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BS EN IEC 60812:2018

BS EN IEC 60812:2018

$215.11

Failure modes and effects analysis (FMEA and FMECA)

Published By Publication Date Number of Pages
BSI 2018 82
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IEC 60812:2018 explains how failure modes and effects analysis (FMEA), including the failure modes, effects and criticality analysis (FMECA) variant, is planned, performed, documented and maintained. The purpose of failure modes and effects analysis (FMEA) is to establish how items or processes might fail to perform their function so that any required treatments could be identified. An FMEA provides a systematic method for identifying modes of failure together with their effects on the item or process, both locally and globally. It may also include identifying the causes of failure modes. Failure modes can be prioritized to support decisions about treatment. Where the ranking of criticality involves at least the severity of consequences, and often other measures of importance, the analysis is known as failure modes, effects and criticality analysis (FMECA). This document is applicable to hardware, software, processes including human action, and their interfaces, in any combination. An FMEA can be used in a safety analysis, for regulatory and other purposes, but this being a generic standard, does not give specific guidance for safety applications. This third edition cancels and replaces the second edition published in 2006. This edition constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition: a) the normative text is generic and covers all applications; b) examples of applications for safety, automotive, software and (service) processes have been added as informative annexes; c) tailoring the FMEA for different applications is described; d) different reporting formats are described, including a database information system; e) alternative means of calculating risk priority numbers (RPN) have been added; f) a criticality matrix based method has been added; g) the relationship to other dependability analysis methods have been described. Keywords: failure modes and effects analysis (FMEA), failure modes effects and criticality analysis (FMECA)

PDF Catalog

PDF Pages PDF Title
2 undefined
5 Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
6 English
CONTENTS
10 FOREWORD
12 INTRODUCTION
13 1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
17 3.2 Abbreviated terms
18 4 Overview
4.1 Purpose and objectives
4.2 Roles, responsibilities and competences
19 4.3 Terminology
5 Methodology for FMEA
5.1 General
Tables
Table 1 – Example of terms commonly associated with levels of hierarchy
20 Figures
Figure 1 – Overview of FMEA methodology before tailoring
21 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
23 5.2.4 Define decision criteria for treatment of failure modes
24 5.2.5 Determine documentation and reporting requirements
25 5.2.6 Define resources for analysis
26 5.3 Perform the FMEA
5.3.1 General
5.3.2 Sub-divide item or process into elements
27 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
28 5.3.6 Identify local and final effects of failure modes
29 5.3.7 Identify failure causes
30 5.3.8 Evaluate relative importance of failure modes
32 5.3.9 Identify actions
33 5.4 Document the FMEA
34 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
35 A.1.3 Degree of detail in analysis
Table A.1 – Characteristics of top-down and bottom-up approaches to FMEA
36 A.1.4 Prioritization of failure modes
37 A.2 Factors influencing FMEA tailoring
A.2.1 Reuse of data/information from analysis of similar item
Table A.2 – General application of common approaches to FMEA
38 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
39 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
40 A.3.4 Example of tailoring an FMEA for medical processes
A.3.5 Example of tailoring an FMEA for electronic control systems
41 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
42 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
43 B.2.3 Assessing likelihood
44 B.3 Assigning criticality using a matrix or plot
B.3.1 General
B.3.2 Criticality matrix
Figure B.1 – Example of a qualitative criticality matrix
45 B.3.3 Criticality plots
Figure B.2 – Examples of criticality plots
46 B.4 Assigning criticality using a risk priority number
B.4.1 General
B.4.2 Risk priority number
48 B.4.3 Alternative risk priority number method
50 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
51 Figure C.1 – Database information system to support FMEA report generation
Figure C.2 – Diagram of power supply type XYZ
52 Table C.1 – Example of fields selected for FMEA report of power supply based on database information
53 Table C.2 – Example of report of component FMEA
54 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
55 Figure C.3 – Criticality matrix for FMECA report in Table C.5 created as a two dimensional image without taking into account detectability
Table C.5 – Example of report of FMECA using criticality matrix for global effect
56 Annex D (informative)Relationship between FMEA and other dependability analysis techniques
57 Annex E (informative)Application considerations for FMEA
E.1 General
E.2 Software FMEA
59 E.3 Process FMEA
Figure E.1 – General software failure model for a component software unit (CSU)
60 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
61 E.6.2 FMEA in planning a safety application
E.6.3 Criticality analysis including diagnostics
62 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
63 E.7.3 Criticality assessment for repairable systems with allocated availability
Figure E.2 – Allocation of system failure probabilities
64 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
Table F.1 – Extract from FMEA of the process of ordering a drug from a pharmacy
65 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
Table F.2 – Extract from FMEA of paint spraying step of a manufacturing process
66 F.5 Example of an FMEA with criticality analysis for a complex non-repaired system
Figure F.1 – Hierarchy of a series electronic system, its subsystemsand assemblies with allocated unreliability values, F(t)
67 F.6 Software application for a blood sugar calculator
F.7 Automotive electronics device
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
68 F.8 Maintenance and support application for a hi-fi system
Figure F.2 – Automotive air-bag part
69 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
Table F.5 – Hazards and safe/dangerous failures in an automated train control system
70 F.11 Marking and encapsulation process for an electronic component
71 Table F.6 – Extract from FMEA of the process of monitoring blood sugar (1 of 2)
73 Table F.7 – Extract of automotive electronic part FMEA
74 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
75 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
76 Table F.12 – Extract from an FMEDA for an electronic circuit in a safety control system (1 of 2)
78 Table F.13 – Extract from an FMEA for a coffee-maker
79 Table F.14 – Extract from an FMEA for an electronic component marking and encapsulation process
80 Bibliography

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BS EN IEC 60812:2018
$215.11