What determines the contents of an FMEA (Failure Modes and Effects Analysis)?

Jim Wynne

Staff member
Admin
#11
jpolley said:
Heres my problem........
My company sells to a distributor who sells to distributor so on and so on until it meets the end user. sometimes i have little knowledge of what is the end process. so in cases like that would i be justified in only providing what i see as potential failures? i understand the importance of the end users functionality process, but in cases when its unknown, i can only provide what is known.?
No one should expect you to include information you don't have in your PFMEA.

jpolley said:
another concern is how much detail needs to be included. using as an example, a fastener thats cold headed, would i have to go into detail about every possible die break out, upset break out, bad wire, bad wire feed, dimensions, etc. or would what i know from experience? allow me to put down what i think to be potential failures. for example, a carbide hammer insert wont break out for a purchase order of only 10,000pcs. but would i still have to list it as a potential failure even though historically its never happened. just using this as an example of course.
The best way to start the PFMEA process is with a brainstorming session which should include everyone who might have useful knowledge of the process, from raw material receipt to final shipment. In brainstorming, the participants are encouraged to suggest possible failure modes, no matter how unlikely they might be (or appear). After a list is compiled, the group should go over each item and decide which ones are most likely to create problems. Some will be discarded altogether, some might be considered marginally significant, and some will be obviously important. From this review comes a preliminary "Occurrence" ranking. The point it's usually a good idea to initially consider everything that might go wrong, but in most cases only a small fraction of those potential failures will appear in the final FMEA document.
 
Elsmar Forum Sponsor
B

Brian Myers

#12
I have always approached FMEA as a brainstorming opportunity to act in a preventative manner.

If I THINK it can happen, if I THINK ANYONE will find it objectionable, then it makes it into the appropriate FMEA (D or P).

As for "historical" data and experience... thise are important. CAN the failure mode happen? If Yes, then include it, use your data and experience to set the Occurance Numbers properly. Say for instance your data and experience point to a failure occuring every 1 in 100,000 times. It really doesn't matter how many units you actually run, each of them stands the same odds of that failure ocurring. Besides, just because you plan on running only 10,000 doesn't keep you from running 50,000 because your customer had some other issue (or really great sales!).

Again, don't approach the FMEA from a "gee I guess we have to do this so lets get it over" attitude. FMEAs should be living documents, as you learn, as you run that process or execute that design make sure you include what is "discovered" along the way. FMEAs are an oppportunity to think "outside the box" and look for new ways to improve your designs/processes. Go looking for improvements, not obstacles. A FMEA can teach you an immense amount about a design or process if you dig deep and let your best minds wander a "bit off the farm".


Brian
 

Jim Wynne

Staff member
Admin
#13
Brian Myers said:
Again, don't approach the FMEA from a "gee I guess we have to do this so lets get it over" attitude. FMEAs should be living documents, as you learn, as you run that process or execute that design make sure you include what is "discovered" along the way. FMEAs are an oppportunity to think "outside the box" and look for new ways to improve your designs/processes. Go looking for improvements, not obstacles. A FMEA can teach you an immense amount about a design or process if you dig deep and let your best minds wander a "bit off the farm".
Brian
Very good advice, Brian :agree1: .
 
