(WP)EHE(T)ICPIEI-ll-1.100 1-E
Report series number: RS/96/GE/ll(AUS)
English only
REPORT WORKSHOP ON QUALITY ASSURANCE IN THE MICROBIOLOGICAL ANALYSIS OF FOOD
Convened hy: WORLD HEALTH ORGANIZATION COLLABORATING CENTRE IN ENVIRONMENTAL HEALTH Richmond, N.S.W. , Australia 24-28 June 1996
Not for sale Printed and distributed by: World Health Organization Regional Office for the Western Pacific Manila, Philippines October 1996
WHO/WPRO LffiRARl Manila. Philippmes
0 4 UCf 2000
NOTE
The views expressed in this report are those of the participants in the Meeting of the Workshop on Quality Assurance in the Microbiological Analysis of Food and do necessarily reflect the policies of the World Health Organization.
This report has been prepared by the World Health Organization Regional Office for the Western Pacific for govenunents of Member States in the Region and for those who participated in the Workshop on Quality Assurance in the Microbiological Analysis of Food held in Richmond, N.S.W., Australia, from 24 to 28 June 1996.
CONTENTS
SUMMARY 1. INTRODUCT ION 1.1 1.2 1.3 1.4 2. Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Participants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Organization . . . .... .. .... . .... . .. . . .. . . .. . . . . . . . .. ... ... . . ...... ... .. .. ... .. . . .. . .. . . .. .. . .. . Opening ceremony . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2 2 2 2
PROCEEDING S Summary of country situation reports .. .. .. .. .. .. .. .. .. . .. .. ... .. .. .. .. .. .. .. .. .... .. .. Summary of working papers and discussions .. .. .. .... .. .. .. .. .. .. . . .. .. .. .. .. ...... . Summary of field trip .. .. .. .. .. .. .. .. .. .... . . .. .. .. .. .. .. .. .. .. .. .. .. . . .. .. .. .. ... ......... Summary of practical/laboratory sessions .. .. .. .. .. .. .. . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. Group and plenary discussions on the development of a plan of action and a protocol for external quality assessment .. .. .. .. .. .. .. . .. .. .. .. .. .. . 2.6 Evaluation of the workshop .. .. .. .. .. .. .. .. .. .. .. .. .. .... .. .. .... .. .. .. .. .. .. . .. .. .. .. .. . 2.1 2.2 2.3 2.4 2.5
3 3 4 6 7 7 7
3.
CONCLUSION S TABLES: TABLE l TABLE 2 COUNTRY SITUATIONS SUMMARY ................. .... ............
8
9
METHODS OF ISOLATION AND IDENTIFICAT ION OF SALMONELL A USED IN THE WESTERN PACIFIC REGION ...... .. .. .............. ................... . .. . .. .... .. .... 10 .. . . .. .. . . . .. . . .. . .. .. .. . . . . . . . . . . . . . . .. .. . . .. . . . . . . . .... .. . . . . . .. . . . . . . .. . . . . . . . . . . .. . 11
GLOSSARY ANNEXES: ANNEX 1 ANNEX 2 ANNEX 3 ANNEX 4 ANNEX 5 ANNEX 6 -
LIST OF PARTICIPAN TS
............ .. .. ........ .. ...... ........ .. .. ...... 13 .... .. ................ .. ...... .. .... ..... 17
PROGRAMME OF ACTIVITIES LIST OF DOCUMENTS
................ .. .................. ...... .. ..... ... 19
OPENING SPEECH OF THE WHO REGIONAL DIRECTOR FOR THE WESTERN PACIFIC .............. .. .................. . .. .... . 21 SUMMARY OF COUNTRY SITUATION ........ .... ....... . .... ...... 23 .. .. 29
EXTERNAL QUALITY ASSESSMENT DRAFT PROTOCOL
Key words
IFood analysis I Food microbiology I Food hygiene I Food - standards I Australia
SUMMARY
The objectives of the workshop were: (1) to review the current methods used to isolate and/or enumerate food spoilage organisms and foodborne microorganisms of public health significance; (2) to develop the laboratory skills of analysts in the isolation/identification of selected foodborne microorganisms of public health significance, through practical experience; (3) to develop an understanding of, and skill in implementing, laboratory quality assurance; and (4) to develop a protocol for an external quality assessment programme for use in food analysis in the Region. Summary of proceedings and conclusions: The workshop, held at the WHO Collaborating Centre in Environmental Health, University of Western Sydney, Hawkesbury, Richmond, Australia from 24 to 28 June 1996, was attended by 16 participants and l observer from 16 countries in the Western Pacific Region. The proceedings comprised presentations hy participants, (country situation reports and activities related to the quality assurance in the microbiological analysis of food) and technical papers hy WHO staff, a short-term consultant, a temporary adviser and staff of the WHO Collaborating Centre. In addition, participants took part in practical work and group and plenary discussions on elements of external quality assessment programmes. A field visit was made to the Australian Government Analytical Laboratories (AGAL) to familiarize all participants with the requirements of laboratory quality assurance programmes. An evaluation of the workshop hy the participants showed that the objectives of the workshop had been achieved. The following conclusions were made as a result of presentations and workshop discussions: (l) The methods of food analysis employed in the Region are diverse. Quality assurance in food analysis is an essential component of natinnal food safety programmes.
(2) In the Western Pacific Region, some countries and areas have a form of laboratory quality assurance system integrated into their national food safety programmes. (3) Quality assurance systems in laboratory analysis have not been widely adopted by countries in the Region. However, the majority of the countries to review their analytical programmes with the intention of facilitating the introduction of such systems. (4) Those countries where laboratory analysis quality assurance systems are still to be introduced, should he encouraged and supported by international, regional, national, and bilateral organizations to promote and develop appropriate strategies for their introduction.
