Circular No. 45/2015/TT-BCT stipulates the management of the Program for the development of certain high-tech industries.

Circular

Regulations on product quality inspection during production under the management of the Ministry of Industry and Trade are provided for.

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Pursuant to Decree No. 95/2012/NĐ-CP dated November 12, 2012, of the Government, detailing the functions, tasks, powers, and organizational structure of the Ministry of Industry and Trade;

Pursuant to the Law on Product Quality and Commodities dated November 21, 2007;

Pursuant to Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain provisions of the Product Quality Law;

Pursuant to the proposal of the Director of the Science and Technology Department,

The Minister of Industry and Trade shall issue a Circular to regulate product quality inspection during production under the management of the Ministry of Industry and Trade.

Chapter I GENERAL PROVISIONS

Article 1. Scope of Regulation

1.    This Circular stipulates the contents, procedures, formalities, and organization of implementation of product quality inspection during production under the management responsibility of the Ministry of Industry and Trade.

2.     Products in production within the scope regulated by this Circular are defined in Point đ Clause 2 Article 32 Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing certain provisions of the Law on Product Quality, except for products specified in Clause 3 of this Article.

3.    Products not within the scope regulated by this Circular include:

a) Chemicals, industrial explosives, fertilizers;

b)   Machinery and equipment with strict requirements for labor safety under the management of the Ministry of Industry and Trade;

c)   Services in the fields of industry and trade;

d)   E-commerce;

đ) Products that have quality inspection regulations during production set out in other Circulars issued by the Ministry of Industry and Trade.

Article 2. Applicability

This Circular applies to:

1.   Organizations and individuals producing products under the management responsibility of the Ministry of Industry and Trade as specified in Clause 2 Article 1 of this Circular;

2.   State agencies responsible for product and commodity quality management;

3.   Other organizations and individuals related to the matter.

Article 3. Basis and Forms of Product Quality Inspection During Production

1.    Product quality inspection during production is carried out according to an annual plan approved by the competent authority.

2.    Product quality inspection during production may be conducted at short notice when any of the following grounds exist:

a)    Information or warnings about domestically produced goods intended for export that do not comply with the conditions set forth in Article 32 of the Law on Product Quality;

b)   Survey or inspection results of circulating goods on the market by inspection agencies revealing goods that do not meet applicable standards, technical regulations, or corresponding technical requirements;

c)   Authentic information from domestic and foreign organizations and individuals reflecting on product and commodity quality.

3.    Product quality inspection during production as stipulated in Clauses 1 and 2 of this Article shall be conducted through inspection teams. Inspection teams shall be established in accordance with Article 48 of the Law on Product Quality.

Article 4. Principles of Inspection

Inspection activities must ensure the following principles:

1.    Clear division of responsibilities and effective coordination; no harassment or inconvenience affecting the operations of inspected production facilities.

2.   Objectivity, accuracy, transparency, and non-discrimination.

3.    Inspections shall be based on technical regulations, technical standards, announced standards, labeling requirements, and state management measures regarding product quality during production.

4.   Protecting confidential information, documents, and inspection results of inspection agencies and production facilities until a formal conclusion is reached.

5.    Being accountable under the law for inspection results and conclusions related thereto.

authority.

Chapter II

CONTENTS, PROCEDURES, AND VIOLATION HANDLING DURING PRODUCT QUALITY INSPECTION DURING PRODUCTION

Article 5. Content of product quality inspection during production

1. Inspection of the implementation of requirements related to production process conditions and state management measures regarding product quality during production, including:

a) Inspection of conformity certification file, conformity declaration file (for products and goods that require conformity certification and declaration); standard conformity declaration file (for products and goods that declare conformity to standards); quality management system certification file in accordance with standards (for products applying a quality management system); product and goods quality inspection file (for products and goods subject to corresponding technical regulations);

b) Inspection of the implementation of standards declared in accordance with Article 23 of the Product and Goods Quality Law;

c) Inspection of labeling, warning information content (for products and goods with prescribed warning information display); information and advertising file (for products and goods with advertising information); conformity mark display (for products and goods requiring conformity certification and declaration), standard conformity mark (for products and goods certified as conforming to standards) and accompanying documents for products that need to be inspected;

d) In cases where technical regulations have provisions related to production process conditions, inspection of the implementation of these provisions during product production;

đ) Inspection of the implementation of other state management measures regarding product quality during production as prescribed by competent authorities;

2. Inspection of production process control work of production facilities related to product formation and maintaining quality assurance, including:

a) Inspection of product technical files (design documents, product technical standards);

b) Inspection of the entire production process or one of its stages (from input through intermediate stages until product formation, including packaging, handling, storage, and transportation processes);

c) Inspection of raw material quality (in accordance with technical regulations/declared standards/applicable technical regulations and the use of prohibited materials and expired raw materials);

d) Inspection of the implementation of requirements concerning technological equipment and measurement, inspection, and testing equipment;

đ) Inspection of workers' skill files and technical staff files;

e) Other necessary technical contents;

3. In case of necessity, the inspection agency may use experts to conduct evaluations according to technical regulations/ applicable technical regulations. The evaluating expert must be independent, objective, and legally responsible for their evaluation results;

4. Testing samples to check product compliance with technical regulations/declared standards/applicable technical regulations shall be carried out in accordance with the law.

