Does "Responsibility" need to be mentioned in the Corrective Actions ?

M

MichelleN

#1
I work in a small company (started quite recently) but with a high volume of work and a pretty good quality system. However, after I did the internal audits, I found that their Corrective actions did not have responsibility indicated. No corrective action created indicated any responsibility. A great amount of them were raised for customer complaints and the Quality Manager insisted that no responsibility should be indicated for these CARs because..."this is a small company and when Quality is responsible then how can Quality check the implementation of the corrective action and close it?"

In a way I understand him, but to me it does not seem correct to not indicate the responsibility. So then what happens in a bigger company if Quality is at fault(responsible)?? Isn't exactly the same issue? I have a lot of experience in Quality and auditing and worked in different companies, and until present I don't remember anybody else closing the CARs but just the Quality Managers (except when it comes to auditing, of course, when the auditor closes the CARs if they are used for audit non-conformances). Now that I found this issue, I am thinking that in cases like these probably somebody else should close the CARs...

I would very much like to find your opinion on this, too.

Thanks a lot,
Michelle
 
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K

kgott

#2
Re: Is "Responsibility" need to be mentioned in the Corrective Actions ?

There is no requirement in ISO to allocate responsibility for corrective actions. Only good management requires this.

The underlying issue is how many customer complaints are received and why. While you do not indicate the volume of CA required, having a lot of complaints indicates that there may be fundamentaly poor process to begin with.

If this is the case raising CARs for each individual case is not going to solve the problem anyway. It may be more profitable to study the common themes in the reasons for customer complaints and then raise an NCR for those underlying reasons. Its then up to management to monitor, measure and if necessary take action to improve the appropriate processes to reduce the incidence of those events which cause customers to complain.
 
M

MichelleN

#3
Re: Is "Responsibility" need to be mentioned in the Corrective Actions ?

I know that the standard does not indicate to have responsibility for the CAR. Still, that is an action and somebody should be responsible to solve the issue appeared (correct the issue). Even the CQE primer indicates that the responsibility should be assigned.
There are not many complaints compared with the number of parts they produce. But of course, we'll try to find out some reasons and possibly solve them. However, my question was strictly related to responsibility, though, this is what actually bothers me now...especially that in 2-3 weeks from now we'll have a recertification audit...

Michelle
 
#4
Re: Is "Responsibility" need to be mentioned in the Corrective Actions ?

kgott explained it well. The standard doesn't require it, but it may be a good practice.

You may get further by trying to sell it as a really good idea instead of saying it is something that has to be done.
 
#5
Re: Is "Responsibility" need to be mentioned in the Corrective Actions ?

I know that the standard does not indicate to have responsibility for the CAR. Still, that is an action and somebody should be responsible to solve the issue appeared (correct the issue). Even the CQE primer indicates that the responsibility should be assigned.
There are not many complaints compared with the number of parts they produce. But of course, we'll try to find out some reasons and possibly solve them. However, my question was strictly related to responsibility, though, this is what actually bothers me now...especially that in 2-3 weeks from now we'll have a recertification audit...
It comes to the root cause finding for any CA process. When the root cause gets identified, it is that area responsible personnel (That process owner) who has (rather should take) the responsibility to address the root cause and find the CA and implement and check effectiveness. Whether the CA effectiveness was monitored and provided satisfactory results comes in the audit process.
Any typical 8D method for addressing CA has the 8th D as "Congratulate team"
This team and the person heading the team are direct responsible.
If not then its like the story of...
This is a little story about four people named Everybody, Somebody, Anybody, and Nobody.

There was an important job to be done and Everybody was sure that Somebody would do it.

Anybody could have done it, but Nobody did it.

Somebody got angry about that because it was Everybody's job.

Everybody thought that Anybody could do it, but Nobody realized that Everybody wouldn't do it.

It ended up that Everybody blamed Somebody when Nobody did what Anybody could have done
 

Helmut Jilling

Auditor / Consultant
#7
Re: Is "Responsibility" need to be mentioned in the Corrective Actions ?

I know that the standard does not indicate to have responsibility for the CAR. Still, that is an action and somebody should be responsible to solve the issue appeared (correct the issue). Even the CQE primer indicates that the responsibility should be assigned.
There are not many complaints compared with the number of parts they produce. But of course, we'll try to find out some reasons and possibly solve them. However, my question was strictly related to responsibility, though, this is what actually bothers me now...especially that in 2-3 weeks from now we'll have a recertification audit...

Michelle

Someone needs to do it or it will just sit on the table and people will avoid it. Frequently, companies will assign it to the process or dept. responsible for the failure or the root cause. Also, the standards promote a multi-functional approach when that is appropriate. Root causes frequently fall into a couple departments or processes.
 
J

JaneB

#8
Re: Is "Responsibility" need to be mentioned in the Corrective Actions ?

Someone needs to do it or it will just sit on the table and people will avoid it. Frequently, companies will assign it to the process or dept. responsible for the failure or the root cause. Also, the standards promote a multi-functional approach when that is appropriate. Root causes frequently fall into a couple departments or processes.
Yes, as Helmut says, someone needs to be responsible or nothing will happen.

OK, the Standard doesn't specifically prescribe that responsibility needs to be allocated in this specific clause... but the Standard does have over-arching requirements for responsibilities and the management system itself most certainly should take care of it. What does the relevant procedure (s) say about responsibility?

The argument that there shouldn't BE any responsibility allocated on a CAR because then Quality couldn't close them doesn't make sense to me. Someone has to be responsible - sounds like Quality is, but doesn't want it made formal? Which doesn't make sense to me.

I'd also look at the part that review of the action taken for effectiveness plays in this. OK, it sounds like it's normal in this small company for 'Quality' to assume responsibility for the action, and to close it also.
If that works, and there's little/no evidence to say it doesnt, OK. But who reviews the action for effectiveness? Is that Quality also? That still could work in a small company, but good practice would be to have some kind of higher level review - eg, at periodic review/management meetings? Or a review by GM/business owner, etc?
 

harry

Trusted Information Resource
#9
Re: Is "Responsibility" need to be mentioned in the Corrective Actions ?

........... What does the relevant procedure (s) say about responsibility? .................
I echo what Jane mentioned above.

Coming back to the thread title: Is "Responsibility" need to be mentioned in the Corrective Actions?, there isn't a need to be mentioned in corrective actions as long as it is found in the relevant procedure.
 
D

Darrell B

#10
Speaking CA's, I just had an audit last week. The auditor gave me a minor finding because our written procedure did not mention the requirement for a response to be timely. All our CA's are issued through an ERP system, and the Reply By date is assigned. To me, if they met the date assigned, the response is "timely". Since "timely" is such a subjective term, I was a little incredulous on the finding, but it's an easy fix. Sometimes I feel auditors are bound and determined to find something, and are not above grasping low hanging fruit.
 
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