Supplier Approval
Supplier Selection and Qualification SOP
Purpose: Define the process for selecting and qualifying new suppliers.
- Criteria for supplier qualification (e.g., certifications, compliance with regulations).
- Steps for initial supplier evaluation and assessment.
- Review of supplier documentation (e.g., licenses, certifications, quality systems).
- Supplier risk assessment procedures.
Supplier Audit SOP
Purpose: Establish the procedures for auditing and assessing supplier facilities and practices.
- Pre-audit planning and notification to suppliers.
- Criteria and checklists for conducting supplier audits (e.g., quality control, safety).
- Reporting audit findings and corrective action requirements.
- Frequency of re-audits based on supplier performance.
Supplier Approval and Certification SOP
Purpose: Outline the steps for officially approving a supplier for use.
- Documentation and criteria required for supplier approval.
- Supplier certification process (e.g., trial orders, pilot testing).
- Final approval steps and communication with the supplier.
- Assignment of supplier approval status (e.g., approved, conditionally approved, rejected).
Supplier Risk Assessment SOP
Purpose: Define the process for assessing the risks associated with suppliers.
- Criteria for assessing supplier risk (e.g., financial stability, geographical location).
- Risk categorization (e.g., low, medium, high risk).
- Procedures for ongoing risk monitoring and mitigation.
- Action plans for managing high-risk suppliers.
Supplier Performance Monitoring SOP
Purpose: Establish ongoing monitoring procedures to assess supplier performance.
- Key performance indicators (KPIs) for supplier performance (e.g., delivery times, defect rates).
- Procedures for recording and reviewing supplier performance data.
- Regular performance reviews with suppliers.
- Corrective actions for underperforming suppliers.
Non-Conformance and Corrective Action SOP
Purpose: Define the steps to handle supplier non-conformance and corrective actions.
- Procedures for identifying and reporting supplier non-conformances.
- Root cause analysis and corrective action planning.
- Supplier follow-up on corrective actions.
- Procedures for escalating issues with non-compliant suppliers.
Supplier Re-evaluation and Re-approval SOP
Purpose: Establish criteria and processes for re-evaluating and re-approving suppliers.
- Frequency and triggers for supplier re-evaluation (e.g., annual review, performance issues).
- Re-assessment of supplier qualifications and performance.
- Documentation and approval of re-approved suppliers.
- Procedures for removing a supplier from the approved list if necessary.
Supplier Documentation and Record Keeping SOP
Purpose: Ensure that supplier-related documentation is maintained accurately and securely.
- Record retention requirements for supplier approvals, contracts, and audits.
- Procedures for updating and maintaining supplier records.
- Access control for sensitive supplier documentation.
- Regulatory compliance for recordkeeping (e.g., FDA, ISO standards).
Supplier Communication SOP
Purpose: Establish guidelines for clear and consistent communication with suppliers.
- Communication protocols for updates, performance reviews, and corrective actions.
- Templates for official communications (e.g., performance review reports, audit findings).
- Procedures for conflict resolution or disputes with suppliers.
- Timelines for responding to supplier inquiries and issues.
Supplier Approval Criteria SOP
Purpose: Define the criteria for evaluating suppliers based on the type of products or services they provide.
- Quality standards (e.g., GMP, ISO, HACCP) that suppliers must meet.
- Regulatory compliance requirements (e.g., 21 CFR, GFSI standards).
- Financial stability and operational capacity assessments.
- Product-specific requirements (e.g., raw materials, packaging, equipment).
New Supplier Onboarding SOP
Purpose: Outline the steps for onboarding new suppliers once they are approved.
- Initial documentation and contract signing procedures.
- Introduction to company policies, requirements, and expectations.
- Training for suppliers on specific quality and safety standards.
- Setting up supplier accounts and supply chain integration.
Supplier Termination SOP
Purpose: Define procedures for terminating relationships with non-compliant or underperforming suppliers.
- Criteria for supplier termination (e.g., repeated non-compliance, financial issues).
- Documentation and notification procedures for terminating supplier agreements.
- Transition plans for switching to alternative suppliers.
- Procedures for safeguarding supply continuity during supplier termination.
Supplier Contract Management SOP
Purpose: Establish guidelines for managing supplier contracts and agreements.
- Procedures for drafting and reviewing supplier contracts.
- Key terms and conditions to be included (e.g., quality standards, delivery schedules).
- Contract renewal and renegotiation processes.
- Recordkeeping for contracts and agreements.
Supplier Approval for Critical Control Points SOP
Purpose: Ensure suppliers for critical ingredients or components meet higher scrutiny standards.
- Identification of critical control points (CCPs) and related suppliers.
- Additional documentation and approvals for suppliers affecting CCPs.
- Increased frequency of audits and monitoring for critical suppliers.
- Special handling and quality assurance for critical products.
Supplier Complaint Management SOP
Purpose: Establish procedures for handling complaints about suppliers.
- Logging and investigating supplier-related complaints.
- Corrective actions and follow-up with suppliers.
- Tracking and documenting complaint resolution.
- Communication protocols with suppliers during the complaint process.