QUALITY ASSURANCE SYSTEM MANUAL€¦ · 1 If a customer invokes any of the supplements associated...

ASSURANCE TECHNICAL SERVICES INC 400 PARK AVENUE DELAWARE OH 43015

ATS QAS-NQA1 Rev 1 27 Jun 2013 of 35

© 1989 – 2011 ATS Inc. All Rights Reserved

Uncontrolled unless stamped in red ink on cover page.

Definite Scope

QUALITY ASSURANCE SYSTEM MANUAL

For Nuclear Safety Related Test Programs Performed by, or Under the Management of,

Assurance Technical Services, Inc.

This Document is controlled only if stamped above, with copy number and assignee’s name, by the ATS Quality Organization.

APPROVALS

Approved by:

27 Jun 2013

Andrew P. Clark PE, ATS President Date

Approved by:

27 Jun 2013

J. Edward Thomas, ATS Q. A. Manager Date





REVISIONS

Rev Date Description

0 23 Mar 2011

Original revision. This document was extracted from ATS QAS 89-001 Rev 4 and edited as necessary.

Approvals: A. P. Clark PE (ATS President) J. W. Eblin (ATS QA Manager)

1 27 Jun 2013

Chapter 0: Changed title of this section. Added the approval of the Level 1 manual in ¶2.

§3.04: Added Management Review to QA Manager’s Responsibilities.

§4.07.03: QA Manager verifies purchasing requirements are met.

§4.07.04: Removed exemption.

§4.07.05: Reworded exemption 05 and renumbered as 04.

§4.07.06: Rewritten to clarify usage of unaudited calibration suppliers as being an application of Commercial Grade Dedication.

§4.08.00: Added clarification language to Commercial Dedication.

§4.11.00: Added clarification language to Process Control.

§4.16.00: Added clarification language to Nonconforming Product.

§4.29.00: Added clarification language to Deviations.

Approvals: Andrew P. Clark PE (ATS President) J. Edward Thomas (ATS QA Manager)

A bar in the right margin marks text containing significant changes implemented in the most recent revision of this document





