Many FDA-regulated manufacturers find themselves without the resources or processes to efficiently manage product complaints. When the resulting backlog isn’t cleared quickly and completely, the issue can compound into serious safety and compliance problems requiring many hours of work to resolve.
Here, we present eight complaint-handling problems that can lead to complaint backlogs and generalized strategies for remediation.
These scenarios were compiled by The FDA Group's Alan Greathouse, a regulatory compliance expert with extensive experience identifying the causes of complaint backlogs and working to develop efficient and effective ways to remediate them in companies large and small, all over the world.
Each of these problems was experienced firsthand and solved through a tailored remediation program we've generalized for generic use.
This is an excerpt from our extensive white paper: Clearing Complaint Backlogs: A Guide to Efficient Complaint Management.
Experiencing a complaint backlog right now? Contact us today to get expert complaint handling and/or backlog reduction assistance from an experienced regulatory consultant.
Problem #1: Under-trained or under-experienced intake personnel miscategorizing genuine complaints from field incidents
While those receiving complaints from the field are typically experienced complaint handlers, those submitting complaints from the field should also be able to accurately discern genuine complaints from field incidents.
When too many field incidents enter your intake disguised as complaints, valuable time and energy is robbed from those triaging and investigating these issues.
Problem #2: Inadequate or incomplete service records
Thorough complaint investigations rely on good thorough record-keeping. When field technicians fail to capture the information needed, time is wasted tracking that information down. Worse still, serious problems can fly under the radar due to improper processing.
A “broken hose,” for example, isn’t useful as an entry when the device has twenty hoses attached to it. The level of detail provided must be appropriate to the complexity of the specific device in question.
Problem #3: Improper handling of medical devices with problems
In the medical device space, malfunctioning or damaged equipment must be returned to the manufacturer to conduct a physical investigation of the unit.
Too often, though, under-trained field technicians unknowingly sabotage the complaint process from the start by disposing of problematic devices on-site, making it impossible to investigate.
“When it comes to complaint intake, there has to be a fluid interchange between those in the field and those back home assessing the complaint. In many cases, field techs should have a background in complaint investigation. That way, they truly understand the problem and can determine whether or not what they’re seeing in front of them is a genuine complaint or just a field incident.”
Alan Greathouse, The FDA Group
Problem #4: Avoidable translation from one language to another
Products sold in several markets must be supported by a complaint management system free of translational hiccups. Companies extending their reach around the world have to bring their processes along for the ride. A complaint handling group used to processing complaints in one language can’t be expected to be as effective when they’re asked to process complaints from three or four.
Physical problems compound this. When problematic devices are returned to somewhere other than where the complaint handling group resides, for example, another group—sometimes in a different country—must step in to provide the complaint handlers with the information they need.
This extra step, while likely convenient from a logistical standpoint, only invites inefficiency elsewhere, leading to a possible backlog in addition to missed information.
“I worked with a company with a backlog that was, in part, due to a complaint group in Europe that was handling complaints about devices they didn’t even manufacture. Those handling them had very limited knowledge of that device. More importantly, when the device was returned, it was returned to a site in the United States. This kind of problem makes for a very poor process. You’re asking people, one, ‘you have to translate it from English to German’ if they don’t read and write English. Then, before it gets put into the U.S. system, it has to be translated back. That’s a massive opportunity for error.”
Alan Greathouse, The FDA Group
Problem #5: Poor complaint handling procedures lead to user error, incomplete data, and friction
It’s a hard question for internal teams to answer objectively (and why they often hire consultants to answer it for them): Are there adequate procedures for those handling complaints to follow? More precisely, can someone pick up the procedure, read it, and actually perform the process without having to work from memory?
Complaints should be assigned a risk number and prioritized accordingly. However, many complaint handlers are not qualified to perform the level of analysis required for this task.
Assigning risk accurately and consistently typically requires the expertise of a product engineer who has a thorough understanding of how to use the software that assigns risk numbers, as well as the factors that software is analyzing to arrive at its answer.
Problem #7: Improper medical device complaint classification
Improperly classifying complaints can spark a cascade of compounding problems. It skews complaint analytics, tracking, and trending. It’s also something regulators make a point of looking for (and routinely issue observations for) as it can result in MDRs not getting filed when they need to be. Improper classification not only causes backlogs but can create a barrier to eliminating them by introducing the tedious task of re-opening and re-investigating closed files.
“In one backlog remediation project, we were told that none of the 2,500 complaints needed an MDR. That didn’t turn out to be true. We found complaints that were two or three years old that never had MDRs filed. The industry expectation is 30 days to file. Not only were there MDRs to file, but we also ended up having to go back and open closed complaints to fill out additional supplemental documents and do further investigation. In some cases, complaints were just misclassified. The risk was inappropriately assigned. So, we had to go in and fill out what’s called supplemental forms, which, as you can imagine, that’s like a whole other investigation in itself, so you’re doing double and triple the work when you do improper investigation up front.”
Alan Greathouse, The FDA Group
Problem #8: Inefficient closure due to long wait times for cross-functional input
Poor alignment between cross-functional teams can let complaints sit partially completed as they wait for someone’s input. When complaints aren’t prioritized by a critical function, a few complaints can lead to a lengthy backlog by bottlenecking the entire process.
The Consequences of Inaction
When discovered by regulators, the first and most obvious consequence of a complaint backlog is a written observation. This could cite improper investigation and, in some cases, inadequate quality oversight.
Like any observation, expect this to trigger much more digging. Regulators will likely examine your processes and the backlogged files themselves to determine what is causing the delay.
Complaints indicating missed MDRs or unknown patient risks will very likely lead to critical observations and/or warning letters or other serious enforcement action.
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