Inspection Procedures of Testing and Inspection Agencies
Applicable Regulations
- 「The Act on Testing and Inspection of Food and Drugs」
- 「Enforcement Rule of the Act on Testing and Inspection of Food and Drugs」
- The 「Regulation on Evaluation of Food and Drug Testing and Inspection Agencies」
| Classification | Act | Enforcement Rule | Notification |
|---|---|---|---|
| Designation of Testing and Inspection Agencies | Article 6 (1)~(4), (6) | Article 2, [Appendix 1], [Appendix 2] | The 「Regulation on Evaluation of Food and Drug Testing and Inspection Agencies」 |
| Changes to Testing and Inspection Agencies | Article 6 (5), (6) | Article 4 | |
| Procedures of Testing and Inspection | Article 11 | Article 11, Article 12 | - |
| Matters to be Observed by Testing and Inspection Agencies | Article 12 | Article 15, [Appendix 6] | - |
| Evaluation and Management of Testing and Inspection Agencies | Article 16 | Article 20 | The 「Regulation on Evaluation of Food and Drug Testing and Inspection Agencies」 |
| Inspection of Testing and Inspection Agencies | Article 22 | - | - |
Ⅰ. Designation & Changes of Testing and Inspection Agencies
Designation of Testing and inspection Agencies
- Designation Procedure
| Process | Required documentation & Assessment |
|---|---|
|
|
|
|
|
A list of testing·inspection agencies are available on the MFDS Website at www.mfds.go.kr > Customer Risk Prevention > A list of testing·inspection Agencies |
- Designation Requirements
| Process | Required documentation & Assessment |
|---|---|
| ① Required Document | Whether a testing· inspection agency is equipped with an adequate numbers of testing personnel, facilities and equipment necessary to conduct a test |
| ② Quality Assurance |
|
| ③ Testing Competence |
|
- Designation Requirements
| Processing Time | Fees | Remarks |
|---|---|---|
| 45days |
380,000 KRW (Online Application) 342,000 KRW |
Including re-designation |
Changes to Designation details
- Approval and Reporting of Changes
| Changes to be approved | Changed to report |
|---|---|
Name & Address of testing laboratories
|
Representative
|
- Procedure for Change
| Process | Required documentation & Assessment |
|---|---|
|
|
| *Only applicable to changes that require approval |
- Processing Time and Application Fees
| Type of Change to be made | Processing Time | Fees | |
|---|---|---|---|
| Changes to be | 1. Name of testing and inspection agency | 14days | Free |
| approved | 2. Address | 14days | 190,000 KRW |
| 3. Scope of testing and inspection | 45days | (Online Application) 171,000 KRW |
|
| 4. Product classification and test items | 30days | ||
| 5. Testing fees and fee calculation methods | 14days | Free | |
| Changes to report | 1. Representative | 14days | Free |
| 2. Testing manager and/or Quality assurance manager | |||
| 3. An optimal number of tests or inspections and its supporting data | |||
Ⅱ. Inspection of Testing and Inspection agencies
Objectives
- To ensure the appropriateness and reliability of tests and inspections conducted by testing and inspection agencies by ascertaining whether they continues to comply with specifications and applicable regulations
Inspection Period
-
March, 2016 ∼ December, 2016 (For 9months)
- Inspection takes 1 to 3days for each laboratory based on its testing scopes and the number of tests executed, etc.
Inspection Type
-
Regular Inspection
- Regular inspection for all testing and inspection agencies is carried out at least once every year
- Each testing and inspection agency is routinely inspected on advance notice, pursuant to 「the Framework Act on Administrative Investigations」
-
Special Inspection
- The MFDS may perform a special inspection, without advance notice, when the Minister of Food and Drug Safety deems it necessary to conduct an inspection in response to a complaint, report, petition or other request filed
- Special inspection is carried out without prior notice
-
Planned Inspection
- Each year, the MFDS prepares an inspection schedule for the year by analyzing potential risk factors and evaluating the existing vulnerabilities of a particular testing or inspection agency
- Planned inspection is carried out without prior notice
Inspection Details
- A laboratory shall comply with the designated scope of testing
- Laboratory organization and personnel
- A laboratory shall be composed of a testing manager, a quality assurance manager and one or more testing personnel for each test item
- The actual number of laboratory personnel on duty shall be equal to the number of personnel written on an application provided. The laboratory shall report any changes in laboratory personnel to the MFDS by a given date
- Article 10-1-5 of 「the Act on Testing and Inspection of Food and Drugs」
- Testing Inspection facilities and equipment
- A laboratory shall make alterations to the designated matter in accordance with applicable regulations.
