What should the FMEA Severity for SC & CC Characteristics be?

#1
Hello All,

According to FMEA mentality; what should be the severity for the SC & CC Characteristics one by one?

I mean as i know severity is constant for them but i dont remember the range like for SC; 6 < X < 9.

If anyone knows, please share :)
 
Elsmar Forum Sponsor
R

randomname

#2
Are you asking for a particular industry?

I would think it might depend on your product application.

Also might depend on who your customers are.
 

amiuda

Involved In Discussions
#3
I have same question.

From AIAG 4th edition ranking tables, as far as I know, SC comes from:
Severity 5-8 AND Ocurrence 4-10 .

More expert opinions??
 

dhakadmilind

Starting to get Involved
#5
Generally 9 & 10 in severity rating for CC as these parameter are related with safety requirement.
While SC is from 5 to 8, it is related with functional requirement of the product
 
Thread starter Similar threads Forum Replies Date
L FMEA - Should a severity of 9 or 10 be always followed by recommended actions? FMEA and Control Plans 2
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
D Design FMEA for a component - Should I make the following assumptions? FMEA and Control Plans 7
Mr.Happy Should all Drawing Dimensions be in the FMEA FMEA and Control Plans 5
H What should be included in a Machining Process FMEA? FMEA and Control Plans 8
R Should I include all possible Risks of our software in the FMEA? US Food and Drug Administration (FDA) 7
C DFMEA (Design FMEA) and PFMEA (Process FMEA) - Who should lead? FMEA and Control Plans 14
Gabble FMEA start point - should it be flexible? FMEA and Control Plans 2
A Should inspection be part of the FMEA FMEA and Control Plans 2
A FMEA Reviews - At what frequency should FMEA's be reviewed? FMEA and Control Plans 26
A Process FMEA - Should FMEA be done for all processes? FMEA and Control Plans 7
A What should the FMEA Occurence Rating be based upon? FMEA and Control Plans 9
P Shipping by our own truck as part of an FMEA - Where FMEAs should end FMEA and Control Plans 6
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
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 2
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 21
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 82
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