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When to issue a CAPA (corrective action preventive action)?

Ajit Basrur

Ajit Basrur

Staff member
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#11
#11
raghakrish said:
Hi, Im developing a CAPA software which can be used in medical devices and other allied industries. Im looking for beta testers who can implement the software in their company.

Im ready to give that software free of cost. And also do the modifications and customize the software to suit your needs. Please note that this is a free software and Im giving this for free. It is not for sale.

Im ready to provide full support for the software. If you are interested I can show a demo of the software to you.

regards,
Satheesh
Click to expand...
Hi Satheesh,

Pl note that I have deleted your email address from the post as it violates the TOS. Any one interested will contact you through the Private Messaging.
 
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hitesh

#12
#12
To be more specific on the criteria to initiate a corrective action,

I would say when a systematic (recurring) process or design problem has
• Increased FMEA risk classification due to hazard severity and/or probability change.
• Adversely affected the customer related processes (customer order processing, complaint handling, contract review etc.).
• Caused deviation from product performance specifications (design inputs) and/or regulatory requirements.
• Resulted in significant rejection of the products/raw material.
• Significantly and adversely affected manufacturability/cost of the product.

Any comments or suggestion on the criteria to initiate corrections? I would appreciate for feedback from the subject matter experts.
 
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