Potential Effects of Failure(s)

kedarg6500

Quite Involved in Discussions
#1
Hi Folks

I am bit confused to write "Potential Effects of Failure".
if I take OD turning operation, Failure mode shall be OD oversize or OD under-size. but when writing Effects of Failure, whether it shall be
1. rejection, rework, sorting OR
2. problem at next operation, problem at customer end

Silly question. isn't it?
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
I'm not sure what you mean.

Potential effects of a failure can be catastrophic. It depends upon the end product, it's use, and even in-house failures can be deadly.

I can not remember the specifics, but not so very long ago a small child's toy was found to have lead paint on its exterior.

I once worked in airbag D&D, and I have worked in explosives. In both scenarios an in-house failure could potentially cause death(s), just as an external (customer) failure could cause death. I remember working in explosives the first rule new employees were given is you must always back your car into a parking space so if something went sour (so to speak) there would be minimal confusion in evacuating the area. Not doing so was cause for dismissal.

Your question is not a silly question. Maybe you could give some more context of what you are doing and be a bit more specific.
 

yodon

Staff member
Super Moderator
#3
Certainly agree with Marc in that it's not a silly question!

Here, I believe, the concept of detectability can play an important role.

Assume that if your operation makes a part that's too big and it's put into the system as is (too large), the system may jam or fail to operate. If this is a part, say, for an infusion pump, the potential effects could be rather severe! However, if the output is 100% verified (all non-conforming parts are detected) then the likelihood that a system is built with a bad part is virtually eliminated. You may not need to implement any additional (possibly quite costly) controls to control the parts better (at which point it comes down to business decisions).

I think it's important to have some understanding of the downstream impact so you can focus efforts where needed. For example, if that same non-conforming part would have no bearing on form/fit/functionality then you don't want to spend a lot of time on the controls (or level of downstream verification).
 

Miner

Forum Moderator
Staff member
Admin
#4
You should evaluate the effect of the failure at multiple levels.

  • What is the effect on the next/subsequent manufacturing operations?
  • What is the effect on the sub-assembly/assembly/product?
  • What is the effect on the system this product goes into?
  • What is the effect on the customer/end user?
 

rob73

looking for answers
#5
This should be limited by the scope of your FMEA, if you are manufacturing an end product then you can identify what affect it will have later on in life, i.e nipple in fuel line too small, fuel leak, explosion. If however you are supplying in a sub-contractor role, you will be limited by your customer specification, unless they are willing to involve you in the wider FMEA.
 

RoxaneB

Super Moderator
Super Moderator
#6
Hi Folks

I am bit confused to write "Potential Effects of Failure".
if I take OD turning operation, Failure mode shall be OD oversize or OD under-size. but when writing Effects of Failure, whether it shall be
1. rejection, rework, sorting OR
2. problem at next operation, problem at customer end

Silly question. isn't it?
Why must you chose between effect #1 or effect #2? There could be more than one effect...especially if it is not detected immediately. If it is detected immediately, effect #1 is the result. If it is not detected immediately, effect #2 is the result...and then what happens?

Your 'OR' should be an 'AND', in my opinion.
 

Golfman25

Trusted Information Resource
#7
Hi Folks

I am bit confused to write "Potential Effects of Failure".
if I take OD turning operation, Failure mode shall be OD oversize or OD under-size. but when writing Effects of Failure, whether it shall be
1. rejection, rework, sorting OR
2. problem at next operation, problem at customer end

Silly question. isn't it?
First, I agree with what Rob said. If you're a subcontractor all you can really do is look at the failure effect on the next step of your process.

In your case, if the OD is undersized, you likely made scape. Oversized can be re-worked. Then you also look at the effect on the next part of the assembly. Usually it will be some sort of assembly issue. Good luck.
 

kedarg6500

Quite Involved in Discussions
#8
if OD oversize or OD under-size is not detected internally or at customer end, and the part goes to customer assembly line, then how we can describe what shall be problem at customer end?
 

Golfman25

Trusted Information Resource
#9
if OD oversize or OD under-size is not detected internally or at customer end, and the part goes to customer assembly line, then how we can describe what shall be problem at customer end?
You really can't without customer input. The best you can assume is that an out of spec part either will not fit (assembly problem) or not perform properly (hard to know what the particular performance issue will be).
 

SQ_Joe

Involved In Discussions
#10
"The best you can assume is that an out of spec part either will not fit (assembly problem) or not perform properly (hard to know what the particular performance issue will be)."

You will find out very quickly what the particular performance issue is when the Customer sends you their C.A.R.

A PFMEA, which is the subject of this thread, should anticipate every method of creating an out of spec. O.D., or provide a current detection control of the failure mode for the dimension which you are turning. If there is no current detection control method, then Detection will have a ranking of a 10. A 10 is required with no current detection control.

Note(1): The Current Detection ranking of the Failure Mode or Failure Cause must be low enough to meet the Detection ranking require for the S x O, criticallity, risk matrix.

Note(2): It is best to use the Form G template when performing a PFMEA.
 
