ITER Quality Assurance

Transcription

1 US ITER Central Solenoid Vendor Meeting ITER Quality Assurance by John Mashburn USIPO QA Manager 1

2 QA Topics ITER s Nuclear License Graded Approach Proposal QA Items Quality Plan Specific to Contract Manufacturing and Inspection Plan Access for Surveillance and Inspection Seller-Requested Deviations Non-Conformances Release Note 2

3 Quality Assurance Our Project, US Contributions to ITER, is a U.S. DOE Project, and it is managed under DOE Orders. ITER will be a licensed nuclear facility in France. In order to be licensed it must comply with French regulations for nuclear facilities. The quality assurance expectations for vendors are based on these two facts. A few contracts have special compliance requirements for European and French safety and quality standards. A graded approach to the degree of QA discipline is used, in order to put the most emphasis where needed for safety, risk to project cost and schedule, operational reliability and performance of the ITER, etc. 3

4 QA in Proposals Most proposals will need to include a copy of the vendor s Quality Program Description and a completed Quality Questionnaire summarizing the quality practices of the vendor. For the smallest contracts, a questionnaire alone may be acceptable. The Quality Program Description is a general term for what many vendors call their quality manual, quality program, or quality management system. It is not their entire procedure collection unless that is compact enough for a single document. The Quality Questionnaire is provided along with the solicitation, and gives a picture of the vendor s quality practices by answering approximately 30 questions about how various tasks related to quality are performed in the company. 4

5 Contract-Specific Quality Plan After the contract is awarded, one of the first deliverables is a Quality Plan specifically describing how the contract will be executed, with names of responsible individuals, major subcontractors, and other details that are not in the vendor s permanent Quality Program Description or answered in the Quality Questionnaire. A template is provided to help with writing the plan. Hold Point the contract-specific Quality Plan must be submitted and approved before work begins on the contract. Approval requires US ITER to review the plan and obtain acceptance from affected persons in the international organization in France. A Manufacturing and Inspection Plan (MIP) is also required, showing the list of operations affecting quality, and is used to coordinate oversight by ITER inspectors. It must also be approved before work begins, and a template is provided. 5

6 Access for Surveillance or Inspection Access for Source Surveillance Inspections Source surveillance activities may be conducted at the Seller s facility or any subtier seller facility that US ITER determines necessary to ensure quality objectives are met. Representatives of the ITER International Organization may come with inspectors as observers. The vendor must provide the US ITER representatives access to all data and operating areas pertinent to the contract. Surveillance by the US ITER representative does not constitute product acceptance and in no way relieves the vendor of the responsibility to furnish acceptable items. 6

7 Sellers Can Request Deviations Seller-Requested Deviations The vendor may propose deviations from the specifications, drawings, or other technical requirements of this procurement. The request should identify the affected items, drawing/ specification number & revision number, a description of the proposed deviation, and the justification for it. Remember, these are planned deviations, and they must be approved in advance. 7

8 Non-Conformances Nonconformances US ITER expects to receive equipment items, components, materials, software, and documentation that conform to all codes, standards, specifications, and procedures in the Agreement. When a nonconformance is identified, the vendor must: identify, and segregate when practical, the non-conforming item, stop any further work on the item until a decision is made, record and report the occurrence to US ITER in a Non- Conformance Report, or NCR. Two categories of non-conformances are considered, Major and Minor. The categorization is made by US ITER in consultation with the International Organization. Major non-conformances often require on-site inspections and verification of corrective actions before work can proceed, whereas minor non-conformances may not require on-site inspections. 8

9 Release Note Contractor s Release Note Each delivery of item(s) for installation at ITER shall have a Contractor Release Note. The Contractor Release Note is a document that, for a particular equipment/service: identifies the applicable requirements, certifies that the equipment/service complies with these requirements, records the status of the documentation, highlights any outstanding obligation. A standard ITER form is available for documenting the Release Note. 9