Complaint Definition Question

In my experience, any nonconformities with our product up to the point of installation and release to a customer were investigated only as a nonconformance internally. Once a product was released/installed, any nonconformities were usually captured through complaints from the customer and are categorized as a complaint, as such. However, another colleague in QA brought up the fact that the definition of a complaint in the CFR states “after it is released for distribution”. My colleague is taking that to mean that even when the product is with a distributor (non-customer) and nonconformity is found with the system, it should be filed as a complaint.

Was hoping people could chime in about this and whether what I believed to be true all these years was in fact wrong at a multi-billion dollar company.

8 Replies
Trish Borzon
1489 Posts

Great question Jonathan! Tagging some experts to chime in - @Duke Okes , @Grace Duffy, @Steven Prevette, @Jeremiah Genest. Please tag others who might have some knowledge in this area.



Grace Duffy
111 Posts

My question would be “What is your definition of a customer?” If the distributor is considered a customer, then a notice from them of a defect would become a customer complaint. If, as your note identified that a distributor is a (non-customer), then they are part of your internal supply chain and would be classified as a nonconformance. Full transparency - I am NOT an ISO Lead Auditor. I am a Certified Quality Auditor and Senior Manager/President. I look forward to hearing from my colleagues.

21CFR211.198 (drugs) and 820.198 (medical devices) always cause a bit of discussion. If you meant another CFR than 21, sorry for the misinterpretation.

The requirement is that each node in the supply chain has a way to investigate a problem, and when it is upstream, pass it on to the point upstream who then does the investigation to determine why it happened.

How you construct that in your quality system depends on a lot of variables, that should be appropriately documented. In the case with your distributor that includes a quality agreement.

The distributor notices a defect - let's say a carton is crushed). The distributor needs a process to quarantine, investigate, and notify the market authorization holder. If the crushing happened when in the distributor warehouse, then its appropriately documented, and action is taken at the distributor. You as MAH would evaluate notification from the distributor, determine the investigation and actions are correct, ensure product is appropriately dealt with. Whether you call it a product complaint or not is really beside the point.

Now, if the distributor decides it happened outside their control (and the packager), then you need the mechanism to drive the investigation at the packager.

For simplicity, a lot of companies call that a product complaint. Personally, I can call it a “Itchy=itchy=zoomba” and as long as I meet all the requirements AND am willing to get puzzled looks from outsides it doesn't really matter.

So, make sure you QMS meets 211.198 and/or 820.198 (and related EU requirements….and…and…) and you'll be all set.

As an AAMI instructor of medical device Quality Systems courses where I teach FDA personnel I have concur with the citation of 21 CFR 820.198 in a previous post in this thread.

Once a device is released for definition, then any discovered nonconformity is a complaint. When you release a device at final acceptance you are stating the device is ready for use by a customer, so it becomes a complaint because you have released a nonconformity and need to investigate how that happened, or what in the distribution processes has caused the nonconformity. That is part of your post-production processes which is covered by complaint processes. Nonconformances are part of your production processes and are covered by NCMR.

Hi Jeremiah, you're correct. I did mean 21CFR. What you wrote is exactly where my thought process is but you just put it in a cohesive way, so thank you for that and appreciate your response.

Hi Edwin, thanks for your reply. That's the perspective of my colleague. As a follow-up question, when presenting metrics during periodic reviews i.e. management reviews etc., do you then lump all these under the complaints category OR do you subcategorize within complaints to distinguish issues that occurred in the warehouse, shipping, etc?

Thanks Grace. Our definition of a customer is an actual customer. Our third-party vendors that help with logistics do not own the product so we do not consider them customers either.

Divide them in such a way that it makes investigation and analysis of the complaint most effective. Sometimes that might depend on complaint volume, for smaller volume your might not have to divide them.

But in any case, you do need to either investigate or identify why not and who made that decision. That may be if there has already been an investigation for that failure, in which case you could connect the second complaint to the investigation.