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Do I Need to Write a CAR for..... (All Opinions Wanted :) )

NikkiQSM

Quite Involved in Discussions
#1
Hello Friends,

I am curious to get everyones opinion on what really needs a CAR or not. I have been writing them for a number of years, and since our company has grown and business has increased dramatically, I find I am writing one after another.

Little Background: Our company produces plastic pellets per our customer's specifications - the pellets are eventually extruded into medical catheters and / or medical devices.

Our current system requires that I write a CAR for any internal rejection. Basically if we have to fix it, a CAR is initiated. But I have come across several delimmas.

For example, a customer specifies that we use a colorant that when compounded into the plastic has a horrible dispersion. We, seeing this, have to run it over again to produce a more acceptable dispersion. Would this really be a reason to write a CAR? Since it's not our fault really?

We have been in other similiar situations like this that are out of our control. My gut tells me that I am wasting my time writing these up, but then my head states that because it is additional work I should make it a point to bring it up to the managers - This way if it is required we can quote the work correctly.

Thoughts?
 
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Q

Quality_Steve

#2
Re: Do I Need to Write a CAR for..... (All Opinions Wanted :) )

Hello,

I am wondering how you are able to produce a more acceptable dispersion by simply running it over? Do you change any factors in the production of the pellets? If you are able to make adjustments to the formula or process to make it work the second time, why can't it be done right the first time?

I don't know much about plastics so maybe these are dumb questions. I'm just trying to see if there is something that is in your control that you might be overlooking because you might be too close to the process.

Steve
 

NikkiQSM

Quite Involved in Discussions
#3
Re: Do I Need to Write a CAR for..... (All Opinions Wanted :) )

As I have been told, and truely believe, there are no dumb questions.

The colorant is very stubborn - so it is impossible to disperse it evenly with affecting the physical properties of the resin carrier. Giving it another heat history and introducing it back into the extruder blends the agglomerates of colorant to a more even dispersion. Basically, we dont change anything when it goes through again.

We could definately produce a product with perfect color dispersion, in one shot, if we were allowed to change the formulation - but as I mentioned, it is all customer specified, so we must use what they tell us to use.
 

Big Jim

Super Moderator
#4
Re: Do I Need to Write a CAR for..... (All Opinions Wanted :) )

Back to your basic question. If I read it correctly, you are asking if you need to perform a full blown corrective action every time you recognize a problem.

You do not. You are permitted to make correction without going through the added determination of cause and how to prevent it from happening again when appropriate. That is, you do not, unless you say that you will, so you need to re-visit your procedure and give yourself some wiggle room.

In ISO 9000, correction is defined as action taken to overcome a nonconformance. Corrective action is defined as action taken to overcome the CAUSE of a nonconformance.

It may help to add a layer for a discrepant material report or something of that nature to handle corrections, and then review all of those to determine which ones should be elevated to a corrective action.

As you have discovered, attempting to perform corrective action on everything that comes along ends up not being very effective and consumes a lot of unnecessary time.
 
Q

Quality_Steve

#5
Re: Do I Need to Write a CAR for..... (All Opinions Wanted :) )

In our procedure, we write up Corrective Action Requests which then are put in front of the Leadership Team to review and decide which requests to act on based on "bang for the buck" and the other are marked as closed without further action. They stay in the log this way so I can watch for trends. Minor problems start to reveal a bigger issue once you see the trends.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#6
there is a difference between quality system non-compliances and product non-conformances.

Typically Product non-conformances are simply 'fixed' (rework or scrap). CARs are NOT required...CARs are only written when it desired to get at root cause so a corrective action that will prevent re-occurence can be implemented. and some companies don't write CARs for this - they just launch projects...

As for quality system for non compliances, not all (interanl) findings require a corrective action as stated above. My organization only issues CARs for serious non-conformances or for repeat/systemic non-complaince...it's a choice...
 

NikkiQSM

Quite Involved in Discussions
#7
Thanks so much for the input... I took a look at all the CARs I wrote, and O-M-G..... If I were to change those CARs to simple NCMR's instead, my CAR count would be reduce drastically...

Everything makes a lot more sense now...

Thanks for all the help!!
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#8
Nikki, try looking at these types of issues outside the regular CAR system if it helps - In the Looking For Excel Template for Tracking & Trending Rejections thread you're running I am sending you to elephant charts and a CA log I have attached in the Cove.

I hope to not add an administrative burden, but to instead offer a chance to keep track of trends and what's been done for them outside the formal CAR system, which I agree is meant for management system.
 
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