Informational How to develop a Control Plan from a PFMEA (Process FMEA)

2

20131011a

#31
Hi all,


Wow, finally i found a site / forum with experts on the FMEA subject, and all related stuff.

I searched the forum for some answers, and i got a lot out of it, but I still haven't found something.

My company has bought dedicated FMEA-software (APIS) and want me to help them implement this software. But before that can happen, they want to know what the (potential) users of this software need concerning FMEA's, control plans, FTA's etc.

Does anyone have any answers?

Greetings!
 
Elsmar Forum Sponsor

Kales Veggie

People: The Vital Few
#32
Welkom Arthur.

All users need solid training and be competent in creating FMEAs. (we often say garbage in / garbage out).

I suggest to focus on FMEA training. Control plan will flow naturally from a well done FMEA.

FMEAs should be done early in the design process, starting with Design FMEA (following ISO 9001 product realization clause). The biggest gains and improvement can be made here.

FMEAs are about risk to the customer and to your company.

FMEAs are team work. (not done by a single engineer behind the computer screen).

FMEAs are living documents and should be updated when processes change and new failure modes are found.

FMEAs should be reviewed / analyzed when problems are found (such as customer complaint, major scrap). Is the current problem a know failure mode or is it new? Are the controls working? Are they in place? Did we underestimate the risk?

FMEAs should reflect the process from "raw material" receipt to shipping the product (including labeling, storage).

FMEAs are not documents that we create and maintain because the customer or management wants it.

I am not familiar (anymore, ben sinds 1992 in Amerika) with Dutch training organizations, but there are other Dutch "covers" who might respond.
 

Stijloor

Staff member
Super Moderator
#33
Hi all,


Wow, finally i found a site / forum with experts on the FMEA subject, and all related stuff.

I searched the forum for some answers, and i got a lot out of it, but I still haven't found something.

My company has bought dedicated FMEA-software (APIS) and want me to help them implement this software. But before that can happen, they want to know what the (potential) users of this software need concerning FMEA's, control plans, FTA's etc.

Does anyone have any answers?

Greetings!
Hallo Arthur,

Zoals Kees al zei, er zijn FMEA cursussen verkrijgbaar in Nederland en Belgie.
Ik raadt het zeer sterk aan. Hier is een link. Er zijn er waarschijnlijk meer, Google maar....

Veel geluk!

Hello Arthur,

As Kees stated, there are FMEA courses available in The Netherlands and Belgium.
I recommend it strongly. There are probably more organizations that offer these, just Google.

Good Luck!

Stijloor.

Disclaimer: I am not associated with this training organization.
 
2

20131011a

#34
Ha allen,

Dank voor jullie reply's. Gelukkig wordt hier ook serieus gereageerd. (ik had niet anders verwacht).

Het probleem is niet eens zozeer FMEA-methode. Wat Kales Veggie schreef wist ik in grote lijnen al.

Ik zal wat meer info geven over waarom ik deze vraag stelde. Ik werk als afstudeerder bij het bedrijf dat FMEA's gebruikt. Zij willen graag IQ FMEA (APIS) invoeren. Ze hebben het pakket reeds gekocht.

Nu is mijn taak om gebruikerscriteria en bedrijfscriteria van gebruikte documenten van de FMEA-methode in kaart te brengen en hierop een werkmethode te ontwikkelen en te implementeren.

Ik heb me daarom verdiept in de FMEA-methode, en alles wat Kales Veggie schreef heb ik ook geconcludeerd. Daar bovenop vind ik dat het bedrijf niet slim heeft gehandeld om meteen zo'n lastig te gebruiken softwarepakket aan te schaffen. De reactie van het bedrijf was daarop dat ze dit toch wilde gaan gebruiken, en dat ik dus nu die criteria moet gaan opstellen, met de bijbehorende implementatie van de werkwijze.