CONTENTS

0 Scope and Authority .........................................................................................6

1 Introduction ......................................................................................................8

1.01 Purpose ......................................................................................................8

1.02 Background ................................................................................................8

1.03 Provenance ................................................................................................9

1.04 Organization of ATS Quality System Documentation ............................... 10

1.05 Organization and Use of this Manual ........................................................ 10

2 Quality Policy ................................................................................................. 12

3 Organizational Structure ................................................................................ 13

3.00 Scope ....................................................................................................... 13

3.01 Legal Structure ......................................................................................... 13

3.02 Internal Organization ................................................................................ 13

3.03 President .................................................................................................. 14

3.04 Quality Assurance Manager ..................................................................... 14

3.05 Lead Auditors ........................................................................................... 15

3.06 Project Technical Managers ..................................................................... 15

3.07 Project Responsible Engineers................................................................. 16

3.08 Project Quality Managers ......................................................................... 16

3.09 All Personnel ............................................................................................ 16

4 Quality System Elements ............................................................................... 18

4.01 Contract Review ....................................................................................... 18

4.02 Project Quality Planning ........................................................................... 19

4.03 Design Control .......................................................................................... 19

4.04 Design Documents ................................................................................... 19

4.05 Controlled Documents .............................................................................. 19

4.06 Logbooks .................................................................................................. 20

4.07 Procurement Control ................................................................................ 21

4.08 Commercial Dedication ............................................................................ 23

4.09 Control of Customer Supplied Product ..................................................... 23

4.10 Inventory Control ..................................................................................... 24

4.11 Process Control ........................................................................................ 24

4.12 Inspection Control ..................................................................................... 24





CONTENTS

4.13 Test Control .............................................................................................. 25

4.14 Metrology .................................................................................................. 25

4.15 Identification of Product Status ................................................................. 26

4.16 Control of Nonconforming Product ........................................................... 27

4.17 Corrective and Preventive Action ............................................................. 27

4.18 Handling, Storage, and Shipping .............................................................. 28

4.19 Quality Assurance Records ...................................................................... 28

4.20 Internal Audits ........................................................................................... 29

4.21 External Audits ......................................................................................... 29

4.22 Supplier Audits ......................................................................................... 30

4.23 Personnel Qualifications ........................................................................... 31

4.24 Servicing ................................................................................................... 31

4.25 Statistical Techniques ............................................................................... 32

4.26 Hold and Notification Points...................................................................... 32

4.27 Intellectual Property .................................................................................. 33

4.28 Reporting of Defects and Noncompliance ................................................ 33

4.29 Deviations ................................................................................................. 33

4.30 Software Control ....................................................................................... 34

5 References .................................................................................................... 35





TABLES AND FIGURES

Table 0.01 Cross Reference from Applicable US Regulations ..................................7

Figure 3.01 Organization Chart ................................................................................. 13





0 SCOPE AND AUTHORITY

This Quality Assurance System Manual covers only those elements of ATS’ (Assurance Technical Services) comprehensive system that must apply to orders for testing of nuclear safety related equipment.

The initial issue and all revisions of this Quality Manual are prepared by the Quality Assurance Manager and approved by the President. Revision status is indicated in the title block.

The regulations given in 10CFR21 and 10CFR50 Appendix B apply statutorily to nuclear safety related equipment intended to be used in the United States. As a matter of ATS policy, the requirements and practices necessitated by these regulations shall be applied to nuclear safety related work regardless of the intended application country.

This Manual applies to work performed by ATS if either of the following condition applies:

a. The terms of a written and accepted customer Purchase Order invoke this Manual, 10CFR50 Appendix B, 10CFR21, or NQA1-19941.

b. The President (§3.03) orders applicability based upon the nature of the subject project.

All projects subject to this Manual shall be designated as “Special” QA grade per the comprehensive system and thereby will be easily distinguishable from other projects.

Table 0.01 lists the applicable sections of US regulations, including all 18 criteria specified in 10CFR50 Appendix B, with cross-references to the applicable chapters or sections of this Manual.

1 If a customer invokes any of the supplements associated with NQA1-1994, ATS’s

compliance to those supplements will be addressed at contract review.





Table 0.01: Cross Reference from Applicable US Regulations

US Regulation QAS-NQA1 Chapter or Section

10CFR21................................................................................................................... §4.28

10CFR50 Appendix B Criteria:

I Organization ............................................................................................. Chap 3

II Quality Assurance Program ................................................ Chap 1, §3.02, §4.02

III Design Control ............................................................................................. §4.03

IV Procurement Document Control .................................................................. §4.07

V Instructions, Procedures, and Drawings .................................... §4.01, 4.02, 4.04

VI Document Control ........................................................................................ §4.05

VII Control of Purchased Material, Equipment, and Services ......... §4.07, 4.08, 4.10

VIII Identification and Control of Materials, Parts, and Components ......... §4.09, 4.10

IX Control of Special Processes ....................................................................... §4.11

X Inspection .................................................................................. §4.12, 4.25, 4.26

XI Test Control ................................................................................................. §4.13

XII Control of Measuring and Test Equipment .................................................. §4.14

XIII Handling, Storage, and Shipping ................................................................. §4.18

XIV Inspection, Test, and Operating Status .............................................. §4.06, 4.15

XV Nonconforming Materials, Parts, or Components ........................................ §4.16

XVI Corrective Action ......................................................................................... §4.17

XVII Quality Assurance Records ......................................................................... §4.19

XVIII Audits ........................................................................................ §4.20, 4.21, 4.22





1 INTRODUCTION

1.01 Purpose

There are three principal reasons for ATS to maintain a documented quality assurance program.

1. It promotes focus and discipline to be shared by all ATS personnel and suppliers.

2. The ATS Quality Assurance System Manual provides a framework for the application of planned and systematic actions necessary to provide adequate confidence that products provided by ATS will meet or exceed the requirements of our customers.

3. It is a statutory requirement in some instances (such as the testing of nuclear safety related equipment, the work-scope of this Manual).

