The Origin of the FMEA Detection Rating

P

phelix

#1
In a paper about an fmea variant (scenario based fmea) i read that in the sae j1739 from 1994 there was no detection rating. Does anyone know who first suggested use of this criteria?

one thing about the fmea that seems odd to me is that there is so little information about why things are the way they are.

=Felix=
 
Elsmar Forum Sponsor
P

phelix

#3
? That's where i got the idea in the first place.

In MIL-STD-1629A from 1980 there is no detection rating as far as i can see. I'd like to know why it was added to the FMEA and who did it.

=Phelix=
 

Jim Wynne

Staff member
Admin
#4
? That's where i got the idea in the first place.

In MIL-STD-1629A from 1980 there is no detection rating as far as i can see. I'd like to know why it was added to the FMEA and who did it.

=Phelix=
I don't have my copies in front of me, but I think it's safe to assume that the changes were made by the AIAG people responsible for the manual. Also note that in the most recent edition, the "Current Process Controls" column was bifurcated in order to differentiate between "Detection" and "Prevention" controls. Somewhere in the manual there is a list of the representatives of the B3 (can I still use that term?) who participated in its development. You might want to try to contact one of them (or just query AIAG) for more detailed information.
 
B

bgwiehle

#5
In a paper about an fmea variant (scenario based fmea) i read that in the sae j1739 from 1994 there was no detection rating. Does anyone know who first suggested use of this criteria?
One thing about the fmea that seems odd to me is that there is so little information about why things are the way they are.
=Felix=
I have copies of the GM & Ford FMEA manuals from 1988. Ford has a severity rating table and the FMEA template form looks very similar to later versions. GM's version seems a lot more primitive, and there are no ratings at all.

The 1st edition of the AIAG FMEA manual (1993), also has severity ratings. Although the earlier OEM documents reference SAE J-1739, this AIAG manual has no mention of it.

B.G. Wiehle
 
S

Steve Kmenta

#6
So, I'm not sure when the Detection rating was introduced into FMEA. If you look at some FMECA standards, the rating does not exist as such. But there might be a clue as to why the FMEA added the Detection rating... if you think about the definitions of the "Occurrence" rating, it refers strictly to the probability of the "cause" event (for example a broken fastener). But in order to evaluate risk of any event, you need the entire story - what is the probability of the cause event AND the probability that the cause event will result in the stated "end effect." It's my opinion that the Detection rating is an attempt to bridge the gap between (A) the probability of the cause event, and the (B) probability that the cause event will result in the end effect. Really, what any one is interested in any risk analysis is the entire picture "what's the probability of something bad happening" from cause event all the way to the end effects. It's tough to do using 1-to-10 scales, but that's what FMEA tries to do.
 
#7
Talking about 'Detection' rating, it is related to the Current Process Control. I was recently working with a FMEA team, and noticed that their RPN number is so low are the times.
Upon checking, I found out that they have included 'OUTGOING INSPECTION - AUTOMATED INSPECTION' in ALL their processes - giving a low ranking of 2-3, which they said it is effective.

My argument is that 'Current PRocess Control' is to detect the failure mode and/or the cause.....so, they cannot use OGI as one of their current process control even for the front end process.

Their argument was that whatever failure or errors produced in the front end, will be able to capture by the automated OGI....

I think they are wrong...
 
P

phelix

#8
@Steve:
for a risk analysis it is definitely necessary to include the probability that a cause leads to an effect (don't you do that in your scenario based fmea?) - but it is not there in the fmea. you just take the B-rating of the worst possible effect. this implies that a failure mode with a lower B-rating where the consequences occur very often can be worse than a failure mode with a higher B-rating and very rarely occurring consequences.

the detection rating makes sense to me as a measure of how likeley it is to miss the whole problem. still i had hoped for a scientific or official explanation.

@YKT:
i'm with you in that these guys are wrong: controls do only count if their output comes in time. e.g. before the failure causes additional costs. in a design fmea it is way to late to notice a failure just before handing the finished product to the customer

