Cheat Sheet For FSMA and 3rd Party Audits
An FDA official told me that she had to put the whole PC For Human Food rule into a spreadsheet format to understand it, so my business partner and I did the same.
Blueprinting
We call it a BLUEPRINT because it creates the ideal framework for checking all of your compliance boxes when performing an internal audit or initial gap analysis. I can't imagine performing a qualified audit without it.
Blueprinting beyond the PC rules
Our process and tool was so successful that we created one for popular 3rd party audit criteria, including Whole Foods Market supplier audits, GMP audits (SCS Global, NSF International, Mérieux NutriSciences, etc.), the Costco addendum, and SQF (Level 2 for Module 2 and 11).
Blueprint Improvements
In the transcription process, we improved the legibility of the regulation in the following way:
#1 - Eliminated distractors
We have re-written the provisions to exclude distractors. For example, references that pressure the reader to flip back and forth in the code have been re-located to a citation note column, where succinct explanations provide the reader with the equivalent of a helpful footnote.
#2 - Improved the listing convention
FDA's listing convention disorientates the reader For example, 117.136(a)(4)(ii)(B)(1). This was one of the biggest complaints from the FDA official. As a result, we adopted the SQF listing convention (1, 1.1, 1.2, 1.2.1, 1.2.2, 1.3, etc.)
#3 - Broke up the subparts
Separating the subparts help prevent making fatigue-related errors during an audit or initial gap analysis. My preferred approach is the following:
- C and G first (Day 1 - Desk Audit)
- A, B, and F last (Day 2 - Inspection and On-site audit)
Want to learn more?
Contact Food Safety Guides to learn more about our unique approach to food safety and quality system development. Or shoot me an email to get in touch direct!
Food Scientist
8 年What a terrific idea! It really breaks down the tasks so they don't seem so overwhelming and through your use of google docs everyone can see what needs to be done.
Formerly- Environmental Scientist at California Department of Food and Agriculture. Caregiver, jewelry maker.
8 年Excellent tool for the food industry and auditors. Thank you Michael Kalish.