BS EN IEC 60812-2018 PDF

Full title and description

BS EN IEC 60812:2018 — Failure modes and effects analysis (FMEA and FMECA). British adoption of IEC 60812:2018 providing a generic, application‑neutral procedure for planning, performing, documenting and maintaining Failure Modes and Effects Analysis and the FMECA variant.

Abstract

This standard defines the principles and step‑by‑step procedure for conducting Failure Modes and Effects Analysis (FMEA) and Failure Modes, Effects and Criticality Analysis (FMECA). It explains objectives, preparatory tasks, analysis execution, documentation and maintenance. The 2018 edition extends the earlier text with application examples (safety, automotive, software and service/processes), guidance on tailoring FMEA to different uses, alternative risk‑ranking approaches (including alternative RPN calculations and a criticality‑matrix method), reporting formats (including database approaches) and relationships with other dependability methods.

General information

• Status: Current (British adoption of IEC 60812:2018; supersedes BS EN 60812:2006).
• Publication date: 15 October 2018 (BSI publication). IEC base publication date: 10 August 2018.
• Publisher: BSI (British Standards Institution) — adoption of IEC 60812:2018 / International Electrotechnical Commission (IEC) original publisher.
• ICS / categories: 03.120.01 (Quality in general), 03.120.30 (Application of statistical methods), 21.020 (Characteristics and design of machines, apparatus, equipment).
• Edition / version: 2018 edition (BS EN IEC 60812:2018; corresponds to IEC 60812, Edition 3.0, 2018).
• Number of pages: 82 pages (BSI paperback/PDF pagination); IEC bilingual publication lists extended pagination (165 pages) for the IEC edition.

Scope

Provides a generic, application‑neutral procedure for carrying out FMEA and FMECA on items and processes so that potential failure modes, their causes and effects are identified and prioritized for treatment. Applicable to hardware, software, processes (including human action) and their interfaces in any combination. The standard is informational for safety use and does not replace application‑specific regulatory requirements; it shows how to tailor FMEA for different sectors and reporting needs.

Key topics and requirements

• Definitions and objectives of FMEA and FMECA.
• Preliminary tasks: scope, boundaries, functions, assumed operating conditions and data collection.
• Stepwise procedure for identifying failure modes, effects and causes, and documenting them in worksheets or a database.
• Prioritization techniques including traditional RPN, alternative RPN calculations and a criticality‑matrix method.
• Guidance on tailoring FMEA to specific applications (safety, automotive, software, service/processes).
• Examples of reporting formats, worksheet structures and use of database information systems.
• Consideration of common‑cause failures, human factors and software errors.
• Relationship and integration with other dependability and risk‑analysis techniques.

Typical use and users

Used by reliability engineers, design and development teams, quality and process engineers, safety and compliance specialists, maintenance planners and programme managers. Typical applications include early‑stage design risk reduction, production/process improvement, safety analyses, regulatory compliance assessments and as input to maintenance and service planning. Useful across industry sectors (automotive, aerospace, medical devices, industrial equipment, software and services).

Related standards

Commonly used alongside sector or topic specific standards and guidance such as ISO 9001 (quality management), ISO 14971 (medical device risk management), ISO 31000 (risk management), ISO 26262 (automotive functional safety), IEC 61508 (functional safety) and industry FMEA guidance (for example the AIAG‑VDA FMEA handbook). It also complements other dependability and safety assessment standards and methods.

Keywords

FMEA, FMECA, failure modes, effects analysis, criticality, risk priority number (RPN), reliability, dependability, FMEA worksheet, failure causes, prioritization, tailoring, criticality matrix.

FAQ

Q: What is this standard?

A: BS EN IEC 60812:2018 is the British adoption of IEC 60812:2018 that sets out a generic procedure for performing Failure Modes and Effects Analysis (FMEA) and Failure Modes, Effects and Criticality Analysis (FMECA).

Q: What does it cover?

A: It covers planning, execution, documentation and maintenance of FMEA/FMECA, including preparatory tasks, analysis steps, prioritization methods (traditional and alternative RPN, criticality matrix), tailoring guidance and example reporting formats and annexes showing applications for safety, automotive, software and service/process analyses.

Q: Who typically uses it?

A: Reliability and design engineers, quality and process specialists, safety and compliance personnel, maintenance planners and programme managers across multiple industries — wherever systematic failure analysis and prioritization are needed.

Q: Is it current or superseded?

A: The 2018 edition is the current edition of IEC 60812. BS EN IEC 60812:2018 supersedes earlier editions such as BS EN 60812:2006. (IEC records a stability date into the medium term; check your national standards body for current national status or any later amendments.)

Q: Is it part of a series?

A: IEC 60812 is a standalone standard addressing FMEA/FMECA, but it is related to other dependability, safety and risk management standards (for example IEC 61508, ISO 26262, ISO 14971). National and industry bodies may publish companion or sector‑specific documents that reference or adapt its procedure.

Q: What are the key keywords?

A: FMEA, FMECA, failure mode, effect, criticality, RPN, risk prioritization, reliability, dependability, FMEA worksheet, tailoring, criticality matrix.