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(5) An external quality assessment programme addressing food microbiology should be developed, implemented and evaluated among the Member States in the Region. The workshop drafted a protocol for such an external quality assessment programme. Specific areas of support for the programme were identified including resources, documentation and information.
l. INTRODUCTION
The workshop on quality assurance in the microbiological analysis of food was held at the WHO Collaborating Centre in Environmental Health on the campus of the University of Western Sydney, Hawkesbury, Richmond, NSW, Australia, from 24 to 28 June 1996. 1.1 Objectives The objectives of the workshop were: (1) to review the current methods used to isolate and/or enumerate food spoilage organisms and foodborne microorganisms of public health significance;
(2) to develop the laboratory skills of analysts in the isolation/identification of selected foodborne microorganisms of public health significance through practical experience; (3) to develop an understanding of, and skill in, implementing laboratory quality assurance; and (4) to develop a protocol for an external quality assessment programme for use in food analysis in the Region. 1.2 Participants
The workshop was attended by 16 participants and 1 observer from 16 countries in the Western Pacific Region. A list of participants. observer, secretariat members is given in Annex 1. 1.3 Organization
The workshop programme is given in Annex 2 and a list of documents distributed during the workshop in Annex 3. The documents include country situation reports prepared by participants and working papers prepared by WHO staff, a consultant, a temporary adviser and by a WHO Collaborating Centre staff. Each presentation was followed by questions and discussion. Copies of all workshop documents are available upon request from WHO Regional Oft1ce in Manila. A field visit was made to the Australian Government Analytical Laboratories (AGAL) to familiarize all participants with the requirements of laboratory quality assurance programmes. Participants took part in practical work and group and plenary discussions on elements of external quality assessment programmes.
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1.4
Opening ceremony
The opening ceremony was attended by the Regional Adviser in Environmental Health on behalf of the WHO Regional Director for the Western Pacific, the Dean of Faculty of Science and Technology, University of Western Sydney Hawkesbury and the Foundation Chair in Environmental Health of the University of Western Sydney Hawkesbury. Professor Paul Baumgartner addressed the workshop and welcomed participants to the University campus and to Australia. He outlined the diversity of courses available at the University and emphasized the importance of food safety to the University's courses. He endorsed the WHO Collaborating Centre's involvement in the promotion of quality assurance in the microbiological analysis of food. The Dean went on to pledge continued university support for WHO and the WHO Collaborating Centre in Environmental Health. The Regional Adviser in Environmental Health then delivered the opening speech on behalf of the Regional Director. The speech noted that WHO provides the international scientit1c consensus which underlies the health and safety aspects of all international food standards, codes, guidelines and recommendations so that they appropriately protect the health of consumers. The speech emphasized the collaborative role of WHO in the development of analytical capabilities in the Region. It identitied the broad objectives of the workshop and encouraged participants to play an active role in the workshop. The full text of the speech is given in Annex 4.
2.
PROCEEDINGS
2.1
Summary of country situation reports
The partiCipants presented their country situation reports with emphasis on the current situation in their respective countries. A detailed summary of the country reports is provided in Annex 5. The Guidelines for the Preparation of a Coulltt)' Situation Report provided to participants by WHO are also included in Annex 5. Reports presented by the 16 participants highlighted that the infrastructure and availability of technical resoun.:es varies radically from country to country. All countries indicated a need for support, however, in developing quality assurance in the microbiological analysis of food. Laboratory accreditation is not well established in most countries in the Region. Some stated that an embryonic form of accreditation was available but that often these services are provided by the same government Ministry or Department which supports the analytical (public health) laboratory. It was considered that a review under the circumstances would have the potential to he seen to lack independence and therefore, probably will not get formal recognition by developed countries of the trading blocks. Five of the countries represented, Brunei Darussalam, China, Malaysia, Papua New Guinea, and Viet Nam are signatories to the 1995 Asia Pacific Laboratory Accreditation (APLAC) agreement but in some cases delegates were unaware of this fact. Participation in proficiency testing programmes in food microbiology was very limited, although a willingness to take part in programmes, if they became available and were appropriately resourced, was indicated by all participants.
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During discussion of country reports, it was commonly acknowledged that communication and coordinated action between laboratory staff and other external officers involved in food analysis (e.g., health inspectors, enforcement officers and personnel involved with the interpretation of analytical results) was very limited. Laboratory staff thus lacked "ownership" of the results of their work. It was felt that the importance and benefit of a fully developed quality assurance programme was not recognized by many government sectors involved in food inspection and assessment. Many food analysts worked within large organizations that had responsibilities for a wide range of services (e.g., clinical, medical) and had difficulty in promoting the benetits of quality assurance in the microbiological analysis of food. A summary of country situations is presented in Table l. 2.2 Summary of working papers and discussions
2.2.1 The role of international organizations in the harmonization of laboratory quality assurance programmes. The Regional Adviser in Environmental Health stated that it is a basic human right to have access to food which is safe, of good quality and nutritious. He emphasized the importance of harmonized food standards, codes of practice and other guidelines but noted that such standards, codes and guidelines are dependant on the analytical methods used to ascertain compliance. For consumers, industry, trade and regulatory authorities to have confidence in data generated in the microbiological analysis of food. laboratories must implement a programme of quality assurance procedures. He highlighted the role of the Codex Alimentarius Commission, WHO, and other international organizations in the development and implementation of quality assurance procedures in the analysis of food . He concluded by focusing on WHO's collaboration in the Western Pacitic Region and encouraged participants to work with WHO in the development of quality assurance in the microbiological analysis of food. 2.2.2 Principles of quality assurance
Principles of quality assurance were reviewed by the Consultant. The purpose of a food microbiology laboratory is to provide information on the safety and quality of food, on the acceptability of food, and confirmation of an appropriate standard. The aim of quality assurance is to assist laboratory management in establishing and maintaining an effective operating system that will ensure that the laboratory produces accurate and reliable analytical results necessary to support regulatory actions. An effective quality assurance programme has several operational advantages. It provides established, verified procedures, and a tracking record to ensure sample integrity, with documentation to verify that laboratory instruments are functioning properly and that laboratory data are generated according to approved written protocols. Such documentation is important in regulatory laboratories where analytical tindings must withstand the scrutiny of legal proceedings. A quality assurance programme must consider the various elements required within an appropriate quality system. Because of the diverse nature of food control laboratories, a single uniform 'generic' programme cannot cover all laboratory activities. Instead, a quality assurance programme must be tailored to cover the functions of a particular laboratory. To be
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effective, a quality assurance programme must have a recognized structure; be written down; have its relevant parts available to all staff; and be able to be adapted to change and, continue to be an 'active' document. 2.2.3 Quality assurance manuals
The quality assurance manual was discu~sed by the Consultant. The manual is a practical handbook for the establishment and maintenance of a quality assurance programme for a food microbiology laboratory. Its ultimate aim is to assure that the laboratory produces reliable high quality analytical results with a continuity of documentation providing a clear, accurate analysis with all segments of documentation in agreement. Each laboratory with a quality assurance programme should have a manual that documents the operation of the laboratory and the manual should be considered as a 'living' document which evolves as the laboratory develops. There is no single, specitic structure or format for a quality assurance manual. It should convey accurately, completely and concisely the quality policy, objectives and governing documented procedures of the organization. The number of quality assurance manuals may depend on the size of an organization. A small organization may find the entire description of the system fits within a single volume. An outline of a typical manual and examples of completed manuals were discussed with the participants. A manual may assist in identifying deficiencies in training or in laboratory equipment, however, the manual cannot substitute or supplant appropriate training and analytical facilities. 2.2.4 Calibration of equipment and validation of test method
The critical requirement for calibration of equipment and validation of test methods was reviewed by the Consultant. Calibration involves measuring, comparing, and adjusting the performance of equipment relative to that of an accepted standard. It was noted that certain tolerances are usually applicable to the performance of the standard. and the performance of the equipment being calibrated must be within this tolerance to he acceptable. Equipment found in the food microbiology laboratory which routinely requires calibration was reviewed. In choosing methods for the microbiological analysis of foods, it is essential that the analytical method used can produce results of sufticient accuracy and that the data are available to show this in a way that will be accepted by the users of the results. The Consultant outlined a number of national and international organizations that are involved in the development and publication of validated analytical methods. It was stressed that there is no scarcity of methodology for the microbiological analysis of foods. The microbiologist must choose the most appropriate method after consideration of such factors as reliability, speed, and cost. The methods selected for use must be practical. However, what is practical in one laboratory may not be practical in another. Furthermore, different methods of analysis of a particular food will often lead to different results. These points were particularly emphasized for situations where a laboratory was geographically isolated from other 'verifying' laboratories. This led to discussions of the advantages of proficiency testing programmes. 2.2.5 Accuracy of measurement methods and results
As noted earlier in discussions on quality assurance, it was stressed that reliability/acceptability of results is dependent upon the accuracy of the test methods used to achieve those results. Basic concepts of standard methods, accuracy, trueness and precision were reviewed.
