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Do we have to document all corrections and corrective actions in ISO 9001 10.2.2 ?

Ed Panek

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#31
#31
For me as I go I create a Corrective Action list that becomes our project list. The process should allow you to document them all. Not documenting them would seem to skirt the reason CAPA exists.

Also consider the mind of the auditor. Normally a major finding means a systemic lack of conformance to the standard. If you have 4 CAPAs to audit and 3 of them are lacking its easy to assert your CAPA system isnt working. If you 25 CAPAs and 3 of them are lacking its hard to make that same argument. If you have CAP activity that is simple to correct surely you should add it to the overall list.
 
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normzone

Trusted Information Resource
#32
#32
I misread this as " I believe in flogging ... " and thought "Wow, he's not the fellow I thought he was".

Kronos147 said:
...FWIW, I believe in logging, and then determining thresholds where logical (like Jen says, based on risks, opportunities, context, needs and expectations of interested parties, etc... and of course resources!) where to take formal corrective action...
Click to expand...
 
Crusader

Crusader

Trusted Information Resource
#35
#35
I'm so tired of shop personnel getting upset over a corrective action that I initiated...and I handle for them! Then they get the attitude and say to me: "but it was only this 1 time out of thousands of orders." Right. I initiated a CAR. I DID THE CAR FOR YOU. AND oh yeah, I changed your inspection check off sheet by adding one more check with a photo of what to look for on all orders. "BUT IT WAS ONLY 1 OUT OF xxxxxx ORDERS!

and oh yeah, the customer is xxxxx fuming because they cannot mount this $$$$ product because you guys screwed it up. But it's only 1 time.

I just want to clobber these guys. and tell them to go xxxx off. I'm really sick and tired of the production manager not doing his job. Not enforcing good practices. Not....and it goes on.

I do not even issue a CAR as much as I should be. I am buried. Half the time, I do not even work in quality. and that is what I was hired to do.

oh man....venting... sorry!
 
C

Cari Spears

Super Moderator
Staff member
Super Moderator
#36
#36
Vent away, sister!

I haven't always worked for people who embrace a good corrective action and root cause analysis, but I'm really fortunate where I'm at now. I work directly for the big cheese and he is a big proponent of using our corrective action process and stressing that it's not a bad thing, etc. So our management and the shop guys don't really freak over them and we accomplish good things.
 
Crusader

Crusader

Trusted Information Resource
#37
#37
Our guys just hate paperwork. They were trained to do CARs. Yet, they won't do them and then they say, I don't know how to fill this out.
I get so frustrated.
 
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