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Justification for No CAPA in Complaint Files

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audit nonconformances and findings, capa (corrective and preventive action), complaints (general), customer complaints and customer found nonconformance, escalation process
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  Post Number #1  
Old 25th July 2013, 09:26 AM
calimar75

 
 
Total Posts: 16
Please Help! Justification for No CAPA in Complaint Files

Had our recertification audit a couple weeks ago and the auditor gave a Minor NC because he did not like the justification that was written in many of our complaints regarding our decision for not escalating the issue to a CAPA.
Has anyone ever experienced this before? I have worked at a number of medical device companies and used very similar verbiage and never had an issue.
The statement is in three parts. First it states that the issue has been investigated and root cause assigned (satisfying the fact that it's not an unknown failure). Then it states that the issue is a known failure and that this type of issue has been investigated in the past for the product family in question. Then last it states that trending is performed at our cross-functional complaint meeting on a monthly basis and that if trends are identified within product families that the need for escalation will be addressed then.
Anyone have any feedback or comments on my justification or any experience with responding to such a subjective NC?

Thanks Forum Members.

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  Post Number #2  
Old 25th July 2013, 09:35 AM
Ninja's Avatar
Ninja

 
 
Total Posts: 1,088
Re: Justification for No CAPA in Complaint Files

Out of curiosity...how was your justification written?

If I saw the reason for no escalation written as "too busy" or "stupid customer" I might have an issue with it too.

I doubt yours are written like this, but how are they written?
  Post Number #3  
Old 25th July 2013, 10:01 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: Justification for No CAPA in Complaint Files

Quote:
In Reply to Parent Post by calimar75 View Post

...the auditor gave a Minor NC because he did not like the justification that was written in many of our complaints regarding our decision for not escalating the issue to a CAPA.
Presumably he must have written more than just that he didn't "like" the justification. What did he not like--that what you say you do is not always what you actually do? That the facts of some instances are not consistent with the rationale? Something else? Auditors usually explain themselves well enough that their own work can withstand an audit.

I can understand an auditor being at least suspicious of a generalized justification that the auditor perceives was written to take care of a requirement, instead of to effectively address each complaint-issue.

Of course, I don't know the facts other than as you've presented them, so maybe none of the above is applicable.
  Post Number #4  
Old 25th July 2013, 10:02 AM
calimar75

 
 
Total Posts: 16
Re: Justification for No CAPA in Complaint Files

Specifically it states:
Escalation to CAPA is not required. The complaint has been investigated and root cause determined. Additionally, this failure mode has been previously investigated and is a known failure mode for this product family. Complaint trending is performed on a monthly basis for all product families and the need for escalation is discussed and determined by a cross-functional team during the complaint review.

The NC states that this justification is not considered a reason for non-escalation.

Additionally, while I grant canned statements aren't ideal, they are helpful for low-risk issues. Anything that warrants immediate escalation has a CAPA or other method of escalation referenced in the justification section. In other instances the justification is more robust, if warranted (such as the issue was investigated and the failure mode couldn't be duplicated, or that the patient complication is anticipated and known physiological effect of the patient procedure as noted in the DFU).
  Post Number #5  
Old 25th July 2013, 10:58 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,371
Re: Justification for No CAPA in Complaint Files

Justification for no CA must come from someone authorized who can take a complete look at the problem and causes, and decide that the root cause is something beyond the scope of the present system.
If for instance a failure is reported in field and the root cause is due to wrong handling, which has been well covered in the IFU, one may decide to take a correction and justify why a CA is not warranted in the case.
For me your justification sounds insufficient, and seems to me that your CA was ineffective in the first place.

Last edited by somashekar; 25th July 2013 at 12:12 PM.
  Post Number #6  
Old 25th July 2013, 11:11 AM
Ninja's Avatar
Ninja

 
 
Total Posts: 1,088
Re: Justification for No CAPA in Complaint Files

Quote:
In Reply to Parent Post by somashekar View Post

Justification for no CA must come from some authorized who can take a complete look at the problem and causes, and decide that the root cause is something beyond the scope of the present system.
If for instance a failure is reported in field and the root cause is due to wrong handling, which has been well covered in the IFU, one may decide to take a correction and justify why a CA is not warranted in the case.
For me your justification sounds insufficient, and seems to me that your CA was ineffective in the first place.
I'm not sure I understand...you seem to be assuming that all complaints require a CA while the justification shared by the OP displays that the company mgmt is ok with the complaint and they choose not to fix it at this time.

What am I misunderstanding?
  Post Number #7  
Old 25th July 2013, 11:14 AM
Doug Tropf

 
 
Total Posts: 396
Re: Justification for No CAPA in Complaint Files

Quote:
In Reply to Parent Post by calimar75 View Post

Specifically it states:
Additionally, this failure mode has been previously investigated and is a known failure mode for this product family.
It appears that this type of failure has occurred previously, should not corrective action have been taken to prevent further occurrences?
  Post Number #8  
Old 25th July 2013, 11:25 AM
TPMB4

 
 
Total Posts: 394
Re: Justification for No CAPA in Complaint Files

If a complaint is made regarding a defective or rejected part isn't the usual action to detail the defect, carry out containment actions, investigate the root cause, find a permanent preventative/corrective action, implement the action, validate the action and record the lessons learnt applying it to similar products in the same product family????

If you did that in the first instance of a this type of defect / complaint then it should not be occurring again. Well in an ideal world.

Mind if I ask whether you have looked back at the first instance of this type of complaint in this product family? Was a corrective action carried out then or was this justification used not to escalate it to a CAPA?

I don't know about the medical/medical devices sector being from an automotive and general manufacturing field so perhaps things are done completely different. Our system would use an 8D reporting structure when we receive a complaint or material rejection report from customers or internally identified defects. We would then find root cause and a permanent corrective action according to the flow above (but we don't have the American style "congratulate the team" as it is a little bit ridiculous to see in a system document/report/record IMHO). If that was carried out and the results applied to other parts the justification and hence the NC would not be needed. Could be wrong or na?ve about this.
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