| 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 dont 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. Does negative not persuasive for the following reason:
Mr. Does 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 dont 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. |