Circular No. 24/2023/TT-BKHCN on State Inspection of Product Quality in Production under the Management Responsibility of the Ministry of Science and Technology

CIRCULAR

Regulations on State Quality Control of Products and Goods in Production under the Management Responsibility of the Ministry of Science and Technology

in production under the management responsibility of the Ministry of Science and Technologymanagement responsibility of the Ministry of Science and Technology

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

Pursuant to the Law on Standards and Technical Regulations dated June 29, 2006;

Pursuant to the Law on Measurement dated November 11, 2011;

Pursuant to the Law on Handling Administrative Offenses dated June 20, 2012;

Pursuant to the Law Amending and Supplementing Certain Provisions of the Law on Handling Administrative Violations dated November 13, 2020;

Pursuant to Decree No. 28/2023/NĐ-CP of June 2, 2023 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology;

Pursuant to the Government Decree number132/2008/NĐ-CPPursuant to the Government's Decree No. 132/2008/NĐ-CP dated December 31, 2008 detailing the implementation of certain articles of the Law on Product and Goods Quality;

Pursuant to Decree No. 74/2018/NĐ-CP of May 15, 2018 of the Government amending and supplementing certain articles of Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing the implementation of certain articles of the Law on Product and Goods Quality;

Pursuant to Decree No. 154/2018/NĐ-CP of November 9, 2018 of the Government amending, supplementing, and abolishing certain provisions on investment and business conditions within the scope of state management of the Ministry of Science and Technology and certain provisions on specialized inspection;

Pursuant to Decree No. 86/2012/NĐ-CP of October 19, 2012 of the Government detailing and guiding the implementation of certain articles of the Law on Metrology;

Pursuant to Decree No. 13/2022/NĐ-CP of January 21, 2022 of the Government amending and supplementing certain articles of Decree No.132/2008/NĐ-CPdated December 31, 2008, Decree No.74/2018/NĐ-CPdated May 15, 2018 of the Government detailing the implementation of certain articlesLaw on Product Quality and Decree No. 86/2012/NĐ-CPdated October 19, 2012 of the Government detailing and guiding the implementation of certain articlesof the Law on Metrology;

Pursuant to Decree No. 127/2007/NĐ-CP of August 1, 2007 of the Government detailing the implementation of certain articles of the Law on Standards and Technical Regulations;

Pursuant to Decree No. 78/2018/NĐ-CP of May 16, 2018 of the Government amending and supplementing certain articles of Decree No. 127/2007/NĐ-CP of August 1, 2007 of the Government detailing the implementation of certain articles of the Law on Standards and Technical Regulations;

Pursuant to Decree No. 107/2016/NĐ-CP dated July 1, 2016, issued by the Government, on business conditions for conformity assessment services;

Pursuant to Decree No. 43/2017/NĐ-CP of April 14, 2017 of the Government on product labeling;

Pursuant to Decree No. 111/2021/NĐ-CP of December 9, 2021 of the Government amending and supplementing certain articles of Decree No.43/2017/NĐ-CPa) Goods circulating in the Vietnamese market.

b) Goods in the defense and security sector are not subject to inspection under this Circular.

Pursuant to Decree No. 126/2021/NĐ-CP of December 30, 2021 of the Government amending and supplementing certain articles of the decrees stipulating administrative penalties for violations in the field of industrial property; standards, metrology, and product and goods quality; scientific and technological activities, technology transfer, and atomic energy;

Pursuant to Decree No. 118/2021/NĐ-CP of December 23, 2021 of the Government detailing certain articles and measures for implementationDecree No. 26/2024/NĐ-CP dated September 15, 2024 of the Government amending and supplementing certain articles of Decree No.;

At the proposal of the Director General of the National Standardization, Metrology and Quality Control Department and the Head of the Legal Affairs Department;

The Minister of Science and Technology issues this Circular regulating the form, content, procedure for handling, and organization of implementation of state quality control of products and goods in production under the management responsibility of the Ministry of Science and Technology. issuance falls under the management responsibility of the Ministry of Science and Technology.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

Article 1. This Circular regulates the form, content, procedure for handling, and organization of implementation of state quality control of products and goods in production under the management responsibility of the Ministry of Science and Technology.

