Complaint - The FDA's definition of Complaint

[zibsan]

I am struggling to validate my definition of a complaint. The FDA definition is:

(b) Complaint means any written, electronic, or oral communication
that alleges deficiencies related to the identity, quality, durability,
reliability, safety, effectiveness, or performance of a device after it
is released for distribution.


The "alledges deficiencies" is the part I am having a problem with. I am looking for others opionions.

[Cathy]

When you allege something you are implying without any evidence to back this up. This would be your customer reporting a complaint - you will not be able to prove there is a deficiency until you investigate.

On many occasions your customer may report that the product is not functioning correctly or it is defective or damaged. The reasons for this could be mis-use by the customer or a failure on your part to ensure the device was suitable for use. The latter would qualify as a customer complaint. However, you would not be unable to determine the cause until you investigated. Therefore the alleged deficency becomes either a deficiency ot not a deficeincy.

I think the definition the FDA has given is very good.

What I find somethimes is that a manufacturer will accept a customers comment about the failure of a device as a customer complaint. I do not do this. I accept a customer comment and evidence of a failure, then I investigate the problem and if it turns out the failure was associated with our manufacturing process or any other area in the business, I will accept the comment as a complaint. If I discover that the product was misused or tampered with I tell the customer so and refuse to accept it as a complaint.

Maybe you don't agree with my take on this?

[Aaron Lupo]

Originally Posted by Cathy

When you allege something you are implying without any evidence to back this up. This would be your customer reporting a complaint - you will not be able to prove there is a deficiency until you investigate.

On many occasions your customer may report that the product is not functioning correctly or it is defective or damaged. The reasons for this could be mis-use by the customer or a failure on your part to ensure the device was suitable for use. The latter would qualify as a customer complaint. However, you would not be unable to determine the cause until you investigated. Therefore the alleged deficency becomes either a deficiency ot not a deficeincy.

I think the definition the FDA has given is very good.

What I find somethimes is that a manufacturer will accept a customers comment about the failure of a device as a customer complaint. I do not do this. I accept a customer comment and evidence of a failure, then I investigate the problem and if it turns out the failure was associated with our manufacturing process or any other area in the business, I will accept the comment as a complaint. If I discover that the product was misused or tampered with I tell the customer so and refuse to accept it as a complaint.

Maybe you don't agree with my take on this?

I agree with Cathy on this. The only thing I would add is that if through your investigation you determine that it is not really a ‘complaint’ as defined by the FDA the information should be categorized as feedback. Remember that even though you performed your investigation and determined that your process is not at fault the customers perception is that you did something bad and they want you to listen to what they have to say. So I with that said, I would not refuse any feedback/complaint you receive from the customer rather instead of classifying it as a complaint use it as feedback for possible system improvements.

[Cathy]

Yes, Feedback - Very important with Medical devices - forgot about that one!! We keep this filed as 'Serive Issues' and analyse them once in a while for recurring issues.

[zibsan]

Thank you for your input.
However, I still have the same question. My understaning is that if the Customer "alleges a malfunction" it is a complaint, regardless of the outcome of my investigation. The result of my investigation will determine how I would catogorize it, but it would be a complaint. I review all the call from our Technical support department; this leads to quest for a definition. If a Customer calls and says that it doesn't do X and the technician tells them to change a setting, is that:

- a complaint
- Customer training
- equipment configuration change

By the FDA definition, I think this would be a complaint. But logically I would say not. My main concern is that if everything starts becoming a complaint, we will not focus on the REAL issues.

What do you think?

[Cathy]

We are getting into very sticking ground here Zibsan!
Understanding what a complaint is, is central to customer issues, but I know where you are coming from. You are very right in what you are saying about attention to real issues.

Your example is very good and demonstrates where confusion can arrise. I would class this as a training need or configuration issue - providing the technical support team can do this without an issue.

This brings us back to the orginal issue of implication of a problem without the evidence - alleging the problem is the fault of the manufacturer.

Don't concentrate too much on the FDA definition while it is signifcant you still need to operate as a business.

With a technical support team you must seperate enquiries with complaints. Customers will allege deficencies until they understand. You have addressed an issue in creating a TS dept. Since you have dedicated technial support I would allow them to help out customers with queries such as the one above without promoting them to complaint status - however - if they are unable to resolve the problem with the customer and the balance of evidence shows that the equipment may be at fault, only then would I record this as a complaint.

This is where your skills as a quality professional come in. You need to be able to assess and investigate an issue and determine its status against the FDA and company guidelines. As long as you can jusify your decission you are on the right track.

[Bulksupplier]

We have 5 levels of complaint severity to help with prioritisation:
A: Lost business
B: Potential lost business
C: Formal complaint
K: Concern
N: Nonconformance (internally identified only)

We used to also split them into 'Justified' and 'Not Justified' following investigation, but we dropped that on the basis that the customer may not always be right, but is never wrong - if he went to the trouble to raise a complaint, there must be an opportunity somewhere to improve his perception of us as a supplier

[zibsan]

We are getting into very sticking ground here Zibsan!
Understanding what a complaint is, is central to customer issues, but I know where you are coming from. You are very right in what you are saying about attention to real issues.

Your example is very good and demonstrates where confusion can arrise. I would class this as a training need or configuration issue - providing the technical support team can do this without an issue.

This brings us back to the orginal issue of implication of a problem without the evidence - alleging the problem is the fault of the manufacturer.

Don't concentrate too much on the FDA definition while it is signifcant you still need to operate as a business.

With a technical support team you must seperate enquiries with complaints. Customers will allege deficencies until they understand. You have addressed an issue in creating a TS dept. Since you have dedicated technial support I would allow them to help out customers with queries such as the one above without promoting them to complaint status - however - if they are unable to resolve the problem with the customer and the balance of evidence shows that the equipment may be at fault, only then would I record this as a complaint.

This is where your skills as a quality professional come in. You need to be able to assess and investigate an issue and determine its status against the FDA and company guidelines. As long as you can jusify your decission you are on the right track.

Cathy, sticky isn't even close. I have been loosing sleep over this. The precedent was set before my arrival here. But it was from the 5 Customer 10 sales days. We have grown ALOT since then. I want to maximize our efficiency. We are spending so much time on writing up complaints that we don't have time to trend them. All in the name of "FDA Requirements". I know it is missing the point; you document to trend to prioritize your efforts. This is why I want to develop a analytical definition that will satisfy our regulartory requirements as well as logic.

Thanks Again!