“Are regulatory inspection procedures documented and are inspection records available for review?” - SCS Global Services GMP Audit, Regulatory Inspection, Clause 2.8.47
Successfully completing a GMP audit certification is evidence that your food facility has procedures for each of the following:
1. Explain your performance record. FDA’s Inspection Classification Database Search webpage allows for customers to search for your compliance history, so be prepared to explain your record and related corrective actions. While there are many classification codes, these are the most commonly used:
No Action Indicated (NAI)
Voluntary Action Indicated (VAI)
Official Action Indicated (OAI)
Auditors want to see it all - so be sure to preserve your inspection records (Forms 482, 483, etc.). For more on 483 forms, check out FDA’s 483 Form FAQ.
2. Accommodate regulators. While procedures for accommodating (not guiding!) regulators are indispensable, a note card that provides employees with on-the-fly advice is a good idea.
3. Verify and document your compliance. To avoid guessing, we make a list of requirements and systematically address each requirement in two steps:
List compliance evidence and
Make an action plan
Step (a) is known as “indexing” or “blueprinting”. It’s purpose is to create a master key that you (and the auditor) can use to navigate the audit, seamlessly. Step (b) establishes an exhaustive “to do” list that you can delegate to members of your team.
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