PCB007 Magazine

PCB007-Dec2020

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70 PCB007 MAGAZINE I DECEMBER 2020 Editor's note: Read Part 1, which originally appeared in the November 2020 issue of PCB007 Magazine. Introduction While documentation is often viewed as a necessary evil, it is a very important aspect of any quality system but needs to be functional. Part 2 details more tips and techniques to sim- plify and streamline your QMS documentation. Document Control Now called documented information, this is another area that is prone to an auditor's find- ing, and in most cases, results from a lack of discipline. The key concept of document con- trol is that any document related to product quality needs to be under document control. Examples include documents such as proce- dures, forms, logs, checklists, etc. I would argue that every document in any organization is related to product quality and needs to be controlled. It is a far superior strat- egy to include every form, log, etc., in the doc- ument control system than to defend to a cus- tomer or auditor why the uncontrolled form they just found is not related to product qual- ity in some way. There are a number of key elements that need to be thoroughly understood and con- sidered within any document control system. These elements are briefly discussed here and need to be defined in the document control procedure. Centralized Control Document control by committee does not work; every effort should be made to design a system in which all documenta- tion flows through a single person/position, such as a quality analyst or QMS co- ordinator. Flowing down responsibility to function- al departments is a disas- ter waiting to happen and makes the "control" part of document control very difficult to maintain. Cen- Simplify Your QMS Documentation Through KISS, Part 2 The Right Approach by Steve Williams, THE RIGHT APPROACH CONSULTING

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