PFMEA for manufacturing - Please review my Process FMEA

A

Annette

#1
Historically, our company has created the PFMEA's listing every dimension on a print. We do not get the DFMEA from our customers, yet we are very vague with the failure mode. They have passed PPAP submissions to the Big Three, but I don't feel that there are correct. I am looking for some advice as to how they should be addressed.

Thanks,
 

Attachments

Elsmar Forum Sponsor

Caster

An Early Cover
Trusted Information Resource
#2
Some quick thoughts

Annette said:
Historically, our company has created the PFMEA's listing every dimension on a print. We do not get the DFMEA from our customers, yet we are very vague with the failure mode. They have passed PPAP submissions to the Big Three, but I don't feel that there are correct. I am looking for some advice as to how they should be addressed.Thanks,
Hi Annette

I have no doubt that the Big 3 accept this as is. However, someday you may get a knowledgeable SQE or auditor. It happened to us and we are still trying to get an acceptable FMEA together.

I see very low RPNs, can you defend these numbers with data? Or are they set low so no action is needed? Hey - we do it.

On that point, there is not a single improvement activity arising from the FMEA. Are your PPMs zero? If you ever had a return, the FMEA should have been reviewed and revised. What is the point of FMEA? There should be some improvement actions IMHO.

Finally this is a PART FMEA, not a Process FMEA. Machines make dimensions, where are the speeds, feeds, coolant, CNC programs, tool break detectors, first offs, etc?

Where are the move operations (do you get handling damange?)

We got hammered on our last audit for this same thing. Part focused, not process focused.

Ford has a really detailed FMEA handbook if you have access to their supplier portal.

All this said, it may be a tough sell tying to improve on this if the customer already buys it. Good luck, I'm keen to see what others have to say.
 

Helmut Jilling

Auditor / Consultant
#4
I agree with Castor

I agree with Castor's comments. Also, the date on this FMEA is 2003. Any revisions should include bringing the scoring into the range the 3rd ed. sets forth. Most Big 3 customer SQE's require it nowadays.

To get a Detection of 3 would require everything to be error-proofed. Not very likely, I assume.
 
B

Bill Ryan - 2007

#5
Caster said:
Finally this is a PART FMEA, not a Process FMEA. Machines make dimensions, where are the speeds, feeds, coolant, CNC programs, tool break detectors, first offs, etc?

Where are the move operations (do you get handling damange?)
This is the methodology we use and I will argue that Annette's PFMEA does address the Process. I agree with you that it probably needs more depth in regards to the Potential Causes (as you listed), but when carried over to the Control Plan, the Causes will/should show up in the Process Characteristics column - which is where they belong. The Failure Modes will/should show up in the Product Characteristics column - which is where they belong. I've gone through too many excersizes with arguments (read: wastes of time) on whether something is a Mode or a Cause and this methodology (Mode=measureable on the product and Cause= measureable in the process) certainly gets that out of the way.

I also concur that ratings appear to be a little on the low side and all processing steps/actions don't appear to be detailed.
 
Thread starter Similar threads Forum Replies Date
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
O PFMEA - Reducing Severity (S) Ranking - Manufacturing Process Design Changes FMEA and Control Plans 4
N PFMEA for Non-Manufacturing Processes such as audits, direct procurement, etc. FMEA and Control Plans 5
G Manufacturing -> Warehouse -> Tier 1/OEM - Process flow, PFMEA, & Control Plan FMEA and Control Plans 9
P Is PFMEA for Manufacturing and Assembly Processes Only? FMEA and Control Plans 11
P Equipment URS, pFMEA and dFMEA ISO 14971 - Medical Device Risk Management 3
W Pfmea function requirement and failure mode FMEA and Control Plans 6
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 1
M Material incoming to the production process reflected in PFMEA FMEA and Control Plans 9
R Power Failure or Cold Start Situation in PFMEA FMEA and Control Plans 6
M "Issue & continuous improvement" columns in AIAG-VDA PFMEA form FMEA and Control Plans 4
C AIAG-VDA PFMEA - 1st special Characteristics? [5step vs. 6step] FMEA and Control Plans 3
T Linking Control Plans and PFMEA's FMEA and Control Plans 3
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
R DFMEA/PFMEA mitigation of high severity (9-10) in low volume products IATF 16949 - Automotive Quality Systems Standard 1
T Annual Validation as a detection mode on a PFMEA? FMEA and Control Plans 5
P Understanding DFMEA and PFMEA - Supplier Related IATF 16949 - Automotive Quality Systems Standard 21
D Can PFMEA be used in disposition of NC material? ISO 14971 - Medical Device Risk Management 4
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
V Customer Print Specifications on PFMEA FMEA and Control Plans 13
blile Increasing PFMEA occurrence ranking after non-conformance FMEA and Control Plans 4
A PFMEA new AIAG FMEA and Control Plans 0
Q Is that any difficulty to do software DFMEA and PFMEA in ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 5
bobdoering Informational New AIAG PFMEA Process - Excel Template Attached FMEA and Control Plans 23
A Redesigning our process flow chart, PFMEA and Control Plan Process Maps, Process Mapping and Turtle Diagrams 4
A PFMEA English language question IATF 16949 - Automotive Quality Systems Standard 4
S Is there any connection between PFMEA and Acceptance Plan FMEA and Control Plans 1
K PFMEA (Process FMEA) - Can be common for 3000 products? FMEA and Control Plans 2
N PFMEA repetitive failure modes in subsecuent stations. FMEA and Control Plans 1
T DFMEA/PFMEA and SCCAF alignment FMEA and Control Plans 19
N Control plan evaluation methods - Which methods should be carried over from the PFMEA? FMEA and Control Plans 3
A PFMEA - How long should the recommended actions remain in the recommended actions column? APQP and PPAP 3
S How to fulfill PFMEA "requirement" column? FMEA and Control Plans 2
T Informational Family or Baseline PFMEA Rules FMEA and Control Plans 22
A PFMEA severity score different applications FMEA and Control Plans 11
M Control Method correspondence between PFMEA and CP FMEA and Control Plans 8
O Difference Between PFMEA & Control Plan FMEA and Control Plans 3
N In-Process Production Test Stations in PFMEA (Process FMEA) FMEA and Control Plans 18
W Is the RPN (risk priority number) in the PFMEA really a RPN without the detectability ISO 14971 - Medical Device Risk Management 4
I Making a process PFMEA, no DFMEA (non-automotive toll manufacturer) FMEA and Control Plans 1
Proud Liberal DFMEA / PFMEA linkage - Where in the standards do I find it? FMEA and Control Plans 5
N PQC (Product Quality Characteristics) and PFMEA FMEA and Control Plans 3
N PFMEA Potential Failure Mode for Weight FMEA and Control Plans 5
M I need a sample Reverse PFMEA Process Checklist FMEA and Control Plans 2
C PFMEA example with machining (lathe+mill) FMEA and Control Plans 1
L Simple Example for PFMEA / Control Plan Training Training - Internal, External, Online and Distance Learning 1
B Proactive efforts to reduce risk - PFMEA risk reduction activities IATF 16949 - Automotive Quality Systems Standard 8
N PFMEA no effect ratings FMEA and Control Plans 15
N DFMEA, Drawings and PFMEA of an Assembly Process FMEA and Control Plans 12
A PFMEA for DC Motor FMEA and Control Plans 5

Similar threads

Top Bottom