Pursuant to …;

Regarding the Issuance of General Requirements for the Competence of Animal Feed Testing Laboratories

 

DIRECTOR OF THE VIETNAM ANIMAL FEEDING MANAGEMENT AGENCY

 

Pursuant to Decision No. 18/2008/QD-BNN dated January 28, 2008 of the Minister of Agriculture and Rural Development on the functions, tasks, powers, and organizational structure of the Vietnam Animal Feeding Management Agency;

Pursuant to the Law on Product and Goods Quality No. 05/2007/QH12 dated November 21, 2007;

Pursuant to Decree No. 179/2004/NĐ-CP dated October 21, 2004 of the Government on state management of product and goods quality;

Pursuant to Decree No. 15-CP dated March 19, 1996 of the Government on animal feed management and Circular No. 08/NN-KNKL/TT dated September 17, 1996 of the Ministry of Agriculture and Rural Development guiding the implementation of Decree No. 15-CP;

Pursuant to Circular No. 02/2006/TT-BKHCN dated January 10, 2006 of the Ministry of Science and Technology guiding conditions and procedures for designating organizations to perform product and goods quality inspections;

Considering the proposal of the Head of the Animal Feed Department and the Head of the Inspection and Legal Affairs Department,

 

 DECIDES:

Article 1. To issue the General Requirements for the Competence of Animal Feed Testing Laboratories.

Article 2. This Decision takes effect from the date of signature.

Article 3. The Head of the Animal Feed Department, Heads of units, organizations, and individuals concerned shall be responsible for implementing this Decision./.

 

 

REGULATIONS

GENERAL REQUIREMENTS FOR THE COMPETENCE OF ANIMAL FEED TESTING LABORATORIES

(Issued together with Decision No.    186/QD-CN-TACN dated October 31, 2008 of the Director of the Vietnam Animal Feeding Management Agency)

This regulation is established based on TCVN ISO/IEC 17025:2007.

 

Chapter 1

GENERAL PROVISIONS

 

Article 1. Scope and Applicability

This regulation sets out general requirements for the competence of animal feed testing laboratories to conduct tests. This regulation also applies to the evaluation and designation of animal feed testing laboratories.

REQUIREMENTS FOR MANAGEMENT

 

Chapter 2

1. The testing laboratory or organization that includes the testing laboratory (hereinafter referred to as the Laboratory) must have legal personality and be organized and operated in accordance with the requirements of this regulation.

Article 2. Organization

2. The Laboratory must:

a) Have competent managerial staff and technical staff with the necessary expertise to fulfill assigned tasks.

b) Ensure an organizational structure that prevents leadership and Laboratory employees from being subjected to any pressure that could affect the quality of their work.

c) Have policies and procedures for protecting customer information and intellectual property rights.

d) Have regulations regarding responsibilities, authorities, and relationships of all Laboratory employees and leaders.

e) Conduct supervision of testing personnel, including trainees, through methods and procedures of testing and the purpose of each test by qualified personnel.

f) Have a technical manager responsible for all technical activities and providing necessary resources to ensure the quality of Laboratory operations.

g) Have a designated quality manager. The quality manager must have clear responsibilities and authorities to ensure that the quality management system is implemented and fully adhered to. The quality manager must have direct contact with the highest authority responsible for making decisions on policy and resources of the Laboratory.

g) Having staff assigned to manage quality. The quality management staff must have clear responsibilities and authorities to ensure that the management system related to quality is always implemented and fully adhered to. The quality staff must have direct contact with the highest-level leadership authorized to make decisions on policy and resources of the R&D institution.

Article 3. Management System

1. Testing and Calibration Laboratories (PTN) must establish and maintain a quality management system appropriate to their scope of activities and must have written procedures to ensure the quality of testing results.

2. Quality policies must be expressed through a declaration and must be presented in the quality manual. The quality policy declaration must be issued according to authority.

3. PTN must develop a quality manual, including:

a) Quality policy;

b) Management requirements including: legal status, organizational structure;

c) Technical requirements including: personnel, facilities and environment, testing methods, equipment, sample management and result reporting.

Article 4. Document and Record Control

1. Document control

a) PTN must establish and maintain procedures for controlling documents within the management system such as: standards, testing methods, technical regulations, guidelines, and the quality manual;

b) PTN must establish a master list of documents within the management system. This list must be clear and easily accessible. Documents must be reviewed and approved by authorized persons before issuance.

2. Record control

a) PTN must establish and maintain procedures for identifying, collecting, classifying, accessing, filing, storing, maintaining, and disposing of quality and technical records. Records kept include: original observation records, processed data, employee records, and copies of each issued test report for a certain period. Stored records include forms, contracts, logbooks, inspection reports, calibration certificates, correspondence, and customer feedback, etc.

b) Records must be clear and preserved and stored for easy access.

Article 5. Internal Assessment of Laboratory Activities

1. Annually, PTN must conduct assessments of activities according to planned procedures to check and confirm that laboratory operations comply with the requirements of the quality management system and this regulation. The person responsible for quality must plan and organize these assessments according to schedule and leadership requirements. These assessments must be carried out by trained and qualified individuals and must be independent from the activities being assessed.

2. Findings from inspections or reviews, as well as corrective actions, must be documented. The person responsible for quality must ensure that these tasks are completed within the agreed timeframe.

