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Complaint Handling

  • 1.  Complaint Handling

    This message was posted by a user wishing to remain anonymous
    Posted 15-May-2020 17:05
    This message was posted by a user wishing to remain anonymous

    At our company, we have had a bit of discussion over who "handles" complaints.  Should it be regulatory? should it be quality? I would think that regulatory receives the complaint, engages quality and manufacturing for the investigation process, but then regulatory processes the documents, files any FDA MDR submission, and closes the complaint.  How does everyone else departmentalize complaint processing? (Note: small company)


  • 2.  RE: Complaint Handling

    Posted 17-May-2020 04:45
    Good day Anon,

    Afraid to say there is not a clear nor succinct answer to your question about who handles complaints.  This really depends on the organisation, resources, knowledge, and understanding of the overall post market surveillance process.  I have seen it managed by customer service, technical support, quality assurance, quality compliance, regulatory affairs, regulatory compliance ... all through the different areas.  When you say regulatory receives the complaint, I would agree it is something like regulatory compliance or compliance conducting the first initial risk-based approach on the complaint such as asking questions like is it an adverse event? has this happened before? does it need an investigation? or is is just customer feedback (not a complaint).  But again this could be a quality role if the person conducting this assessment understands how to answer all those questions.  I have been in small companies and worked with many small companies where again the role for handling complaints is a shared activity with either Quality or Regulatory "managing" or responsible for the overall process.  My advice is to clearly define your process including roles and responsibilities (like a swim-lane process flow).

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: Complaint Handling

    Posted 18-May-2020 09:39
    I agree with Richard that there is no "standard" way to assign this responsibility. I have seen it run through Quality, Regulatory, Medical and Clinical, Customer Service and Technical Service, to name a few. In a small company, much depends on expertise and bandwidth. Does your regulatory person understand the technical details of the product well enough to investigate fully? has your quality engineer (or QS person) done this before in a previous job? are you centralizing safety questions in the clinical group? If, as is likely, you need to share various aspects of this responsibility (engineering does technical investigation, customer service follow up with customer, regulatory files any MDRs etc) , you should clarify who does what in your SOP.

    In any case, you should make sure and include metrics in your Management Review, and look for if capacity in one area is becoming a bottleneck.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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  • 4.  RE: Complaint Handling

    Posted 19-May-2020 10:49
    Hello Richard,

    I ​had a quick question in regards to the question you posed "or is it just customer feedback (not a complaint)".  How do you make a distinction between customer feedback and complaint? I work in a contract laboratory where the majority of our complaints are received as SCARs.  However, when we receive evidence of client dissatisfaction without the term "complaint" or accompanying SCAR paperwork, it can be more challenging to determine whether the complaint process is warranted or not, particularly when it is a service issue.  Any thoughts on delineating between negative feedback and complaints?  Or are they one in the same? 

    Thanks so much in advance!

    Becky

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    Rebecca Anderson
    Senior Quality Manager
    Cottonwood Heights, UT
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  • 5.  RE: Complaint Handling

    Posted 19-May-2020 11:03
    I'm interested in Richard's thoughts, but will weigh in with my $0.02, as this can be a super challenging area to sort out. In general though, it ties to items that don't "allege a deficiency" in the laundry list of items in the definition of a complaint, nor do they allege the product "failed to meets specifications or perform as intended". Some examples of non-complaint customer feedback I've seen are....

    - can you change your hex bolt to a phillips bolt....
    - it would be nice if your surgical tool came with planning software
    - could you package all these things in a kit
    - can we get a blue version of this....
    - can we add a different view to the screen?
    - i wish this came in a robotic compatible version

    Of course, there is a very fine line even with these seemingly obvious ones, because you need to answer the question "why". For instance, for the "hex bolt" you need to know if their reason is "we have more Phillips drivers lying around" vs "the hex bolt keeps stripping" on a part that must be re-attached for every use. Or if they want blue because the current version is hard to see in blood, or low light, and they think blue would show up better, rather than an aesthetic preference.

    Generally, you need someone pretty experienced in your product and complaints handling to effectively sort these out. A lot of companies get in trouble when actual complaints disguise themselves as more benign feedback. I'd urge you to err on the side of keeping in the complaint system if you aren't sure, but having a "category" for low risk complaints.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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  • 6.  RE: Complaint Handling

    Posted 22-May-2020 08:54
    ​Hi Rebecca,
    In our complaints procedure we define what a complaint is and list some examples (e.g., dissatisfaction relative to the identity, quality, durability, reliability, safety, effectiveness or performance of a finished device) including MDR, device malfunction, design or manufacturing fault, mislabeling, or customer's intent to contact regulatory authorities. We also define what a complaint is not - product inquiries, product returns, billing/shipping discrepancies, or cosmetic concerns.

    We are a smaller organization so only one person handles complaints but it should be cross-functional. Regulatory should be aware of these communications as well as Quality Engineers for updating risk management/design files and upper management as part of management reviews.

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    Stacey Benser
    Quality/Regulatory Manager
    York PA
    United States
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  • 7.  RE: Complaint Handling

    Posted 18-May-2020 08:53
    Anon:

    Richard's response is absolutely correct, in my opinion. The regulations do not dictate how complaints need to be processed as long as regulatory obligations are met. However, I would like to add one additional piece of advice from the preservative of an Ex-FDA field investigator. Whatever system you establish for your company, please be sure that the people evaluating the complaint are looking at it from both a quality and pharmacovigilance perspective. A "quality" complaint could have a pharmacovigilance aspect, such as 'lack of effect' and a 'pharmacovigilance' complaint could have a quality aspect such as super-potent or sub-potent product. If quality complaints are not identified/recognized as potential pharmacovigilance complaints as well, at the time of receipt, you may miss your regulatory reporting time period. Therefore, it's important how complaints are triaged at the time of receipt. The personnel doing the triaging need to be adequately trained so that they can forward them to the correct departments for proper handling.

    Tony Warchut

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    Anthony Warchut
    Principal
    Glastonbury CT
    United States
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  • 8.  RE: Complaint Handling

    Posted 19-May-2020 02:49
    As always, you have already received some very useful and precise answers.

    I do not know the size and the expertise of your company, but I will advise to built a system which is fit-for-purpose.
    You have to be flexible and utilize your resources in the most efficient way.

    There is not requirement for certain responsibilities, as long as you have a well constructed system, where you collect all the required information and you also have a good system of analyzing the data, both quality and vigilance data, as Anthony mentioned.
    Just describe in the organizational chart, the responsibilities of each job description and move on with that. As long as someone has the qualifications to perform a given task, it does not matter if he is a quality person, or a regulatory, or just an assistant, or customer service.

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    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
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  • 9.  RE: Complaint Handling

    Posted 20-May-2020 01:09
    Hello Rebecca,

    Greetings to you in Cottonwood Heights (lived in Salt Lake for a few years and brings back memories of that area !).

    Your question is really valid and have helped a few companies over the years distinguish between a complaint and a feedback.  There is definitions for complaints, US FDA's being the most common, but also the EU MDR definition called 'device deficiency' which adds in use errors (a topic for a different thread).  In essence, anything not falling under a definition of complaint would be considered feedback.  Easy.  Not so as we know in the regulatory world because many medical devices and services there can be a grey area considering whether it really is a complaint or not.

    One of the ways we addressed this in companies I worked for is we tried to define or provide sufficient examples in our customer communications procedure concerning what is customer feedback and what is a customer complaint.  (We had a customer communications procedure "above" the other customer feedback and customer complaint handling procedure for customer service.)  In this procedure we gave examples, specifically to our products and services, as what would be considered a feedback or complaint.  In addition, for customer complaints we had clearly defined "incident codes" or Complaint Codes which were types of failures observed with the product or service, then customer service could pick one.  If they could not pick one, then it was determined whether it was feedback or a new type of complaint incident.  Usually this was fairly easy because if it was a new type of complaint incident it was fairly obvious, so anything else fell into the customer feedback database, i.e. screen would be nicer being at this height, we like to select colours, can the software do this, etc.

    A further comment I can make is do keep track of your customer feedback because this is expected under ISO 13485 and part of post market surveillance under the EU MDR (if you CE Mark any product or deal with CE Marked products).  The whole idea with tracking customer feedback is to take actions based on recurring type of feedback.  Just because a person is not complaining about something, but if 30 people raise the same question or thought,  As an example, if one person says it would be nicer if the screen was brighter, not a complaint just a comment to be considered (though could be a complaint as well) or the font would be easier to see if it was blue.  One person ok, but when 30 people give the same feedback, this is an indication maybe to change something.  So gathering, tracking, measuring, and analysing customer feedback can be just as important.

    Finally a note on customer service or technical support, there are companies with software or durable products (equipment or instruments) who have a customer service or technical support department.  This is also quite important to have a process and procedure defined for how this is being managed.  As an example, someone calls up because the software is doing this or the instrument is doing that.  The Technical Support person walks them through troubleshooting, where they get the customer able to use the device or product again.  Is this a complaint?  Most would say no, most would say yes.  However, under the world of ISO 13485 and post market information, this definitely needs to be tracked.  Again as an example, if one person calls because they forgot to plug the device in .... but if you get the 10th or 12th call helping a person to properly install the device - maybe the instructions are not sufficient or not clear, and should be reviewed for updating.  Rebecca, you could probably use the same type of approach at your facility because often customer service is probably helping someone with an issue, but is not necessarily a complaint or they are able to help the person resolve their issue on the phone.  This should all be gathered, tracked, and analysed, so up to you to determine what actually becomes a complaint and what is part of feedback/customer service/technical support.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 10.  RE: Complaint Handling

    Posted 20-May-2020 09:18
    This is a good question and I think several excellent and thoughtful suggestions have been provided by others. I would just add that you should consider not only the regulatory aspects but also operational efficiency aspects as well. Create a process with clear roles/responsibilities that integrates well within your current organizational structure. For example, you may have more flexibility if Regulatory Compliance and Quality functions report into the same management. In a small company, these roles may not be clearly defined and everyone may be doing multiple things at once. In these situations, it is even more important to keep it simple and very clear. 

    Think of all the functional roles you would need - receiving, logging, evaluating, MDR assessment and reporting, trending/monitoring, investigating, CAPA decisions, Management review, etc. All these activities need to be conducted as part of complaints "handling". Taking a systems approach and integrating it within our current operation is the best way to make sure you don't miss any required deliverables. 

    If you would like to discuss more, please don't hesitate to reach out to me directly. I have direct operational experience in this area. 

    Best regards

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    Naveen Agarwal
    Jacksonville FL
    United States
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  • 11.  RE: Complaint Handling

    This message was posted by a user wishing to remain anonymous
    Posted 22-May-2020 12:21
    This message was posted by a user wishing to remain anonymous

    Thank you everyone for the responses. They are immensely helpful. 

    From your perspective, what amount of regulatory oversight should a complaint have? Does RA come in after the initial complaint receipt? During the investigation? Complaint submissions if eMDR? Complaint closure?  Currently, RA is only informed of the complaint at a monthly review meeting and has no other involvement. 

    Again, thank you for the information.