Figure 1 - Process of establishing controls for products and services obtained from suppliers

Description - Figure 1 - Process of establishing controls for products and services obtained from suppliers

Phase 3.1 Planning

Activities:

• 1) Describe what is to be obtained
• 2) Identify technical and process information
• 3) Identify potential supplier(s)
• 4) Identify risk(s)
• 5) Identify controls

Examples: 

• (1) Identification of product and services
• (2) Specifications, part requirements, procedures, work instructions
• (3) Name and contact information of potential suppliers
• (4) Documented list of the risks identified
• (5) Documented process/product controls for manufacturer and supplier

Phase 3.2 Selection of potential supplier(s)

Activities:

Investigate business capability of supplier(s)

• 6) Investigate operational capability of supplier(s)
• 7) Select potential supplier(s)

Examples:

• (6) Technological and operational capabilities, logistics, quality, technical risks
• (7) Selection criteria for potential suppliers, decision rationale

Phase 3.3 Supplier evaluation and acceptance

Activities:

• 8) Planning for evaluation and selection criteria
• 9) Communicate with potential supplier(s)
• 10) Evaluate supplier(s) ability to fulfill specified requirements
• 11) Supplier acceptable?
  • No - single source and/or process improvement?
    1. No - select Potential supplier(s) (refer to Activity 7)
    2. Yes - Communicate with potential supplier(s) (refer to Activity 9).
  • Yes - refer to Activities 12-15

Examples

• (8) Documented evaluation and selection criteria
• (9) Documented initial agreement(s)
• (10) Documents and records
• (11) Documented decision and rationale

Phase 3.4 Finalization of controls

Activities:

Establish -

• 12) Purchasing information
• 13, 14, 15) Controls (Acceptance Activities, Verifications, etc.

Examples:

• (12) Contracts, purchase orders, etc.
• (13) Acceptance procedures; purchasing requirements
• (14) Specifications and requirements
• (15) Records of review and acceptance

Phase 3.5 Delivery, measurement and monitoring

Activities:

Product realization and related processes. 16, 17, 18, 19)

• Receive product/service
• Carry out acceptance activities
• Conduct measurement and monitoring
• Analyze data

• Problems identified
  • 20) Conduct correction.
  • Additional action required?
    • No - refer to Activity 21,
    • Yes - refer to Activity 22
• Periodic re-evaluation of supplier

Examples:

• (16) Receiving records
• (17) Inspection records
• (18) Acceptance records
• (19) Records of results of any analysis of data
• (20) Records of any corrections

* This box delineates activities that can identify problems with the supplied product/services as well as supplier problems associated with adherence to the supplier arrangements.

Phase 3.6 Feedback and communication, including Corrective Action and Preventive Action process.

Activities:

• 21) Feedback and communication
• 22) Corrective Action and Preventive Action process (re-evaluation of supplier)

Examples:

• (21) Manufacturer and/or supplier correspondence
• (22) Documentation and records of corrective and preventive action process