How to monitor the effectiveness of the CAPA system

[NdumisoN]

Hello.

I would like to know, how would one monitor the CAPA system?

 

[greatwhitebuffalo]

I imagine it can be done through verification of effectiveness (close out activities) and through internal audits.

 

[yodon]

Just off the top of my head...

• are you meeting all your deadlines established?
• are containment actions effective (or are things slipping through the cracks after identified)?
• (the obvious one) are the CAPA actions effective in eliminating the issue (root causes properly identified)?
• are CAPAs re-opened as ineffective (or new ones opened when CAPAs deemed ineffective)?
• are your CAPA processes being followed?

There are more, no doubt, but maybe this gets the juices flowing.

 

[blackholequasar]

This is something that I have trouble with where I work. We make very specialized parts (PCBs) and sometimes we won't have another order come in for six months to a year. We'll evaluate the situation, put a corrective action in place, but as far as monitoring effectivity... it takes a while to get another order in, which leaves our CAPAs open for exceedingly long periods of time. Before, I worked in a situation where stock was generated but recently that has not been the case. In some instances, it may work to close the CAPA once the corrective action has been determined and put into place with a note to monitor for continued effectiveness, but not all auditors like that.

 

[RoxaneB]

...which leaves our CAPAs open for exceedingly long periods of time.

Where processes like this exist, I wouldn't use "time to close" as a metric. Besides, "time to close" really doesn't measure the effectiveness of the actions taken.

If I throw 10 darts in 5 seconds, I'm efficient at getting them out of my hand...but if I missed the target (or even the dart board), my effectiveness at throwing is quite poor. Time is not always a suitable indicator or measure.

In some instances, it may work to close the CAPA once the corrective action has been determined and put into place with a note to monitor for continued effectiveness, but not all auditors like that.

The management system is meant to work for and add value to your organization...it's not there for the auditors. And auditors who cannot grasp why "time to close" doesn't work for all organizations do not deserve to be auditors.

 

[blackholequasar]

Where processes like this exist, I wouldn't use "time to close" as a metric. Besides, "time to close" really doesn't measure the effectiveness of the actions taken.

This is a good way of wording it! I think it may be a pitfall for organizations to use 'time to close' as a driving metric. I'm much more concerned with the fact we may have 'repeat' CAPAs (obviously it was not effective) than ones that are closed in under 90 days. Thank you for your feedback, Roxane!

 

[RoxaneB]

This is a good way of wording it! I think it may be a pitfall for organizations to use 'time to close' as a driving metric. I'm much more concerned with the fact we may have 'repeat' CAPAs (obviously it was not effective) than ones that are closed in under 90 days. Thank you for your feedback, Roxane!

Just some additional food for thought - when it comes to 'repeat' CAPAs, considering where the repetition is occurring.

If it's with the effect (e.g., parts coming from Machine or Process A), then perfects the actions were ineffective at addressing the root cause - OR - the initial root cause wasn't really the root cause.

If the repetition is with the root cause (i.e., regardless of the process/team/department), then there is potentially an issue at an organizational system level.

There are times that we are so focused on "fixing" the localized effect that we don't step back and look for patterns with the causes from a higher perspective.

 

[rajeshmahida_16]

Hello.

I would like to know, how would one monitor the CAPA system?

you need to monitor effectiveness once preventive action finalized. once your had taken preventive action then you need to monitor atleast 3 lots fresh lots. if there will no repetitive issue raised then your preventive action also satisfactorily and effectiveness also monitored.

 

[NdumisoN]

Dear all

Thank you very much for your Advise. you gave me good ideas to think about and it looks like we have been looking at the capa system the wrong way because we have been measuring it based on how long it takes to close.