Integrating the FMEA Process to address identification of Aspects and Impacts

[Diana Cadwalader]

Hi. I have read through most of the threads posted here and must say that I have found a new fave site on the web. I am primarily a quality systems person, but have been asked to drive the implementation of 14001 in one of our smaller more contained tier 1 automotive facilities.

In attempting to revamp our fmea forms used in mfg so that they have less subjectivity and become more relavent to our processes rather than building an auto, it occurred to me that I could revamp the venacular around the severity and occurance levels and have a very solid tool for identifying aspects and their impacts and this would ensure a solid significance ranking. We have a process for id'g a/i at the facility but it is very subjective. I am looking for long term continual improvement of that system.

I have been told that quality systems people do not make good ems people,,,, so am seeking some expert opinion here.

Thanks so much for all the helpful info that has been posted here. I feel much better and more confident now in the interpretations that I have made and many of the steps taken thus far to get us ready for certification.

Regards
Di

[Randy]

I have been told that quality systems people do not make good ems people

Most of the people that say that aren't sharing the stuff they're smoking. Anybody can be a good EMS person. I just had dealings with a gentleman that is a highway engineer that is the MR for a great EMS. I'm the Lead and Surveillance Auditor for their certificate, and he understands EMS real well.

Marc has some good A&I info here (use the search machine on this site). Another good reference is Marilyn Blocks book on Aspects & Impacts.

[Diana Cadwalader]

Randy- Thanks - the search engine is great. I have found that i have to be careful because I could literally spend all night in here reading and benchmarking.
You are right as well about Marily Blocks book. When we first considered implementing a global system, I had her in to do the initial iso14001 training to my global implementation team. The only downfall to that was that even though she brought alot of knowledge to the table, I found that there was not alot of good input or guidance relative to implementing in manufacturing environment or implementing with qs. Maybe we were just too green then and did not get the full benefits of the training.

[Randy]

There are some providers out there (CEEM for one) that have courses on implementation and integration of QS & EMS. Marilyn Block (who I've never met or talked to) also has a book on integration of systems (it's kinda dated towards 9001:94 though). I'm not pushing any specific authors or organizations, I've just got some knowledge of these specific ones.

You might want to try even ol' Marc here, he's done some combined things recently. And he's close by.

[kalehner]

I have used and audited both FMEA and Non-FMEA aspect identification procedures. I prefer the non-FMEA approach. Here are some reasons why I don’t like FMEA for aspect identification:

· There is a tendency for FMEA to identify only aspects that have a high potential impact under abnormal circumstances. Many of the aspects that already have operational controls in place and should be in the EMS fall short in the ranking process because they are perceived to be already under control and therefore irrelevant.

· People working with the aspects (in the production areas) need to be engaged in the identification and significance determination process. It has been my experience that when you try to engage these folks in a complicated ranking system they loose interest in the process or worse do not respect the EMS. Its not that these folks are not bright. In fact they are usually very bright and are quick to recognize when something is being made harder than it needs to be.
· At some point a significance threshold value will need to be established for the ranking system. More often than not I have found that the organization establishes this value to return a limited number of aspects. I have yet to hear an organization give a good justification for the significance threshold value. Occasionally I will get an honest answer like “we only thought we could manage 10 significant aspects so we set the threshold value where it would only return that number of significant aspects.�

I know that many of the ISO 14001 “experts� swear by FMEA but I believe they are giving bad advice and causing a lot of unnecessary effort to be made during Implementation. If you feel compelled to prioritize your aspects do it after you have determined which are significant. Implementing an EMS is not like brain surgery. It does not take a highly gifted mind to do it. It is more like learning to ride a bicycle. Its better to learn to do it with someone there to help you get the feel for it. And maybe catch you if you are going to fall.

[mdobovsek - 2005]

Diana!
Do not get problematic your life.
I´m too from quality (the heavy one -pharmaceutical industry)

My advice:

We address the responsibility to detect aspects to our workers.
The approach:

identify an impact or posibility to one
relate it to an aspect from a list we (EMS managers) develop (not more than 20-30)---> purpose to group them for selecting as a objective

estimate impact:
2 levels matrix:
inside the plant, outside the plant (interested parties)
lo, mid and hi consecuences ----> 6 possible values of A

estimate frecuence of ocurrence:
each week
each month
each year
in 10 years
4 possible value of B

Multiply A x B

You get a number

EMS manager must define the number above one impact is significative----> operational documented control

Apply only common sense.

We are DNV certified

Good luck

PD: similar approach use Nasa at Glenn Space Center