es to q ua lit y m on ito rin g • E nc ou ra ge p ar tic ip an ts to tr y di ffe re nt m et ho ds • Li st s om e si m pl e to ol s fo r d at a an al ys is • D es cr ib e ho w th es e si m pl e to ol s m ay b e us ed to m on ito r pe rfo rm an ce ¾ h ou r Q M T 8. 7 An al ys in g da ta an d m on ito rin g pe rfo rm an ce A ct iv it y To il lu st ra te th e va lu e of m on ito rin g th e da ta th at ar e ge ne ra te d • U si ng d iff er en t t yp es o f da ta • A pp ro pr ia te a na ly si s of da ta • C rit ic al a na ly si s of d at a • R ec og ni zi ng p ot en tia l pr ob le m s • S ta tis tic al p ro ce ss co nt ro l ( S P C )/( S P M ) • Id en tif yi ng a nd m on ito rin g tre nd s • M an y B TS a ct iv iti es ge ne ra te d at a • N ot a ll da ta a re a m ea su re o f pe rfo rm an ce • M on ito rin g fo cu se s on w ha t i s ac tu al ly ha pp en in g • V is ua l p re se nt at io n of da ta is a n ef fe ct iv e m et ho d of a na ly si s an d un de rs ta nd in g • Ex pl ai n w hy c er ta in d at a ha ve li m ite d m on ito rin g va lu e • G iv e ex am pl es o f di ffe re nt ty pe s of an al ys is a nd th ei r ad va nt ag es a nd di sa dv an ta ge s • K ee p th e w or k fo cu se d on a s im pl e an al ys is o f th e da ta • Ex pl or e po ss ib le re as on s fo r t re nd s in da ta • A na ly se s om e ty pi ca l la bo ra to ry d at a • P re pa re s im pl e ch ar ts to m on ito r a nd e va lu at e pe rfo rm an ce • U se S P C (S P M ) t o de m on st ra te a nd m on ito r t re nd s 1½ h ou rs Q M T/ Co re C ou rs e M at er ia ls 39 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 8. 8 E rro r m an ag em en t Pr es en ta ti on To d em on st ra te th e im po rta nc e of p ut tin g sy st em s in p la ce to d ea l w ith e rro rs • D ef in in g er ro rs • E rro r p ol ic y • E rro r r ep or tin g • E rro r a na ly si s • C or re ct io n, c or re ct iv e ac tio n an d pr ev en tiv e ac tio n • E rro rs (q ua lit y in ci de nt s) m us t b e de fin ed c le ar ly • S ys te m s to re po rt qu al ity in ci de nt s ne ed to be in p la ce s o th at th ey ca n th en b e in ve st ig at ed • S ys te m s of c or re ct io n, co rre ct iv e an d pr ev en tiv e ac tio n ne ed to b e in p la ce • A ll st af f a nd u se rs o f pr od uc ts /s er vi ce s m us t be a w ar e of th es e sy st em s • In ci de nt s m us t b e us ed to im pr ov e pr oc es se s/ pr oc ed ur es , n ot p un is h st af f • D ef in e "e rro rs " • D is cu ss th e bo un da ry be tw ee n m is ta ke s an d er ro rs • D is cu ss th e di ffe re nc es be tw ee n m is ta ke s, er ro rs a nd n on - co m pl ia nc e • D em on st ra te a n un de rs ta nd in g of e rro rs an d th ei r r ep or tin g • Ex pl ai n th e im po rta nc e of ta ki ng a ct io n to co rre ct e rro rs a nd pr ev en t f ur th er oc cu rre nc es ¾ h ou r Q M T 8. 9 Pr ep ar in g an S O P on e rro r r ep or tin g A ct iv it y To p ro vi de p ra ct ic e in pr ep ar in g an S O P on de al in g w ith e rro rs • Id en tif yi ng e rro rs • R ep or tin g an d re co rd in g er ro rs • An al ys in g er ro rs • C or re ct iv e an d pr ev en tiv e ac tio n • R ep or tin g of e rro rs is es se nt ia l • S ta ff ne ed to fe el a bl e to re po rt er ro rs w ith ou t fe ar o f p un is hm en t • Fo cu s on th e be ne fit s of er ro r r ep or tin g • E ns ur e fe ed ba ck m ec ha ni sm s ar e in cl ud ed • R ei nf or ce th e de fin iti on of e rro rs a nd th ei r re po rti ng • Em ph as iz e th e ne ed fo r co rre ct iv e an d pr ev en tiv e ac tio n • W rit e an S O P o n er ro r re po rti ng fo r t he ir B TS • C le ar ly d ef in e er ro rs , re po rti ng m ec ha ni sm s an d ac tio n re qu ire d 1½ h ou rs Q M T/ Co re C ou rs e M at er ia ls 40 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 8. 10 A ud its a nd au di tin g Pr es en ta ti on To in tro du ce th e im po rta nc e of a ud its w ith in th e qu al ity s ys te m • Au di ts a nd a ud iti ng • A ud it de fin iti on s • Au di t p la nn in g • Be ne fit s an d va lu e of au di ts • A ud its a re e ss en tia l t o m ai nt ai n an d im pr ov e qu al ity • A ud its m us t b e pe rfo rm ed a nd re ce iv ed as p os iti ve e ve nt s • Au di ts s ho ul d be v ie w ed as "i m pr ov em en t op po rtu ni tie s" • Ap pr op ria te a nd re le va nt s ta nd ar ds m us t be u se d • A ll st af f s ho ul d be co m e in vo lv ed a nd b e ab le to co nt rib ut e to th e au di t an d its o ut co m e • R ei nf or ce th e im po rta nc e an d va lu e of au di ts • S tre ss th e im po rta nc e of p re pa rin g fo r a ud its • C on si de r a ny re le va nt na tio na l s ta nd ar ds • D ef in e qu al ity a ud it • Li st th e di ffe re nt ty pe s of q ua lit y au di t • D es cr ib e th e au di t pl an ni ng p ro ce ss • O ut lin e th e be ne fit s an d va lu e of a n au di t 1 ho ur Q M T 8. 11 Th e au di t p ro ce ss Pr es en ta ti on To d es cr ib e th e au di t pr oc es s an d ho w to re po rt on th e fin di ng s • A ud it pr oc es s • A ud it re po rts • Th e au di t p ro ce ss in vo lv es th e fo llo w in g st ep s: ─ P re pa ra tio n ─ P er fo rm an ce ─ C on cl us io n ─ R ep or t ─ F ol lo w -u p • A ud it fin di ng s m us t b e do cu m en te d in th e fo rm of a re po rt w hi ch s ho ul d be c on tro lle d an d fo llo w a de fin ed fo rm at • Th e au di t i s in co m pl et e un til a ny c or re ct iv e ac tio n re qu ire d is ta ke n • Em ph as iz e th e ne ed fo r au di to rs to p re pa re ca re fu lly b ef or e an a ud it • S tre ss th e im po rta nc e of a ud iti ng to th e st an da rd s • Em ph as iz e th e im po rta nc e of m ak in g th e au di t a p os iti ve ex pe rie nc e • D es cr ib e th e st ep s in th e au di t p ro ce ss • S ta te th e m ai n el em en ts of a n au di t r ep or t ¾ h ou r Q M T 8. 12 D ev el op in g an au di t p la n A ct iv it y To p ro vi de p ar tic ip an ts w ith p ra ct ic e in p re pa rin g an a ud it pl an • Ty pe s of a ud it • U si ng s ta nd ar ds a s a ba si s fo r a n au di t • Au di t p la ns s ho ul d be si m pl e • Au di t p la ns s ho ul d re fle ct th e st an da rd s be in g us ed • P re - a nd p os t-a ud it m ee tin gs a re e ss en tia l • R em em be r t ha t t he co ur se d oe s no t a im to tra in a ud ito rs , b ut to gi ve p ar tic ip an ts a to ol fo r m on ito rin g th ei r qu al ity s ys te m • E ns ur e th e pl an s ar e si m pl e an d ap pr op ria te • D es ig n an a ud it pl an 1 ho ur Q M T/ Co re C ou rs e M at er ia ls 41 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 8. 13 Id en tif yi ng n on - co m pl ia nc es ag ai ns t a s et o f st an da rd s A ct iv it y • To il lu st ra te a ty pi ca l au di t s itu at io n • To p ro vi de p ra ct ic e in id en tif yi ng n on - co m pl ia nc es a nd ob se rv at io ns in a n au di t si tu at io n • Id en tif yi ng n on - co m pl ia nc es • R el at in g no n- co m pl ia nc es to a ud it st an da rd s • D ef in in g ob se rv at io ns • Th e au di to r m us t b e ab le to id en tif y an d un de rs ta nd th e ke y qu al ity e le m en ts in a pr oc ed ur e • It is im po rta nt to b e ve ry sp ec ifi c ab ou t a ny n on - co m pl ia nc es id en tif ie d an d do cu m en t t he m ca re fu lly • E ns ur e th at p ar tic ip an ts un de rs ta nd th e ai m o f th e ac tiv ity • En co ur ag e qu es tio ns ab ou t t he p la ye rs ’ a ud it te ch ni qu e • En su re a ll no n- co m pl ia nc es a re id en tif ie d • Id en tif y no n- co m pl ia nc es fr om ob se rv at io ns m ad e du rin g an a ud it 1½ h ou rs Q M T 8. 14 A ud it of a w or k ar ea A ct iv it y To il lu st ra te th e ex pe rie nc e of a n au di t f ro m th e pe rs pe ct iv e of a n au di to r • U si ng a n au di t p la n to co nd uc t a n au di t • Id en tif yi ng n on - co m pl ia nc es • A ud its m us t b e pe rfo rm ed in a pr of es si on al , s en si tiv e an d po si tiv e w ay • S uc ce ss fu l a ud its a re sy st em at ic • It is e ss en tia l t o ha ve pr e- a nd p os t-a ud it m ee tin gs to o ut lin e th e pr oc es s an d re vi ew th e fin di ng s • C on tro l t he a ud it • E ns ur e th at a ll m em be rs o f t he g ro up s ar e in vo lv ed • R ei nf or ce th e im po rta nc e of re co rd in g ob se rv at io ns • In vi te th e au di te es to pa rti ci pa te in th e re vi ew of th e au di t • D em on st ra te a n un de rs ta nd in g of th e au di t p ro ce ss 1½ h ou rs Q M T 8. 15 An al ys in g qu al ity sy st em fa ilu re s A ct iv it y To il lu st ra te th e pr ob le m s th at c an o cc ur w ith ou t go od q ua lit y sy st em s • S ys te m fa ilu re s af fe ct qu al ity • M in or e rro rs c an co m bi ne to c re at e on e se rio us fa ilu re in th e qu al ity s ys te m • Th e co ns eq ue nc es o f a qu al ity fa ilu re c an b e se rio us • A n an al ys is o f f ai lu re s of te n id en tif ie s a nu m be r o f m in or e rro rs as th e ca us e • Ex pl ai n th e ac tiv ity cl ea rly • E ns ur e al l p ar tic ip an ts ta ke p ar t • Ke ep th e ro le p la y lig ht - he ar te d an d fu n • E ns ur e th at a ll th e qu al ity fa ilu re s ar e id en tif ie d • Ex pl ai n ho w q ua lit y fa ilu re s ca n af fe ct th e qu al ity o f p ro du ct s an d se rv ic es • D em on st ra te a n ab ilit y to id en tif y er ro rs a nd po te nt ia l e rro rs in pr oc es se s 1½ h ou rs Q M T 8. 16 M id -c ou rs e as se ss m en t A ct iv it y To a ss es s pa rti ci pa nt s' br oa d un de rs ta nd in g of M od ul es 1 −8 • P ar tic ip an ts s ho ul d ha ve a ch ie ve d im pr ov ed k no w le dg e an d co m pe te nc e in th e to pi cs c ov er ed in M od ul es 1 −8 • D em on st ra te im pr ov ed kn ow le dg e an d un de rs ta nd in g of th e to pi cs c ov er ed in M od ul es 1 −8 1 ho ur Q M T/ Co re C ou rs e M at er ia ls 42 DE CL AS SIF IED P A RT 2 A PP LY IN G Q U A LI TY M A N A GE M EN T IN T H E BT S M od ul e 9 Q ua lit y M an ag em en t in t he B TS Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 9. 1 Ap pl yi ng q ua lit y m an ag em en t i n th e B TS Pr es en ta ti on To in tro du ce h ow q ua lit y sy st em s ar e ap pl ie d to bl oo d tra ns fu si on pr oc es se s • W H O s tra te gy fo r b lo od sa fe ty • Q ua lit y sy st em s fo r bl oo d sa fe ty • In tro du ct io n to P ar t 2 o f th e co ur se • M od ul es 9 −1 4 w ill de m on st ra te h ow to ap pl y kn ow le dg e ab ou t qu al ity s ys te m s to th e B TS : ─ Q ua lit y m an ag em en t in th e B TS ─ H yg ie ne a nd s af et y ─ D on or m an ag em en t an d bl oo d co lle ct io n ─ L ab or at or y te st in g ─ B lo od c om po ne nt pr od uc tio n an d m an ag em en t ─ T he c lin ic al in te rfa ce • E ns ur e pa rti ci pa nt s un de rs ta nd th at P ar t 2 of th e co ur se w ill as si st th em in a pp ly in g w ha t th ey h av e le ar ne d to th e va rio us a re as o f t he B TS • E m ph as iz e th at th e m od ul es a re d es ig ne d to g ui de p ar tic ip an ts in w ha t t o do , b ut n ot ne ce ss ar ily h ow to d o it • Ex pl ai n th e W H O st ra te gy fo r b lo od s af et y • D ef in e th e ke y el em en ts of th e W H O A id e- M ém oi re : Q ua lit y S ys te m s fo r B lo od S af et y ½ h ou r Q M T 9. 2 Id en tif yi ng c rit ic al co nt ro l p oi nt s an d pr ep ar in g flo w ch ar ts fo r B TS ac tiv iti es A ct iv it y • To a na ly se s om e ac tiv iti es w ith in th e tra ns fu si on p ro ce ss a nd id en tif y cr iti ca l c on tro l po in ts • To d ra w a fl ow ch ar t o f th e se le ct ed a ct iv iti es • An al ys in g pr oc es se s an d pr oc ed ur es in th e tra ns fu si on p ro ce ss • Id en tif yi ng c rit ic al co nt ro l p oi nt s in B TS ac tiv iti es • U si ng fl ow ch ar ts to an al ys e B TS p ro ce ss es an d pr oc ed ur es • An u nd er st an di ng o f pr oc es se s an d pr oc ed ur es is v ita l t o en su re q ua lit y • C rit ic al c on tro l p oi nt s ca n be id en tif ie d fo r a ll B TS a ct iv iti es • Fl ow ch ar ts a ss is t i n an al ys in g ac tiv iti es • U se c om m on B TS pr oc es se s • Fo cu s on ly o n th e cr iti ca l c on tro l p oi nt s • E ns ur e th at a ll th e cr iti ca l c on tro l p oi nt s ha ve b ee n id en tif ie d • Fo cu s on p ro bl em s ar is in g fro m th e in co rre ct id en tif ic at io n of cr iti ca l c on tro l p oi nt s • R ev ie w p ro ce ss es in B TS a ct iv iti es • Id en tif y cr iti ca l c on tro l po in ts • Pr od uc e ac cu ra te a nd co ns is te nt fl ow ch ar ts o f B TS p ro ce ss es a nd pr oc ed ur es 1½ h ou rs Q M T/ Co re C ou rs e M at er ia ls 43 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 9. 