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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Original Message:
Sent: 19-May-2020 02:49
From: Spyros Drivelos
Subject: Complaint Handling
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
Original Message:
Sent: 15-May-2020 16:31
From: Anonymous Member
Subject: Complaint Handling
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)