Corrective Action Request (CAR) Form Examples and Discussion

[Big Jim]

It should also be noted that risk is not new to business. It has always been there, making it much easier for companies to recognize it and how to handle it. The term preventive action just wasn't something they easily got a handle on.

 

[Sidney Vianna]

The writers of the standard went to great lengths to end the comingling of corrective action and preventive action. They openly stated that preventive action did not live up to its mission and that risk was the new or replacement term. They not only renamed it, they gave it its own place in the standard, section 6, way away from corrective action.

Risk mitigation sounds like preventive action to me.

Albeit better expressed.

I think that it is important to remember that the deletion of "preventive action" as a stand-alone, artificial and non-sensical clause also came about with the introduction of the HLS-based ISO 9001:2015. And, that's why ISO 13485:2016 STILL has that as a separate requirement in their text.

From the TC 176 Paper:

One of the key changes in the 2015 revision of ISO 9001 is to establish a systematic approach to considering risk, rather than treating “prevention” as a separate component of a quality management system.

In previous editions of ISO 9001, a clause on preventive action was separated from the whole. By using risk-based thinking the consideration of risk is integral. It becomes proactive rather than reactive in preventing or reducing undesired effects through early identification and action. Preventive action is built-in when a management system is risk-based.

 

[Big Jim]

Interesting article. Any idea when it was written? I couldn't find a date.

The thrust of my comments came from a webinar about the upcoming changes involved with the 2015 version given by Nigel Croft. If memory serves me right he was the chairman of TC-176 at the time.

Since preventive action is no longer included in the standard I have a tough time understanding why it seems to need to continue to be concerned with it.

As for 13485, it has always lagged behind.

 

[Mike S.]

Frankly I don't care what ISO has done as far as eliminating Preventive Action as a section to itself. They still talk about

" preventing negative effects"
"the actions taken to prevent adverse impacts"
the need to "prevent, or reduce, undesired effects"
"correcting, preventing, or reducing undesired effects"

and on and on as part of their "risk based thinking".

I still have a procedure called Corrective and Preventive Action.

 

[John Broomfield]

Mike,

How often are PARs issued to remove causes of potential nonconformity from your system?

Do they come out of planning sessions, the design of products and processes, employee suggestions or some other activity?

Ratio of PARs to CARs?

Thanks.

John

 

[simonyeeklang]

I'd be interested to see these forms as well.

We tried a simple - "Combo" type form - Used a box checkoff to identify what the form was addressing Cor/Prevent/ Non-Com only but it did not work well for us.

Frankly IMHO would suggest you keep them separate.

We found it to easy to confuse the issues when reported on one from format. What happened was both Corrective and Preventative went un-reported because of the confusion....not only when filling out the form and deciding what was Corrective - what was Preventative - but in explaining how we handled and recorded the info to our external auditor.

Regards
Jim



[This message has been edited by Jim Biz (edited 20 February 2001).]

Hi, Jim do you have this form?
Would like to have a sample
Thanks

 

[Big Jim]

Hi, Jim do you have this form?
Would like to have a sample
Thanks

That post is from 2001. The standard has undergone two revisions since then and the likelyhood of the original poster still participating is slim to none.

 

[Marc]

You replied to a post from twenty years ago, and there's no telling when the last time the OP (not registered now) might have been here. Look through the thread. There are a lot of forms that have been posted.

Not to mention, Check the Attachments list.