Is any dissatisfaction over a Medical Device considered as a complaint?

SGquality

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#1
We have a customer satisfaction survey that in addition to feedback also resulted in certain dissatisfaction over the product - would this be considered a customer complaint? How do companies handle these situations - via Customer Complaint process or CAPA process or any other? Thank you!
 
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Sidney Vianna

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#2
What is the CONTEXT? What type of products? As mentioned numerous times here, in the FDA Medical Device regulated sector, ANY negative feedback, must be treated as a complaint and processed accordingly.

Without CONTEXT and ENVELOPE CONDITIONS, one can only guess....
 
#5
I work with a direct-to-consumer and retail Class II medical device manufacturer that gets literally several hundred "customer inquiries" a month. We cull them based upon a very, very simple concept of a "Complaint" by customer service reps. That definition of a "Complaint" is similar to the one shown above, but with more details added to product-specific situations. When it doubt, they get tagged. These culled out Complaints then get further analyzed for reportability by dedicated quality staff and investigated as necessary.
I disagree with Sidney that ANY "negative feedback" is a Complaint. For example, someone that straight-up buys the wrong product for their use ("my spoon doesn't make a good fork!"), or the wrong size--those aren't Complaints. The key is that the feedback must allege "deficiencies [...] of a device." Of course, when in doubt just call it a Complaint and handle according to your Complaint process, it's not a big deal.

Regarding CAPAs, your Complaint process should have very clear guidelines for when a Complaint must be escalated to a CAPA and I'd also recommend adding some guidelines for when it's recommended, such as:
  • The Complaint has a similar cause to any other Complaints within the last year​
  • There is no easy/specific correction.​
  • The device failure was severe/catastrophic.​
  • The cause is a design-level issue.​
  • The cause is a manufacturing issue.​
This is essentially verbatim from the slideshow Sydney posted from above, the entirety of it can be found here:
Search for "cdrh-industry-basics-workshop-nonconforming-product-and-complaint-files-november-7th-2017"

Hope this helps,
Josh
 

Cthames

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#7
What is the CONTEXT? What type of products? As mentioned numerous times here, in the FDA Medical Device regulated sector, ANY negative feedback, must be treated as a complaint and processed accordingly.

Without CONTEXT and ENVELOPE CONDITIONS, one can only guess....
Not all negative feedback constitutes a complaint. If a customer says that your product is too expensive, that would not be a complaint. If the customer says they don't like the color of the product, but the product's color as never specified in the order agreement, that is not a complaint.

The picture you posted with 820.3's definition of a complaint is the resource I would point to if someone is trying to determine whether or not negative feedback constitutes a complaint.
 
#8
In the modern era with so many streams of information, to me the definition of a Complaint is much less interesting (i.e., it's very clear-cut) than how you monitor the various streams through which Complaints can be communicated. I think this cuts to the core of the OP's original question.

At the end of the day, you should be routing Amazon reviews, Facebook responses to your marketing posts, etc. through your Complaint handling process, if the content meets the definition of a Complaint. This also means your social media/CX/brand management folks need to have documented training on what constitutes a Complaint and there needs to be a documented process for routing those types of communications to relevant quality personnel within the organization for analysis and investigation.

The main problem here is, e.g., with Amazon they own the customer so you cannot really engage in normal investigative practices. Make sure you copy and paste and/or screenshot the complaint itself because, e.g., with Facebook posts they very quickly get lost in a massive sea of other posts which makes finding the original content impossible even just a few weeks later when doing a more detailed investigation/evaluation of the Complaint.
 

Cthames

Involved In Discussions
#9
To clarify on my last post, I make a distinction between evaluating negative feedback as to whether or not it is a complaint, and handling it as a complaint. All negative feedback should be evaluated as to whether or not it is a complaint. Only negative feedback which meets 820.3's definition of a complaint is required to be handled and processed as a complaint.
 
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