1.02 Background

Beginning with ATS’ founding in 1986, the documented quality system applied only to nuclear qualification testing and was primarily focused on one customer. Although no documented quality system applied outside this scope, ATS management informally applied the same quality standards to all its work and products.

In 1998, ATS’ documented Quality Assurance System was expanded to encompass virtually all work performed by, or under the management of, ATS. The expanded quality system was responsive to the intent of ISO9001:1994 with extensions as required to continue ATS’ commitments to safety, quality, workmanship, and customer satisfaction.

In order to accommodate ATS’ wide range of customer and regulatory requirements, without burdening less demanding projects with unnecessary administrative overhead, the comprehensive system was designed around three quality grades. The ATS quality grades are as follows.

Exempt work is not subject to any documented quality assurance requirements. This includes projects performed where ATS is the end user and projects where the customer specifically waives application of formal quality procedures. Exempt grade project numbers are designated with the suffix “X”.

Basic work is subject to typical quality and documentation requirements of industrial or commercial work. Basic grade projects numbers are designated with the suffix “B”.

Special work is subject to more demanding quality and documentation requirements. This includes work subject to strict safety related requirements such as those specified in 10CFR50 Appendix B. All Special quality grade projects require preparation of a Project Quality Plan. This plan includes documentation of any quality requirements specific to that project that are not included in ATS’ documented quality system. Any such additional requirements are designated as Supplemental requirements. Special grade project numbers are designated with the suffix “S”.





The original revision of this Manual (ATS QAS-NQA1), published in 2011, was prepared in response to customer requests for a simple, top-level manual, focused on ATS’ compliance with the requirements of 10CFR21 and 10CFR50 Appendix B as they apply to testing of nuclear safety related equipment defined as Special Work in this Manual. Efforts have been made to keep the system presented herein both coherent as a stand-alone document and consistent with ATS’ long history of comprehensive quality management.

Within this Manual, ATS’ quality and documentation requirements are tailored to the applicable scope of work: testing of nuclear safety related equipment. Hence, the Special quality grade applies to crucial activities (e.g. metrology). Other activities that do not directly influence nuclear safety (e.g. design and construction of test fixtures) are treated according to the Basic or Exempt quality grade as applicable.

1.03 Provenance

ATS’ quality system is responsive to the following factors, listed in order of decreasing precedence.

1.03.01 Engineering Law & Ethics

As a licensed engineering firm, ATS is subject to the requirements of ORC 4733 and associated engineering ethics per OAC 4733-35. Although these laws and regulations do not address quality assurance per se, they do influence the structure of the quality assurance system in an engineering firm.

Furthermore, ATS management believes that nuclear safety related testing services, as provided by ATS, fall within the scope of the legal definition of engineering services subject to licensure law per ORC 4733.01(D). Hence, this Manual must address the organization and responsibility requirements of laws relating to the practice of engineering.

1.03.02 Nuclear Regulations

In order to provide nuclear safety related testing in the United States, ATS must comply with the quality assurance requirements of 10CFR50 Appendix B. Hence, the system presented in this Manual is substantially structured to address the applicable quality criteria of this regulation as shown in Table 0.01.

Additionally, ATS must comply with the reporting requirements of 10CFR21. These requirements are addressed in §4.28.

1.03.03 ATS Quality Philosophy

ATS management is committed to the ideal that it is desirable and feasible to apply the ethic of craftsmanship, on an organizational level, within a framework of modern quality assurance.





1.03.04 Industry Standards

In order to streamline cooperation on quality related issues between ATS and other organizations, it is useful to conform to widely accepted standards. To this end, ATS management historically selected ISO-9001. Recently, ATS management has recognized that ISO/IEC 17025 is a preferred model quality standard, particularly in ATS’ areas of business, for those quality related issues beyond the scope of 10CFR50 Appendix B.

1.04 Organization of ATS Quality System Documentation

ATS’ Quality System is organized into multi-level documentation as follows:

Level 1 is a system-wide policy manual (e.g. this Manual) that addresses the approach, responsibilities, and general requirements under ATS’ quality system. It is generally available for distribution to qualified organizations and is protected under US copyright law.