Article 2. This Circular applies to the following entities:

a) Quality control agencies of products and goods: Agencies performing the function of managing the quality of products and goods under the General Department of Standardization, Metrology, and Quality; Agencies performing the function and task of managing standards, metrology, and quality under the science and technology departments of provinces and centrally-administered cities.

b) Organizations for conformity assessment.

c) Organizations and individuals producing products and goods under the management responsibility of the Ministry of Science and Technology.

d) State management agencies, organizations, and related individuals.

Article 2. Objects to be inspected

1. Products and goods in production under the responsibility of the Ministry of Science and Technology as stipulated in point p, Clause 2, Article 32 of Decree No. 132/2008/ND-CP dated December 31, 2008 of the Government detailing certain provisions of the Law on Product and Goods Quality (amended and supplemented by Clause 14, Article 1 of Decree No. 74/2018/ND-CP dated May 15, 2018 of the Government amending and supplementing some articles of Decree No. 132/2008/ND-CP dated December 31, 2008 of the Government detailing certain provisions of the Law on Product and Goods Quality).

2. Nuclear reactors, nuclear materials, nuclear source materials, radioactive substances, radiation equipment are not objects to be inspected as prescribed in this Circular.

3. Measuring instruments, tools, and equipment shall be applied in accordance with the laws on measurement.

Article 3. Explanation of Terms

In this Circular, the following terms are understood as follows:

1. Production is the implementation of one, several, or all manufacturing, processing, extraction, recycling, assembly, mixing, compounding, dividing, transferring, filling, packaging, and other activities that produce products and goods.

2. Organizations and individuals producing products and goods under the responsibility of the Ministry of Science and Technology are organizations and individuals producing products and goods specified in Article 2 of this Circular.

Article 4. Basis for inspection

1. Information and warnings about exported goods that do not comply with the conditions prescribed in Article 32 of the Law on Product and Goods Quality.

2. Information reflecting in any form from domestic and foreign organizations and individuals regarding signs of violations of product quality, goods labeling.

3. Survey or inspection results of product quality circulating in the market discovering goods with non-compliant labels or signs indicating non-conformity with applicable standards or technical regulations.

4. At the request of competent authorities.

5. Decision to revoke entirely or partially the validity of the Certificate of Conformity to National Technical Regulations issued by conformity assessment bodies; non-conformity assessment results of conformity assessment bodies.

6. In accordance with the annual inspection plan approved by competent authorities.

Chapter II

FORM AND CONTENT OF INSPECTION

Article 5. Forms of Inspection

1. Planned Inspection

a) Establishing the inspection plan:

Annually, the inspection agency bases on management requirements, the situation of product and goods quality, evaluation of compliance with laws on product and goods quality; previous inspection results; financial situation and directives from higher-level management agencies to develop an inspection plan as prescribed in Clause 2, Article 47 of the Law on Product and Goods Quality. Based on the approved inspection plan, the inspection plan for the following year must be issued at the latest before November 30 each year.

b) Before conducting planned inspections, the inspection agency shall notify organizations and individuals producing products and goods (inspected entities) at least three working days in advance.

c) For inspected entities included in the approved plan, based on actual circumstances or management authority's requirements, if the inspection agency does not inspect at the inspected entity, it shall send a letter requesting a report on compliance with relevant laws concerning the products and goods being produced by the entity. If violations regarding standards, measurements, quality, and labels are detected through these reports, the inspection agency shall conduct an unscheduled inspection as prescribed in Clause 2 of this Article.

2. Surprise Inspection

The product and goods quality inspection agency conducts unscheduled inspections during production when there is one of the grounds prescribed in Clauses 1, 2, 3, 4, and 5 of Article 4 of this Circular.

Article 6. Contents of Inspection

1. Inspect the application of requirements stipulated in published standards and corresponding technical regulations related to production process conditions and state management measures on quality in production, including:

a) Inspect certification and declaration conformity files (for products and goods requiring certification and declaration of conformity); standard conformity declaration files (for products and goods declaring conformity to standards); quality management system certification conformity files (for products and goods applying quality management systems).

b) Where corresponding technical regulations specify conditions for the production process, inspect the implementation of these regulations during production.

c) Inspect the implementation of other state management measures on product and goods quality in production as prescribed by competent authorities.

2. Inspect conformity assessment results, product labels, conformity marks, and accompanying documents of products and goods to be inspected, including:

a) Inspect the implementation and results of production process conformity assessments.

b) Inspect product and goods labels, information:

- Inspect contents displayed on product and goods labels; codes, barcodes, traceability information according to the law and compare with accompanying documents.

