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Change Management System


 

National Semiconductor's Quality Policy focuses on continuous improvement of its products and processes. Improvement, however, implies change, and therefore some risk.

To control this risk, change must be carefully managed to ensure it remains controlled and delivers on the promise of higher quality and value. To do this, National has implemented a Change Management System. Highlights of the system are discussed below.

National's approach to managing change focuses on five key areas:

Classification: Proposed changes are classified in one of four classes, as determined by the extent of the proposed change. The classification level dictates the level of approval and qualification required.

  • Level 1
  • Level 2
  • Level 3
  • Datasheet

Approval: Two levels of review boards have been established to provide for the proper review of proposed changes. The involvement of each board is dictated by the change.

  • QRB: Quality Review Board – local review boards at each site that review all changes
  • L3QRB: Level Three Quality Review Board – a centralized board that reviews major changes

Qualification: Proposed changes requiring qualification are associated with an extensive qualification plan that, when completed, will help ensure that there will be no unintended negative consequences related to the change.

Implementation: When all aspects of a proposed change have been reviewed and approved, the implementation of the change takes place.

Customer notification: Customers are notified of the change, and approval of the change is sought if appropriate.

Classification

Proposed changes are classified in one of the four levels, determined by the magnitude of the proposed change. The classification level dictates the level of approval and qualification required.

Level 1 changes include any change to a process, material, method, or product design that does not represent a fundamental change to the process technique, material components, or product functionality. These changes typically require no formal qualification.

Level 2 changes include any change to a process, material, method, process architecture or product design that might impact device performance. These changes represent a more fundamental change and typically require a formal qualification, but do not typically require customer notification.

Level 3 changes represent a fundamental change to process technique, material components or product design and require a formal qualification. This level includes full or partial transfers of existing, qualified core processes. These changes may require customer notification based on agreements and contracts.

Datasheet changes consist of changes to datasheet limits or parameters. These changes are communicated to all customers and do not typically require customer notification.

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Approval

Proposed changes to products or processes are reviewed in a controlled document called a Process Qualification Plan Business Case (PQPBC) . The PQPBC includes the following types of information, as applicable:

  • Proposed classification level
  • Reason for the proposed change
  • Potential benefit/impact to customers
  • Identification of manufacturing sites affected
  • Complete detailed risk assessment
  • Detailed qualification plan

Two review boards have been established to review the PQPBCs and provide the proper overview of the proposed changes. The classification level of the proposed change dictates the involvement of each review board.

A Quality Review Board (QRB) is established for each product line and at each manufacturing location. They are involved in and have responsibility for:

  • Confirming and approving level classification
  • Defining and confirming qualification method
  • Reviewing completed qualification data
  • Approving implementation of Level 2 changes
  • Recommendations to L3QRB

The Level 3 Quality Review Board (L3QRB) is a corporate review board responsible for approval of Level 3 changes. Their responsibilities include:

  • Review of completed qualification data
  • Approving implementation of Level 3 changes based on QRB recommendations
  • Reviewing upcoming changes as contained in Quarterly Horizon Report
  • Resolve QRB appeals

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Qualification

Proposed changes requiring qualification are associated with a qualification plan that, when completed, will help ensure that there are no unintended negative consequences related to the change. The content of the qualification is dependent on the change proposed. An extensive matrix specifies what qualification testing is required for the classification level and type of change proposed.

Among the qualification tests that might be applied are:

  • Operational Life
  • Temperature Cycle
  • Power Cycle
  • ESD Level
  • Latch-up
  • Analog Stability
  • Autoclave
  • Gate Oxide Integrity
  • Passivation Integrity
  • Beta Degradation
  • Lead Fatigue
  • Solderability
  • IR Reflow
  • Wire Wash
  • Wire Pull
  • Ball Shear
  • Die Shear
  • Mark Permanence
  • Thermal Shock
  • Salt Atmosphere
  • Residual Gas Analysis
  • Moisture Sensitivity
  • Drop Test
  • Post Bake Ball Shear
  • Centrifuge
  • Pack Material Bake Test

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Implementation

The change is implemented opon completion of the review and approval cycle.

After the PQPBC has been approved and the qualification testing successfully completed, the change is authorized by the appropriate review board. At this time, a Final Process Change Notification (PCN) is created and, if appropriate, customers are notified.

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Customer Notification

Customers are notified of changes by a Process Change Notification (PCN).

Forecast PCNs are created for Level 2 changes if required and for Level 3 changes and are issued prior to initiation of qualification. Final PCNs are issued after completion of qualification and approval by the appropriate review board.

There are three categories of customer notification. The categories, as they relate to a particular customer, are defined by customer specifications and contracts.

The Customer Quality Engineer (CQE) group is responsible for ensuring all PCNs reach the designated customers and for ensuring that customer requirements and deliverables are satisfied as they relate to acceptance.

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