Level 2 includes Standard Operating Procedures (SOPs) that provide implementation details on an organization wide basis and draw their provenance directly from the Level 1 Quality Manual. SOP’s are numbered according to the applicable section number in the Level 1 Manual. (e.g. SOP 4.29-01, Deviations, provides implementation instructions for §4.29 of this Manual). SOPs are only rarely released outside of ATS and only when a valid non-disclosure agreement is in place. SOPs are protected under US trade secrecy law.

Also included under Level 2 is ATS’ glossary of quality related terms, ATS QAS-Glossary.

Level 3 is any other quality documentation. This includes plans, procedures, drawings, and reports that apply only to particular projects, products, or devices.

1.05 Organization and Use of this Manual

This Manual serves as primary documentation of the ATS Quality Assurance System as applied to work covering testing of nuclear safety related equipment. The approach, responsibilities, and general requirements defined in this Manual are designed to ensure that ATS products and services conform to all necessary requirements (whether or not explicitly specified in contract documents).

The organization of this Manual is detailed as follows to assist in its effective use.

Authority of this Manual is defined in Chapter 0.

This chapter (1) is included to provide background information to give the reader a basis for, and context of, ATS’ quality system for testing of nuclear safety related equipment as described in this Manual.

A concise statement of quality policy promoted by ATS management, and endorsed by ATS employees, is presented in Chapter 2.





The organization of ATS management is described in Chapter 3 with particular emphasis on those organizational features that concern management of quality assurance within the scope of this Manual.

Chapter 4 contains descriptions of all relevant quality system elements. Each section of Chapter 4 includes subsections of scope (§4.XX.00) and, if applicable, purpose (§4.XX.01). Each “scope” subsection addresses only the applicability2 of its section. The “purpose” subsections are included only as an aid for understanding context; they contain no enforceable provisions.

Chapter 5 is a list of significant references used in the preparation of this Manual or cited herein. Each reference is preceded in boldface by an abbreviated title. These abbreviated titles are used throughout this Manual for citations.

Refer to the most recent revision of the separate document, ATS QAS-Glossary, for concise meanings of quality assurance and metrology related terms used herein.

2 Since this Manual is focused on work covering testing of nuclear safety related equipment,

some sections are not necessary herein and therefore only a brief description of why the section is not applicable is included under the applicable “scope” subsection.





2 QUALITY POLICY

ATS management and employees are committed to the following Quality Policy:

1. Hold public health and safety paramount.

2. Strive to meet and exceed the expectations and needs of customers regarding quality and value.

3. Retain and promote the traditional quality of craftsmanship.

4. Whenever feasible, understand the end use of products and fulfill all reasonable requirements, whether specified or not.





3 ORGANIZATIONAL STRUCTURE

3.00 Scope

Only significant features of the ATS organizational structure which are germane to the Quality System and which are not business sensitive (such as financial features) are described here.

Except as described in this chapter, management reserves the right to establish chain of command and to assign tasks to its employees as it deems appropriate.

3.01 Legal Structure

Assurance Technical Services Inc. (ATS) is a closely held, for-profit corporation organized under Chapter 1701 of the Ohio Revised Code (ORC). It was incorporated on 06 Feb 1986.

ATS is licensed to provide professional engineering services pursuant to ORC 4733.

ATS conducts business on a fiscal year beginning on 01 February.

3.02 Internal Organization

ATS is functionally organized into five general areas of responsibility: Administration, Quality, Production, Facilities, and Marketing. Of these, Quality and Production are germane to this Manual. Figure 3.01 depicts the functional relationship of positions under these two areas of responsibility. The duties, responsibilities, and authorities associated with these positions are described in the sections that follow.

Figure 3.01: Organization Chart

QUALITY ASSURANCE

PROJECT QUALITY

MANAGER

PRESIDENT

PROJECT RESPONSIBLE

ENGINEER / PROJECT

TECHNICAL MANAGER

PROJECT STAFF





Note that Quality and Production are organized on a project basis. That is, project management positions (§3.06 - §3.08) are specifically assigned for each project.