- Inspect the publication of applicable standards, the display of conformity marks (for products and goods requiring certification and declaration of conformity), conformity marks (for products and goods certified as conforming to standards).

- Inspect the accuracy of advertising content displayed on labels (if any) of products and goods.

3. Inspect the production process control activities of inspected entities related to product and goods formation and maintaining quality assurance, including:

a) Inspect technical files of products and goods (design documents; published standards and corresponding technical regulations of products and goods).

b) Inspect the entire production process (from input, through intermediate stages until product formation including packaging, handling, storage, and transportation processes).

c) Inspect the use of measuring instruments related to the production process in accordance with the laws on measurement.

d) Inspect raw material quality (according to published standards and corresponding technical regulations, the use of prohibited raw materials, expired raw materials).

đ) Other necessary technical contents.

e) In cases where necessary, the inspection agency may use experts to conduct evaluations according to the requirements of the published standards and corresponding technical regulations. The evaluating expert must be independent, impartial, and bear legal responsibility for the results of their evaluation.

4. Testing samples to check the conformity of product and commodity quality with published standards and corresponding technical regulations.

During the inspection process at the production facility, sampling for quality testing shall be carried out as follows:

a) Samples shall be taken according to the sampling method prescribed in the corresponding standards and technical regulations. In the absence of a sampling method provision, sampling shall be conducted randomly, ensuring that the sample represents the batch of products or commodities. Each sample shall consist of one unit sample or more but not exceeding four (04) unit samples. One (01) unit sample shall be sent for testing, and the inspected entity has the right to retain or not retain up to three (03) unit samples. The test sample must be coded (according to Model 8. BBMHM - Appendix attached to this Circular).

b) Based on the testing method for the product or commodity, the sampling inspection team shall ensure the quantity of products or commodities required to test the indicators according to the published standards and corresponding technical regulations and inspection requirements.

c) After sampling, the product or commodity sample must be sealed (according to Model 4.TNPM - Appendix attached to this Circular), and a record shall be established (according to Model 3.BBLM - Appendix attached to this Circular) signed by the person taking the sample and the representative of the sampled entity.

- If the representative of the sampled entity does not sign the sampling record and seal the sample, there must be a signature from a local government representative or an observer invited by the inspection team confirming that the representative of the sampled entity did not sign the record and seal the sample.

- If the record does not have a signature from a local government representative or an observer, the inspection team must clearly state the reason in the record. The sampling and sealing record with the signature of the person taking the sample and the head of the inspection team still has legal validity.

d) Sample retention

If the inspected entity retains samples taken by the inspection team, it must comply with current legal provisions regarding sample retention without affecting the original nature of the retained sample.

Upon receiving the test results, the inspection agency shall notify the inspected entity to handle the retained samples:

- For samples meeting quality requirements, the inspected entity may continue to put them into circulation or use.

- For samples violating quality requirements, the inspected entity must change their purpose of use, recycle, or destroy them in accordance with legal provisions.

đ) Sample testing

In cases where there are no specific provisions regarding the time limit for sending samples for testing, within a maximum period of five (05) working days from the date of sampling, the inspection team must send the product or commodity samples to the designated testing organization in accordance with legal provisions for testing.

The designated testing organization is responsible for prioritizing the testing of product or commodity samples from the inspection team performing state management functions, ensuring that the testing time complies with the regulations.

Article 7. Sampling and testing costs

The sampling and testing costs shall be implemented in accordance with Article 41 of the Product Quality Law and Circular Joint Circular No. 28/2010/TTLT-BTC-BKHCN dated March 3, 2010, issued by the Minister of Finance and the Minister of Science and Technology guiding the management and use of funds for state quality control activities on products and goods.

The inspection team and inspection agency shall not pay for the number of retained samples at the inspected entity.

Chapter III

PROCEDURE AND HANDLING OF INSPECTION RESULTS

Article 8. Inspection procedure

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

1. Announce the inspection decision (in Model 1.QĐKT - Appendix attached to this Circular) before conducting the inspection.

2. Conduct the inspection in accordance with the contents stipulated in Article 6 of this Circular.

3. Prepare the inspection record (in Model 2.BBKT - Appendix attached to this Circular). The completed record must have the signature of the representative of the inspected entity, the head of the inspection team, and other members of the inspection team.

