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Hello, Is This Thing On? Understanding What Your Customers Are Telling You (Complaint Handling).

Updated: Jul 12, 2023

While I work on many different pieces of the Quality System for my clients, the one that I spend the most time on at Quality Systems Services is complaint handling. In the last few years, I have worked with almost a dozen clients addressing their complaint handling programs.

They all have received a version of one of these FDA observations: “Failure to investigate customer complaints”, “Failure to determine root cause in complaint investigations”. The pharmaceutical and medical device company’s gut reaction to the observation is to focus on how the investigators use the information they have available to them to determine the root cause (e.g., root cause analysis tools, sampling testing, etc.). This is logical because they were told that they did not investigate the customer complaint or complete the investigation.

However, if the company looked at their whole complaint handling process, they would discover that the real issue (aka the root cause) is further upstream in the process.

This is where I come in.

The Root Cause of Poor or Inadequate Complaint Handling Processes

The first thing I do with my clients in these situations is to understand what is really going on in their process, (i.e., the root cause). I ask them questions about the process and review complaint investigations and the entire complaint handling file.

Most of the time, the issue comes down to one thing: Getting Information from the customer (e.g., patient, doctor, pharmacist, etc.). Not only is the initial step to the complaint handling process, but it is also good customer service.

Talking to Your Customers Like a Mechanic

I know many people are not fans of their auto mechanic, but I like my auto mechanic, Anthony. Anthony is easy to talk to and spends most of his time understanding my car concerns then puttering around my car. He will ask me what sounds the car is making, what is the car (and me) doing when the sound is going off, etc. He does not judge but asks key clarifying questions to understand the problem. Once Anthony understands the problem, he can fix it with the efficiency and at a reasonable price that we all want from our auto mechanics.

That is what an excellent pharmaceutical or medical device company’s complaint handling team does. They create key clarifying questions for the call center to ask the customers. They spend time listening and asking key clarifying questions to get to the problem. If you do not understand or misinterpret the problem, you cannot determine the root cause or even determine the incorrect root cause.

A person handing keys to a person in a car.

We want to be heard as customers particularly when it comes to something personal like our health. Customers take the time to share their concerns and frustrations because they are spending money to improve their health.

When a patient or a doctor calls a pharmaceutical or medical device company’s call center, they are calling about one of two things: (1) to clarify instructions, or (2) to give product feedback.

Typically, the product feedback is negative or a complaint. To investigate and resolve their complaint, the call center needs to obtain as much detailed information as possible during the initial call. This is crucial since the investigation results are only as good as the information gathered, also known in the business world as “garbage in equals garbage out”.

This sounds very similar to the start of a deviation or nonconformance investigation for in-house issues. In fact, it is. The key difference here is who is providing the information. In a deviation investigation, the key players providing the information are fellow colleagues who use the same terms and the same procedures as the investigators. Here are some skills to help you understand your customers’ complaints.

Learn Your Customers’ Language

For deviations and nonconformances, the initial information the investigator receives is typically clear and understood.

The investigator is talking to colleagues who are knowledgeable in the company’s process and product terms. They are trained on the same site procedures so there is little room for misunderstanding of what the problem is that needs to be resolved.

For complaints, it is more nuanced. Depending on how the pharmaceutical or medical device is used, the customer calling in the complaint could be a patient or a medical staff.

Customers do not know your company’s procedures and may not use the same terms as your manufacturing technicians. In fact, every type of customer may describe the same issue differently. A doctor or a nurse will use medical terms whereas patients will use descriptive terms like they would to their mechanic. They only know how they communicate the issue and what the directions on the package say and mean to them.

It is important to listen and ask right clarifying, open-ended questions to ensure that the investigator determines the root cause for the correct issue.

Write Down Everything

Pharmaceutical and medical device companies understand that importance the good documentation practices. There is the adage “If it was not documented, then it did not happen.”. This is also true for complaints. The Call Centers must document everything the customer says even if it does not appear at the time to be relevant.

A person writing something down with a pen and paper.

Customers will make comments during the initial call such as “I had a cold” or “I took the medication while I was watching the kids”. These statements at the time seem like pleasant conversation on the surface, but deep down it provides a clearer picture of what was going on when the customer had the issue and may have contributed to the issue occurring.

Assess How Many Times the Event Occurred

Customers, particularly patients, will state that this is not the first time that the issue has occurred. While the customer is directly sharing information about one event, they are really sharing information about multiple events at once.

When this happens, the Call Center needs to document this information and notify the Complaint Handling Team that this may be multiple events. Many pharmaceutical and medical device companies will require multiple complaints to be opened in these situations. This is the difference between having an isolated event, a lot specific issue or an overall product issue in the market.

Need to Assess Your Complaint Handling Process?

If you would like to assess your overall complaint handling process, please contact me at I have helped many pharmaceutical and medical device companies assess their process for gaps and determine solutions.

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