Product/Process Quality System Review

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• Is customer assistance or approval required for the development of the control plan?

• Has the organization identified who will be the quality liaison with the customer?

• Has the organization identified who will be the quality liaison with its suppliers?

• Has the quality management system been reviewed and approved per customer specific requirements?

• Are there sufficient personnel identified to cover:

  • Control plan requirements?

  • Layout inspection?

  • Engineering performance testing?

  • Problem reaction and resolution analysis?

• Is there a documented training program that:

  • Includes all employees?

  • Lists whose been trained?

  • Provides a training schedule?

• Has training been completed for:

  • Statistical process control?

  • Capability studies?

  • Problem solving?

  • Mistake proofing?

  • Reaction Plans?

  • Other topics as identified?

• Is each operation provided with process instructions that are keyed to the control plan?

• Are standard operator instructions accessible at each work station?

• Do operator instructions include pictures and diagrams?

• Were operator/team leaders involved in developing standard operator instructions?

• Do inspection instructions include:

  • Easily understood engineering performance specifications?

  • Test frequencies?

  • Sample sizes?

  • Reaction plans?

  • Documentation requirements?

• Are visual aids:

  • Appropriate, easily understood and legible?

  • Available?

  • Accessible?

  • Approved?

  • Dated and current?

• Is there a procedure to implement, maintain, and establish reaction plans, for issues such as out of control conditions based on statistical process control?

• Is there an identified problem solving process that includes root cause analysis?

• Are the latest drawings and specification available for the operator, in particular at the points of the inspection?

  • Have engineering tests (dimensional, material, appearance, and performance) been completed and documented as required in accordance with customer requirements?

• Are the current forms/logs available for appropriate personnel to record inspection results?

• Are the following available and placed at the appropriate points of the operation?

  • Monitoring and measurement devices?

  • Gage instructions?

  • Reference samples?

  • Inspection logs?

• Have provisions been made to certify and calibrate gages and test equipment at a defined frequency that is appropriate?

• Have required measurement system capability studies been:

  • Completed?

  • Accepted?

• Have initial process capability studies been conducted per customer requirements?

• Are layout inspection equipment and facilities adequate to provide initial and ongoing layout of all details and components in accordance with customer requirements?

• Is there a documented procedure for controlling incoming material that may include, for example, the following items:

  • Characteristics to be inspected?

  • Frequency of inspection?

  • Sample size?

  • Designated location for approved product?

  • Disposition of nonconforming products?

• Have sample production parts been provided per customer requirements?

• Is there a procedure to identify, segregate, and control nonconforming products to prevent shipment?

• Are rework/repair procedures available to assure conforming product?

• Is there a procedure to requalify repaired/reworked material?

• Has a master sample, if required, been retained as part of the part approval process?

• Is there an appropriate lot traceability procedure?

• Are periodic audits of outgoing products planned and implemented?

• Are periodic assessments of the quality system planned and implemented?

• Has the customer approved the packaging and the packaging specification?