Supplier Performance Evaluation – Standard Operating Procedure

1) Purpose

To establish guidelines for evaluating supplier performance to ensure continuous improvement and alignment with quality and delivery expectations within the pharmaceutical purchase department.

2) Scope

This SOP applies to evaluating and monitoring supplier performance based on defined metrics and criteria.

3) Responsibilities

Purchasing Team: Responsible for evaluating supplier performance and maintaining supplier records.
Quality Assurance Team: Responsible for providing input on supplier quality performance.

4) Procedure

4.1) Supplier Selection Criteria:
4.1.1) Define criteria for selecting suppliers based on quality, delivery, reliability, and compliance.
4.1.2) Establish performance metrics and benchmarks for evaluation.

4.2) Performance Data Collection:
4.2.1) Collect performance data from various sources including quality audits, delivery performance, and customer feedback.
4.2.2) Maintain accurate records of supplier performance metrics and evaluations.

4.3) Performance Evaluation:
4.3.1) Analyze performance data against established metrics and benchmarks.
4.3.2) Assess supplier performance in terms of quality, delivery, responsiveness, and compliance.

4.4) Performance Review Meetings:
4.4.1) Conduct periodic performance review meetings with key suppliers.
4.4.2) Discuss performance metrics, improvement opportunities, and action plans.

4.5) Performance Improvement Plans (PIPs):
4.5.1) Develop PIPs for underperforming suppliers to address identified issues.
4.5.2) Collaborate with suppliers to implement and monitor PIPs for effectiveness.

4.6) Documentation and Records:
4.6.1) Document supplier performance evaluations, meetings, and improvement plans.
4.6.2) Maintain supplier performance records for reference and future evaluations.

5) Abbreviations, if any

PIP – Performance Improvement Plan

6) Documents, if any

• Supplier Performance Evaluation Reports
• Performance Metrics and Benchmarks
• Performance Review Meeting Minutes
• Performance Improvement Plans

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211.84, ICH Q9
Industry Standards: ISO 13485:2016

8) SOP Version

Version 1.0