/ BHUTAN AGRICULTURE FOOD REGULATORY AUTHORITY
ANALYTICAL AND CERTIFICATION DIVISION / QUALITY PROCEDURE
DOC. BAFRA-ACD-PR-7.4-01/ ISSUE 01 / REVISION 00 / 26 DECEMBER 2016
PROCEDURE FOR PROCESSING OF APPLICATION FOR CERTIFICATION
To ensure proper evaluation, review and recommendation for certification in the product certification activities.
This covers evaluation, review of application and recommending for taking certification decision.
Director General is responsible for defining criteria for evaluation, review and certification decision for management and personnel involved in product certification scheme.
Chief ACD is responsible for arranging evaluation, review and certification decision on application file to BAFRA-ACD.
4.1 Planning for evaluation
4.1.1 After the application is registered,aquality plan for certification depending on the characteristics of the certification scheme and the product requirements is prepared including evaluation of the quality management system(See Exhibit 01) for the evaluation of applications registered.
4.1.2The process plan for the operations of product certification is indicated in the Exhibit 01 is based on Scheme 5 Product Certification Process as provided in ISO/IEC 17067:2013. The certification process is carried out by ACD. When enough technology specific expertise is not available utilizing staff from different Divisions and testing from Testing Division if capability exists otherwise outsourced.
4.1.3BAFRA-ACDevaluation process consists of preliminary inspection (where required) factory evaluations and review and recommendation for certification and BAFRA-ACD performs this evaluation through itscompetent personnel. BAFRA-ACDensures all needed information and/or documentation is made available for performing the evaluation tasks. The evaluation tasks can include activities such as design and documentation review, sampling, testing, inspection, audit, etc.
EXHIBIT 01 Process plan for the operations of product certification
4.2 Preliminary visit
4.2.1 BAFRA-ACDorganizes a preliminary visit by appointing a Technical Auditor to gather information for evaluation of applicant’s capability to implement the certification scheme:
a)to prepare the scheme of testing and inspection (STI)
b)To calculate thecertification marking fee.
The Inspector submits a preliminary inspection report on the prescribed format recommending whether or not the applicant is ready for Factory audit.
4.3 Factory audit/inspection
4.3.1BAFRA-ACDbased on the information provided in the application and the preliminary inspection report determines the man days required for the technical evaluation. A team is then constituted of Inspectors competent to carry out inspection in the technology area based on NACE-02 applied for after ascertaining convenience of the applicant and it is intimated to the applicant for acceptance of the team for the inspection. If any valid reasons for change in the team composition are received it is examined on the basis of any conflict of interest.
4.3.2 The Inspection Teamcarries out full factory inspectionof the products against the requirements covered by the scope defined in its application including requirements specified in the certification scheme. This includes among other things the following:
a)Visit to different functional areas comparing the organization set provided,
b)Establishing legal entity of the premises,
c)Establishing technical competence of personnel engaged in the manufacture of the product,
d)Establishing competence of quality control personnel,
e)Testing a sample in their Quality Control Laboratory, if feasible and compare the results with the test results recorded by the QC Lab.
4.3.3The team will take samples for independent testing in accordance withBAFRA-ACD-G7.4-01 Guidelines for Drawl, Coding, Sealing and Dispatch of Samples or personally bringing to BAFRA-ACD.
4.3.4A brief report of the evaluation especially indicating the nonconformities is provided to the client and seeking time taken for corrective action by the client.Based on the non-conformities informed the client to take carry out root cause analysis and ensure appropriate correction and corrective actions.
4.3.5Depending on the nature of nonconformities andif the client expresses interest in continuing the certification process, BAFRA-ACDshall decide whether additional evaluation tasks needed to verify that nonconformities have been corrected at site. Appropriate, competent person(s) within the BAFRA’s internal resources shall be authorised to take this decision.
4.3.5The Inspection Team submits its report on the prescribed format within a weekfor taking subsequent application processing steps.
4.4Review and recommendation
4.4.1 BAFRA-ACDassigns at least one person to review all information and results related to the evaluation. The review shall be carried out by personnel who have not been involved in the evaluation activities.
4.4.2 The results of all evaluation activities as given below shall be documented prior to review. This documentation can provide opinion whether product requirements have been fulfilled:
a)Preliminary inspection report,
b)Factory technical audit report,
c)Report of samples tested in an independent laboratory.
4.4.3 The reviewing officergives his/her review report including recommendations for being considered by the Certification Marks Committee(See BAFRA-ACD- PR7.6-01).
BAFRA-ACD -PR7.2-01 Procedure for Receipt, Review and Registration of Application
BAFRA-ACD -PR7.6-01 Procedure for Grant of Certification
BAFRA-ACD -PR7.4-02 Procedure for Calculation of Man Days for Technical Audit
BAFRA-ACD -GL7.4-01 Guidelines for Drawl, Coding, Sealing and Dispatch of Samples
BAFRA-ACD -PR7.4-01-FM-01 Report Format for Preliminary Inspection
BAFRA-ACD-PR7.4-01-FM-02 Nomination of Team Leader/Audit Team Product Certification
BAFRA-ACD-PR7.4-01-FM-03 Intimation to the Applicant of Audit Team and Audit Dates
BAFRA-ACD-PR7.4-01-FM-04 Inspector Plan
BAFRA-ACD-PR7.4-01-FM-05 Factory Inspection Checklist (General)
BAFRA-ACD-PR7.4-01-FM-06 Factory Inspection Checklist (Food products)
BAFRA-ACD-PR7.4-01-FM-07 Factory Technical Audit/Inspection Report Form
BAFRA-ACD-PR7.4-01-FM-08 NonconformityReport Form
BAFRA-ACD-PR7.4-01-FM-09Request for Analysis Form
BAFRA-ACD -PR7.4-01-FM-10Form for Review and Recommendation for grant ofLicense
BAFRA-ACD -PR7.4-01-FM-11 Product Certification Marks Decision FormApproved by CACD / Issued by MR / Page 1 of 4