Internal Audit - FMEA approach

[Eric CC Chen]

Hi,
This is the 1st time I posted in this Forums.
And hope I can get your help to solve my question regarding to the internal audit.
Most of audits that from customers' side are proceeding with control plan approach in my company. Recently, someone in my company has a idea that would like to use the FMEA as the check-list to perform the internal audit. Could this be a formal or correct method from QS point of view?
Thanks for your help.

 

[Bill Ryan - 2007]

Welcome to the Cove

I've been trying to think of how the "FMEA approach" would work and I, honestly, can't envision it. The FMEA is more of a "diagnostic" type of tool while the Control Plan is the actual "nuts and bolts" of what you do. My feeling is that auditing against the FMEA may point out a Potential Mode, Cause, or Control which may have been "overlooked" during the FMEA excersize, but how would you justify a finding because the team missed something that could "POTENTIALLY" happen????

Bill

 

[p_tww]

Hi,
This is the 1st time I posted in this Forums.
And hope I can get your help to solve my question regarding to the internal audit.
Most of audits that from customers' side are proceeding with control plan approach in my company. Recently, someone in my company has a idea that would like to use the FMEA as the check-list to perform the internal audit. Could this be a formal or correct method from QS point of view?
Thanks for your help.

Hi, Eric,
welcome.

doesn't matter which auditor use FMEA approach, if it was internal audit, you could not use PFMEA as the whole check list because it only covered the product manufacturing process. It was system audit, you should cover all the processes in the system.

For the auditor who want FMEA approach, I thought they would like to test whether you employee understood the potential/happened failure mode and how your employee prevent it.
You known, for clause 6.2.2 of ISO9ky2k, it focused totall employee involvement, so your employee should understand the importance & relevance of their job and how they contribute to archieving target.make sense?

 

[Diana Cadwalader]

Eric
Like Bill, I am having a hard time envisioning the FMEA as an audit checklist. However, I always make sure that i have a look at the FMEA during an audit.

Pick a product that is running, look at the CP and other operational docs, look up customer complaints and internal issues regarding that product.

Now - compare CP to FMEA - do the two agree with each other?

compare complaints to fmea - are the complaint areas on the FMEA as failure modes? Does the occurence ranking agree with the number of times that the failure has actually occurred?

Compare internal failures to fmea - are the failures on the FMEA? Does the occurence ranking agree with the number of times that the failure actually occurred?

In my experience, companies who are only doing fmeas because the standard requires them to (and not because they recognize the value of the tool) need to have the fmea assessed more thoroughly and more frequently. I always make it a point to review in depth.

Just MHO of course - - good luck.