- Standards, methods, and procedures for Testing and Inspection
- Reporting of test or inspection results that are determined inappropriate
- Reporting of yearly results of tests or inspections
- A laboratory shall store documents related to tests and inspections prescribed by Ordinance of the Prime Minister for 3 years (In cases of medical devices, for 5 years).
- A laboratory shall implement corrective measures based on the results of a proficiency test and/or a quality assurance test.
Matters to be Observed by Testing and Inspection Agencies
- Each laboratory shall not issue a test or inspection report beyond the designated scope of testing or inspection.
- Each laboratory shall issue a test or inspection report based on the established test time and optimal number of testing rounds.
- Only the approved testing or inspection fees by the Minister of Food and Drug Safety shall be charged.
- Where the result of a test or inspection is determined inappropriate, the test materials used in such tests shall be stored for more than 60 days.
- When there is an uncertainty in test results, tests shall be repeated until the results become clear.
- All reference materials, reagents and mediums shall not be used beyond their expiration dates. Provided, That the foregoing shall not apply where their efficacy has been proved.
- A laboratory shall conduct a test or inspection in accordance with standards, procedures and applicable regulations, and all or any part of test items shall not be omitted from a test or inspection report.
- Each test material shall be uniquely identified and kept in a place free from any contamination and confusion.
- A laboratory shall plan and conduct internal audits as required by the schedule. If necessary, a cause analysis and corrective actions shall be taken, and details of such activities along with internal audit findings shall be recorded and retained.
- A records management system, Audit Trail, shall be established to store and retain all records of testing activities.
Ⅲ. Evaluation and Management of Ability of Testing and Inspection
Target of Evaluation
- Testing and inspection agencies home and abroad designated pursuant to Article 6 and Article 8 respectably
- Article 6 and 8 of 「the Act on Testing and Inspection of Food and Drugs」
Evaluation Plan
- An annual plan for the evaluation of testing and inspection agencies is established and promptly notified An annual evaluation plan includes target of evaluation, evaluation items and evaluation scheme
Proficiency Testing
- Proficiency Testing is organized and conducted using Certified Reference Materials (CRMs) or Reference Materials (RMs) in order to check the capability of laboratories to deliver accurate test results to their customers
- Test materials to be analyzed are determined based on the assigned testing scope and test items of each testing and inspection agency
- A participating laboratory is required to submit a report of test results to the Laboratory Audit and Policy division of the MFDS within 30 days after test materials are distributed.
-
Quantitative or Qualitative Evaluation
-
Quantitative Evaluation (Z-score):
-│Z│≤ 2: Satisfactory
- 2 <｜Z｜< 3: Questionable
-│Z│≥ 3: Unsatisfactory
-
Quantitative Evaluation (Z-score):
-
Qualitative Evaluation:
- If the test results are correct: Satisfactory
- If the test results are incorrect: Unsatisfactory
Quality Assurance Evaluation
- Objectives: to evaluate testing competence of testing and inspection agencies using Quality Assurance Standards
- Private agency: once a year
- Prescribed agency: once every two years
Audit Parameters
- Management of Organization
- Key managerial personnel, a testing manager, a quality assurance manager and adequate numbers of laboratory personnel who are competent to perform testing activities shall be appointed. And their qualifications shall be fulfilled
- A laboratory shall be equipped with proper facilities and equipment to perform laboratory testing
- Documents or records relating to education·training, quality assurance and testing activities shall be recorded and retained
- Facilities and equipment
- A laboratory shall have adequate facilities, equipment and environment for testing activities
- Each item of equipment and apparatus used for testing shall be uniquely identified and its use shall be kept documented
- Test materials and reagents shall be promptly stored in a controlled environment
- Harmful chemical substances, etc. shall be used and stored in compliance with pertinent regulations.
