What does "Class" mean in an FMEA?

Elsmar Forum Sponsor

Miner

Forum Moderator
Staff member
Admin
#6
I found the following description.

For Automotive applications the following applies:

Critical Characteristic is a product feature, dimension or note that reasonably anticipated variation could directly affect compliance with government regulations or safe operation of the equipment. Any of those characteristics that affect a failure mode with a severity of 9 or 10 must be reviewed to determine if they should become a critical characteristic.

Significant Characteristic is a feature, dimension, or note that reasonably anticipated variation could affect principal fit, function, durability, customer satisfaction, or manufacturability. Any of those characteristics that affect a failure mode with a severity of 5 to 8 and an occurrence of 4 or higher must be reviewed to determine if they should become a significant characteristic
 

Jimmy123

Involved In Discussions
#7
I found the following description.

For Automotive applications the following applies:

Critical Characteristic is a product feature, dimension or note that reasonably anticipated variation could directly affect compliance with government regulations or safe operation of the equipment. Any of those characteristics that affect a failure mode with a severity of 9 or 10 must
be reviewed to determine if they should become a critical characteristic.

Significant Characteristic is a feature, dimension, or note that reasonably anticipated variation could affect principal fit, function, durability, customer satisfaction, or manufacturability. Any of those characteristics that affect a failure mode with a severity of 5 to 8 and an occurrence of 4 or higher must be reviewed to determine if they should become a significant characteristic
How does this improve the quality?
 

Miner

Forum Moderator
Staff member
Admin
#8
These are characteristics that require special action to mitigate the risk. That action might be a design change to reduce the severity, preventive controls to reduce occurrence, or detection controls.
 
Thread starter Similar threads Forum Replies Date
A AMS Specification QQ-N-290 - What does the class 1, Type IV (QS) mean? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
E Does every metallic part have to be protectively earthed (class I ME)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Does Class I (exempt) device have requirements of Shelf Life and Expiration Dating ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J How does your organization store documents for Class I and Class II Medical Devices? Benchmarking 4
B Does a US FDA Class I (exempt) device require a Statement of Intended Use? Other US Medical Device Regulations 3
I Biocompatibility Testing Requirements for a Class I device - Does not contact patient 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C Does a "Significant Change" apply to Class II Medical Devices? Canada Medical Device Regulations 8
D SAE AMS 2750D - Pyrometry - Heat Treating - Does anyone know of a good class? Training - Internal, External, Online and Distance Learning 5
L CE Mark - FDA - Class I traction systems - What is involved and how long does it take EU Medical Device Regulations 5
D Does anyone know of a good FMEA training class for TE Supplement suppliers? Training - Internal, External, Online and Distance Learning 2
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
0 To which part of 13485 does this refer? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
lanley liao Does the customer`s trademark belong to customer-supplied property? Oil and Gas Industry Standards and Regulations 2
H How does a gas turbine work on diesel fuel? Oil and Gas Industry Standards and Regulations 12
G What does performance specification include? US Food and Drug Administration (FDA) 1
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
B Does anybody know how to get older versions of Minitab to work in Windows 10? Quality Tools, Improvement and Analysis 9
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
C Does an accessory need an IFU if it use is discussed in the Parent device IFU? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S How long does it take to register a product with MHRA? UK Medical Device Regulations 3
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16

Similar threads

Top Bottom