Measuring Corrective and Preventive Action System Effectiveness

[Sandra Gauvin]

This is my first time blogging....It's been my experience that nonconformance investigations are quickly closed out to meet a timeline prescibed in an SOP and to release product, which ultimately leads to poor investigations, incorrect root cause(s), and finally ineffective CAs. Take a look at the number of new nonconformance investigations per month and if it's increasing then it's usually a good indication that you're not getting to root cause (assuming you didn't introduce a new product)...if the root cause(s) is incorrect, then your CA will also be incorrect.

 

[mjbupp]

Anyone ever consider measuring the reduction of RISK as the measure of corrective or preventive action? If what you did lowers the occurrence or increases the likelihood of detection of a problem then you have reduced risk of the problem. FMEA concept of RPN - severity x occurrence x detection. Of course, you have to have an FMEA for the process or system in which the problem occurs.

 

[Sandra Gauvin]

Yes....However, you just have to be cautious that people don't select a lower risk ratings so that you have a less complicated Corrective Action, otherwise you won't have a true indication of the effectiveness. I've seen this happen when people are spread too thin.