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The following is an excerpt from The Complete Guide to the CQA by Steve Baysinger, © Quality Publishing. It may be ordered from the Quality Publishing Order Form.

Importance and Utility of Quality Documentation, Part 2

Prior Information

When preparing for the audit, it is always prudent to review the auditee’s past performance history. A review of prior audit records, closed and/or in-process corrective actions, receiving inspection records, contractual documents and other on-going issues are valuable sources of information. If any past deficiencies are identified, they should be included in the audit plan. Corrective actions taken from previous audits should also be examined during the course of the upcoming audit to verify that their implementation was effective in preventing recurrence of nonconformities. (Haney, 1994) (Refer to Chapter 11, Audit Plan.)

When reviewing an auditee’s performance history, one of the most important tasks to accomplish is to review as much of the their documentation as possible prior to beginning the audit. Much of the information needed to perform this pre-audit documentation assessment can be found in the auditee’s quality manual. If the auditee permits, the auditor should also review the corresponding procedures and work instructions that address the quality system, process, product, etc., to be assessed. Doing so greatly facilitates the construction of audit checklists. (See Chapter 9, Checklists.) Often the auditee will classify procedures and work instructions as proprietary information. If this happens, the auditor will almost always have to sign a nondisclosure statement before taking possession of these documents. This is done to protect the auditee from losing sensitive trade and manufacturing information to competing firms. (ASQ’s Code of Ethics, Paragraph 2.4, specifically addresses this issue.) When researching prior (audit) information, the auditor, during the course of the pre-audit documentation review, must ask of himself (or herself) three very important questions:

1. Are all of the required elements (of the relevant quality system) adequately addressed in the source documentation?

2. Are the policies, procedures and work instructions adequate to ensure that activities are adequately controlled?

3. Are there any deficiencies identified that would make proceeding with the audit questionable? (Haney, 1994)