How many of you experienced the NCN & CAPA Management through EtQ / QPulse and how effective to implement in an organization?

Question

Mohammad Mahtab Alam · Answer

i have the exposure to CAPA management as per ISO 9001:2015 and 21 CFR 820.100

safaa chak chak · Answer

i have the exposure to CAPA management as per ISO 2000:2015

Mohamed dawood Mohamed dawood · Answer

I received Complaints from various Sources

Registered in NCR Register and notify to to the concern process for the Correction / Immediate Action.

Later Conducting Root Cause Analysis and found out the Corrective/Preventive Action.

Follow up over the implementation of Corrective/ Preventive Aciton and collect the evidences to ensure the implementation.

Make on spot audit over and ensure the Effeciveness of CAPA and Close.