Production site audit for EAC certification: New GOST standard is being introduced
From January 1, 2021, a new standard GOST R 54293-2020 “Analysis of the state of production during confirmation of compliance”, approved by the Federal Technical Regulation and Metrology Agency (Rosstandart) of Russia No. 583-st of August 28, 2020, becomes effective.
It should be noted that until changes are made to TR EAEU / TR CU – technical regulations of the Eurasian Economic Union / Customs Union – concerning new possible certification schemes, the introduced standard GOST R 54293-2020 will be used at the national level in the part that does not contradict the provisions established in regulatory legal acts. Which means, standard schemes adopted by the Decision of the Customs Union Commission No. 621 “On the Regulation on the Procedure for the Application of Standard Schemes for Assessment (Confirmation) of Compliance with the Requirements of the Technical Regulations of the Customs Union” dated April 7, 2011, as well as voluntary certification.
GOST R 54293-2020 “Analysis of the state of production during confirmation of compliance” sets the requirements to Certification bodies regarding adoption of decisions and presentation of results of the analysis of the state of production.
Production site audit (analysis of the state of production) is carried out by the certification body when confirming the compliance of mass-produced (serial released) commodities in order to establish that the manufacturer has the necessary conditions to ensure the constant compliance of the products with the requirements confirmed during certification.
The following is being checked during production site audit:
- technical documentation (design, technological and operational) for products as well as documented procedures, records;
- competence of the personnel who are responsible for the compliance of products with the established requirements;
- manufacturing infrastructure which includes production, transport facilities, warehouses, premises, etc.;
- equipment as well as its maintenance and repair;
- management of control, measuring and testing equipment;
- measuring instruments required to ensure product compliance with established requirements;
- incoming control of purchased products affecting the safety performance of certified products (raw products, materials, components);
- technological processes, including special ones (if there are relevant requirements in technical regulations or regulatory documents);
- acceptance control and periodic testing of finished products related to the control of characteristics, the requirements for which are established by technical regulations or regulatory documents;
- product identification and traceability;
- marking of finished products, conditions of their storage, packaging and conservation;
- interaction with the consumer (including consideration of complaints and claims);
- management of nonconforming products, corrective and preventive actions.
Analysis of the state of production is carried out by experts / expert-auditors of the Certification body who have the knowledge and skills to confirm the compliance of a certain product and have accreditation for certain technical regulations (TR CU).
Production site audit (analysis of the state of production) should be performed during certification of products, as well as during inspection control procedure of already certified products.
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