Mechanical Failure as a Failure Mode in the PFMEA

Wes Bucey

Quite Involved in Discussions
#21
I think we are in partial agreement.

Suppliers "may" consider all sorts of things in their Business Management System, up to and including hiring security guards to protect against crazy people coming in to wreak havoc on personnel and equipment.

That said, what the supplier "shall" provide in a formal PFMEA to a customer is an entirely different matter and "should" be covered by the terms of the contract between customer and supplier. Further, no supplier should agree to investigation beyond its normal practice without fair compensation. I happen to believe the compensation should be billed separately to make it easy for all to see the COST of "extras" over and above the cost of producing a product which meets specifications.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#22
A quick 'add'. In a small job shop, everything will be done differently to some degree because, amongst other aspects, many people will wear many hats. I do consider the size and complexity of the company when looking at a company and their processes. I don't expect a Mom and Pop job shop to be doing what Borg Warner does.
 
J

jstrickjr

#23
FMEA Advice Needed

After reading for the past few month's I have decided to jump in and test the waters.

I found this thread concerning FMEA's and Mechanical downtime very appropriate (and educational) as we are having the very same discussions here in our plant.

My question deals with the role of the machine operator as part of the PFMEA. Would operator performance, training, etc., qualify as a failure mode if the operators actions resulted in non-conforming material? As I write this I seem to remember a message stating that a trained, competent operator was assumed in the PFMEA--Is this correct?

Thanks,
Julian
 

Jim Wynne

Staff member
Admin
#24
jstrickjr said:
After reading for the past few month's I have decided to jump in and test the waters.

I found this thread concerning FMEA's and Mechanical downtime very appropriate (and educational) as we are having the very same discussions here in our plant.

My question deals with the role of the machine operator as part of the PFMEA. Would operator performance, training, etc., qualify as a failure mode if the operators actions resulted in non-conforming material? As I write this I seem to remember a message stating that a trained, competent operator was assumed in the PFMEA--Is this correct?

Thanks,
Julian


Because the whole idea of the PFMEA process is defect prevention, it's appropriate to consider all sources of possible process failures, including operator error. In general, operator training and work instructions are considered preventive process controls. Remember--the PFMEA document is a record--it's not the PFMEA. The PFMEA is a collaborative process of discovery, wherein all sources of undesireable variation should be sought out and considered.
 
B

Bill Ryan - 2007

#25
jstrickjr said:
After reading for the past few month's I have decided to jump in and test the waters.

I found this thread concerning FMEA's and Mechanical downtime very appropriate (and educational) as we are having the very same discussions here in our plant.

My question deals with the role of the machine operator as part of the PFMEA. Would operator performance, training, etc., qualify as a failure mode if the operators actions resulted in non-conforming material? As I write this I seem to remember a message stating that a trained, competent operator was assumed in the PFMEA--Is this correct?

Thanks,
Julian
Welcome to the Cove :bigwave:

FWIW - I would not categorize "operator performance, training, etc." as a Failure Mode. In my methodology they are examples of either Failure Causes (if stated as "poor operator performance" or "lack of training", for example) or, as JSW05 stated, "preventive process controls".
 
R

Randy Stewart

#26
The basis for the FMEA is that "everything" is received from the previous operation correctly. Operators are on station, alert, trained and ready to go. Remember, it is a process or design (sometimes equipment) FMEA. Most OEMs do not accept operator error as a "root cause" because your process should protect against variables and what bigger variable to you have? The one touch placement, autonomation, etc. (12 guiding principles) are all items used to protect against the dreaded operator!!!
Tommorow afternoon we will be dealing with the annual "March Madness diversion" problem again. People sneak in their pocket radios and listen to the basketball games and don't pay as close attention as they should.
 

Jim Wynne

Staff member
Admin
#27
Randy Stewart said:
The basis for the FMEA is that "everything" is received from the previous operation correctly. Operators are on station, alert, trained and ready to go. Remember, it is a process or design (sometimes equipment) FMEA..
Although the AIAG manual doesn't make it clear, the "everything" you refer to applies in all cases except for inspection processes, where it must be assumed that the condition of the material entering is unknown. Also, there is no reason to assume that operators who "...are on station, trained and ready to go" will not make mistakes. To expect otherwise is to invite trouble.

Randy Stewart said:
Most OEMs do not accept operator error as a "root cause" because your process should protect against variables and what bigger variable to you have?
Speaking as an OEM employee who regularly reviews supplier PPAPs, including PFMEAs, I look for evidence that the supplier has considered operator error, because operator error is inevitable. It's true that using operator error as a catch-all is not a good thing, but if you think that people won't make mistakes, or if you acknowledge that they will and believe that you can poke-a-yoke your way out of all of them...
 
R

Randy Stewart

#28
there is no reason to assume that operators who "...are on station, trained and ready to go" will not make mistakes. To expect otherwise is to invite trouble.
I thought my statement concerning Demings 12 Guiding Principles covered this issue. But that's just me speaking as an ex-OEM employee.

I think our 2 signatures speak volumes about this.:agree:
 
C

chalapathi

#29
Equipment FMEA & Process FMEA

GoKats78 said:
We are having an in-house discussion about whether Mechaincal Failure is a failure mode in the PFMEA.
Thoughts, Opinions?

