Design FMEA - Detection Rating criteria

#1
Hi guys,

For medical devices how can we arrive with the detection table ,what are all will be the criteria to define those, kindly help me on this

Note: Consider the device is not software controlled, specifically for a implants devices

What I was thinking is like, you would rate the scale as 1 and likelihood of detection as most certain for any devices which has under gone a stimulation test in the end user environment, so that the potential failure mode will be detected at the earliest.

Like that if I am scaling the detection table to 1-10, what are all will be the criteria.
 
Last edited:
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#3
I agree with @indubioush - we don't use detection in DFMEAs. If the *system* can detect it, the system should do something about it. If you're relying on the user to detect it, you're also relying on them understanding and doing the right thing. To me, that's a slippery slope.
 

John Predmore

Quite Involved in Discussions
#4
I use a different definition of Detection in a Design FMEA , the likelihood Design Controls will uncover and correct a design flaw before the product exits the design phase, before the product makes it into the customer's hands. This definition is philosophically different from Detection in a Process FMEA or a System FMEA where the opportunity to uncover and fix the problem in the design phase is long past.

The way Design Controls uncover a design flaw is thru model simulation, finite element analysis, prototype testing, tolerance stack-up analysis, and other engineering methods. Remember, DFMEA considers the likelihood of uncovering unknown design failures, not just the likelihood of detecting actual or latent failures. So more representative samples and greater sample size and multiple avenues of validation will lower Detection score. The Detection score is also better (lower) if planned engineering/validation testing is done earlier in the design development process, where there is greater opportunity to make economical and more impactful corrections to product design (instead of band-aids to patch up flaws!)

I found useful guidance searching online for "Detection in Design FMEA", such as the article Understanding-FMEA-detection .
 
Thread starter Similar threads Forum Replies Date
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
K Design FMEA Detection Scoring - FMEA 3rd edition manual FMEA and Control Plans 7
A DFMEA (Design FMEA) - Occurance and Detection Ratings FMEA and Control Plans 2
M Reducing both Detection and Occurance in a Design FMEA WITHOUT a Design Change FMEA and Control Plans 8
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
P Design FMEA for Industrial Machinery FMEA and Control Plans 3
Marc Definition DFMEA (Design FMEA) - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
D Design FMEA for a component - Should I make the following assumptions? FMEA and Control Plans 7
D Do you need requirements for a Design FMEA FMEA and Control Plans 1
R Development of Design FMEA - Functional Requirements FMEA and Control Plans 1
K Determining Effect of Failure without a DFMEA (Design FMEA) FMEA and Control Plans 1
Moncia Design FMEA - Where to Start FMEA and Control Plans 20
T Would a Leak be a Failure Mode on a Design FMEA? Design and Development of Products and Processes 2
M Severity Reduction in a Design FMEA (DFMEA) FMEA and Control Plans 25
G How to identify Key Characteristics (KC) in a Design FMEA (DFMEA) FMEA and Control Plans 2
V Examples of Design and Process FMEA for Pharmaceutical Product Development ISO 14971 - Medical Device Risk Management 7
V Linking the FMEA Causes & Action Plan with DOE Experiments or Experimentation Design FMEA and Control Plans 1
C AIAG FMEA 4th Ed "Design Assumption" - I Need Examples FMEA and Control Plans 15
R DFMEA (Design FMEA) on Printed Circuit Boards (PCB's) FMEA and Control Plans 2
R Rear Axle Gear Group DFMEA (Design FMEA) - Example wanted FMEA and Control Plans 2
M ISO 14971 Risk Analysis and use of a DFMEA (Design FMEA) ISO 14971 - Medical Device Risk Management 8
A AIAG Design FMEA Severity Rankings - Noncompliance Government Regulation? FMEA and Control Plans 9
Chennaiite DFMEA (Design FMEA) at Vehicle Level - Some inputs needed. FMEA and Control Plans 4
V Biggest bottleneck/hurdle in Implementation of Effective Design FMEA FMEA and Control Plans 4
A Design FMEA, Process FMEA, Component FMEA --> FDA requirements? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
P Design FMEA (DFMEA) Basics - Help needed IATF 16949 - Automotive Quality Systems Standard 3
S DFMEA (Design FMEA) for a New Line Operation of the Underground Operation FMEA and Control Plans 10
T Electronic Assembly Design FMEA (DFMEA) FMEA and Control Plans 6
V In Design FMEA, how to give Occurrence Rating? FMEA and Control Plans 4
michellemmm Reverse Engineering a Design FMEA using aerospace DFMEA guidelines FMEA and Control Plans 2
M What are Comfort and Convenience Items on a Design FMEA FMEA and Control Plans 4
R Use of Design and Process FMEA tools - Kitchen Cabinets Manufacturing Quality Tools, Improvement and Analysis 6
O Bulk Material PPAP - Design Matrix instead of a normal Design, Production FMEA APQP and PPAP 3
T DFMEA (Design FMEA) - We already have a PFMEA (Process FMEA) FMEA and Control Plans 5
P Design FMEA (DFMEA) required on all products and their parts? Design and Development of Products and Processes 5
R Can a DFMEA (Design FMEA) effectively analyse design modifications? FMEA and Control Plans 12
C DFMEA (Design FMEA) and PFMEA (Process FMEA) - Who should lead? FMEA and Control Plans 14
B How to fill s/c and c/c in DFMEA (Design FMEA)? Design and Development of Products and Processes 3
S DFMEA - Is a Design FMEA required? FMEA and Control Plans 3
M DFMEA (Design FMEA) for Trailers or any heavy vehicle design Design and Development of Products and Processes 1
D Would Design & Process FMEA (PCBA) be sufficient to fulfill requirement of Cl 7.1? ISO 13485:2016 - Medical Device Quality Management Systems 2
N How to Calculate RPN in Design FMEA (DFMEA) vs. Process FMEA (PFMEA) FMEA and Control Plans 9
D Bulk Suppliers - Design FMEA Required? Aluminium ingots FMEA and Control Plans 10
M When to start a DFMEA (Design FMEA)? APQP and PPAP 2
K Could a good Design FMEA have prevented this? Death inside centrally locked car FMEA and Control Plans 6
B What is the meaning of the Occurrence in the DFMEA (Design FMEA)? FMEA and Control Plans 8
S FMEA Severity Rating - Will a Process Design Change also Change the Severity Rating? FMEA and Control Plans 21
R DFMEA (Design FMEA) - Document or Record? Document Control Systems, Procedures, Forms and Templates 3
S Do you have any information about Design FMEA? FMEA and Control Plans 1
W DFMEA (Design FMEA) for Bulk Material - Resin for Plastic Injection Moulding FMEA and Control Plans 1

Similar threads

Top Bottom