3 S te ps in de ve lo pi ng a qu al ity s ys te m in th e B TS Pr es en ta ti on To h ig hl ig ht th e st ep s in de ve lo pi ng a nd im pl em en tin g a qu al ity sy st em in th e B TS • C om m itm en t a nd su pp or t • Q ua lit y w or ki ng g ro up • Q ua lit y po lic y: ─ N at io na l ─ L oc al • S ta nd ar ds • D oc um en ta tio n • A ct iv ity p la n • Tr ai ni ng • A ss es sm en t • C om m itm en t f ro m a ll co nc er ne d is e ss en tia l fo r s uc ce ss • Fi na liz e a qu al ity p ol ic y • D ev el op a q ua lit y pl an en su rin g: ─ A ll pr oc es se s an d th ei r a pp ro pr ia te qu al ity n ee ds a re id en tif ie d ─ M on ito rin g an d ev al ua tio n ar e bu ilt in to th e pl an • Th e pl an m us t b e do cu m en te d, fo llo w ed an d m on ito re d • Fo cu s on a ch ie va bl e st ep s in d ev el op in g an d im pl em en tin g a qu al ity sy st em in th e B TS • B e se ns iti ve to th e va ry in g si tu at io ns o f t he pa rti ci pa nt s • Li st th e st ep s in de ve lo pi ng a nd im pl em en tin g a qu al ity sy st em in th e B TS ½ h ou r Q M T 9. 4 C os tin g ac tiv iti es in a b lo od tra ns fu si on se rv ic e Pr es en ta ti on To h ig hl ig ht th e im po rta nc e of c os tin g al l B TS a ct iv iti es • D ef in iti on o f c os tin g • B en ef its o f c os tin g • W H O m an ua l " C os tin g Bl oo d Tr an sf us io n S er vi ce s" • B as ic c os t a na ly si s of B TS a ct iv iti es • Th e qu al ity m an ag er ne ed s to u nd er st an d th e pr in ci pl es o f c os tin g • A cc ur at e co st in g of B TS ac tiv iti es e na bl es ac cu ra te b ud ge t pl an ni ng a nd re so ur ce m ob iliz at io n • S us ta in ab ilit y of th e B TS is n ot a ch ie va bl e w ith ou t c os tin g pr oc ed ur es • C os tin g B TS a ct iv iti es co nt rib ut es to q ua lit y m on ito rin g • Fo cu s on s im pl ic ity • C on ce nt ra te o n ba si c pr in ci pl es a nd p ra ct ic e ra th er th an tr yi ng to id en tif y sp ec ifi c co st s • G iv e a ra ng e of ex am pl es w he re th e ac tu al c os t i s hi gh er th an e xp ec te d du e to po or q ua lit y • Ex pl ai n th e va lu e of co m pr eh en si ve c os tin g of a ll B TS a ct iv iti es • D ef in e ke y fa ct or s th at ne ed to b e ta ke n in to ac co un t i n co st in g th e ac tiv iti es o f a B TS ¾ h ou r Q M T/ Co re C ou rs e M at er ia ls 44 EC LA SS IFI ED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 9. 5 P rin ci pl es o f s to ck co nt ro l Pr es en ta ti on To h ig hl ig ht th e im po rta nc e of s to ck c on tro l a nd c or re ct st or ag e co nd iti on s • S to ck c on tro l a nd or de rin g • Pe ris ha bl e an d no n- pe ris ha bl e m at er ia ls • D el iv er y ch ec ks • Q ua ra nt in e of m at er ia ls • In sp ec tio n of in co m in g m at er ia ls • C or re ct s to ra ge o f pe ris ha bl e m at er ia ls • M on ito rin g co rre ct st or ag e co nd iti on s • D oc um en ta tio n • Al l B TS s ne ed a g oo d st oc k m an ag em en t sy st em • S uf fic ie nt s to ck s of cr iti ca l i te m s m us t b e m ai nt ai ne d at a ll tim es • Al l i nc om in g m at er ia ls m us t b e ap pr op ria te ly ch ec ke d be fo re u se • Q ua ra nt in e an d re le as e pr oc ed ur es m us t b e in pl ac e fo r c er ta in it em s • M on ito rin g of u sa ge c an he lp e ns ur e ad eq ua te st oc k le ve ls a re m ai nt ai ne d • H ig hl ig ht th e pr ob le m s of s to ck c on tro l w he n de liv er y tim es c an no t b e gu ar an te ed • S tre ss th e im po rta nc e of c or re ct s to ra ge co nd iti on s • Em ph as iz e th e ne ed fo r co nt in ge nc y pl an s fo r re fri ge ra to r/ fre ez er fa ilu re • R ei nf or ce th e im po rta nc e of do cu m en tin g th e m on ito rin g of s to ra ge co nd iti on s • D es cr ib e m et ho ds o f m on ito rin g th e st oc k co nt ro l s ys te m • Id en tif y th e fa ct or s th at ca n in flu en ce s to ra ge co nd iti on s • Ex pl ai n th e pr in ci pl es o f qu ar an tin e/ re le as e pr oc ed ur es • Li st e ss en tia l do cu m en ta tio n an d re co rd s fo r s to ck c on tro l ¾ h ou r Q M T 9. 6 Q ua lit y as pe ct s of co nt in ge nc y pl an ni ng Pr es en ta ti on To e nc ou ra ge th e de ve lo pm en t o f co nt in ge nc y pl an s to en su re a n ad eq ua te s up pl y of s af e bl oo d pr od uc ts a t al l t im es • M ai nt ai ni ng th e sa fe ty an d ad eq ua cy o f t he bl oo d su pp ly • Pl an s an d pr oc ed ur es • M aj or d is as te rs o r in ci de nt s • R es po ns ib ilit y: ro le o f th e qu al ity m an ag er • Pl an ni ng to m in im iz e ad ve rs e ou tc om es • C o- or di na tio n w ith o th er ag en ci es • Th in gs d o go w ro ng • D is as te rs d o ha pp en • Th e co nt in ui ty o f t he bl oo d su pp ly is es se nt ia l • C on tin ge nc y pl an ni ng is es se nt ia l • D oc um en te d pr oc ed ur es n ee d to b e in p la ce , a va ila bl e to a ll st af f a nd re vi ew ed a t ap pr op ria te in te rv al s • B TS p la ns n ee d to b e in co rp or at ed in to ap pr op ria te n at io na l a nd lo ca l c on tin ge nc y pl an s • Pr ov id e ex am pl es o f di ffe re nt s itu at io ns in w hi ch th e sa fe ty a nd ad eq ua cy o f t he b lo od su pp ly m ay b e co m pr om is ed • Id en tif y si tu at io ns th at m ay th re at en th e sa fe ty an d ad eq ua cy o f t he bl oo d su pp ly • D ev el op a c on tin ge nc y pl an fo r t he B TS ½ h ou r Q M T/ Co re C ou rs e M at er ia ls 45 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 9. 7 Q ua lit y st at us an al ys is A ct iv it y To a ss is t p ar tic ip an ts to as se ss th e qu al ity s ta tu s of th ei r B TS • Th e us e of th e Q ua lit y S ta tu s Q ue st io nn ai re a s a to ol fo r e du ca tio n an d m on ito rin g • Th e Q ua lit y S ta tu s Q ue st io nn ai re w ill he lp pa rti ci pa nt s to b eg in th e pr oc es s of p re pa rin g th ei r a ct io n pl an s • If ne ce ss ar y, a ss is t pa rti ci pa nt s in an sw er in g th e qu es tio ns • B e se ns iti ve to p os si bl e la ng ua ge p ro bl em s • B e al er t t o in di ca tio ns o f a pa rti ci pa nt b ei ng un ab le to a ns w er d ue to la ck o f u nd er st an di ng – th is c ou ld b e an in di ca to r f or s om e re in fo rc ed le ar ni ng fo r th e pa rti cu la r p ar tic ip an t • U se th e in fo rm at io n in th e qu es tio nn ai re to m on ito r t he ir ow n pr og re ss 1 ho ur Q M T 9. 8 Pr ep ar in g an ac tio n pl an Pr es en ta ti on To in tro du ce p ar tic ip an ts to th e pr ep ar at io n of th ei r in di vi du al a ct io n pl an s • In tro du ct io n to pr ep ar in g an a ct io n pl an • S te ps in th e ac tio n pl an • Id en tif yi ng p rio rit y ar ea s • Th e ac tio n pl an s ho ul d in cl ud e al l t he m ai n el em en ts o f a q ua lit y m an ag em en t s ys te m • Id en tif y pr io rit y ar ea s fro m th e qu al ity s ta tu s qu es tio nn ai re • Ac tio n pl an s de ve lo pe d du rin g th e co ur se w ill fo rm a fo un da tio n fo r pl an ni ng p ar tic ip an ts ’ qu al ity s ys te m s • E m ph as iz e th at th e su gg es te d st ep s ar e on ly e xa m pl es a nd th at pa rti ci pa nt s’ p la ns w ill va ry c on si de ra bl y de pe nd in g on th ei r o w n si tu at io n • Em ph as iz e th e ne ed to ba se th e ac tio n pl an o n id en tif ie d ne ed s • En co ur ag e si m pl ic ity • Li st th e m ai n ar ea s to co ns id er w he n pr ep ar in g th e fir st d ra ft of a b as ic p la n of a ct io n ½ h ou r Q M T 9. 9 P re pa rin g a dr af t ac tio n pl an A ct iv it y To a ss is t p ar tic ip an ts in dr af tin g th ei r i nd iv id ua l ac tio n pl an s • Th e fir st d ra ft of th e ac tio n pl an w ill be re fin ed a t t he e nd o f t he co ur se • Pa rti ci pa nt s w ill ha ve a n op po rtu ni ty fo r in di vi du al d is cu ss io n w ith fa ci lit at or s • O th er h el p w ill be av ai la bl e, a s re qu ire d • P ar tic ip an ts s ho ul d in iti al ly fo cu s on th e ne xt 6 –1 2 m on th s • Pl an s sh ou ld b e re al is tic an d ac hi ev ab le • Pl an to s uc ce ed • E nc ou ra ge p ar tic ip an ts to b e ho ne st a nd re al is tic a bo ut w ha t i s ac hi ev ab le • Tr y to id en tif y sp ec ifi c pr ob le m s in p ar tic ip an ts ’ in di vi du al B TS s • Lo ok fo r g ap s in th e pa rti ci pa nt s’ p la ns • S ug ge st a lte rn at iv es ac tiv iti es , w he re ap pr op ria te • Id en tif y pr io rit y ar ea s fro m th e qu al ity s ta tu s qu es tio nn ai re • Ap pl y th e kn ow le dg e ga in ed in th e co ur se to pr ep ar e an a ct io n pl an 3 ho ur s Q M T/ Co re C ou rs e M at er ia ls 46 DE CL AS SIF IED M od ul e 10 H yg ie ne a nd S af et y in t he B TS Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 10 .1 In tro du ct io n to hy gi en e an d sa fe ty in th e B TS Pr es en ta ti on To re vi ew th e el em en ts o f a qu al ity s ys te m in re la tio n to h yg ie ne a nd s af et y in th e B TS • H yg ie ne a nd s af et y as qu al ity is su es • S af et y po lic y an d pr oc ed ur es • B io sa fe ty • O th er s af et y is su es - M ec ha ni ca l/e le ct ric al / ch em ic al /fi re /ra di at io n sa fe ty • D is po sa l o f w as te • R es po ns ib ilit ie s fo r sa fe ty • A s af et y po lic y is a n es se nt ia l c om po ne nt o f th e el em en ts o f t he qu al ity s ys te m • Th e sa fe ty p ol ic y sh ou ld re fle ct th e co m m itm en t by th e or ga ni za tio n to hy gi en e an d sa fe ty is su es • R es po ns ib ilit ie s fo r hy gi en e an d sa fe ty sh ou ld b e de fin ed • E m ph as iz e th at th e qu al ity m an ag er is re sp on si bl e fo r e ns ur in g a hy gi en e an d sa fe ty po lic y is in p la ce • Pr ov id e ex am pl es o f sa fe ty p ol ic ie s • Id en tif y qu al ity is su es in re la tio n to h yg ie ne a nd sa fe ty in th e B TS • D ef in e ke y el em en ts o f a sa fe ty p ol ic y fo r a B TS • Id en tif y th e re sp on si bi lit ie s of th e or ga ni za tio n an d st af f fo r h yg ie ne a nd s af et y • Id en tif y th e ro le o f t he qu al ity m an ag er in en su rin g hy gi en e an d sa fe ty in th e B TS ½ h ou r Q M T 10 .2 H yg ie ne in th e B TS Pr es en ta ti on To d em on st ra te th e im po rta nc e of h yg ie ne a nd cl ea nl in es s in th e B TS • H yg ie ne in w or k ar ea s as a q ua lit y re qu ire m en t • Pe rs on al h yg ie ne • G oo d hy gi en e re qu ire s cl ea nl in es s an d tid in es s • C le an lin es s an d tid in es s of th e w or k ar ea is a qu al ity re qu ire m en t t o pr ot ec t d on or s, s ta ff an d pr od uc ts • Pe rs on al h yg ie ne is es se nt ia l • Em ph as iz e th e im po rta nc e of h yg ie ne fo r t he q ua lit y of th e pr od uc t a nd th e pr ot ec tio n of s ta ff an d do no rs • Em ph as iz e th e ne ed fo r th e co nt in ua l c le an in g of su rfa ce s, e qu ip m en t, et c. • E ns ur e pa rti ci pa nt s un de rs ta nd th at cl ea ni ng is th e re sp on si bi lit y of a ll st af f • Ex pl ai n w hy h yg ie ne is a qu al ity re qu ire m en t • Id en tif y th e ac tio ns re qu ire d to e ns ur e hy gi en e in th e BT S ¾ h ou r Q M T/ Co re C ou rs e M at er ia ls 47 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 10 .3 Bi ol og ic al a nd ch em ic al s af et y in th e B TS Pr es en ta ti on To d em on st ra te th e im po rta nc e of b io lo gi ca l an d ch em ic al s af et y in th e B TS • Ty pe s of h az ar do us m at er ia l • U ni ve rs al s af et y pr ec au tio ns • Sa fe h an dl in g of ha za rd ou s m at er ia l • S af e di sp os al o f ha za rd ou s w as te • U ni ve rs al s af et y pr ec au tio ns m us t b e fo llo w ed a t a ll tim es fo r th e pr ot ec tio n of s ta ff, th e en vi ro nm en t a nd th e ge ne ra l p ub lic • P ot en tia lly h az ar do us m at er ia l m us t b e ha nd le d sa fe ly a nd di sp os ed o f i n th e co rre ct m an ne r • B io ha za rd ou s m at er ia l m us t b e ap pr op ria te ly la be lle d an d tra ns po rte d in a pp ro pr ia te co nt ai ne rs • Al l h az ar do us s pi lls m us t b e co nt ai ne d an d de co nt am in at ed • E ns ur e th at p ar tic ip an ts ar e fa m ilia r w ith un iv er sa l s af et y pr ec au tio ns • D is cu ss th e ro le o f t he qu al ity m an ag er in en su rin g th er e is a sy st em fo r t he c or re ct ha nd lin g an d di sp os al o f ha za rd ou s w as te • Id en tif y th e ac tio ns re qu ire d to e ns ur e bi ol og ic al a nd c he m ic al sa fe ty in th e B TS ¾ h ou r Q M T 10 .4 S af et y is su es a nd m in im iz in g ris ks A ct iv it y To p ro vi de p ar tic ip an ts w ith p ra ct ic e in id en tif yi ng sa fe ty is su es a nd h ow to re so lv e th em • Id en tif ic at io n of k ey sa fe ty is su es • C re at in g aw ar en es s of sa fe ty is su es • A ct io ns n ee de d to m in im iz e ris ks • A n an al ys is o f t he sa fe ty a sp ec ts o f a ll pr oc es se s an d pr oc ed ur es is e ss en tia l • G iv e ex am pl es o f t he ty pe s of p ot en tia l r is k to st af f, do no rs a nd th e pu bl ic • E ns ur e th at s af et y pl an s ar e fe as ib le a nd c ov er ke y ar ea s • Id en tif y ke y B TS s af et y is su es • Li st th e ke y el em en ts o f m ai nt ai ni ng a s af e w or kp la ce • D es ig n a pl an fo r s af et y ch ec ks in th e B TS 1½ h ou rs Q M T/ Co re C ou rs e M at er ia ls 48 DE CL AS SIF IED M od ul e 11 Q ua lit y Sy st em s in B lo od D on or M an ag em en t Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 11 .1 In tro du ct io n to qu al ity s ys te m s in bl oo d do no r m an ag em en t Pr es en ta