Supplier Evaluation and Monitoring Procedures

Compass Health SOP: Supplier Evaluation and Monitoring

• This document outlines the process and responsibilities for evaluating, selecting, and approving suppliers.
• Compass evaluates suppliers to ensure they meet quality, product, and service requirements.
• Only suppliers who meet requirements are added to the Approved Supplier List.
• QA/RA (Quality Assurance - Regulatory Affairs) continually monitors supplier quality.
• Suppliers with inadequate performance may be asked to implement corrective actions; if not effective, they are removed from the list.
• Compass utilizes contractors/consultants for product development (e.g., contract engineering or regulatory).
• Their skills are evaluated and performance tracked according to service contracts.
• Supplier evaluations are conducted by members of top management.
• Supplier evaluation focuses on products/services affecting product quality.
• Products/services not affecting product quality are still listed but exempt.

Applicable Standards

• FDA QSR § 820.30 - Design Controls
• ISO 13485:2016 Section 7.3 - Design and Development
• ISO 13485:2016 Section 7.4 - Purchasing
• TG(MD)R Sch1 P1 2, Sch3 P1 Cl1.4(5)(d)(ii)

Reference Documents

• Supplier Evaluation and Re-evaluation Form (QMS-FRM-0008)
• Approved Suppliers List (CLR-REC-2000)
• SOP: Document Controls (QMS-SOP-0002)
• SOP: Control of Records (QMS-SOP-0003)
• SOP: Software Development Process (QMS-SOP-0008)
• SOP: Risk Management (QMS-SOP-0013)

Acronyms

• SOUP: Software of Unknown Provenance
• QA-RA: Quality Assurance Regulatory Affairs
• SOP: Standard Operating Procedure
• QMS: Quality Management System

Supplier Evaluation Process

• The process evaluates potential suppliers based on specifications, quality, quantity, and standards.
• The process follows a high-level flow (Initial Selection, Evaluation, Approval, Monitoring).
• All suppliers are registered on the Approved Suppliers List (QMS-REC-0045).
• This process is separate for each product or service.
• Any additions to the list of items require re-evaluation.

Initial Selection

• Compass personnel select potential suppliers as needed.

Process Roles

• Originator: Selects the supplier.
• QA-RA: Evaluates the choice, reviews evidence of suitability, consults with the originator, and performs an effective review.
• Other Compass staff may be involved in evaluations as needed.

Supplier Evaluation and Monitoring Process—Additional Details

• Suppliers are added to the Approved Suppliers List after review.
• Supplier performance is monitored.
• Monitoring methods include: incoming inspection, verification/validation reports, non-conformance reports, corrective/action reports, delivery times, service level agreements (SLAs), etc.
• Non-conformances result in Supplier Evaluation and Re-evaluation.

Supplier Re-evaluation

• Supplier re-evaluation is indicated on the Approved Supplier List.
• Results from supplier monitoring are used in re-evaluations
• Re-evaluation is documented on a form.
• Unsuitable suppliers are removed from the list.

Process Monitoring

• QA-RA monitors non-conformance rates annually.
• Monitoring checks for evidence deficiencies.
• Results are provided to management on a regular basis.

Quality Records

• Approved Supplier List documents all approved suppliers.
• Supplier Evaluation and Re-evaluation Form documents evaluations and re-evaluations.

This document details Compass Health's Standard Operating Procedures for evaluating and monitoring suppliers. It outlines the roles of top management in ensuring that suppliers meet quality and service requirements to be included on the Approved Supplier List. Continuous monitoring and corrective actions are key components of maintaining supplier performance.