Complaints handling and corrective actions

Assuming complaints including full investigation and CAPA correction/corrective actions recommendation.

Answer
Not all complaints investigation needs to end in a CAPA.
When an organization receive a complaint, it should not care about CAPA. When a complaint is received the priority is arriving at an answer to the client. I see it as if the clock was ticking, the sooner the client receives an answer the more likely the relationship and the credibility will be saved. When a complaint is received the top job is to close it, the client wants his or her problem solved. After arriving at an agreed solution with the client, the complaint can be closed. The last step when closing a complaint can be evaluating the need for a CAPA. I invite organizations to ask two questions:
• Was the complaint very serious, ca n it damage credibility and image?
• Is the complaint recurring with an unacceptable frequency?
If the answer to at least of one those questions is yes, then perhaps the organization should develop a CAPA. Now there is no time pressure, the client is no longer part of the problem. Well in some B2B cases, clients require information about the implementation of a CAPA. Developing an effective CAPA can take a lot a time because hypothesis must be tested and root causes find and that is not something necessarily linear.

The following material will provide you more information about complaint answering:
- ISO 13845 – How to comply with ISO 13485:2016 requirements for handling complaints - https://advisera.com/13485academy/blog/2017/03/21/how-to-comply-with-iso-134852016-requirements-for-handling-complaints/
- ISO 13485 continual improvement: Seven-step process for corrective and preventive actions - https://advisera.com/13485academy/knowledgebase/iso-13485-continual-improvement-seven-step-process-for-corrective-and-preventive-actions/
- free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
- book – Discover ISO 9001:2015 Through Practical Examples – https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/