ti on To re vi ew th e el em en ts o f a qu al ity s ys te m in re la tio n to b lo od d on or m an ag em en t • E le m en ts o f a q ua lit y sy st em a s ap pl ie d to bl oo d do no r m an ag em en t • Q ua lit y is su es in d on or m an ag em en t: ─ R ec ru itm en t ─ S el ec tio n ─ B lo od c ol le ct io n ─ D oc um en ta tio n ─ D on or c ar e, sa tis fa ct io n an d re te nt io n • R ol e of th e qu al ity m an ag er • Th e qu al ity s ys te m in bl oo d do no r m an ag em en t s ho ul d fo cu s on th e ac tiv iti es of : ─ R ec ru itm en t ─ S el ec tio n ─ C ol le ct io n ─ D oc um en ta tio n ─ D on or c ar e, sa tis fa ct io n an d re te nt io n • Ac kn ow le dg e an d ex pa nd o n th e di ffe re nc es in a pp ro ac h by d iff er en t B TS s • R eg ul ar lo w -ri sk b lo od do no rs a re th e fo un da tio n of a s af e an d ad eq ua te b lo od s up pl y • D is cu ss th e ro le o f t he qu al ity m an ag er in en su rin g qu al ity in b lo od co lle ct io n • Id en tif y th e ac tio ns re qu ire d to e ns ur e qu al ity in b lo od d on or m an ag em en t • Id en tif y th e ro le o f t he qu al ity m an ag er in en su rin g qu al ity in b lo od do no r m an ag em en t ½ h ou r Q M T 11 .2 D on or re cr ui tm en t an d se le ct io n Pr es en ta ti on To d em on st ra te h ow to ap pl y qu al ity to d on or re cr ui tm en t a nd s el ec tio n • D on or re cr ui tm en t • D on or s el ec tio n • A ss es sm en t • Ap pl yi ng q ua lit y to do no r r ec ru itm en t en su re s th at : ─ T he lo w es t r is k bl oo d do no r p op ul at io ns ar e id en tif ie d ─ T he s af es t d on or s ar e re cr ui te d an d re ta in ed • Ex pl ai n th e im po rta nc e of an a na ly si s of po pu la tio ns to id en tif y gr ou ps to ta rg et o r a vo id • E m ph as iz e th at q ua lit y m ea ns m ee tin g an d ex ce ed in g th e cu st om er ’s ex pe ct at io ns • E ns ur e th at a ll re le va nt W H O re co m m en da tio ns an d gu id el in es a re in cl ud ed in th e pr es en ta tio n • Id en tif y th e qu al ity is su es re la te d to th e pr oc es se s of d on or re cr ui tm en t a nd se le ct io n • Id en tif y th e ac tio n re qu ire d to e ns ur e qu al ity in b lo od d on or re cr ui tm en t a nd se le ct io n • Id en tif y th e ro le o f t he qu al ity m an ag er in bl oo d do no r r ec ru itm en t an d se le ct io n 1 ho ur Q M T 11 .3 D on or re cr ui tm en t an d se le ct io n A ct iv it y To e na bl e pa rti ci pa nt s to ex am in e th e be ne fit s of in tro du ci ng a q ua lit y sy st em in b lo od d on or re cr ui tm en t a nd s el ec tio n ac tiv iti es • Q ua lit y aw ar en es s tra in in g of th e st af f i n do no r r ec ru itm en t a nd se le ct io n • D on or re cr ui tm en t s ta ff sh ou ld u nd er st an d th e im pa ct o f q ua lit y on th e B TS • D is cu ss th e ad ve rs e af fe ct o f p oo r d on or re cr ui tm en t s tra te gi es an d at tit ud es • Ex pl ai n th e im po rta nc e of q ua lit y in b lo od d on or re cr ui tm en t a nd se le ct io n 1 ho ur Q M T/ Co re C ou rs e M at er ia ls 49 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 11 .4 Bl oo d co lle ct io n Pr es en ta ti on To d em on st ra te h ow to ap pl y qu al ity to b lo od co lle ct io n • P re -d on at io n ch ec ks o f eq ui pm en t a nd m at er ia ls • D on or id en tif ic at io n • D on or a rm c le an si ng • Ve ne pu nc tu re a nd co lle ct io n • C ar e of th e do no r • H an dl in g of d on at io ns an d sa m pl es • Q ua lit y is su es a t m ob ile do no r s es si on s • Q ua lit y in b lo od co lle ct io n pr ot ec ts th e do no r a nd th e re ci pi en t • Q ua lit y in b lo od co lle ct io n en su re s th e qu al ity o f t he p ro du ct • In tro du ce th e to pi c in a ve ry b ro ad w ay • B e aw ar e of s ig ni fic an t di ffe re nc es b et w ee n co un tri es in th e w ay in w hi ch b lo od is c ol le ct ed • Ke ep th e fo cu s on q ua lit y as pe ct s of b lo od co lle ct io n • D is cu ss th e ad di tio na l pr ob le m s in a pp ly in g qu al ity in m ob ile d on or se ss io ns • Id en tif y th e qu al ity is su es re la te d to th e pr oc es s of b lo od co lle ct io n • Id en tif y sp ec ifi c qu al ity is su es re la te d to b lo od co lle ct io n at m ob ile do no r s es si on s • Id en tif y th e ac tio n re qu ire d to e ns ur e qu al ity in b lo od co lle ct io n • Id en tif y th e ro le o f t he qu al ity m an ag er in en su rin g qu al ity in b lo od co lle ct io n ¾ h ou r Q M T 11 .5 Bl oo d co lle ct io n A ct iv it y To e na bl e pa rti ci pa nt s to ex am in e th e be ne fit s of in tro du ci ng a q ua lit y sy st em to b lo od c ol le ct io n ac tiv iti es • Th e ro le o f t he q ua lit y m an ag er in b lo od co lle ct io n • M on ito rin g of b lo od co lle ct io n ac tiv iti es • Ap pl yi ng s ta nd ar d pr oc ed ur es to c ol le ct io n ac tiv iti es • Tr ai ni ng o f b lo od co lle ct io n st af f • E ns ur e th e pa rti ci pa nt s cl ea rly u nd er st an d th e ro le o f t he q ua lit y m an ag er in b lo od co lle ct io n • Ex pl ai n th e im po rta nc e of g oo d qu al ity in b lo od co lle ct io n • Ex pl ai n th e ro le o f t he qu al ity m an ag er in bl oo d co lle ct io n 1 ho ur Q M T 11 .6 D ev el op in g a do cu m en ta tio n sy st em fo r b lo od do no r m an ag em en t Pr es en ta ti on To d em on st ra te h ow to de ve lo p an e ffe ct iv e do cu m en ta tio n sy st em fo r bl oo d do no r m an ag em en t • Ty pe s an d le ve ls o f do cu m en ts re qu ire d • Tr ac ea bi lit y – do no r t o do na tio n • C on fid en tia lit y • M on ito rin g an d ev al ua tio n • E ac h ac tiv ity in th e do no r c lin ic , a nd th e ou tc om e of e ac h ac tiv ity , s ho ul d be do cu m en te d • A do cu m en ta tio n sy st em e na bl es th e B TS to m an ag e th e bl oo d do no r p ro gr am m e e. g. ─ A ss is ts in d on or re ca ll an d re te nt io n ─ E ns ur es tr ac ea bi lit y ─ R ec or ds a nd an al yz es s uc ce ss es an d fa ilu re s ─ A ss is ts in e rro r an al ys is • Ke ep th e fo cu s on th e ne ed fo r s im pl ic ity o f a ll re co rd s • D is cu ss w hy tr ac ea bi lit y is e ss en tia l • Em ph as iz e th e im po rta nc e of co nf id en tia lit y • A pp ly th e pr in ci pl es o f do cu m en ta tio n in q ua lit y sy st em s to b lo od d on or m an ag em en t • Ex pl ai n th e ne ed fo r tra ce ab ilit y ½ h ou r Q M T/ Co re C ou rs e M at er ia ls 50 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 11 .7 D on or c ar e, sa tis fa ct io n an d re te nt io n Pr es en ta ti on To e m ph as iz e th e im po rta nc e of h ig h qu al ity do no r c ar e in e ns ur in g do no r s at is fa ct io n an d re te nt io n • D on or c ar e • D on or s at is fa ct io n • D on or re te nt io n • D on or c om pl ai nt s • Th e qu al ity s ys te m sh ou ld e ns ur e th at th e do no r i s tre at ed a s an im po rta nt c us to m er • D on or s at is fa ct io n an d re te nt io n ar e di re ct ly in flu en ce d by th e qu al ity of d on or c ar e • C om pl ai nt s m us t b e fo rm al ly in ve st ig at ed bo th to s at is fy th e do no r an d to c rit ic al ly e xa m in e B TS p ra ct ic e • In tro du ce th e co nc ep t o f th e do no r a s a cu st om er • Em ph as iz e th e im po rta nc e of re co gn iz in g an d un de rs ta nd in g do no rs ’ ne ed s • Ex pl ai n ho w h ig h qu al ity do no r c ar e pr om ot es do no r s at is fa ct io n w hi ch le ad s to re te nt io n • Id en tif y th e ac tio ns re qu ire d to e ns ur e hi gh qu al ity d on or c ar e • Ex pl ai n th e ro le o f t he qu al ity m an ag er in en su rin g do no r sa tis fa ct io n ½ h ou r Q M T 11 .8 D on or s at is fa ct io n A ct iv it y • To e nc ou ra ge pa rti ci pa nt s to e xa m in e an y as pe ct s of th e do no r s el ec tio n an d bl oo d co lle ct io n pr oc es s th at m ay le ad to d on or di ss at is fa ct io n • To a ss is t p ar tic ip an ts to ex am in e th os e as pe ct s of a q ua lit y sy st em th at w ou ld p ro m ot e do no r sa tis fa ct io n • Th e im po rta nc e of do no r s at is fa ct io n • C om m un ic at io n be tw ee n th e do no r a nd th e B TS • D on or s at is fa ct io n is es se nt ia l t o ac hi ev e re te nt io n of v ol un ta ry do no rs • A ll st af f n ee d to b e aw ar e of th e im po rta nc e of d on or s at is fa ct io n • E m ph as iz e th at d on or sa tis fa ct io n ca n be v er y de pe nd en t u po n st af f at tit ud e an d re sp on si ve ne ss • Ac kn ow le dg e th e ne ed fo r s pe ci al iz ed co m m un ic at io n sk ills in th e bl oo d do no r c lin ic • Ex pl ai n ho w a q ua lit y fo cu se d ap pr oa ch c an pl ay a m aj or p ar t i n en su rin g bl oo d do no r sa tis fa ct io n ½ h ou r Q M T 11 .9 Id en tif yi ng a nd m on ito rin g cr iti ca l co nt ro l p oi nt s in bl oo d do no r m an ag em en t A ct iv it y To id en tif y th e cr iti ca l co nt ro l p oi nt s fo r as se ss in g th e pr oc es se s in bl oo d do no r m an ag em en t • U si ng fl ow ch ar ts to id en tif y cr iti ca l c on tro l po in ts in th e pr oc es s of bl oo d do no r m an ag em en t • Id en tif yi ng in di ca to rs an d to ol s fo r m on ito rin g an d co nt ro llin g th e bl oo d do no r m an ag em en t p ro ce ss • Th e se le ct io n of d on or s is th e fir st s te p in en su rin g th e sa fe ty o f th e bl oo d su pp ly • Th e qu al ity o f t he b lo od co lle ct io n pr oc es s m ay di re ct ly a ffe ct th e qu al ity of th e ra w m at er ia l • Em ph as iz e th e re as on s fo r m on ito rin g • E ns ur e th at a pp ro pr ia te m on ito rin g to ol s ar e id en tif ie d • Fo cu s on th e ke y in di ca to rs • Id en tif y th e cr iti ca l co nt ro l p oi nt s in th e pr oc es s of b lo od d on or m an ag em en t • Id en tif y in di ca to rs a nd ap pr op ria te to ol s fo r m on ito rin g th e cr iti ca l co nt ro l p oi nt s in th e pr oc es s of b lo od d on or m an ag em en t 1½ h ou r Q M T/ Co re C ou rs e M at er ia ls 51 DE CL AS SIF IED M od ul e 12 Q ua lit y Sy st em s in L ab or at or y Te st in g Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 12 .1 In tro du ct io n to qu al ity s ys te m s in la bo ra to ry te st in g Pr es en ta ti on To re vi ew th e el em en ts o f a qu al ity s ys te m in re la tio n to la bo ra to ry te st in g • E le m en ts o f a q ua lit y sy st em a s ap pl ie d to la bo ra to ry te st in g • Q ua lit y is su es in la bo ra to ry te st in g: ─ E qu ip m en t ─ S am pl es ─ S el ec tio n an d us e of re ag en ts a nd te st k its ─ Q ua lit y co nt ro l ─ L ab or at or y do cu m en ts ─ H an dl in g of te st re su lts • A q ua lit y sy st em is es se nt ia l i n th e la bo ra to ry to e ns ur e th e co rre ct re su lts fo r t he co rre ct d on at io n/ do no r an d pa tie nt • Th e qu al ity s ys te m in th e la bo ra to ry s ho ul d co ve r: ─ O rg an iz at io n an d st af f ─ F ac ilit ie s an d eq ui pm en t ─ R ea ge nt s/ te st k its ─ D oc um en ta tio n ─ S am pl es ─ H an dl in g of te st re su lts ─ Q ua lit y co nt ro l ─ A ss es sm en t • E m ph as iz e th at a ll la bo ra to rie s ha ve s im ila r qu al ity n ee ds • Id en tif y th e ac tio ns re qu ire d to e ns ur e qu al ity in la bo ra to ry te st in g • Id en tif y th e ro le o f t he qu al ity m an ag er in en su rin g qu al ity in la bo ra to ry te st in g ½ h ou r Q M T 12 .2 Ev al ua tio n an d us e of im m un o- ha em at ol og y re ag en ts Pr es en ta ti on To d em on st ra te h ow to ap pl y qu al ity to th e ev al ua tio n an d us e of im m un oh ae m at ol og y re ag en ts • D ef in iti on s • Se le ct io n an d ev al ua tio n • Va lid at io n • C on tro l d ur in g ro ut in e us e • S el ec tio n of im m un o- ha em at ol og y re ag en ts is a p ro ce ss th at n ee ds to b e pl an ne d ca re fu lly • Th e ch ar ac te ris tic s th at sh ou ld b e ex am in ed in cl ud e sp ec ifi ci ty , se ns iti vi ty , p ot en cy , av id ity • O ve ra ll pe rfo rm an ce de pe nd s up on a nu m be r o f f ac to rs , in cl ud in g m et ho do lo gy an d st af f • Te st in g ne ed s an d th e re so ur ce s av ai la bl e to m ee t t ho se n ee ds m us t be ta ke n in to a cc ou nt in se le ct io n of re ag en ts • B e aw ar e of th e lim ita tio ns o n pr oc ur em en t i n di ffe re nt co un tri es • P ro m ot e th e id ea l w ith a n ac ce pt an ce o f t he re al ity • Id en tif y th e ac tio ns re qu ire d to e ns ur e qu al ity in th e ev al ua tio n an d us e of im m un oh ae m at ol og y re ag en ts • Id en tif y th e ro le o f t he qu al ity m an ag er in th e ev al ua tio n an d us e of im m un oh ae m at ol og y re ag en ts ¾ h ou r Q M T/ Co re C ou rs e M at er ia ls 52 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 12 .3 Ev al ua tio n an d us e of te st k its fo r tra ns fu si on - tra ns m is si bl e in fe ct io ns Pr es en ta ti on To d em on st ra te h ow to ap pl y qu al ity to e va lu at io n an d us e of te st k its fo r tra ns fu si on -tr an