Root Cause - Missing Risk analysis for our clothing policy
I got an NC for not having a risk analysis to go with my clothing policy. Now I need a root cause, which to put it simply, "I didn't have one". That's not good enough. I am the only one in charge of absolutely everything in QA and food safety.
Why? - I was not aware.
Why? - You can't be aware of something you don't know about.
Why? - Because we have had this same clothing policy for years and the FDA, SQF, etc. have never batted an eye to see a risk analysis.
Why? - I have absolutely no idea what to write for a Root Cause.............. HELP!
Here's the guidance for module 11 than mentions clothing, pages 33-35
https://www.bing.com...Zlci5wZGY&ntb=1
This topic is interesting to me because I've never been asked for this in 20 years of SQF. So, since risk analysis considers biological, chemical, and physical risks, I would use the HACCP model and tailor it to your plant's choices of required uniforms/clothing/cleaning of the clothing.
For instance:
- "no buttons, no top pockets" policy is to eliminate physical risk. We all know that but is it in a risk analysis document?
- "we have our clothing laundered at "X" degrees with non-scented detergent because it has been proved effective to kill pathogens at this temperature and is stored in "x" place to keep it clean until used". Or your outside laundry facility may have a document you can incorporate.
-"We have a policy to leave all company clothing at work and not take it outside to eliminate risk of outside contamination such as overhead birds, soil, etc.". If you go through your particular uniforms and why you chose them, you also may find that you've missed something, like that production shirts have no top pockets, but maintenance shirts do. Then you have a corrective action to take care of.
As to the root cause - In my case I would assert that the risk and its mitigation as far as uniform policy is a part of my GMP policy, and i was under the impression that was adequate. I will pull it out and create a separate risk assessment document. I'm going to take a look at mine now! Good luck to you.
PS here's another model that looks easy to use:
State that it was overlooked when the code was updated. I've used that before and they were fine with that RC.
State that it was overlooked when the code was updated. I've used that before and they were fine with that RC.
Hi Scotty,
Nice one.
I guess that ultimately equates to RC = Human Error which usually implies "Training". Probably the oldest one in the "Book". :smile:
Hi Scotty,
Nice one.
I guess that ultimately equates to RC = Human Error which usually implies "Training". Probably the oldest one in the "Book". :smile:
Definitely lol...Those ones are always rough to me as there is such a thing as human error. Not all of us are robots...lol...yet. (AI could someday take over aspects of our job, who knows?)I have read over something and totally forgot to have something in place for it. Some times these codes can get so wordy, that it is hard to read between the lines to know what you actually should have in place. I have had some good experiences with auditors that are understanding and then say, 'just have it covered next year' for something really minor.
We got this one too. Thanks for the tips here!