IS EN IEC 60812:2018, Failure Modes and Effects Analysis (FMEA and FMECA) was published in October 2018 and replaces the 2006 version of the standard.
The standard describes how to perform a systematic failure modes and effects analysis (FMEA). An analysis of this kind establishes how a product or process might fail to perform its function and suggests how an identified failure might be treated or remedied.
It encourages the design team to consider:
- What could go wrong;
- How badly it could go wrong;
- What needs to be done to prevent or mitigate the problem.
The standard also covers failure modes, effects and criticality analysis (FMECA) which allows failure modes to be prioritised to support decisions about treatment or amelioration.
It explains how failure modes and effects analysis (FMEA) is planned, performed, documented and maintained and addresses the following:
- Describes the principles
- Provides the steps in analysis
- Gives examples of the documentation
- Provides example applications
FMEA is a structured approach to analysing root causes of failure, estimating the severity or impact of failure, and developing effective strategies for prevention. It helps to reduce the adverse effects of failure or reduce their likelihood of occurrence. Specific reasons for using FMEA include:
- identifying failure modes that have unwanted effects on system operation;
- improving the design and development of products or processes in a cost-effective manner through early intervention;
- satisfying statutory and business obligations;
- providing a foundation for other dependability analyses;
- developing a reliability test programme.
FMEA can be adapted to meet the needs of any industry or organisation and is applicable to hardware, software, processes, human action and their interfaces, in any combination.
The 2018 version of the standard has been updated to reflect current best practice.
This edition includes the following significant technical changes with respect to the previous edition:
- the normative text is generic and covers all applications;
- examples of applications for safety, automotive, software and (service) processes have been added as informative annexes;
- tailoring the FMEA for different applications is described;
- different reporting formats are described, including a database information system;
- alternative means of calculating risk priority numbers (RPN) have been added;
- a criticality matrix-based method has been added;
- the relationship to other dependability analysis methods have been described.
FMEA is divided into three phases:
These functions are usually carried out sequentially, but the process can be tailored to meet individual needs.
In the planning phase, the objectives of the exercise are defined along with the scope of the analysis. Boundaries and scenarios are identified along with decision criteria for treatment of failure modes. Choices are also made about documentation and reporting requirements, and resources for analysis are defined.
Performing the analysis should be carried out with the product or process broken down into different elements. The assessment then looks at issues such as failure modes, detection methods and existing controls.
The final part of the process, documentation, produces the key data that will be used to create a report. Documentation should create a clear audit trail to show that, for example, regulatory and contractual obligations are being met and so that the information can serve as evidence to inform decisions based on the analysis.