FMEA as a Live Document

E

Enrigh04

#1
Hello all,

Reading a number of the posted threads on the topic of risk mangament / FMEAs there seems to be a lot of experience and knowledge... I am hoping to draw on some of this.....

I am in the process of developing a risk managament system for a elctonic production process. Currently we have defined the procedure on how to best appraoch a PFMEA (Process map / IPO linking directly in the PFMEA etc..).

As stated over and over again, an PFMEA on it's own is typically a paper exercise. I need to take the next step and develop it into a living process which evolves with the business. My problem is the sheer volume of PFMEAs and how to keep them live.

What is the experience of others? Is it simply a case of take them one by one and update as you go, or is there a proven systematic approach? What approach have others taken?

Any comments and opinions would be great.
 
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Stijloor

Staff member
Super Moderator
#2
Welcome to The Cove Forums! :bigwave: :bigwave:

You stated "...the sheer volume of PFMEAs...." Have you considered reducing this volume of PFMEAs? PFMEAs for families of parts are possible when they share a common process.

As long as the part(s) is (are) active, you need to maintain your PFMEAs.

You need to update the PFMEAs as the manufacturing process changes, the assessment with respect to Severity (S), Occurrence (O) and Detection (D) change, or new information becomes available as a result of customer feedback, internal feedback and continual improvement activities.

Hope this helps.

Stijloor.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
<snip> I need to take the next step and develop it into a living process which evolves with the business. My problem is the sheer volume of PFMEAs and how to keep them live.
First is a database solution and second is links (inputs) from processes such as engineering change system, process change system, customer complaints, internal non-conformance investigations, etc.

Theoretically it would be a good idea to review each FMEA at least yearly (actually each part and process as well), but in many cases that's just not feasible.

Can you give us an approximate number of PFMEAs you have? "Sheer volume" is rather vague.
 
E

Enrigh04

#4
Thanks guys for the replies.

Being an electronic manufacturing process we typical have a large number of product families and product variants in the pipe line at any one time. As such, when reviewing and discussing the best appraoch to risk management we decided to develop process FMEAs rather than concentrate soleyproduct FMEAs. What i mean by this is each process step, be it screen printing , component placement etc etc gets it's own FMEA. The thinking behind this is that a detailed FMEA of each process will be "generic" enough to cover maybe 90% of all products.

Our long term appraoch is to complete all process FMEAs which could number up to 50 plus, and keep them live by integrating all process activities like weekly improvement meetings, porcess optimisation work etc. Our feeling is that a lot of good work is done by our technicans and engineers on a daily / weekly / monthly bases which may go unnoticed or localised to one production line. We want to capture this information to use as updates for FMEAs.

Not forgeting the product itself, each new product will have a shorter FMEA which will cover product specific item which the "generic" FMEA do not cover.

Not sure if this helps or confuses matter more. As i say, we have defined the best apprach to risk assemment, know we are look for a practical way to gather all "improvment work" to include in FMEA updates..
 

Stijloor

Staff member
Super Moderator
#5
Thanks guys for the replies.

Being an electronic manufacturing process we typical have a large number of product families and product variants in the pipe line at any one time. As such, when reviewing and discussing the best approach to risk management we decided to develop process FMEAs rather than concentrate soleyproduct FMEAs. What i mean by this is each process step, be it screen printing , component placement etc etc gets it's own FMEA. The thinking behind this is that a detailed FMEA of each process will be "generic" enough to cover maybe 90% of all products.

Our long term approach is to complete all process FMEAs which could number up to 50 plus, and keep them live by integrating all process activities like weekly improvement meetings, process optimisation work etc. Our feeling is that a lot of good work is done by our technicians and engineers on a daily / weekly / monthly bases which may go unnoticed or localised to one production line. We want to capture this information to use as updates for FMEAs.

Not forgetting the product itself, each new product will have a shorter FMEA which will cover product specific item which the "generic" FMEA do not cover.

Not sure if this helps or confuses matter more. As i say, we have defined the best approach to risk assessment, now we are looking for a practical way to gather all "improvement work" to include in FMEA updates..
The "lessons learned" as a result of your regular meetings can be captured in a database and sorted by (manufacturing) process. You can then decide which of these practices will be captured in the FMEA as a modified control and/or if assessment criteria need to be modified. The upkeep of FMEAs takes time but is well worth it. You may want to look at available FMEA software packages to speed up this process. Keep in mind however, that FMEA software does not replace the "hard thinking" process. ;)

Currently (if I understand you correctly), you have an FMEA for each of the operations (process steps). Keep in mind that risks exist in the transfer from one process to the next. Make sure that this is not overlooked in your current FMEAs.

Stijloor.
 

Chennaiite

Never-say-die
Trusted Information Resource
#6
Thanks guys for the replies.

Being an electronic manufacturing process we typical have a large number of product families and product variants in the pipe line at any one time. As such, when reviewing and discussing the best appraoch to risk management we decided to develop process FMEAs rather than concentrate soleyproduct FMEAs. What i mean by this is each process step, be it screen printing , component placement etc etc gets it's own FMEA. The thinking behind this is that a detailed FMEA of each process will be "generic" enough to cover maybe 90% of all products.
.
.
.
.
Not forgeting the product itself, each new product will have a shorter FMEA which will cover product specific item which the "generic" FMEA do not cover.

Not sure if this helps or confuses matter more. As i say, we have defined the best apprach to risk assemment, know we are look for a practical way to gather all "improvment work" to include in FMEA updates..
If my understanding is right, you have Process based PFMEA which is prepared comprehensively and then you have PFMEA for each Product, probably addressing the Potential Failure modes/risk that are specific to the product.

Now, coming back to your concern
Our feeling is that a lot of good work is done by our technicans and engineers on a daily / weekly / monthly bases which may go unnoticed or localised to one production line. We want to capture this information to use as updates for FMEAs.
I would normally recommend something called "Past trouble data base". This can be imagined as a big data base consisting of all Quality problems/Improvements(Process/Product Family wise) that are encountered in the past and then the corressponding causes and action taken. Every time when a good solution is concluded for a Quality problem or everytime when an improvment point is identified, be it during Morning Meeting or Multi Disciplinary meeting or Quality Circle or Monthly Meeting or after Corrective action, etc, the aforesaid document is updated. Later, when any PFMEA is reviewed, each point in the data base is studied for applicability and taken to PFMEA, if applicable.
 
E

Enrigh04

#7
Thanks all..

I guess there is no one quick solution to gathering and reviewing improvment data.

:agree:Your ideas confirm that i am on the right trial of thought.
 
M

mfenati

#9
:) Nevertless you're doing a good job, but consider by product family.
:confused: Indeed I'm a little bit concerned for the below statement
> "I would normally recommend something called "Past trouble data base".

FMEA (applied for both Design and Process) is a risk analysis method, there are several indeed.
So it should take into account the potential problems and consider those having an higher score. Once a risk has been selected and assessed maybe some actions feed the Control Plan, other risks removed or ignored.

Indeed the past troubles belong to the Problem Solving (G8D, KT, 5Ws, etc..) database, which n turn can feed both a Control Plan or rise attention to another potential risk.

Maybe I misunderstood the statement meaning, anyway I do not want to hurt the original poster.
Regards,
Maurizio
 
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