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ISO 9001: 2000 Quality Management System Design - page 53


Endnotes

[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.



Chapter 9: Other Mandatory Documents

9.1 SHALL Analysis of Other Mandatory Documents

To borrow a phrase, "Discretion is the better part of the QMS." It's everywhere! Consider the requirement Par. 4.2.1(d), which alerts us to the fact that we need to produce documents that result in effective process planning, operation, and control. A SHALL of this type must be broken down into a little "SHALL analysis." There are three mandates to this one liner, and we will use a matrix to clarify this imperative (see Table 9.1) [1] .

Table 9.1: Other Mandatory Documents "Shall Analysis"

Requirement

Key Word

Fits into This Tier with Typical Documents Called...

The documents required to ensure effective process planning

Planning

Tier II:

  • Quality plan

  • Control plan

  • Business plan

  • Manufacturing plan

  • Manufacturing engineering plan

  • Test plan

  • Quality-assurance plan

  • Technology transfer plan

The documents required to ensure effective process operation

Operation

Tier II:

  • SOPs

  • Process maps

  • Process flow charts

  • Work orders

  • Routers

Tier III:

  • Work instructions

  • Process instructions

  • Functional test procedures

The documents required to ensure effective process control

Control

Tier III:

  • SPC charts

  • Pareto charts

  • FMEAs

  • Risk-analysis reports

  • Yield reports

Tier IV:

  • All of the formats

  • Templates

  • Drawings

  • Schematics

  • Check sheets used to collect data for analysis and record keeping

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 auditor question is "which documents do you use to ensure the effective planning, operation, and control of your processes?" In this case, "effectiveness" is defined (i.e., Par. 3.2.14 of the vocabulary) and we are informed that we are effective when what we plan to do gets done.

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 concerned with this requirement. See, for example, Page, Stephen B., "The Continued Importance of Documented Procedures to ISO 9000:2000 Standards," Software Quality , Summer 2001, p. 13.

[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.



9.2 The Special Case of Product Characteristics

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 appeal to reason. In our hierarchal documentation structure, we suggest the use of documented specifications, marketing requirements, and technical brochures and manuals to accomplish this purpose. We just cannot see how verbal information can be stable enough to work in a real enterprise scenario.

According to the vocabulary, the specific characteristics are essentially unlimited in that they can be either qualitative or quantitative and include all manner of categories such as physical, sensory , behavioral, temporal, ergonomic, and functional.

However, we normally speak in terms of preliminary, final, critical, intermediary, regulatory, and validated specifications to describe a product with regard to form, fit, function, performance, safety, and environmental behavior. The documents include specifications, drawings, schematics, test plans, blue-prints, work orders, and travelers and routers. As a result, the documents needed fit into all three of the lower level tiers (i.e., II, III, and IV).

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 tier III document. A drawing under engineering change-order control is normally classified as a tier IV document.

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 term used would be Control Item (V) Parts, where the inverted delta is used to denote the parts that have critical characteristics (e.g., dimensions or performance tests that could affect safe vehicle operation or impact compliance with regulatory requirements) [3] .

[3] See "Quality System Requirements, QS-9000," obtained from AIAG at tel: (810) 358–3003.