Circular No. 54/2011/TT-BNNPTNT on Requirements for Testing Laboratories' Competence in Quality and Safety of Agricultural, Forestry, Aquatic Products, and Salt

CIRCULAR

Requirements for laboratory capacity regarding quality and safety of agricultural, forestry, aquatic products, and salt

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Pursuant to Decree No. 01/2008/ND-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development; Decree No. 75/2009/ND-CP dated September 10, 2009 of the Government amending Article 3 of Decree No. 01/2008/ND-CP dated January 3, 2008;

Pursuant to the Law on Technical Standards and Regulations No. 68/2006/QH11 adopted by the National Assembly at its 11th session on June 29, 2006 and effective from January 1, 2007;

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

Pursuant to the Law on Product Quality No. 05/2007/QH12 adopted by the National Assembly at its 12th session on November 21, 2007 and effective from July 1, 2008;

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

The Ministry of Agriculture and Rural Development hereby issues guidelines on the requirements for laboratory capacity for laboratories testing the quality and safety of agricultural, forestry, aquatic products, and salt as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the requirements for laboratory capacity for laboratories capable of conducting biological and chemical tests to support state management activities related to the quality and safety of agricultural, forestry, aquatic products, and salt under the jurisdiction of the Ministry of Agriculture and Rural Development.

Article 2. Applicability

This Circular applies to laboratories registered and designated as laboratories for testing the quality and safety of agricultural, forestry, aquatic products that serve state management activities under the jurisdiction of the Ministry of Agriculture and Rural Development (hereinafter referred to as laboratories).

Article 3. Explanation of Terms

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1. Laboratory quality management system: A system managing personnel, equipment, infrastructure, quality manuals, records, and documents to ensure the quality of test results.

2. Laboratory quality manual: Documentation defining the laboratory's quality management system.

3. Approval of test methods: Activities evaluating parameters (accuracy, measurement uncertainty, etc.) to provide evidence and confirm the reliability and scope of application of the method.

4. Proficiency testing: Conducting tests on the same sample by two or more laboratories under predetermined conditions to assess the ability of the laboratory to perform the test.

5. is the organization and evaluation of tests conducted on the same test sample or similar test samples performed by two (two) or more testing laboratories under predetermined conditions.: An evaluation of the quality of test results between two or more laboratories conducted by an independent organization through comparing analysis results on identical samples with the common value derived from the set of results obtained from participating laboratories.

Other terms are understood according to standard TCVN ISO/IEC 17025:2007 General requirements for the competence of testing and calibration laboratories.

Chapter II

PROVISIONS ON LABORATORY CAPACITY REQUIREMENTS

Article 4. Management Requirements

1. Laboratories or organizations having laboratories under their direct supervision must have legal personality and have registered their inspection activity fields in accordance with Circular No. 08/2009/TT-BKHCN dated April 8, 2009 of the Ministry of Science and Technology guiding the requirements, procedures, and formalities for registering inspection activity fields.

2. Laboratories must comply with the management requirements specified in Section 4 of standard TCVN ISO/IEC 17025:2007 General requirements for the competence of testing and calibration laboratories.

3. Laboratories must have a manager; there must be at least two technical staff members with university degrees relevant to each field of testing for the quality and safety of agricultural, forestry, aquatic products, and salt, and with at least three years of work experience.

Article 5. Technical requirements

1. Laboratories must meet the technical requirements specified in Section 5 of standard TCVN ISO/IEC 17025:2007 General requirements for the competence of testing and calibration laboratories.

2. Test methods used in laboratories

a) Test methods must meet:

- Suitability for application to the food items to be analyzed;

- Minimum detection limits (MRPL) or detection limits (LOD) or quantitation limits (LOQ) appropriate to enable conclusions about compliance with current Vietnamese or importing country regulations regarding maximum permitted levels for tested parameters or groups of parameters;

- Application of analytical techniques to minimize adverse effects on the health of inspectors and protect the environment;

b) Test methods applied in laboratories must be evaluated and confirmed for their suitability according to the annex attached to this Circular and must meet the quality control requirements for the safety of agricultural, forestry, aquatic products, and salt by Vietnamese authorities or importing countries;

c) For laboratories involved in exporting agricultural, forestry, aquatic product quality inspections, test methods must also meet additional requirements of the importing country's authorities (if applicable).