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The importance of standard reference materials and difficulties in developing standard food samples for microbiological analysis were discussed. Achieving both trueness and precision in analysis were presented as long-term, developmental goals for the participants and their home laboratories. 2.2.6 The isolation and identification of select foodhorne pathogens (Mr A. R. Hazzard)
A staff of the WHO Collaborating Centre in Environmental Health, discussed the diversity of methods employed in the isolation and identification of select pathogens. He noted that quality assurance in the laboratory demands an understanding of the ability of the chosen analytical methods to detect low levels of pathogens in foods examined. He also emphasized the need to employ isolation and identification methods specifically designed and validated to isolate sub-lethally impaired cells from food. Inadequately considered, Improperly designed and inappropriately implemented isolation/identification methodologies may result in underreporting of food contamination . In the presentation, he explained participant identification of methods used in the Western Pacific Region to isolate and identify Salmonella (fable 2). 2.2. 7 Proficiency testing: general principles
The temporary adviser outlined the key components of proficiency testing and highlighted the difficulties associated with such programmes in the microbiological analysis of food. He discussed the need for proficiency testing to monitor laboratories' competence to perform specific tests, and also to supplement laboratories' own internal quality control procedures (by providing an external assessment of their performance). He explained that proficiency testing had an important role in assisting laboratories to solve problems, thus improving the quality of their data . Proficiency testing is now accepted as a key component of the formal recognition of technical competence particularly as international attention is focusing on the need for comparable test results in important areas such as public health and trade. He emphasized that support was necessary to develop and implement appropriate proficiency testing programmes that would he available to laboratories in the Region . 2.2.8 Laboratory accreditation and proficiency testing in the Western Pacific Region
The temporary adviser reviewed the current situation with respect to the provision of laboratory accreditation and related quality management systems in Australia and similar models that currently exist, or are being developed, in other Western Pacific countries. He emphasized the need for proficiency testing to complement on-site activities. He gave an overview of the role of Asia Pacitic Economic Cooperation (APEC) and APLAC agreements and stated that the objective of the activities of these international bodies was to establish multilateral mutual recognition agreements . Such agreements would facilitate the acceptance of test data accompanying traded goods and services in the region by instilling confidence and trust in the competence of national accreditation bodies and the laboratories accredited by them . He stated that further support was required to supplement existing efforts to establish formal multilateral mutual recognition agreements in the Region. 2.3 Summary of field trip
A visit to the Australian Government Analytical Laboratories (AGAL) in Sydney was made to review laboratory facilities and discuss the laboratory's quality assurance programme. A Senior Microbiologist at AGAL, explained AGAL's quality assurance programme with
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particular emphasis on documentation and training of personnel. Participants discussed how such quality assurance procedures could he adopted for use in their own national laboratories. 2.4 Summary of practical/laboratory sessions
Participants had the opportunity to employ the validated methods of the Association of Official Analytical Chemists (AOAC) for enumeration of coliforms and isolation and identification of Salmonella from nonfat dry milk powder. As the Salmonella method requires more than five days to complete, participants were provided pre-incubated material at each step (resuscitation, selective enrichment, selective plating and biochemical confirmation) as well as being able to perform the procedure themselves. Pre-incubated material also demonstrated typical responses of E. coli, C. freundii, P vulgaris, K. pneumoniae and E. aero genes on each of the media. Participants were also provided a series of demonstration methods of isolation and identification for L. monocytogenes. V. parahaemolyticus, V. vulnificus and S. aureus. Participants took the opportunity of the practical sessions to contrast methods used in each of the countries and to enhance their skills in the isolation and identification of selected pathogens. Practical sessions also addressed the application of proficiency testing in the enumeration of aerobic mesophiles. This session was supported hy resource persons from the National Association of Testing Authorities, Australia (NATA) with software used in their proficiency testing programmes. Staff of NAT A interpreted a set of typical results and the participants' own results. In particular they focused on inter- and intra-laboratory interpretation and discussed with participants how such data could be used to enhance laboratory performance. 2.5 Group and plenary discussions on th e clevelopnlent of a plan of action and a protocol for external quality assessment
Participants identified key elements of a protocol for the development and implementation of an external quality assessment procedure for use in the Region. Groups then presented their considerations in a plenary session which adopted the Plan of Action given in Annex 6. 2.6 Evaluation of the workshop
Evaluation questionnaires were completed by each of the participants. The participants agreed that the specific objectives of the workshop were adequately or well achieved. Two participants felt that there was insufficient time to address the topics fully while two indicated that their low level of English language proficiency interfered with their capacity to obtain maximum benefit. Participants generally felt that they had learned new concepts that would be applied. A follow-up to this workshop may be carried out to determine the degree to which these perceived skills are applied. Organization and administrative arrangements were very well received with most being satisfied, and more than half strongly commending this aspect of the workshop. However, two participants felt the per diem should cover day of arrival at place of origin. There was general agreement among the participants that the workshop was beneficial to their countries as well as to them personally. Participants were convinced of the benefits of applying analytical quality assurance systems. A number of follow-up activities were identified.
