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Complaints handling and corrective actions

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Guest user Created:   Jul 02, 2019 Last commented:   Jul 02, 2019

Complaints handling and corrective actions

Does a formal CAPA is always needed when complaints investigation results with corrective action task? or can it be included as part of the complaint activity and follow up? also if CAPA was assigned, can Complaint be closed?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Carlos Pereira da Cruz Jul 02, 2019
Assuming complaints including full investigation and CAPA correction/corrective actions recommendation.

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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://training.advisera.com/course/iso-9001-foundations-course/
- book – Discover ISO 9001:2015 Through Practical Examples – https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
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