QMS-045 Vendor Selection and Evaluation Procedure

Department

Quality Management

Document no

QMS-045

Title

Vendor Selection and Evaluation

Prepared by:

Date:

Supersedes:

Checked by:

Date:

Date Issued:

Approved by:

Date:

Review Date:

Vendor

Any Manufacturer / Vendor / Supplier which has been identified (Via Phase 1) as a potential source of supply for a specific material.

A vendor is a company from whom we directly obtain the material.  The vendor may also be the manufacturer and may be local or overseas based.  The non-manufacturing vendor can only purchase material from the approved manufacturer as directed by the Buyer.

Manufacturer

A manufacturer is the company that synthesises or produces the material.  The manufacturer is normally responsible for all aspects of manufacture and quality control of the material.  Technical support is often provided with respect to product knowledge, stability data, impurity profile of the material and technical expertise relating to the material.  In the case of active manufacturers the manufacturer is responsible for the provision and maintenance of a Master Files.  (See SOP QMS-115)

Approved Vendor

A Vendor or Vendor/ Manufacturer combination which has been assessed and approved (Via Phase 3) for a specific material and listed on approved vendor list

Approved Vendor List

List of approved vendor / manufacturer material combination maintained by Quality Assurance and by Technical Service Departments.

Vendor

The process of assuring the vendor’s ability to fulfil given requirements before the Vendor is approved.  Vendor assessment must address the issue of quality

Vendor Review

The ongoing assessment of an approved vendor based on experiences with the Vendor.  For this purpose data on quality, capacity, price and service must systematically be collected and evaluated.  This data must be used to reconsider the approval of the vendor whenever possible

Audit Team

The Audit team can be comprised of different specialists to cover quality, commercial and technical aspects.  The Team leader must be a Qualified Lead Auditor.  (See SOP QMS-080)

General Vendor Audits

The Quality Assurance function of the vendor assessment (Phase 2)

Certification

Is the act of approving the analytical (QC) results provided by the vendor; thereby eliminating the need to undertake some or all of the analysis on receipt by the buyer.

De-certification

Is the act of reverting back to full or partly increased analysis on receipt

Critical Packaging Component

A component in contact with the final product, or provides a level of protection for stability proposes and/or microbiological integrity

Non critical Packaging Component

No product contact, or affect on the stability of the product or microbiological impact

Critical Vendor

A service supplier who has a direct impact on Quality, on Machinery and supply to Production

Form-385

Vendor Audit Questionnaire

Form-390

New Supplier Assessment Form

QMS-030

Preparation, Maintenance and Change Control of Master Documents

QMS-080

Audits

QMS-110

Management and Control of Contract Work

QMS-115

Criteria for Sourcing of RM, Critical Packaging Components and Imported Finished Goods

PUR-005

Material Purchasing Information Record and Source List

Responsibility

PROCEDURE

See Flow diagram (Appendix – 1)

All employees

Any unit within the organization may propose the need to source a new vendor of goods or services.

Procurement

The initiator of the request must contact Procurement who will then commence the vendor assessment. It is the responsibility of Procurement to ensure the progression of the vendor through the vendor assessment process

Phase 1

Source suitable vendor who is capable of manufacturing the material according to in-house Requirements, as per SOP QMS-115.

– Vendors are selected using the following parameters:

– Ability to consistently supply material to the specification (laboratory records)

– Ability to deliver the required material in the quantities ordered (purchasing records)

– Previous experience with the supplier (raw material records, laboratory records, reject material/component forms)

– Cost of material

– Ability to supply technical support where required.

Procurement/ Technical/QA

Upon selection of a vendor an assessment need to be done for material to be purchased.   This assessment may include sample testing, on-line testing and in house trials.  This assessment is to be filed in the vendor file maintained by Procurement.  Original data will be filed in the Technical files.

Phase 2

QA

A Vendor Questionnaire is to be sent and completed by the prospective vendor and filed with vendor file (e.g. Form-385).

QA

The vendor’s manufacturing and quality control practices must be reviewed by means of General Vendor audit.

QA

All audits must be documented in a report, which should include a recommendation whether or not the vendor shall be considered as approved.

QA/Procurement

The results of material testing and the vendor questionnaire are to be assessed and a decision made as to whether the vendor has the capability to produce the material in question and whether to proceed with the assessment process.  If the results are unacceptable then the selection process starts again.

The frequency of General Vendor Audits depends on the needs in the individual case and is to be determined by the auditor at the completion of the audit process and documented on the audit report. Audits shall be planned scheduled and conducted in lines with SOP QMS-080

Phase 3

Procurement/ QA

Phase three involves a negotiation with the vendor to handle any matters specific to the material as a result of material testing, questionnaire results or general vendor audit results.

Technical

Specifications are to be finalized and approved.

QA/ Procurement

Vendor Approved/Certification.  This is valid for one item or group of items and for one site only.  If the vendor manufactures several items of interest, each item or group of items must be dealt with separately.

Procurement

Initiate Purchasing Item Master Update as per SOP PUR-005.

Supply Chain

Approved Vendor listing to be update in accordance with SOP PUR-005.

Phase 4

Procurement /QA

The quality of subsequent deliveries is continually monitored by compliance of the material to the agreed specifications and comparison with previous deliveries via trend analysis.

Vendors/manufacturers are evaluated based upon the following criteria:

Ability to consistently comply with the agreed material specification requirements.

Quality of materials monitored as part of the post-production stability surveillance of finished products.

Data reviewed from compilation of number of deliveries, degree of rejects, number and extent of problems encountered in production, stability data showing untoward trends attributed to material deficiencies or changes.

QA

Approved vendors are to be re-audited at regular intervals as determined by Business needs.

De-certification of Approved Vendor

QA/ Procurement Manager

If an approved vendor, for reasons such as failure in quality and / or commercial issues is no longer considered appropriate for use, the vendor is to be withdrawn from the approved vendor list.  See SOP PUR-005.