SFMEA - System Failure Mode Analysis

H

hollowman010

#1
SFMEA

HI GUYS, CAN SOMEBODY TELL ME WHERE CAN I FOUND INFORMATION RELATED TO SFMEA (SYSTEM FAILURE MODE ANALYSIS), MENTIONED IN FMEA MANUAL?
 
Elsmar Forum Sponsor
R

Rick Goodson

#5
There is a chapter in the Stamatis book, "Failure Mode and Effect Analysis, FMEA from theory to Execution" ISBN 0-87389-300-X. Stamatis says "A system FMEA usually is accomplished through a series of steps to include conceptual design, detail design and development, and test and evaluation...The design in this phase is an evolutionary process involving the application of various technologies and methods to produce an effective system ouput. The results will be used as an input for the design FMEA...The focus in this stage is to transform an operational need into a description of system performance parameters and as perfect as possible system configuration through the use of an interactive process of functional analysis, synthesis, optimization, design, test, and evaluation."

Hope that helps.
 
P

Paul Alexander

#6
I am at present facilitating workshops for Systems FMEAs on a new car platform. The approach I have taken is to treat each component/sub-system as a black box and try to concentrate on the system interactions.

Historically, people (okay engineers!) are good at doing their thing, but are not good at communication to others.

SFMEA makes them consider how their product affects the entire system as a whole and like a DFMEA can look at potential failures, effect, and possible design controls.

If anyone has any other comments or viewpoints I would be glad to hear them.
 
Thread starter Similar threads Forum Replies Date
O Quality Management System Implementation framework and Gap analysis checklist Manufacturing and Related Processes 7
A Applying agile model for Computer system Validation Medical Device and FDA Regulations and Standards News 2
Q Change Control Numbering system Document Control Systems, Procedures, Forms and Templates 6
G RO/DI water system qualification Qualification and Validation (including 21 CFR Part 11) 3
T Quality Management System Q1 and Q2 Interpretations Misc. Quality Assurance and Business Systems Related Topics 0
Sidney Vianna Informational ISO/CD 7101 Health Care Quality Management System Standard Hospitals, Clinics & other Health Care Providers 0
G Logging of a decision if a computerized system needs to be validated ISO 13485:2016 - Medical Device Quality Management Systems 5
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
R Quality adjusting inventory in ERP system AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
C Do components of a system require UDIs? Other US Medical Device Regulations 4
R SAP B1 Computer System Validation Qualification and Validation (including 21 CFR Part 11) 0
D Verify Audit Trail of SaaS system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
K System of medical devices EU Medical Device Regulations 0
D Validating Operating system Qualification and Validation (including 21 CFR Part 11) 4
H Article 22 MDR System EU Medical Device Regulations 16
S Searching for TOYOTA Floor Management Development System (FMDS) board Customer and Company Specific Requirements 3
M Procedure for vigilance system according to new MDR EU Medical Device Regulations 0
bobdoering Most typical universal Quality System Funny Stuff - Jokes and Humour 8
G Organizing internal audit program for an Integrated QHSE Management System Internal Auditing 13
K Bioreactor/ incubator system in tissue engineering EU Medical Device Regulations 9
D Integrated Management System Software Quality Manager and Management Related Issues 2
E System&Procedure pack or accessory EU Medical Device Regulations 0
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
C Quality Management System Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
V Csv, excel format - audit trail file of HPLC system ( Empower, openlab, EZchrom or any other ) Qualification and Validation (including 21 CFR Part 11) 0
I Class VI certification on seals, o-ring and plastic for a WFI system Qualification and Validation (including 21 CFR Part 11) 0
A System for Supplier Documents Quality Assurance and Compliance Software Tools and Solutions 7
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
T Device & Accessory, Components in device, or System EU Medical Device Regulations 0
M Go Live With New ERP System before Recertification Audit General Auditing Discussions 6
John C. Abnet Terms- Different Items in a system ISO 26262 - Road vehicles – Functional safety 0
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
G Management Review (integrated system) Management Review Meetings and related Processes 21
M Unique Quality Management System for 2 sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Orthopedic Implants (Knee system) Sterilization Indicators Manufacturing and Related Processes 6
C Projects in the CAPA system Preventive Action and Continuous Improvement 6
E Insulation diagram for ECG monitoring and diagnosis system. IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Quality System Functional Safety Checklist / Guidance IATF 16949 - Automotive Quality Systems Standard 0
J Mastercontrol or other system ISO 13485:2016 - Medical Device Quality Management Systems 0
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P MSA - what exactly mean "system" and master sample Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
P MSA study for visual system with artifical inteligence Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
D Big companies suffer from quality management system? ISO 13485:2016 - Medical Device Quality Management Systems 1
qualprod Assign a name to a home-made ERP system? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
H IEC 60601-1 ME equipment or ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Biological indicator system classification under MDR EU Medical Device Regulations 2
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
J Audit Checklist for Integrated Management System for ISO 9001:2015, ISO 14001 & OHSAS18001 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R How would you work without a quality management system? IATF 16949 - Automotive Quality Systems Standard 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom