Standard Operating Procedure for Monitoring and Evaluating Supplier Performance in Raw Material Delivery
| Department | Procurement / Quality Assurance / Quality Control / Warehouse |
|---|---|
| SOP No. | SOP/RM/049/2025 |
| Supersedes | SOP/RM/049/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the systematic process for monitoring and evaluating the performance of suppliers involved in raw material delivery. It ensures suppliers meet quality, delivery timelines, regulatory compliance, and service expectations, promoting continuous improvement and reliable sourcing.
2. Scope
This SOP applies to all suppliers of raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, packaging materials, and solvents. It includes procedures for tracking delivery performance, quality compliance, documentation accuracy, and overall supplier reliability.
3. Responsibilities
- Procurement Department: Monitor supplier performance metrics, maintain supplier evaluation records, and communicate feedback to suppliers.
- Quality Assurance (QA): Review quality-related issues, ensure regulatory compliance, and contribute to supplier evaluations.
- Quality Control (QC): Conduct testing of raw materials and report any quality deviations.
- Warehouse Team: Track delivery accuracy, timeliness, and packaging condition, reporting discrepancies to Procurement and QA.
4. Accountability
The Procurement Manager is responsible for overall supplier performance monitoring and evaluation. The QA Manager holds the authority to approve or disqualify suppliers based on quality performance. The QC Manager ensures materials meet quality specifications, while the Warehouse Manager reports delivery-related issues.
5. Procedure
5.1 Supplier Performance Metrics
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Key Performance Indicators (KPIs): Supplier performance will be evaluated based on the following metrics:
- On-Time Delivery (OTD): Percentage of deliveries made within the agreed timeline.
- Delivery Accuracy: Correct quantity and type of materials delivered as per Purchase Order (PO).
- Quality Compliance: Number of rejected batches, quality deviations, and compliance with specifications.
- Documentation Accuracy: Completeness and accuracy of Certificates of Analysis (CoA), Bills of Lading, and other required documents.
- Packaging and Handling: Condition of packaging upon receipt and adherence to specified transport conditions.
5.2 Monitoring Supplier Performance
-
Data Collection:
- Warehouse logs delivery accuracy, packaging condition, and timeliness in the Supplier Delivery Log (Annexure-1).
- QC records material testing results and any quality deviations in the QC Test Report (Annexure-2).
- QA tracks regulatory compliance and documentation accuracy.
- Monthly Performance Review: Procurement consolidates data from Warehouse, QC, and QA to generate a Supplier Performance Review Report (Annexure-3).
5.3 Supplier Evaluation and Rating
- Quarterly Evaluation: Suppliers are evaluated quarterly based on collected performance data.
-
Rating Criteria: Suppliers are rated using the following scale:
- Excellent (90-100%): Consistently meets or exceeds performance expectations.
- Good (75-89%): Meets most expectations with minor issues.
- Average (60-74%): Frequent minor issues, but manageable.
- Poor (<60%): Consistent issues, requiring corrective actions or potential disqualification.
- Documentation: The Supplier Evaluation Form (Annexure-4) is completed for each supplier after each evaluation period.
5.4 Handling Non-Performance and Corrective Actions
- Identification of Issues: Non-conformities, delayed deliveries, or documentation issues are logged in the Supplier Non-Conformance Report (Annexure-5).
- Corrective Actions: Procurement contacts the supplier to initiate corrective actions. QA reviews and approves the effectiveness of corrective measures.
- Supplier Disqualification: Repeated non-performance or failure to address issues may lead to supplier disqualification, documented in the Supplier Disqualification Log (Annexure-6).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- API: Active Pharmaceutical Ingredient
- QA: Quality Assurance
- QC: Quality Control
- PO: Purchase Order
- CoA: Certificate of Analysis
7. Documents
- Supplier Delivery Log (Annexure-1)
- QC Test Report (Annexure-2)
- Supplier Performance Review Report (Annexure-3)
- Supplier Evaluation Form (Annexure-4)
- Supplier Non-Conformance Report (Annexure-5)
- Supplier Disqualification Log (Annexure-6)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- EU Guidelines on Good Distribution Practices (GDP)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Supplier Delivery Log
| Date | Supplier Name | Material Name | Batch Number | Quantity Delivered | Delivery Timeliness | Packaging Condition | Reported By |
|---|---|---|---|---|---|---|---|
| 01/02/2025 | PharmaSupplies Ltd. | API-X | X-2025-001 | 100 kg | On Time | Intact | John Doe |
| 02/02/2025 | Global Chemicals | Solvent-Y | Y-2025-002 | 200 L | Delayed | Damaged | Jane Smith |
Annexure-2: QC Test Report
| Date | Supplier Name | Material Name | Batch Number | Test Performed | Result | Conclusion |
|---|---|---|---|---|---|---|
| 03/02/2025 | PharmaSupplies Ltd. | API-X | X-2025-001 | Purity Test | Pass | Approved |
| 03/02/2025 | Global Chemicals | Solvent-Y | Y-2025-002 | Impurity Test | Fail | Rejected |
Annexure-3: Supplier Performance Review Report
| Supplier Name | On-Time Delivery (%) | Delivery Accuracy (%) | Quality Compliance (%) | Documentation Accuracy (%) | Overall Performance (%) | Rating |
|---|---|---|---|---|---|---|
| PharmaSupplies Ltd. | 100% | 100% | 100% | 100% | 100% | Excellent |
| Global Chemicals | 75% | 80% | 50% | 90% | 74% | Average |
Annexure-4: Supplier Evaluation Form
| Supplier Name | Evaluation Period | Performance Summary | Strengths | Areas for Improvement | Corrective Actions Recommended |
|---|---|---|---|---|---|
| Global Chemicals | Q1 2025 | Average Performance | Accurate Documentation | Quality Issues, Delivery Delays | Improve Quality Controls, Review Logistics |
Annexure-5: Supplier Non-Conformance Report
| Date | Supplier Name | Material Name | Batch Number | Non-Conformance Description | Corrective Action | Status |
|---|---|---|---|---|---|---|
| 03/02/2025 | Global Chemicals | Solvent-Y | Y-2025-002 | Impurity Above Limit | Supplier Investigated and Adjusted Process | Open |
Annexure-6: Supplier Disqualification Log
| Date | Supplier Name | Reason for Disqualification | Disqualification Approved By | Remarks |
|---|---|---|---|---|
| 01/04/2025 | Global Chemicals | Repeated Quality Failures | QA Head | Supplier to Reapply Post Corrective Actions |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Added Disqualification Criteria | Standardization | QA Head |