Draft of Elements of System FMEA

T

Taliesyn

#1
I'm trying to put a system FMEA together and I'm stuck. I'm used to PFMEA so taking that "pace backwards" to look at just the processes is a little difficult. I attach a file which is where I've got to over the past week or so and I'm throwing it out to you guys for your comment/trashing/support or whatever! I'm trying not to get too hyperdetailed and record absolutely everything that can go wrong but is ridiculously unlikely. What do you guys think of it so far?
Thanks
 

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TPMB4

Quite Involved in Discussions
#2
Interesting document. I've not really thought of doing a FMEA for elements in our system. Don't know why but it never crossed my mind. Of course I use FMEA for individual processes required for producing our products but not the system.

Thank you for posting this. I think it is looking good but you will need to wait for someone more knowledgeable and experienced than me to comment.
 

whtan02

Involved In Discussions
#3
I thought System-FMEA is more related to Quality system, such as APQP, PPAP system as a whole, rather than HR related functions. I have experience in Design-FMEA, & I hope to learn more as well in System-FMEA.
 
T

Taliesyn

#4
The idea is to add a risk management element to the audit process. I'm used to DFMEAand PFMEA related to either a specific product or a manufacturing process but I rolled that over to the functions that are also covered by TS - such as recruitment, training, purchasing etc.
I really am struggling with this so any help would be gratefully received! Thanks y'all!
 
A

adamsjm

#5
The idea is to add a risk management element to the audit process. I'm used to DFMEA and PFMEA related to either a specific product or a manufacturing process but I rolled that over to the functions that are also covered by TS - such as recruitment, training, purchasing etc.
I really am struggling with this so any help would be gratefully received! Thanks y'all!
Can you define the scope of your activity in precise terms? Are you wishing to write a "TS16949 / APQP" system FMEA's and Control Plan to better understand the cause of failure to your company's QMS and control / prevent their occurrence, or are you describing something else?

I applaud your effort, but while filling in the details of a System FMEA with process and design knowledge is a useful and beneficial activity, you must be cognoscente of the concept:
Failure Mode equals "anti-Requirement", but
Requirement does not equal "anti-Failure Mode".

You may need to go back to the Customer QFD to understand the essence of the Requirement, perform a "system" level Requirements QFD and DFMEA, before cascading the Requirements into "lower level" TS/ISO/APQP elements and performing the proper level of PFMEA & Control Plan for integration into the System.

IMHO, if your desire is to write a "TS16949 / APQP" system FMEA's and Control Plan to better understand the cause of failure to your company's QMS and control / prevent their occurrence, this would be my approach.

You should be able to have capable QFD & FMEA facilatators within your corporation to support your efforts.
 
T

Taliesyn

#6
Guys
After reading one of the other threads about system FMEA, I suddenly realised that we are all talking about different things! I'm talking about, for example, what functions go on within the HR department (recruitment, training, etc.), what can go wrong, what effects those failures can have and what do we have in place to prevent/detect the failures.
I don't mean system as in the door panel assembly as a "system", rather the activities that make up the QMS as a whole - at quite a high level.
If that makes it any clearer for you guys, then can someone come back to me. I've never seen this anywhere else and, to be honest, I am doing this to help myself with the audit planning - risk assessing the various departments who have what I believe are the "significant" elements of TS under their jurisdiction and control.
Thanks - and over to you!! :)
 

insect warfare

QA=Question Authority
Trusted Information Resource
#7
I'm trying to put a system FMEA together and I'm stuck. I'm used to PFMEA so taking that "pace backwards" to look at just the processes is a little difficult. I attach a file which is where I've got to over the past week or so and I'm throwing it out to you guys for your comment/trashing/support or whatever! I'm trying not to get too hyperdetailed and record absolutely everything that can go wrong but is ridiculously unlikely. What do you guys think of it so far?
Thanks
I think this would be a good tool under the right set of management, but have you considered the resources that you will need in order to maintain and keep this up (for review, update, re-evaluation, so on and so forth)? Any FMEA is a living document (therefore it is a continuing activity), and the accurate assessment of each individual item is highly dependent on several things - such as: subject matter expertise, a willingness to be impartial and unbiased in assigning judgments, and sometimes even cross-functional input because (as we all know), processes interact with each other, and sometimes on a deeper level than we are prepared to understand.

Will you have these resources available at the appropriate junctions, every time? If so, then I applaud you for your efforts, because that valuable input will be the water that feeds the tree. Without their continuing support the leaves will wither, the branches will weaken and the tree will eventually die.

Take this into consideration and good luck....

Brian :rolleyes:
 
A

adamsjm

#8
Taliesyn,

You stated that you wanted to know ?? what functions go on within the HR department (recruitment, training, etc.), what can go wrong, what effects those failures can have and what do we have in place to prevent/detect the failures.?
I believe that I was answering that specific question along with the others which constitute a QMS.


BEFORE a PFMEA can be conducted, the design requirements must be defined and a process flow diagram or VSM must be proposed to understand what process needs (requirements) are necessary to meet the interaction of design requirements and process flow.
[Please use the AIAG form H for the starting point of your PFMEA development in order to separate design requirements from process requirements. This helps later on when identifying Failure Mode causes related to the process (i.e. The HR System).]


As I stated my earlier post;
Failure Mode equals "anti-Requirement", but
Requirement does not equal "anti-Failure Mode".
Therefore, this means system?s design requirements (which are documented in the ?Product Requirements? column) must be identified before any worthwhile PFMEA can be conducted. This leads us back to ?guided? QFD activities with the ?responsible? department (i.e., HR). I say ?guided? because as an experience quality professional, I (you/someone) have experiences from HR failure modes. This allows me to ask questions to start the requirement discovery process via the SIPOC or COPIS process.


First:
Who are the customers and who are the suppliers of the ?HR system.? [Note: People or functions can be both suppliers and customers at different times and levels of engagement.]
A potential list:
The ?willing worker? / production associate
HR Training
HR as ?willing worker? advocate
HR as ?willing worker? needs provider
- Pay rates
- Pay for performance (Hopefully never - Performance is a system result and, therefore, PONC must be responded to by the offending QMS system.)
- Meeting socialization needs
- Pay for knowledge
HR as talent acquisition provider
- ensuring diversity (All from the same school <death within engineering>? How many left and right handed people are necessary to handle left and right handed operations? Fine motor control? Sight/color/hue requirements, 100?s of other operation specific requirements.)
- Who will define & provide the requirements and when will they provide them to HR-talent acquisition?
- What is their process for doing this type of work?
Literally thousands of questions with requirement/failure mode/cause answers will be discovered just within the HR section of the QMS. Other groups may add more or less than the HR department does as you continue developing your workbook.


Moving on to the PFMEA.
Training is a preventive action whose failures are system driven, never is it a detection control. Therefore, retraining is never a viable CAR response.
Process issue: A worker cannot train the next worker who trains the next worker. A (one) trainer or methodology must be in place to train workers ? undocumented instruction leads to disaster. This is the basis for Deming?s forth funnel experiment (out of control from the start and is not recoverable.)


Constructive comment: you are placing too many actions/ideas in the non-requirement cells of the FMEA. An example: ?Personnel not empowered, motivated, developed or retained? is not a failure mode but four failure modes; 1) Personnel not empowered, 2) Personnel not motivated, 3) Personnel not developed, and 4) Personnel not retained. This will help in identifying some specific causes that may otherwise go unnoticed during a broad grouping.


OBTW: relative to ?4) Personnel not retained? ? what turnover rate does your company desire? Jack Welch of GE wanted a minimum of 5% per year and implemented ?2) Personnel not motivated? activities to get 5% per year to leave. Long term company viability is based upon controlled growth and reduction of the workforce, not early retirement or massive layoff programs to meet budgetary constraints.



Just remember:
Failure Mode equals "anti-Requirement", but
Requirement does not equal "anti-Failure Mode".
 