regards,
=Phelix=
 
Thread starter Similar threads Forum Replies Date
C FMEA key date and FMEA Date (Origin) - Which one keeps changing FMEA and Control Plans 7
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
J Requirement for Retention of Records of Withdrawn Documents of External Origin Document Control Systems, Procedures, Forms and Templates 3
DMLqms Country of Origin on Commercial Invoices EU Medical Device Regulations 2
M Medical device country of origin Medical Device and FDA Regulations and Standards News 5
MDD_QNA Country of origin - Made in EU or Made in Finland? EU Medical Device Regulations 1
M Informational EU – Meeting minutes – Competent Authorities on Substances of Human Origin Expert Group Medical Device and FDA Regulations and Standards News 0
R Do we need to treat local law as external origin documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
T Change to Country of Origin on Medical Device Labeling Other Medical Device Regulations World-Wide 0
C Legal requirement for same indications as in Country of Origin Other Medical Device Regulations World-Wide 4
K Markets with No Prior Approvals? Without Country of Origin or other Prior Approval Other Medical Device Regulations World-Wide 3
F Country of Origin or Made In Tags - Where a country is a principality EU Medical Device Regulations 11
I Shipping Product from Canada to China - Where to obtain the Certificate of Origin? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
E Types of nonactive Medical Device implants - What is the origin of this codification? EU Medical Device Regulations 6
C ISO 9001:2008 4.2.3(f) - Controlling Documents of External Origin Quality Manager and Management Related Issues 9
T Can Medical Devices with Animal Origin material be imported in India Other Medical Device Regulations World-Wide 1
D What is difference between Statutory and Regulatory with Documents of External Origin ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Control of Customer Documents (Documents of External Origin) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
B I wish to know about Concept of Supporting Documents (Documents of External Origin) Document Control Systems, Procedures, Forms and Templates 1
G Country of Origin Medical Labeling - Foreign Content, Domestic Assembly Other US Medical Device Regulations 3
C Class I Medical Devices - Country of Origin Marking on Retail Packaging (Labeling) Other US Medical Device Regulations 4
somashekar Can Documents of External Origin be a Quality Plan? ISO 13485:2016 - Medical Device Quality Management Systems 2
T External Document (Documents of External Origin) Control Template example wanted Document Control Systems, Procedures, Forms and Templates 14
S Animal Origin and Human Origin Products Import Requirements Other Medical Device Regulations World-Wide 7
L ISO 9001:2008 - Control of Documents of External Origin Document Control Systems, Procedures, Forms and Templates 13
M Defining and Controlling External Documents (Documents of External Origin) Quality Tools, Improvement and Analysis 5
S Weld Cell Repeatability Studies - Origin - The 'drilled hole panel' Methodology Manufacturing and Related Processes 3
Q Suppliers info into my Documents Control (Documents of External Origin)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Labeling Requirements and COO (Country of Origin) Other US Medical Device Regulations 13
F Can a website be considered a Document of External Origin? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T FTC "Made In U.S.A" Labeling Rules vs. Saudi Arabia's "Country of Origin" Regulations Other Medical Device Regulations World-Wide 6
H Tier 1 ISO/TS 16949 Subscribers (Origin of TS 16949) IATF 16949 - Automotive Quality Systems Standard 9
M Labelling External Documents - Documents of External Origin Document Control Systems, Procedures, Forms and Templates 15
M Documents of External Origin - Periodic or annual verification of revision status ISO 13485:2016 - Medical Device Quality Management Systems 10
N How to Control Documents of External Origin Document Control Systems, Procedures, Forms and Templates 7
P Is there a requirement for country of origin on packaging of class 2a medical device? Other Medical Device and Orthopedic Related Topics 17
K How to Control and 'Monitor' External Documents (Documents of External Origin)? Document Control Systems, Procedures, Forms and Templates 1
R Who should do NAFTA Certificates of Origin? Misc. Quality Assurance and Business Systems Related Topics 9
D The Origin of the 10:1 Resolution Ratio for Measurement Equipment General Measurement Device and Calibration Topics 17
D Understanding ANSI Z1.9 Origin and the Acceptability Constant (k) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
W Controlling Revisions of External Documents - Documents of External Origin Document Control Systems, Procedures, Forms and Templates 10
P Documents of external origin not identified? ISO9001 Clause ISO 9001:2000 5.4.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 55
S Documents of external origin? Manufacturer's operating manual of that machine Document Control Systems, Procedures, Forms and Templates 5
C Advice on "Country of Origin" regulation with regard to medical devices Other Medical Device and Orthopedic Related Topics 2
P Customer Furnished Drawings Retained? Control of Documents of External Origin Records and Data - Quality, Legal and Other Evidence 4
C Controlling External Customer Documents (Documents of External Origin) Document Control Systems, Procedures, Forms and Templates 5
B Method to Ensure Latest Customer Specifications (Documents of External Origin) Customer and Company Specific Requirements 2
V Identification & Control - Documents of External Origin - ISO13485:2003 Clause 4.2.3f Document Control Systems, Procedures, Forms and Templates 8
D Customer Quality Manuals - Document of external origin and must be controlled? Document Control Systems, Procedures, Forms and Templates 14
V Definition Fit, form, and function - Origin and defintion of fit, form, and function Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 14

Similar threads

Top Bottom