Supplier Questionnaire for 100320-SPEC-ENG-078 Instrument Air Accumulator Tank.docx

100320-SPEC-ENG-078, Instrument Air Accumulator Tank Supplier Quality Assurance Questionnaire

SUPPLIER QUALITY ASSURANCE QUESTIONNAIRE

Supplier or Sub-Tier Name:

Location/Address of Supplier facility (ies):

Product Description:

Does the manufacturer (distributors should obtain the assistance of the manufacturer to complete this) or contractor have a written Quality Assurance Program (QAP) Management System that is developed, implemented and maintained?

Yes |_| No |_| [Hint: Double-click on a box to default to checked, then cut and paste box for the rest of the answers.]

QA/QC MANUAL TITLE ________________________________

REVISION AND ISSUE DATE _________________

ATTACH A TABLE OF CONTENTS OR LISTING AND OTHER SUPPORTING INFORMATION TO THE QUESTIONNAIRE

QA/QC program table of contents and other supporting information attached? Yes |_| No |_|

IDENTIFY CODES AND/OR STANDARDS WITH WHICH YOUR QA/QC PROGRAM COMPLIES

5. What industry standards do you currently use to develop software/firmware? _______________________________

6. Other Codes and Standards:__________________________________________________________________

ASME NQA-1-2008/ASME NQA-1a-2009 Indicate whether your QA/QC Manual and/or implementing procedures address the following:

ASME NQA-1, Requirement 9, Control of Special Processes Identify the welding codes_______________

Identify other ASME NQA-1 Part II, Subparts applicable to the quality assurance/quality control program___________

DOE ORDER 414.1

Indicate whether your QA/QC Manual and/or implementing procedures address the following:

DOE Order 414.1, Attachment 2, Quality Assurance Criterion (1) - Program Establish an organizational structure, functional responsibilities, levels of authority, and interfaces for those managing, performing, and assessing work. Establish management processes, including planning, scheduling, and providing resources for work.

(An NQA-QA program will need to describe the management process for providing resources.)

DOE Order 414.1, Attachment 2, Quality Assurance Criterion (2) - Personnel Training and Qualification Establish an organizational structure, functional responsibilities, levels of authority, and interfaces for those managing, performing, and assessing work. Establish management processes, including planning, scheduling, and providing resources for work.

DOE Order 414.1, Attachment 2, Quality Assurance Criterion (3) - Quality Improvement Establish and implement processes to detect and prevent quality problems. Identify, control, and correct items, services, and processes that do not meet established requirements. Identify the causes of problems and work to prevent them. Review item characteristics, process implementation, and other quality-related information to identify items, services, and processes needing improvement.

(The DOE Order extends the requirements of NQA-1 to all problems including all conditions [not limited to significant] adverse to quality and to all nonconforming items [not limited to generic]).

DOE Order 414.1, Attachment 2, Quality Assurance Criterion (4) - Documents and Records Prepare, review, approve, issue, use, and revise documents to prescribe processes, specify requirements, or establish design. Specify, prepare, review, approve, and maintain records.

DOE Order 414.1, Attachment 2, Quality Assurance Criterion (5) - Work Processes Perform work consistent with technical standards, administrative controls, and hazard controls adopted to meet regulatory or contract requirements using approved instructions, procedures, etc. Identify and control items to ensure their proper use. Maintain items to prevent their damage, loss, or deterioration. Calibrate and maintain equipment used for process monitoring or data collection.

DOE Order 414.1, Attachment 2, Quality Assurance Criterion (6) - Design Design items and processes using sound engineering/scientific principles and appropriate standards. Incorporate applicable requirements and design bases in design work and design changes. Identify and control design interfaces. Verify/validate the adequacy of design products using individuals or groups other than those who performed the work. Verify/validate work before approval and implementation of the design.

DOE Order 414.1, Attachment 2, Quality Assurance Criterion (7) - Procurement Procure items and services that meet established requirements and perform as specified. Evaluate and select prospective suppliers on the basis of specified criteria. Establish and implement processes to ensure that approved suppliers continue to provide acceptable items and services.

DOE Order 414.1, Attachment 2, Quality Assurance Criterion (8) - Inspection and Acceptance Testing Inspect and test specified items, services, and processes using established acceptance and performance criteria. Calibrate and maintain equipment used for inspections and tests.

DOE Order 414.1, Attachment 2, Quality Assurance Criterion (9) - Management Assessment Ensure that managers assess their management processes and identify and correct problems that hinder the organization from achieving its objectives.

DOE Order 414.1, Attachment 2, Quality Assurance Criterion (10) - Independent Assessment Plan and conduct independent assessments to measure item and service quality and the adequacy of work performance and to promote improvement. Establish sufficient authority and freedom from line management for independent assessment teams. Ensure that persons conducting independent assessments are technically qualified and knowledgeable in the areas to be assessed.

DOE Order 414.1, Attachment 2, Suspect/Counterfeit Items Preventing the introduction and use of S/CIs through engineering involvement, design, procurement, testing, inspection, maintenance, evaluation, disposition, reporting, trend analysis, and lessons learned work process controls. Training and informing managers, supervisors, and workers on S/CI processes and controls (including prevention, detection, and disposition of S/CIs). Identifying and disposing of S/CIs on site. Restricting S/CI use to only those items that have been found acceptable through engineering analysis and formal disposition process. Collecting, maintaining, disseminating, and using the most accurate, up-to-date information on S/CIs and associated suppliers using all available sources.

(An NQA-1 QA program will need to be expanded to address Suspect/Counterfeit items.)

DOE Order 414.1, Attachment 2, Safety Software Quality Requirements Is your software quality assurance program based on national or international standards?

If yes, identify which ones apply below:

___ASME NQA-1, Part I, Requirement 3 ___ASME NQA-1, Part I, Requirement 11 ___ASME NQA-1, Part II, Subpart 2.7 Other______________________

DOE Order 414.1, Attachment 2, Safety Software Quality Requirements Is your software quality assurance program based on DOE G 414.1-4, Safety Software Guide for use with 10 CFR 830 Subpart A, Quality Assurance Requirements, and DOE O 414.1C, Quality Assurance?

DOE Order 414.1, Attachment 2, Safety Software Quality Requirements Does your software quality assurance program include controls for software configuration management and quality planning, software risk management, software procurement and supplier management, software requirements identification and management, software design and implementation, software verification and validation, and problem reporting and corrective action?

Do you understand the questions above? Yes |_| No |_|

If no, please provide your comments or suggestions. Also, provide any additional information relevant to your quality assurance program.

General

Preparer_____________________ Signature_______________ Title________________________ Date_________

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