We will soon put our CAPA into place (woo hoo) and there will need to be some instruction given to the management staff on what it is, how it will work, etc. I've put together a PowerPoint presentation with the basics.

My boss has asked if I could write a work instruction or guideline document on how to do a root cause analysis. The steps and the tools. Like, this is a fishbone and it works this way, and here is a Pareto chart and it works this way, or the 5 why approach is used thusly, and a fault tree looks like this and you use it this way,..... Something to introduce everyone to the tools that can be used and the methodologies. Has anyone here got any material that would be useful? I've scanned the web but don't have much of substance.

Also, I thought that presenting a case study in the training session would be a good exercise. Does anyone have a case study or a real life example that they would be willing to share?

We've recently had some classic cases where corrective action should be rolled out, but with nothing formal in place we are just dealing with it the same old band-aid way. When getting the CAPA procedure into place was mentioned, someone responded "what does this have to do with QA?" They just figure everything is a "technical" failure and that QA is some sort of standing-in-the-corner process thing.

Anyway back to my requests: guidelines on how to do root cause analysis, and a case study?

Thanks in advance ya'll!:bigwave:

Lucinda,
Myself and our training manager are getting ready to do just this with our top management. Though we don't have any WI's in place outlining the whole process of root cause analysis, we have put together an in-house training class and are getting ready to try it out on the hard cases (i.e. top management). This has been put together from info out of the book "Corrective Action" available from Paton Press. I found it a good resource for this subject. You can download several of the forms in the book from their site. You will need some "good" case studies, and some "bad" (stinkers) case studies for examples to show your people how not to fill them out. I might be able to come up with a few good & bad ones I have received back after an internal audit if that will help.
:thedeal:

Lucinda said:

My boss has asked if I could write a work instruction or guideline document on how to do a root cause analysis. The steps and the tools. Like, this is a fishbone and it works this way, and here is a Pareto chart and it works this way, or the 5 why approach is used thusly, and a fault tree looks like this and you use it this way,..... Something to introduce everyone to the tools that can be used and the methodologies. Has anyone here got any material that would be useful?
______________________
Lucinda,

If you haven't already, take a peek at www.freequality.org. They might have a few items that might save you a few steps. I have not been there for a long while so I can't comment on how good the content might be -- the memory ain't what it used to be!

Good Luck,

Mike S.

Lucinda,

For some basic and simple instructional material on Pareto & fishbone, take a look at: http://www.carillontech.com/QE.htm
rgds,
-Atul.

Hi Cinda...

The Team Handbook by Joiner & Associates has a really good section on Tools & when to use them, Processes & Systems, SIPOC Diagrams, process mapping, Ishikawa diagrams, Scatter plots, etc. It also has a chapter on Building an Improvement Plan that is pretty thorough. I highly recommend the book.

Hope this helps!!!

Thanks to everyone for your help. I got some good info from these sites and should be able to craft something.

energy, the guide is wonderful. I am plageri.....um, using it as a resource that will go in our Training section. (uh oh, now you'll be plagued with requests!)

Is Energy holding out on the rest of us? I'm hurt...

Mike S.

Mike S. said:

Is Energy holding out on the rest of us? I'm hurt...

Mike S.

Mike,

It's 16 page document that I've had for about 15 years. See how things haven't really changed that much. Same O Same O. It's not in electronic format so I faxed it to Lucinda. My motive was, of course, was just to get Lucinda's fax number so I can send sweet nothings to her. You want some? :biglaugh:
:ko: :smokin:

energy said:
Mike,
My motive was, of course, was just to get Lucinda's fax number so I can send sweet nothings to her. You want some? :biglaugh:
:ko: :smokin:
________________
Oops. Once again I misinterpreted. I seem to be doing that alot lately.:bonk:

Nothing personal, Energy, but I think ...uh...um... our fax machine is broken.:)

Mike S.:vfunny: