AS/NZS IEC 60812:2020
Failure modes and effects analysis (FMEA and FMECA)
Objective of this Standard is to explain how failure modes and effects analysis (FMEA), including the failure modes, effects and criticality analysis (FMECA) variant, is planned, performed, documented and maintained. This Standard is identical with, and has been reproduced from, IEC 60812:2018, Failure modes and effects analysis (FMEA and FMECA).
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AS/NZS IEC 60812:2020 Failure modes and effects analysis (FMEA and FMECA)
CONTENTS
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviated terms
4 Overview
4.1 Purpose and objectives
4.2 Roles, responsibilities and competences
4.3 Terminology
5 Methodology for FMEA
5.1 General
5.2 Plan the FMEA
5.2.1 General
5.2.2 Define the objectives and scope of analysis
5.2.3 Identify boundaries and scenarios
5.2.4 Define decision criteria for treatment of failure modes
5.2.5 Determine documentation and reporting requirements
5.2.6 Define resources for analysis
5.3 Perform the FMEA
5.3.1 General
5.3.2 Sub-divide item or process into elements
5.3.3 Identify functions and performance standards for each element
5.3.4 Identify failure modes
5.3.5 Identify detection methods and existing controls
5.3.6 Identify local and final effects of failure modes
5.3.7 Identify failure causes
5.3.8 Evaluate relative importance of failure modes
5.3.9 Identify actions
5.4 Document the FMEA
Annex A (informative)General considerations for tailoring an FMEA
A.1 General
A.1.1 Overview
A.1.2 Start point for FMEA in the hierarchy
A.1.3 Degree of detail in analysis
A.1.4 Prioritization of failure modes
A.2 Factors influencing FMEA tailoring
A.2.1 Reuse of data/information from analysis of similar item
A.2.2 Maturity of item design and project progress
A.2.3 Degree of innovation
A.3 Examples of FMEA tailoring for items and processes
A.3.1 General
A.3.2 Example of tailoring an FMEA for an office equipment product
A.3.3 Example of tailoring an FMEA for a distributed power system
A.3.4 Example of tailoring an FMEA for medical processes
A.3.5 Example of tailoring an FMEA for electronic control systems
A.3.6 Example of tailoring an FMEA for a pump hydro block
A.3.7 Example of tailoring an FMEA for a wind turbine for power generation
Annex B (informative)Criticality analysis methods
B.1 General
B.2 Measurement scales for criticality parameters
B.2.1 General
B.2.2 Scale definition
B.2.3 Assessing likelihood
B.3 Assigning criticality using a matrix or plot
B.3.1 General
B.3.2 Criticality matrix
B.3.3 Criticality plots
B.4 Assigning criticality using a risk priority number
B.4.1 General
B.4.2 Risk priority number
B.4.3 Alternative risk priority number method
Annex C (informative)Example of FMEA report content
C.1 General
C.2 Example of generation of reports from a database information system for an FMEA of a power supply unit
Annex D (informative)Relationship between FMEA and other dependability analysis techniques
Annex E (informative)Application considerations for FMEA
E.1 General
E.2 Software FMEA
E.3 Process FMEA
E.4 FMEA for design and development
E.5 FMEA within reliability centred maintenance
E.6 FMEA for safety related control systems
E.6.1 General
E.6.2 FMEA in planning a safety application
E.6.3 Criticality analysis including diagnostics
E.7 FMEA for complex systems with reliability allocation
E.7.1 General
E.7.2 Criticality assessment for non-repairable systems with allocated unreliability
E.7.3 Criticality assessment for repairable systems with allocated availability
Annex F (informative)Examples of FMEA from industry applications
F.1 General
F.2 Health process application for drug ordering process
F.3 Manufacturing process application for paint spraying
F.4 Design application for a water pump
F.4.1 General
F.4.2 Item function
F.4.3 Item failure modes
F.4.4 Item failure effects
F.5 Example of an FMEA with criticality analysis for a complex non-repaired system
F.6 Software application for a blood sugar calculator
F.7 Automotive electronics device
F.8 Maintenance and support application for a hi-fi system
F.9 Safety related control system applications
F.9.1 Electronic circuit
F.9.2 Automated train control system
F.10 FMEA including human factors analysis
F.11 Marking and encapsulation process for an electronic component
Bibliography
Figures
Figure 1 – Overview of FMEA methodology before tailoring
Figure B.1 – Example of a qualitative criticality matrix
Figure B.2 – Examples of criticality plots