Maar ik denk bij mezelf:
- waarom is er niet nagedacht over deze criteria alvorens het softwarepakket te kopen?
- kan ik überhaupt wel gebruikerscriteria en bedrijfscriteria in kaart gaan brengen als ze niet weten hoe het pakket werkt?
- Is het niet gewoon een kwestie van doen, of training inkopen bij de softwareleverancier?

Mijns inziens heb je gewoon een goede training over FMEA's en aanverwante zaken nodig, daarna bepalen welk softwarepakket je wil op basis van wat je gebruikers aangeven, en daarna het gewoon gaan DOEN.

Dus om concreet terug te komen op mijn hulpvraag: wat zijn nou typische gebruikswensen van gebruikers die de FMEA-methode doen?

Groeten, Arthur

________________________________________

Hello all,

Thanks for your reply's on my question. Thankfully, in this Forum there are serious reactions! (I didn't expect otherwise)

The problem I am facing doesn't concern the FMEA-method in general. What Kales Veggie wrote, I already knew a bit.

I will provide some additional info about my original question. I am graduating at the company who works with FMEA's. They have already bought the IQ-FMEA (APIS) software, an want to start working with it.

My job is to analyse and collect user and company criteria regarding FMEA and related documents (S/D/PFMEA, control plan, inspection plans, Flow charts etc. etc.. Afterwards, I have to come up with a working method and implement this working method.

I have dived into the FMEA-method, and concluded all things that Kales Veggie wrote. On top of that, I think that the company made a mistake of buying such a difficult program at forehand. (don't know if this is a correct translation, but I think you'll understand) I told them that, but they still wanted to use this software.

But my concerns are the following:
- Why didn't they think about those criteria before they bought the software?
- Is it even possible in general to formulate user and company criteria, if they don't know how the program works?
- Don't they just have to DO the FMEA, and use the program, or buy advice or training from the supllier of the software?

I think that the only thing you need is a thorough training about FMEA's and related topics. Afterwards, you can decide what kind of software program you need, based on your experience and/or wishes. And then just DO the stuff you need to do.

So my question is: what are typical user/company criteria of the FMEA-method, which you need to asses before you start working with a software program?

Thanks in advance!

Arthur
 
I

immokalee98

#35
This is a great thread!!! i'm in the process of creating control plans for automotive interior parts and this will be a big help. However, it's like pulling teeth to get my Engineering group to help with Process Flows and PFMEA's.
 

qusys

Trusted Information Resource
#36
This is a great thread!!! i'm in the process of creating control plans for automotive interior parts and this will be a big help. However, it's like pulling teeth to get my Engineering group to help with Process Flows and PFMEA's.
My suggestion is to follow the requirements of ISO TS. Based upon the request of your customer, try to understand if there is also the need of prototype control plan.
The last part of ISO TS says that it is also allowed to have a control plan for family part. SOmetimes this chance is not caught and the organization produce only documents as a burden.
Multidisciplinary approach is key and fundamental to formalize process flow, Fmea and control plan. If you are also responsible for product design, DFMEA is another requirement for you. I do not know if you have ISO TS certification or you have a plan to get certified. I am saying this because there are also room for you to have MSA for equipment and tool reported in the control plan as well.
Pls, let us know how the job will proceed. The forum is full of advice and expert Cover will surely provide support and precious advices for your project.
:bigwave:
 
D

dviking

#37
Re: Develop Control plan from PFMEA: how to?

Has anyone ever developed a matrix detailing if your RPN value is X then your sample size and frequency on the control plan needs to be Y?
 
D

dviking

#39
The product produced is assembly rich and labor intensive and yes it can be sampled. A few processes involved in the assembly can be error proofed but final assembly can not.
 
D

dviking

#40
My thinking is if a failure mode PFMEA produces an RPN value greater than 100, then sample size and frequency on the control plan needs to be at y and z. I can probably back into it based on the Occurrence value but I would like to use the whole RPN value. We currently do not use SPC because the processes themselves do not provide much variable data. It is mostly a visual inspection based.

This is a cut & sew process incorporating foam filler, injection molded bases, gluing, and upholstery.
 
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