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)<\/p>\n
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| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Annex ZA(normative)Normative references to international publicationswith their corresponding European publications <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | English CONTENTS <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | FOREWORD <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | INTRODUCTION <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 1 Scope 2 Normative references 3 Terms, definitions and abbreviated terms 3.1 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 3.2 Abbreviated terms <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 4 Overview 4.1 Purpose and objectives 4.2 Roles, responsibilities and competences <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4.3 Terminology 5 Methodology for FMEA 5.1 General Tables Table 1 \u2013 Example of terms commonly associated with levels of hierarchy <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | Figures Figure 1 \u2013 Overview of FMEA methodology before tailoring <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 5.2.4 Define decision criteria for treatment of failure modes <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 5.2.5 Determine documentation and reporting requirements <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 5.2.6 Define resources for analysis <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 5.3 Perform the FMEA 5.3.1 General 5.3.2 Sub-divide item or process into elements <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 5.3.6 Identify local and final effects of failure modes <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 5.3.7 Identify failure causes <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 5.3.8 Evaluate relative importance of failure modes <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 5.3.9 Identify actions <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 5.4 Document the FMEA <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | A.1.3 Degree of detail in analysis Table A.1 \u2013 Characteristics of top-down and bottom-up approaches to FMEA <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | A.1.4 Prioritization of failure modes <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | A.2 Factors influencing FMEA tailoring A.2.1 Reuse of data\/information from analysis of similar item Table A.2 \u2013 General application of common approaches to FMEA <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | A.3.4 Example of tailoring an FMEA for medical processes A.3.5 Example of tailoring an FMEA for electronic control systems <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | B.2.3 Assessing likelihood <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | B.3 Assigning criticality using a matrix or plot B.3.1 General B.3.2 Criticality matrix Figure B.1 \u2013 Example of a qualitative criticality matrix <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | B.3.3 Criticality plots Figure B.2 \u2013 Examples of criticality plots <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | B.4 Assigning criticality using a risk priority number B.4.1 General B.4.2 Risk priority number <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | B.4.3 Alternative risk priority number method <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | Figure C.1 \u2013 Database information system to support FMEA report generation Figure C.2 \u2013 Diagram of power supply type XYZ <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | Table C.1 \u2013 Example of fields selected for FMEA report of power supply based on database information <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | Table C.2 \u2013 Example of report of component FMEA <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Table C.3 \u2013 Example of report of parts with possible common cause failures Table C.4 \u2013 Example of report of FMECA using RPN criticality analysis <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | Figure C.3 \u2013 Criticality matrix for FMECA report in Table C.5 created as a two dimensional image without taking into account detectability Table C.5 \u2013 Example of report of FMECA using criticality matrix for global effect <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | Annex D (informative)Relationship between FMEA and other dependability analysis techniques <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | Annex E (informative)Application considerations for FMEA E.1 General E.2 Software FMEA <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | E.3 Process FMEA Figure E.1 \u2013 General software failure model for a component software unit (CSU) <\/td>\n<\/tr>\n | ||||||
| 60<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | E.6.2 FMEA in planning a safety application E.6.3 Criticality analysis including diagnostics <\/td>\n<\/tr>\n | ||||||
| 62<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 63<\/td>\n | E.7.3 Criticality assessment for repairable systems with allocated availability Figure E.2 \u2013 Allocation of system failure probabilities <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | 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 \u2013 Extract from FMEA of the process of ordering a drug from a pharmacy <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | 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 \u2013 Extract from FMEA of paint spraying step of a manufacturing process <\/td>\n<\/tr>\n | ||||||
| 66<\/td>\n | F.5 Example of an FMEA with criticality analysis for a complex non-repaired system Figure F.1 \u2013 Hierarchy of a series electronic system, its subsystemsand assemblies with allocated unreliability values, F(t) <\/td>\n<\/tr>\n | ||||||
| 67<\/td>\n | F.6 Software application for a blood sugar calculator F.7 Automotive electronics device Table F.3 \u2013 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 \u2013 Allocation and assessment of unreliability values for different criticality categories of failure modes for subsystem 2 of the system represented in Figure F.1 <\/td>\n<\/tr>\n | ||||||
| 68<\/td>\n | F.8 Maintenance and support application for a hi-fi system Figure F.2 \u2013 Automotive air-bag part <\/td>\n<\/tr>\n | ||||||
| 69<\/td>\n | 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 \u2013 Hazards and safe\/dangerous failures in an automated train control system <\/td>\n<\/tr>\n | ||||||
| 70<\/td>\n | F.11 Marking and encapsulation process for an electronic component <\/td>\n<\/tr>\n | ||||||
| 71<\/td>\n | Table F.6 \u2013 Extract from FMEA of the process of monitoring blood sugar (1 of 2) <\/td>\n<\/tr>\n | ||||||
| 73<\/td>\n | Table F.7 \u2013 Extract of automotive electronic part FMEA <\/td>\n<\/tr>\n | ||||||
| 74<\/td>\n | Table F.8 \u2013 Extract from system FMEA for a remote control for a hi-fi system Table F.9 \u2013 Extract from design FMEA for a remote control for a hi-fi system <\/td>\n<\/tr>\n | ||||||
| 75<\/td>\n | Table F.10 \u2013 Extract from process FMEA for a remote control for a hi-fi system Table F.11 \u2013 Extract from maintenance service FMEA for a remote control for a hi-fi system <\/td>\n<\/tr>\n | ||||||
| 76<\/td>\n | Table F.12 \u2013 Extract from an FMEDA for an electronic circuit in a safety control system (1 of 2) <\/td>\n<\/tr>\n | ||||||
| 78<\/td>\n | Table F.13 \u2013 Extract from an FMEA for a coffee-maker <\/td>\n<\/tr>\n | ||||||
| 79<\/td>\n | Table F.14 \u2013 Extract from an FMEA for an electronic component marking and encapsulation process <\/td>\n<\/tr>\n | ||||||
| 80<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Failure modes and effects analysis (FMEA and FMECA)<\/b><\/p>\n |