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Once again about the safety case

The requirement to develop and present of the safety case, when confirming compliance with, is come from some technical regulations, namely from TR CU 010/2011 and TR CU 032/2013.

We already wrote earlier what kind of document it is and why it is needed. However, in connection with the entry into force of GOST 33855-2016 "Safety case of equipment. Recommendations for the preparation" we believe that it is necessary to give a number of explanations, drawing attention to some points.

In accordance with the above technical regulations (hereinafter - TR CU) "safety case" - 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 key point here is that, according to TR CU, the safety case MUST CONTAIN a risk analysis of the equipment, as well as the minimum necessary safety measures, i.e. - this is a concept for sharing responsibility for the safe use of the machine and / or equipment.

GOST 33855 gives a slightly different definition: “safety case” - a package of technical documents or a specially designed document used to confirm the safety of equipment and its compliance with the requirements of technical regulations.
Note that in this definition there is no risk analysis, as an integral part of the safety case, and the purpose of the safety case is indicated - only to confirm compliance with the requirements of technical regulations ....

The authors of GOST 33855 note that ".. the safety of equipment for which requirements are established in the TR CU, is justified at the stage of development (design) of equipment ...". The documents package for safety case may include:
  • design documentation (drawings, specifications, calculations, etc.);
  • operational documentation (passport, operating manual etc.);
  • acts and / or test reports;
  • analytical materials (risk analysis and / or risk assessment, analysis of operational reliability, etc.).

The safety case for vessels and high pressure equipment may be the confirmation of their strength, stability and tightness during the design life using the strength calculation and the fulfillment of a set of technical requirements related to it.

This is very similar to the requirements for the technical file, which is created in accordance with Directive 2006/42/EC "On Machinery", so we can assume that this standard makes it easier for foreign manufacturers to understand the essence of the safety case according by the TR CU.

As well GOST 33855 permits to prepare / sign a safety case by a person performing the functions of the foreign manufacturer (Authorized Representative) or an importer.

An interesting requirement is providing the possibility of not conducting a risk assessment for the equipment:

  • for embedded or used together with other equipment for which it is impossible to assess the severity of the consequences of a dangerous event at the development (design) stage;

  • during the design (design) of which standards were applied that set specific safety requirements for equipment included in the Lists of standards for TR CU (for example, standards of group C).

In this case, we draw attention to the fact that GOST 33855 is only a recommendation, since the standard is applied on a voluntary basis, it is not included in the List of Standards to the TR CU. According to TR CU, risk analysis as part of the safety case is mandatory.

GOST 33855 is best used together with GOST R 54122-2010, as they complement each other. A number of requirements listed in the GOST 33855 standard allows for a wider disclosure of GOST R 54122-2010 clauses, as well as clarify some of the security case functions with respect to technical regulations.

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