Doubleclick cell if N/A
Partial Credit
Full Credit
Assessment Item
Observations and Notes
Supplier Response
Mandatory Key Questions
N/A Explanation
1. Is there a published Quality Policy and is it communicated to all personnel (e.g., Quality Manual)? 2. Is there an organization chart with responsibilities assigned? Is there an independent set of resources assigned to assuring the quality of the product provided to IR? 3. Are the quality control systems adequately documented? ·Work Instructions ·Standard Operating Procedures ·Quality Objectives ·External Documents 4. Do systems and processes focus on defect prevention in all areas? 5. Has training been provided for each job function or operation according to requirements? Can a training matrix and current training records be provided? 6. Is there a documented internal audit process and do they perform scheduled product and system audits to assure compliance with defined quality requirements? ·Audit schedule ·Adherence to schedule 7. Are systems and audit results periodically reviewed by management? ·Management Reviews frequency ·Agenda and meeting minutes from the last Management Review 8. Is there a Corrective Action system and does it have a means to track/measure performance of the system? · Number of CA’s are processed in a year · Number of CA’s that are past due 9. Do systems and audit deficiency corrective actions have a due date and are they closed on time? 10. Is there a Preventative Action system and does it have a means to track/measure performance of the system? · Number of PA’s are processed in a year · Number of PA’s that are past due 11. Is there a process established for the control of records and system documentation? ·Policy for control of quality records ·Retention policy or matrix ·Revision control process for quality documents ·Customer documents identified and their distribution controlled
Observations and Notes
Supplier Response
Mandatory Key Questions N Y
N/A Explanation
N
N
N
N
N
N
N
N
N
N N N
OSA
2 of 7
Doubleclick cell if N/A
PartialБайду номын сангаасCredit
Full Credit
N
N
Y
N
Y
N
N
Y
N
N
Y
OSA
1 of 7
Doubleclick cell if N/A
Partial Credit
Full Credit
Assessment Item 12. Is the supplier ISO or TS registered? 13. Is there a formally documented system used to select and manage suppliers through advanced evaluation or by review of quality performance? (Verify if approved suppliers list exists) 14. Is there a formal corrective action program implemented for the Supplier's purchased material? How do they monitor their supplier compliance to this process? 15. Are raw materials / components identified and traceable to test or certification reports? ·Date Codes ·Serial numbers ·Certificates of Analysis ·Bar coding technology 16. Are raw materials / purchased components inspected, tested or otherwise verified prior to use? Do they use in-house testing or external lab tests? 17. If work is subcontracted to external sources, are there controls to assure the quality of the subcontracted work? 18. Is there a system for verification, storage, reporting and maintenance of their customer’s consigned material, equipment, tools, dies, patterns, gages? 19. Are the environmental conditions in the laboratory and work areas adequate for the work performed? Are the work areas organized (using 5S or other methods) for the work performed? Does the work environment appear safe? 20. Is Statistical Process Control being used as the parts are produced or after the fact? 21. Are statistical methods effectively used for assuring parts are produced within control limits (e.g., histograms, X & R charts, P charts, etc.). If yes, indicate the % of parts involved in the Notes field. 22. If control charts are used throughout the production areas are they used effectively? Note how many are attribute vs. variable charts, how many use control limits vs. spec limits, frequency and recency of updates. Check to see if out of control points are identified and acted on. Include comments in the Notes field. 23. Is there evidence of control charts leading to actions? 24. Are process operators and inspectors trained on the work instructions for their area? 25. Are machine operators and inspection personnel sufficiently trained to utilize the statistical process control concepts?