sm is si bl e in fe ct io ns (T TI s) • D ef in iti on s • Se le ct io n an d ev al ua tio n • Va lid at io n • C on tro l d ur in g ro ut in e us e • Th e ba si c pr in ci pl es o f se le ct io n an d ev al ua tio n ap pl y to a ll as sa ys u se d in th e B TS • B at ch te st in g is es se nt ia l • O th er fa ct or s in flu en ce ch oi ce ─ C on st ra in ts ─ R es ou rc es • B e aw ar e of th e lim ita tio ns o n pr oc ur em en t i n di ffe re nt co un tri es • P ro m ot e th e id ea l w ith a n ac ce pt an ce o f t he re al ity • D em on st ra te th e po te nt ia l f al se e co no m y of u si ng c he ap te st k its • Id en tif y th e ac tio ns re qu ire d to e ns ur e qu al ity in th e ev al ua tio n an d us e of T TI te st k its • Id en tif y th e ro le o f t he qu al ity m an ag er in th e ev al ua tio n an d us e of TT I t es t k its ¾ h ou r Q M T 12 .4 Se le ct in g re ag en ts an d te st k its A ct iv it y To p ro vi de p ra ct ic e in se le ct in g re ag en ts a nd te st ki ts fo r s pe ci fie d ac tiv iti es • G en er al c rit er ia fo r se le ct in g re ag en ts a nd te st k its • Id en tif yi ng th e co rre ct re ag en ts a nd te st k its to us e • Im po rta nc e of s el ec tin g hi gh q ua lit y, c os t- ef fe ct iv e re ag en ts a nd te st k its • C on st ra in ts o n th e se le ct io n of id ea l re ag en ts a nd te st k its • Se le ct io n is d ec id in g "fi tn es s fo r p ur po se " • Em ph as iz e th e ba la nc e be tw ee n w ha t i s ne ed ed an d w ha t i s av ai la bl e • En co ur ag e di sc us si on ov er d iff er en t w ay s to so lv e pr ob le m s • An al ys e re qu ire m en ts an d lis t k ey c rit er ia fo r se le ct in g te st k its a nd /o r re ag en ts 1½ h ou rs Q M T 12 .5 D ev el op in g a do cu m en ta tio n sy st em fo r t he la bo ra to ry Pr es en ta ti on To d em on st ra te h ow to de ve lo p an e ffe ct iv e do cu m en ta tio n sy st em in th e la bo ra to ry • E ss en tia l do cu m en ta tio n in th e la bo ra to ry • La bo ra to ry re co rd s • R ec or di ng a nd an al ys in g la bo ra to ry da ta • La bo ra to ry do cu m en ta tio n is es se nt ia l f or tr ac ea bi lit y • La bo ra to rie s pr od uc e la rg e am ou nt s of d at a • D at a sh ou ld b e an al ys ed a nd u se d to im pr ov e la bo ra to ry pe rfo rm an ce • C la rif y th e in fo rm at io n th at n ee ds to b e do cu m en te d • G iv e ex am pl es o f di ffe re nt ty pe s of do cu m en ta tio n • Id en tif y th e ty pe s of do cu m en ts th at a re re qu ire d in th e la bo ra to ry • Li st th e es se nt ia l la bo ra to ry re co rd s th at sh ou ld b e m ai nt ai ne d • Id en tif y th e da ta th at sh ou ld b e an al ys ed to en su re c on tin uo us im pr ov em en t ¾ h ou r Q M T 12 .6 E xt er na l Q ua lit y A ss es sm en t (E Q A ) s ch em es Pr es en ta ti on To p ro m ot e th e pa rti ci pa tio n of B TS la bo ra to rie s in a pp ro pr ia te E Q A s ch em es • P rin ci pl es o f E Q A • O bj ec tiv es o f E Q A • B en ef its o f E Q A • O rg an iz at io n an d pr oc es s of E Q A • W H O E Q A s ch em es • Ex te rn al q ua lit y as se ss m en t p ro vi de s co nf id en ce in th e ov er al l pe rfo rm an ce in th e la bo ra to ry • E Q A is o ne o f t he to ol s us ed to m on ito r a nd im pr ov e qu al ity • G iv e ex am pl es o f na tio na l a nd in te rn at io na l sc he m es • En co ur ag e pa rti ci pa tio n in E Q A s ch em es • Li st th e ob je ct iv es a nd be ne fit s of E Q A • D ef in e th e ro le o f E Q A in a q ua lit y sy st em • Id en tif y th e ro le o f t he qu al ity ¾ h ou r Q M T/ Co re C ou rs e M at er ia ls 53 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 12 .7 Id en tif yi ng a nd m on ito rin g cr iti ca l co nt ro l p oi nt s in la bo ra to ry te st in g A ct iv it y To id en tif y th e cr iti ca l co nt ro l p oi nt s fo r as se ss in g an d co nt ro llin g th e pr oc es se s in th e te st in g la bo ra to ry • U si ng fl ow ch ar ts to id en tif y cr iti ca l c on tro l po in ts in th e pr oc es se s in th e te st in g la bo ra to ry • In di ca to rs a nd to ol s fo r m on ito rin g an d co nt ro llin g th e pr oc es se s in th e la bo ra to ry • En su rin g a w el l-d ef in ed flo w o f w or k in th e la bo ra to ry le ad s to im pr ov ed q ua lit y • Th e la bo ra to ry en vi ro nm en t p ro vi de s m uc h da ta fo r a na ly si s an d us e as in di ca to rs • In di ca to rs in th e la bo ra to ry s ho ul d be m on ito re d th ro ug h th e us e of S P C • Em ph as iz e th e ne ed fo r w el l-d ef in ed fl ow ch ar ts • Em ph as iz e th e re as on s fo r m on ito rin g an d an al ys in g da ta in th e la bo ra to ry • Fo cu s on th e ke y in di ca to rs • Id en tif y th e cr iti ca l co nt ro l p oi nt s in th e pr oc es se s in th e te st in g la bo ra to ry • Id en tif y in di ca to rs a nd ap pr op ria te to ol s fo r m on ito rin g th e cr iti ca l co nt ro l p oi nt s 1½ h ou rs Q M T/ Co re C ou rs e M at er ia ls 54 DE CL AS SIF IED M od ul e 13 Q ua lit y Sy st em s in C om po ne nt P ro du ct io n an d M an ag em en t Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 13 .1 In tro du ct io n to qu al ity s ys te m s in bl oo d co m po ne nt pr od uc tio n an d m an ag em en t Pr es en ta ti on To re vi ew th e el em en ts o f a qu al ity s ys te m in re la tio n to b lo od c om po ne nt pr od uc tio n an d m an ag em en t • E le m en ts o f a q ua lit y sy st em a s ap pl ie d to bl oo d co m po ne nt pr od uc tio n an d m an ag em en t • Q ua lit y is su es in b lo od co m po ne nt p ro du ct io n an d m an ag em en t: ─ E qu ip m en t ─ S el ec tio n of m et ho do lo gy ─ L ab el lin g ─ Q ua ra nt in e an d re le as e ─ B lo od s to ck m an ag em en t ─ S to ra ge a nd tra ns po rta tio n ─ I ss ue o f b lo od co m po ne nt s ─ D oc um en ts ─ Q ua lit y m on ito rin g • A ll th e ac tiv iti es as so ci at ed w ith th e pr oc es si ng o f b lo od co m po ne nt s m us t b e w el l-c on tro lle d an d fu lly do cu m en te d • Q ua lit y sy st em s m us t be in p la ce to e ns ur e th at : ─ U nt es te d or un su ita bl e bl oo d co m po ne nt s ar e se gr eg at ed fr om th os e th at a re su ita bl e fo r u se ─ B lo od c om po ne nt s ar e st or ed a nd tra ns po rte d in a w ay th at p re ve nt s de te rio ra tio n ─ B lo od s to ck s ar e ad eq ua te ly m an ag ed • R em em be r t ha t s om e B TS s do n ot p re pa re co m po ne nt s • Pr ov id e ex am pl es o f pr od uc t s pe ci fic at io ns • R ei nf or ce th e us e of flo w ch ar ts in a na ly si ng pr oc es se s • Id en tif y th e ac tio ns re qu ire d to e ns ur e qu al ity in b lo od co m po ne nt p ro du ct io n an d m an ag em en t • Id en tif y th e ro le o f t he qu al ity m an ag er in en su rin g qu al ity in b lo od co m po ne nt p ro du ct io n an d m an ag em en t ¾ h ou r Q M T 13 .2 Q ua lit y m on ito rin g of b lo od co m po ne nt pr od uc tio n Pr es en ta ti on To d em on st ra te h ow to ap pl y qu al ity m on ito rin g in bl oo d co m po ne nt pr od uc tio n an d m an ag em en t • S pe ci fic at io ns • In co m in g bl oo d un its • P ro du ct m on ito rin g • M on ito rin g pl an s • An al ys is a nd u se o f re su lts • Th e pu rp os e of m on ito rin g is to a ns w er th e ba si c qu es tio n – ar e w e pr od uc in g w ha t w e ar e m ea nt to b e pr od uc in g? • Th e pa ra m et er s to b e m on ito re d ne ed to b e m at ch ed to th e pr od uc t an d its in te nd ed u se • M on ito rin g is a to ol to ge ne ra te d at a – po si tiv e or n eg at iv e – to fe ed ba ck in to th e pr oc es s • M on ito rin g is a n in te gr al pa rt of a ny p ro du ct io n pr oc es s • Ke ep th e em ph as is o n G M P • Id en tif y w ha t n ee ds to be m on ito re d to e ns ur e qu al ity in b lo od co m po ne nt p ro du ct io n an d m an ag em en t • Id en tif y th e ro le o f t he qu al ity m an ag er in qu al ity m on ito rin g ¾ h ou r Q M T/ Co re C ou rs e M at er ia ls 55 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 13 .3 Ev al ua tio n an d m on ito rin g of bl oo d co m po ne nt pr od uc tio n ac tiv iti es A ct iv it y To p ro vi de p ra ct ic e in an al ys in g co m po ne nt pr od uc tio n ac tiv iti es a nd id en tif yi ng a pp ro pr ia te m on ito rin g m et ho ds • Id en tif yi ng th e m on ito rin g po in ts av ai la bl e • Id en tif yi ng m on ito rin g st ra te gi es a nd ev al ua tio n m et ho ds • C rit ic al c on tro l p oi nt s in th e pr oc es s ne ed to b e id en tif ie d • E ns ur e th at th e te rm s "m on ito rin g" a nd "e va lu at io n" a re c le ar ly un de rs to od • E ns ur e th e pl an s ar e fe as ib le • E ns ur e th e pl an s do n ot in te rfe re w ith th e w or kf lo w • O ut lin e th e pr in ci pl es o f m on ito rin g an d ev al ua tio n of co m po ne nt p ro du ct io n • Pr ep ar e a pl an fo r m on ito rin g an d ev al ua tio n of co m po ne nt s 1½ h ou rs Q M T 13 .4 Q ua ra nt in e an d re le as e Pr es en ta ti on To d em on st ra te h ow to de ve lo p sy st em s fo r qu ar an tin e an d re le as e • Pr in ci pl es • Q ua ra nt in e • R el ea se • R es po ns ib ilit y • C on ce ss io ns • D oc um en ta tio n • Al l d on at ed b lo od sh ou ld b e pl ac ed in qu ar an tin e on re ce ip t fro m c ol le ct io n te am s • Th er e sh ou ld b e cl ea r ph ys ic al s eg re ga tio n of te st ed a nd u nt es te d pr od uc ts • R es po ns ib le p er so ns ne ed to b e id en tif ie d w ho c an a ut ho riz e th e re le as e of p ro du ct s • A c on ce ss io n sy st em m ay b e ne ed ed in de fin ed c irc um st an ce s • Ex pl or e th e is su e of re sp on si bi lit y fo r r el ea se • Ex pl ai n th e im po rta nc e of q ua ra nt in e an d re le as e • Li st th e ke y el em en ts o f an e ffe ct iv e qu ar an tin e an d re le as e sy st em • Id en tif y th e ro le o f t he qu al ity m an ag er in qu ar an tin e an d re le as e ¾ h ou r Q M T 13 .5 St or ag e an d tra ns po rta tio n of bl oo d co m po ne nt s Pr es en ta ti on To d em on st ra te h ow to ap pl y qu al ity in th e st or ag e an d tra ns po rta tio n of b lo od co m po ne nt s • St or ag e • Pa ck ag in g • Tr an sp or ta tio n • M ai nt en an ce o f t he bl oo d co ld c ha in • D oc um en ta tio n • St or ag e an d tra ns po rta tio n ne ed to be c on tro lle d to e ns ur e th e qu al ity o f p ro du ct s is m ai nt ai ne d fro m d on or to p at ie nt , f ro m "v ei n to ve in " • Th e bl oo d co ld c ha in ne ed s to b e m ai nt ai ne d • Tr an sp or ta tio n co nd iti on s ar e es pe ci al ly im po rta nt • M on ito rin g is e ss en tia l • Fo cu s on th e ne ed to pr ot ec t t he p ro du ct fr om "v ei n to v ei n" • Ex pl or e di ffe re nt m et ho ds o f t ra ns po rti ng pr od uc ts to m ai nt ai n th e bl oo d co ld c ha in • Id en tif y th e ac tio ns re qu ire d to e ns ur e qu al ity in s to ra ge a nd tra ns po rta tio n • Ex pl ai n w ha t i s m ea nt by th e bl oo d co ld c ha in • D es cr ib e th e el em en ts of a n ef fe ct iv e bl oo d co ld c ha in • Id en tif y th e ro le o f t he qu al ity m an ag er in en su rin g qu al ity in st or ag e an d di st rib ut io n ½ h ou r Q M T/ Co re C ou rs e M at er ia ls 56 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 13 .6 St or ag e an d tra ns po rta tio n of bl oo d co m po ne nt s A ct iv it y To p ro vi de p ra ct ic e in de ve lo pi ng s ta nd ar ds a nd po lic ie s fo r t he s to ra ge , tra ns po rta tio n an d di st rib ut io n of b lo od co m po ne nt s • Q ua ra nt in e an d re le as e pr oc ed ur es • Bl oo d co ld c ha in m ai nt en an ce • S ec ur ity d ur in g tra ns po rta tio n • Al l s ta ff sh ou ld b e m ad e aw ar e of th e im pa ct o f po or q ua lit y du rin g st or ag e, tr an sp or ta tio n an d di st rib ut io n of b lo od pr od uc ts • Ex pl or e al l p os si bl e sc en ar io s, k ee pi ng in m in d th at m an y co un tri es do n ot h av e th e re so ur ce s av ai la bl e to co un tri es in th e de ve lo pe d w or ld • D ev el op s ta nd ar ds fo r st or ag e, tr an sp or ta tio n an d di st rib ut io n • Li st th e do cu m en ts re qu ire d to e ns ur e a qu al ity a pp ro ac h 1 ho ur Q M T 13 .7 B lo od s to ck m an ag em en t Pr es en ta ti on To d em on st ra te h ow to ap pl y qu al ity to b lo od s to ck m an ag em en t • Im po rta nc e of b lo od st oc k m an ag em en t • M an ag in g bl oo d st oc ks • M an ag in g flu ct ua tio ns in su pp ly a nd d em an d • M in im um b lo od s to ck le ve ls • D oc um en ta tio n • Th e pr op er m an ag em en t o f s to ck is es se nt ia l f or th e B TS to be a bl e to p ro vi de cl in ic al u se rs w ith su ffi ci en t p ro du ct s • S to ck m an ag em en t in cl ud es th e m an ag em en t o f t he ot he r f ac to rs th at c an af fe ct th e st oc ks o f bl oo d • M in im um s to ck le ve ls an d ac tio ns to b e ta ke n to re pl en is h st oc ks n ee d to b e de fin ed • S tre ss th e im po rta nc e of m an ag in g st oc ks to en