3.03 President

The President shall be a Registered Professional Engineer in the state of Ohio and shall be on record with the Ohio Professional Engineers and Surveyors Board as being in responsible charge of engineering work product of ATS. As such, he is responsible for ATS’ compliance with engineering licensure laws.

The President exercises all of the powers and bears all of the responsibilities normally associated with that position except as modified by the powers and responsibilities of a Project Responsible Engineer (§3.07).

The President is responsible for ensuring that the quality system is established, implemented, maintained, reported on, and improved. The President may delegate any part of any of these responsibilities to any qualified individual. Within this delegation authority, the President is responsible for appointing the Quality Assurance Manager (§3.04).

The President is also responsible for the technical competence of ATS work and may delegate this responsibility as necessary. Within this delegation authority, the President is responsible for appointing a Project Technical Manager (§3.06) or a Project Responsible Engineer (§3.07) to each project. Until such time that the President assigns a Project Technical Manager or a Project Responsible Engineer to a particular project, the President will serve as the Project Responsible Engineer on that project.

If a Project Technical Manager that is not a Project Responsible Engineer is assigned to a project, then the President will serve as Project Responsible Engineer on that project.

3.04 Quality Assurance Manager

The Quality Assurance Manager is appointed by the President. The President will not serve as the Quality Assurance Manager.

The primary role of the Quality Assurance Manager is to ensure that all work and products of ATS meet all applicable statutory, regulatory, and contractual requirements regarding quality and documentation.

The Quality Assurance Manager is subordinate only to the President (§3.03). Within the limitations of the authority of the position, the Quality Assurance Manager is responsible for the following quality activities:

01. The Quality Assurance Manager is responsible for management of QA activities and records on the corporate (as opposed to project) level.

02. The Quality Assurance Manager will direct internal audits, host & respond to external audits, and direct implementation of corrective and preventive actions identified by audit or otherwise. He will determine any useful improvements to the quality system and, if necessary, cause this Manual and/or other applicable quality system documents to be revised or created accordingly.





03. The Quality Assurance Manager will review the quality and documentation requirements of each order accepted by ATS and will appoint a Project Quality Manager (§3.08) thereto. He will supervise and/or supplement the appointee’s activities to verify that he is competently completing his duties. Until such time that the Quality Assurance Manager assigns a Project Quality Manager to a particular project, the Quality Assurance Manager will serve as the Project Quality Manager on that project.

04. The Quality Assurance Manager shall verify and document compliance with the requirements of 10CFR21.

05. The Quality Assurance Manager will conduct a documented annual review of the Quality Management System (QMS) with the President. At a minimum the following quality records of the Quality Management System will be reviewed;

a. The output (plan) from previous QMS reviews

b. Audits including Internal & Customer Audits.

c. Corrective & Preventive Actions

d. Documented Deviations.

e. 10CFR21 Compliance

f. Employee Training

g. Changes that could affect the Quality System

h. Improvements to the Quality System

3.05 Lead Auditors

Qualified Lead Auditors will perform internal audits of ATS per §4.20 and audits of ATS suppliers per §4.22. Lead Auditors will report to the President and the Quality Assurance Manager. Lead Auditors may be either employees of ATS or outside contractors.

Lead Auditors will be qualified to objective criteria that demonstrate knowledge and experience in auditing organizations to the requirements of 10CFR50 Appendix B or ASME NQA1. Lead auditors will not be used to audit their own work or in circumstances that would otherwise present a significant conflict of interest.

3.06 Project Technical Managers

Every order accepted by ATS will have a Project Technical Manager. (Note that, depending on his qualifications, the Project Technical Manager may also be a Project Responsible Engineer per §3.07).

The Project Technical Manager for each project is appointed by the President. The President may appoint himself to this position. When a Project Technical Manager has not been explicitly appointed for a particular project, the President will automatically serve in this capacity.

