CAPA and Your QMS Internal Audit

March 1, 2017 BY

  Through the article from here (Disclaimer: The site or article through which the link or URL here in direct to has no bearing with iTGRC.Asia. Your discretion to proceed is advised.), a ...

What CAPA means after your Internal Audit findings? 

 

Through the article from here (Disclaimer: The site or article through which the link or URL here in direct to has no bearing with iTGRC.Asia. Your discretion to proceed is advised.), a few things learnt may probably attest to the short-comings that most organizations tend to overlook, including that from my own experience. 

 
 
Even when one has done enough of QMS internal audit, the followings extract may be interesting to pay attention to; 
 
" Companies might assume that virtually everything needs to fall under CAPA, when in fact there are plenty of things that can be handled with your change management system and wouldn’t be considered part of CAPA. Companies overburden themselves with CAPA and find that they miss the real issues.
On the opposite side of that are those who under-use CAPA, perhaps missing out key areas for “preventive action.” Dealing only with known problems, or "corrective actions", is very reactionary. You should also consider being more proactive in identifying potential issues before they happen. This is the essence of preventive action side of CAPA."
 
“...there are always at least two causes of any problem. There is always a preexisting condition and an action (or catalyst) that when combined result in a problem. Therefore, employees should always look for at least two causes of any problem. Causes often extend beyond the area or function where they are detected, so for major problems, assemble a cross-functional team to perform the root-cause analysis.”
 
“ Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.”
 
 
 
Disclaimer: Strictly for sharing purpose without prejudice, bias or intent to infringe or acquire any rights, privileges or commercial benefits with respect to the site and it's content, under the local Legal and Regulatory jurisdiction.