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Summary of Regulations, Standards and Requirements |
IEC 812 standard - Analysis Techniques for System Reliability - Procedure for Failure Mode Effects Analysis
The Failure Mode and Effects Analysis (FMEA) and Failure Modes, Effects and Criticality Analysis (FMECA) are methods of reliability analysis intended to identify failures, which have significant consequences affecting the system performance in the application considered.
Generally, failures or failure modes of any component will reduce the system performance drastically. In the study of system reliability, safety and availability, both qualitative and quantitative analyses are required and these complement each other.
IEC 812, published by the International Electrotechnical Commission, describes Failure Mode and Effects Analysis (FMEA) and Failure Mode, Effects and Criticality analysis (FMECA), and gives guidance as to how the following objectives could be achieved when using FMEA/FMECA as risk analysis tools including:
- Procedural steps necessary to perform an analysis
- Identification of appropriate terms, assumptions, criticality measures, failure modes
- Determining basic principles
- Form for documenting FMEA/FMECA
- Criticality grid to evaluate failure effects
Global Automotive Standards -ISO/TS 16949
ISO/TS 16949 is an ISO Technical Specification, which harmonizes the supplier quality requirements of the U.S.Big three (QS-900, 3rd edition) and French, German and Italian automotive manufacturers and was written by the International Task Force. This task force consists of an international group of vehicle manufacturers including Ford, General Motors and Daimler Chrysler as well as various automotive trade organizations such as AIAG (America), VDA/QMC (Germany), SMMT (UK), ANFIA (Italy), CCFA and FIEV (France).
ISO/TS 16949 aligns the existing automotive quality system requirements within the global automotive industry. In conjunction with ISO 9001/9002, ISO/TS 16949 details the QSR (quality system requirements) for the design/development, production, and where relevant, installation and servicing of automotive-related parts. ISO/TS 16949 has been designed to improve product and process quality while increasing efficiency and reducing variation.
By obtaining ISO/TS 16949 registration, clients that provide automotive products to international markets will have the option of maintaining one quality system registration to satisfy multiple customer quality requirements. Along with customer specific requirements, ISO/TS 16949 will satisfy QS-9000 (U.S), VDA 6.1 (Germany), AVSQ (Italy) and EAQF (France).
Risk Assessment and Risk Reduction - A Guide to estimate, Evaluate and Reduce Risks Associated with Machine Tools - ANSI B11.TR3:2000
This technical report provides guidance for machine suppliers and users, to analyze and reduce risks associated with hazards generated by machines, and associated equipment, where it is possible for persons to come in contact with or otherwise be affected by these hazards.
This document provides an overview of risk assessment and risk reduction and describes a general approach to arrive at tolerable risk.
The following sections are covered in this document:
- Overview of Risk Assessment
- Determining the limits of the Machinery
- Task and Hazard Identification
- Risk Estimation Matrix
- Risk Reduction Process
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