QA MANUAL CHECKLIST
Supplier: / MANUAL No.:

MOX QUALITY ASSURANCE MANUAL QUESTIONNAIRE

TO BE COMPLETED BY SUPPLIER

This is a non-quality documentRevision 4, 17 Nov 14

Name Of Company:
Division Of:
Address:
Address
City / State / Zip
Phone #:
QA Manual:
Title / Rev./Date
Type Of Product, Service Or Process:
Questionnaire Completed By:
Name / Title / Date
Comments:

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QA MANUAL CHECKLIST
Supplier: / MANUAL No.:
QUALITY ASSURANCE QUESTIONNAIRE / SECTION AND PARAGRAPH OF QA MANUAL / SAT / UNSAT / N/A
ORGANIZATION
1.1 / Are the authorities and responsibilities associated with implementing the QA program established in writing?
1.2 / Is the organizational structure and lines of communication for activities affecting quality established in writing?
1.3 / Do persons responsible for assuring program appropriateness and verification of quality activities have sufficient authority, access to work area, and organizational freedom to:
  1. Identify quality problems
  2. Initiate, recommend solutions to identify problems
  3. Verify implementation of solutions
  4. Control further processing

1.4 / Do persons assuring quality:
  • Have access to responsible management levels to effect appropriate actions.
  • Have sufficient freedom from cost and scheduling.

QA PROGRAM

2.1 / Does the program describe items and services to which it applies?
2.2 / Does the program provide control over activities effecting quality to an extent consistent with their importance?
2.3 / Does the program describe planning and accomplishment of activities affecting quality under suitably controlled conditions?
2.4 / Does the program describe special controls, processes, equipment, tools, and personnel skills to attain and verify quality?
2.5 / Does the program provide for indoctrination and training of personnel performing activities affecting quality to assure proficiency is achieved and maintained?
i.e., NDE and auditing personnel
2.6 / Does management of organizations implementing the QA program, or portions thereof, to regularly assess their responsible area for effectiveness?

DESIGN CONTROL

3.1 / Does the program describe the design process?
3.2 / Are applicable design inputs such as performance requirements, regulatory requirements, codes and standards reviewed and approved by the responsible design organization?
3.3 / Does the design program include design analysis to support the design output?
3.4 / Are design interfaces identified and controlled and is design adequacy verified by persons other than those who designed the item?

PROCUREMENT DOCUMENT CONTROL

4.1 / Does the program require procurement documents to contain applicable design bases and other requirements such as Scope of Work, Technical requirements, quality program requirements, customer right of access to suppliers and subcontractors, and required documentation?
4.2 / Does the program require procurement documents to include reporting and approval of nonconforming conditions?
4.3 / Does the program require procurement documents to be reviewed by competent personnel in order to verify appropriate provisions are included to assure items meet the specifications?
4.4 / Are controls established to assure procurement document changes are subject to the same degree of control that was utilized in the preparation of original documents?

INSTUCTIONS, PROCEDURES AND DRAWINGS

5.1 / Does the program require the use of instruction, procedures and drawings in performance of activities affecting quality?
5.2 / Does the program require the use of quantitative qualitative acceptance criteria when appropriate in order to assure quality activities have been satisfactorily completed?

DOCUMENT CONTROL

6.1 / Does the program provide controls to assure documents that specify quality requirements are prepared, issued and changed using adequate controls to assure that the correct documents are available and used during performance of quality activities?
6.2 / Are adequate controls addressed to assure the adequacy, completeness and accuracy of the document prior to their issue?
6.3 / Are major changes to quality documents reviewed and approved in the same manner as the original document?
CONTROL OF PURCHASED ITEMS AND SERVICES
7.1 / Does the program provide for supplier source evaluation and selection based on supplier providing identical or similar products, Supplier quality records based on qualitative and quantitative information and the direct evaluation of the Supplier’s technical and quality capabilities?
7.2 / Does the program provide for the establishment of measures for the Purchaser to interface with the Supplier to verify the Supplier’s performance?
7.3 / Does the program provide for acceptance of an item or service by Supplier Certificates of Conformance, source verifications, receiving inspections and post-installation tests?
7.4 / Does the program provide for Purchaser resolution of nonconforming conditions including evaluation of the item and submittal of the nonconformance notice to Purchaser by Supplier for resolution?
7.5 / Does the program include details of a Commercial Grade Dedication (CGD) program?
IDENTIFICATION AND CONTROL OF ITEMS
8.1 / Does the program establish controls to assure items are correct and accepted items are used or installed? Does the program allow the identification of the item to relate to the applicable design or other pertinent documents?
8.2 / Does the program require identification to be maintained on items or in documents traceable to the items or in a manner which assures that identifications is established and maintained?

