Effectiveness Evaluation

GOOD MANUFACTURING PRACTICE (cGMP) REGULATORY TRENDS AND QA
1

As per EU GMP Chapter 1,

"An appropriate level of root cause analysis should be applied during the investigation of deviations, suspected product defects and other problems. This can be determined using Quality Risk Management principles. In cases where the true root cause(s) of the issue cannot be determined, consideration
should be given to identifying the most likely root cause(s) and to addressing those. Where human error is suspected or identified as the cause, this should be justified having taken care to ensure that process, procedural or system based errors or problems have not been overlooked, if present. Appropriate
corrective actions and/or preventative actions (CAPAs) should be identified and taken in response to investigations. The effectiveness of such actions should be monitored and assessed, in line with Quality Risk Management principles."

How Effectiveness of actions are monitored and assessed in line with QRM ?
Which QRM tool is used to assess this?

2

Effectiveness review is a common 483 currently in the unites states. Various agencies are keying in on practices which are systemic and cause multiple failures.

Effectiveness is monitored through any/all of the following. Again this should be a system or a concerted effort, not just a once-in-a-while or after-the-fact kind of activity. Systems for assessing are required.
a) a review of a CAPA at a later date.
b) scheduled re-assessment of the CAPAs
c) trending/statistics/process control/metrics
d) review of old CAPAs when a new CAPA is initiated.
e) team of dedicated CAPA and quality engineers.

Which QRM tool is used? Many options here, and EU/FDA don’t specify which is required.
FMEA, “5 whys”, Fishbone analysis, Six Sigma analysis are some of the tools. You can also use a combination of the tools.