3. Sample management: Storage conditions must comply with the technical standards of each type of product and corresponding test methods. Additionally, for certain food samples used to analyze microbiological indicators, temperature and time conditions must comply with the provisions of Section 8.2 of standard TCVN 6404:2007 (ISO7218:1996), Microorganisms in Food and Feed - General Principles of Microbiological Examination. Sample receipt, coding, and result processing must ensure traceability of the information specified in Clause 5 of this Article.

4. Ensuring the quality of test results:

a) Laboratories must select proficiency testing/inter-laboratory comparison program providers capable of meeting the suitability criteria for the objects and parameters being analyzed and participate regularly with a frequency of at least once every three years per parameter or group of parameters, including:

- The laboratory participating in the TNTT/SSLP program must meet the requirements of the TNTT/SSLP programs designated by the accreditation body, the appointing organization, or the lead organization; organized by international and regional organizations; provided by standard ISO/IEC 17043 Conformity Assessment - General Requirements for Proficiency Testing or equivalent organizations, and must achieve satisfactory results.

- The laboratory must retain the results of all participated TNTT/SSLP programs. This record is part of the review during the accreditation body's evaluation and designation.

b) The laboratory must conduct internal proficiency testing annually. Internal proficiency testing includes repeatability tests, reproducibility tests, and recovery tests. The type of sample, number of times performed, method of implementation, calculation methods, criteria, and acceptance levels for each method must be specified in the quality manual and approved by the authorized personnel of the laboratory.

c) The laboratory must perform proficiency testing and staff skill assessments at least once per year per criterion or group of criteria. Criteria and acceptance levels for staff skill assessments must be detailed in the quality manual and approved by the authorized personnel of the laboratory. The laboratory shall only assign sample analysis tasks to staff who have passed the skill assessment.

d) Quality control data for test results must be retained and statistically analyzed regularly to assess trends and implement timely preventive measures.

đ) For chemical tests, at least one control sample and one blank sample must be tested concurrently with the test samples in each batch of analysis. A blind sample may replace the blank sample only if there is evidence that a blank sample cannot be found for that test. In cases where a blind sample cannot be obtained, there must be evidence that a blind sample cannot be found for that test.

e) For biological tests, at least one positive control sample and one negative control/sample white must be tested concurrently with the test samples in each batch of analysis. A pure positive strain may replace the positive control sample only if there is evidence that a positive control sample cannot be found for that test. A pure negative strain may replace the negative control/sample white only if there is evidence that a negative sample or a white sample cannot be found for that test.

5. Test Result Reporting

a) If there is an agreement with the customer on transferring results electronically, it must be ensured to match the original and have verification marks.

b) Test reports must contain minimum information to ensure traceability of the test sample source, including:

- Date of sampling;

- Sample identification number at the laboratory;

- Date and person sending/receiving the sample;

- Analysis date and result delivery date;

- Test results (as requested by the customer);

- Test method: Name and code of the test method;

- Method detection limit or quantitation limit (LOD or LOQ, if applicable) or other parameters as required by the importing country's regulatory authority;

- Product characteristics and special storage conditions (if any).

The laboratory must ensure accurate, impartial reporting of test results, timely notification, and take responsibility for the test results.

Chapter III

RESPONSIBILITY OF THE TESTING ORGANIZATION

Article 6. Responsibilities of testing organizations

1. Ensuring the capacity of the laboratory in accordance with the provisions of this Circular.

2. Reporting to the competent authority when there is a change in the capacity of the laboratory.

3. Being subject to inspection and supervision regarding the capacity of the laboratory by authorized agencies.

Chapter IV

IMPLEMENTING PROVISIONS

Article 7. Effective Date

1. This Circular takes effect forty-five (45) days from the date of issuance.

2. This Circular replaces Decision No. 115/2008/QĐ-BNN dated December 3, 2008 of the Minister of Agriculture and Rural Development on requirements for the capacity of food safety quality laboratories for agricultural, forestry, and aquatic products.

3. In the course of implementing this Circular, if there are difficulties or obstacles, organizations and individuals shall report to the Ministry of Agriculture and Rural Development for review, amendment, and supplementation./.