[1] The subject has received some deserved dedicated attention. See, for example, Brumm, Eugenia K., "Managing Records for ISO 9000 Compliance," Quality Progress , January 1995, p. 73. The book of the same title is also available from the ASQ, ISBN 0-87389-312-3.
[2] Quality System Regulation, Part VII, Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 820, Current Good Manufacturing Practices (CGMP): Final Rule, October 7, 1996, published by the SAM Group, Stat-A-Matrix, Edison, N.J., Sec. 820.181: Device Master Record.
To
|
Requirement |
Key Word |
Fits into This
|
|---|---|---|
|
The documents required to ensure effective process planning |
Planning |
Tier II:
|
|
The documents required to ensure effective process operation |
Operation |
Tier II:
Tier III:
|
|
The documents required to ensure effective process control |
Control |
Tier III:
Tier IV:
|
Those who believe that only a few documents are really needed for the new Standard are well advised to take a cautious position on this matter because of Par. 4.2.1(d) of the Standard. For example, the perfect
Clearly, it is best to have a well-documented set of tier I, II, III, and IV documents. Of course, we contend that this will produce an overall effective QMS because all of the requirements of the Standard will be covered. Thus, a win-win scenario. A checklist to help organize your thoughts in this matter is addressed in Appendix C [2] .
[1]
I am not the only one
[2] The use of checklists has begun show up as articles. See, for example, Kaganov, Mark, "Checklists—A Perfect Tool To Tune Up Your Quality Manual," Quality Progress , October 2000, p. 37.
We have now reached the last requirement summarized in Table 3.4 (i.e., the discussion of Par. 7.5.1, of the Standard), which deals with describing the characteristics of product. We are to provide information for this purpose but are not told in what form it is to occur. The information need not be documented. If we state that it makes sense to prepare such information in documented form, we create a specification and the ISO 9000:2000 vocabulary informs us that specifications are documents that address requirements (Par. 3.7.3). So we can solve the Catch 22 problem if we
According to the vocabulary, the specific characteristics are
However, we normally speak in terms of preliminary, final, critical, intermediary, regulatory, and
For example, a marketing brochure that contains explicit product specifications should be a controlled document at the tier II level. A test plan that includes specific performance values and tolerances should be a controlled
Critical characteristics are also highlighted on drawings and are a key ingredient of conditions set down by automotive companies engaged in QS-9000 certification protocols. A typical
[3] See "Quality System Requirements, QS-9000," obtained from AIAG at tel: (810) 358–3003.