S

Sandy S

#9
I have a question for anyone.... I ave recentley started a new company. When reviewing the FMEA it is terrible. We have things like wrong material with a 1 ranking.... as if it means nothing.. would have no impact... I know a joke. Saying that you can see I am going to have to start from ground and build it up. We are an injection molding company. Therefore, our processes are primarlly the same. I understand each component will have unique characteristics. However we have hundreds of parts. No way I can attack thi from part by bart basis. How do I begin? Do I begin with new items that are general common molding defects? And then start from that foundation with each new PFMEA thereafter? Confused on where to start!!!!

Thanks
 
A

adamsjm

#10
Hi Sandy,


Welcome to the Journey. You have passed the first hurdle by recognizing that your PFMEA?s are useless and you are willing to start over with an improved process. I was lucky enough to be in your position years ago with a very good company who wanted to be the best. Within a few years they became world leaders in cost and quality for injection molders (~2.3 PPM while producing 220MM pieces per year consisting of 1400 different part numbers using 80 different compounds.) The APQP Teams could produce a new, custom PFMEA within 2 hours. It took a while to get there, but it was not an overwhelming task.


First, study the AIAG APQP Manual?s Supplement A - EQUIPMENT: SET-UP DOMINANT PROCESS: The process is highly capable and stable, therefore set-up is major variable impacting product variation. It explains the concept behind a ?Process Controlled? type of PFMEA which injection molding falls under.


Next, identify a standard, common, higher volume part that your company produces. Begin with a listing of the parts requirements from the blueprint(s), engineering specification(s), customer?s quality, shipping, & purchasing manual(s). Identify any and all requirements. While useful for the part layout PPAP requirement you do not need to identify all of the molding dimensions as they are controlled by the mold itself.


Create 5 columns in a spreadsheet labeled: 1) Process step, 2) Process Requirement, 3) Requirement ID, 4) Product Requirement and 5) Process Requirement. Place that list produced above in the 4th column. Now, across the top place the process steps that are required to produce the product, everything from receiving material to setting the mold to 1st piece inspection to last piece inspection to shipping (on the truck) [A shipping requirement may be that it shipped via ?air-ride? truck.] You are producing a level 3 QFD characteristics matrix. At each intersection of requirement and requirement producing process place the process step ID in the 1st column; the general Process Requirement being produced at that Process step in the 2nd column; a Requirement ID (print balloon number, Engr. Spec ID, etc.) in the 3rd column.
The 5th column is where you place the specific processes, forms, set-up parameters, etc. to produce the product requirement(s) associated with that particular step. Wa-la, you have now produced the first 5 columns of the AIAG Form-H PFMEA for Process/Set-up dominate processes. [Note: if your company does not have a predetermined PFMEA package, I would begin with MS Excel as it is flexible and allows you to understand your company?s process before a large investment in a fixed package. Systems2win?s FMEA2 and other templates are an excellent starting point for training in proper techniques while performing activities.]


You will identify molding process/product requirements such as: Shorts, Flash, "(Material) Contamination", Splay, Warpage, "Stress Cracks / Knit Lines", "Grease or Mold Protectant", "Broken or Pushing Ejector Pins", Gate Vestige, Blisters, Breakage, Strings, ?Delamination?, Sinks/Voids, Gas Burn, Wrong Material, Color, Frost, Shine, Texture, Scratches, Scuffs, White Marks, Gate Blush, Knit Lines, Correct Date Code, etc. depending upon the type of parts you produce.


Hot runner vs. cold runner, re-grind amount and mixing process, machine set-up and documented adjustments, compound dryness, etc. all effect the molding process step. There are literally hundreds of items to identify and control.


Next, you must conceive the concept of a Legacy / Master / Standard PFMEA. What are common and specific caused of failure, prevention and detection. Common are reused in future PFMEA?s. Keep them in your Legacy / Master / Standard PFMEA for future use.


The next big step is working on your Process error symptoms, 5-Why, CAR/PAR reporting system to qualify occurrence and detection levels.


There are many other tricks to produce Process Step diagrams, PFMEA?s, and Control Plans simultaneously with all product knowledge in a couple of worksheets (with Excel 2007 & above), with the help of a few macro buttons. You will need to conceive of variable substitution in your requirement and control ?cells? for that level of integration. The company described above did this using Excel 2000 and paper so it can be done without expensive tools.


Good Luck on your Journey.
 
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