PFMEA (Process FMEA) Recommended Actions help

The Taz!

Quite Involved in Discussions
Recommended Actions? is there an easy way to do this?
Well. . . if I understand your post correctly, you only need to take recommended actions when 1) more information is needed or, 2) a High RPN requires a change

If there is no recommended action, state "None"

When an action is taken or improvement made, fill in the right side of the form with the Severity, Occurrence and Detection scores and calculate the new RPN.

IF I understand your post correctly. . .:confused:
 
S

Sandy S

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
 
J

JayJay

Phil and Sandy -

To properly perform FMEA, you need to consider WHAT you are evaluating - is it the Design of the product or the Process which makes it? FMEA is all about RISK MANAGEMENT.

Design and Process FMEA are very different in terms of what's evaluated - in a Design FMEA, you evaluate things from an engineering perspective and seek to ensure your requirements ARE DEFINED and ARE MET, or THE GAP between then. DFMEA helps with taking high-level requirements and flowing them down component-level requirements - it also ensures that you've evaluated how requirements are fulfilled. It ensures that if you set out to design, say a ballpoint pen, that you don't end up making a pencil instead. For molding injections - this would be things like specified hardness, color, rigidity, density, shape, thickness, etc.

In a Process FMEA, you're evaluating the process's ability to carry out the design and the ways you could deviate from the specified design. Here you're analyzing things like maintenance failures (leaks, lack of equipment, equipment breaks), inspection equipment failures, people failures, mixups, supply shortages, supplier failures etc.

If you already have a solid product design, start with the PFMEA - when complete, it will reveal a lot about your DFMEA.

Mark - your problems sound related to lack of a comprehensive rating scale, or one that is ambiguous enough to be meaningless.

To perform a PFMEA, start by:

1) Defining your processes - Scope, Inputs, Outputs; If you don't already have this documented, then do it. What are the boundaries of the process you're evaluating, what information/materials do you have to start the process, and what is expected when the process is complete. It's really good to be specific here - particularly with your outputs. Always reference internal specs where you can.

2) Define your RATING SCALE (I recommend 1-10 for Severity, and 1-5 for occurrence and detection) On a 1-10 Severity, 9 should always be Serious Injury or Death WITH warning (there is some detection), where a 10 would be WITHOUT warning (there is no detection). Send out the rating scale before having FMEA meetings

3) Pre-Plan your FMEA meetings with a defined time and set one person as the facilitator/moderator - above all other creative input, this person's main job during the meeting is to keep it focused and end on time. Start by allotting 30-45 minutes per process with the intent of being broad and complete like a sketch rather than a high-definition photo.

4) Dig up any internal / external customer complaints, nonconforming material, corrective actions, design changes, process changes, material changes, etc. and bring copies of them to your FMEA activity meeting - use them as inputs - and show how these actions affected the risk (by increasing or decreasing it).

5) Maintain your FMEA documents - they are a living and breathing document which rationalizes "The Way of Thinking" - Risks are OK, so long as you know what they are. When your team identifies new risks - add them to the FMEA - when you change the process - evaluate and update your PFMEA if you reduced or changed a risk and most importantly to ensure you haven't added new risks that went unnoticed.

You won't be able to correct your FMEA activities overnight - unless it's already done and just your rating scale needs an update or review. Other than that, it's an ongoing process that should be triggered by things like design changes, process changes, nonconforming material, management reviews, etc.

Please feel free to contact me privately if you need assistance - I have several forms that would help you if I knew your specific needs, and would be happy to help any way that I can.

Sincerely,

JayJay
 
J

JayJay

I would also add to this that you need to ensure that your FMEA team is on board with being totally objective and honest - DO NOT mitigate your risks by knowingly reducing a severity, occurrence, or detection rating simply because you're afraid of the number - the number is meaningless - at the end of the day the only thing an FMEA is going to tell you is what effects and causes are your RISKIEST in relation to each other - it's not saying that any cause or effect is sure to happen at a pre-determined point.

Recommended Actions DO NOT have to be carried out - You can always recommend an action to reduce a risk but it may not be worth it - or may not be realistically possible. You should, however, determine the threshold for which risks you will recommend action for; this could be related to the RPN, the cause, effect, severity, occurrence, or detection, and any combination thereof.

There is no product in this world that does not have some type of risk associated with it - even if the person has to be a complete idiot, moron, senseless individual to make it happen - the job of the FMEA is not to purposely mitigate these things to try and prove they don't exist - it's to ensure that you ARE aware of them and to detect just what level of failure (or stupidity, negligence, etc.) would be needed for the cause/effects to occur.
 
B

bluepagen

Jay Jay, would you consider sharing your forms with othes. I am working on the risk requirements and a risk register for our company to help with the compliance for the New API Q1 9th edition. We just went through and ISO audit, and the auditor, who came from the aerospace industry suggested the PFMEA.
Today is the first day I started looking for information on it, an in the first thread I read, I see you seem to have knowledge that perhaps you would share. If so, that may be a huge help for not only the ones involved in the thread, but others that are also facing the same issue.
Please advise.
Thanks for your post.
 
T

TShepherd

Recommended Actions? is there an easy way to do this?
Hello Pilliswinning -

Your question may not be specific enough to provide specific answers - and in addition to that - the responses may vary due to the issue of each customer enforcing thier own requirements in reference to P/FMEAs.

I agree with every word that JayJay posted, however it may be a little overpowering to be emersed with so much information at once.

You did note that your question was in reference to a P/FMEA and you suggested that a severity rating of 1 would mean no impact whatever.

Just as JayJay pointed out - that rating of 1 only has meaning in relationship to other severity ratings within the same P/FMEA - but it does carry a wieght which can only be determined by your organization with guidlines from your customers.

I would suggest that a more indepth understanding would serve to help you in a meaningful way.

Perhaps a forum or group to walk through the building of P/FMEA?

Best of Luck - Tom
 
J

jerome_mecphils

Should PARETO can greatly help to assign ranking SOD?,,how can i understand this method
 
G

gmsqengineer

Hello I guess my question goes along the same lines. What do you do once you have completed recommended actions and data has been gathered to prove that it works? Do the recommended actions remain on the PFMEA or do you roll it over and update your requirements making the Action taken the new requirement?

Thanks for the feedback
 

Jim Wynne

Leader
Admin
Hello I guess my question goes along the same lines. What do you do once you have completed recommended actions and data has been gathered to prove that it works? Do the recommended actions remain on the PFMEA or do you roll it over and update your requirements making the Action taken the new requirement?

Thanks for the feedback

There should be a record of the actions taken, so I generally favor leaving the Recommended Actions where they are, along with the recalculated RPN. They can be come Current PRocess Controls for similar products.

In the end, how you do this is up to you so long as a FMEA for an active product shows the current stated of affairs.
 
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