su re th e av ai la bi lit y of de si re d co m po ne nt s or pa rti cu la r b lo od g ro up s at a ll tim es • Ex pl or e th e is su e of re tu rn in g bl oo d fo r re -u se • H ig hl ig ht th e im po rta nc e of m in im iz in g th e nu m be r o f b lo od u ni ts th at e xp ire • Ex pl ai n th e im po rta nc e of m an ag in g bl oo d st oc ks • Id en tif y th e ac tio ns re qu ire d to e ns ur e th at bl oo d st oc ks a re m an ag ed e ffe ct iv el y • Id en tif y th e ro le o f t he qu al ity m an ag er in en su rin g ef fe ct iv e bl oo d st oc k m an ag em en t ¾ h ou r Q M T 13 .8 D ev el op in g a do cu m en ta tio n sy st em fo r b lo od co m po ne nt pr od uc tio n Pr es en ta ti on To d em on st ra te h ow to de ve lo p an e ffe ct iv e do cu m en ta tio n sy st em fo r bl oo d co m po ne nt pr od uc tio n • W ha t t o do cu m en t • Ty pe s of d oc um en ts • La be llin g • Tr ac ea bi lit y • A do cu m en ta tio n sy st em is a n es se nt ia l re qu is ite • G M P gu id el in es s ho ul d be fo llo w ed • Al l p ro ce ss in g an d as so ci at ed a ct iv iti es ne ed to b e do cu m en te d • Th e la be llin g of pr od uc ts is a c rit ic al ar ea w ith th e po te nt ia l fo r m aj or e rro rs if n ot ef fe ct iv el y co nt ro lle d • C la rif y th e in fo rm at io n th at n ee ds to b e do cu m en te d • G iv e ex am pl es o f t he di ffe re nt ty pe s of do cu m en ta tio n • Id en tif y th e in fo rm at io n th at n ee ds to b e do cu m en te d • Id en tif y th e ba si c la be llin g re qu ire m en ts on b lo od p ro du ct s ½ h ou r Q M T/ Co re C ou rs e M at er ia ls 57 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 13 .9 Id en tif yi ng a nd m on ito rin g cr iti ca l co nt ro l p oi nt s in bl oo d co m po ne nt pr od uc tio n A ct iv it y To id en tif y th e cr iti ca l co nt ro l p oi nt s fo r m on ito rin g bl oo d co m po ne nt p ro du ct io n • U si ng fl ow ch ar ts to id en tif y cr iti ca l c on tro l po in ts in b lo od co m po ne nt p ro du ct io n • In di ca to rs a nd to ol s fo r m on ito rin g an d co nt ro llin g bl oo d co m po ne nt p ro du ct io n • Th e pr in ci pl es o f q ua lit y sy st em s an d G M P sh ou ld b e ap pl ie d to th e pr od uc tio n of b lo od co m po ne nt s • S P C a ss is ts in m on ito rin g an d co nt ro llin g th e pr oc es se s in b lo od co m po ne nt p ro du ct io n • Em ph as iz e th e re as on s fo r m on ito rin g • E ns ur e th e ap pr op ria te m on ito rin g to ol s ar e id en tif ie d • Fo cu s on th e ke y in di ca to rs • Id en tif y th e cr iti ca l co nt ro l p oi nt s in th e pr oc es se s at w hi ch m on ito rin g sh ou ld ta ke pl ac e • Id en tif y in di ca to rs a nd to ol s fo r m on ito rin g 1½ h ou rs Q M T/ Co re C ou rs e M at er ia ls 58 DE CL AS SIF IED M od ul e 14 Q ua lit y Sy st em s an d th e Cl in ic al I nt er fa ce Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 14 .1 In tro du ct io n to qu al ity s ys te m s at th e cl in ic al in te rfa ce Pr es en ta ti on To re vi ew th e el em en ts o f a qu al ity s ys te m in re la tio n to th e cl in ic al in te rfa ce • D ef in iti on o f t he c lin ic al in te rfa ce • E le m en ts o f a q ua lit y sy st em a s ap pl ie d to th e cl in ic al in te rfa ce • Q ua lit y is su es a t t he cl in ic al in te rfa ce : ─ I m po rta nc e of a n ef fe ct iv e cl in ic al in te rfa ce ─ R ol e of th e BT S/ ho sp ita l b lo od ba nk ─ H os pi ta l t ra ns fu si on pr oc es s ─ A pp ro pr ia te c lin ic al us e of b lo od • Th e ne ed fo r q ua lit y co nt in ue s af te r t he bl oo d le av es th e BT S • Th e BT S ha s an im po rta nt ro le in en su rin g th e qu al ity o f th e cl in ic al tr an sf us io n pr oc es s • Th e ne ed s of b ot h th e pa tie nt a nd th e cl in ic ia n m us t b e co ns id er ed in de te rm in in g ho w to en su re c us to m er sa tis fa ct io n • Th e qu al ity s ys te m o f do cu m en ta tio n ex te nd s to th e cl in ic al in te rfa ce • A ll st af f i nv ol ve d in th e cl in ic al in te rfa ce re qu ire tra in in g • E ffe ct iv e co m m un ic at io n is re qu ire d be tw ee n th e BT S an d th e ho sp ita l • Ac kn ow le dg e th e di ffe re nt re la tio ns hi ps be tw ee n BT Ss a nd ho sp ita ls in d iff er en t co un tri es • R ef er to W H O re co m m en da tio ns a nd le ar ni ng m at er ia ls o n th e cl in ic al u se o f b lo od • Id en tif y th e ac tio ns re qu ire d to e ns ur e qu al ity a t t he c lin ic al in te rfa ce • Id en tif y th e ro le o f t he qu al ity m an ag er in en su rin g qu al ity a t t he cl in ic al in te rfa ce ½ h ou r Q M T 14 .2 Po lic y an d gu id el in es o n th e cl in ic al u se o f bl oo d Pr es en ta ti on To d em on st ra te h ow a po lic y an d gu id el in es o n th e cl in ic al u se o f b lo od ca n im pr ov e th e qu al ity o f cl in ic al tr an sf us io n pr ac tic e • Po lic y on th e cl in ic al us e of b lo od • G ui de lin es o n th e ap pr op ria te c lin ic al u se of b lo od • Th e ro le o f t he B TS in th e de ve lo pm en t o f a na tio na l p ol ic y an d gu id el in es o n th e ap pr op ria te c lin ic al u se of b lo od • Th e ro le o f a h os pi ta l tra ns fu si on c om m itt ee • Th e BT S sh ou ld p la y a ke y ro le in th e de ve lo pm en t o f a na tio na l p ol ic y an d gu id el in es o n th e cl in ic al us e of b lo od , i n co lla bo ra tio n w ith na tio na l h ea lth au th or iti es a nd c lin ic al sp ec ia lis ts • Tr an sf us io n co m m itt ee s, bo th n at io na l a nd ho sp ita l-b as ed , n ee d to be fo rm ed to e ns ur e ef fe ct iv e po lic y m ak in g an d m on ito rin g • R ef er to W H O re co m m en da tio ns a nd ot he r r el ev an t m at er ia l, in cl ud in g le ar ni ng m at er ia ls : T he C lin ic al U se o f B lo od • Pr ov id e ex am pl es o f na tio na l p ol ic ie s • Ex pl ai n th e im po rta nc e of th e ap pr op ria te cl in ic al u se o f b lo od fo r sa fe tr an sf us io n • Id en tif y th e ac tio ns re qu ire d to p ro m ot e th e ap pr op ria te c lin ic al u se of b lo od • Id en tif y th e ro le o f t he B TS in p ro m ot in g th e ap pr op ria te c lin ic al u se of b lo od ¾ h ou r Q M T/ Co re C ou rs e M at er ia ls 59 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 14 .3 R ol e of th e B TS a t th e cl in ic al in te rfa ce A ct iv it y To e xp lo re th e ro le o f t he B TS a t t he c lin ic al in te rfa ce • Th e BT S ha s an im po rta nt ro le to p la y in th e ap pr op ria te c lin ic al us e of b lo od • En su rin g th e ap pr op ria te c lin ic al u se of b lo od re qu ire s ef fe ct iv e co lla bo ra tio n be tw ee n th e BT S an d pr es cr ib er s of b lo od • Th e B TS /h os pi ta l co m m un ic at io n lin k is a tw o- w ay p ro ce ss • C on tin uo us q ua lit y im pr ov em en t r eq ui re s qu al ity d at a fro m ho sp ita ls s up pl ie d by th e B TS • D is cu ss d iff er en t ap pr oa ch es to e ns ur e th e "q ua lit y" u se o f b lo od pr od uc ts • D es cr ib e th e ro le o f t he B TS a t t he c lin ic al in te rfa ce • Li st th e pl ay er s in es ta bl is hi ng q ua lit y at th e cl in ic al in te rfa ce 1 ho ur Q M T 14 .4 D oc um en ta tio n in th e ho sp ita l tra ns fu si on pr oc es s Pr es en ta ti on To d em on st ra te h ow a n ef fe ct iv e do cu m en ta tio n sy st em c an b e us ed to im pr ov e th e ho sp ita l tra ns fu si on p ro ce ss • In fo rm at io n to b e re co rd ed • Th e im po rta nc e of do cu m en ta tio n in th e ho sp ita l t ra ns fu si on pr oc es s • U si ng d oc um en ta tio n in th e ho sp ita l t ra ns fu si on pr oc es s fo r im pr ov em en t o f a ll as pe ct s of b lo od tra ns fu si on • A ll st ag es o f t he tra ns fu si on m us t b e do cu m en te d, fr om th e tim e th e pa tie nt is id en tif ie d an d th e sa m pl e ta ke n to th e tim e th e tra ns fu si on is co m pl et ed • N ot in g al l s ta ff in vo lv ed he lp s to id en tif y tra in in g ne ed s an d cl ar ify e rro rs • Em ph as iz e th e im po rta nc e of fu ll tra ce ab ilit y of d on at io ns • Fo cu s on th e la ck o f tra ce ab ilit y if re co rd s ar e in co m pl et e or in ac cu ra te • Id en tif y th e in fo rm at io n th at n ee ds to b e do cu m en te d in re la tio n to th e ho sp ita l tra ns fu si on p ro ce ss • Id en tif y th e ac tio ns re qu ire d to e st ab lis h an ef fe ct iv e sy st em fo r do cu m en tin g th e ho sp ita l t ra ns fu si on pr oc es s • Id en tif y th e ro le o f t he BT S in d ev el op in g an ef fe ct iv e sy st em fo r do cu m en tin g th e ho sp ita l t ra ns fu si on pr oc es s ½ h ou r Q M T 14 .5 D es ig ni ng a b lo od re qu es t f or m A ct iv it y To d et er m in e th e ke y in fo rm at io n re qu ire d to id en tif y a pa tie nt a nd hi s/ he r b lo od n ee ds • R el ev an t c lin ic al in fo rm at io n • Si m pl ify in g do cu m en ta tio n to fo cu s on ly o n th at w hi ch is ne ed ed • Id en tif yi ng w ho s ho ul d de si gn a b lo od re qu es t fo rm • Tr an sf us io n sh ou ld o nl y oc cu r w he n cl in ic al ly in di ca te d • P at ie nt d et ai ls m us t b e co m pl et ed a cc ur at el y to en su re c or re ct id en tif ic at io n • R em in d pa rti ci pa nt s of th e im po rta nc e of th e ba si c in fo rm at io n re qu ire d • Em ph as iz e th e im po rta nc e of le gi bi lit y • D is cu ss re le va nt a nd irr el ev an t i nf or m at io n • Li st th e es se nt ia l in fo rm at io n re qu ire d on a bl oo d re qu es t f or m • Ex pl ai n w hy th is in fo rm at io n is re qu ire d • Pr od uc e an a pp ro pr ia te an d ef fe ct iv e bl oo d re qu es t f or m 1 ho ur Q M T/ Co re C ou rs e M at er ia ls 60 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 14 .6 Q ua lit y in th e ho sp ita l tra ns fu si on pr oc es s Pr es en ta ti on To id en tif y th e ro le o f t he BT S in e ns ur in g qu al ity in th e ho sp ita l t ra ns fu si on pr oc es s • H os pi ta l t ra ns fu si on pr oc es s • P os iti ve id en tif ic at io n • St or ag e of b lo od co m po ne nt s • R eq ue st s fo r b lo od • R es po ns ib ilit ie s of th e co m pa tib ilit y te st in g la bo ra to ry • A dm in is tra tio n of b lo od • R ol e of th e B TS /b lo od ba nk • Th e B TS h as a re sp on si bi lit y to e ns ur e th at h os pi ta ls u si ng it s pr od uc ts m ee t q ua lit y st an da rd s in tr an sf us io n pr ac tic e • Th e B TS s ho ul d as si st ho sp ita ls to d ev el op po lic ie s an d S O P s fo r ea ch s ta ge o f t he cl in ic al tr an sf us io n pr oc es s • S tre ss th e im po rta nc e of th e ro le o f t he B TS in th e tra ns fu si on p ro ce ss • E m ph as iz e th e ro le o f a do cu m en ta tio n sy st em in en su rin g pa tie nt , sp ec im en a nd p ro du ct id en tif ic at io n • Id en tif y th e ac tio ns re qu ire d to e ns ur e qu al ity in th e ho sp ita l tra ns fu si on p ro ce ss • Id en tif y th e ro le o f t he BT S/ bl oo d ba nk in en su rin g qu al ity in th e ho sp ita l t ra ns fu si on pr oc es s • Id en tif y th e ro le o f t he qu al ity m an ag er in en su rin g qu al ity in th e ho sp ita l t ra ns fu si on pr oc es s ¾ h ou r Q M T 14 .7 Q ua lit y in th e ho sp ita l tra ns fu si on pr oc es s A ct iv it y To id en tif y ke y qu al ity as pe ct s of tr an sf us io n re qu es ts a nd ad m in is tra tio n of b lo od pr od uc ts • S am pl e id en tif ic at io n • P at ie nt id en tif ic at io n • P ro du ct id en tif ic at io n • Th e B TS h as a n ac tiv e ro le in e ns ur in g qu al ity at th e be ds id e • C or re ct s am pl e fro m th e co rre ct p at ie nt • C or re ct p ro du ct fo r co rre ct p at ie nt • D is cu ss th e di ffe re nt ap pr oa ch es to e ns ur in g qu al ity a t t he b ed si de • Li st th e do cu m en ts ne ed ed to e ns ur e qu al ity a t t he b ed si de 1 ho ur Q M T 14 .8 M on ito rin g an d ev al ua tio n of th e ho sp ita l tra ns fu si on pr oc es s Pr es en ta ti on To d em on st ra te h ow m on ito rin g an d ev al ua tio n ca n be u se d to im pr ov e th e qu al ity o f t he h os pi ta l tra ns fu si on p ro ce ss • M on ito rin g an d ev al ua tio n • In di ca to rs • An al ys in g an d us in g da ta fo r i m pr ov em en t i n al l a sp ec ts o f b lo od tra ns fu si on • A ll as pe ct s of th e pr oc es s of tr an sf us io n sh ou ld b e m on ito re d an d th e re su lts an al ys ed a nd a ct ed o n • A h os pi ta l t ra ns fu si on co m m itt ee s ho ul d be es ta bl is he d in e ve ry ho sp ita l • Th e BT S an d ho sp ita l bl oo d ba nk s ho ul d be re pr es en te d on th e ho sp ita l t ra ns fu si on co m m itt ee • Th e cl in ic al u se o f b lo od sh ou ld b e m on ito re d us in g de fin ed in di ca to rs • Ill us tra te th e im po rta nc e of m on ito rin g an d fe ed ba ck w ith re fe re nc e to c ro ss m at ch : tra ns fu si on ra tio s • Em ph as iz e th e im po rta nc e of u si ng m on ito rin g da ta to re du ce un ne ce ss ar y tra ns fu si on s • G iv e ex am pl es o f