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Supplier Audit SOP
"I need a Supplier Audit SOP for our pharmaceutical manufacturing facility in Mumbai, compliant with Indian FDA requirements and incorporating remote audit capabilities for overseas suppliers starting January 2025."
1. Purpose and Scope: Defines the objective of the SOP and its applicability across supplier categories
2. References: Lists all relevant standards, regulations, and internal policies that govern the audit process
3. Definitions: Explains key terms and acronyms used throughout the document
4. Roles and Responsibilities: Defines the roles of audit team members, management, and other stakeholders
5. Audit Planning: Details the process of scheduling audits, selecting suppliers, and preparing audit plans
6. Audit Types and Criteria: Describes different categories of audits (initial, routine, for-cause) and their specific requirements
7. Audit Execution Procedure: Step-by-step instructions for conducting the audit, including opening meeting, assessment, and closing meeting
8. Documentation Requirements: Specifies required documents, forms, and evidence collection procedures
9. Non-conformance Management: Process for identifying, documenting, and following up on non-conformances
10. Reporting Requirements: Guidelines for preparing and submitting audit reports
11. Corrective Action Process: Procedures for requesting, reviewing, and closing corrective actions
12. Record Retention: Requirements for maintaining audit records and related documentation
1. Risk Assessment Framework: Used when implementing risk-based supplier audits, includes risk categorization and assessment criteria
2. Remote Audit Procedures: Include when organization conducts virtual or remote audits
3. Industry-Specific Requirements: Add when dealing with specialized industries like pharmaceuticals or food processing
4. Supplier Performance Metrics: Include when audit results feed into supplier scoring system
5. Ethical Considerations: Add when dealing with sensitive industries or regions with specific ethical concerns
6. Security Protocols: Include when audits involve access to sensitive or confidential information
1. Audit Checklist Template: Standard checklist covering all areas to be evaluated during an audit
2. Audit Report Template: Standardized format for documenting audit findings and conclusions
3. Non-conformance Report Form: Template for documenting and tracking non-conformances
4. Corrective Action Request Form: Standard form for requesting and tracking corrective actions
5. Audit Schedule Matrix: Template for annual audit planning and scheduling
6. Risk Assessment Matrix: Tool for evaluating and categorizing supplier risks
7. Document Review Checklist: List of documents to be reviewed during pre-audit preparation
8. Audit Team Evaluation Form: Template for assessing audit team performance
Authors
Manufacturing
Pharmaceuticals
Automotive
Electronics
Food and Beverage
Chemicals
Textiles
Consumer Goods
Medical Devices
Aerospace
Defense
Construction Materials
Industrial Equipment
Information Technology
Quality Assurance
Procurement
Supply Chain
Compliance
Internal Audit
Operations
Risk Management
Legal
Regulatory Affairs
Vendor Management
Quality Assurance Manager
Supplier Quality Engineer
Procurement Manager
Compliance Officer
Supply Chain Director
Quality Control Specialist
Regulatory Affairs Manager
Audit Manager
Operations Director
Quality Systems Specialist
Supply Chain Analyst
Vendor Development Manager
Risk Management Specialist
Quality Auditor
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