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Risk Assessment for Machinery - EN 1050

EN 1050 is the European Standard for Risk Assessment. This standard details how the risk assessment process should be carried out. EN 1050 should be used as a basis for any risk analysis for machinery. The standard does not specify the precise method but provides detailed guidance as to what should be considered. EN 1050 covers hazard identification providing a list in Annex A to the standard. The elements to be considered in risk estimation are listed, and general advice is given on risk reduction. The standard states that the risk assessment documentation shall demonstrate the procedure and the results.

EN 1050 describes risk assessment as a process intended to help designers and safety engineers define the most appropriate measures to enable them to achieve the highest possible levels of safety, according to the state of the art and the resulting constraints. The standard also defines several techniques for conducting a risk assessment, including:

  • Hazard and Operability Studies (HAZOP)
  • Failure Mode and Effects Analysis (FMEA)
  • Fault Tree Analysis (FTA) and Preliminary Hazard Analysis (PHA)
  • What if Method
ISO Series
The International Organization for Standardization series is a set of individual but related international standards on quality management and quality assurance. They are generic but can be specific to any particular products. These standards are used by manufacturing, design and service industries alike.

The ISO 9000 series standards do not specify the technology to be used for implementing quality system elements, but these standards enable industries to improve the quality of systems by covering a variety of significant areas, including the following ISO standards:

  • The ISO 9001 is the most comprehensive standard, covering design, manufacturing, installation and servicing systems
  • ISO 9002 covers production and installation
  • ISO 9003 covers final product testing and inspection
  • ISO 9004 provides guidelines for internal use by the producer to develop a quality system to meet the requirements

Revisions have been made to these standards and were published on December 15, 2000 by the International Organization for Standardization.

Revisions include the integration of some of the standards listed above. ISO 9001, ISO 9002 and ISO 9003 have been integrated into a new standard, called ISO 9001:2000. This new standard specifies the requirements for a quality management system for any organization that strives to consistently provide products that meet customer satisfaction and regulatory requirements. ISO 9004:2000 is designed for the implementation of a quality management system to effectively meet business goals.

The following is an update of the ISO family of standards:

  • ISO 9000:2000 - Quality Management Systems-Fundamentals & Vocabulary
  • ISO 9001:2000 - Quality Management Systems-Requirements
  • ISO 9004:2000 - Quality Management Systems-Guidelines for Performance improvements
  • ISO 19011 - Guidelines on Quality and/or Environmental Management Systems Auditing
  • ISO 10005:1995 - Quality Management Guidelines for Quality Plans
  • ISO 10006:1997 - Quality Management Guidelines for Quality in Project Management
  • ISO 10007:1995- Quality Management Guidelines for configuration management.
  • ISO/TS 16949:1999 - Quality Systems - Automotive Suppliers-Particular Requirements for the application of ISO 9001:94
  • ISO/DIS 100012 - Quality Assurance requirements for measuring Equipment -Part 1: Metrological confirmation system for Measuring Equipment
  • ISO 10012-2:1997 - Quality Assurance for Measuring Equipment -Part 2:Guidelines for control of measurement of processes
  • ISO 10013:1995 - Guidelines for Developing Quality Manuals
  • ISO/TR 10014:1998 - Guidelines for Managing the Economics of Quality
  • ISO 10015:1999 -Quality Management Guidelines for Training
MIL STD 1629A - Procedures for Performing a Failure Mode Effects and Criticality Analysis

IL STD 1629A provides requirements and procedures for performing failure mode, effects and criticality analysis (FMEA) to systematically evaluate and document the potential failure mode associated with each component and the effects associated with it. Based on MIL STD 1629A, item failure mode analysis includes the potential impact of each functional or hardware failure, personnel and system safety, system performance, maintainability and maintenance requirements. Each potential failure is ranked according to the severity of its effects, and corrective actions are required to mitigate or improve the risk.

The following tasks are included in MIL STD 1629A:

  • Task 101 - Failure Mode and Effects Analysis
  • Task 102 - Criticality Analysis
  • Task 103 - FMECA - Maintainability Information
  • Task 104 - Damage Mode and Effects Analysis
  • Task 105 - Failure Mode, Effects, and Criticality Analysis Plan

The above list of tasks applies to all items of equipment and does not apply to software.
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