CONTROL OF SPECIAL PROCESSES

9.1 / Does the program address process controls to assure process parameters, environmental conditions and associated records meet the applicable process / activity requirements?
9.2 / Does the program require special processes be performed using appropriate procedures, qualified personnel and equipment in accordance with specified requirements?

INSPECTION

10.1 / Does the program provide for inspection through planning, identification of characteristics to be verified, method of verification, inspection personnel qualification and records of completed inspections?
10.2 / Does the program require independency of personnel performing acceptance inspections?
10.3 / Does the program require acceptance of an item be documented and approved by authorized personnel?
10.4 / Does the system provide for establishing and controlling Hold Points?

TEST CONTROL

11.1 / Does the manual define test control measure to demonstrate satisfactory performance to design requirements?
11.2 / Are test control measures established to include characteristics and methods for testing?
11.3 / Are test results required to be documented and evaluated by qualified personnel?

CONTROL OF MEASURING AND TEST EQUIPMENT

12.1 / Does the program require tools, gages and other measuring and test equipment to be controlled, calibrated at specified frequencies and adjusted in order to maintain accuracy within necessary limits?
12.2 / Are nationally recognized standards required for calibration of measuring and test equipment?
12.3 / Does the program require M&TE found to be out of calibration evaluated for impact on previously completed inspections and tests?
12.4 / Does the program require calibration status to be identified on the applicable M&TE and records maintained?

HANDLING, STORAGE AND SHIPPING

13.1 / Does the program describes policies or requirements to control the handling, storage, cleaning, packaging, shipping, and preservation of items to prevent loss or damage and to minimize deterioration
13.2 / Does the program address special handling tools and equipment, as necessary, and its testing and maintenance?

INSPECTION, TEST AND OPERATING STATUS

14.1 / Does the program provide for maintaining the status of items either directly on the item or in documents directly traceable to the item?
14.2 / Does the program define the authorities and responsibilities in applying and removal of the tags, markings, labels, and stamps?
CONTROL OF NONCONFORMING ITEMS
15.1 / Does the program require items determined not to be in conformance with the requirements, be controlled to prevent inadvertent use or installation?
15.2 / Does the nonconformance program include identification, documentation, segregation, evaluation and disposition?
15.3 / Does the program require demonstrated competence for personnel authorized to disposition nonconforming material?
15.4 / Does the program require a technical justification for
Use-As-Is and Repair dispositions to NCRs?

CORRECTIVE ACTION

16.1 / Does the program require that failures, malfunctions, defective items and nonconforming conditions are promptly identified, documented and corrected?
16.2 / Are expected actions to be taken toward significant conditions adverse to quality properly described in the program?
16.3 / Does the program require significant conditions adverse to quality be reported to management for development and implementation of corrective measures?

QUALITY ASSURANCE RECORDS

17.1 / Does the program provide for identification, preparation, and maintenance of records that provide documentary evidence of quality?
17.2 / Does the program provide for the record protection against damage, deterioration, or loss?
17.3 / Are the responsibilities and requirements for record transmittal, distribution, retention, maintenance and disposition established and documented?
17.4 / Does the program describe a records system that includes storage facilities, access controls, temporary storage, retrieval and disposition?

AUDITS

18.1 / Does the program establish controls for a planned audit schedule of periodic audits which identified when and what areas of the quality program are to be audited in the future?
18.2 / Does the program require audits to be performed in accordance with preplanned checklist or procedures which identify the specific items to be audited?
18.3 / Does the program require audits to be performed by personnel not having direct responsibilities in the areas being audited?
18.4 / Are audit results required by the program to be documented and reviewed by management?
18.5 / Does the program establish controls for follow-up action, including re-audit of deficient areas?

10CFR21

19.1 / Does the supplier have in place a documented process for implementing 10CFR21?

NQA-1 Subpart 2.7 QA Requirements for Computer Software for Nuclear Facility Applications

20.1 / Does the supplier have in place a documented process to control quality for software used directly in the design, analysis and operation of purchased items?

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