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I Was Cooking When the FDA Showed Up

The FDA showed up one day at Heavenly Harvest, Inc, (my company, a small, woman owned organization, operating in a hub-zone). We designed, produced, and distributed FDA-regulated over-the-counter Fluoride Tooth Powder and Toiletries. We adhered to ISO 9001, ISO 14001, ISO 45001 (OHSAS 18001), and ISO 22000 requirements. I wasn't home. I was at my daughter's in another town cooking gluten free corn bread for a wedding dinner! Four Hundred were made and ready.

Have you found that audits always happen at the most unexpected times?

The FDA Audit occurred while I was out of town cooking. My office manager led the audit.

There were zero nonconformances.

The auditor was in awe. The system was built to ISO requirements. We had mistake proofed it. Risks were known and mitigations were in place to ensure the organization was data driven, and continually consistent and improving. It was a great day for us.

I dream of that great day for you and your company.

Dream with me now. Imagine your company.

Imagine that while you are away there is a crisis back at the factory.

Imagine your total lack of stress when you realize EVERYONE KNOWS WHAT TO DO, we have practiced it. No mistakes. No failures to follow planned arrangements.

What could have been a crisis is instead one more opportunity for continual improvement. Hard to imagine. Let's talk, this is entirely possible! This is my dream for you!

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