na tio na l m on ito rin g an d re po rti ng s ys te m s • Ex pl ai n ho w d at a fro m m on ito rin g an d ev al ua tio n ca n be u se d to im pr ov e ho sp ita l tra ns fu si on p ra ct ic e • Id en tif y th e ac tio ns re qu ire d to d ev el op a sy st em fo r t he m on ito rin g an d ev al ua tio n of th e ho sp ita l t ra ns fu si on pr oc es s • Id en tif y th e ro le o f t he B TS in th e m on ito rin g an d ev al ua tio n of th e ho sp ita l t ra ns fu si on pr oc es s 1 ho ur Q M T/ Co re C ou rs e M at er ia ls 61 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 14 .9 H ae m ov ig ila nc e Pr es en ta ti on To p ro m ot e th e de ve lo pm en t o f a n at io na l re po rti ng s ys te m fo r ad ve rs e tra ns fu si on e ve nt s • D ef in iti on • Pr in ci pl e • R eq ui re m en ts • B en ef its • To b e ef fe ct iv e ha em ov ig ila nc e re qu ire s op en a nd ho ne st re po rti ng a nd in ve st ig at io n • H ae m ov ig ila nc e de pe nd s up on tra ce ab ilit y in th e ho sp ita l a nd th e BT S • H ae m ov ig ila nc e is a n es se nt ia l p ar t o f t he qu al ity s ys te m in B TS /c lin ic al in te rfa ce • In fo rm at io n is fe d ba ck in to th e tra ns fu si on sy st em to im pr ov e th e ov er al l s af et y an d qu al ity o f t ra ns fu si on pr ac tic e in th e B TS a nd th e ho sp ita l • Em ph as iz e th e im po rta nc e of u si ng th e in fo rm at io n ga th er ed to im pr ov e bl oo d sa fe ty • Ex pl ai n ho w a ha em ov ig ila nc e sy st em ca n he lp to im pr ov e th e qu al ity o f e ve ry a sp ec t of b lo od tr an sf us io n • D es cr ib e th e el em en ts of a h ae m ov ig ila nc e sy st em • Id en tif y th e ac tio ns re qu ire d to e st ab lis h a na tio na l h ae m ov ig ila nc e sy st em • Id en tif y th e ro le o f t he qu al ity m an ag er in de ve lo pi ng a n at io na l ha em ov ig ila nc e sy st em an d ut iliz in g th e da ta to im pr ov e tra ns fu si on pr ac tic e ¾ h ou r Q M T 14 .1 0 Id en tif yi ng a nd m on ito rin g cr iti ca l co nt ro l p oi nt s fo r th e cl in ic al in te rfa ce a nd th e ad m in is tra tio n of bl oo d A ct iv it y To id en tif y cr iti ca l c on tro l po in ts a t t he c lin ic al in te rfa ce a nd p la n sy st em s fo r m on ito rin g • Id en tif yi ng th e m on ito rin g po in ts av ai la bl e • Id en tif yi ng th e m on ito rin g st ra te gi es an d ev al ua tio n m et ho ds • C rit ic al c on tro l p oi nt s in th e pr oc es s m us t b e id en tif ie d • Em ph as iz e th e im po rta nc e of g oo d co m m un ic at io n be tw ee n th e BT S/ bl oo d ba nk a nd th e ho sp ita l • E m ph as iz e th e ro le o f t he ho sp ita l t ra ns fu si on co m m itt ee in e ns ur in g th e sa fe ty o f t he p at ie nt re qu iri ng tr an sf us io n • Id en tif y th e cr iti ca l co nt ro l p oi nt s in th e pr oc es s at w hi ch m on ito rin g sh ou ld ta ke pl ac e • Id en tif y th e ki nd o f m on ito rin g th at s ho ul d ta ke p la ce 1 ho ur Q M T/ Co re C ou rs e M at er ia ls 62 DE CL AS SIF IED M od ul e 15 Fi na liz at io n of P ar ti ci pa nt s’ A ct io n Pl an s an d Co m pl et io n of t he C ou rs e Ti tl e Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 15 .1 R ev ie w o f t he co ur se A ct iv it y To e na bl e pa rti ci pa nt s to id en tif y an y ar ea s w he re cl ar ifi ca tio n/ ad di tio na l w or k is n ee de d • R ev ie w a ny a sp ec ts o f th e co ur se th at re qu ire cl ar ifi ca tio n or a dd iti on al di sc us si on • Id en tif y th e sp ec ifi c is su es • C la rif y/ ex pl ai n, u si ng re le va nt e xa m pl es w he re po ss ib le 1 ho ur Q M T 15 .2 La bo ra to ry /c lin ic vi si ts in B TS A ct iv it y To e xp lo re s pe ci fic a sp ec ts of B TS a ct iv iti es in d et ai l • D et ai le d lo ok a t t he B TS fro m a q ua lit y pe rs pe ct iv e • D is cu ss io n of ap pr oa ch es ta ke n by th e BT S an d th e re as on s fo r t he m • R ev ie w o f a ny a re as o r ac tiv iti es o f s pe ci fic in te re st • E ns ur e as b es t a s po ss ib le th at p ar tic ip an ts ’ in fo rm at io n ne ed s ar e m et 1– 2 ho ur s Q M T 15 .3 C om pl et in g in di vi du al a ct io n pl an s A ct iv it y To e ns ur e ea ch p ar tic ip an t pr od uc es a n ap pr op ria te an d ac hi ev ab le a ct io n pl an • Pr od uc in g an ap pr op ria te a nd re al is tic pl an • P la nn in g: w ha t, ho w of te n an d w he n • D ef in in g th e tim es ca le fo r t he p la n (i. e. s ho rt, m ed iu m a nd lo ng -te rm ) • Pl an s ne ed to b e ap pr op ria te a nd re al is tic • E ns ur e pl an s ar e re al is tic an d ac hi ev ab le • Em ph as iz e th e va lu e of de ve lo pi ng s ho rt, m ed iu m a nd lo ng -te rm pl an s • Id en tif y ne ed s • P re pa re a d ra ft ac tio n pl an fo r t he ir B TS 2– 3 ho ur s Q M T 15 .4 D is cu ss io n of in di vi du al a ct io n pl an s A ct iv it y To a ss is t p ar tic ip an ts in fin al iz in g th ei r a ct io n pl an s • O ve ra ll st re ng th s an d w ea kn es se s of pa rti ci pa nt s’ a ct io n pl an s • Fi na liz at io n of a ct io n pl an s • If po ss ib le , o bt ai n th e in pu t o f t he fa ci lit at or w ho ga ve c om m en ts o n th e dr af t p la ns • G ui de d is cu ss io ns to en su re th ey a re p os iti ve an d co ns tru ct iv e • Pr od uc e an a m en de d ac tio n pl an fo r t he ir B TS 1½ ho ur s Q M T 15 .5 R ev ie w o f q ua lit y sy st em s Pr es en ta ti on To re vi ew th e ro le o f qu al ity in b lo od tr an sf us io n • R ev ie w o f k ey a im s an d pr in ci pl es o f q ua lit y sy st em s • Q ua lit y in a ll B TS ac tiv iti es • A ll B TS a ct iv iti es co nt rib ut e to q ua lit y • Q ua lit y is o nl y as g oo d as th e w ea ke st li nk in th e ch ai n • S um m ar iz e th e ke y el em en ts o f t he c ou rs e • Br in g ev er yt hi ng to a su ita bl e co nc lu si on • O ut lin e th e re as on s fo r es ta bl is hi ng q ua lit y sy st em s in a B TS • Li st th e m aj or e le m en ts in e st ab lis hi ng q ua lit y sy st em s ½ h ou r Q M T/ Co re C ou rs e M at er ia ls 63 DE CL AS SIF IED T it le Te ac hi ng A im Co re T op ic s Ke y Po in ts Te ac hi ng F oc us Le ar ni ng O ut co m es Ti m e Q M T 15 .6 P os t-c ou rs e as se ss m en t A ct iv it y To d et er m in e pa rti ci pa nt s’ le ve ls o f k no w le dg e an d un de rs ta nd in g of q ua lit y an d qu al ity s ys te m s • D et er m in in g pa rti ci pa nt s’ k no w le dg e an d un de rs ta nd in g of qu al ity in c om pa ris on w ith th e pr e- co ur se as se ss m en t • P os t-c ou rs e as se ss m en t i s no t a n ex am in at io n • It w ill he lp s ub se qu en t co ur se s by id en tif yi ng ho w to s tre ng th en a re as of w ea kn es s or g ap s in th e cu rri cu lu m • E ns ur e th at p ar tic ip an ts un de rs ta nd th at th e as se ss m en t i s no t a n ex am in at io n • D em on st ra te in cr ea se d kn ow le dg e an d un de rs ta nd in g of q ua lit y an d qu al ity s ys te m s in th e B TS ½ h ou r Q M T 15 .7 C ou rs e ev al ua tio n A ct iv it y To o bt ai n fe ed ba ck o n th e qu al ity a nd o ve ra ll ef fe ct iv en es s of th e co ur se • Ev al ua tin g th e ef fe ct iv en es s of th e tra in in g, in cl ud in g pr es en ta tio ns , a ct iv iti es , fa ci lit at or s, fa ci lit ie s • H on es t o pi ni on s ar e ne ed ed • Fe ed ba ck is n ee de d ab ou t c ou rs e m et ho ds an d ef fe ct iv en es s • M ak e cl ea r t o th e pa rti ci pa nt s th at th ei r vi ew s ar e ge nu in el y re qu ire d • Fr ee ly e xp re ss th ei r vi ew s an d/ or c on ce rn s ab ou t t he c ou rs e ½ h ou r Q M T 15 .8 Fi na l d is cu ss io ns A ct iv it y To p ro vi de a fo ru m fo r f in al di sc us si on a nd c la rif ic at io n • O ut st an di ng is su es • Fo llo w -u p co ur se s an d ot he r Q M P /Q M T ac tiv iti es • St re ng th en in g th e lin ks an d co lla bo ra tio n be tw ee n th e tra in in g ce nt re a nd o th er co un tri es in th e re gi on • Th e fin al fo ru m fo r di sc us si on • C le ar u p an y ou ts ta nd in g pr ob le m s, q ue rie s or is su es • Id en tif y an y fin al is su es th at re qu ire c la rif ic at io n or d is cu ss io n 1 ho ur Cl os in g Ce re m on y Q M T/ Co re C ou rs e M at er ia ls 64 DE CL AS SIF IED Q U A LI T Y M A N A GE M EN T T RA IN IN G EX A M PL E O F A W EE KL Y PR O GR A M M E O F W O RK W ee k O ne M on da y Tu es da y W ed ne sd ay Th ur sd ay Fr id ay Sa tu rd ay Q M T 1. 1 W H O s tra te gi es fo r bl oo d sa fe ty Q M T 2. 3 In tro du ci ng q ua lit y Q M T 3. 4 D ev el op in g a pr oc es s flo w ch ar t Q M T 4. 5 Jo b de sc rip tio ns , re sp on si bi lit y an d de le ga tio n Q M T 6. 3 W rit in g an S O P Q M T 7. 4 M on ito rin g an d ev al ua tio n of tr ai ni ng Q M T 1. 2 W H O Q ua lit y M an ag em en t P ro gr am m e (Q M P ) f or bl oo d tra ns fu si on se rv ic es Q M T 2. 4 Q ua lit y ch ar ac te ris tic s Q M T 4. 1 M an ag em en t re sp on si bi lit y fo r q ua lit y Q M T 4. 6 W rit in g a jo b de sc rip tio n Q M T 6. 4 V al id at in g an S O P Q M T 8. 1 A ss es sm en t w ith in qu al ity s ys te m s Q M T 1. 3 In tro du ct io n to th e W H O Q M T co ur se Q M T 2 .5 To ur o f t he B lo od Tr an sf us io n C en tre Q M T 4. 2 D ev el op in g a qu al ity po lic y Q M T 4. 7 Th e co st o f q ua lit y Q M T 6. 5 D oc um en t c on tro l Q M T 8 .2 V al id at io n Q M T 1. 4 P ar tic ip an ts ’ ex pe ct at io ns Q M T 3. 1 Q ua lit y sy st em s Q M T 4. 3 O rg an iz at io na l st ru ct ur e an d ro le o f t he qu al ity m an ag er Q M T 5. 1 In tro du ct io n to st an da rd s fo r q ua lit y sy st em s Q M T 6. 6 C on tro lli ng a d oc um en t Q M T 8. 3 P re pa rin g a va lid at io n pl an Q M T 1. 5 P re -c ou rs e as se ss m en t Q M T 3. 2 P ro ce ss es a nd pr oc ed ur es Q M T 4. 4 D ev el op in g an or ga ni gr am Q M T 5. 2 P rin ci pl es o f G oo d M an uf ac tu rin g P ra ct ic e Q M T 7. 1 Tr ai ni ng in th e qu al ity sy st em Q M T 8 .4 M ai nt en an ce a nd ca lib ra tio n of eq ui pm en t Q M T 2 .1 Th e im po rta nc e of qu al ity in th e B TS Q M T 3. 3 Fl ow ch ar tin g as a to ol fo r m ap pi ng p ro ce ss es Q M T 6. 1 D oc um en ta tio n in qu al ity s ys te m s Q M T 7. 2 Tr ai ni ng n ee ds a nd pl an s Q M T 8. 5 D es ig ni ng a m ai nt en an ce a nd ca lib ra tio n pl an Q M T 2. 2 Th e co ns eq ue nc es o f po or q ua lit y in th e B TS Q M T 6. 2 S ta nd ar d op er at in g pr oc ed ur es Q M T 7 .3 C re at in g a tra in in g pl an Q M T/ Co re C ou rs e M at er ia ls 65 DE CL AS S F IED W ee k Tw o M on da y Tu es da y W ed ne sd ay Th ur sd ay Fr id ay Sa tu rd ay Q M T 8. 6 Q ua lit y m on ito rin g to ol s Q M T 8 .1 2 D ev el op in g an a ud it pl an Q M T 9. 3 S te ps in d ev el op in g a qu al ity s ys te m in th e B TS Q M T 1 0. 1 In tro du ct io n to h yg ie ne an d sa fe ty in th e B TS Q M T 1 1. 4 B lo od c ol le ct io n Q M T 1 2. 1 In tro du ct io n to q ua lit y sy st em s in la bo ra to ry te st in g Q M T 8. 7 A na ly zi ng d at a an d m on ito rin g pe rfo rm an ce Q M T 8 .1 3 Id en tif yi ng n on - co m pl ia nc e ag ai ns t a se t o f s ta nd ar ds Q M T 9. 4 C os tin g ac tiv iti es in a B TS Q M T 1 0. 2 H yg ie ne in th e B TS Q M T 1 1. 5 B lo od c ol le ct io n Q M T 1 2. 2 E va lu at io n an d us e of im m un oh ae m at ol og y re ag en ts Q M T 8. 8 E rr or m an ag em en t Q M T 8 .1 4 A ud it of w or k ar ea Q M T 9. 5 P rin ci pl es o f s to ck co nt ro l Q M T 1 0. 3 B io lo gi ca l a nd c he m ic al sa fe ty in th e B TS Q M T 1 1. 6 D ev el op in g a do cu m en ta tio n sy st em fo r bl oo d do no r m an ag em en t Q M T 1 2. 3 E va lu at io n an d us e of te st k its fo r t ra ns fu si on - tra ns m is si bl e in fe ct io ns (T TI s) Q M T 8. 9 P re pa rin g an S O P o n er ro r r ep or tin g Q M T 8 .1 5 A na ly si ng q ua lit y sy st em fa ilu re s Q M T 9. 6 Q ua lit y as pe ct s of co nt in ge nc y pl an ni ng Q M T 1 0. 4 S af et y is su es a nd m in im iz in g ris ks Q M T 1 1. 7 D on or c ar e, s at is fa ct io n an d re te nt io n Q M T 1 2. 4 S el ec tin g re ag en ts a nd te st k its Q M T 8 .1 0 A ud its a nd a ud iti ng Q M T 8 .1 6 M id -c ou rs e as se ss m en t Q M T 9. 7 Q ua lit y st at us a na ly si s Q M T 1 1. 1 In tro du ct io n to q ua lit y sy st em s in b lo od d on or m an ag em en t Q M T 1 1. 8 D on or s at is fa ct io n Q M T 1 2. 5 D ev el op in g a do cu m en ta tio n sy st em fo r t he la bo ra to ry Q M T 8 .1 1 Th e au di t p ro ce ss Q M T 9. 1 Ap pl yi ng q ua lit y m an ag em en t i n th e B TS Q M T 9. 8 P re pa rin g an a ct io n pl an Q M T 11 .2 D on or re cr ui tm en t a nd se le ct io n Q M T 11 .9 Id en tif yi ng a nd m on ito rin g cr iti ca l co nt ro l p oi nt s in b lo od do no r m an ag em en t Q M T 12 .6 Ex te rn al Q ua lit y A ss es sm en t ( E Q A ) sc he m es Q M T 9. 2 Id en tif yi ng c rit ic al co nt ro l p oi nt s an d pr ep ar in g flo w ch ar ts fo r B TS a ct iv iti es Q M T 9. 9 P re pa rin g a dr af t a ct io n pl an Q M T 1 1. 