- In case the representative of the inspected entity does not sign the inspection record, there must be a signature of the representative of the local authority where the inspection is being conducted or the inspection team invites at least one witness to confirm that the representative of the inspected entity did not sign the record.

- In case the inspection record does not have the signature of the local authority representative or the witness, the inspection team must clearly state the reason in the record. The inspection record signed by the head of the inspection team and other members of the inspection team still has legal validity.

4. Report in writing to the inspection agency about the inspection results and recommend the inspection agency to notify the inspected entity of the test results of the product and goods samples (in Model 5.TBKQTN - Appendix attached to this Circular) immediately upon receiving the test results from the testing organization.

5. In case of violation discovery, the inspection team and inspection agency shall handle the inspection results in accordance with Article 9 of this Circular.

Article 9. Handling of inspection results

1. During the inspection of product and goods quality in production, if administrative violations are discovered, the inspection team shall handle them as follows:

a) Prepare the Administrative Violation Record according to Model MBB01 - Administrative Violation Record prescribed in the Appendix accompanying Government Decree No. 118/2021/NĐ-CP dated December 23, 2021, detailing certain provisions and measures to implement the Law on Handling Administrative Violations.

At the same time, propose the Head of the Inspection Agency to issue a Notice requiring the producer to take corrective measures to ensure product and goods quality before releasing them to the market (in Model 7.TBKPSC - Appendix attached to this Circular).

b) Prepare the file for the authorized person to issue an administrative penalty decision according to Model MQĐ02 - Administrative Penalty Decision prescribed in the Appendix accompanying Government Decree No. 118/2021/NĐ-CP.

c) In case of violation related to product labeling, in addition to implementing the contents of the administrative penalty decision, the inspected entity must also comply with the handling and rectification requirements regarding labeling of the non-compliant goods in accordance with relevant laws.

d) In case the product and goods do not meet the applicable standards or technical regulations, the inspection team shall prepare the Administrative Violation Record according to point a, Clause 1 of this Article. At the same time, prepare the Sealing Record according to Model MBB26 - Sealing Record of Violation Items and Means Temporarily Held According to Administrative Procedures prescribed in the Appendix accompanying Government Decree No. 118/2021/NĐ-CP, seal the non-compliant batch of products and goods at the place of production or warehouse (in Model 6.TNPSP - Appendix attached to this Circular).

Implement the provisions of Clause 2, Article 30 of the Product Quality Law in cases where the product and goods quality does not meet the standard and poses a threat to human, animal, plant, property, and environmental safety.

e) After the inspected entity has complied with the violation handling requirements, the inspection agency prepares the Unsealing Record according to Model MBB27 - Unsealing Record of Violation Items and Means Temporarily Held According to Administrative Procedures prescribed in the Appendix accompanying Government Decree No. 118/2021/NĐ-CP for the inspected entity to carry out rectification or destruction as prescribed. Specifically:

- In case the inspected entity reprocesses the goods, when the reprocessing is complete, the inspected entity reports in writing for the inspection agency to conduct another sample test on the non-conforming criteria. If the test results meet the applicable standards or technical regulations, the inspection agency issues a notice allowing the product to continue production.

- In case the inspected entity destroys the non-compliant goods according to the administrative penalty decision, the inspected entity must fully comply with all relevant laws concerning the destruction of non-compliant goods.

f) Upon receipt of the test result notification, if the inspected entity lodges a complaint, it shall be resolved in accordance with the law on complaints.

2. The agency issuing the administrative penalty decision is responsible for publicly announcing the handling of administrative violations in accordance with the law on handling administrative violations.

In case the inspected entity fails to comply with the inspection team's requirements for rectifying and repairing products and goods to ensure quality before circulation, the inspection agency shall announce this on mass media in accordance with the law on quality.

3. The administrative penalty file transferred to the authorized person includes: Inspection Decision; Inspection Record; Administrative Violation Record; Sealing Record; Notification from the inspection agency requesting the authorized person or competent authority to proceed with the penalty procedures as prescribed by law or handover record of the file (if any) and other related documents.

Chapter IV

RESPONSIBILITY FOR IMPLEMENTATION

Article 10. Responsibilities of the Agency Implementing Quality Management Functions for Products and Goods under the General Department of Standardization, Measurement, and Quality

1. Develop plans and budget estimates for inspection activities

Based on the actual implementation of market inspections for product quality and production quality inspections, the Agency Implementing Quality Management Functions for Products and Goods shall develop inspection plans in accordance with Clause 1 of Article 5 of this Circular and the budget estimate for product quality inspections in production for the following year, which shall be included in the overall inspection plan for products and goods, and report to the General Department of Standardization, Measurement, and Quality.

