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ROI CalculatorCustomer Complaint Investigation is the process of investigation of customer complaints with the purpose of identifying the root cause of the problem with the product, assessing the risk, and taking corrective measures. According to 21 CFR 211.198 for medicines, any complaint related to possible quality defects needs to be investigated and reviewed, and all records need to be kept. In case of medical devices, it is affected by 21 CFR 820.198.
Customer Complaint Investigation is an active process and plays a major role in continuous improvement within the QMS system. Complaints may be about process problems, product problems, or service faults. By looking at the complaint trends, companies could find evidence of defects and solve them if it complies with the idea of customer satisfaction supported by ISO 9001.
For example, if there are many reports of durability from customers, chances of possible design or manufacturing defects are high. An efficient customer complaint investigation system not only solves the cases but also provides information in identifying risks and taking preventive measures. Therefore, complaints help the company to get rid of systemic problems and maintain its quality standards.
Well-handled complaints can help implement a strategy for innovation and secure future customers. Well-established complaint management practice can turn any risk into an excellent chance for systemic quality improvement. The complaint investigation process, when executed correctly, becomes a key pillar of a mature QMS rather than a compliance checkbox exercise.
The principle of customer focus is central around any QMS. Customer satisfaction is not attainable solely through product-quality deliverance. Instead, it is accomplished through proper responsiveness to complaints and inquiries through customer complaint investigation. Overall, every complaint is a good opportunity to prove accountability.
Complaints that are acted upon in a bold and transparent manner can turn unhappy customers into loyal friends. Complaint investigation closely relates to customer satisfaction research, obtaining feedback, and monitoring market reputation.
ISO 9001, known for being the most popular standard for QMS, highlights the significance of customer satisfaction, as well as continuous improvement through appropriate customer complaint investigations. The process of complaint investigation is already included in certain sub clauses related to customer feedback, nonconformity, and corrective action. It is required to have procedures for taking in, recording, examining, and solving complaints in the complaint management system.
It is very important that the record of complaint handling is included in the management review, providing control and accountability for the management. ISO 9001 guides successful customer complaint investigation which contributes to compliance and improvement of the complaint investigation. In addition, the customer complaint investigation process should clarify interaction processes and procedures used to secure a balance between the openness of information about a case and confidentiality.
Compliance with ISO 9001 standard means that any complaint management system includes collection of necessary information and indicates the reasoning for all decisions made during the investigation process.
