In this webinar, we’ll start by reviewing the current state of complaint management (spoiler alert: it isn’t good!).  We’ll talk about some of the common ways companies tackle complaints and why these methods are inadequate.

We’ll then take a step back and review the requirements from regulations and standards. It’s important to understand what constitutes a complaint in the first place to ensure that the information received is properly reviewed to determine if it constitutes a complaint. We’ll discuss the distinction between feedback and complaints and show how feedback can result in complaints. We’ll look at some examples of what constitutes a complaint and a few examples of what is NOT a complaint.  We’ll also delve a bit into the gray area of misuse and discuss why even if misuse is the conclusion, there may still be nuggets to mine. To ensure common understanding as we go through the remainder of the presentation, we’ll discuss the terminology used and how that helps provide an understanding of the process.

Next, we’ll discuss the source of complaints. Companies often think that only problems formally reported to customer service are complaints; however, there are many more sources from which complaints can arise and, again, without proper attention to these sources, opportunities are lost and, quite possibly, issues are not seen and acted upon in a timely manner.

Now that we have a baseline understanding of the concepts, we’ll jump into the process and discuss best practices.

Documentation is absolutely critical to this process.  Documentation shows what’s done and provides the proper paper trail. Regulatory reviewers will absolutely review complaint records so the content needs to be clear, concise, and comprehensible. Poor documentation will often lead to regulatory findings. The FDA, after adopting ISO 13485 as the base standard for quality systems, retained the complaint documentation requirements from 21 CFR 820. We’ll look at these requirements to ensure the required content is well understood.

We’ll drill down into the process a good bit to address the investigation part of the efforts. The investigation is the most critical aspect of complaint management and needs to be done well.  We’ll spend a little time on root cause analysis to ensure The concept is understood.

Results of the investigations will vary from closing the complaint with no action to a complaint that triggers a medical device report, Nonconformance Report, and CAPA (yes, could be “all of the above!).  We’ll discuss how maintaining linkages between any other documentation (like a CAPA) is important.

We’ll wrap up with a discussion about trending and closure then revisit the common issues with complaint management and how, hopefully, we have provided information and tools to avoid these issues.

Areas Covered

Who Should Attend

Why Should You Attend

One of the first things any regulatory agency will look at when doing an inspection or audit will be the complaint file. And, too often, it is the source of regulatory findings (483s, nonconformances). Most often, issues arise due to lack of commitment on the part of management. Complaint management is not revenue-generating so minimal resources are applied.  Unfortunately, this not only results in regulatory issues, but it can also be a lost opportunity. Complaints (and any feedback) give the pulse of the customer and by not appropriately addressing complaints, companies can lose opportunities for improvement – both in the device from which the complaint arose, but also for future work.

To minimize the overhead impact, companies often put new hires / early-stage engineers in charge of complaint management and do not provide sufficient resources (time, expertise) to enable a reasonable analysis.  As a result, complaint handling is often untimely and falls short of a thorough investigation. Often, it’s quicker and easier (and less costly) just to refund the customer’s expenses than to actually investigate. This, again, is a lost opportunity and companies often make the same mistakes over and over.

Management needs to recognize the opportunities provided by complaints – both for the product in question and for the future. Adequate resources (time, personnel with expertise, devices for testing, etc.) need to be provided to properly investigate complaints. Even if the complaint looks frivolous, it may be an indication of some underlying issues that will manifest differently in the future. 

Complaint management teams need to also understand the opportunities presented and take the time to do proper investigations. The resources to do the investigation need to be identified, including time, expertise, and materials necessary to investigate.

Topic Background

Once you market a medical device, complaints are inevitable. Some are “frivolous” (“I don’t like the color”) but some are legitimate. All need to be managed in a timely manner.