2. Organize state inspections of product quality in production for products such as gasoline, diesel fuel, biofuel; engine lubricating oil; gas (liquefied petroleum gas - LPG, liquefied natural gas - LNG, compressed natural gas - CNG), and other products and goods specified in Article 2 of this Circular as required by management.

3. Organize state inspections of product and good quality in production for newly emerging products and goods according to the requirements of state management of quality or at the request of competent state agencies.

4. Notify the agencies referred to in Article 11 of this Circular of decisions to revoke the entire or partial validity of National Technical Regulation Conformity Certificates, and the results of non-conformity assessments by conformity assessment organizations as required by management.

5. Summarize the situation and results of inspections as stipulated in Clause 3 of Article 11 of this Circular, and submit reports to the General Department of Standardization, Measurement, and Quality on an urgent basis or periodically before December 1st each year.

6. Report and summarize the situation and results of inspections of product and good quality within the scope of inspections as prescribed in Article 2 of this Circular to the General Department of Standardization, Measurement, and Quality for reporting to the Ministry of Science and Technology before December 20th each year.

Article 11. Responsibilities of the Agencies Implementing Functions and Tasks of Standardization, Measurement, and Quality Management under Provincial and Central City Departments Specializing in Science and Technology

1. Inspect products and goods specified in Article 2 of this Circular produced within their jurisdiction, except for products such as gasoline, diesel fuel, biofuel; engine lubricating oil; gas (liquefied petroleum gas - LPG, liquefied natural gas - LNG, compressed natural gas - CNG).

2. In cases where goods circulating in the market do not meet quality regulations 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 General Department of Standardization, Measurement, and Quality (through the Agency Implementing Quality Management Functions for Products and Goods) and the corresponding inspection agency in the production locality of those products and goods to coordinate and organize production inspections as prescribed.

3. Report on the situation and results of inspections

The inspection agency is responsible for submitting annual periodic reports on the situation and results of inspections according to Form 15a/KTCL - Results of Product and Good Quality Inspections of the locality as stipulated in Circular No. 13/2021/TT-BKHCN dated December 30, 2021 on the General Department of Standardization, Measurement, and Quality (through the Agency Implementing Quality Management Functions for Products and Goods) before November 15th each year.

Article 12. Responsibilities of conformity assessment organizations

1. Provide information on production facilities for products and goods under the management responsibility of the Ministry of Science and Technology that have been assessed and certified as conforming to National Technical Regulations on a six-monthly or annual basis to the agency responsible for product and good quality management functions.

2. Send decisions to revoke the entire or partial validity of Certificates of Conformity to National Technical Regulations, and non-conformity assessment results to the agency responsible for product and good quality management functions.

Article 13. Responsibilities of organizations and individuals producing products and goods under the management responsibility of the Ministry of Science and Technology

Organizations and individuals producing products and goods under the management responsibility of the Ministry of Science and Technology shall be responsible in accordance with Article 10 of the Product and Good Quality Law.

Chapter V

IMPLEMENTING PROVISIONS

Article 14. Effective Date

1. This Circular takes effect from February 15, 2024.

2. Circular No. 16/2012/TT-BKHCN dated August 27, 2012, issued by the Minister of Science and Technology, regarding state inspection of product quality during production under the management responsibility of the Ministry of Science and Technology, shall cease to be effective from the date this Circular takes effect.

3. Cases being processed before the date this Circular takes effect shall continue to be handled according to the provisions of Circular No. 16/2012/TT-BKHCN.

4. In cases where laws and regulations cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new laws and regulations.

Article 15. Responsibility for Implementation

1. Quality control agencies for products and goods, production facilities for products and goods under the management responsibility of the Ministry of Science and Technology, related agencies, organizations, and individuals are responsible for implementing this Circular.

2. The Standardization, Metrology, and Quality Control General Department will guide and organize the implementation of this Circular. During the implementation process, if there are difficulties or obstacles, organizations and individuals should promptly report them to the Standardization, Metrology, and Quality Control General Department for reporting to the Ministry of Science and Technology for consideration and decision./.