How to make a root cause analysis, any procedure please?

please help!

how to make a root cause analysis. any procedure please.

thanks!

Hi Javy,

Re: Root Cause Analysis Example/Scenario:

You have identified a non-conformance, let's say non-conforming product as a result of an instrument being out of calibration. You make corrections to bring the instrument back into calibration and corrective action to rectify the product such as rework.

You also carry out a root cause analysis which is an investigation to determine why the incident happened, in this case why the instrument was out of calibration. It may be old and require replacement, it may not be checked sufficiently, it may not be calibrated regularly enough. Your investigation/root cause analysis will determine the cause and subsequently you decide what action to take, this could be increased calibration frequency, instrument replacement etc.

You will then follow up and confirm all actions have been completed and the actions have been effective.

Regards,

Tony

Hi Javy,

We use the 5Y's RCA as part of the Corrective/ Preventive Action Procedure.

Pls see below. Hope this helps.

Mae

5Ys ROOT CAUSE ANALYSIS.pdf   21.74KB   522 downloads

Mae's 5Y is a wonderful simple premise. However, it is absolutly critical especially in detemining root cause in a recall situation that a cross functional team is established and always start from a premise...when was the defect first noted etc.

Hi Javy

The most extensively used tools for root cause analysis is 5 why analysis. It is most widely accepted and used tool. I am attaching another example to show the 5 why analysis for easy under standing.........Each 5 why analysis will  lead to set of corrective action and preventive action  which can be implemented to avoid to repeat of deviation and put corrective action in place to have NC. It is as simple as GMP norm to keep shutter closed while production is on. But on audit - we find shutter is kept open. Once we apply 5 why Root Cause to this issues we amazed to see to have 8 corrective action to taken to stop it immediately and 9 preventive action to prevent it not to repeat.

Hope this will help you.........

B T GortiCase study 1.xlsx   142.26KB   248 downloads