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PCB007-June2020

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66 PCB007 MAGAZINE I JUNE 2020 • Blanks throw up red flags that something required wasn't completed and make it difficult to defend missing information Tip 10: Include All Forms All forms should be included in the docu- ment control system (manufacturing, office, etc.). Preventive maintenance forms/logs are often overlooked and should be posted at the equipment and highly visible. Forms are qual- ity records, and you would be hard-pressed to find an example that doesn't contribute to the quality of the product in some form or another. Tip 11: Resolve All Temporary Process Changes Use three-month or six-month durations to sync with ISO surveillance audits. Try to re- solve all TPCs prior to surveillance audits. If they can't, or for customer audits, review the entire list of TPCs to make sure they are not ex- pired. Also, verify that all resolved TPCs have been closed out appropriately (i.e., approved with appropriate procedure revision and unap- proved with documented reason). Tip 12: Procedure Revision Procedure revisions show an auditor that continuous improvement is happening. A red flag to most auditors are procedures that were written five years ago and have not been re- vised since. For example: • Preference: Annual procedure revision for a sample of procedures • Acceptable: Touch all procedures at least once every three years Don't forget forms that may need revision accordingly, and don't go overboard on revi- sions. Use a temporary process change process to combine multiple small changes. Conclusion It is my desire that as we work through the various strategies, techniques, and tactics pre- sented throughout this series, you will appreci- ate these are tried-and-true, practical applica- tions and lessons learned over the course of my career. I hope you will find some value in them. PCB007 Steve Williams is the president of The Right Approach Consulting. To read past columns or contact Williams, click here.

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