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.