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Questions and Answers
Who is responsible for originating the purchase request?
Who is responsible for originating the purchase request?
What is a critical step that must be completed before supplier evaluation?
What is a critical step that must be completed before supplier evaluation?
What must Compass Health Inc. evaluate in its suppliers?
What must Compass Health Inc. evaluate in its suppliers?
Which of the following is NOT part of the specifications to be documented by Compass?
Which of the following is NOT part of the specifications to be documented by Compass?
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What does Compass require suppliers to do when changes affect specified purchase requirements?
What does Compass require suppliers to do when changes affect specified purchase requirements?
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What is the main purpose of the purchasing procedure outlined in the document?
What is the main purpose of the purchasing procedure outlined in the document?
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Which items are excluded from the scope of the purchasing procedure?
Which items are excluded from the scope of the purchasing procedure?
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Which standard is explicitly mentioned as applicable to the purchasing controls?
Which standard is explicitly mentioned as applicable to the purchasing controls?
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What does the acronym SOP stand for in the context of the document?
What does the acronym SOP stand for in the context of the document?
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What role is responsible for initiating the purchasing process?
What role is responsible for initiating the purchasing process?
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Study Notes
Compass Health SOP: Purchasing
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Purpose: This procedure establishes controls for acquiring products, materials, and services to maintain quality, safety, and effectiveness. Ensures purchased items meet specifications.
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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.
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Description
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.
