TABLE OF CONTENTS 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].
| Requirement | Key Word | Fits into This Tier with Typical Documents Called... |
|---|---|---|
| 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:
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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,...