Thread starter Similar threads Forum Replies Date
M Difference between potential failure mode and potential effects of failure FMEA and Control Plans 11
S What is the use of bar code? The Potential Effects of Missing Bar Code Labels FMEA and Control Plans 6
S Potential Equalization Conductor vs Functional Earth Terminal IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
G Self Assessment Audit from a new potential customer General Auditing Discussions 3
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
T Potential Off-Label Use question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Informational USFDA – Efforts to evaluate materials in medical devices to address potential safety questions Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy Medical Device and FDA Regulations and Standards News 0
M Medical Device News Letter to the health and care sector: update on preparations for a potential no-deal Brexit Medical Device and FDA Regulations and Standards News 0
G Options for failing a VDA POTENTIAL audit VDA Standards - Germany's Automotive Standards 2
S FMEA column column ''therblig motion'' for a given potential failure FMEA and Control Plans 12
MrPhish Should Potential Customer Complaint Outcome Define Registrar NC Rating? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Selecting potential internal auditors Internal Auditing 3
N PFMEA Potential Failure Mode for Weight FMEA and Control Plans 5
L "Potential" Essential Performance in IEC 60601-2-54 (Definition) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
R Need Help on Analysis: How to know potential causality model from historical data Problem Solving, Root Cause Fault and Failure Analysis 5
J Potential Customers Asking for EIRs / 483s when evaluating a CRO for future work US Food and Drug Administration (FDA) 2
G ISO/TS 5.6.2.1 - Potential Field Failures on OEMs IATF 16949 - Automotive Quality Systems Standard 3
P TS 16949 Clause 5.6.2.1 - Review of Potential Field Failures IATF 16949 - Automotive Quality Systems Standard 16
J CRB (Certification Registration Body) Notification of Potential Escape AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Marc LinkedIn Accused Of Secretly Selling Members Professional Data To Potential Employers World News 9
N Scouting Potential Suppliers - Strategy and Tactics Supplier Quality Assurance and other Supplier Issues 7
Colin Interesting Discussion Potential Issues for Auditing ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 84
B Providing a potential Customer with a Sample Medical Device in Brazil Other Medical Device Regulations World-Wide 1
Ron Rompen Wording of potential cause of failure in a PFMEA FMEA and Control Plans 8
F Supplier Quality Engineer Beginner - Potential Interview Questions Supplier Quality Assurance and other Supplier Issues 3
A Potential Equalization Conductors IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
GURU SDI VDA 6.3 Hand Book - Two sections for Potential Analysis VDA Standards - Germany's Automotive Standards 1
H Identifying Potential Automotive Suppliers before Developing New Products Supplier Quality Assurance and other Supplier Issues 2
T Attribute (Check Fixtures) - Breaking the Ice with Potential Customers Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
P Lessons Learned Identification - Potential Preventive Action Responsibilities Preventive Action and Continuous Improvement 4
Hershal Metrology Careers - Potential good Paying Jobs in the Science of Measurement Field Career and Occupation Discussions 1
C List of Potential Hazards Definitions in Annex E of BS EN ISO 14971:2009 ISO 14971 - Medical Device Risk Management 4
Mikey324 Assessing Potential Field Failures (TS 16949 Requirements) Quality Manager and Management Related Issues 5
K Observation - Potential Nonconformity - How to address this Audit Finding? General Auditing Discussions 9
8 Introducing a Balance Line - Identifying potential future pitfalls etc. Lean in Manufacturing and Service Industries 2
M Analysis of Potential Field Failures - Impact on Quality, Safety or the Environment Management Review Meetings and related Processes 10
Q Potential Field Failure as Mgmt Review Input for TS16949: How to meet the clause? IATF 16949 - Automotive Quality Systems Standard 1
hogheavenfarm Potential Employer Questions Reason for Leaving Career and Occupation Discussions 37
B Mining Nonconformance Data for Potential Missed Audit Findings Misc. Quality Assurance and Business Systems Related Topics 2
M Correlation between 2 Variables - Potential X's that might affect yield percentage Quality Tools, Improvement and Analysis 5
M PFMEA (Process FMEA - Potential Causes and Failure) - Operator's Role FMEA and Control Plans 11
E Tips on how to notify customers (and potential ones) of ISO Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A Procedure to Identify Potential Emergency Situations and Accidents Miscellaneous Environmental Standards and EMS Related Discussions 4
S Should an auditor document potential nonconformities in the audit report? General Auditing Discussions 41
N Definition Nonconformity vs. Potential Nonconformity - Difference? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
automoto ISO TS 16949 Management Review Input - Potential Field Failures IATF 16949 - Automotive Quality Systems Standard 10
Chennaiite FMEA Severity Rating for Potential Manufacturing Effect mentioned in the FMEA manual FMEA and Control Plans 9
J Google Offers Peek at Operating System, a Potential Challenge to Windows After Work and Weekend Discussion Topics 2
J Sources of Potential Measurement Variation for Brinell Hardness Test Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4

Similar threads

Top Bottom