The inspection team leader decides on sample collection for testing as follows:

a) Samples are collected according to the sampling method prescribed in technical regulations, standards, and applicable technical regulations. In the absence of a sampling method provision, samples are taken randomly, ensuring they represent the batch of products. Each sample is divided into three (three) units, of which: one unit is sent for testing, one unit is retained by the inspection agency, and the remaining unit is handed over to the inspected entity for storage and preservation;

b) After collecting the product sample, it must be sealed (Sample No. 4 attached to the Circular) and a record (Sample No. 3 issued together with this Circular) signed by the sampler and the representative of the sampled entity. If the representative of the sampled entity does not sign the sample collection record and seal the sample, the inspection team invites a witness in accordance with the law and records in the record: "representative of the entity did not sign the sample collection record and seal the sample"; the sample collection and sealing record has signatures of the sampler, the inspection team leader, and the witness in accordance with the law;

c) Within a maximum of three (3) working days from the date of sample collection, the inspection team is responsible for sending the product sample to the designated testing organization for testing.

Article 6. Sampling and Testing Costs

The costs for sampling and testing samples shall be implemented according to the norms prescribed in Circular Joint Circular No. 28/2010/TTLT-BTC-BKHCN dated March 3, 2010, issued by the Ministry of Finance and the Ministry of Science and Technology guiding the management and use of funds for state quality control activities of products and goods.

Article 7. Procedure and Formalities for Inspection

The inspection team conducts inspections according to the following procedure and formalities:

1. Present the inspection decision (Form No. 1 attached to this Circular) before conducting the inspection.

2. Conduct the inspection according to the contents stipulated in Article 5 of this Circular.

3. Prepare the inspection record (Form No. 2 attached to this Circular) with signatures from representatives of the inspected entity and the inspection team. In cases where the representative of the inspected entity does not sign the record, the inspection team shall clearly note in the record "representative of the inspected entity did not sign the record," and the record shall have the signature of the head of the inspection team, members of the inspection team, and witnesses.

4. In cases where it is necessary to take samples of goods for testing, the inspection team shall take samples according to the provisions of Clause 4, Article 5 of this Circular.

5. Report the results of the inspection to the inspection authority or the person issuing the inspection decision.

6. Handle the results of the inspection

a. In cases where no violations are found, the inspection team and the inspection authority issue a notice allowing the product to continue production and circulation (Form No. 10 attached to this Circular) and clearly state that the product does not violate the provisions of this Circular.

b. In cases where violations are discovered, the inspection team and the inspection authority handle the violations according to the provisions of Article 8 of this Circular.

Article 8. Handling Violations During the Inspection Process

1. During the inspection of product quality during production, in cases where violations by the production facility are discovered, they shall be handled as follows:

a. The inspection team prepares a record, requiring the production facility to implement corrective measures within the time limit specified in the record. During the period of implementing corrective measures, the production facility is not permitted to release non-compliant products onto the market.

The production facility may only release products onto the market after having corrected them according to the requirements of the inspection team, reporting the corrections in writing to the inspection authority, and receiving a notice from the inspection authority allowing the product to continue production and circulation (Form No. 10 attached to this Circular);

b. In cases where, after being required by the inspection team, the production facility continues to violate, depending on the nature, degree of violation, extent, and scale of impact, the product quality inspection authority shall, within 07 (seven) working days (from the date of the conclusion regarding the continued violation by the production facility), publicly announce on mass media (newspapers, radio, television) at the local or central level the name, address of the production facility, the name of the non-compliant product, and the degree of non-compliance of the product (Form No. 6 attached to this Circular);

c. After the public announcement on mass media, if the production facility continues to violate, the product quality inspection authority shall, within 05 (five) working days (from the date of the public announcement on mass media), prepare an administrative violation record, transfer the file according to the provisions of Clause 3 of this Article, and recommend the competent state authority to handle the matter according to the law.