Thread starter Similar threads Forum Replies Date
T Logic that determines what production testing is needed ISO 13485:2016 - Medical Device Quality Management Systems 2
D AS9100 - Who Determines What This Applies To In My Facility? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M What determines a Critical Subcontractor? Other ISO and International Standards and European Regulations 5
R What determines the frequency of third party (registrar) audits? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
R Procedure style determines motive? Document Control Systems, Procedures, Forms and Templates 8
D Contents of a 510k Q submission Other US Medical Device Regulations 1
D Questions about the contents of a Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
R US FDA Mandatory Labelling contents for an OTC medical device US Food and Drug Administration (FDA) 0
M Informational IMDRF final document – Assembly and Technical Guide for IMDRF Table of Contents Submissions Medical Device and FDA Regulations and Standards News 4
M Informational Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format Medical Device and FDA Regulations and Standards News 0
B IATF 16949 Table of Contents IATF 16949 - Automotive Quality Systems Standard 1
M List of Packaging Contents - Medical Devices - Interpreting EU Directive 93/42/EEC CE Marking (Conformité Européene) / CB Scheme 3
E Control Plan Contents - Part Number / Latest Change Level FMEA and Control Plans 2
M How to best prioritize Medical Device Label Contents Other Medical Device and Orthopedic Related Topics 16
A What should be the contents of the New Gage Introduction Form ? General Measurement Device and Calibration Topics 3
T Traceability of the Contents in Gas Cylinders General Measurement Device and Calibration Topics 5
A Should the Table of Contents be held to a revision? Document Control Systems, Procedures, Forms and Templates 3
R FDA 510(k) Cover Letter Contents US Food and Drug Administration (FDA) 2
alonFAI Design Approval Tests Procedure Contents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Auditor found Form with Identical Contents but different Format - is this an NC? Document Control Systems, Procedures, Forms and Templates 28
C Lean Sigma Manufacturing Handoff Package Contents FMEA and Control Plans 8
J Contents of DMR (Device Master Record) when manufacturing is by 3rd party 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
somashekar Label Details and Contents for Reusable Surgical Instruments EU Medical Device Regulations 7
B How to copy rows to another worksheet based on the contents of a column Excel .xls Spreadsheet Templates and Tools 6
B Checklist Contents - Do ISO clause references need to be included? Internal Auditing 4
S Control Plan Details vs. Operator Instruction Sheets - Document Contents IATF 16949 - Automotive Quality Systems Standard 9
L Contents of PPAP Control Plan - Product & Process Characteristics? FMEA and Control Plans 10
M What do the asterisks (*) in the table of contents mean? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Quality Policy Contents for Power Sector - Biomass Power Generation Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Assembly Procedure (Work Instruction) Contents and Requirements Manufacturing and Related Processes 10
howste Calibration Certificate Contents: How to report Measurement Uncertainty? Measurement Uncertainty (MU) 18
A Unlabled Containers as to the Contents from my Suppliers - Labeling Requirements Miscellaneous Environmental Standards and EMS Related Discussions 2
J Does my company's Business Plan Contents comply with requirements of TS 16949? IATF 16949 - Automotive Quality Systems Standard 2
Q Inspection and Test Plan Contents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Technical File Contents ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
M Environment Policy Statement Contents ISO 14001:2015 Specific Discussions 15
M APQP Timing Plan Details and APQP Package Contents (e.g.: floor plan) - Batch Mfg. APQP and PPAP 5
B Test Package Contents Requirements - Hydraulic Piping and Pressure Testing Other ISO and International Standards and European Regulations 3
Ajit Basrur Pre Filled Syringes (PFS) - Effect of Containers on the Contents 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
E "Sales Packaging" contents - Medical Device company Other ISO and International Standards and European Regulations 1
Chennaiite Contents of a 'Past trouble' data base Records and Data - Quality, Legal and Other Evidence 5
D Suggestions and inputs for title and contents of Company Newsletter Misc. Quality Assurance and Business Systems Related Topics 4
D In-house Internal Auditor (ISO9001 & ISO13485) Training & Course Contents Training - Internal, External, Online and Distance Learning 5
M In-Process Non-Conformance Report Contents ISO 13485:2016 - Medical Device Quality Management Systems 12
V When to add contents to Quality Manual amendment table? Quality Management System (QMS) Manuals 3
H Management Review contents for Multiple Standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M FDA - "Net Quantity of Contents" - Manufacturing Filling Process Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 12
J Management System Presentation Contents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
G Restructure of Procedures - Need Table of Contents Examples Document Control Systems, Procedures, Forms and Templates 5
S A detailed ISO 17025 'Table of Contents' ISO 17025 related Discussions 9

Similar threads

Top Bottom