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3. CONCLUSIONS
The following conclusions were made: (l) The methods of food analysis employed in the Region are diverse and quality assurance in food analysis is an essential component of national food safety programmes. (2) In the Western Pacific Region, some countries and areas have a form of laboratory quality assurance system integrated into their food safety programmes. (3) Quality assurance systems in laboratory analysis have not been widely adopted by countries and areas in the Region. However, the majority of the countries plans to review their analytical programmes with the intention of facilitating the introduction of such systems. (4) Those countries and areas where laboratory analysis quality assurance systems are still to be introduced, should be encouraged and supported by international, regional and bilateral organizations to promote and develop appropriate strategies for its introduction. (5) An external quality assessment programme addressing food microbiology should be developed, implemented and evaluated among the Member States of the Region. The workshop drafted a protocol for an external quality assessment programme. Specific areas of support for the programme were identitied and induded resources. documentation and information (Annex 6).
Table 1: Country Situation Summary Tttttll' I. ('nuntr·, S'tu11tlon Suntm ttry B H U CAM
C H N
C 0 K
F IJ
l A 0
M A II
M IC
M 0 G
P N G
P H l
S M II
S 0 l
T0 N
V II N
V T ll
:l 0 o • 1 1 n 1 1110 n 1 I c on U M I n 1 n I m o .rHI o rl n 9 .. + _ _ ... + + .. + • • • .. (+ 1 ~ rou•emme ••••• -'--·----------------------- ll-------f--------t-------+-------~-------+-------+------~------~-------1~------t-----~~------+-------+-------~--------~_:--~~ No letU No lelll I W hal ""lcroblologlcalenelytet do 1111
ro
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r o u lin • ly "nder•
!l ellonal food leboreloru!lt roullnely
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+ nt
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+ +
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1
+
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mlcroblology
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·~·~·~··~~~·~·~··~· ~·~·~·~~~· ,~ ·· ~ ·· ~ ~·~··~-----------------11~----~--------+---~--+--------t-------t-------+--~--~r------t--~--~r-------t-------r------ -~----~~-------+--------~----~
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C 0 4hl 1\IIIOft l l rood II bOII IO rl l I
11 OA CHint & ob l f'clrvet b l 0 f4. toordlnllort
+ +
+ +
(+ ) (+ ) (+)
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11 0 a revutltlont 1nd &llnderdt eddrett: It Q"IIIIUCI II~nt ol I 'I'U I'J'tlt
+ v 11 t lin; c u rr 1 n ~~~ • + • + + + .. • .. food ~o~n~o~l~r~·~ "~'----------------- I~------}-------4-------~------~--------~-----1--------+------+--------+-------4-------+--------~------~--------~-------+--------J + • •
+
(+ )
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l-~·~·~·~·~m~p~lln~o~•~·~·~·~·~·~~~·~·~l·~--------------~~---~~----~·---f--·~ ·---t----"----t---~·---f--~---+--~n~l--1---~--r-~·~~~-1~--~----+---+~-1~--~--f-~"~'~-+----~·---4----~-----~--·:___ K E )" ; !) ,\ () u ality t\ !'Ill ran oe A ffirn1 a lh• c ··· N c,Yt~l i '-1.! ·· ·• - -··· · - - -- - - - -- --
1
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- 10-
Table 2: Methods of isolation and identification of Salmonella* used in the Western Pacific Region Isolation/Identification Step 1. Resuscitation** Media Used (a) Buffered Peptone Water (BPW); Country Employing Specified Media Brunei Darussalam, Malaysia, Mongolia, Papua New Guinea, Samoa, Vanuatu Cambodia, Lao People's Democratic Republic, Philippines, Tonga (occasionally), Viet Nam Tonga, People's Republic of China, Fiji
(b) Lactose Broth (LB)
(c) BPW and LB (d) Trypticase soy broth 2. Selective Enrichment (a) Rapapport (R V) Selenite: (b)
+
Malaysia, Papua New Guinea, Solomon Islands Mongolia, Papua New Guinea (occasionally), Vanuatu, Viet Nam Cambodia, People's Republic of China, Fiji, Lao People's Democratic Republic, Solomon Islands, Tonga Cook Islands* Solomon Islands
BPW
+ Selenite;
(c) Selenite only
3. Selective Plating
Salmonella Shigella (SS): SS, Desoxycholate Citrate (DCA), Xylose Lysine Desoxycholate (XLD); SS, XLD; SS, XLD. Hektoen Enteric (HEA); Bismuth Sulphite (BSA), XLD, DCA or SS; BSA only
Cambodia, Samoa, Tonga, VietNam People's Republic of China; Lao People's Democratic Republic Malaysia, Fiji, Papua New Guinea Mongolia, Philippines
* FSM does not currently test for Salmonella ** Solomon Islands does not employ a resuscitation step ***Cook Islands does not employ resuscitation or selective enrichment
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GLOSSARY
AGAL APEC AOAC APLAC CASCO GEMS GLP HACCP IEC ILAC ISO IUPAC NATA QA OECD WHO
Australian Government Analytical Laboratories Asia Pacific Economic Cooperation Association of Official Analytical Chemists Asia Pacific Laboratory Accreditation and Certification ISO Conformity Assessment Council Global Environmental Monitoring System Good Laboratory Practice Hazard analysis critical control point techniques International Electrotechnical Commission International Laboratory Accreditation Conference International Standards Organization International Union of Pure and Applied Chemists National Association of Testing Authorities (Australia) Quality Assurance Organization for Economil: Cooperation and Development World Health Organization
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ANNEX 1 LIST OF PARTICIPANTS, CONSULTANT, TEMPORARY ADVISER, OBSERVER AND SECRETARIAT 1.
