calimar75

Starting to get Involved
#1
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.
 

Ninja

Looking for Reality
Trusted
#2
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?
 

MIREGMGR

Inactive Registered Visitor
#3
...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.
 

calimar75

Starting to get Involved
#4
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).
 

somashekar

Super Moderator
Staff member
Super Moderator
#5
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.
 
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Ninja

Looking for Reality
Trusted
#6
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?
 

Doug Tropf

Quite Involved in Discussions
#7
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?
 

TPMB4

Quite Involved in Discussions
#8
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.
 

Kales Veggie

People: The Vital Few
#9
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).
I would agree with the auditor. Excessive use of canned statements are disturbing, giving the impression that your organization does not want to fix problems. (another complaint, and another cut and paste response).

Now, if you could show me results of the investigation, referring the new complaints to a tracking sheet showing complaint history, showing RCA and C/A and showing reduction in complaints, I maybe swayed to not giving a minor.
 

calimar75

Starting to get Involved
#10
Not all complaints warrant corrective action. Some levels of failure are inherent in the design. In capital equipment there are certain failure rates for component parts that are considered acceptable.
As you know, you can't chase everything, otherwise you are sapping vital resources that should be working on the high risk issues and not diving into something for which has been deemed is occurring at an exceptable level; both from a patient risk and a business risk perspective.
Additionally, it's not often that you can determine if there is a systemic issue from a singular complaint event. Which is why the justification defaults to monthly trending to determine if escalation is required.
Patient risk is already addressed via the assessment for reportability to regulatory authorities and through an assessment for potential health hazard.
Lastly, the finding is laced with subjectivity. The disagreement with the statement cannot be directly linked to any elements of the QSR, the MDD, ISO 13485, 9001 or the Health Canada regulation.
 

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