IEC 60812-2018 pdf free download.Failure modes and effects analysis (FMEA and 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
IEC 60050-192, International electrotechnical vocabulary — Part 192: Dependability (available at http://www.electropedia.org)
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
For the purpose of this document, the terms and definitions given in IEC 60050-192 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http:/!www.electropedia.orgl
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1.1 failure mode DEPRECATED: fault mode manner in which failure occurs
3.1.2 failure effect consequence of a failure, within or beyond the boundary of the failed item
Note 1 to entry: For some analyses, it may be necessary to consider individual failure modes and their effects.
Note 2 to entry: Failure effect also covers the consequence of a failure, within or beyond the boundary of the tailed process.
(SOURCE: IEC 60050-192:2015. 192-03-08. modified — Note 2 has been added.]
3.1.3 system combination of interacting elements organized to achieve one or more stated purposes
3.1.4 item subject being considered
4.3 Terminology
For convenience in this document, the title lailure modes and effects analysis abbreviated to “FMEA” is used as a generic term to represent any application or degree of tailoring of the analysis, including FMECA.
The term “item or “process” is used to denote the subject of the FMEA analysis. The item or process can be part of a larger system for which multiple FMEA analyses are required. Examples of the terms commonly associated with the top, mid and low hierarchy levels are given in Table 1. The terms within Table 1 are not exhaustive. For example, software can be embedded within a hardware system, or a system can contain human aspects.
5 Methodology for FMEA
5.1 General
Figure 1 shows a flowchart of the activities undertaken during an FMEA. It distinguishes three phases: planning, performing, and documenting. The activities are normally performed sequentially but there can be iterations, for example when FMEA is performed as part of a development programme, or where the analysed system is subject to change.
An FMEA should be conducted in a manner that is consistent with any legislation, which is in effect within the scope of FMEA, or the type of risks involved.
When reference is made in this document to record/identify/specifyldescribe/state/document some information, it means the information is to be included in the relevant FMEA documentation, for example FMEA report, FMEA plan, post-FMEA documentation such as the action plan.
The activities shown in Figure 1 should be tailored to the application. This means that not all the listed activities always need to be performed. Annex A gives general guidance and examples of tailoring.
5.2 Plan the FMEA
5.2.1 General
Planning an FMEA involves considering why an analysis is to be performed, what item or process elements are to be analysed and under what scenarios, and how the analysis should be most effectively and efficiently performed. Managers and stakeholders should be consulted, as appropriate, so that their objectives and interests in the analysis are properly understood and taken into account.
The output of the planning phase is an FMEA plan that describes a tailored, cost effective application of the FMEA for the particular context that:
• defines the objectives and scope of analysis (5.2.2);
• identifies the analysis boundaries and use scenarios (5.2.3);
• defines decision criteria for the treatment of failure modes (52.4);
• determines how the analysis will be documented and reported (5.2.5);
• specifies how resources will be allocated to the analysis activities (5.2.6).
The plan can also include a description of the factors which influence the approach to analysis, such as:
• a description of the interfaces with project milestones to determine the required timing of analysis outcomes;
• methodologies or documentation for understanding the item function or process sequence;
• contractual requirements;
• previous experience and available information.
The FMEA plan can be stand-alone or part of a higher level document, such as a project plan
or a system engineering management plan.
5.2.2 DefIne the objectives and scope of analysis
The definition of the objectives and scope sets the foundations for the analysis effort, and informs the choice of approach to FMEA so that the outcome of analysis is aligned with the objectives.IEC 60812 pdf download.