Customer Complaint Vs. Nonconformance - CAPA SYSTEM

[QA-RA Jones]

All:

I am hoping someone can help identify to me if we are on the right track with our system or not in how we differentiate complaints vs nonconformances...

Customer Complaints (External nonconformance): When a customer identifies an issue with our parts we issue a customer complaint in our system (often times there will be an NCMR form the customer will send us identifying the issues they found - this record will be maintained in the complaint processes form). Through this complaint system we complete three steps: Complaint Initiation, Complaint Investigation/Root Cause, and Complaint Resolution (Corrective and/or Preventive Actions). We always address corrective and possible preventive actions through this system as applicable. If we receive more than one complaint and it continues to be an issue we will launch our CAPA form for a systematic addressing of the issues at hand and more in depth look at to what systematically needs to be addressed, this would further include verification of systematic correction after a period of 3-6 months depending on the issue.

Nonconformances (internal nonconformance): When we identify an issue with a part internally during final inspections we will issue a nonconformance internally, if this is in relation to work a vendor completed we will issue them our form to complete the investigation/root cause and possible corrective/preventive action. Through this form we complete the following steps: Nonconformance initiation, Nonconformance investigation/root cause, and Nonconformance Resolution (Corrective and/or Preventive actions determined by MRB). If we receive more than one nonconformance on the same issue we will launch our CAPA (or SCAR) form for a systematic addressing of the issues at hand and more in depth look at what systematically needs to be addressed.

Outside of these two processes CAPA's can be initiated based off an observation or audit finding, etc (we utilize a risk based approach to determining if CAPA is necessary).

In order to reduce the amount of paperwork we do not issue a nonconformance for any of our complaints, as this is extremely redundant and provides the same output in either form. We are always doing an investigation and resolution determination for both processes and they both feed into the CAPA system.

Does this seem like an adequate way to approach these systems?

Also, if we receive a complaint on a product in the field and it is a vendor supplied part my thought is that we could just issue them our complaint form with the initiation completed so that they can address the investigation/root cause. No additional nonconformance forms would need to be created, again due to redundancy. Does this seem like a correct approach?

Thanks for any input you can all offer. It is greatly appreciated!

 

[Mark Meer]

The obvious - albeit unsatisfying - answer is "whatever works for you".

Without knowing any details beyond what you've summarized, however, I'll put in my 2-cents/observations:

Customer Complaints (External nonconformance)

Not all complaints involve a non-conformance.

Through this complaint system we complete three steps: Complaint Initiation, Complaint Investigation/Root Cause, and Complaint Resolution (Corrective and/or Preventive Actions).

Your description seems to muddy the distinction between complaint-handling activities and CAPA activities.

For example, I'd limit the term "root-cause" to CAPA. In standard complaint handling, you might determine that an event is due to a broken part, and simply replace the broken part. This resolves the complaint, but the broken part is not a "root cause" and issuing a replacement to the customer is not "corrective action" in the CAPA sense.

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In general, I'd say that keeping the records distinct has value. To generalize:
- NC Record: What's wrong? How was it disposed?
- Complaint Record: What feedback? How severe? How was it resolved?
- CAPA Record: What is the root-cause of a problem/potential-problem? What actions are taken to address? How are we demonstrating that these actions are effective?

Like I say though, ultimately up to you. If what you've got works, go with it. ...you can always make revisions later on...

 

[Mark Meer]

Another thing to consider: how are records closed?

For example, again simplifying, you might have:
- NC Record: Closed once prescribed disposition activities have been carried out.
- Complaint Record: Closed once complaint is resolved to satisfaction of the customer.
- CAPA Record: Closed once prescribed actions are carried out, and effectiveness evidence has been gathered.

Now consider:
1. A complaint is received regarding a broken part (NC product).
2. A replacement is sent to the customer (customer is satisfied), and the customer returns the NC product.
3. The NC product is received, and can be repaired.

In the case above, if the NC record and complaint record are one-and-the-same (as you are suggesting), then do you wait for the NC product to be repaired to close the record, despite the fact that the actual complaint may have been resolved a long time ago?

Just another consideration in favor of keeping the records distinct...

 

[amcoope3]

If I define Customer Complaints as an external nonconformance on product at end customer and a nonconformance record as internal nonconformance then how should I define a quality issue on product that is released for sale but still in our manufacturer warehouse control. It has not yet been sold or currently at a customer but the Device history record is complete. Should this be handled as a nonconformance record or complaint record? We are trying to delineate what is in-control versus out-of-control to determine if quality issue is handled as nonconformance (in manufacturer control) versus complaints/field action (out of manufacturer control...with end customer).

 

[RoxaneB]

Hello, amcoope3...

If the customer hasn't complained, this is, from my perspective, a nonconformance and part of the disposition is to communicate actions to be taken by the customer (if the product is there) such as returning it to you, isolating it, etc.

Taking a step back from the situation, though, I do question the need for two records - they essentially serve the same purpose and could possibly be streamlined into one record with a section added for "source" (e.g., internal, customer, etc.). Unfortunately, when systems are so rigid in their definitions (such as one form for internal people and another for people who are external to the organization), well, situations such as this do occur.