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Analysis of production state

To take a decision about conformity (unconformity) products to requirements of technical regulations, in certain cases is provided assessment of the production, which may be presented by the following main types:

- analysis of the production state (only for schemes 1c, 5c, 7c),

- certification of management systems (only for schemes 2c, 6c, 8c).

Certification schemes 1c, 5c, 7c include a procedure of analysis of production state at the manufacturer. To evaluate the conformity of products to requirements set out in the technical regulations of the Customs Union (CU TP), these works are carried out by accredited certification bodies, included in the Unified Register of certification bodies and testing laboratories (centers) of the Customs Union.

The purpose of the analysis of production state is determining the availability of necessary conditions to ensure the conformity of products with technical regulations.

The necessary conditions are specified in the form of requirements to the state of the following objects:

- Infrastructure (the territory, production facilities, transport, etc.);

- Documentation (design, technological, registration and accounting);

- Means of technological equipment;

- Measurement tools;

- Personnel;

- Incoming inspection;

- Special processes (operations);

- Operational and acceptance control and periodic tests;

- Marking of finished products.


Typical programm of the analysis of production state


Objects of the inspection

Instructions for carrying out of the inspection



1. Check availability of the necessary infrastructure elements that provide the execution in the production process of mandatory requirements for manufactured products;

2. If the technical regulations for manufactured products includes some requirements to the infrastructure elements , these elements are subject to verification on a mandatory basis



Check the documentation:

а) required by the technical regulations with respect to the certified product or its manufacturing process;

b) necessary for the maintenance in work condition the infrastructure of process equipment and measuring instruments;

c) describing the performance of special processes and control operations related to the formation and control of the mandatory requirements for the finished product;
d) laying down requirements for incoming inspection (raw,  materials, components);

e) defining the mandatory requirements for personnel (in terms of knowledge, experience, health status, etc.);

f) relating to the records, confirming fulfillment of the requirements established by subparagraphs a) to e)


Technological equipment

Check the availability of means technological equipment (jigs, fixtures and tools) and the conditions for maintain their in working condition (for equipment, designed to perform the technological operations associated with the formation of the product characteristics, for which are established mandatory requirements)


Measurement tools

1. Check availability of the necessary measuring instruments and their compliance to the Law "On ensuring the uniformity of measurements" (in respect of measuring instruments used to control the characteristics of the product, for which are established mandatory requirements).

2. When carrying out inspection should make sure that the measuring instruments are in managed conditions: periodically are verified (calibrated), used and stored properly



Check personnel influencing the conformity of the product with obligatory requirements, if there are requirements for the competence, for sanitary and hygienic state of personnel in the technical regulations, for acting technological instructions, for rules for product manufacturing


Incoming inspection

1. Check the performance of incoming inspection of products (in respect of products for which there are safety requirements).

2. During carrying out inspection ensure , that are installed and are respected the requirements for:

- the composition of the monitored parameters the input products;

- monitoring frequency;

- amount of control;

- methods of control;

- registration of inspection results;

- identification of status monitored products or methods of protection against transfer in the production of nonconforming product


Special processes

1. Check the performance the validation of special processes (operations) associated with the formation of the product characteristics for which mandatory requirements are established.

2. In the event that, in accordance with the current legislation a special process is subject to periodic validation, you should check the availability of documents confirming carrying out in target dates the last two validations of this process


Operational and acceptance control and periodic tests

1. Check the fulfillment of the established requirements for the acceptance inspection and periodic testing of the final product (in relation to operations related to the control of the final product characteristics for which mandatory requirements are established).

2. Must verify that there established requirements to:

a) the composition of the controlled parameters;

b) methods of inspection and testing besides operations performed by an accredited testing laboratory;

c) monitoring plans (in the case of sampling inspection parameters), including the requirement for the application of defect-free control plans and changing of control stiffness depending on the accumulated results;

d) the frequency of periodic testing;

e) keeping records on the results of monitoring (periodic testing);

f) the conditions of testing.

3. When testing, ensure the availability of records on the results of monitoring (periodic testing)



Check fulfillment of the requirements established by the applicable normative documentation, to the composition of markable data, methods and quality of their application on the products, on consumer, group and transport packaging (where applicable)


The expert makes an act based on the received information of production state. This act is taken into account when issuing the certificate of conformity and establishing its period of validity. Expert presents in the act some analysis results, references to supporting documents and materials, as well as the findings about the ability of production consistently to produce products that meet the established requirements.

Remarks can be found in the annex to the act. The manufacturer must prepare a corrective action plan. If there is such a plan, it is given in the annex to the act.

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