- Testing and inspection
- Each test material and reagent shall be uniquely identified
- Raw data for testing shall include prerequisite items, and shall be retained and managed
- Test reports shall be designed to minimize the possibility of misunderstanding and misuse
- Quality assurance
- A laboratory shall conduct an internal audit and its findings shall be reported and retained
- A laboratory shall take corrective actions for nonconforming work
- Records of intra- and inter-laboratory proficiency testing shall be documented and retained
- Measurement uncertainty shall be estimated using key equipment
- Periodic calibration of analytical equipment and apparatus shall be performed, and records of such activities shall be documented and retained
- Test methods used in testing activities shall be verified and validated
- Verification and validation of test methods which utilize analytical equipment shall be conducted with the use of CRM, RM or equivalent reference materials
- Evaluation Criteria
| Exemplary testing and inspection agencies | Food, Livestock product testing and inspection agencies | Others | |
|---|---|---|---|
| Prerequisites | Satisfactory | Satisfactory | Satisfactory |
| Other items | over 90 points | over 85 points | over 80 points |
Follow-up activities
- Reporting of the results of cause analysis & corrective measures taken
- When a corrective action has been taken and a cause analysis has been conducted, outcome and records of such activities shall be submitted to the MFDS within 30 days
- A laboratory who receives “Questionable“ or “Unsatisfactory“ grade in a proficiency testing, and/or “Inappropriate“ results in a quality assurance evaluation
- Re-evaluation (On-site Audit or Review of Documentation)
- A laboratory who receives “Unsatisfactory“ grade in a proficiency testing, and/or “Inappropriate“ results in a quality assurance evaluation
- Administrative actions
- 1st violation: Business Suspension for one month
- 2nd violation: Business Suspension for 3 months
- 3rd violation: Revocation of Designation
Partial Revision of the Regulation on Evaluation of Food and Drug Testing and Inspection Agencies
Background
- Recently, several testing laboratories have issued false test reports, raising concerns over the reliability of test results produced by testing laboratories in general. In response, the MFDS has decided to take regulatory reforms aimed at reinforcing the management of testing laboratories.
Revised Contents
- 1. Promoting self-compliance with optimal number of testing rounds
- Any person who intends to be designated as a testing agency shall submit a report of optimal number of tests based on testing capabilities, including testing personnel, facility, etc. and its supporting data. In the event of violation, administrative actions shall be taken
- 2. Tougher standards for re-designation of testing laboratories
- The designation of a testing laboratory whose period of validity (3 years from the date it is designated) expires might not be renewed, based on its proficiency test results and a record of administrative actions.
- Re-designation maybe limited in case where a testing laboratory has no record of testing performance for more than one year without due cause, or has been suspended for more than three times, or has failed to pass the proficiency test for 3 consecutive times
- 3. Mandatory establishment of “Audit trail”
- A records management system, Audit Trail, shall be established to store and retain all records of testing activities
- 4. Newly designed test reports for forgery prevention
- Test reports shall be designed to prevent forgery
- 5. Stricter administrative actions
- Tougher administrative actions shall be imposed in case of the following violations
- where a testing laboratory fails to report test results that are determined inappropriate from self-quality inspection: 7 day suspension of business a 1 month suspension
- where a testing laboratory fails to conduct a test or inspection in accordance with applicable standards or procedures: revocation of designation on the 4thviolationa Revocation on the 3rdviolation
- where a testing laboratory collects testing fees in violation of law: corrective actions taken a 15day suspension of business
- Tougher administrative actions shall be imposed in case of the following violations
- 6.International Standards shall be applicable to testing on medical devices
- Testing laboratories are allowed to follow international standards, including ISO and IEC, in addition to standard specifications and test method for medical devices prescribed by the Minister of MFDS
- 7.Shortening the processing time for representative change of a testing laboratory (14days a 7days)
