Documenting Rejected Corrective Actions
Hello!
I was wondering if anyone could help me with a situation - I would be grateful for any input!
I am an internal auditor for my company, and have issued a CAR to a dairy manufacturing facility (human consumption) for not documenting rejected corrective actions and not documenting a new due date after rejection for facility-issued CARs. The Leadership is challenging it, stating that requirement is not in any code. I know I have come across this somewhere in my training (in Quality for 9 years), but am having some difficulty locating this information.
It would be a simple fix to add a space in their documentation to document rejection of the provided corrective actions, and a space for a new due date, but the push back is that it isn't required to begin with.
The facility is Dairy and located in Texas, so falls under CFR, Food Code, FDA, TDH, and we are SQF Level 3 certified.
Any assistance or input would be greatly appreciated!
Thank you,
Christy
Hi Christy,
I assume you have audited a supplier to your company - that is what it sounds like.
If I am wrong, then what Mr. Kerabatsos mentioned above is correct - however if this is one of your suppliers or soon to be suppliers there would be two ways of looking this --
1. If your supplier is a CONTRACT MANUFACTURER that supplier is required to either be or meet SQF requirements - then SQF 7.2 Module 2 - 2.5.5.2 would apply as mentioned above.
2. Here may be the trip up however, if they are not a contract manufacturer and thus classified as a supplier they might have a point in that if you look at 2.4.5 you won't find anything about corrective action closure but only about maintaining records of inspections and audits. Technically speaking that means that you can go an audit them but they don't have to do anything about corrective actions... except for this one...
As you know you rate your suppliers for RISK and you could rate them for corrective actions ----- as in not doing them or providing closure for you, then you would be able to say - yes, it's right here!
I like the idea of an open-ended CAPA process (Corrective Action and Preventative Action): CA = what did you do to correct it the first time, PA = what did you do to prevent it from happening again.
Thus the CAPA is an ongoing "diary" or what worked or didn't, and how the correction was made permanent. This may not sit well with some people, but it is a good way to capture all the history instead of trying to go back through several CAR's to see what was done, why initial actions did not succeed or were not acceptable, and what was done to prevent it from happening again.