Failure Investigation/Root Cause Procedure Examples

E

erla4 - 2007

#1
I've recently been put in charge of establishing a Quality System at our company fortunately I have 4 1/2 months to get it up and running.
Would anyone have an example of a Failure Investigation/Root Cause Procedure? I've created a CAPA procedure but need a work instruction type document on how to conduct and record the investigation. Any help would be appreciated.
 
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C

Casey Cochran - 2009

#2
Our RC procedure is embedded in our CA/PA procedure.

I noticed that you said "fortunately I have 4 1/2 months to get it up and running." Don't know where you are starting from, but that sounds like quite a job. Are you sure you did not mean unfortunately?
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#3
erla4 said:
I've recently been put in charge of establishing a Quality System at our company fortunately I have 4 1/2 months to get it up and running.
Would anyone have an example of a Failure Investigation/Root Cause Procedure? I've created a CAPA procedure but need a work instruction type document on how to conduct and record the investigation. Any help would be appreciated.

erla4,

You do have a great task to have a complete QMS in place within 4.5 months. The fastest I wrote, implemented, and audited policy and procedures, and had the pre-assessment audit, and registered QMS was 8.5 months (20+ years in Quality), which was starting from the ground-up with no policies or procedures established and 5 facilities. In my eyes that was quick. The company projected 2.5 years for the process.

If you are thinking of getting your company registered, you will have had performed a complete internal audit, had management reviews and each employee within your organization needs to have a basic knowledge of the QMS.

I may want to rethink the time frame if was in your position.

Just my thought.

As for the CAPA procedure that should include your failure investigation/root cause.

Good luck.


Coury Ferguson
Program/Contracts Manager
 
G

Greg B

#6
Re: Failure Investigation/Root Cause Procedure Examples?

erla4 said:
I've recently been put in charge of establishing a Quality System at our company fortunately I have 4 1/2 months to get it up and running.
Would anyone have an example of a Failure Investigation/Root Cause Procedure? I've created a CAPA procedure but need a work instruction type document on how to conduct and record the investigation. Any help would be appreciated.
Does anyone have anything further on this topic? Is there a standard set of questions you ask when analysing a Non Conformance etc? such as:
1: State Problem
2: Location/Date/Time
3: Immediate action
4: etc etc
 
#7
Re: Failure Investigation/Root Cause Procedure Examples?

Hello Greg,

Here is what my company looks at:

? Exactly what the problem is
? Where and when the problem occurred
? The extent of the problem
? Significance to the identity, strength, quality or purity (ISQP) of clinical supplies
? Who is affected
? Quantity of product affected
? Has the problem occurred and/or been observed before?

The information is compiled into a Non-conformance Report and issued to QA. I hope this helps you.
 
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