Thanks for all answers. As I see it you make a balloned "hard" record when you are doing the acctual measurments and then transforms it into an electronic record.
Now here comes a new question. The different
FMEA, how did your company learned how to do them? Well there is a manual and its pretty basic and easy to understand. But as soon as you start with a real case there is always some isues regarding detail level, different rpn with in the group and across different groups.
There is no standard approach to developing an FMEA. I have seen PFMEAs that cover everything from receiving to shipping (busy and hard to follow), PFMEAs that cover only the manufacturing process (superficial), and PFMEAs that are broken down by each process identified in the Process Flow Diagram. For
DFMEA, usually consideration is given to product safety, functionality, risk, design for manufacturing & assembly, serviceability, maintainability, etc.
I prefer the last approach to
PFMEA because often times many processes are standardized within an organization regardless of the product (i.e. receiving, storage, material handling). A new product/process development would require just the creation of a specifc PFMEA & control plan; therefore for the PPAP all you have to do is compile the specific and the other standardized PFMEAs and Control Plans. This results in a lot of time savings and more focus on the new product/process. It also facilitates more effective documentation and easier control of documents.
Regarding how to do the FMEA, you definitely need to do it using a team approach; not only is more effective but it is also a requirement in some standards (I believe TS16949). Define the scope of the FMEA (where the process at hand starts and ends) and stay within the scope, otherwise you'll be wondering all over the place. As a team, you can always decide to narrow the scope (i.e. look at sub-processes within a process) if the FMEA seems to expansive or to expand the scope (look at the higher process) if you feel the FMEA is not clear enough. The RPN should be consistent within the group because it is the result of a group consensus. The individual ratings might vary from member to member because of everyone's perspective, but try to use hard data whenever possible and follow the established rating criteeria (per FMEA manual or approved by your customer). This ensures most accurate RPN calculations. Also do not hesitate to argue the RPN values and the need for action with your customer. It is very easy to get an RPN over 100 using the latest AIAG FMEA criteria; however many customers ares till stuck about 10 years ago in time when the criteria was less specific and more subjective. Back then most customers demanded that action is taken for every RPN over 100, which is unrealistic today. From my experience, nowdays many companies are taking actions on RPNs over 150 based on the current ratings.
Whatever approach you use, always follow this sequence: process flow diagram -> PFMEA(s) -> Control Plan(s). One step feeds into the other and cannot me mixed, although some can overlap (like PFMEA and Control Plan).