Example 10

Example of a well-crafted committee response.

REASON FOR NEGATIVE AND COMMITTEE ACTION

Mr. Doe voted negative for the following reason:
1. Para 4.5 refers to " benefits outlined above." I don’t see any benefits outlined above this line.
2. I am not sure that I see a need for both sections 5.6 and 5.8, nor 5.7 and 5.9. Section 5.6
introduces Section 11. The introductory paragraph in 5.6 refers to continuous improvement which is not referenced anywhere in Section 11. Moreover, Section 11 adds nothing of value to the standard that is not better addressed elsewhere. I think the entire Section 11 (and therefore, section 5.6) can be eliminated without harming the standard. Section 5 is missing a subsection that introduces the requirements for subcontracting, outside support and customer feedback
3. Para 10.4.2 suggests that duplicate records be maintained, one set in the proximity of the machine, and the other in a central repository. I find that it difficult enough to insure that a single set of records is kept up-to-date, and the added complexity of maintaining duplicates is not worth the hassle. Keep a good set near the machine – which is after all where the corrective actions occur, and forget about duplicating them.
4. Para 7.2 is missing a "t" in front of the third word of the para.

SUBCOMMITTEE ACTION
At the meeting on 04/9/99, Subcommittee X99.99 voted 8-0-0 to rule Mr. Doe’s negative not persuasive for the following reason:
Mr. Doe’s negative contained a total of 4 points. In a subsequent phone conversation and e-mail exchange with the Chairman, Mr. Doe identified which points he considered to be editorial and which were "substantive or structural." Of the four points, only one was deemed editorial and the remaining were voted not persuasive for the following reasons:

1. Para 4.5 refers to " benefits outlined above." I don’t see any benefits outlined above this line.
Response: Paragraphs 4.1-4.5 contain the benefits referenced in 4.5. Benefits are having a quality management system (4.1), use of documented accountability and QC assuring clients that adequate accuracy and precision are achieved (4.2), use of guide to develop a QM system (4.3), usefulness to clients, regulatory agencies and evaluators (4.4).

2. Structural: I am not sure that I see a need for both sections 5.6 and 5.8, nor 5.7 and 5.9. Section 5.6 introduces Section 11. The introductory paragraph in 5.6 refers to continuous improvement which is not referenced anywhere in Section 11. Moreover, Section 11 adds nothing of value to the standard that is not better addressed elsewhere. I think the entire Section 11 (and therefore, section 5.6) can be eliminated without harming the standard. Section 5 is missing a subsection that introduces the requirements for subcontracting, outside support and customer feedback.
Response: Section 5.6 refers to QA and 5.8 to QC. They do not duplicate. Section 5.9 refers to reporting procedures, while 5.7 refers to all aspects including reporting. Because a whole section (17) covers reporting, it was deemed desirable to emphasize this aspect in the introductory section (5). Section 11 simply introduces and summarizes critical elements of the QA system, which are covered in detail in subsequent sections.

3. Substantive: Para 10.4.2 suggests that duplicate records be maintained, one set in the proximity of the machine, and the other in a central repository. I find that it difficult enough to insure that a single set of records is kept up-to-date, and the added complexity of maintaining duplicates is not worth the hassle. Keep a good set near the machine – which is after all where the corrective actions occur, and forget about duplicating them.
Response: Duplicates are easy to make and both a central repository and a copy with the equipment serve different purposes. The Quality Assurance Manager should have copies of all such documents, for example.

4. Editorial Para 7.2 is missing a "t" in front of the third word of the paragraph.
Subcommittee agrees that this is editorial and change will be made.

MAIN COMMIITTEE ACTION
At their meeting on 04/10/99 the main committee voted 17-0-1 to uphold the decision of the subcommittee.