ISO 13485 Complaint Processing Requirements

[compliancejim]

Dear Friends,

I'm relatively new to compliance work and would appreciate some input.....
I have just finished our second surveillance inspection from the NB and am rather dumbfounded by one of the nonconformances.....

We were written up for our Complaint Process procedure not reflecting preventive actions to be recorded "per requirements of the standard". Our procedure does state that corrective actions are documented in our complaint form, which I now feel should just be remove, but this all seems terribly redundant since all complaints, upon completion of root cause investigation, are resolved with high priority by our CAPA process...... Though my rationale makes sense to me, and my boss, I couldn't get the auditor to do anything more than shake his head and say no....

After reviewing the standard I feel relatively certain that our auditor is off his rocker... or perhaps he's just used to seeing other organizations handle this differently?..... idk

Ultimately my question is.... Do I easily modify the complaint procedure to add " and/or preventive action" (and procedurally create the Department of Redundancy Department) or do I have sufficient grounds to argue this one out?

Thank you kindly for your input.

 

[RoxaneB]

Re: Complaint Processing Requirements

I'm relatively new to compliance work and would appreciate some input.....

I have just finished our second surveillance inspection from the NB and am rather dumbfounded by one of the nonconformances.....We were written up for our Complaint Process procedure not reflecting preventive actions to be recorded "per requirements of the standard". Our procedure does state that corrective actions are documented in our complaint form, which I now feel should just be remove, but this all seems terribly redundant since all complaints, upon completion of root cause investigation, are resolved with high priority by our CAPA process...... Though my rationale makes sense to me, and my boss, I couldn't get the auditor to do anything more than shake his head and say no....

After reviewing the standard I feel relatively certain that our auditor is off his rocker... or perhaps he's just used to seeing other organizations handle this differently?..... idk

Ultimately my question is.... Do I easily modify the complaint procedure to add " and/or preventive action" (and procedurally create the Department of Redundancy Department) or do I have sufficient grounds to argue this one out?

Thank you kindly for your input.

Welcome to the Cove and congrats on your first post!

Would your auditor, by any chance, be saying that your process to resolve customer complaints, while it includes "corrective action" does not include steps to reduce the likelihood of it occurring again aka "preventive"?

 

[RA Guy]

Re: Complaint Processing Requirements

An example of this being, we changed a component in product "A" as a corrective response to the complaint, but as a further step, we should identify same component in similar devices (products "B" and "C") and determine if the same failure could occur and if so take preventive action.

In this example, products "B" and "C" have no similar compliants to date, thus action would be preventive vs. corrective.

 

[compliancejim]

Thanks for your feedback guys

Our preventive actions, and corrective actions for that matter, are recorded on a CAPA form.... I think the issue is that our Complaint form contains a check box field (that I think I want to get rid of) labeled "Corrective Action" stating whether no action, document change, or engineering change order is required.... Unless "No Change" is marked and justified the process requires resolution via CAPA... which documents corrective and preventive action....

However our auditor found it insuffient that our procedure for completing the Complaint form only mentions corrective action and not preventive.... despite my pointing out that both these measures are resolved and documented in the CAPA.....

 

[DannyK]

There are still some auditors who are nitpickers.

I would suggest that you just add " and/or preventive action" because that is what the ISO 13485:2003 clause 8.5.1 states.

 

[Sidney Vianna]

However our auditor found it insuffient that our procedure for completing the Complaint form only mentions corrective action and not preventive.... despite my pointing out that both these measures are resolved and documented in the CAPA.....

It is very hard to second guess what your auditor was alluding to, but he might have been concerned with your way to comply with the following requirement:

The organization shall establish a documented procedure for a feedback system [see 7.2.3 c)] to provide early warning of quality problems and for input into the corrective and preventive action processes (see 8.5.2 and 8.5.3).

 

[Roberticus]

Re: Complaint Processing Requirements

An example of this being, we changed a component in product "A" as a corrective response to the complaint, but as a further step, we should identify same component in similar devices (products "B" and "C") and determine if the same failure could occur and if so take preventive action.

In this example, products "B" and "C" have no similar compliants to date, thus action would be preventive vs. corrective.

Aren't such actions to prevent recurrence among similar parts or processes an element of comprehensively implementing and confirming the chosen Corrective Action? As long as the activities being conducted were initiated due to a documented nonconformity (complaint), how can such activities be considered preventive?