PARTICIPANTS Dk Hjh Sotiah binti Pg Hj Bakar Scientific Officer Laboratory of Scientific Services Jalan Sumbilng 2084 Bandar Seri Begawan Tel: 6732 240399 Fax: 6732 240646 Mrs. Nam Nivanna Chief of Laboratory National Laboratory for Drug Quality Control Ministry of Health 151 Kampuchea Krom Street Phnom Penh Tel: 855 23.3 66 381 Dr Ran Lu Director, Department of Microbiology Institute of Food Safety Control and Inspection Ministry of Health Beijing Tel: 68 10 6772 1166 ext. 409 Fax: 68 10 6771 1813 Mr Vaevae Vaevae Pare Acting Charge Technologist Ministry of Health Rarotonga Tel: 682 22664 ext. 203 Fax: 682 22670 & 682 22664 Ms Sainimere Kato Bavaro Medical Laboratory Technician (Class I) Pathology Laboratory, C.W.M. Hospital Ministry of Health Suva Tel: 679 21 5592 or 679 31 3444 ext. 592 Mr Keophilavanh Vorakoumane Acting Vice Chief of Microbiology Division Food-Drug Quality Control Center Ministry of Health Vientiane Tel: 856 21 21 7503 (work) 856 21 222099 (home)
BRUNEI DARUSSALAM
CAMBODIA
PEOPLE'S REPUBLIC OF CHINA
COOK ISLANDS
FUI
LAO PEOPLE'S DEMOCRATIC REPUBLIC
- 14 Annex 1
MALAYSIA
Mr Jamal Khair Hashim Food Technologist/ Acting Director Food Quality Control Division Ministry of Health Kuala Lumpur Tel: 60 03 3318822 Mr Moses Pretrick Quality Control Officer Pohnpei Fisheries Corporation PFC. PO Box 448 Dekehtik Pohnpei, FM 96941 Tel: 691 320 2061 Fax: 691 320 2062 Dr Shinee Enkhtsetseg Microbiologist National Centre for Hygiene, Epidemiology and Microbiology Ministry of Health Ulaanbaatar Tel: 976 1 51911 (work) 976 1 52021 (home) Fax: 976 1 358509 Mr Willie Porau Otlicer-in-Charge Food and Water Examination Section Department of Health Boroko, N.C.D. Tel: 675 324 8331 Ms Myracil Alix Food-Drug Regulation Officer II Bureau of Food and Drug Department of Health Alabang, Muntinlupa City 1702 Tel: 632 842 4625 (LSO) 632 842 4580 (Admin.) Mr Vaomalo Kini Supervisor of Microbiology Section National Health Laboratory Health Department Apia Tel: 0685 21212 ext. 256 Mr Dickson Manongi Medical Laboratory Assistant Ministry of Health and Medical Services Honiara Tel: 677 30655 ext. 208 (work) 677 25295 (home) Fax: C/- WHO Oftlce Honiara
FEDERATED STATES OF MICRONESIA
MONGOLIA
PAPUA NEW GUINEA
PHILIPPINES
SAMOA
SOLOMON ISLANDS
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Annex 1
TONGA
Mr Viliami Pakalani Medical Laboratory Scientist Ministry of Health Nukuatofa Tel: 676 23200 (work) 676 25295 (home) Fax: 676 24291 Mr Daniel Kalorib Deputy Director of Health Department of Health Port Vila Tel: 678 22512 Fax: 678 26204 Mrs. To Bich Phuong Food Microbiological Analyst Scientist Researcher Food Quality Safety Control National Institute of Nutrition Hanoi Tel: 844 257 090 253 784 Fax: 844 257 885
VANUATU
VIETNAM
2.
CONSULTANT
Dr Herbert John Bavor Associate Professor and Head of School of Applied and Environmental Sciences Director of Water Research Laboratory University of Western Sydney Hawkesbury Richmond, NSW 2753 Australia Tel: 61 45 701264 Fax: 61 45 701267 Email: bavorj@uws.edu.au
3.
TEMPORARY ADVISER
Mr Allen Squirrell National Association of Testing Authorities 7 Leeds Street Rhodes, NSW 2138, Australia Tel: 61 2 736 8222 Fax: 61 2 743 5311 asquirrl@nata.asn.au
- 16Annex I
4.
OBSERVER
UNIVERSITY OF THE SOUTH PACIFIC
Mrs. Arun L. Pande Institute of Applied Sciences University of the South Pacific Suva Fiji Tel: 679 313 900 ext. 2339 Fax: 679 300 373
5. SECRETARIAT
Mrs. Kathy Mitchell WHO Collaborating Centre, School Applied & Environmental Sciences University of Western Sydney Hawkesbury Richmond, NSW 2753 Australia Tel: 61 45 701662 Fax: 61 45 701267 Email: kathy .mitchell@uws.edu.au Dr A. Basaran (Operational Officer) Regional Adviser in Environmental Health WHO Western Pacific Regional Office PO Box 2932, Manila 01099, PHILIPPINES Tel: 632 528 800 ext. 9942 Fax: 632 521 1036 Email: basarana@who.org.ph
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ANNEX 2 WORKSHOP ON QUALITY ASSURANCE IN THE MICROBIOLOGICAL ANALYSIS OF FOOD 24 - 28 June 1996 WHO Collaborating Centre in Environmental Health, Richmond, N.S.W., Australia PROGRAMME OF ACTIVITIES
Monday 24 June 0900-1000 1000-1030 1030-1045 1045-1120 1120-1200 1200-1300 1300-1500 1500-1530 1530-1600 1600-1700 Opening Ceremony Morning tea Administrative brieting The role of international organizations in the harmonization of laboratory quality assurance programmes (Dr A. Basaran) Principles of quality assurance (Dr H .J. Bavor) Lunch break Country reports Afternoon tea Introduction to the laboratory Country reports
Tuesday 25 June 0900-1000 1000-1030 1030-1200 1200-1300 1300-1500 1500-1530 1530-1615 1615-1700 Country reports Morning tea Enrichment and selective enrichment (Practical) Lunch break Selective plating and biochemical contirmation (Practical) Afternoon tea Quality assurance manuals (Dr H.J. Bavor) Calibration of equipment and validation of test methods (Dr H.J. Bavor)
Wednesday 26 June 0830-0915 0915-1000 1000-1030 1030-1200 1200-1300 1300-1630 Accuracy of measurement methods and results (Dr H.J Bavor) The isolation and identification of select food-borne pathogens (WHO Collaborating Centre staft) Morning tea Isolation and identification of select pathogens and serological testing of Salmonella (Practical) Lunch break Study tour of select laboratories
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Annex 2
Thursday 27 June 0830-0915 0915-1000 1000-1030 1030-1200 1200-1300 1300-1500 1500-1530 1530-1700 Proficiency testing: general principles (Dr A. Squirrell) Laboratory accreditation and proficiency testing in the Western Pacific Region (Dr A. Squirrell) Morning tea Proficiency testing (Practical) Lunch break Development of a protocol for external quality assessment applied to the microbiological analysis of food (Group work) Afternoon tea Development of a protocol for external quality assessment applied to the microbiological analysis of food (Group work)
Friday 28 June 0900-1000 1000-1030 1030-1200 1200-1300 1300-1500 1500-1530 1530-1600 Proficiency testing (Practical follow up) Morning tea Isolation and identification of selected organisms (Practical follow up) Lunch break Development of a protocol for external quality assessment applied to the microbiological analysis of food (Plenary session) Afternoon tea Conclusions and closure
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ANNEX 3
LIST OF DOCUMENTS DISTRIBUTED DURING THE WORKSHOP
WorkinK Papers WPR/ICP/EHH(l)/96.2 WPR/ICP /EHH( 1)/96. 3 WPR/ICP /EHH (1 )/96 .4 WPR/ICP/EHH(l)/96.5 The role of international organizations in the harmonization of laboratory quality assurance programmes (Dr A. Basaran) Principles of quality assurance (Dr H .J. Bavor) Quality assurance manuals (Dr H .J. Bavor) Calibration of equipment and validation of test methods (Dr H.J. Bavor) Accuracy of measurement methods and results (Dr H.J. Bavor) The isolation and identification of select food borne pathogens (WHO Collaborating Centre staft) Proticiency testing: general principles (Dr A. Squirrell) Laboratory accreditation and proticiency testing in the Western Pacitic Region (Dr A. Squirrell)
