Compass Health SOP: Purchasing Procedure

Compass Health SOP: Purchasing

• Purpose: This procedure establishes controls for acquiring products, materials, and services to maintain quality, safety, and effectiveness. Ensures purchased items meet specifications.

• Scope: Applies to products and services affecting Compass's products/services quality, safety or effectiveness. Excludes standard/commodity items like office supplies, furniture, or airfare.

Applicable Standards

• FDA QSR § 820.50: Purchasing Controls
• ISO 13485:2016 Section 7.4: Purchasing
• TG(MD)R Sch1 P12, Sch3 P1 Cl1.4(5)(d)(ii): (Specific regulation details unclear)

Reference Documents

• QMS-FRM-0060: Supplier Evaluation Form

Purchasing Process Roles

• Originator: Initiates the purchase request and collects relevant info from others for purchase requirements.
• QA/RA: Spot-checks & monitors purchasing activities at Compass, ensures purchases adhere to the process.
• Management: Reviews documentation, expenditure appropriateness, and supplier selection.

Purchasing Process Flow

• The process is outlined in Figure 1.
• Compass evaluates suppliers and purchases only from compliant suppliers. (SOP: Supplier Evaluation & Monitoring)

Purchasing Process Steps

• Identify Product: Begin with a need for a product.
• Document Product Nature: If purchase is confirmed, document product nature.
• Purchase Requirements: Define Compass's own specifications (e.g., design parameters, quantity, required processes, sampling plans, quality management requirements, applicable contract clauses).
• Supplier Evaluation: Supplier evaluation according to the SOP (Supplier Evaluation & Monitoring section 5.2). This is critical to product evaluation.
• Conduct Purchase: Purchase orders are documented in the system and can be made via Purchase Order Form or corporate accounts if applicable. Purchases made with personal credit cards are treated as expenses.
• Service Purchase: No service purchase limits are defined, thorough communication, and training are required to purchase services.

Product Classification

• Class I: Very low risk of affecting Compass's products.
• Class II: Medium risk of affecting Compass's products.
• Critical: High risk of affecting quality and significant performance degradation.

Process Monitoring

• QA monitors purchasing activities regularly to ensure compliance with the procedure and regulatory requirements, managing risk.

Quality Records/Documentation

• Purchase Order Form: Used for formally ordering parts from suppliers. Details product properties.
• Purchase and Receiving Log: Lists all Purchase and Receiving orders requested by Compass personnel.
• Purchase Order Records: Completed purchase order forms.

This quiz covers the Standard Operating Procedure (SOP) for purchasing at Compass Health. It focuses on the controls, applicable standards, and roles involved in the purchasing process to ensure quality and compliance. Test your understanding of the regulations and guidelines that govern purchasing practices in a healthcare context.