1. Quality Assurance U. S. ITER Project Office U.S. ITER Project 1 November 15, 2006 U. S. ITER QUALITY ASSURANCE Gail Okulczyk, Presenter U. S. ITER Quality Assurance Representative Oak Ridge Project Office

2. Quality AssuranceU. S. ITER Project Office 2 QA Mission for Business The Quality Assurance Groups Mission in Support of Doing Business with the U. S. ITER Project: – To clearly define Quality expectations for Suppliers – To provide the end customer a product that is delivered on time and works the first time – To provide formal, traceable documentation to demonstrate and support the quality processes – To support the U. S. ITER Project Staff and its Suppliers in meeting the technical and administrative mission

3. Quality AssuranceU. S. ITER Project Office 3 U. S. ITER Quality Assurance Program As Related to Procurements and Supplier Pre-Qualification and Oversight Activities – U. S. ITER QA will review specifications, drawings, statements of work, instructions, and related procurement documentation – Issue a QA Questionnaire and review the completed response – Consult with scientists and engineers to discuss any quality affecting issues associated with the procurement – Conduct a Quality Systems Survey (if required) – Conduct a Source Surveillance (after contract award) – Develop an internal strategy to verify quality requirements and create an Acceptance Criteria Listing (ACL) – Full notification of activities and progress are reported to the U. S. ITER Procurement Group (includes test and verification information)

4. Quality AssuranceU. S. ITER Project Office 4 Graded Approach The U. S. ITER Project utilizes a graded approach in its quality system implementation for Suppliers Suppliers are not required to have in place a formal quality system (ISO 9000, NQA-1, etc.) Suppliers will be judged on an individual basis for the specific work associated with the U. S. ITER Project Aspects of quality systems are applied and documentation is not only explained but is expected Standards such as NIST or other international standards may apply (notification will be made to Supplier) No Approved Supplier List exists (each Supplier will be qualified based on U. S. ITER Procurements selection process)

5. Quality AssuranceU. S. ITER Project Office 5 U. S. ITER Vendor/Supplier Qualifications The U. S. ITER will implement a Supplier Qualification process utilizing a graded approach. In accordance with the U. S. ITER Graded Approach, the QA Group will perform: – Pre-Award Supplier Qualification activities. These activities will range from a review of a questionnaire to a full, on-site quality system survey. – Source Surveillance activities. These on-site activities will be performed after a contract is awarded to monitor progress, ensure proper delivery, and effectively resolve any discrepancies that may occur. These quality activities are performed in a Team fashion involving members of ITER QA, Procurement, and associated technical staff. These practices are performed at the ITER/ORNL facility and all ITER procurement partners.

6. Quality AssuranceU. S. ITER Project Office 6 Quality Elements Reviewed During an On-Site Quality Systems Survey 1.Management of Quality 2.Specifications and Change Control 3.Control During Processing 4.Control of Nonconforming Items 5.Control of Finished Products 6.Control of Measuring and Test Devices 7.Quality Records and Documentation 8.Training

7. Quality AssuranceU. S. ITER Project Office 7 Activities Reviewed During an On-Site Source Surveillance Review current progress and verify QA applications Review any changes and determine any implications to the products total quality Observe any ongoing test and/or final inspections Address any Nonconforming issues Observe finished products Verify any corrective actions identified during the Quality Systems Survey (systems, practices, equipment, staff, etc.) Review Quality records and documentation Document (formal report) the visit and notify all parties including Procurement Ask Procurement to contact the Supplier if there are any QA concerns or additional requests Implementation of Quality Standards and Practices will also be observed during the survey (ex: ISO, ASME, NQA-1, etc.)

8. Quality AssuranceU. S. ITER Project Office 8 Stop! Suppliers working with the U. S. ITER Project are required to STOP WORK! and obtain clarification if there are questions regarding items such as: – Specifications – Drawings – Request for Proposals Supplier assumptions on how to proceed are not allowed Work is not allowed to proceed until resolution and approval through U. S. ITER Project Procurement as the Suppliers main point of contact is obtained Direct contact with Quality Assurance will be allowed only after authorization by Procurement The mission is to provide the end customer a product that works the first time

9. Quality AssuranceU. S. ITER Project Office 9 How We Will Get There Maintain effective communication Disposition of concerns discovered during pre-award surveys Effectively manage change control throughout the entire organization All changes and correspondence through U. S. ITER Procurement Never assume Impeccable documentation

10. Quality Assurance U. S. ITER Project Office U.S. ITER Project 10 Questions? Mike Skonicki U. S. ITER Quality Program Developer Gail Okulczyk U. S. ITER Quality Assurance Representative 303.833.9062 303.507.3046 (cell) skonickifam@aol.com 865.574.9818 865.771.5491 (cell) okulczykgm@ornl.gov