WPR/ICP/EHH(l)/96.6 WPR/ICP/EHH(l )/96. 7 WPR/ICP/EHH(l)/96 .8 WPR/ICP/EHH(l)/96.9
Country Reports WPR/ICP/EHH(l)/96.1 Brunei-Darrusalaam By Dk Hjh Sotiah binti Pg Hj Bakar Cambodia By Mrs. Nam Nivanna People's Republic of China By Dr Ran Lu Cook Islands By Mr Vaevae Vaevae Pare Fiji By Ms Sainimere Kato Bavoro Lao People's Democratic Republic By Mr Keophilavanh Vorakoummane Malaysia By Mr Jamal Khair Hashim Federated States of Micronesia By Mr Moses Pretrick
WPR/ICP/EHH(l)/96.2
WPR/ICP/EHH(l)/96.3 WPR/1 CP /EHH ( 1)/96. 4
WPR/ICP/EHH(l)/96.5
WPR/ICP/EHH(l)/96.6
WPR/ICP/EHH(l)/96.7 WPR/1 CP /EHH (1 )/96. 8
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Annex 3
WPR/ICP/EHH(l)/96.9
Mongolia By Dr Shinee Enkhtsetseg Republic of Papua New Guinea By Mr Willie Porau Philippines By Ms Myracil Alix Samoa By Mr Vaomalo Kini Solomon Islands By Mr Dickson Manungi Tonga By Mr Viliami Pakalani Vanuatu By Mr Daniel Kalorih VietNam By Mrs. To Bich Phuong
WPR/ICP/EHH( 1)/96.10
WPR/ICP/EHH(1)/96.11
WPR/ICP/EHH( 1)/96.12
WPR/ICP/EHH( 1)/96.13
WPR/ICP/EHH(1)/96.14
WPR/ICP/EHH( 1)/96.15
WPR/ICP/EHH( 1)/96.16
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ANNEX 4
OPENING SPEECH BY DR S.T. HAN, WHO REGIONAL FOR THE WESTERN PACIFIC DELIVERED ON HIS BEHALF BY THE REGIONAL ADVISER (ENVIRONMENTAL HEALTH), WHO WESTERN PACIFIC REGIONAL OFFICE, MANILA.
Ladies and Gentlemen, I welcome you to this workshop on quality assurance in the microbiological analysis of food on behalf of Dr S.T. Han, the Regional Director for the Western Pacific Region of the World Health Organization (WHO). Dr Han could not be with you this morning due to a previous commitment. Food, one of the essential requisites for human life. may pose a risk to public health if its safety and nutritional value are not adequate for consumer protection . Therefore, governments, and in particular, the public health sector, play a crucial role iri promoting food safety, which we view as a responsibility shared among government. industry and trade and consumers. With its establishment nearly 50 years ago, WHO was given a constitutional mandate to "develop, establish and promote international standards with respect to food". As the international agency with the prime responsibility for health, WHO provides the international scientitic consensus which underlies the health and safety aspects of all international food standards, codes, guidelines and recommendations so that they appropriately protect the health of consumers. In the field of food safety, WHO performs two functions, normative and technical support. In fulfilling its technical support function WHO, through its six regional offices, collaborates with Member States to facilitate the international trade in safe food and in strengthening their national food safety programmes. WHO has collaborated in the development of analytical capabilities within the Region. In this regard, WHO's activities in recent years have included fellowships and study tours for food analysts, promoting participation in the Food Contaminant Monitoring component of the Global Environmental Monitoring System (GEMS), developing a compendium of rapid food tests and collaboration with a number of countries to enhance analysis for chemical contaminants in food including mycotoxins and environmental pollutants. In addition, laboratories have benetited by gaining experience in food analyses through applied studies of street food and other foodstuffs such as shellfish. More recently, in May 1995, WHO also organized a training course to strengthen environmental laboratory capabilities in Pacific island countries, including food analysis . .The development of analysts and laboratories, competent in the analysis of food, will reassure consumers of the safety of the food supply. The development of competent testing laboratories involved in import and export control of foods will also reduce barriers to trade in safe food and unnecessary duplication of analyses. Hence, the focus on the Region's analytical capability will have direct impact on human health, consumer confidence and international trade in food.
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Annex 4
For a laboratory to be considered a competent authority, it must produce consistently reliable data. To achieve this, it must implement a quality assurance programme. However, many of the Region's food laboratories operate without quality assurance of analyses performed. Sometimes little effort is expanded in employing control cultures, in identitication of method of sensitivity or in determining the probability of false positive or false negative results. In comparison, however, a number of public health laboratories in the region are actively involved in a WHO-sponsored quality assurance programme. This workshop aims to extend what has proved to be a successful quality assurance programme for public health laboratories to laboratories routinely involved in microbiological analysis of food. It will introduce food analysts to international standards in design and practice, laboratory quality assurance, and the concept and principles involved in external quality assessment. The workshop will provide the opportunity for food microbiologists to enhance skills in isolating common food-borne microorganisms of public health signiticance in accordance with published standard methods. Furthermore, it will establish a protocol for an external quality assessment programme for use in food analysis in the Region. The overall goal of the workshop is to strengthen food analysis within the Region through quality assurance and the introduction of an external quality assessment programme for selected food-borne organisms. The specitic objectives of the workshop are: (1) to review the current methods used to isolate and/or enumerate food spoilage organisms and food-borne microorganisms of public health significance;
(2) to develop the laboratory skills of analysts in the isolation/identification of selected food-borne microorganisms of public health signiticance through practical experience; (3) to develop an understanding of and skill in implementing laboratory quality assurance; and (4) to develop a protocol for an external quality analysis in the Region. asse~sment
programme for use in food
Taking this opportunity I would like to thank the staff of the University of Western Sydney, for their collaboration in this important activity and for the excellent arrangements in conducting the workshop. I wish this workshop success in achieving its objectives in the next tive days. I also wish you a pleasant stay in Hawkesbury and a safe journey back to those participants from outside. Thank you for your attention.
