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.

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?

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.

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.

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. :frust:

What do you think?

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.

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

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!

Right, Zibsan - you cannot lose any more sleep over this issue. Put it away for a few days and clear your mind. This forum is a great source of advice so have a good look round to see if you can get any more ideas. If I understood your business more I would be able to give you specific help but I don't so this is my advice to you.


A customer compliant is a product or service that has failed to perform to the customers expectations in line with the specifications stated by the manufacturer, that has been reported to the manufacturer by the customer.

(you have to make the FDA guideline work for you)

To decide a customer complaint;
1. Gather all information from the customer and available failed parts or equipment.
2. Question the customer on status at time of failure and the method in which it has been used and is precieved to have failed.
3. Record this information.
4. Carry out prelimary investigation and decide if this was the manufacturer's fault.
5. If no, pass to customer services/technical support or other customer facing staff (delegate delegate where-ever possible) for response to customer
6. If yes, formally record and acknowledge acceptance of complaint to customer.
7. Investigate root cause and determine the action plan or corrrective and preventive action
8. Report this to the customer and follow up with them when actions are compeleted.

You probably do this anyway but pass out the trend analysis to the technical support team or get another member of the quality department. Or be really tough on you assessment of a complaint!!

Technical support probably need a reminder of what a customer complaint and what an enquiry is!! But you seem well focused on this 'nightmare' so no doubt you will sort them out.

You need to move on with your growth and top management need to see that old ways may not work any more.

Let me know how things go for you.

More for the mix…

If someone calls and complains about the product, it is a complaint. What an organization needs to do is determine if this complaint fits the regulatory definition of a complaint. Create a decision-making algorithm to determine complaint categorization: complaint/feedback. Create methods to process each. Consider what you have resources to do and what is required by your registrations/certifications. Determine the ‘needs’ and the ‘wants’, do the ‘needs’ as a minimum.

As noted, a customer complaint might be reclassified upon further investigation. One might allege a product is defective in order to get it returned and a refund issued. Upon receipt, the organization might realize that they have been duped, but nonetheless, they must treat it initially as a complaint. It is a complaint until objective evidence suggests that it is not. Here, the information might be reclassified as feedback if that suits the organization and does not violate a regulatory expectation.

Kevin

More for the mix…

If someone calls and complains about the product, it is a complaint. What an organization needs to do is determine if this complaint fits the regulatory definition of a complaint. Create a decision-making algorithm to determine complaint categorization: complaint/feedback. Create methods to process each. Consider what you have resources to do and what is required by your registrations/certifications.
Determine the ‘needs’ and the ‘wants’, do the ‘needs’ as a minimum.

As noted, a customer complaint might be reclassified upon further investigation. One might allege a product is defective in order to get it returned and a refund issued. Upon receipt, the organization might realize that they have been duped, but nonetheless, they must treat it initially as a complaint. It is a complaint until objective evidence suggests that it is not. Here, the information might be reclassified as feedback if that suits the organization and does not violate a regulatory expectation.

KevinIt's been awhile since I had responsibility for dealing with FDA issues (now I deal with FAA ), but I remember 5 years ago I had a system for dealing with (resolving) complaints regardless of source:
investigate every complaint
report results as
not valid, complainant error or misunderstanding - discussed with complainant for corrective/preventive action valid, damaged outside our control (customer or transit) - corrective/preventive action is ____________________
valid, our error (design, manufacturing, packaging, paperwork, shipping) - corrective/preventive action is ____________________
In over 6 years of making products subject to FDA regulation, only valid complaints were that we shipped to arrive too early. Lots of complaints were not valid, mostly due to internal error at receiver (wrong revision level documents at incoming inspection or faulty inspection instrument or technique) and they were the worst nightmares to resolve (who wants to tell a customer he goofed?)

Your right: who wants to tell the Customer??

In a review of Mis-ships, 2/3 were Customer error: ordered too many, wrong item, gave wrong shipping location, etc. This can be costly to the organization. In a past life, we actually had a sit-down with one of our largest Customers. They were 14 times more likely to have an error of this type than the grand average. We were being gouged.

Coming back to the problem, it appears that Zibsan's issue is about the ability to process Complaints effectively and efficiently. To be effective, the definition of what a Complaint is or isn't needs to be clearly established. This is where the decision-making algorithm will pay dividends. Through this, you should be able to sift out the feedback from the complaints to process each accordingly. From an efficiency standpoint, consideration should be given to resource allocation and methodology for processing complaints/feedback. From my view, both need to be tracked and trended, only complaints require an investigation. This offers the best benefit as well as coverage. However, if one is resource poor, then complaints take precedence to feedback. Here's the catch: what Standard are you registered too?? Under 13485:2003, you'll need to do both. From a Regulatory viewpoint, post market surveillence is mandated, thus covering feedback. I think that if you're in the Medical Device world, eventually the distinction between feedback and complaints will become somewhat moot.

From the FDA to the FAA...sounds like a glutton for punishment!!

Regards,

Kevin

I would like to thank everyone for their words of wisdom and encouragement. From the business side you do not want to tell your Customer that they are wrong, from the Quality side you do not want to report an excessive amount of complaints. When regulations or requirements contain the words: “Alleged”, “Assumed”, “Perceived” or “Appropriate” there may not be an “Absolute” answer. :bonk: