The following is an excerpt from The Complete Guide to the CQA (QA Publishing, LLC) by Steve Baysinger, which is out of print. Complete coverage of documentation requirements for effective Quality functions may be found in The Handbook for Quality Management (2013, McGraw-Hill) by Paul Keller and Thomas Pyzdek
APPROPRIATE, ADEQUATE, ACCURATE AND CURRENT
The word "documentation" encompasses both records and documents. Records are recorded information, regardless of the medium or characteristics, made or received by an organization that is useful in the operation of the organization. (Association of Records Managers and Administrators Glossary, 1989) They are also any information captured in reproducible form that is required for conducting business. (Penn et al., 1994) Documents, on the other hand, is a term that denotes written or graphical procedures, policies or instructions. Documents explain what an organization plans to do and how it will be accomplished as well as instruct employees how to perform tasks. Unlike records, documents exist before the fact; they provide guidelines, explanations and instructions about how to operate. Records contain information about the activity and, thus, do not exist until after the activity has been performed. Documents include quality manuals, raw materials specifications and procedures on such topics as internal quality audits, marketing, quality control, hazardous waste handling, document control, etc. (Brumm, 1995)
The benefits to the auditee of properly maintaining organizational records and documents should be obvious. First, properly maintained documentation provides employees with the official "company way" of performing their tasks as related to ensuring product quality. Next, documentation can be very useful in simplifying complex (and, thereby, error-prone) processes. Documentation can be used to supplement employee training. It provides a basis for comparing what is required to what is actually done. Documentation, in other words, can be audited to verify compliance. It is an excellent source of objective evidence for the auditor. Documentation also provides a method of evaluating the quality system per-formance of suppliers and sub-tier suppliers to ensure the best provider of quality material and products is selected. (Haney, 1994)
When preparing for the audit, it is always prudent to review the past performance history of the auditee. 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 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 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 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)
Learn more about the Quality Management tools for process excellence in The Handbook for Quality Management (2013, McGraw-Hill) by Paul Keller and Thomas Pyzdek or their online Quality Management Study Guide.