 

Chapter 3

TECHNICAL REQUIREMENTS

Article 6. Human Resources

1. Laboratory leadership must ensure that all personnel operating equipment, conducting tests, evaluating results, and approving test reports have the necessary competence. Laboratory staff must be adequately trained and experienced to perform assigned functions and tasks. When using trainees, appropriate supervision must be provided.

2. Laboratory leadership must develop training programs for staff skills that are suitable for current and future laboratory tasks.

3. Laboratory staff must be regularly trained and educated to improve their expertise.

4. PTN must maintain a file for each staff member. The minimum information includes:

a) Professional responsibilities (planning tests; performing tests; evaluating results; making observations and interpretations; modifying and developing new methods).

b) Competence and experience requirements;

c) Qualifications and training programs;

d) Management responsibilities.

Article 7. Amenities and Environmental Conditions

1. The Testing Laboratory must ensure amenities and testing environments that do not affect the results or quality of tests and high-precision equipment.

2. The Testing Laboratory must have necessary equipment to control environmental conditions that impact test results.

3. The Testing Laboratory needs to implement appropriate measures to ensure good industrial hygiene.

Article 8. Testing Methods

1. The Testing Laboratory must use standard testing methods, including sampling methods, meeting customer requirements and suitable for the tests conducted; priority should be given to using methods that have been issued: international standards, regional standards, or Vietnamese standards.

2. Technical standards, analytical procedures, guidelines, and operation manuals related to testing must be updated and accessible to employees.

3. Any changes to testing methods may only be applied when such changes are documented, technically proven, permitted for use, and accepted by the customer.

Article 9. Equipment

1. The Testing Laboratory must be equipped with all necessary devices for sampling, measuring, and testing to accurately perform testing tasks.

2. Equipment and software used for testing and sampling must have the capability to achieve the required accuracy and must comply with relevant technical regulations concerning corresponding testing methods. Before being put into use, equipment must be calibrated or tested to meet technical requirements.

3. Only authorized personnel may use equipment. The Testing Laboratory must always have up-to-date usage and maintenance instructions available for its staff.

4. The Testing Laboratory must have procedures for storing, transporting, retaining, safely using, and planned maintenance of measurement equipment to ensure their optimal performance and prevent contamination and degradation. The Testing Laboratory must have plans and procedures for calibrating equipment.

5. The Testing Laboratory must establish and retain records for each category of equipment. Records must include at least the following information:

a) Category of equipment;

b) Manufacturer's name, serial number;

c) Information on equipment inspection compliance with technical regulations (as stipulated in Clause 2 of this Article);

d) Manufacturer's instructions;

e) Dates, results, and copies of calibration and adjustment certificates, acceptable standards, and next calibration date;

f) Maintenance plans and actual maintenance performed according to plan;

g) Malfunctions, incidents, repairs, and modifications made to the equipment.

Article 10. Sampling

1. The Testing Laboratory must have a sampling plan and procedure to serve sampling activities when requested. The sampling plan and procedure must be notified to the location where sampling will take place. The sampling process must be reasonable and based on appropriate statistical methods. During sampling, controlled factors must be recorded to ensure the validity of testing results.

2. The Testing Laboratory must retain all relevant records related to sampling activities. Records include: applied sampling procedures, sampler comments, environmental conditions, and diagrams to determine sampling locations if necessary, and applied statistical sampling procedures.

3. Sampling must be carried out by qualified and trained personnel.

Article 11. Management of Test Samples

1. The Testing Laboratory (PTN) must have necessary regulations regarding transportation, receipt, management, storage, protection, retention, disposal of test samples to ensure the integrity of the test samples and protect the interests of the PTN as well as those of customers.

2. The PTN must have a system for coding test samples. The coding of test samples must be maintained in the laboratory throughout the period the samples are retained at the PTN. The coding system must be designed and operated to ensure that samples are not confused. This coding system must be organized into smaller sample groups to facilitate searching, retaining, and transferring samples.

3. The PTN must record in the file when receiving a test sample if there are any differences or discrepancies from the specified conditions. In case of any doubt about non-compliance, the PTN must discuss with the customer.

4. The PTN must have procedures and means for appropriate preservation to prevent damage, loss, or harm to test samples during storage, management, and preparation.

Article 12. Quality Assurance of Test Results

1. The PTN must have quality control procedures to check the accuracy, repeatability of the tests, and the proficiency of the staff performing the tests. This checking must be planned through the following actions:

a) Regularly using certified reference materials and/or internal quality control using laboratory reference materials.

b) Participating in inter-laboratory comparison programs and proficiency testing.

c) Conducting tests using the same method or different methods.

2. Quality control data must be reviewed and corrective and preventive actions taken if any deviations occur.

Article 13. Reporting Results

1. The results of each test or series of tests conducted by the PTN must be reported accurately, clearly, unambiguously, objectively, and in accordance with specific instructions in the testing method.

2. Each test report must include at least the following information:

a) Title, "Test Report".

b) Name and address of the testing laboratory.

c) Unique identification number of the test report.

d) Name and address of the customer.

e) Name and code of the testing method applied.

f) Description of the condition of the test sample, if applicable.

g) Date of sample receipt.

h) Test results along with corresponding units of measurement.

i) Full name and position of the authorized person issuing the certificate or response form and the date of the test report. Announce the validity of the response form for test results.

When necessary, the test report must include additional explanations of the test results including details of the sampling process.