IEC 60812: Definition, Compliance, Tools, and Certifications

Table of Contents

IEC 60812: Definition, Compliance, Tools, and Certifications

Introduction:

In IEC 60812:2018, you’ll learn about Failure Modes and Effects Analysis (FMEA), including the Failure Modes, Effects, and Criticality Analysis (FMECA) variant. This document explains how FMEA is planned, performed, documented, and maintained. The goal of FMEA is to identify potential failures in order to prevent them from happening. By understanding how items or processes might fail, you can take steps to correct any issues before they cause serious problems. IEC 60812:2018 is an essential read for anyone involved in product development or quality assurance!

What is IEC 60812?

IEC 60812 is an international standard that provides guidance on how to conduct a Failure Modes and Effects Analysis (FMEA). The standard was first published in 2004, with the most recent update coming in 2018. IEC 60812 is developed by the International Electrotechnical Commission (IEC) and is used around the world.

The standard is divided into four main sections:

  • Section 1 provides an introduction to FMEA, including its objectives and benefits.
  • Section 2 explains the methodology for conducting an FMEA.
  • Section 3 covers the documentation and reporting requirements for an FMEA.
  • Section 4 contains guidance on tools and techniques that can be used during an FMEA.

IEC 60812 is a voluntary standard, which means that organizations are not required to comply with it. However, many companies choose to follow the standard in order to ensure that their products are of the highest quality.

There are two main types of FMEA: design FMEA (DFMEA) and process FMEA (PFMEA). DFMEAs are conducted on new products, while PFMEAs are carried out on existing manufacturing processes. IEC 60812 provides guidance for both types of FMEAs.

What is the purpose of IEC 60812?

The purpose of IEC 60812 is to establish how items or processes might fail to perform their function. By understanding the potential failure modes, you can take steps to prevent them from happening. This standard provides a systematic method for identifying modes of failure together with their effects on the item or process. The standard also includes guidance on how to prioritize failures in order to make decisions about treatment.

IEC 60812 is an essential read for anyone involved in product development or quality assurance! By following the guidance in this standard, you can help ensure that your products are of the highest quality and that any potential problems are identified early on.

What are the benefits of IEC 60812?

There are many benefits to complying with IEC 60812, including:

  • Improved product quality
  • Reduced customer complaints
  • Increased customer satisfaction
  • Decreased warranty costs
  • Reduced scrap and rework costs

In addition, IEC 60812 can help you to identify potential problems early on in the product development process. This allows you to make changes before the product is released, which can save time and money.

Complying with IEC 60812 can help your organization to improve its products and processes. By following the guidance in this standard, you can make your products more reliable and reduce the likelihood of customer complaints. The standard is an essential read for anyone involved in product development or quality assurance!

IEC 60812: New Version

The latest version of IEC 60812 was released in 2018. This new version includes guidance on how to conduct failure mode, effects, and criticality analysis (FMECA). FMECA is a variant of FMEA that takes into account the severity of the consequences of a failure mode. IEC 60812:2018 is an essential read for anyone involved in product development or quality assurance!

This edition includes the following significant technical changes with respect to the previous edition:

  1. The normative text is generic and covers all applications
  2. Examples of applications for safety, automotive, software, and (service) processes have been added as informative annexes
  3. Tailoring the FMEA for different applications is described
  4. Different reporting formats are described, including a database information system
  5. Alternative means of calculating risk priority numbers (RPN) have been added
  6. A criticality matrix-based method has been added
  7. The relationship to other dependability analysis methods has been described.

IEC 60812 and FMEA:

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 determining the causes of failure modes. Failure modes can be prioritized to support decisions about treatment.

IEC 60812:2018 is an essential read for anyone involved in product development or quality assurance! This standard provides guidance on how to conduct a Failure Modes and Effects Analysis (FMEA), including the important steps of planning, performing, documenting, and maintaining the analysis. An FMEA can help you identify potential problems early in the product development process. This allows you to make changes before the product is released, which can save time and money. IEC 60812:2018 is a voluntary standard, which means that organizations are not required to comply with it.

What is FMEA?

The failure mode is the way in which a specific thing might fail. Failures occur due to an error or mistake during development. Effect analysis is the study of the outcomes or consequences of those failures. They together make Failure Mode and Effect Analysis or FMEA. 

The main aim of FMEA is to take necessary actions to mitigate or minimize the failures as much as possible. The process begins with the ones of the utmost priority. It also prepares documentation that includes details like current knowledge, actions about risks of failures, and areas for improvement. This data is used to evaluate and prepare strategies for avoiding failures. Ideally, the process of FMEA commences during the early stages of designing and continues throughout the product life cycle.

What are the IEC 60812 Tools?

There are many different IEC 60812 tools available to help you comply with this standard. Some of the most popular IEC 60812 tools include:

  • FMEA Worksheet
  • Failure Modes and Effects Diagram
  • Process Flow Diagram
  • Cause and Effect Matrix

Each of these standard-oriented tools can help you to identify potential problems and make changes to your product or process. By following the guidance in this standard, you can ensure that your products are of the highest quality and that any potential problems are identified early on.

IEC 60812 Certification:

IEC 60812 certification is not required in order to comply with this standard. However, many companies choose to get certified in order to show their commitment to quality. IEC 60812 certification can be obtained from many different organizations, including:

  • International Organization for Standardization (ISO)
  • European Cooperation for Accreditation (EA)
  • American National Standards Institute (ANSI)

Organizations that are certified by one of these organizations have demonstrated that they are committed to following 60812 and that their products or processes meet the requirements of this standard.

Visure Requirements ALM Platform:

FMEA is a must process among engineering teams. However, we strongly recommend for it be performed by an ALM Tool to help you remove the administrative overhead of maintaining multiple documents and sharing them between individual stakeholders.

An ALM platform helps in supporting any Requirements level mitigation of risks detection with built-in RPN calculation, putting one platform for all requirements-related activities.

It also should provide a risk dashboard with reports for all levels of the system, all easy to access with a couple of clicks and support for better quality, reduced risk, and avoiding possible failures.

At Visure, our modern ALM platform, seamlessly connects the FMEA and risk management with requirements, enabling you to follow the evolution of the Requirements over time and over the full Requirements lifecycle.

The ALM platform that your entire engineering team will love, helping them avoid project failures and automate repetitive tasks.

Visure Requirements ALM Platform is one of the most trusted modern ALM platforms that specialize in requirements management for organizations of all sizes across the globe. 

It’s a must-have tool for teams building complex products, systems, and software, which require end-to-end traceability from conception to testing and deployment, all the way to source code, along with standard certification compliance.

Visure integrates through the whole ALM processes including risk management, issue and defect tracking, traceability management, change management, and various other areas like quality analysis, requirements versioning, and powerful reporting.

If you are looking for an IEC 60812 compliant ALM platform, look no further than Polarion. Our software development tools are designed to help you comply with IEC 60812 and other standards. With our easy-to-use interface, you can quickly create FMEA diagrams, process flow diagrams, and cause and effect matrices. You can also track changes to your product or process over time and ensure that any potential problems are identified early on.

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