SBS - The best value in QMS software

Should failure mode caused by Fixture problem be into PFMEA?

jelly1921

Quite Involved in Discussions
#1
Background: There were 4 pcs of parts rejected by our customer. Our analysis is that the deformation of these four parts was caused by a fixture during machining. The fixture fixed and no such problem occurs since then.

Question:
Shoud we put such failure mode into PFMEA? (since there is no such failure mode analysis before)
Or should we put such failure mode into fixture FMEA?

Thanks

Jelly
 
Last edited by a moderator:
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Re: Should failure mode casued by Fixture problem be into PFMEA?

The part quality is your focus. The fixture use is a part of your process to get quality part consistently.
You have just found a new failure mode in the fixture that effects your product quality and fixed it. In order that it not repeat, you address the new finding in your PFMEA suitably.
 
G

garibati

#3
Re: Should failure mode casued by Fixture problem be into PFMEA?

Hallo Jelly,

I think you should include it in your P-FMEA as said above. The failure cause goes to one of the 5Ms, i.e., Method. This point is an important step for root cause analysis and/or Problem Solving.

___________
Thanks,
garibati
 
Thread starter Similar threads Forum Replies Date
A I have two doubts about PFMEA failure modes - How should I describe a "failure mode" FMEA and Control Plans 24
L Where should the Process Failure Form reside? Document Control Systems, Procedures, Forms and Templates 6
S Which Sampling Plan(s) Should I Use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
S Which department should prepare the control plan? could you show me a standard regarding to this matter. APQP and PPAP 16
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Master Samples - What should we be keeping? IATF 16949 - Automotive Quality Systems Standard 9
G Supplier delivered recent PPAP, should he deliver yearly layout inspection? IATF 16949 - Automotive Quality Systems Standard 4
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Capability Study - in the beginning of your career what should you have known about the tool Quality Tools, Improvement and Analysis 11
J Should Loading and Unloading be Included in Cycle Times? Lean in Manufacturing and Service Industries 14
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 3
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
M Which incubation condition should be selected to recover both bacteria and fungus effectively Miscellaneous Environmental Standards and EMS Related Discussions 3
D Is there a specific location for PPE such as safety glass holders and glove dispensers should be mounted Occupational Health & Safety Management Standards 10
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M Who should receive the bills from suppliers and vendors, account payable or procurement? Consultants and Consulting 4
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
S Companies that maintain your machine should be in ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 26
D Class II medical device - When should a complaint be closed? Customer Complaints 6
Sidney Vianna IATF 16949 News Presentations from the latest IATF Stakeholder Event - Expectation that IATF 16949 certification should equate with product quality. Misguided? IATF 16949 - Automotive Quality Systems Standard 7
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
H Should I mention machine/Equipment password In SOP? Qualification and Validation (including 21 CFR Part 11) 4
D How long should we keep the spare parts available for our medical device, after we have stopped the production? ISO 13485:2016 - Medical Device Quality Management Systems 0
H Statistical Techniques Procedure - What should be included Document Control Systems, Procedures, Forms and Templates 4
Q How should I analyze measurement correlation between me and customer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
Sidney Vianna Interesting Discussion ISO 9001:2024 - What should be changed in the next Edition of ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 105
N Should it even be on the hazard analysis (software)? FMEA and Control Plans 2
V Which batches should or could be considered for design validation and design verification? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
M Routine testing of medical electrical systems - What specific electrical safety tests should be performed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G ISO 17025:2017 7.1.2 - Should I produce a document for the customer? ISO 17025 related Discussions 8
F Quality Objectives - Where in the QMS Quality Objectives should be located ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8

Similar threads

Top Bottom