Process Failure Mode Effects Analysis (PFMEA) Basics

S

sureshramadurgam

#1
Hello every one out there,

i am new to this discussion forum.dont know whether i am posting this question to all. but my request is please help me in preparing PFMEA and control plan for the company which i am working. This is my own initiativeness to prepare fmea and control plan for the company.please help me i am in the begining stage.
 
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T

Tom W

#2
Re: process failure mode effect analysis

Well welcome to the Cove...

If you complete a search for FMEA and/or Control Plan you will find an incredible amount of information on both. Click on the search feature in the blue bar above the forum and you should be able to find what you are looking for. Please make sure to ask more questions if you do not understand or cannot find what you want.

I am sure a moderator or two can help you get started.

Again - welcome and come back often.
 

Stijloor

Staff member
Super Moderator
#3
Re: Process Failure Mode Effects Analysis (PFMEA)

Hello every one out there,

i am new to this discussion forum.dont know whether i am posting this question to all. but my request is please help me in preparing PFMEA and control plan for the company which i am working. This is my own initiativeness to prepare fmea and control plan for the company.please help me i am in the begining stage.
Hello and welcome to The Cove Forums! :bigwave::bigwave:

Thank you for your post.

I did an advanced forum search on PFMEA and found this.

I also found some documents in the Post Attachments List. Look here.

You may want to start there. If you have some specific questions about PFMEA, please post them here. We are happy to help. And you may be able to assist others. We're all about sharing knowledge and experience here. :agree1:

Hope this helps.

Stijloor.
 
G

gholland

#4
One thing to remember is that in a FMEA you are looking for harms to the patient/caregiver. In the case of pFMEA you must assume that your design is perfect and that something in the process causes not only a failure but a failure that will cause a harm to your end user/patient.

You will want to take each step in the process separately and evaluate them in terms of 'what can make the output of the process harmful?' Your control plans will then be driven off of your FMEA results.

For example I had a project where a machine was cycling once every few seconds. A piece of the machine was sliding back and forth and had the potential to cause aluminum shavings. These shavings, while very small, could cause an embolysm if infused into the patient as the process that was considered had the potential to introduce these shavings into a fluid path. The FMEA identified this and drove a material change from aluminum to plastic for this part.

It is helpful to have a process flow diagram while doing this.

:2cents:
 

pmwong

Involved - Posts
#5
Hi,

It is also to have some of the basics:

1) A copy of the NEW APQP 2nd Edition and the FMEA 4th Edition Reference manual where you can learn from the start. (ensure that you know your customer requirements, whether you are using customer specified format or your own format ) as this is important.

2) Before preparing any FMEA and Control Plan, you will need to have a basic process flow of your internal process activities, which you can number from 1 to 10 for example.

3) Where to start? Start from process flowchart, follow by FMEA and then Control Plan.

4) You would need to specific your parts manufactured as different industries have differ failure mode and control points.

5) The rest can search at this forum for formats that you need :)
 
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