Common Mistakes Made when Handling Complaints

by | Dec 27, 2021 | CAPA, Compliance, Consulting Group, FDA, Guidance, QMS, Quality, Quality Systems, Regulatory, Requirements, Standardization, Standards


‌ 

Manufacturers may find themselves without the resources and processes needed to effectively and efficiently manage product complaints in many regulated industries. When a backlog occurs and is not cleared quickly, the issues can compound themselves into serious safety and compliance problems. In 2020 the FDA issued 193 483s that cited complaints [1]. Here are several common mistakes when handling complaints and possible solutions to avoid them.

  1. Inadequate employee training on risk management and the assessment of complaints.
    Complaints should be prioritized based on their overall risk. Assigning risk accurately and consistently usually requires a thorough understanding of the risk assessment process. Developing a training program that trains the personnel to handle and categorize complaints can help mitigate this potential issue.
  2. Inadequate complaint handling procedures can lead to user error, incomplete data, or complaint processing.

The information contained in the handling procedures should be adequate. It contains information on what needs to be included, adequately evaluated, document and assign risks, and make an MDR determination.

  1. Inappropriate corrective and preventative action (CAPA) handling allows for delays in problem identification and solution implementation.

CAPA’s provide insight into the root cause and solutions for recurring issues within a manufacturing process. Failure to open, process, and close CAPA’s promptly can significantly affect complaints. If a company is unaware of many complaints around the same issue, they may not notice the trend to open a CAPA. On the other hand, improper CAPA implementation may cause an increase in complaints if the problem is not handled correctly.

  1. Insufficient or incomplete service records.

Complaint handling requires thorough record-keeping. If the servicing personnel fail to capture the information needed, time will be lost in tracking down that information. This can cause an even longer backlog as time is diverted away from the complaint handling to track down technicians or additional information. A simple solution to this is to train all personnel on what information is crucial to a complaint.
A backlog of complaints can quickly compound into more significant issues and hide a more profound problem within an organization. EMMA International can help remediate any issues or sort through the backlog of complaints. Experts at handling complaints in the life sciences industry can help. Contact us at 248-987-4497 or email us at info@emmainternational.com.

[1]https://www.meddeviceonline.com/doc/the-top-most-cited-issues-in-fda-fy-medical-device-inspections-0001

Alexis Ferrier

Alexis Ferrier

Alexis is a Technical Writer at EMMA International. She has research and development experience in both device and drug products. Additionally, Alexis has experience in quality assurance, quality control, regulatory requirements, and international compliance. She holds a Bachelor of Science in Chemistry from Michigan Technological University.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

Ready to learn more about working with us?

Pin It on Pinterest

Share This