Generic Molding FMEA - Can some one provide me with an example?

Ragnar

Involved In Discussions
#1
Hello All! Can some one provide me with a sample of a molding FMEA. Our company molds (Injection) fascia for the big three. I'm hopeing some one can provide me with a list of potential failures within the molding process. Our molding techs insist the potential failures are very few, and the things I suggest with my limited (But not that limited) knowledge of the molding process can NEVER possibly happen, and yet they do and we have a parking lot full of scrap to proove it. Any help would be greatly appreciated.
Thank-you: :thanx:
Kindly:
Ragnar.
 
Elsmar Forum Sponsor
B

bgwiehle

#2
Ragnar said:
Hello All! Can some one provide me with a sample of a molding FMEA. Our company molds (Injection) fascia for the big three. I'm hopeing some one can provide me with a list of potential failures within the molding process. Our molding techs insist the potential failures are very few, and the things I suggest with my limited (But not that limited) knowledge of the molding process can NEVER possibly happen, and yet they do and we have a parking lot full of scrap to proove it. Any help would be greatly appreciated.
Thank-you: :thanx:
Kindly:
Ragnar.
A good way to start is to list the cause codes (reasons for scrapping material) used in your system. In other words, what defects were identified? What do your operators and inspectors look for when evaluating product? If ever a customer rejected product, how did they describe the problem? What criteria for good product are listed on the purchase order or prints?

We make rubber products so these failure modes may not be completely applicable but...

Incorrect/ off-spec. performance requirements.
Contamination (embedded particles raised marks, moisture).
Undercured / Overcured.
Nonfills (partially filled), flow marks.
Splits, tears (esp. if in critical locations).
Gas, blisters.
Part distortion.
Missing or wrong colour (where applicable).
Deformed or torn edge. Excess trim or gouging.
Rough edges, insufficient trimming.

B.G. Wiehle
 
B

Bill Ryan - 2007

#3
Ragnar - B.G. has a pretty good list to start you off. We die cast thin walled housings (mostly) and a lot of B.G.'s examples apply to our processes also. Let us know if you if you still need some help.
 
R

ralphsulser

#4
Would anyone be willing to share an example of a current PFMEA approved by TS and automotive? We have been using PFMEAs previously which were approved by our customer. However, during our TS16949 pre-assessment last week the auditor wrote a NC because we were not using the latest AIAG FMEA format addressing the additions for Current Process Controls-Prevention and actions taken. Looking at the AIAG manual, but it really does not provide clear info as to when and if this is always required.
Appreciate any help you can provide.
 
B

Bill Ryan - 2007

#5
Here's an example of our format - TS compliant. This is produced from a "relational database" software package. I do however have the format in an Excel spreadsheet also.

As you can see, some of the Failure Modes have a "Prevention" control and some do not. All, however, need a "Detection" control. If you'd like to see more of this PFMEA let me know (I didn't attach the entire 89 pages).
 

Attachments

Last edited by a moderator:

Jim Wynne

Staff member
Admin
#6
Bill Ryan said:
Here's an example of our format - TS compliant. This is produced from a "relational database" software package. I do however have the format in an Excel spreadsheet also.

As you can see, some of the Failure Modes have a "Prevention" control and some do not. All, however, need a "Detection" control. If you'd like to see more of this PFMEA let me know (I didn't attach the entire 89 pages).

I spend a good part of my working life reviewing PFMEAs from suppliers and doing PFMEA training. Although the original question had to do with format, I'm wondering if you would like some critical feedback on the document you posted, which could be helpful to others here as well.
 
B

Bill Ryan - 2007

#7
JSW05 said:
I spend a good part of my working life reviewing PFMEAs from suppliers and doing PFMEA training. Although the original question had to do with format, I'm wondering if you would like some critical feedback on the document you posted, which could be helpful to others here as well.
Always welcome and I invite others in on the critiqueing (sp?) also.

NOTE: At times, with some of our customers, emotion has come into the "discussions" (both theirs and mine :rolleyes: ). I do hope to keep that aspect out of whatever ensues.
 

Jim Wynne

Staff member
Admin
#9
Bill Ryan said:
Always welcome and I invite others in on the critiqueing (sp?) also.

NOTE: At times, with some of our customers, emotion has come into the "discussions" (both theirs and mine :rolleyes: ). I do hope to keep that aspect out of whatever ensues.
I hear you. The reason I asked was that I didn't want this to seem like an attack, especially on an individual or his work and there's nothing worse than unsolicited advice. I'll also disclaim by saying that this is only one page of an 89-page document, so the observations are limited to what I can see. Keep in mind I'm not suggesting that you should change anything; if you and your customers are happy, that's the important thing. And if you do change something your customers have already signed off on it could open a worm can that's better left shut. So this is really in the spirit of helping others, and you are to b e commended for allowing me to use your document as an example :agree1: .

The page you posted addresses receiving verification. I advise our suppliers to stick with potential failures that are caused in the operation in question. In other words, insofar as the PFMEA is concerned, I'm not especially interested in sub-supplier errors because they are not controlled by the receiving verification process. I want to see what can potentially go wrong in my supplier's process. In this case, it's possible that "bad" material may be accepted, or "good" material may be rejected. Depending on materials procedures, it's also possible to misidentify incoming material. I want to see the controls in place for those possibilities.

The other thing I noticed is that the potential causes listed are essentially the same as the modes. For example, the potential failure mode of "Sow chemistry inaccurate" is essentially repeated as the cause--"Supplier sent out of spec material." The first rule of thumb in PFMEA construction is that failures don't cause themselves. The problem here also speaks to my first observation; it's not possible to identify the cause because it's a sub-tier error; what I want to know is how that material is kept from being accepted (the potential failure mode of your process).

