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PROPOSED DRAFT GENERAL GUIDELINES ON SAMPLING[1] (Agenda Item 4)

5. The Committee at its 20th Session in 1995 had agreed that the Proposed Draft Guidelines on Sampling be further revised to consist of two main parts: Part I - Discrete Lots Moving in International Trade and Part II - Control of Manufacturing Process; and that the revised document should identify its potential users[2]. The revised document had been circulated under CL 1996/38-MAS for comments. The comments submitted were considered to further improve the draft document.

6. In introducing the revised document[3] as a member of the Codex Secretariat, Dr. Ray Coker stated that, in revising the document, materials from relevant ISO documents, i.e., ISO/TR 8550: 1994(E), ISO 2859-0:1995(E), ISO 2859-1:1989(E), ISO 2859/2:1985(E), and ISO 3951:1989(E), together with material[4] from the International Commission on Microbiological Specifications for Foods (ICMSF), were utilized and that a variety of worked examples had been included to assist in the clarification of the guidelines. Non-food examples provided in the text would be replaced with relevant ones in the food area. The Committee noted that most of the source materials were under revision.

7. The consensus opinion expressed after discussing the draft was that the document should be further revised in light of the comments made and the written comments submitted during the meeting. In order to facilitate consideration of the proposed revised text, the Committee agreed that an ad hoc Working Group comprising Australia, Austria, Canada, Czech Republic, France, Hungary, India, The Netherlands, Thailand, United Kingdom, the United States and the Codex Secretariat should convene outside the working hours of the Committee, to address the following issues.

· The nature of the target audience;

· The nature of the document; and

· The inclusion (or otherwise) of: (a) double, multiple and sequential sampling plans; (b) zero acceptance number sampling plans; (c) sampling from bulk material; (d) non-random sampling; (e) risk assessment issues; and (f) measurement error.

8. The Committee considered the proposals of the ad hoc Working Group which are summarized as follows:
· the primary target audience will be Member governments and Codex Committees;

· the guidelines should primarily address the acceptance sampling of isolated lots;

· the guidelines should include an introductory section confirming the nature of the target audience, the precise purpose of the document, and a summary of Codex Sampling Principles and their relationship with international organizations dealing with inspection;

· the standards referred to in the documents should be referenced and briefly summarized in an Appendix;

· the following items should be added:

(a) brief introduction of double, multiple and sequential sampling plans;

(b) brief introduction of zero acceptance number sampling plans;

(c) sampling from bulk material (using ISO standards (ISO/WD 11648-0; ISO/CD 10725-2; ISO/CD 11648-1));

(d) brief introduction of non-random sampling; and

(e) all relevant figures and diagrams

· acceptance sampling plans for a continuous series of lots from a single process or source should be retained as a fully referenced, brief introduction;

· reformulated worked examples relating to foodstuffs should be retained, utilizing existing sampling plans for food materials wherever possible;

· mention should be made of the relationship between perceived risk and sampling plan design; but an in-depth discussion of risk assessment should be avoided;

· the guidelines should be as simple and user-friendly as possible so that they can be readily understood by all participants in Codex Committees; and the guidelines should contain a brief introduction to the concept of measurement error, ensuring that the end-users are aware of the implications of measurement error on the efficiency of sampling plans.

9. The Committee accepted the proposals above and requested the Codex Secretariat to further revise the Proposed Draft General Guidelines on Sampling in light of the above points, with assistance provided by Australia, Austria, Canada, Czech Republic, France, Hungary, India, The Netherlands, Thailand, UK and USA. The revised guidelines should be circulated for comments well before the next session of the Committee.

Status of the Proposed Draft General Guidelines on Sampling

10. The Committee decided to return the Proposed Draft General Guidelines to Step 3 of the Codex Procedure for further revision and comments.


[1] CL 1996/38-MAS; CX/MAS 97/2 (comments from Czech Republic, Hungary, Italy, South Africa, United Kingdom and International Dairy Federation); CX/MAS 97/2-Add. 1 (CRD 2) (comments from Canada and Denmark); CRD 7 (comments from Hungary); CRD 8 (report of the ad hoc Working Group); Written comments were submitted by France, the Netherlands and the USA at the Session.
[2] ALINORM 97/23, paras. 8-9.
[3] CL 1996/38-MAS.
[4] Microorganisms in Foods . 2 . Sampling for Microbiological Analysis, 1986, ISBN 0-632-015 67-5.

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