Figure C.1 – Database information system to support FMEA report generation
Figure C.2 – Diagram of power supply type XYZ
Figure C.3 – Criticality matrix for FMECA report in Table C.5 created as a two dimensional image without taking into account detectability
Figure E.1 – General software failure model for a component software unit (CSU)
Figure E.2 – Allocation of system failure probabilities
Figure F.1 – Hierarchy of a series electronic system, its subsystemsand assemblies with allocated unreliability values, F(t)
Figure F.2 – Automotive air-bag part
Tables
Table 1 – Example of terms commonly associated with levels of hierarchy
Table A.1 – Characteristics of top-down and bottom-up approaches to FMEA
Table A.2 – General application of common approaches to FMEA
Table C.1 – Example of fields selected for FMEA report of power supply based on database information
Table C.2 – Example of report of component FMEA
Table C.3 – Example of report of parts with possible common cause failures
Table C.4 – Example of report of FMECA using RPN criticality analysis
Table C.5 – Example of report of FMECA using criticality matrix for global effect
Table F.1 – Extract from FMEA of the process of ordering a drug from a pharmacy
Table F.2 – Extract from FMEA of paint spraying step of a manufacturing process
Table F.3 – Allocation and assessment of unreliability values for different criticality categories of failure modes for the electronic system represented in Figure F.1
Table F.4 – Allocation and assessment of unreliability values for different criticality categories of failure modes for subsystem 2 of the system represented in Figure F.1
Table F.5 – Hazards and safe/dangerous failures in an automated train control system
Table F.6 – Extract from FMEA of the process of monitoring blood sugar (1 of 2)
Table F.7 – Extract of automotive electronic part FMEA
Table F.8 – Extract from system FMEA for a remote control for a hi-fi system
Table F.9 – Extract from design FMEA for a remote control for a hi-fi system
Table F.10 – Extract from process FMEA for a remote control for a hi-fi system
Table F.11 – Extract from maintenance service FMEA for a remote control for a hi-fi system
Table F.12 – Extract from an FMEDA for an electronic circuit in a safety control system (1 of 2)
Table F.13 – Extract from an FMEA for a coffee-maker
Table F.14 – Extract from an FMEA for an electronic component marking and encapsulation process
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AS/NZS IEC 60812:2020 Failure modes and effects analysis (FMEA and FMECA)
CONTENTS
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviated terms
4 Overview
4.1 Purpose and objectives
4.2 Roles, responsibilities and competences
4.3 Terminology
5 Methodology for FMEA
5.1 General
5.2 Plan the FMEA
5.2.1 General
5.2.2 Define the objectives and scope of analysis
5.2.3 Identify boundaries and scenarios
5.2.4 Define decision criteria for treatment of failure modes
5.2.5 Determine documentation and reporting requirements
5.2.6 Define resources for analysis
5.3 Perform the FMEA
5.3.1 General
5.3.2 Sub-divide item or process into elements
5.3.3 Identify functions and performance standards for each element
5.3.4 Identify failure modes
5.3.5 Identify detection methods and existing controls
5.3.6 Identify local and final effects of failure modes
5.3.7 Identify failure causes
5.3.8 Evaluate relative importance of failure modes
5.3.9 Identify actions
5.4 Document the FMEA
Annex A (informative)General considerations for tailoring an FMEA
A.1 General
A.1.1 Overview
A.1.2 Start point for FMEA in the hierarchy
A.1.3 Degree of detail in analysis
A.1.4 Prioritization of failure modes
A.2 Factors influencing FMEA tailoring
A.2.1 Reuse of data/information from analysis of similar item
A.2.2 Maturity of item design and project progress
A.2.3 Degree of innovation
A.3 Examples of FMEA tailoring for items and processes
A.3.1 General
A.3.2 Example of tailoring an FMEA for an office equipment product
A.3.3 Example of tailoring an FMEA for a distributed power system
A.3.4 Example of tailoring an FMEA for medical processes
A.3.5 Example of tailoring an FMEA for electronic control systems
A.3.6 Example of tailoring an FMEA for a pump hydro block
A.3.7 Example of tailoring an FMEA for a wind turbine for power generation
Annex B (informative)Criticality analysis methods
B.1 General
B.2 Measurement scales for criticality parameters
B.2.1 General
B.2.2 Scale definition
