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