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Four Considerations for Managing Product Quality Complaints

Receiving product quality complaints is inevitable. The key to navigating product quality complaints, however, is establishing a robust product quality complaint management system. No matter your industry or the type of product your organization produces, effective complaint management is an important part of your Quality Management System Below we outline four considerations for managing product quality complaints: 

Four Considerations


When a complaint is reported, effective documentation of the complaint is critical. Think of the complaint as a story, and document it as if you’re telling that story: Who reported this issue? What happened? Where and when was the issue observed? Why is this a complaint? 

Once you have documented the events that tell your story and have a clear understanding of the issues involved, you will need to determine a path forward for your investigation and resolution of the issue. 


Upon receipt of a complaint, it’s important to determine the complaint type. There are a wide range of complaint types, from a broken tablet in a bottle, to defects in packaging, to falsification or adulteration of products. 

Once you determine your complaint type, you can proceed to assess the risk level of your complaint and determine what type of investigation is required. A more in-depth investigation is required if there is increased risk to the consumer.  A broken tablet is low risk and a minor complaint, while falsified or adulterated medication is significantly higher risk and deemed a critical complaint. Critical complaints also require timely notification to the Food and Drug Administration (FDA).  


Based on your complaint type and classification, you can determine what type of investigation is required. Critical complaints require a more in-depth investigation. In the case of falsified or adulterated products, it’s imperative to determine whether the product was obtained legitimately via an authorized supply chain or an adulterated process. FDA notification is required in these cases, which may lead to other agency involvement, such as the Office of Criminal Investigation. A chain of custody must be identified and reviewed to ensure appropriate distribution channels were utilized and determine how the falsification or adulteration occurred.  

Complaints that are classified as minor also require investigation and should also be monitored for potential trends. Organizations should establish a threshold for repeat occurrences based on product and complaint type to determine if there are any trends present. Trending of data can be an important predictor of potential quality issues in the future.  


In order to close a product quality complaint investigation, it’s important to ask a few questions. What was the root cause of the complaint? Did the issue occur outside of the organization’s control? What corrective actions are required?  

One thing to keep in mind is that your complaint investigation should be comprehensive and documented accordingly. The benefit of this practice is that a regulatory agency is less likely to have questions during an audit if they see evidence of a thorough investigation. If they do find that the investigation was not thorough or documentation is missing, it can raise questions and a citation can be issued.  

If corrective actions were identified, it’s important to document what the action is, who is responsible for resolving the issue, and the timeline for resolution and effectiveness check. This is another area for potential citations by regulatory agencies.  

Managing Product Quality Complaints

Product quality complaints range in scope and can be multifaceted. Clarkston Consulting has a team of experienced quality operations consultants that can help you improve your complaints management process.   

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Tags: Quality Operations, Quality Management Systems