May 30, 2023

Effective complaint handling is fundamental to life sciences quality management, with implications for operations, product design, risk management, and more.

It’s also critical to ISO 9001, FDA Quality System Regulation (QSR) and EU Medical Device Regulation (MDR) compliance.

Manufacturers that get complaint management right can use it to improve products and reduce risk to patients and the company. Those that get it wrong, however, run the risk of future product failures, recalls, and regulatory penalties.

With that in mind, today’s article looks at how life sciences companies can strengthen complaint management with an automated quality management system (QMS). Included are considerations for building your workflow and how to incorporate risk into the process for better decision making and patient protection.


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The Basics of an Effective Complaint Management Workflow

Each manufacturer will have its own complaint handling workflows, which may differ based on inputs like issue type or source. That said, there are several common elements that organizations typically build their workflow around in the QMS:

  • Intake: The QMS helps standardize intake forms for logging complaints and capturing the relevant details needed for subsequent stages of the process.
  • Review: During the review stage, the QMS can help automatically determine whether the issue requires investigation and/or is reportable. If a complaint can be closed, the QMS will route it for closure and create a record of the event.
  • Investigation: At this point, complaints are routed to the appropriate root cause analysis investigation such as a 5 Why or 8D. This determination may be based on the nature of the problem, or internal processes and preferences.
  • Corrective and Preventive Action (CAPA): Once investigation is complete, teams can use the QMS to assign action items and track the CAPA to closure.
  • Regulatory reporting: The QMS can help determine reportability using decision trees and responses provided during intake. It can also automatically populate forms with required data for regulatory reporting, e.g. FDA 3500A submissions and EU MDR’s Manufacturing Incident Report (MIR) form. This ensures compliance with applicable regulations and streamlines regulatory reporting to minimize administrative errors and related issues.

An automated QMS streamlines this process by automatically routing complaints to the right people at each stage of complaint handling. This helps ensure companies handle complaints in a timely manner, eliminating inefficiencies associated with server files and manual approvals. Those responsible for action items receive notifications and reminders, with escalations providing accountability when people don’t complete assigned tasks.

Considerations for Your Process

Within the above framework, there are several questions you’ll want to ask to determine what your complaint handling workflows will look like. For example:

  • Does the process change depending on the source of the issue? You may have different processes for handling manufacturing issues versus supplier or customer issues.
  • What are your triggers for opening a CAPA? You’ll need to identify the triggers for opening a corrective action, whether that’s by source, risk level, or other criteria. In some cases, you may want to launch a deviation or a nonconformance rather than a full CAPA with investigation.
  • What’s the process for recurring issues? To address systemic risk, consider whether to automatically launch a CAPA and/or escalation when a problem occurs more than once.

Using Risk Within Complaint Handling Processes

Complaint handling and risk management are closely linked. As such, managing complaints within the QMS should necessarily incorporate principles of risk management throughout. A robust QMS will make it easy to trigger risk management activities at several steps.

As you design your complaint handling and CAPA workflow, it’s crucial to examine your products and their inherent risks. For instance, complaints impacting patient health may go straight to a full investigation and CAPA to ensure timely handling. The same goes for recurring issues, which may signal unresolved problems and systemic risk.

This is in contrast to, say, a cosmetic defect on a product that poses a lower risk to a patient. In these cases, you may have a fast-track process involving less documentation, investigation and requirements for verification.

The initial review stage is another place risk plays an important role. At this step, a risk matrix can help quantify the risk associated with the event based on severity and occurrence. This score can be used to prioritize investigations and filter out high-risk complaints needing immediate attention.

Finally, risk tools are essential when it comes to closing the loop on product quality and safety issues. For instance, teams should use the results of investigations and CAPAs to update failure mode and effects analysis (FMEA). In this way, knowledge gained from complaints feeds back into product and process design to promote continuous improvement.


At the end of the day, there’s no one-size-fits-all approach to complaint management. Even with a QMS built around industry best practices, companies need to be able to align workflows with business processes and regulatory requirements.

In this sense, a highly configurable QMS acts as a catalyst for greater operational efficiency. What you don’t want is to have to adjust your process to the software’s capabilities. Instead, you should be able to configure the software to your processes, which you’ve likely spent considerable time developing.

With the right QMS, life sciences companies can accelerate the resolution of complaints from intake to post-market reporting. Just as important, an automated QMS creates an accurate, comprehensive record, complete with FDA-compliant audit trails and electronic signatures. Combined with better visibility into KPIs and trends, the QMS enables manufacturers to take a proactive approach to complaints that keeps them compliant while reducing risks to patients.


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About the Author

Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.