Department | Quality Management | Document no | QMS-050 | ||
Title | Vendor Certification Procedure | ||||
Prepared by: | Date: | Supersedes: | |||
Checked by: | Date: | Date Issued: | |||
Approved by: | Date: | Review Date: | |||
Document Owner
Procurement / Quality Assurance Manager
Affected Parties
All colleagues working in a team for vendor selection, evaluation and certification process from the Procurement, QA, Technical Services, Manufacturing and Laboratory Departments.
Purpose
This procedure aims to describe the process by which a vendor may be certified to supply materials or services.
Scope
This procedure applies to vendors that supply a material or service to be used at any stage of manufacture by operations.
Definition
Certification | “Is the act of approving quality control results provided by the supplier in relation to a specific material, thus eliminating the need to undertake some or all laboratory tests on receipt of that material unless specifically required to meet regional/local GMP and/or regulations”. |
De-certification | “Is the act of reverting back to full or partially increased testing of a specific material on receipt from the supplier”. |
Certified Material | A certified material is evaluated based on agreed testing by the Vendor and may also undergo additional laboratory testing by the buyer, if the supplier does not perform all tests required to release the material. |
Supplier | An umbrella term that covers both Vendors / Contractors. |
Vendor | A supplier of commercially available materials and/or services. |
Certification Team | The team is to comprise of the following representatives; QA Manager and Procurement Manager. |
C of A | Certificate of Analysis |
DR | Deviation Report |
Related Documents
TEM-005 | Raw Material Specification and Test Report Template |
TEM-100 | Quality Assurance Agreement Template |
TEM-150 | Packaging Material Specification and Test Report |
QMS-015 | Quality Documentation Management and Change Control |
QMS-030 | Preparation, Maintenance and Change Control of Master Documents |
QMS-035 | Deviation Report System |
QMS-080 | Audits |
EHS Statement
This procedure describes a documentation process with no EHS impact.
Procedure
This procedure will identify the responsibilities of Departments to contribute to the process.
1. Procurement Department
The Procurement Department is to:
1.1. Identify and submit to the Quality Assurance Department, the names of suppliers who can supply high value and/or substantial volume of materials.
1.2. Identify Vendor representative.
1.3. Monitor KPI performance with respect to supply and quality. (See TEM-100, Appendix 8)
1.4. Initiate a Supply agreement with the supplier.
2. Quality Assurance Department
The Quality Assurance Department is to:
2.1. Submit proposed Certified Vendors, together with Procurement, for approval to management team.
2.2. Initiate a Change Control to have the vendor changed from Approved vendor to Certified vendor. (See SOP QMS-015 for quality document change control procedure)
2.3. Produce a Project plan.
2.4. Monitor and analyze quality and rejection issues documented in Deviation Report.
2.5. Initiate a Quality audit of the supplier. (See SOP QMS-080)
2.6. Liaise with supplier to enhance their understanding of company requirements.
2.7. Create or review and update the relevant Raw Material Control Test Methods to reflect required testing terminology, requirements and methods.
2.8. Together with Procurement, present a report to the Management Certification Committee requesting certification of the supplier. The report is composed of typically the following; quality supply history, delivery performance, Project plan, Change Control request, audit information, Supply agreement, a Certificate of Analysis from the vendor, supplier inspection planning requirements, matrix.
2.9. Produce a Certificate to be presented to the successful vendor
3. Technical Service Department
The Technical Department is to:
3.1. Determine any Regulatory impact of changes to testing procedure and provide support for obtaining Regulatory approvals as required.
3.2. For relevant suppliers, review current Raw Material testing carried out on site and provide a summary of proposed testing to be performed by the Vendor. Liaise with the vendor and buyer’s Laboratory to obtain agreement on testing accountabilities and format of Certificate of Analysis provided by the vendor.
3.3. For Printed Materials,
3.3.1. Produce and distribute Packaging Specification Templates signed off by the supplier.
3.3.2. Produce and distribute Packaging Specifications created from the Packaging Specification Templates for each supplied material. A controlled copy of each template is provided to the supplier.
3.4. Produce Raw Material/Packaging Material Specification and Test Report on approved Raw Material/packaging material specifications respectively. A controlled copy of the Test Report is provided to the supplier.
4. Laboratory
The Laboratory is to:
4.1. Review all components delivered.
4.2. Raise a DR (See SOP QMS-035) for both rejection and quality issues, where required.
4.3. Liaise with the supplier and Technical Service Department regarding testing to be performed and presentation of results on a Certificate of Analysis.
5. Production
Production area is to:
5.1. Advise Quality Assurance Department of any quality issues using a Deviation Report supported by an example of the issue.
5.2. Communicate with Vendor representative to enhance understanding of buyer’s needs and Vendor limitations.
6. Vendor
Vendor is to:
6.1. Liaise with buyer’s QA and manufacturing team regarding issues with components.
6.2. Initiate visit of buyer’s sites to view their product or service being used by the buyer.
6.3. Ensure their Quality System supports quality supply.
7. Records
Records of the certification process are stored in procurement department.
8. Maintenance of Certification
Buyer shall undertake an annual review of the certification status of a vendor. This review will occur as part of the annual vendor review led by Procurement with support from Quality Assurance team.
This will include, but not limited to:
8.1. Monitoring
8.2. Historical Quality Review
8.3. Audit history
Summary of Changes
Version # | Revision History |
QMS-050 | New |