FMEA as a Risk Analysis Tool for ISO 14001 Aspects and Impacts Analysis

E

Eric Sleeckx

#1
FMEA and ISO14000


I want to use a kind of FMEA-procedure in ISO14000 to prevent envir. risks. Is there such a procedure available, where, suggestions?
 
Elsmar Forum Sponsor
L

Lassitude

#2
I don't know of such a 'procedure', but I expect you could use the 'standard' FMEA format. Then just do your pridictions and such. You might want to make it a 5 level rating sequence, rather than a 10 level.
 

Kevin Mader

One of THE Original Covers!
Leader
Admin
#3
Eric,

I agree with Lassitude. I use the FMEA format for many different types of Risk Analysis. What you will need to do is to create a rating system for Severity, Occurrence, and Detection if you can not find an accepted "industry" format. It is important to keep in mind that you are the authority for your processes/products provided you do not have to observe a mandated (regulatory) standard or practice. These authorities will need to discuss and agree what the rating (scale) system will be. I recommend that you all are in full agreement prior to starting this process as it isn't recommended that you change the process midstream.

Regards,

Kevin
 
Thread starter Similar threads Forum Replies Date
R The difference b/w FMEA & Risk analysis as per iso 14971 ISO 14971 - Medical Device Risk Management 8
P FMEA Risk Analysis Recommended Action Priority FMEA and Control Plans 2
M Name for FMEA (Risk Analysis Approach) Program FMEA and Control Plans 1
M ISO 14971 Risk Analysis and use of a DFMEA (Design FMEA) ISO 14971 - Medical Device Risk Management 8
M Risk Analysis using FMEA Process Flow Chart - Health Care Information System FMEA and Control Plans 6
U 1. Hardware Life Cycle; 2. Requirements tracking; 3. FMEA Risk Analysis ISO 13485:2016 - Medical Device Quality Management Systems 7
J Medical Device Risk Analysis - FMEA vs ALARP (As Low As Reasonably Possible) FMEA and Control Plans 3
howste FMEA vs. Risk Analysis - What are the differences - Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 10
Q FMEA and Risk assessment in Microsoft Access FMEA and Control Plans 6
M Risk and Corrective actions - Currently no FMEA's - Car systems Risk Management Principles and Generic Guidelines 8
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
F Risk Management vs. FMEA ISO 14971 - Medical Device Risk Management 11
Moncia Recalculating RPN (FMEA Risk Priority Number) - Customer Request APQP and PPAP 10
R Is PFMEA (Process FMEA) for OEM sufficient to address Risk? ISO 13485:2016 - Medical Device Quality Management Systems 7
V Risk Assessment Precedence - FMEA > Risk Matrix (Modified PHA) > Ishikawa? FMEA and Control Plans 11
P What are FMEA Risk assessment techniques? FMEA and Control Plans 4
J Online FMEA Risk Management Course Recommendations ISO 14971 - Medical Device Risk Management 2
V Examples of Risk Assessment (FMEA) through the Life Cycle of the Product Development ISO 14971 - Medical Device Risk Management 16
K Risk Assessment / FMEA - Using the same Risk Opportunities - Opinion Question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
R TS 16949 Alternative Risk Assessment FMEA, Apendix C Requirements FMEA and Control Plans 5
T Using FMEA to determine Risk in minimising Testing FMEA and Control Plans 6
J FMEA Evaluation of "User Risk" - Wording FMEA 3rd party advisors ISO 14971 - Medical Device Risk Management 3
I Feasibility Study rather than an FMEA on a Risk Issue - Clause 7.2.2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
B What to include in a "Risk management/FMEA" process FMEA and Control Plans 3
M Include Risk of Rework in a PFMEA (Process FMEA)? FMEA and Control Plans 5
J FMEA "Types" - ISO 14971 (Medical Devices - Application of Risk Management) ISO 14971 - Medical Device Risk Management 7
C Is Risk Assessment Still Necessary? The AIAG FMEA Manual does not address FMEA and Control Plans 1
A FMEA Risk Priority Number Reduction Worksheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
L TS 16949 - Feasibility Review, including Risk Anaylsis vs. FMEA General Auditing Discussions 4
A FMEA 3rd edition - FMEA is required only for high risk operations? FMEA and Control Plans 7
D Twin Screw Extrusion FMEA FMEA and Control Plans 4
M FMEA Severity Scores Between Two Sister divisions? FMEA and Control Plans 6
Casana Step 7 in AIAG/VDA FMEA form FMEA and Control Plans 15
C FMEA Severity Rating for aggravating failures IATF 16949 - Automotive Quality Systems Standard 6
A FMEA Official Rankings S-O-D? FMEA and Control Plans 9
R FMEA's for non-manufacturing sites FMEA and Control Plans 4
M ISO 14971:2019 vs FMEA methodology ISO 14971 - Medical Device Risk Management 23
Y FMEA link to Control Plan frequency and sample size FMEA and Control Plans 19
A FMEA Software IATF 16949 - Automotive Quality Systems Standard 6
Dan Pare Ford CSR Update (FMEA's) - January 2022 FMEA and Control Plans 24
H RPN in AIaG-VDA FMEA Manual FMEA and Control Plans 1
M Process FMEA for Laser Cutting/Press Brake/Welding FMEA and Control Plans 2
L Looking for Control Plan and FMEA Stamping process FMEA and Control Plans 2
OpExPro AIAG VDA FMEA Rating Tables FMEA and Control Plans 5
OpExPro The note at the bottom of DFMEA occurrence tables in AIAG VDA FMEA FMEA and Control Plans 0
W FMEA - Current control and occurrence rating FMEA and Control Plans 3
J FMEA Handbook 2019 IATF 16949 - Automotive Quality Systems Standard 3
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 4
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
P Design FMEA - Detection Rating criteria ISO 14971 - Medical Device Risk Management 3

Similar threads

Top Bottom