B.2.3 Assessing likelihood
B.3 Assigning criticality using a matrix or plot
B.3.1 General
B.3.2 Criticality matrix
B.3.3 Criticality plots
B.4 Assigning criticality using a risk priority number
B.4.1 General
B.4.2 Risk priority number
B.4.3 Alternative risk priority number method
Annex C (informative)Example of FMEA report content
C.1 General
C.2 Example of generation of reports from a database information system for an FMEA of a power supply unit
Annex D (informative)Relationship between FMEA and other dependability analysis techniques
Annex E (informative)Application considerations for FMEA
E.1 General
E.2 Software FMEA
E.3 Process FMEA
E.4 FMEA for design and development
E.5 FMEA within reliability centred maintenance
E.6 FMEA for safety related control systems
E.6.1 General
E.6.2 FMEA in planning a safety application
E.6.3 Criticality analysis including diagnostics
E.7 FMEA for complex systems with reliability allocation
E.7.1 General
E.7.2 Criticality assessment for non-repairable systems with allocated unreliability
E.7.3 Criticality assessment for repairable systems with allocated availability
Annex F (informative)Examples of FMEA from industry applications
F.1 General
F.2 Health process application for drug ordering process
F.3 Manufacturing process application for paint spraying
F.4 Design application for a water pump
F.4.1 General
F.4.2 Item function
F.4.3 Item failure modes
F.4.4 Item failure effects
F.5 Example of an FMEA with criticality analysis for a complex non-repaired system
F.6 Software application for a blood sugar calculator
F.7 Automotive electronics device
F.8 Maintenance and support application for a hi-fi system
F.9 Safety related control system applications
F.9.1 Electronic circuit
F.9.2 Automated train control system
F.10 FMEA including human factors analysis
F.11 Marking and encapsulation process for an electronic component
Bibliography
Figures
Figure 1 – Overview of FMEA methodology before tailoring
Figure B.1 – Example of a qualitative criticality matrix
Figure B.2 – Examples of criticality plots
Figure C.1 – Database information system to support FMEA report generation
Figure C.2 – Diagram of power supply type XYZ
Figure C.3 – Criticality matrix for FMECA report in Table C.5 created as a two dimensional image without taking into account detectability
Figure E.1 – General software failure model for a component software unit (CSU)
Figure E.2 – Allocation of system failure probabilities
Figure F.1 – Hierarchy of a series electronic system, its subsystemsand assemblies with allocated unreliability values, F(t)
Figure F.2 – Automotive air-bag part
Tables
Table 1 – Example of terms commonly associated with levels of hierarchy
Table A.1 – Characteristics of top-down and bottom-up approaches to FMEA
Table A.2 – General application of common approaches to FMEA
Table C.1 – Example of fields selected for FMEA report of power supply based on database information
Table C.2 – Example of report of component FMEA
Table C.3 – Example of report of parts with possible common cause failures
Table C.4 – Example of report of FMECA using RPN criticality analysis
Table C.5 – Example of report of FMECA using criticality matrix for global effect
Table F.1 – Extract from FMEA of the process of ordering a drug from a pharmacy
Table F.2 – Extract from FMEA of paint spraying step of a manufacturing process
Table F.3 – Allocation and assessment of unreliability values for different criticality categories of failure modes for the electronic system represented in Figure F.1
Table F.4 – Allocation and assessment of unreliability values for different criticality categories of failure modes for subsystem 2 of the system represented in Figure F.1
Table F.5 – Hazards and safe/dangerous failures in an automated train control system
Table F.6 – Extract from FMEA of the process of monitoring blood sugar (1 of 2)
Table F.7 – Extract of automotive electronic part FMEA
Table F.8 – Extract from system FMEA for a remote control for a hi-fi system
Table F.9 – Extract from design FMEA for a remote control for a hi-fi system
Table F.10 – Extract from process FMEA for a remote control for a hi-fi system
Table F.11 – Extract from maintenance service FMEA for a remote control for a hi-fi system
Table F.12 – Extract from an FMEDA for an electronic circuit in a safety control system (1 of 2)
Table F.13 – Extract from an FMEA for a coffee-maker
Table F.14 – Extract from an FMEA for an electronic component marking and encapsulation process