Safety Case or Safety Justification: One Document, Two Names
Safety Case and Justification of Safety are the same document. TR CU 010 and TR CU 032 both require it, and TR CU 032 points at the standard that sets its form: GOST 33855-2016. It has to be dated inside the design phase, it can cover a product family, and if the manufacturer will not produce it, the importer must.
Which regulations require it?
Two technical regulations of the Customs Union oblige the designer or manufacturer of equipment to produce this document:
- TR CU 032/2013, On safety of the equipment operating under excessive pressure
- TR CU 010/2011, On safety of machinery and equipment
Both reference the Justification of Safety. TR CU 032 goes further and references the standard that sets the form of the document: GOST 33855-2016, Safety justification. Recommendations for preparation.
What does GOST 33855-2016 say it is?
A set of technical documents, or a specially designed document, used to confirm the safety of equipment and compliance with the requirements of the technical regulation.
Safety here is considered against three kinds of harm during operation: damage to human health, damage to property, and negative changes to the environment, flora and fauna included.
When does it have to be written?
During the design phase of the equipment. When manufacturers sign a JoS, the date on it should fall inside the period in which the equipment was designed, so agree the date before the document is drawn up.
What sections does it need?
| Section | Contents |
|---|---|
| General description | What the equipment is |
| Basic parameters and characteristics | The specification |
| Risk assessment | What can go wrong and how likely it is |
| Proof of compliance | Evidence the equipment meets the TR CU |
References to operational manuals, test reports and other documents are permitted inside it.
Can a set of design documents do the job instead?
The definition says safety can be proved by a set of technical documents, so in principle yes. The complication is that GOST 33855-2016 adds requirements to the sections above, and in practice expert organisations, certification laboratories and certification bodies, work with a separate JoS written by people who know the standard.
If you do go with a document set, there is a practical step that helps: include a table headed “List of documents justifying the safety of equipment” in one of the operational documents, the installation and operating manual, or the passport, giving the designation and title of each relevant document.
Can one JoS cover several models?
Yes, where every section above holds true for all of them. That produces one unified document for a product type or family. The main parameters and characteristics then have to be given for each model and modification the JoS applies to, rather than for one representative unit.
Who develops it when the manufacturer does not?
The importer. Where a manufacturer cannot provide the documents justifying safety for imported equipment, the Safety Justification is developed by the importer, the seller, or the person performing the functions of the foreign manufacturer, the local representative acting as applicant.
Plants and production companies in the Union importing equipment tend to be exacting about this document, because they are under strict control from the authorities responsible for construction and operation. The practical answer is to write the JoS to the GOST requirements and to whatever list of technical documentation requirements the buyer supplies.
Sources
- GOST 33855-2016, Safety justification. Recommendations for preparation
- TR CU 032/2013, On the safety of equipment operating under excessive pressure, Eurasian Economic Commission
- TR CU 010/2011, On the safety of machinery and equipment
Frequently asked questions
When should the Justification of Safety be dated?
Inside the design phase of the equipment. The document is meant to be prepared while the equipment is being designed, so the signature date should fall within that period. Certification bodies check this, and a JoS dated after the equipment was already in production invites questions the applicant does not want.
Can a set of design documents replace a separate JoS?
In principle yes, the definition allows safety to be proved by a set of technical documents. In practice, expert organisations work with a separate document written to GOST 33855-2016, because the standard adds requirements to the sections. If you go the document-set route, include a table titled "List of documents justifying the safety of equipment" in one of the operational documents.
Who writes it if the manufacturer will not?
The importer. Where the manufacturer cannot provide documents justifying safety for imported equipment, the Safety Justification is developed by the importer, seller, or the person performing the functions of the foreign manufacturer, the local representative acting as applicant.
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