Members

CAPA FDA & CAPA Quality - An Effective CAPA Plan

The ten objectives of CAPA FDA implementation are:

Validate that the CAPA system procedures that deal with the quality system requirements regulation have been specified and documented.
Define if appropriate sources of product and quality problems have been identified and make sure the data sources are analyzed to identify existing product and quality problems that may require corrective action.
Identify the unfavorable trends of product and quality sources and make sure that data from these sources are analyzed to find out potential product and quality problems that may need preventive action.
Verify that the quality data information received by the CAPA system is complete, precise and appropriate.
Verify that accurate statistical methods are operating to detect recurring quality problems.
Determine if failure investigations are implemented to detect the root cause
Determine if suitable actions have been taken for product and quality problems identified from data sources.
Determine if corrective and preventive actions were potent and confirmed or validated prior to implementation and ensure that corrective and preventive actions do not adversely impact the finished device.
Validate that corrective and preventive actions for product and quality problems were executed and documented.
Determine if information related to nonconforming product and quality problems and corrective and preventive actions has been properly distributed, including dissemination for management review.

Views: 2

Comment

You need to be a member of On Feet Nation to add comments!

Join On Feet Nation

© 2024   Created by PH the vintage.   Powered by

Badges  |  Report an Issue  |  Terms of Service