Marc,
Sorry to get back to you so late (I overlooked this forum). Thanks for the kind words, but I must admit that my post takes from many of your own posts. So thanks for the insights.
The post in particular that spelled it out the best for me was the one where you commented on doing FMEAs for processes (operations) as opposed to running through a Process
FMEA for each product (QS9000). Made excellent sense to me, as I have found in my experience that the past FMEAs we ran were quite redundant. A great time saver once you get over the initail investment of doing FMEAs on the determined CRITICAL operations (don't get hung up on the insignificant). But I made an additional discovery.
I have been working with our Chicago facility to help bring them to ISO 9001 registration. A common question asked was to the point of when to create a work instructions. A review of our past FMEAs indicated that we planned to control everything through the creation of work instructions. There associated RPNs were for the most part, rather low and part of the "trivial many". Why create work instructions where it has been decided that a specific step in a process was of a low risk? In lieu of this discovery, instructions are only created where risk is determined to be significant (reasonable risk). Now, instructions are issued less than 1/10 the time they once were.
Aside from applying the FMEA process to the manufacturing environment, I have instructed other in the use of this process and encourage them to use it in their worlds (all aspects and departments of the organization). The advantage to doing this type of FMEA is that it creates a record of our thought process. Since folks are the authorities in there respective areas, they give due consideration to the activities they have identified as being critical to the daily operation of the organization. They will invite their internal suppliers and customers to these meetings to fairly represent the overall needs of those involved. What I have noticed, folks often over complicate issues, often over/under estimate impact, and create extra work while individually estmitating process inputs and outputs. The group effort, however, tends to ground things better, they debate ratings in a collaborative effort. The side benefit to this process, increased,better communication!
Determining risk involved is essential in my opinion. Use a risk analysis tool and use group concensus. Often times, folks just don't know where to start. I was one of those folks too! No harm, no foul. Hopefully, people visiting your forums can take away from the experiences of the many folks here who, in one way or another, fell on our noses as often as we have hurdled seemingly insurmountable obstacles. My suggestion here is just one of many solutions to this problem. I hope it helps.
Regards,
Kevin