2. During the inspection of product quality during production, if the test results or evidence confirm that the product does not meet technical regulations/announced standards/technical regulations and pose a threat to human safety, animal, plant, property, or the environment, they shall be handled as follows:

a. Notify the production facility being inspected of the test results indicating that the product does not meet quality standards (Form No. 5 attached to this Circular) within 05 (five) working days from the date of receipt of the test results;

b. The head of the inspection team prepares an administrative violation record (Form No. 12 attached to this Circular), prepares a sealing record (Form No. 8 attached to this Circular), and seals the non-compliant product batch at the place of production or warehouse (Form No. 9 attached to this Circular). The product quality inspection authority issues a notice temporarily suspending production and circulation of non-compliant products (Form No. 7 attached to this Circular), requires the production facility to recall non-compliant products already released to the market, publicly announce on mass media, and simultaneously transfer the file according to the provisions of Clause 3 of this Article and recommend the competent state authority to handle the matter according to the law;

c. The production facility may only resume production of the product after completing corrective actions, complying with the handling procedures, and reporting in writing to the inspection authority for the inspection authority to conduct a re-inspection and issue a notice allowing the product to continue production and circulation (Form No. 10 attached to this Circular).
the inspection agency shall conduct a re-inspection and issue a notice allowing the product to continue production and circulation (Form No. 10 attached hereto).

3. The file transferred to the competent state authority for handling violations includes: Inspection decision, inspection record, test result notification or evidence confirming non-compliance of the product, administrative violation record, sealing record, temporary suspension of production notice, and a letter from the inspection authority requesting the competent authority to proceed with the legal handling procedures.

4. The competent state authority handles the violation; it is responsible for examining and handling according to the law and informing the inspection authority of the handling results for monitoring and summarizing.

Chapter III IMPLEMENTATION PROVISIONS

Article 9. Implementation Organization

1. The Department of Science and Technology is the lead agency for inspecting product quality during production under the management of the Ministry of Industry and Trade. Specifically:

a)    Lead and coordinate with relevant agencies and units to conduct inspections on product quality during production as prescribed in Clause 1 and Clause 2, Article 3 of this Circular;

b)    Aggregate and report on the situation of inspections on product quality during production as prescribed in this Circular;

c)    Aggregate the annual inspection plan and budget for inspecting product quality during production of the Ministry of Industry and Trade to submit to the competent authority for approval and organize its implementation;

d)    Be responsible for urging, guiding, and inspecting the implementation of this Circular.

2.    Departments under the Ministry of Industry and Trade and other state management agencies related:

a)     Lead the inspection on product quality during production within their jurisdiction as prescribed in Clause 2, Article 3 of this Circular;

b)    Coordinate and participate in conducting inspections on product quality during production according to their assigned functions and tasks;

c)    Propose the annual inspection plan for products under their management and send it to the Department of Science and Technology.

3.     Provincial Departments of Industry and Trade shall be responsible for leading and coordinating with relevant units and organizations to organize inspections on product quality during production as prescribed in Clause 2, Article 1 of this Circular within their jurisdiction. Specifically as follows:

a)    Conduct inspections on product quality during production within the assigned area in accordance with the law;

b)    In case goods circulating in the market do not meet the regulations on quality and these goods are produced in another locality or fall under the jurisdiction of another sectoral management agency, handle them according to their authority, and simultaneously notify in writing the corresponding inspection agency at the place where the goods were produced to coordinate and organize inspections during production as prescribed;

c)    Develop the annual inspection plan and budget for inspecting product quality during production to submit to the People's Committee of the province/city directly under the Central Government for approval and organize its implementation;

d)    Send the annual inspection plan for product quality during production that has been approved by the People's Committee of the province/city directly under the Central Government to the Department of Science and Technology, Ministry of Industry and Trade;

đ)    Report to the People's Committee of the province/city directly under the Central Government and the Ministry of Industry and Trade (through the Department of Science and Technology) every six months, annually, and urgently about the situation and results of inspections. The content of the report follows Model No. 11 attached to this Circular;

4.    Organizations and individuals producing products shall be responsible for:

a)    Ensuring that the products they produce meet the requirements for quality as prescribed;

b)    Withdrawing and handling goods that do not meet quality standards sold into the market by the organization or individual. In cases where products must be destroyed due to non-compliance with quality standards, they must bear all costs associated with the destruction of goods and be responsible for the consequences of such destruction according to the law;

c)    Comply with the provisions on handling violations during inspections on product quality during production by competent state management agencies;

d)    Comply with state inspections on product quality during production conducted by competent state management agencies.

Article 10. Effective Date

1. This Circular takes effect from July 1, 2016.

2.    In cases where legal normative documents cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new document.

3.     During the implementation process, in case of difficulties, agencies, organizations, and individuals shall promptly reflect them to the Ministry of Industry and Trade (through the Department of Science and Technology) for consideration and resolution./.