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PCB007-June2020

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62 PCB007 MAGAZINE I JUNE 2020 Introduction Continuing Part 1 and Part 2 on "Guerilla Tactics to Pass Any QMS Audit," I share Tac- tic 9. Hopefully, you are finding a number of solid strategies you can apply immediately to improve your audit success. Guerrilla Tactic 9: Documentation Tips To Avoid Audit 'Dings' Williams' Law 9 Teach it, preach it, and audit to it. Prepare so that no question should be able to be asked that an operator does not know the answer to. Williams' Law 9.1 If you can't prove it, it didn't happen! Williams' Law 9.2 The ONE time a supervisor asked someone else to sign for them, the auditor will find it. Tip 1: KISS "Keep it simple, Steve." The goal is to develop a system that: • Is effective • Is easy to understand • Is flexible • Minimizes opportunity for error • Is simple Tip 2: Standardization Develop a standardized procedure template. Standardized sections might include the fol- lowing: • Responsibilities Section 2.0 • Quality Requirements Section 3.0 • Operations Section 5.0 • PM Section 7.0 • Forms Appendix A This standardization should facilitate: • Ease-of-use • Training • Recall • Memorization of structure, not procedure • Time-to-retrieval Tip 3: Verbiage Consider verbiage as follows: • Functional vagueness – Precise enough for functionality – Vague enough for practicality • Shall/must – Critical – Non-compliance would jeopardize operation The Right Approach by Steve Williams, THE RIGHT APPROACH CONSULTING Guerilla Tactics to Pass Any QMS Audit, Part 3 Avoid audit dings.

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