Sanitation documentation, frequency of verification
Hi all,
I'm looking for some feedback on how other facilities document sanitation activities. My company is small (10 people). We produce to PO (no inventory), and sanitize after each production/PO run. We are currently documenting on paper the different steps of sanitation and they are initialed/dated when completed. There is a column for QA verification in which we as QA sign off on after we have performed ATP swabbing of the area.
My concern is that this will not be "enough" for our impending FSMA inspection. Additionally, we have over 8 months of ATP data with less than 2% oos - can the frequency of verification be revisited or is it best practice to perform after every sanitation? We use one allergen - soy lecithin.
Would love your feedback, thank you!
This is going to sound crazy to you but in my view, 2% out of specification is still pretty high. I wouldn't reduce my ATP testing, especially if you think it will not be "enough" for your inspection.
In reality, you can use trend analysis to justify your cleaning program and verification frequency, but I'd wait until you get that number down to almost 0.
As an aside, if I were auditing you, I'd much rather see your ATP testing as a PRE-OPERATIONAL check, not an 'after cleaning' check because I don't know what happens between when you verify it is clean and you start up again.
Just some food for thought. Not sure if it even speaks to your specific concerns.
Thank you - I appreciate your input! A second question based on your pre-op check recommendation -- is it a faux pas to have production personnel perform the ATP swabs at pre-op checks?
As long as they are trained, competent and documented, anyone can do ATP swab testing.
Marshall
svnh.bell, the problem I think you're referring to, and is a serious one, is that if production people are doing the cleaning, they are not very likely to honestly perform the ATP test. If you have an ATP test system like Accupoint, that's mitigated because the results are automatically logged and you or someone else will verify them to make sure the checks are being done. If you do some sort of manual testing and recording, I would personally feel much more comfortable with having someone perform and document the test who was not involved in the cleaning.