I'm very interested in general feedback on these observations. I'm not big fan of the AIAG/SAE PFMEA documentation, and I've developed a general strategy for job shops to use in their PFMEA processes which I believe is more effective than what AIAG asks for. I'm in the early stages of writing an article on the subject which I might post here in the future. Again in the spirit of helping others and making a small contribution to the BOK I appreciate your willingness to participate.
 
D

D.Scott

#10
I agree with your comments and look forward to seeing your full article when you finish it. I also agree that the AIAG documentation isn't a "one size fits all" strategy. As a job shop way down the supply chain we often run into problems trying to follow it.

Dave
 
Thread starter Similar threads Forum Replies Date
K Generic preventive maintenance form wanted Document Control Systems, Procedures, Forms and Templates 2
V Generic IATF 16949 Audit Checklist wanted IATF 16949 - Automotive Quality Systems Standard 3
V Generic ISO 50001 checklist Various Other Specifications, Standards, and related Requirements 6
N Generic Rework/Reprocessing Procedure Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
V Generic requirements regarding capability study in automotive Capability, Accuracy and Stability - Processes, Machines, etc. 1
M Is IEC 60601 compliance possible when only generic power-supply is specified? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S Family / Generic type of FMEA & Control Plan and Symbols FMEA and Control Plans 3
Marc The Risks of Generic Drugs Coffee Break and Water Cooler Discussions 24
R Connection to a generic separate power supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Marc Are you looking for ISO 31000 - Risk Management Principles and Generic Guidelines? ISO 14971 - Medical Device Risk Management 1
C Appropriate ways to address Competency? Generic vs Specific ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Marc Urine Spills Staining Image of Wockhardt?s Generic Drugs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Ajit Basrur FDA - Guidance for Industry - Generic Drug User Fee Amendments of 2012 - Q & A US Food and Drug Administration (FDA) 0
M Engineering Change Management Generic Procedure Manufacturing and Related Processes 3
D FDA MDDS - Listing Obligations for a Generic Data Interface US Food and Drug Administration (FDA) 3
R Do generic forms bought over the counter need to be controlled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Should the FSMS have a Documented Generic Procedure for Verification and Validation Food Safety - ISO 22000, HACCP (21 CFR 120) 2
T Generic Guides for Procedure Writing Document Control Systems, Procedures, Forms and Templates 20
S Draft Guidance on Generic Drug User Fee Amendments (GDUFA) 2012 Other US Medical Device Regulations 0
C Control Plan Template (Generic) Document Control Systems, Procedures, Forms and Templates 0
AnaMariaVR2 Generic Drug User Fee Act (GDUFA) US Food and Drug Administration (FDA) 0
I Question on Declaration of Conformity for device subcategory or generic device groups EU Medical Device Regulations 2
P Generic Contract Manufacturing of Generic Prescription Medications Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
A Generic or Specific Gauge R&R on Standard Equipment (ie.: Micrometer) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
Hershal Couple of generic TickIT and ISO 27000 questions IEC 27001 - Information Security Management Systems (ISMS) 9
Q Numbering or Naming (Identification) of Generic Company Specifications? Document Control Systems, Procedures, Forms and Templates 3
S Complaint Process flow: Need a generic definition which would flag an "MDR" Customer Complaints 7
optomist1 Generic question regarding Two Way ANOVA Results Statistical Analysis Tools, Techniques and SPC 8
D Seeking Help: Nondisclosure vs. generic QMS documents Misc. Quality Assurance and Business Systems Related Topics 10
M Generic "Compliant Procedure" and "Non-conformance" forms needed Document Control Systems, Procedures, Forms and Templates 1
K Generic Product Development Documents that need Analysis in a Complaint Investigation Problem Solving, Root Cause Fault and Failure Analysis 2
D Process Documentation is extremely generic IATF 16949 - Automotive Quality Systems Standard 4
O Process Audit Checklist - Generic vs. Process Specific Process Audits and Layered Process Audits 17
K Generic worksheet for calculating Supplier Chargeback and Cost of Poor Quality (COPQ) Supplier Quality Assurance and other Supplier Issues 2
Ajit Basrur Facts and Myths about Generic Drugs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
P Device Subcategory and Generic Device Group differences EU Medical Device Regulations 2
R Audit N/C - Quality Policy too generic? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
N Clinical trials - Generic "parent" procedure vs. study-specific "child" versions Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
G Any rule to set Generic Process Target % (per cent) Manufacturing and Related Processes 2
P Generic Label Die Cutting Process flow Manufacturing and Related Processes 5
C Production Audit Checklist - Generic General Auditing Discussions 14
Ajit Basrur GIVE (Generic Initiative for Value and Efficiency) Launched by the FDA (US) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
K Generic Term for Inspection Types FMEA and Control Plans 15
B Generic list of ISO9001 processes for an organisation (manufacturing set up) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
H FDA Site generic Supplier Related forms help needed ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Does anyone have a generic Product Specification template? Document Control Systems, Procedures, Forms and Templates 7
G Is there a standard or generic set of PPAP documentation available? APQP and PPAP 4
G Generic Value Stream Map - Example of how Lean can be applied in a Call Center Lean in Manufacturing and Service Industries 8
D Generic Statement for Measurement Uncertainty for a Quality Manual Quality Management System (QMS) Manuals 6
A Frustration - New to the Medical Device field, I come from generic pharmaceuticals ISO 13485:2016 - Medical Device Quality Management Systems 14

Similar threads

Top Bottom