Corrective Action - Is the Follow up the Record? 4.2.4

[ISO Cheesy]

I have a question on corrective action and the ISO9000:2000 standard....” A documented procedure shall be established to define req. for…..Para e) records of the results of action taken (see 4.2.4)”

The 94' standard states the "Recording the results of the investigation" (para b)

Does this mean that the follow up is now the quality record? I have a separate report for follow up, currently the CAR form is my record.

Thanks,
Christy

[Jimmy Olson]

Hi Christy, welcome to the cove

If you use a seperate form for your follow up then that will have to kept as a seperate record in addition to the CAR.

Just out of curiosity, is there a specific reason that you use a seperate form? If you could combine them it might make things easier. Just wondering, I know different companied hav different ways of doing things.

[ISO Cheesy]

Thanks for the info.

The reason we have a different form is because when I was hired this company had a CAR db and it provide only a check box for follow up…no date, by whom, or even the results. The CA was being closed out with no objective evidence of follow up taking place. I’m a big advocate on follow up (until can learn access) I made up follow up report in a word doc to get the ball rolling.

So now my next question: Do we now have to do follow up on every CA/PA?

[Jimmy Olson]

Originally posted by ISO Cheesy


So now my next question: Do we now have to do follow up on every CA/PA?

Somehow I can see this turning into a long and interesting debate

As far as the standard is concerned, it does require a review of CAs and PAs, however, it is pretty open as to how you want to review. This could just be as simple as reviewing the actions to make sure they have been done, or it could be a follow up and verification. As long as you can show that any actions taken are reviewed somehow you will be okay

We do a verification of some sort on all of our CAs and depending on what the action is the verification can be pretty short and simple. Personally, I think it is a good idea to do some sort of follow up on all CAs to make sure they are effective. This doesn't necessarily need to be anything in depth. On some of our CAs the verification is done the same day as the action (just depends on what is done).

I hope this didn't just create more confusion. It's a Monday and I tend to ramble on Mondays before my brain decides to show up for work.

[ISO Cheesy]

That helps very much; it’s right inline with what I was thinking. I just (unfortunately) needed some “ammo” (or maybe I should say “reassurance”) to just get ANY kind of follow-up and verification going here. MGT. Didn’t like the fact that CARs are not closed out right after the corrective action was filled in…I did follow up on some CARs and realized the actions never even took place, haven’t even touched if they are effective yet.

Ok so now I’m on my Follow up soapbox…I’ll stop

thanks for all your help!

[howste]

The ISO 9000:2000 definition of review is:

review
activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives.

To me this says that the review of corrective action (and records) must include:
• Did you take the right action (suitable)
• Did you take enough action (adequate)
• Did the actions taken do what you intended (effective)

For the question "Do we now have to do follow up on every CA/PA?" I agree with Richard. 8.5.2c talks about evaluating the need for action. This implies that you don't have to take action on every problem you identify. If you've determined you need to act though, you certainly do need to follow up to "determine the suitability, adequacy and effectiveness" of the actions taken.

BTW, if you want to email the database to me (as long as it's not too huge or complicated) I could attempt to add some verification fields to it for you...

[ISO Cheesy]

Howste, I found someone here that is updating the db as I type, but WOW thank you so much for the offer.

Now that I have that taken care of the follow up (recording of it anyway), I just need to define my “Specific actions where timely and/or effective corrective actions are not achieved” AS9100 rev A.

I don’t want to start the bureaucracy of issuing CARs for ineffective CARs. This company is too small (30emp.) not to mention it took me a month to convince them to let me start follow up.

*this too shall pass*

[howste]

Originally posted by ISO Cheesy
I just need to define my “Specific actions where timely and/or effective corrective actions are not achieved” AS9100 rev A.

I guess escalation may not be the best approach if there are only a few in the chain of command. It sounds like you've already started though. Follow-up is IMO the best way to ensure that effective and timely actions are taken. People will forget to do (or deliberately ignore ) corrective actions if you let them.