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ANNEX 5 SUMMARIES OF COUNTRY SITUATION REPORTS
The country situation reports were prepared by participants based on the following guidelines provided by WHO:
Each participant is requested to prepare a report which assesses the program and activities related to the microbiological analysis of food in the country. The report should describe briefly the following topics: 1. 1.1 Foodborne disease Identify whether food borne disease is Notifiable and the extent to which it is reported, including the incidence of diarrhoeal diseases. salmonellosis, typhoid, cholera and other food-borne diseases. Identify whether positive laboratory identitkation is required for case definition.
1.2
2. 2.1
Laboratory Services Describe the laboratory services employed in national, provincial and local food safety programs and how they network. Note whether these laboratories participate in national food contaminant monitoring programs and investigation of food-borne disease outbreaks . If so, describe the programs and participating laboratories. Identify the range of microbiological analyses of which the laboratories are capable in relation to food samples. Identify the foods examined and the number of samples tested in 1994/95 .
2.2
2.3
2.4 3. 3.1
Quality Assurance Systems Identify whether the country's laboratories participate in an analytical quality assurance system and if so, whether it is a national or international system. Do the laboratories have quality assurance plans, objectives, a quality assurance coordinator and/or quality assurance manuals? Do the laboratories routinely use validated methods of isolation and identification and are the methods prescribed in a laboratory specific methods manual?
3.2
3.3
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Annex 5
3.4 3.5 3.6 4. 4.1
Identify the numbers of samples and types of sampling plans used in the collection of samples for analysis. Identify what, if any, proficiency testing Is undertaken by the above laboratory services. Specify the level, type of training and number of analytical staff in the country. Regulations and standards Identify whether regulations prescribe the following: (i) (ii) (iii)
qualifications of analysts good laboratory practice; and laboratory accreditation.
4.2
Identify if food standards exist and whether they describe methods of sampling and analysis.
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Annex 5
SUMMARIES OF COUNTRY SITUATION REPORTS 1. Brunei Darusalaam
Laboratory analysis for food safety is carried out In Brunei in three laboratories. The main laboratory is under the Ministry for Health Scientific Services. The Ministry for Industry and Primary Resources one food chemical analysis lab and one research lab which carries out microbiological and chemical analysis of locally produced food. The main food microbiology laboratory, in the Ministry for Health Scientific Services, was developed in 1990. Approximately 100 samples per month are received from the Public Health Department, but there is no routine food contaminant/safety program. Public Health authorities do random checks on food suppliers and outlets on a non regular basis. Currently, the food regulations from Singapore are used as regulatory guidelines. No quality assurance program or proficiency testing or reference laboratory collaboration has been established. There has been some preliminary training in quality assurance area, however, there has been no follow up to date. 2. Cambodia
Food analysis is primarily carried out in Cambodia in three government areas and one private organization. The Ministry of Industry and the Ministry of Commerce undertake chemical analysis. The Ministry of Health Drug Control Laboratory has developed a section which carries out microbiological analysis of food. At present, only samples from Phnom Penh are collected by health inspectors for analysis by the laboratory. It is recognized that establishment of inspection and food analysis capabilities in rural areas is desirable. There are draft plans to develop a dedicated food microbiological laboratory. Approximately 214 samples were analyzed in 1995 by the Drug Control Laboratory, Including 46 bottled water samples. The Pasteur Institute, a private organization, also carries out some food microbiological analysis and shares some staff members with the Drug Control Laboratory. There is no welldeveloped quality assurance programme or programme of proficiency testing, although as noted above, some staff are common to the Pasteur Institute and government laboratory and use common methods. 3. China
In China, food analysis is coordinated through the Ministry of Health, under the Food Sanitation Administration Inspection and Surveillance System. Food microbiological analysis is conducted by microbiology laboratories within the Institute of Food Safety Control and Inspection (IF SCI), at a number of levels - one national, 30 provindal, 431 prefectural and 1936 county laboratories. The labs participate in an IFSCI coordinated national analyticai quality assurance system and have a developed range of quality plans, methods and manuals. In discussion, the need to broaden an institutional appreciation of quality assurance was identified. 4. Cook Islands
There are no specifically designated laboratories for food safety in the Cook Islands. The Medical Laboratory of the Ministry of Health does, however, carry out some analyses of food. The Laboratory works In conjunction with the Public Health Division and the Department of Water Supply. Equipment and supplies for food and water analysis by the Medical Laboratory have been provided by WHO.
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Annex 5
There are no quality assuran~e or protkiency testing programmes . Difti~ulties of receiving and obtaining meaningful results from outer island <.reas was reported. Food standards are addressed by the Cook Islands Health Act. under Public Health Regulatinns. 5. Fiji
There are microbiology laboratories in the three main hospitals in Fiji, however, food and water microbiology testing is done only in the hospital at Suva. Samples are received irregularly from Health Inspectors, following random checks or complaint incidences . No routine surveillance programmes has been established. The Suva laboratory has methods manuals for food analysis. however. no quality assurance programme has been instituted. The lab participates in a proticiency testing programme for clinical analysis. through the Pacitic Paramedical Training Centre. Wellington. New Zealand. Food analysis is not part of that programme. The report identitieu that training and quality assurance support were areas in which assistance was required. 6. Lao Peoples Democratic Republic
Food microbiological analysis is carried out in Lao through the Ministry of Health, FoodDrug Quality Control Centre. The Centre was established in 1995 and is still developing. Quality assurance practices have been initiated at the Centre. however. further development of the Programme and development of methods and quality systems is required . 7. Malaysia
A Food Quality Control Programme has been established under the Ministry of Health. Through the Ministry, industries are encouraged to adopt hazard analysis critical control point (HACCP) techniques to control food safety . A Malaysian Laboratory Accreditation Scheme is proposed for implementation in 1997 . The Food Quality Control Programme is implemented by 8 Food Quality Control Laboratories which undertake food microbiologil.:al analysis. These labs undergo internal and some external proficiency testing. During presentation of the report, it was identified that support in areas of methods development and network pruticien~y testing would be valuable. 8. Federated States of Micronesia
There is no dedicated food microbiolngical analysis laboratory for the Federated States of Micronesia. Within the Pohnpei Fisheries Corporation (PFC). a food laboratory has been developed which is used for training of local technicians . The PFC laboratory does not, however, extend its lab services beyond its own products . No quality assurance programme has been established for the laboratory. Considerable interest was expressed during the presentation, In networking with support groups and other regional laboratories to develop a quality assurance programme and eventually establish a government food microbiology analysis capability.
