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It can be quite nerve-wracking the very first time your medical device company receives a complaint from a customer. What are your next steps? Is this something serious?
At some point, most companies will need to deal with customer complaints and it is a unique process to be involved with because it’s the only quality process where you interact directly with the customer.
Managing the process so that you are compliant with regulations is an area that is commonly tripped-up on, while simply managing the various channels through which a customer might communicate with you is also a challenge.
Let’s look at what is required and how companies can streamline the complaint handling process.
First of all, every medical device manufacturer should have a good overview of the rules regarding the management of customer complaints. Sometimes these complaints could lead directly into a CAPA and sometimes they must be reported to the FDA. You need to know what is required and when.
The rules state that you must maintain complaint files, you must have clear procedures for receiving, reviewing and evaluating complaints, and you must investigate them in a timely manner.
As for reporting of complaints to the FDA or ISO, as a manufacturer, you are required to report any incidents where you learn that your device may have contributed to serious injury or death, or malfunctioned in such a manner as would be likely to cause serious injury or death should a similar malfunction happen again.
Dig into the FDA and ISO links for further knowledge on the regulations, also take a look at a previous post of ours on creating an effective complaint handling system.
It always helps to learn from the common mistakes that manufacturers have made so that you have the opportunity to avoid them. Here are a few that commonly come up, often resulting in 483 observations or warning letters upon inspection:
Sometimes companies mistakenly believe that they are not required to conduct an investigation for certain complaints. For example, a missing specification on the labeling of the product -- the company might think that the missing IFU does not present a risk, but the regulations are pretty clear that it should be investigated.
21 CFR 820.198(c) requires you to complete an investigation for failure of labeling to meet any of its specifications, even if you think that the missing piece does not create risk. The only time where you don’t have to conduct an investigation is if you have already performed an investigation for a similar complaint.
Another situation where companies have often tripped up and thought they didn’t need to file an MDR is in the case of user error with the product. “Reportable incidents” are any that have caused serious harm or death, or have the potential to cause serious harm or death should a similar incident happen again. The FDA is quite clear that this includes user error.
If your product is in foreign markets and you receive a complaint through one of those, then the FDA still requires you to follow an investigation procedure and report any reportable incidents. Don’t think that overseas complaints can be excluded.
One of the key challenges is to implement a proper management strategy for tracking and monitoring all complaints that you receive.
In today’s digital environment, your company can be receiving complaints from several different sources, like phone, email, snail mail, forms on your company website or even social media. How will you ensure that nothing slips through the cracks across the multiple different channels that you use?
A common place where many companies get tied in knots is if they’re still using a cumbersome, paper-based system to manage all of those complaints. The front desk takes a complaint over the phone and jots it down on a form, a product manager prints out an email sent by a customer, then someone else sends you a complaint via the messaging on your Facebook page. It’s easy for pieces of paper to go missing, for people to think that someone else has picked up the Facebook complaint and generally for multi-channel complaints to fall through the cracks.
Secondly, do you have all employees trained on what to do if they are the first receiver of a complaint? Sometimes, this is where companies go wrong. The person who first handles the complaint doesn’t know what to record, the procedure to follow or the data that is considered to be important, so they miss vital information when recording and passing it on to the appropriate person to manage. In some cases, the person who took the initial complaint didn’t think it was “serious” enough to warrant investigation and it goes no further.
A third area that can result in inefficient handling of complaints is a lack of managerial support for the complaint handling system. This can be seen with reactive behaviors, such as only giving serious consideration to the complaint handling system when they have received 483 observations or warning letters.
Companies also find themselves bogged down when there are not enough resources devoted to managing, investigating and resolving complaints. When this happens, sometimes complaints aren’t handled thoroughly enough or they take too long to resolve.
It’s also important to note that the FDA expects you to have a system through which you can easily note any trends with complaints. For example, has a certain product had an increase in complaint frequency? This is difficult to undertake in a system that is managed inefficiently.
For any of these challenges, the company can help to mitigate them by:
Most issues of mishandling or mismanaging complaints can be largely resolved with an efficient system in place. It’s not something that should be considered as an afterthought and put into place only once complaints have been received, but as a key part of your overall QMS.
An eQMS, such as Greenlight Guru, ensures that complaints are recorded centrally, kept up-to-date and that each complaint's status is clearly visible to anyone who checks. Given Greenlight Guru is designed specifically for the medical device industry, you can be assured the customer complaint process will not only be compliant out-of-the-box, but it is connected to all your other quality processes like CAPAs and Risk Management.
Put in place an efficient system, coupled with knowledge of the regulations, training of staff and the dedicating of appropriate resources to complaint management. This will help to keep your company compliant and ensure that complaints are a direct influence on ensuring your products are safe and effective.
Jon is the founder of Greenlight Guru (the leading cloud-based platform purpose-built for MedTech companies) and a medical device guru with over 20 years of industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help...