Circular No. 46/2015/TT-BCT stipulates quality control of products in production under the management of the Ministry of Industry and Trade.

CIRCULAR

Regulations on quality control of products in production under the management of the Ministry of Industry and Trade

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 Law on Product Quality and Goods;

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

The Minister of Industry and Trade issues this Circular regulating quality control of products in production under the management of the Ministry of Industry and Trade.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. This Circular stipulates the contents, procedures, formalities, and organization of quality control of products in 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 d Clause 2 Article 32 of Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing implementation of certain provisions of the Law on Product Quality and Goods, 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 industry and trade sectors;

d) E-commerce;

đ) Products that have quality control regulations during production 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 managing product and goods quality;

MECHANISMS AND POLICIES REGARDING THE PRICE OF AUCTION SERVICES FOR ASSETS THAT MUST BE SOLD THROUGH AUCTIONS AS PRESCRIBED BY LAW

Article 3. Basis and form of quality control of products in production

1. Quality control of products in production shall be carried out according to the annual plan approved by the competent authority.

2. Quality control of products in production shall be conducted unexpectedly when there is one of the following bases:

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 and Goods;

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

c) Authentic information from organizations and individuals both inside and outside the country reflecting on the quality of products and goods.

3. Quality control of products in production as stipulated in Clauses 1 and 2 of this Article shall be carried out in the form of inspection teams. Inspection teams shall be established in accordance with Article 48 of the Law on Product Quality and Goods.

Article 4. Principles of Inspection

Quality control activities must ensure the following principles:

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

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

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

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

5. Bearing legal responsibility for inspection results and related conclusions.

Chapter II

CONTENTS, PROCEDURES AND FORMALITIES OF QUALITY CONTROL AND HANDLING VIOLATIONS DURING THE QUALITY CONTROL PROCESS OF PRODUCTS IN 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 standard declarations applied according to Article 23 of the Product and Goods Quality Law;

c) Inspection of labeling, warning information content (for products and goods with regulations on displaying warning information); 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) Inspect 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 raw materials and expired raw materials);

d) Inspect the implementation of requirements for technological equipment and measurement, inspection, and testing equipment.

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

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. Evaluating experts 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 sampling products for testing as follows:

a) Samples are taken 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 kept at the inspection agency, and the remaining unit is handed over to the inspected entity for retention and preservation;

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

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

Article 6. Sampling and Testing Costs

Sampling and testing costs shall be implemented according to the norms prescribed in Circular Joint 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 on 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 case 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 for testing, the inspection team takes samples according to the provisions of Clause 4, Article 5 of this Circular.

5. Report the inspection results to the inspection authority or the person who issued the inspection decision.

6. Handling of inspection results

a) In cases where no violations are discovered, 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, if 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 allowed to release non-compliant products onto the market.

The production facility may only release products onto the market after having completed the corrective measures according to the requirements of the inspection team, reporting the completion 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) If, 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 seven working days from the date of concluding 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 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 poses a threat to human safety, animal, plant, property, environment, they shall be handled as follows:

a) Notify the production facility of the test results indicating non-compliance of the product (Form No. 5 attached to this Circular) within 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 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 re-inspection and issuance of a notice allowing the product to continue production and circulation (Form No. 10 attached to this Circular).

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 notice of production, and a letter from the inspection authority recommending the competent authority to proceed with the handling procedures according to the law.

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 jurisdiction of the Ministry of Industry and Trade. Specifically:

a) Take the lead and coordinate with relevant agencies and units to conduct inspections on product quality during production as stipulated in Clause 1 and Clause 2 of Article 3 of this Circular;

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

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

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

2. Departments, Bureaus, and Offices under the Ministry of Industry and Trade and relevant state management agencies:

a) Take the lead in conducting inspections on product quality during production within their jurisdiction as stipulated in Clause 2, Article 3 of this Circular;

b) Cooperate and participate in the implementation of product quality inspections during production according to their assigned functions and tasks;

c) Propose annual inspection plans for products within their jurisdiction and submit them to the Science and Technology Department;

3. Provincial Departments of Industry and Trade shall be responsible for organizing product quality inspections during production as specified in Clause 2, Article 1 of this Circular within their respective jurisdictions in coordination with related units and organizations. Specifically:

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

b) In cases where goods circulating in the market do not meet quality regulations and were produced in another locality or fall under the jurisdiction of other sectoral management authorities, handle the situation within their authority, and simultaneously notify in writing the corresponding inspection agency at the place of production to coordinate and conduct inspections during production as required;

c) Develop annual plans and budgets for product quality inspections during production to submit to the People's Committee of the province/city directly under the Central Government for approval and implementation;

d) Send the approved annual inspection plans for product quality during production by the People's Committee of the province/city directly under the Central Government to the Science and Technology Department, 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 Science and Technology Department) every six months, annually, and urgently about the situation and results of inspections. The report content follows Model No. 11 attached to this Circular;

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

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

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

c) Adhering to regulations on the handling of violations during product quality inspections during production by competent state management authorities;

d) Complying with state inspections on product quality during production conducted by competent state management authorities;

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 documents.

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