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Annex 5
9.
Mon~olia
A national Programme on Food Supply Improvement in Mongolia was adopted in Mongolia in 1993. Each province and major city has a microbiological laboratory for food quality control. The laboratories are coordinated under the National Centre for Hygiene, Epidemiology and Microbiology (NCHEM). There has been a quality assurance system developed through the National Centre for Standards and Measureology (NCSM), which involves calibration and methodology standardization, however, external proficiency testing was not reported to be undertaken. The report noted that there was a need to strengthen laboratory capacity, develop methods and raise the standards of quality assurance to be able to meet international standard requirements. 10. Papua New Guinea
There are a limited number of food microbiological laboratories in Papua New Guinea (PNG). The main laboratory is developing within the Central Public Health Laboratory in Port Moresby. Other hospital laboratories focus on clinical microbiological testing and have no specific training or facilities for food analysis . There is no established quality assurance program for food analysis, however, the National Institute of Standards and Industrial Technology is beginning to accredit some chemical and clinical testing laboratories . The report identified a need to develop a quality assurance program and to provide training in development and implementation of quality programmes. Networking and linking with regional support groups was identified as a mechanism to encourage development of such programmes. 11. Philippines
Food microbiological analysis is coordinated in the Philippines through the Bureau of Food and Drugs (BFAD) and the Department of Agriculture. The BFAD has developed an informal networking of food analysis laboratories to support the food industry's needs. The BFAD and Department of Agriculture laboratories use validated methods and have a range of methods manuals . They have also participated in quality assurance proficiency testing programmes in a number of international programmes. BFAD has plans to initiate a national analytical quality assurance system in the near future. The advantages of networking regionally with other labs and with support groups was identified and would facilitate the development of national quality standards and protocols. 12. Samoa
Laboratory services in Samoa are primarily for clinical analysis, associated with National Health Laboratory Services. Limited food analysis is done in the clinical microbiology section when specific complaints are received. No routine system of food surveillance or quality testing is carried out. There is no programme of quality assurance of proficiency testing for food microbiology analysis. There was an urgent need identified for the establishment of validated techniques and standard procedures for food analysis.
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Annex 5
13.
Solomon Islands
Laboratory services are clinical based in Honiara. Limited food analysis is carried out by the medical laboratory. There is no trained food analyst. Samples are irregularly analyzed for Environmental Health Inspectors. A Pure Food Act has only recently been passed by the government. An urgent need was identified for the development of standardized, validated techniques for food microbiological analysis, aiming for ability to participate in a proficiency testing program. 14. Tonga
The Central Public Health Laboratory is capable of limited microbiological analysis of foods, however, no routing programme of testing is established. The Public Health Division of the Ministry of Health is responsible for monitoring of food safety programmes, however, they do not have a food analysis laboratory. The Central Laboratory does not have a quality assurance program and does not participate in any proficiency testing. In discussions of the report, it was identified that there was a need to develop networking support to establish methods validation procedures, assist in training and future development of a quality assurance programme for microbiological testing of foods. 15. Vanuatu
The government laboratory at the Ministry of Agriculture and Ministry of Health, therefore, food analysis is not routinely carried out. A Public Health Laboratory has been built, however, staff and technicians are currently undergoing training. Clinical analysis staff will be involved in the new laboratory and will require training in food analysis to facilitate the development of an appropriate capability in microbiological testing of food. The report noted that a methods manual was needed to form the basis of a quality assurance programme. Assistance was noted to be required in training, equipment and development of a quality assurance programme. 16. VietNam
The control of food quality, hygiene and food safety is part of a national programme. The National Food Control System and the network of food control provincial laboratories implement the programme, under the Ministry of Health. The Department of Food Science and Hygiene, at the National Institute of Nutrition, and the Directorate of Standards and Quality have developed a national lab accreditation initiative. VietNam takes part in a number of proficiency testing programmes, however, awareness of the programmes and utilisation of results are not widespread. It was recognized that assistance was required and would be very valuable in the development of quality assurance programmes, including methods validation. The advantages of utilization of the outcomes of proficiency testing to improve laboratory performance, were Identified during discussion.
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ANNEX 6 .
EXTERNAL QUALITY ASSESSMENT DRAFT PROTOCOL
In order to develop and implement an external quality assessment programme for microbiological analysis of food in participating laboratories across national borders in the Western Pacific Region, the following elements need to be addressed: 1. Establish Aims and Objectives Key objectives would include the following: (1) to strengthen consumer, industry, trade and government confidence in food analyses and food safety; (2) (3) (4) to facilitate international trade in safe food; to enhance technical capability of food analysts in the Western Pacific Region; to develop and strengthen quality assurance in food analyses in the Western Pacific;
(5) to transfer the capacity to administer proticiency testing capability to regional laboratories in the intermediate/long term. 2. Initial Programme Development
Team coordinate with possible network members to develop and design proficiency programme relevant to the region, including identitication of and networking with existing programmes. 3. Sample Management 3A Initially samples should be in the most stable form (e.g., freeze dried). However, efforts should be made to develop stable t~)od systems. 3B 4. Sample distribution and frequency of analysis needs to be addressed in initial stages.
Analytical Procedures 4A Pre-advice and instructions should be provided.
4B A limited organism range should be used initially, possibly addressing standard plate counts, coli forms, Salmonella, Listeria or Clostridium. 4C Qualitative and quantitative analyses should be considered.
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Annex 6
5.
Data Management SA 5B 5C 50 Data analysis. Evaluation performance. Reporting and communication with participants. Confidentiality of records.
6.
Education and Training of Analysts 6A 6B Education of government authorities and analysts. On site training should be used in conjunction with short course training.
7.
Programme Coordination and Collaboration Maintain network, coordination with regular workshops to advance information 7A exchange on methods. 7B 7C Communication regarding method developments. Analytical support, e.g. reference materials. equipment, etc.
8.
Programme Review SA 8B 8C Feedback/corrective action procedures. Continued improvement. Evaluate continuity of the programme.