Combining Multiple CARs (Corrective Action Request) into One CAR?

[NikkiQSM]

Yesterday our company was audited by a customer. One issue they reviewed very closely was CAPA.

They were shocked to see that last year, I had writen ~230 CARs. The auditors had told me that if I am seeing repeated issues, that I could just add them to a single CAR.

One of our repeated issues is that the plastic we produce is off-color, just slightly. So slightly, that it is close to impossible to figure out what happened. Normally, once the product is corrected, I close the CAR out.

I guess I would like some input from the Cove asking if anyone has ever grouped a CAR. I would think this would make it impossible to close out within a certain period of time. If I open a CAR because of an off-color rejection, and then a month later I have another off-color - Do I re-open that CAR?

I guess I am confused as to what the auditors want me to do.

Thanks for the help!

 

[bluepagen]

Re: Multiple CARs into One CAR?

During our last internal audit I found repeatedly that root causes were not accurate, they were excuses, corrective actions that had been documented were not working and that in multiple cases, several cars were repeated, Originally, after the 8th finding, I looked at the bigger picture, and determined that the best way to address the issues were to note that the Corrective and Preventive Action processes were not being effectively implemented. It was with great thought and a good dose of dread that I wrote that. We had taken a write up for not documenting preventive actions properly, and iI found again that we were not documenting them at all.
I was tough to explain to the quality manager (my boss), so that he was not mad at me as the internal auditor, but it was the best way to address the issues.

 

[Howard Atkins]

Re: Multiple CARs into One CAR?

If I understand correctly there is one issue "off-color" that you have not solved.
I do not understand why you need 230 pieces of paper to tell you that there is a problem.
Stop writing CARS and solve the problem.

Are you not confusing non conforming material with corrective action requests.

 

[NikkiQSM]

Re: Multiple CARs into One CAR?

If I understand correctly there is one issue "off-color" that you have not solved.
I do not understand why you need 230 pieces of paper to tell you that there is a problem.
Stop writing CARS and solve the problem.

Are you not confusing non conforming material with corrective action requests.

Our QMS requires that I write a CAR for every rejected product. If I could solve the problem, I would gladly. But in the situation where there is an off-color, it is extremely difficult. We use a spectrophotometer to check the color of the plastic. It is given to us in a Delta number. Our internal spec, and our customer's spec is that the number must be under a Delta 1.00. If make a product and it produces a number of 1.01, it fails. I have traced back lot numbers of the ingredients used, I have reviewed calibration of equipment used, believe me when I say, I have looked into this issue over and over, but the answer is never there. The off-color is so slight, that it literally is impossible to figure out what happened. Also - A little insight to the company - We extrude custom plastic compounds - So we use many different ingredients and types of plastics - It is not like we are making the same product over and over again (basically a job shop) - So this just adds to the frustration of it all.

 

[Jim Wynne]

Re: Multiple CARs into One CAR?

Yesterday our company was audited by a customer. One issue they reviewed very closely was CAPA.

They were shocked to see that last year, I had writen ~230 CARs. The auditors had told me that if I am seeing repeated issues, that I could just add them to a single CAR.

One of our repeated issues is that the plastic we produce is off-color, just slightly. So slightly, that it is close to impossible to figure out what happened. Normally, once the product is corrected, I close the CAR out.

I guess I would like some input from the Cove asking if anyone has ever grouped a CAR. I would think this would make it impossible to close out within a certain period of time. If I open a CAR because of an off-color rejection, and then a month later I have another off-color - Do I re-open that CAR?

I guess I am confused as to what the auditors want me to do.

Thanks for the help!

There is no point in doing CARs repeatedly for the same issue. Before a CA is closed, you should verify that the actions take were effective--part of the CA exercise is prevention.

If you can't prevent the problem from happening, you should perhaps have a different medium--a simple nonconformance report perhaps--to document the issues, or you should change the specifications to something that reflects the actual capability of the process.

 

[Bev D]

Re: Multiple CARs into One CAR?

The following applies only to PRODUCT nonconfomrances and is not intended to apply to audit findings for process compliance...

It sounds like you are confusing the nonconformance process with the corrective action process.

Typically a nonconformance is 'issued' upon a rejection of product that will be reworked, repaired or scrapped or dispositioned 'use as is'. the action taken is correction. typically NCRs (or some other similar acronym) are issued for every occurence.

a corrective action (to prevent recurrence) is typically only issued for those items that have a large effect (high safety, dollar, customer satisfaction, delivery effect). the intent would be to determine root cause and a solution that prevents recurrence.

you can change your procedure to not require a CA for every nonconformance. (this is a self imposed requiremetn not a requirement of the standard)

you can also decide that the rework is not worth corrective action and just continue to rework....

 

[Jim Wynne]

Re: Multiple CARs into One CAR?

Our QMS requires that I write a CAR for every rejected product. <snip>

Therein lies your problem. CA should be invoked only when it's appropriate to do so (when prevention of recurrence is a reasonable expectation), and in your case it seems like there are a lot of inappropriate CARs being written.

 

[julsbear]

Regarding, the issue of CAR's, I agree that unless you are actually finding and eliminating root causes; you should use a lesser classification for these color issues.

Regarding color:

It sounds that you are just using Delta E, or the overall difference for a criteria. There are several "color spaces" or non Euclidean geometries that are commonly used. The CIE L*a*b* space being similar to rectangular Cartesian coordinates. You should look at the literature provided with your spectrophotometer or their website for more information. There are many ways to arrive at a similar or equal Delta E composed of the values of the three axes. For instance a total Delta resulting from just one is very different from one spread evenly amongst the three.

One answer to your problem could be to track or monitor the components of your compounds and adjust formulas accordingly based on colorant, base resin and additive color and clarity.

 

[NikkiQSM]

Regarding, the issue of CAR's, I agree that unless you are actually finding and eliminating root causes; you should use a lesser classification for these color issues.

Regarding color:

It sounds that you are just using Delta E, or the overall difference for a criteria. There are several "color spaces" or non Euclidean geometries that are commonly used. The CIE L*a*b* space being similar to rectangular Cartesian coordinates. You should look at the literature provided with your spectrophotometer or their website for more information. There are many ways to arrive at a similar or equal Delta E composed of the values of the three axes. For instance a total Delta resulting from just one is very different from one spread evenly amongst the three.

One answer to your problem could be to track or monitor the components of your compounds and adjust formulas accordingly based on colorant, base resin and additive color and clarity.

Some of our customer's require Cielab results as well. But most always specify CMC DE of 1.00 or less....

 

[NikkiQSM]

Re: Multiple CARs into One CAR?

Forgive my ignorance, but after reading all the replies to this question (thanks to all by the way) I think I may have this figured out. Please correct me if I am wrong... I should be issuing a non-conformance report / form for rejections to aid in tracking. And I should be writing CARs on the reasons for those rejections, not the rejection itself correct?