Hi,
with increased focus of regulatory agencies on CAPA, discussion invited on the appraoches to be adopted for CAPA implementation & Timelines.
one more…
What will be the response if the Money matters to implement the CAPA !!
CAPA action plan should contain:
Task list
Prioritization
Task Assignment
Time line
Goal
Training
Tracking
The entire company’s philosophy is know to top management of a company. After first round of discussion the company will assign a Time line.Normally 10 to 12 days.This is because they know where the documents are and where they can find the Root Causes (RC’s).
Some smallr companies ignore CAPA foundation or CAPA Management. For such companies its a sudden burden. First they have to implement drastic changes in the Report Management system , Documentation system ,Implement and Train folks about CAPA.
In such companies it will take a month or more. A well managed CAPA company will have easy ways to fix a Time line.
Normally Simpler problems: 7 days
Packing Problems: 12 days
Production oriented problems: 12 days
Product complaints/Recalls: 15 to 17 days.
Fixing timeline is not most imprtant thing. Finishing with in time line and finding the cause and Fixing that cause and taking measures so that it does not repeat are best results that a company must expect.
CAPA is not an eye wash.
Dear Mr. Ashish,
I shall speak with Mr.Graham and post a comprehensive White paper on CAPA system on this site soon.
Regards
Good sharing Mr. Durga.
Would like to add that now-a-days CAPA is a important key topic for discussion during Quality Managment System review meets…shows gr8 focus.