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How to write a safety case

The safety case is a document containing an analysis risks, as well as information out of the design, operational, technical documentation about the minimum necessary measures to ensuring safety that accompanies the machine and (or) equipment at all stages of the life cycle, and supplement the information about the results of the risk assessment at the stage of operation after a major overhaul.

The safety case is one of the most important documents for certification as well as the declaring certifying that the manufactured products meet the requirements technical regulations of the Customs Union "On the Safety of machinery" TR CU 010/2011.

It is believed that the safety case is the same as the technical file in accordance with Directive 2006/42/EC "On machinery" (see Annex VII).

The safety case as opposed to the technical file is designed for increasing responsibility of product manufacturers.

In accordance with paragraph 7 of Article 4 Technical Regulations of the Customs Union TR CU 010/2011 "On the safety of machines and equipment" and Article 25 of Technical Regulations of the Customs Union TR CU 032/2013 «On the safety equipment of high pressure» a safety case should be developed at designing of the machine, and (or) equipment. Original the safety case of machines and (or) equipment is stored at the developer (designer), and the copy - at the manufacturer of machines and (or) equipment and at the organization operating the machines and (or) equipment.

The safety case should include an introduction and sections, arranged in the following order:

1) The main parameters and specifications machine and (or) equipment;

2) A common approach to safety at designing of machines and (or) equipment;

3) Requirements for the reliability of the machine and (or) equipment;

4) Requirements for personnel / user of the machine and (or) equipment;

5) The risk analysis from application (use) machines and (or) equipment;

6) Safety requirements at commissioning the machine and (or) equipment;

7) Requirements for safety management at the operation of the machine and (or) equipment;

8) Requirements for quality management at the operation of machines and (or) equipment;

9) Requirements for the management of environmental protection at start-up, operation and utilization of machines and (or) equipment;

10) Requirements for the collection and analysis of information on safety in the commissioning, operation and utilization of machines and (or) equipment;

11) Safety requirements at the disposal of the machine and (or) equipment.

The safety case can contain applications with the results of calculations and other information.

The composition of the sections of the safety, their content are determined the developer in accordance with the characteristics of products.

If necessary, the safety case depending on the type and purpose of machine can be supplemented by other sections (subsections), or it can not include separate sections (subsections), or separate sections (subsections) can be combined into one.

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