We have a slpit camp on this issue!
If some thing failes in the process one of the possible cause could be equipment (mechanical failure).
However, there is another type of FMEA, called Machinary FMEA (AIAG Manual is available with this title). I call it Equipment FMEA.
In this FMEA, Mechanical failure is considered as a Failure and the causes could be related to Preventive Maintenance, Quality of Spares etc.
Many people have this confussion between failure, effect and cause. If you see a 5 Why analysis. All are called causes. However, in FMEA terminology, in the 5 Why chain, consider one cause and it is called as failure. The cause before that is called case and case after that is called effect.
 
Thread starter Similar threads Forum Replies Date
Q Failure Analysis Procedure for Electro-Mechanical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
J Defining staff competence - Small mechanical workshop Occupational Health & Safety Management Standards 20
M Device mounted at IV pole - what about mechanical stability testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Mechanical inspection techniques of close tolerance parts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
B IEC 60601 - Creepage Distance - Relay that acts as a means of physical mechanical protection Process Maps, Process Mapping and Turtle Diagrams 0
J GLP accreditation for mechanical tests of medical device? Other Medical Device and Orthopedic Related Topics 1
A Moving and positioning of patient - Mechanical hazard IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
shimonv Design input/output traceability for mechanical parts ISO 13485:2016 - Medical Device Quality Management Systems 13
R Essential Performance of Mechanical Device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
X Heat Treat - Verifying mechanical properties on heat treated material per the ASTM Manufacturing and Related Processes 6
J Mechanical Press Machine Foundation Requirements and Recomendations Manufacturing and Related Processes 2
G Senior Project for BS Mechanical Engineering Student Career and Occupation Discussions 4
M Mechanical Testing for Orthopaedic Implants for CE Marking EU Medical Device Regulations 2
A Auditor's certificate for newly employed graduate? (Mechanical Engineer) Professional Certifications and Degrees 1
R Standard for Reliability/Performance Test on a Electro Mechanical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
T Measurement of uncertainty for standard mechanical properties General Measurement Device and Calibration Topics 1
alonFAI Mechanical Drawing Version Change Document Control Systems, Procedures, Forms and Templates 8
N Need Calibration Service for Mechanical Tester - Zwick Roell General Measurement Device and Calibration Topics 1
D Contract Manufacturer & Mechanical Assembly Supplier Warranty Liability ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Mechanical Tubing Mill Tolerance Reference Manufacturing and Related Processes 5
S Mechanical/Electrical Forces Gage Calibration Methods Calibration and Metrology Software and Hardware 1
W Seeking a Freelance Mechanical Inspector - Source Inspection in Bangalore, India AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
S Medical Device Mechanical Test Method Validation Design and Development of Products and Processes 8
Uriel Alejandro Trouble with a Mechanical Design Technical Verification Check List AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C Inexperienced Mechanical Inspectors and FAI's (First Article Inspection) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Mechanical Auto Repair Shop requires ISO 9001 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J Fastener Manufacturing Research - Mechanical and Engineering Theories Manufacturing and Related Processes 3
J Define Energy Used/Delivered - Applicable to Electrical or Mechanical Power or both? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A HSE Regulations and Legislation for Design of Mechanical Wind Turbine Components Miscellaneous Environmental Standards and EMS Related Discussions 4
P Dimensional Mechanical Inspection only as a Service - ISO17025 or ISO17020 ISO 17025 related Discussions 5
somashekar Insight about Air Changes per hour (ACH) in Mechanical Ventillation Occupational Health & Safety Management Standards 2
C Analyzing Attribute Data - Mechanical Pull Testing of Joint Statistical Analysis Tools, Techniques and SPC 15
J FAA Requirements for Design and Manufacturers of Engine Turbine Mechanical Components Federal Aviation Administration (FAA) Standards and Requirements 2
D Material Handling, Storage & Preservation Procedure for Aerospace Mechanical Parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R Inspection Humidity Control - Range for Mechanical Inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
V Mechanical Testing Lab - PT vs. QC questions General Measurement Device and Calibration Topics 4
P Calibration Standard - Rules of Calibration for Mechanical Comparators General Measurement Device and Calibration Topics 3
N Help please - Mechanical Latch Design Principles? Design and Development of Products and Processes 2
Q REACH Declaration requirements for Mechanical Components RoHS, REACH, ELV, IMDS and Restricted Substances 6
V PPAP for electronics - What do we have to require for PCB compare to mechanical parts APQP and PPAP 4
V Letter of Guarantee - EN 12546-3 (Mechanical & Physical testing on an ice pack) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
R BOMs & Test Procedures - Electronic and electro-mechanical systems Document Control Systems, Procedures, Forms and Templates 4
M Mechanical Maintenance Procedures for Oil & Gas wanted Document Control Systems, Procedures, Forms and Templates 4
ScottK National Pipe Straight Mechanical (NPSM) Specification? Various Other Specifications, Standards, and related Requirements 6
A How to Search for Jobs Abroad - Mechanical Engineering Field Career and Occupation Discussions 3
D Can an Electrical Design Engineer audit the work of a Mechanical Design Engineer? Design and Development of Products and Processes 6
W Surface Finish parameters - Mechanical stylus based testing of a cylindrical part Manufacturing and Related Processes 2
T TV Mounting Question for Mechanical Engineers Coffee Break and Water Cooler Discussions 20
9 Material Specifications using Performance Values on Mechanical Drawings Document Control Systems, Procedures, Forms and Templates 7

Similar threads

Top Bottom