GMP

How to Plan and Implement an Effective Corrective Action System

Hi Everyone

Good evening…………

Today we are going to discuss on the purpose of a quality management system.

QMS is to help businesses improve abilities to consistently meet customer or regulatory requirements, according to the American Society for Quality.

A major component of a successful system is a corrective action program that adequately addresses non-conformance. The problem is that many systems become a burden rather than a tool for improvement, generally, because they are not well-planned prior to implementation.

CAPA Process

  • Root cause investigation
  • Conclusion & Quality design
  • Action plan
  • Implementation and follow up

Important Considerations

  • Tie CAPA implementation to:
  • Document control for products and processes
  • Change control
  • Ensure that controlled documents are reviewed and approved if changes are made.

NOTE: Closing CAPAs when actions are implemented, and tracking the effectiveness checks for CAPAs as a separate quality system metric. If closure takes more than 90 days, the CAPA should probably be converted to a Quality Plan. This is NOT intended to be a “work around” to give companies a way to extend CAPAs that are not making progress in a timely manner.

2 thoughts on “How to Plan and Implement an Effective Corrective Action System”

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s