A requirement of ISO 9001, ISO 13485 and the FDA’s 21 CFR 820 is in regards to complaint files. According to 21 CFR 820, a complaint is defined as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” The verbiage in the ISO standards is similar. In layman’s terms, a complaint is any indication of dissatisfaction with the product or service provided.
Your company must have a procedure in place to define the process for handling complaints. Within this document there should be instructions to handle all complaints in a timely manner, document all verbal complaints, and to require an evaluation of the complaint to determine if an investigation is necessary.
In the complaint record you must capture:
- The name of the product
- Date the complaint was received
- Any control numbers used (UDI, UPC, lot number, etc.)
- Name, address and contact info for the individual filing the complaint
- Description of the issue
- All information related to an investigation on the product
- Any corrective actions taken
- Any reply to the individual filing the complaint
An effective complaint program provides the opportunity to improve your products and/or services, identify and eliminate root causes in order to prevent the issue(s) from recurring, and to potentially improve the image of your company by increasing customer satisfaction and loyalty.
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