Welcome back to another week of MedTech Compliance Chronicles! Still exploring the QMS, we are quickly approaching the point where we will begin to place our device on the US market, and once again, the QMS is back to provide a reality check to anyone getting too excited. As we planned the design of our product and processes, planned measurement systems to monitor them and then created entire processes about what to do when they failed to meet specifications, there is still one last thing we must plan and put procedures in place for before we can say we have a full QMS. That is, what will we do when our product fails to meet its specifications after delivery to a customer? Or what if the customer simply does not like the product? Does not believe it functions as we claim or adequately for the intended use? Broadly, these all fall under the customer feedback and complaint handling process.
The complaint handling process specifically is, at risk of being crude, the process which generates the greatest source of annoyances to those who work in the medical device industry. The primary purpose of this is the subjectivity involved in the inputs but the need for objective outputs. In more practical terms, complaints are often received from users who are not technical experts in the device and, worse, are often received by customer service representatives or sales persons who are also not technical experts in the device. The engineers who are then assigned to investigate the complaint are handed a couple of sentences of vague language and told to find a root cause of why the issue described in the complaint occurred. This probably sounds familiar if you have spent some time working in the industry and may even seem inevitable, a “necessary evil.” It is not. It is, in fact, a symptom of an ineffective complaint handling process. A lot of issues surrounding this process lay in dissecting the subjective information given to accurately and consistently derive objective decisions. Several key contention points include; distinction between general feedback and complaint, determining how to streamline the process and determining when and to what extent investigation and corrective actions are required. Another key point that will be discussed in the next post, about reportable events, is whether the complaint is reportable to FDA or not, tune in in two weeks for that post!
Complaint Handling Requirements
Complaint handling varies greatly from organization to organization, from the types of complaint to the risks associated with them. For that reason, despite the fact that part 820.198 appears longer than some other sections of the QSR, the complaint handling requirements are not too prescriptive in and of themselves. One thing that is required for all organizations is that complaints be handled by a formally designated unit. Depending on the size of your organization, this could be as simple as identifying a role and documenting complaint handling in the job description of that role or as complex as a whole department. Now let's get into some of the requirements around handling complaints themselves.
The first requirement is that all complaints are processed in a uniform and timely manner. This actually tends to be one of the more difficult things to do as you never know who in the company may receive a complaint or from what source (written, email, oral, social media, etc.) a complaint may come from. For this reason it is critical that you have clearly defined in your procedure a method of transcribing the inputs from all sources of complaints into your internal records that should contain the same types/categories of information for each complaint regardless of source.
Next, two decisions must be made and documented with each complaint. One of which is whether the events surrounding the complaint are reportable, this will be covered in the next blog post. The second decision you must make for every complaint is whether or not to perform an investigation to determine the cause of the issue that resulted in the complaint. This second decision comes with a caveat, you are required by regulation to investigate all complaints that allege a failure of the device or its labeling or packaging to meet their specifications. Therefore, you will only ever make the decision not to investigate if the complaint is either not alleging a failure of the device, labeling or packaging to meet their specifications (i.e., customer simply didn’t like the product but the product met all of its requirements) or if the complaint is of a known issue for which an investigation has already been performed and repeating it would be unnecessary. The remaining requirements around complaint handling primarily revolve around what needs to be recorded during an investigation for complaints. First, I will get into setting up an effective complaint handling process and then tie it all back into the investigations.
Setting Up the Process
The best practices for setting up the complaint handling process is going to be heavily dependent on your specific product. You will want to derive a standard list of complaint intake questions based on the foreseeable failure modes for your device that were identified during risk management. The list should also cover basic patient/user and device identification as well. Some other factors to consider for determining standard questions will be regarding the use environment (temperature, humidity, indoors/outdoors, etc.), other equipment being used at the time, smells, noises or warnings displayed by the device or accompanying devices. Draw deeply on your risk management for the device in the beginning and, eventually, on prior complaint history to develop a list of questions that, ideally, will give you enough to perform an investigation with minimal or no further contact with the complainant.
Having a standard list of questions for complaint intake is critical to ensure uniform handling of complaints, however, it is dependent on another factor. Everyone in the organization must be trained adequately on complaint intake. A perfect list of questions that identifies everything you would need to know about a complaint is useless if the person who is actually contacted by the complainant has not been trained on the questions, where to find them or how to properly document a complaint. Since you cannot predict which particular employee will be notified (especially since a complaint can be as simple as a social media post these days) all employees must be adequately trained on complaint intake. It is worthwhile to do a formal training and familiarize all personnel with the complaint intake process, the questions that should be asked and, perhaps most importantly, why each question is important and what necessary information it provides. Explaining the ‘why’ in the training is quite an important step that is often overlooked. Oftentimes, when a complaint is received, the complainant might be upset or the employee receiving the complaint may simply be nervous about receiving a complaint. For these reasons, if the employee does not fully understand why each piece of information is important, they may omit it in an attempt to not further upset the complainant by asking too many questions.
Now that we have completed the complaint intake, it is time to get into the investigation…
Investigate & Resolve
When it comes to investigating and resolving complaints much of the underlying process will be similar to the root cause investigation portion of the CAPA process so I won’t rehash that too much. Instead, focusing on some specific investigation steps for complaint handling, there are three primary sources you will gather your information from. The first being internal records of the specific lot or batch from which the device in question was manufactured. The second will be any information provided by the complainant (the reason a standard list of questions is good for complaint intake) and the final will be from the affected device itself, if the customer is able to return it or a field service technician is able to get out to it.
A key part of complaint investigations will be properly identifying the complaint failure mode within the predicted failure modes from risk management activities. If the failure mode was not identified in prior risk management documentation then the risk management process, in its entirety, must be applied to this new failure mode to determine if it is acceptable or if new risk controls are necessary. The next step is to analyze the description of the event given by the complainant and compare it to the predicted severity described in risk management documentation and determine if the predicted severity is accurate to what has been experienced. Quick tip, never lower your documented severity rating if complaints consistently come in with lower severities, you are primarily looking for if a complaint has resulted in an increase from the predicted severity. For the next step, you will go back and review your complaint files for other complaints for the same failure mode. You will then calculate the actual occurrence rate of the failure mode and compare it to the predicted failure rate in risk management documentation.
Other than customer interaction and comparing documented risk management to actual failure occurrences, the investigations of complaints will be virtually identical CAPA investigations. There are a couple of extra documentation requirements around complaint investigations though. You will need to clearly state whether the device, its labeling or packaging actually did fail to meet its specifications. You must also include the identifying information of the affected device, contact information of the complainant, any correspondence with the complainant and if the device was being used for treatment or for diagnosis at the time of the incident.
Conclusion
Overall, complaint handling is a simple process often made complicated due to human emotion and assumptions. These stressing factors can be significantly reduced by streamlining the complaint intake process and training all employees on the process. A good procedure to follow and a solid understanding of the process will help personnel document complaints more uniformly and, therefore, ease the burden of investigation on the designated complaint handling unit. A well maintained complaint log will be among the most valuable resources for data in post-market surveillance, management review and even new product development or product improvement initiatives.
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