Efficient Complaint Handling System

by | Nov 18, 2019 | Complaints, FDA, Medical Devices, QMS, Quality Systems, Regulatory

Complaint handling can be a daunting task especially if you are a small company. 21CFR 820 requires customer complaints to be handled by a designated customer handling unit and if you are a small company this might seem a little too much to achieve during the early years of your company.

Complaint handling has high emphasis not only in the QSR, but also in ISO 13485, ISO 9001 and the EU MDR. The EU MDR has focused a lot more on the overall post-market surveillance activities than just complaint handling.

The key to an efficient complaint handling operation lies in the procedures of your company. The procedure is the first place to start to assess your complaint handling program. It needs to be perfectly integrated with your adverse event reporting, CAPA, Risk Management and Nonconformance management systems to assure its success.

The second most important point to consider while authoring the procedure is to clearly define and state the roles and responsibilities. A complaint can be received by anyone in the organization but who should document it and move it forward should be defined clearly. Especially true for small companies since there are no fixed departments, or where people wear multiple hats.

Lastly, to ensure compliance, the timelines are very important to be captured in the procedure, as well as conveyed to your employees via a strong training program. If the investigation does not take place in a timely manner, not only are you violating the regulations, but you would never be able to reach the root cause of the problem. Another important deadline to look out for is the adverse event reporting timeline which is 10 days for user facilities and 30 days for the manufacturer. Many companies ignore the requirement to conduct an adverse event reportability determination thinking that their device has almost 0% chance to result in one. However, the best practice here would be conducting the AE determination and document it in your QMS as evidence in case of an inspection.

You don’t have to worry about doing this all alone. Contact us today to see how we can help improve your complaint handling system or your QMS as a whole. Call us at 248-987-4497 or email us at info@emmainternational.com.

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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