3 D on or re cr ui tm en t a nd se le ct io n Q M T/ Co re C ou rs e M at er ia ls 66 DE CL AS SIF IED W ee k Th re e M on da y Tu es da y W ed ne sd ay Th ur sd ay Fr id ay Sa tu rd ay Q M T 1 2. 7 Id en tif yi ng a nd m on ito rin g cr iti ca l co nt ro l p oi nt s in la bo ra to ry te st in g Q M T 1 3. 5 S to ra ge a nd tra ns po rta tio n of b lo od co m po ne nt s Q M T 1 4. 1 In tro du ct io n to q ua lit y sy st em s at th e cl in ic al in te rfa ce Q M T 1 4. 7 Q ua lit y in th e ho sp ita l tra ns fu si on p ro ce ss Q M T 1 5. 1 R ev ie w o f t he c ou rs e Q M T 1 5. 4 D is cu ss io n of in di vi du al ac tio n pl an s, a s ap pr op ria te Q M T 1 3. 1 In tro du ct io n to q ua lit y sy st em s in b lo od co m po ne nt p ro du ct io n an d m an ag em en t Q M T 1 3. 6 S to ra ge a nd tra ns po rta tio n of b lo od co m po ne nt s Q M T 1 4. 2 P ol ic y an d gu id el in es on th e cl in ic al u se o f bl oo d Q M T 1 4. 8 M on ito rin g an d ev al ua tio n of th e ho sp ita l t ra ns fu si on pr oc es s Q M T 1 5. 2 La bo ra to ry /c lin ic v is its in B TS Q M T 1 5. 5 R ev ie w o f q ua lit y sy st em s Q M T 1 3. 2 Q ua lit y m on ito rin g of bl oo d co m po ne nt pr od uc tio n Q M T 1 3. 7 B lo od s to ck m an ag em en t Q M T 1 4. 3 Th e ro le o f t he B TS a t th e cl in ic al in te rfa ce Q M T 1 4. 9 H ae m ov ig ila nc e Q M T 1 5. 3 C om pl et in g in di vi du al ac tio n pl an s Q M T 1 5. 6 P os t-c ou rs e as se ss m en t Q M T 1 3. 3 E va lu at io n an d m on ito rin g of co m po ne nt p ro du ct io n ac tiv iti es Q M T 1 3. 8 D ev el op in g a do cu m en ta tio n sy st em fo r t he b lo od co m po ne nt s pr od uc tio n Q M T 1 4. 4 D oc um en ta tio n in th e ho sp ita l t ra ns fu si on pr oc es s Q M T 1 4. 10 Id en tif yi ng a nd m on ito rin g cr iti ca l co nt ro l p oi nt s fo r t he cl in ic al in te rfa ce a nd th e ad m in is tra tio n of bl oo d Q M T 1 5. 7 C ou rs e ev al ua tio n Q M T 1 3. 4 Q ua ra nt in e an d re le as e Q M T 1 3. 9 Id en tif yi ng a nd m on ito rin g cr iti ca l co nt ro l p oi nt s in co m po ne nt p ro du ct io n an d th e is su e of b lo od Q M T 1 4. 5 D es ig ni ng a b lo od re qu es t f or m Q M T 1 5. 8 Fi na l d is cu ss io ns Q M T 1 4. 6 Q ua lit y in th e ho sp ita l tra ns fu si on p ro ce ss Q M T/ Co re C ou rs e M at er ia ls 67 DE CL AS SIF IED QUALITY MANAGEMENT TRAINING Participant's Final Report QMT COURSE Quality Training Centre Date of course Course Coordinator Facilitators PARTICIPANT Name Qualifications Length of service Position Organization Address Country Tel. no. Fax. no E-mail QMT/Core Course Materials 68 DE CL AS SIF IED LANGUAGE Course language Participant’s language First Second Third Other ASSESSMENT RESULTS Pre-course assessment Mid-course assessment Post-course assessment FACILITATORS’ OBSERVATIONS Understanding of generic concepts of quality Understanding of quality concepts in relation to the blood transfusion service Participation in group work Action plan QMT/Core Course Materials 69 DE CL AS SIF IED PRIORITIES FOR FOLLOW-UP AND SUPPORT Facilitators’ comments Participant's comments Signed Course Coordinator Date Facilitator(s) Date Participant Date QMT/Core Course Materials 70 DE CL AS SIF IED Q M T GL O SS A RY Th is g lo ss ar y ha s be en p ro du ce d to h el p cl ar ify t he t er m in ol og y an d w or di ng u se d in Q M T m at er ia ls . Th e us e of s pe ci al iz ed t er m in ol og y is co m m on i n qu al ity a nd i t is e ss en tia l th at a ll w or ds a nd p hr as es u se d ar e cl ea rly d ef in ed t o en su re t ha t th er e is n o m is un de rs ta nd in g or co nf us io n ab ou t t he ir us e. It is , h ow ev er , a ck no w le dg ed th at d ef in iti on s ar e of te n a so ur ce o f i nt en se d eb at e. C on se qu en tly , a cc ep te d de fin iti on s fro m IS O 9 00 0 (2 00 0) a re us ed , t og et he r w ith a lte rn at iv e de fin iti on s w he re th ey e xi st a nd a re p re se nt ed in a s im pl er a nd m or e m ea ni ng fu l w ay . H ow ev er , n ot a ll of th e te rm s us ed w ith in th e m at er ia ls a re d ef in ed w ith in th e m os t r ec en t I S O s ta nd ar d; in th es e ca se s, th e m os t c om m on ly a cc ep te d de fin iti on s ha ve be en u se d. In s itu at io ns w he re th er e is a ny d ou bt a bo ut th e m ea ni ng o f a ny o f t he te rm s us ed w ith in th e m at er ia ls , t he d ef in iti on g iv en in th is gl os sa ry s ho ul d be a pp lie d. A cc re di ta ti on P ro ce ss b y w hi ch a n in de pe nd en t a nd a ut ho riz ed a ge nc y ce rti fie s th e qu al ity a nd c om pe te nc e of a n or ga ni za tio n on th e ba si s of c er ta in p re de fin ed s ta nd ar ds A cc ur ac y A gr ee m en t b et w ee n th e re su lts o bt ai ne d an d th e tru e va lu e A ud it S ys te m at ic , i nd ep en de nt a nd d oc um en te d ex am in at io n to d et er m in e w he th er a ct iv iti es c om pl y w ith a p la nn ed a nd ag re ed q ua lit y sy st em S ys te m at ic , i nd ep en de nt a nd d oc um en te d pr oc es s fo r o bt ai ni ng e vi de nc e an d ev al ua tin g it ob je ct iv el y to d et er m in e th e ex te nt to w hi ch a ud it cr ite ria a re fu lfi lle d – IS O 9 00 0 (2 00 0) A ud it c lie nt P er so n or o rg an iz at io n re qu es tin g an a ud it – IS O 9 00 0 (2 00 0) A ud it c on cl us io ns O ut co m e of a n au di t d ec id ed b y th e au di t t ea m a fte r c on si de ra tio n of a ll th e au di t f in di ng s – IS O 9 00 0 (2 00 0) A ud it c ri te ri a S et o f p ol ic ie s, p ro ce du re s or re qu ire m en ts a ga in st w hi ch c ol le ct ed a ud it ev id en ce is c om pa re d – IS O 9 00 0 (2 00 0) A ud it e vi de nc e R ec or ds , v er ifi ed s ta te m en ts o f f ac t o r o th er in fo rm at io n re le va nt to th e au di t – IS O 9 00 0 (2 00 0) A ud it f in di ng s Id en tif ie d co m pl ia nc es a nd n on -c om pl ia nc es a ga in st th e st an da rd s us ed fo r t he a ud it R es ul ts o f t he e va lu at io n of th e co lle ct ed a ud it ev id en ce a ga in st a ud it cr ite ria – IS O 9 00 0 (2 00 0) A ud it p ro gr am m e S et o f a ud its to b e ca rr ie d ou t d ur in g a pl an ne d tim ef ra m e – IS O 9 00 0 (2 00 0) A ud it s co pe E xt en t o r r an ge o f a g iv en a ud it – IS O 9 00 0 (2 00 0) Q M T/ Co re C ou rs e M at er ia ls 71 DE CL AS SIF IED A ud it t ea m Th e in di vi du al (s ) p er fo rm in g th e au di t O ne o r m or e au di to rs c on du ct in g an a ud it, o ne o f w ho m is a pp oi nt ed a s le ad er – IS O 9 00 0 (2 00 0) A ud it ee P ro ce ss , d ep ar tm en t, or ga ni za tio n be in g au di te d O rg an iz at io n be in g au di te d – IS O 9 00 0 (2 00 0) A ud it or P er so n qu al ifi ed a nd c om pe te nt to c on du ct a ud its – IS O 9 00 0 (2 00 0) Be nc hm ar ki ng Th e st ud y of a c om pe tit or 's p ro du ct o r b us in es s pr ac tic es in o rd er to im pr ov e th e pe rfo rm an ce o f o ne 's o w n co m pa ny Bl oo d co ld c ha in Th e m ai nt ai ne d st or ag e of b lo od a nd p ro du ct s at th e ap pr op ria te s to ra ge te m pe ra tu re a nd c on di tio ns fr om th e po in t of c ol le ct io n to th e po in t o f u se – "f ro m v ei n to v ei n" Ca lib ra ti on Th e se t o f o pe ra tio ns w hi ch e st ab lis h, u nd er s pe ci fie d co nd iti on s, th e re la tio ns hi p be tw ee n va lu es in di ca te d by a m ea su rin g in st ru m en t o r m ea su rin g sy st em , o r v al ue s re pr es en te d by a m at er ia l m ea su re , a nd th e co rr es po nd in g kn ow n va lu es o f a re fe re nc e st an da rd Ca pa bi lit y A bi lit y of a n or ga ni za tio n, s ys te m o r p ro ce ss to re al iz e a pr od uc t t ha t f ul fil s th e re qu ire m en ts fo r t ha t p ro du ct – IS O 9 00 0 (2 00 0) CE O C hi ef e xe cu tiv e of fic er Ch ar ac te ri st ic D is tin gu is hi ng fe at ur e – IS O 9 00 0 (2 00 0) Cl in ic al i nt er fa ce Th e re la tio ns hi p be tw ee n th e pr od uc er s an d us er s of b lo od a nd b lo od p ro du ct s Co m pl ia nc e M ee tin g re qu ire d st an da rd s Co nc es si on A ut ho riz at io n to u se o r r el ea se a p ro du ct th at d oe s no t c on fo rm to s pe ci fie d re qu ire m en ts – IS O 9 00 0 (2 00 0) Co nf or m it y Fu lfi lm en t o f a re qu ire m en t – IS O 9 00 0 (2 00 0) Co ns is te nc y D oi ng th e sa m e th in g tim e af te r t im e, w hi ch m ak es th e ou tc om e m or e pr ed ic ta bl e an d al lo w s fo r r ed uc ed v ar ia tio n in pr od uc ts a nd p ro ce ss es Co nt in uo us q ua lit y im pr ov em en t Th e on go in g im pr ov em en t p ro ce ss a t t he c en tre o f a ll qu al ity s ys te m s: p la n, d o, c he ck a nd a ct , a s en ca ps ul at ed in th e D em in g C yc le Co nt ra ct Fo rm al a gr ee m en t o f i nt en tio n to s up pl y a pr od uc t o r s er vi ce in a cc or da nc e w ith a gr ee d sp ec ifi ca tio ns Co nt ra ct r ev ie w S ys te m at ic a ct iv iti es c ar rie d ou t b y th e pu rc ha se r t o en su re th at c on tra ct ua l r eq ui re m en ts h av e be en m et Q M T/ Co re C ou rs e M at er ia ls 72 DE CL AS SIF IED Co rr ec ti on R em ed ia l a ct io n ta ke n to re ct ify a n on -c om pl ia nc e or o th er s itu at io n in w hi ch a n er ro r h as o cc ur re d A ct io n ta ke n to e lim in at e a de te ct ed n on co nf or m ity – IS O 9 00 0 (2 00 0) Co rr ec ti ve a ct io n A ct io n ta ke n to e lim in at e th e ca us e of a d et ec te d no nc on fo rm ity o r o th er u nd es ira bl e si tu at io n – IS O 9 00 0 (2 00 0) Cr it ic al c on tr ol p oi nt s Th os e st ep s in a p ro ce ss o r p ro ce du re th at , w ith ou t c on tro l, w ill le ad to a p oo r q ua lit y ou tc om e Cu st om er O rg an iz at io n or p er so n th at u se s a pr od uc t o r s er vi ce O rg an iz at io n or p er so n th at re ce iv es a p ro du ct – IS O 9 00 0 (2 00 0) Cu st om er d is sa ti sf ac ti on C us to m er ’s o pi ni on o f t he d eg re e to w hi ch a tr an sa ct io n ha s fa ile d to m ee t t he c us to m er ’s n ee ds a nd e xp ec ta tio ns – IS O 9 00 0 (2 00 0) Cu st om er s at is fa ct io n C us to m er ’s o pi ni on o f t he d eg re e to w hi ch a tr an sa ct io n ha s m et th e cu st om er ’s n ee ds a nd e xp ec ta tio ns – IS O 90 00 (2 00 0) D ef ec t Fa ilu re o f a p ro du ct o r p ro ce du re to m ee t p ar t o r a ll of it s gi ve n sp ec ifi ca tio n N on -fu lfi lm en t o f a re qu ire m en t r el at ed to a n in te nd ed o r s pe ci fie d us e – IS O 9 00 0 (2 00 0) D em in g cy cl e Th e P la n- D o- C he ck -A ct C yc le D ep en da bi lit y C ol le ct iv e te rm u se d to d es cr ib e th e av ai la bi lit y pe rfo rm an ce a nd it s in flu en ci ng fa ct or s: re lia bi lit y pe rfo rm an ce , m ai nt ai na bi lit y pe rfo rm an ce a nd m ai nt en an ce s up po rt pe rfo rm an ce – IS O 9 00 0 (2 00 0) D es ig n an d de ve lo pm en t S et o f p ro ce ss es th at tr an sf or m s re qu ire m en ts in to s pe ci fie d ch ar ac te ris tic s an d in to th e sp ec ifi ca tio n of th e pr od uc t re al iz at io n pr oc es s – IS O 9 00 0 (2 00 0) D ev ia ti on p er m it A ut ho riz at io n to d ep ar t f ro m th e or ig in al ly s pe ci fie d re qu ire m en ts o f a p ro du ct p rio r t o re al iz at io n, fo r a li m ite d qu an tit y of p ro du ct o r p er io d of ti m e, a nd fo r a s pe ci fic u se – IS O 9 00 0 (2 00 0) D oc um en ta ti on W rit te n po lic ie s, in st ru ct io ns a nd re co rd s in vo lv ed in p ro vi di ng a p ro du ct o r s er vi ce In fo rm at io n an d its s up po rt m ed iu m – IS O 9 00 0 (2 00 0) D oc um en t co nt ro l Fo rm al c on tro l o f t he is su e, u se a nd re vi ew o f a ut ho riz ed d oc um en ts w ith in th e qu al ity s ys te m Ef fe ct iv en es s M ea su re o f t he e xt en t t o w hi ch p la nn ed a ct iv iti es a re re al iz ed a nd p la nn ed re su lts a ch ie ve d – IS O 9 00 0 (2 00 0) Ef fi ci en cy R el at io ns hi p be tw ee n th e re su lt ac hi ev ed a nd th e re so ur ce s us ed – IS O 9 00 0 (2 00 0) EQ A S E xt er na l q ua lit y as se ss m en t s ch em e Q M T/ Co re C ou rs e M at er ia ls 73 DE CL AS SIF IED Er ro r A n in ci de nt w he re th e qu al ity s ys te m h as fa ile d Ev al ua ti on Th e sp ec ifi c se le ct io n pr oc es s to d et er m in e th e su ita bi lit y of a p ro ce du re o r m at er ia l ( e. g. re ag en t, bl oo d pa ck , eq ui pm en t) Ex te rn al q ua lit y as se ss m en t (E Q A ) Th e ex te rn al a ss es sm en t o f a la bo ra to ry ’s p er fo rm an ce u si ng s am pl es o f k no w n, b ut u nd is cl os ed , v al ue s an d co m pa ris on w ith th e pe rfo rm an ce o f o th er la bo ra to rie s Ex te rn al q ua lit y as se ss m en t sc he m e (E Q A S) A re co gn iz ed s ch em e fo r o rg an iz in g E Q A . T hi s ca n be a lo ca l s ch em e or o rg an iz ed a t n at io na l, re gi on al o r in te rn at io na l l ev el s Fi tn es s fo r pu rp os e S ui ta bi lit y of a p ro du ct o r s er vi ce fo r t he p