Non conformance/complaint and CAPA

MDRepair Canada

Starting to get Involved
#1
Dear all,
Sorry in advance if it is a silly question but I would like to make sure the process for handling non conformance/ complaints and CAPA complies with ISO 13485

when we receive a customer complaint or if we detect a non conformance (internal or from a supplier) we record a NCR with the following information :
Date, issuer, non conformance details, immediate cause and immediate correction
Then depending on the issue, a CAPA can be initiated.
if no need it has to be justified and the NCR can be closed.

If à CAPA is needed then we determine the root causes et identify correction and /or preventive action (with pilot, deadline and efficacy of action).
Once the actions are completed and effectiveness assessed the CAPA form can be closed.

Does it sound good to you?
Anything I might have forgotten?
What about the requirement regarding the assessment of any possible impact of the action on compliance with regulation. Does it have to be clearly stated?

many thanks in advance for your help.
MD
 
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AMIT BALLAL

Super Moderator
#2
when we receive a customer complaint or if we detect a non conformance (internal or from a supplier) we record a NCR with the following information :
Date, issuer, non conformance details, immediate cause and immediate correction
Seems good to me. However consider including "The applicable requirement", especially if it is a system nonconformity.
Then depending on the issue, a CAPA can be initiated.
if no need it has to be justified and the NCR can be closed.
Seems a good practice. However, I would suggest determining criteria, so that they won't differ from person to person.
If à CAPA is needed then we determine the root causes et identify correction and /or preventive action (with pilot, deadline and efficacy of action).
You've already covered correction at the start. There won't be a correction based on root cause analysis. And preventive action is not applicable, only a corrective action, as the purpose of corrective action is to prevent recurrence of the problem that occurred.
And the purpose of preventive action is to prevent the occurrence of a certain nonconformity, hence not applicable once a nonconformity has occurred.
What about the requirement regarding the assessment of any possible impact of the action on compliance with regulation. Does it have to be clearly stated?
You'll need to follow a change management process while implementation of the corrective action and it should take care of this.
 
Last edited:

Philip B

Quite Involved in Discussions
#3
We got a nonconformity a year or so back for not formally assessing whether the corrective actions taken had an impact on the ability to meet regulatory requirements or on the safety or performance of the device. So we now have this as a defined part of the CaPA process and documented in our CaPA record. (The answer has always been 'no' so far, but I understand why the requirement exists.)
 

MDRepair Canada

Starting to get Involved
#4
Hi @AMIT BALLAL , thank you so much for the very complete and helpfull answer.

You've already covered correction at the start. There won't be a correction based on root cause analysis. And preventive action is not applicable, only a corrective action, as the purpose of corrective action is to prevent recurrence of the problem that occurred.
Sorry i meant corrective not correction.

You'll need to follow a change management process while implementation of the corrective action and it should take care of this.
If it is stated in the SOP that when implementing a corrective action we need determine if it has an impact on QMS and if change is need, would it be sufficiant ou should we write it every time we implement a corrective action? I am not sure how we can demonstrate this to the auditor apart from the SOP
 

MDRepair Canada

Starting to get Involved
#5
We got a nonconformity a year or so back for not formally assessing whether the corrective actions taken had an impact on the ability to meet regulatory requirements or on the safety or performance of the device. So we now have this as a defined part of the CaPA process and documented in our CaPA record. (The answer has always been 'no' so far, but I understand why the requirement exists.)
Thanks @Philip B for your input. Is it a yes/no question you have added or something for complete? and at what step of your form is it?
 

Philip B

Quite Involved in Discussions
#6
Its an open text field, I normally make a brief statement of no impact. It comes after the corrective action section but during a recent NB audit the auditor argued it should come before your corrective actions. Seems a bit chicken and egg to me, would anyone else like to chip in on this?
 

Zero_yield

No cost too great...for Quality
#7
We include evaluation of risk and statement of impact in the nonconformance. This includes canned language about whether or not the nonconformance needs to be escalated or can be handled on-site.
 
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