1.1 To lay down a standard procedure for selection, qualification and disqualification of vendors.
2.0 SCOPE
2.1 This SOP shall be applicable to material supplier’s selection, qualification and disqualification in Department of Quality assurance (QAD).
3.0 RESPONSIBILITY
3.1 Head- QA
3.2 QA Personnel (QAP)
4.0 DEFINITIONS
4.1 Nil
5.0 PROCEDURE
5.1 Qualification of New Vendor
5.1.1 Purchase department forwards specifications of the material and “Vendor Questionnaire” (Format No. F…………………) for material to the vendor, from whom the material is to be procured.
5.1.2 Procure at least 3 samples (20 g each for analysis or as appropriate) of material from different batches with COA.
5.1.3 Purchase department shall forward the filled Vendor Questionnaire, declaration for TSE / BSE, and sample intimation along with sample to Quality Assurance department.
5.1.4 QA shall forward the sample to Quality Control for analysis.
5.1.5 After receipt of COA from QC, If does not comply, reject the vendor. If complies, circulate the information of new vendor.
5.1.6 QA shall prepare and approve the qualification report of vendor.
5.1.7 Purchase department shall update and QA shall approve the list of approved vendor as per format and circulate to concern department’s quarterly.
5.2 Qualification (Re-Qualification) of Existing Vendor
5.2.1 The frequency of requalification of existing vendors shall every five years + 6 months or when ever require.
5.2.2 Head - QA shall decide on the facility audit of the supplier, if any critical issues are identified on the evaluation of the questionnaire for vendors in both the categories as defined above.
5.2.3 Decision on inclusion of the supplier in the `Approved Vendor list’ (Format No. F…………….) shall then be taken on successful review of the facility.
5.2.4 Trend analysis data shall be compiled on continual basis for all the material, in order for the supplier to continue in the `Approved Vendor list’.
5.2.5 The vendor shall be communicated for necessary corrective actions in case of poor trend record of the supplier.
5.2.6 An approved current list for “Approved Vendor” shall be available with the QA department and the warehouse.
5.2.7 It shall be the responsibility of the Quality Assurance and warehouse department to review and update both type of vendor’s list from time to time.
5.3 Criteria for disqualification of existing vendor
5.3.1 If supplied material gets rejected 3 consecutive occasions.
5.3.2 QA shall be the final authority to disqualify any vendor by filling the vendor disqualification report.
6.0 ENCLOSURES
6.1 Formats
|
Sr. No. |
Format Title |
Format No. |
No. of pages |
|
1. |
Vendor questionnaire |
F…………………….. |
03 |
|
2. |
Approved vendor list |
F…………………….. |
01 |
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 QAD- Department of Quality Assurance
7.3 TSE-Transmissible Spongiform Encephalopathy
7.4 BSE-Bovine Spongiform Encephalopathy
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF DOCUMENT
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