ur po se fo r w hi ch it is in te nd ed GL P G oo d la bo ra to ry p ra ct ic e GM P G oo d m an uf ac tu rin g pr ac tic e Go od m an uf ac tu ri ng p ra ct ic e Th at p ar t o f q ua lit y as su ra nc e w hi ch e ns ur es th at p ro du ct s ar e co ns is te nt ly p ro du ce d an d co nt ro lle d to th e qu al ity st an da rd s ap pr op ria te fo r t he ir in te nd ed u se a nd le ga l r eq ui re m en ts Gu id el in es D oc um en t s ta tin g re co m m en da tio ns o r s ug ge st io ns – IS O 9 00 0 (2 00 0) H ae m ov ig ila nc e Th e m on ito rin g, re po rti ng a nd in ve st ig at io n of a dv er se in ci de nt s/ ne ar m is se s re la te d to a ll bl oo d tra ns fu si on ac tiv iti es In di ca to r In fo rm at io n ga th er ed d ire ct ly o r i nd ire ct ly a t t he c rit ic al c on tro l p oi nt s in a p ro ce ss o r p ro ce du re In fr as tr uc tu re S ys te m o f p er m an en t f ac ilit ie s an d eq ui pm en t o f a n or ga ni za tio n – IS O 9 00 0 (2 00 0) In sp ec ti on C on fo rm ity e va lu at io n by o bs er va tio n an d ju dg em en t a cc om pa ni ed , a s ap pr op ria te b y m ea su re m en t, te st in g or ga ug in g – IS O 9 00 0 (2 00 0) In te re st ed p ar ty P er so n or g ro up h av in g an in te re st in th e pe rfo rm an ce o r s uc ce ss o f a n or ga ni za tio n – IS O 9 00 0 (2 00 0) In te rn al q ua lit y as se ss m en t (I Q A ) Th e as se ss m en t o f a la bo ra to ry ’s o ve ra ll qu al ity s ys te m b y th e pr oc es s of h al vi ng a s am pl e, a na ly si ng e ac h ha lf in th e sa m e m an ne r a nd c om pa rin g th e re su lts IS O In te rn at io na l O rg an is at io n fo r S ta nd ar di sa tio n M an ag em en t C oo rd in at ed a ct iv iti es to d ire ct a nd c on tro l a n or ga ni za tio n – IS O 9 00 0 (2 00 0) M an ag em en t sy st em S ys te m to e st ab lis h po lic y an d ob je ct iv es a nd to a ch ie ve th os e ob je ct iv es Q M T/ Co re C ou rs e M at er ia ls 74 DE CL AS SIF IED M ea su re m en t S et o f o pe ra tio ns h av in g th e ob je ct o f d et er m in in g th e va lu e of a q ua nt ity – IS O 9 00 0 (2 00 0) M ea su re m en t pr oc es s S et o f i nt er re la te d re so ur ce s, a ct iv iti es , a nd in flu en ce s re la te d to a m ea su re m en t – IS O 9 00 0 (2 00 0) M on it or in g Th e (o n- go in g/ co nt in ua l) co lle ct io n an d an al ys is o f d at a ab ou t a n ac tiv ity N on -c om pl ia nc e N ot m ee tin g re qu ire d st an da rd s (G M P ). S ee a ls o N on co nf or m ity N on co nf or m it y N on -fu lfi lm en t o f a re qu ire m en t – IS O 9 00 0 (2 00 0) O bj ec ti ve e vi de nc e D at a su pp or tin g th e ex is te nc e or v er ity o f s om et hi ng – IS O 9 00 0 (2 00 0) O rg an iz at io n G ro up o f p eo pl e an d fa ci lit ie s w ith a n or de rly a rr an ge m en t o f r es po ns ib ili tie s, a ut ho rit ie s an d re la tio ns hi ps – IS O 9 00 0 (2 00 0) O rg an iz at io na l st ru ct ur e O rd er ly a rr an ge m en t o f r es po ns ib ili tie s, a ut ho rit ie s an d re la tio ns hi ps b et w ee n pe op le – IS O 9 00 0 (2 00 0) Po lic y A h ig h- le ve l o ve ra ll do cu m en t e m br ac in g th e ge ne ra l g oa ls a nd in te nt io ns o f a n or ga ni za tio n Pr ec is io n R ep ro du ci bi lit y of th e qu an tif ia bl e ou tc om es o f p ro ce ss es a nd p ro ce du re s Pr ev en ti ve a ct io n A ct io n ta ke n to p re ve nt th e re cu rr en ce o f p ot en tia l n on -c on fo rm ity , d ef ec t o r o th er c au se o f e rr or A ct io n ta ke n to e lim in at e th e ca us e of a p ot en tia l n on co nf or m ity o r o th er p ot en tia lly u nd es ira bl e si tu at io n – IS O 9 00 0 (2 00 0) Pr oc ed ur e S pe ci fic a ct iv ity th at fo rm s th e ba si c un it of a p ro ce ss S pe ci fie d w ay to c ar ry o ut a n ac tiv ity o r a p ro ce ss – IS O 9 00 0 (2 00 0) Pr oc es s A s er ie s of s te ps o r a ct io ns th at le ad to a d es ire d re su lt or o ut pu t S ys te m o f a ct iv iti es w hi ch u se s re so ur ce s to tr an sf or m in pu ts in to o ut pu ts – IS O 9 00 0 (2 00 0) Pr od uc t R es ul t o f a p ro ce ss – IS O 9 00 0 (2 00 0) Pr oj ec t U ni qu e pr oc es s co ns is tin g of a s et o f c oo rd in at ed a nd c on tro lle d ac tiv iti es w ith s ta rt an d fin is h da te s un de rta ke n to ac hi ev e an o bj ec tiv e co nf or m in g to s pe ci fic re qu ire m en ts in cl ud in g th e co ns tra in ts o f t im e, c os t a nd re so ur ce s – IS O 9 00 0 (2 00 0) Q A S Q ua lit y as se ss m en t s ch em e Q M T/ Co re C ou rs e M at er ia ls 75 DE CL AS SIF IED Q ua lif ic at io n C om bi na tio n of p er so na l a ttr ib ut es , m in im um e du ca tio n, tr ai ni ng , w or k an d au di t e xp er ie nc e, a nd c om pe te nc ie s po ss es se d by a n in di vi du al C om bi na tio n of p er so na l a ttr ib ut es , m in im um e du ca tio n, tr ai ni ng , w or k an d au di t e xp er ie nc e, a nd c om pe te nc ie s po ss es se d by a n au di to r – IS O 9 00 0 (2 00 0) Q ua lit y To ta lit y of c ha ra ct er is tic s of a n en tit y th at b ea r o n its a bi lit y to s at is fy s ta te d an d im pl ie d ne ed s A bi lit y of a s et o f i nh er en t c ha ra ct er is tic s of a p ro du ct , s ys te m o r p ro ce ss to fu lfi l r eq ui re m en ts o f c us to m er s an d ot he r i nt er es te d pa rti es – IS O 9 00 0 (2 00 0) Q ua lit y as su ra nc e Th e ov er al l r an ge o f a ct iv iti es a nd s ys te m s th at p ro vi de c on fid en ce w ith in th e or ga ni za tio n an d au th or iti es th at a ll qu al ity re qu ire m en ts a re m et P ar t o f q ua lit y m an ag em en t f oc us ed o n pr ov id in g co nf id en ce th at q ua lit y re qu ire m en ts a re fu lfi lle d – IS O 9 00 0 (2 00 0) Q ua lit y ch ar ac te ri st ic In he re nt c ha ra ct er is tic o f a p ro du ct , p ro ce ss o r s ys te m d er iv ed fr om re qu ire m en t – IS O 9 00 0 (2 00 0) Q ua lit y co nt ro l C he ck s pu t i n pl ac e to e ns ur e th at p ro ce ss es , p ro ce du re s an d pr od uc ts m ee t t he q ua lit y re qu ire m en ts P ar t o f q ua lit y m an ag em en t f oc us ed o n fu lfi lli ng q ua lit y re qu ire m en ts – IS O 9 00 0 (2 00 0) Q ua lit y de pa rt m en t Th e id en tif ie d an d au th or iz ed d ep ar tm en t w ith in a n or ga ni za tio n re sp on si bl e fo r t he o ve ra ll de ve lo pm en t, or ga ni za tio n an d m an ag em en t o f q ua lit y an d qu al ity s ys te m s Q ua lit y ev al ua ti on S ys te m at ic e xa m in at io n of th e ex te nt to w hi ch a n en tit y is c ap ab le o f f ul fil lin g sp ec ifi ed re qu ire m en ts P ro gr es si on in th e pr in ci pl es o f a q ua lit y sy st em fr om in sp ec tio n, q ua lit y co nt ro l, qu al ity a ss ur an ce , t ot al q ua lit y m an ag em en t Q ua lit y im pr ov em en t P ar t o f q ua lit y m an ag em en t f oc us ed o n in cr ea si ng e ffe ct iv en es s an d ef fic ie nc y – IS O 9 00 0 (2 00 0) Q ua lit y lo op o r qu al it y sp ir al C on ce pt ua l m od el o f i nt er ac tin g ac tiv iti es th at in flu en ce q ua lit y at th e va rio us s ta ge s fro m id en tif ic at io n of th e ne ed s to th e as se ss m en t o f s at is fa ct io n Q ua lit y m an ag em en t C oo rd in at ed a ct iv iti es to d ire ct a nd c on tro l a n or ga ni za tio n w ith re ga rd to q ua lit y – IS O 9 00 0 (2 00 0) Q ua lit y m an ag em en t sy st em S ys te m to e st ab lis h a qu al ity p ol ic y an d qu al ity o bj ec tiv es a nd to a ch ie ve th os e ob je ct iv es – IS O 9 00 0 (2 00 0) Q ua lit y m an ag er Th e ap po in te d, re sp on si bl e an d au th or iz ed in di vi du al w ith in a n or ga ni za tio n w ith th e re sp on si bi lit y fo r d ev el op in g an d m an ag in g th e qu al ity s ys te m Q ua lit y m an ua l D oc um en t s pe ci fy in g th e qu al ity m an ag em en t s ys te m o f a n or ga ni za tio n – IS O 9 00 0 (2 00 0) Q M T/ Co re C ou rs e M at er ia ls 76 DE CL AS SIF IED Q ua lit y ob je ct iv e S om et hi ng s ou gh t, or a im ed fo r, re la te d to q ua lit y – IS O 9 00 0 (2 00 0) Q ua lit y of fi ce r A n in di vi du al w ho w or ks w ith in th e qu al ity d ep ar tm en t o f a n or ga ni za tio n an d w ho is p rim ar ily c on ce rn ed w ith th e da y- to -d ay o pe ra tio n an d m ai nt en an ce o f t he q ua lit y sy st em Q ua lit y pl an D oc um en t s pe ci fy in g th e qu al ity m an ag em en t s ys te m e le m en ts a nd th e re so ur ce s to b e ap pl ie d in a s pe ci fic c as e – IS O 9 00 0 (2 00 0) Q ua lit y pl an ni ng P ar t o f q ua lit y m an ag em en t f oc us ed o n se tti ng q ua lit y ob je ct iv es a nd s pe ci fy in g ne ce ss ar y op er at io na l p ro ce ss es an d re la te d re so ur ce s to fu lfi l t he q ua lit y ob je ct iv es – IS O 9 00 0 (2 00 0) Q ua lit y po lic y O ve ra ll in te nt io ns a nd d ire ct io n of a n or ga ni za tio n re la te d to q ua lit y as e xp re ss ed b y to p m an ag em en t – IS O 9 00 0 (2 00 0) Q ua lit y re qu ir em en t R eq ui re m en t f or in he re nt c ha ra ct er is tic s of a p ro du ct , p ro ce ss o r s ys te m – IS O 9 00 0 (2 00 0) Q ua lit y sy st em O rg an iz at io na l s tru ct ur e, p ro ce ss es , p ro ce du re s an d re so ur ce s ne ed ed to im pl em en t q ua lit y re qu ire m en ts Q ua ra nt in e N on -a ut ho riz at io n to p ro ce ed to n ex t s ta ge o f a p ro ce ss u nt il sp ec ifi ed s ta nd ar ds / co nd iti on s ar e m et Re co rd D oc um en t s ta tin g re su lts a ch ie ve d or p ro vi di ng e vi de nc e of a ct iv iti es p er fo rm ed – IS O 9 00 0 (2 00 0) Re le as e A ut ho riz at io n to p ro ce ed to n ex t s ta ge o f a p ro ce ss – IS O 9 00 0 (2 00 0) Re pa ir A ct io n ta ke n on a n on -c on fo rm in g pr od uc t t o m ak e it co nf or m to th e re qu ire m en ts Re qu ir em en t E xp re ss io n of n ee d as d ef in ed q ua nt ita tiv e or q ua lit at iv e re qu ire m en ts N ee d or e xp ec ta tio n th at is s ta te d, c us to m ar ily im pl ie d or o bl ig at or y – IS O 9 00 0 (2 00 0) Re sp on si bl e pe rs on A n in di vi du al fo rm al ly d es ig na te d as b ei ng re sp on si bl e fo r t he q ua lit y of d ef in ed o pe ra tio ns o r o ut co m es w ith in a n or ga ni za tio n Re vi ew A ct iv ity u nd er ta ke n to e ns ur e th e su ita bi lit y, a de qu ac y, e ffe ct iv en es s an d ef fic ie nc y of th e su bj ec t m at te r t o ac hi ev e es ta bl is he d ob je ct iv es – IS O 9 00 0 (2 00 0) Se rv ic e In ta ng ib le p ro du ct th at is th e re su lt of a t l ea st o ne a ct iv ity p er fo rm ed a t t he in te rfa ce b et w ee n th e su pp lie r a nd cu st om er – IS O 9 00 0 (2 00 0) So ft wa re In te lle ct ua l p ro du ct c on si st in g of in fo rm at io n on a s up po rt m ed iu m – IS O 9 00 0 (2 00 0) SO P - S ta nd ar d op er at in g pr oc ed ur e Q M T/ Co re C ou rs e M at er ia ls 77 DE CL AS SIF IED Sp ec if ic at io n D oc um en t s ta tin g re qu ire m en ts – IS O 9 00 0 (2 00 0) St an da rd M in im um le ve l r eq ui re d St an da rd o pe ra ti ng p ro ce du re W rit te n in st ru ct io ns fo r t he p er fo rm an ce o f a s pe ci fic p ro ce du re Su pp lie r O rg an iz at io n or p er so n th at p ro vi de s a pr od uc t – IS O 9 00 0 (2 00 0) Sy st em S et o f i nt er re la te d or in te ra ct in g el em en ts – IS O 9 00 0 (2 00 0) Te ch ni ca l ex pe rt P er so n w ho p ro vi de s sp ec ifi c kn ow le dg e or e xp er tis e w ith re sp ec t t o a pa rti cu la r s ub je ct fi el d to b e au di te d – IS O 9 00 0 (2 00 0) Te st Te ch ni ca l o pe ra tio n th at c on si st s of th e de te rm in at io n of o ne o r m or e ch ar ac te ris tic s of a g iv en p ro du ct , p ro ce ss o r se rv ic e ac co rd in g to a s pe ci fie d pr oc ed ur e – IS O 9 00 0 (2 00 0) To p m an ag em en t P er so n or g ro up o f p eo pl e w ho d ire ct a nd c on tro l a n or ga ni za tio n at th e hi gh es t l ev el – IS O 9 00 0 (2 00 0) To ta l qu al it y m an ag em en t M an ag em en t a pp ro ac h of a n or ga ni za tio n ce nt re d on q ua lit y ba se d on th e pa rti ci pa tio n of a ll its s ta ff an d ai m in g at lo ng te rm s uc ce ss th ro ug h cu st om er s sa tis fa ct io n an d be ne fit s to a ll st af f a nd to s oc ie ty Tr ac ea bi lit y A bi lit y to tr ac e th e hi st or y, a pp lic at io n or lo ca tio n of th at w hi ch is u nd er c on si de ra tio n – IS O 9 00 0 (2 00 0) Va lid at io n Th at p ar t o f a Q A s ys te m th at e va lu at es in a dv an ce th e st ep s in vo lv ed in o pe ra tio na l p ro ce du re s or p ro du ct pr ep ar at io n to e ns ur e qu al ity , e ffe ct iv en es s an d re lia bi lit y (G M P ) C on fir m at io n an d pr ov is io n of o bj ec tiv e ev id en ce th at th e re qu ire m en ts fo r a s pe ci fic in te nd ed u se o r a pp lic at io n ha ve b ee n fu lfi lle d – IS O 9 00 0 (2 00 0) sp W or k en vi ro nm en t S et o f c on di tio ns u nd er w hi ch a p er so n op er at es – IS O 9 00 0 (2 00 0) Q M T/ Co re C ou rs e M at er ia ls 78 DE CL AS SIF ED