Within the scope of this Manual, the positions of Project Technical Manager and Project Quality Manager will not be filled by the same individual.





A Project Technical Manager is subordinate to the President. Within the limitations of his authority, he bears responsibility for the technical content and quality conformance of product delivered under his management.

3.07 Project Responsible Engineers

Every order accepted by ATS that is subject to the scope of this Manual will have a Project Responsible Engineer. When a Project Technical Manager is a Registered Professional Engineer in the state of Ohio or other competent jurisdiction, and he is so authorized by the President, he is also the Project Responsible Engineer for the project to which he is assigned. When a Project Technical Manager is not so registered and authorized, the President will serve as the de facto Project Responsible Engineer on the applicable project3.

A Project Responsible Engineer will exercise ultimate authority over, and bear ultimate responsibility for, the impact on public health and safety of the product delivered under his management.

The Project Responsible Engineer will apply his seal to each ATS Certificate of Conformance, or other applicable document, issued for projects under his supervision.

3.08 Project Quality Managers

Every order accepted by ATS will have a Project Quality Manager.

The Project Quality Manager for each project is appointed by the Quality Assurance Manager. The Quality Assurance Manager may appoint himself to this position. When a Project Quality Manager has not been explicitly appointed for a particular project, the Quality Assurance Manager will automatically serve in this capacity.

Within the scope of this Manual, the positions of Project Technical Manager and Project Quality Manager will not be filled by the same individual.

A Project Quality Manager is subordinate to the Quality Assurance Manager and to the President. Within the limitations of his authority, he is responsible for verifying and documenting the fulfillment of all applicable quality requirements on the project (as opposed to corporate) level.

If, due to the limitation of his authority, the Project Quality Manager cannot resolve a quality assurance related issue, he will document the discrepancy and review the issue and its documentation with the Quality Assurance Manager.

3.09 All Personnel

Each employee is responsible for the systematic implementation and improvement of the ATS quality system. Accordingly, each employee will understand those elements of the quality system that apply to their work. Furthermore, when the detailed implementation of quality system elements appears not to support the Quality Policy, he will notify his

3 Note that the Project Technical Manager and the Project Responsible Engineer may be (and

often are) the same individual.





supervisor so that the issue can be clarified or the Quality System can be appropriately improved.

Personnel assigned to a particular project are subordinate to both the Project Quality Manager and the Project Technical Manager for that project.





4 QUALITY SYSTEM ELEMENTS

4.01 Contract Review

4.01.00 Scope

Contract Review is the process by which quality requirements for each project are determined and applies to any order being considered for acceptance by ATS.

Negotiation of contracts is outside the scope of this Manual. Some of the activities in this section may be completed as part of the negotiation process before a Purchase Order is received. The intent of this section is to ensure that all necessary activities are completed before an order is accepted and work begins.

4.01.01 Purpose

The purpose of Contract Review (and of controlling the process) is to:

a. ensure that ATS and the customer have a clear, common understanding of what is required for each order,

b. determine the applicability of this Manual,

c. ensure that the customer’s purchasing documentation is acceptable,

d. verify that ATS has the resources to meet the order requirements, and

e. ensure that ATS initiates all actions required to meet all applicable quality, statutory, and contractual requirements.

4.01.02 Purchase Orders

Upon receipt of a Purchase Order, including a verbal order, the Quality Assurance Manager shall identify whether that order is subject to the scope of this Manual on the basis of the order’s requirements. For any such identified order, he will be responsible for performance and documentation of a contract review.

Any order that is deemed to be subject to this Manual must meet the following minimum requirements prior to commencement of work thereunder:

01. The order must be in writing and contain a distinct identification (typically a PO number).

02. The order must identify individual(s) with authority to interpret technical requirements and make technical decisions on behalf of the Customer (typically a Cognizant Engineer).

03. The order must not include any terms or language that may create incentives to influence test results in a manner contrary to the interests of Public Health and Safety.





4.01.03 Change Orders

For any Change Orders issued by the customer on a project subject to this Manual, a contract review will be performed subject to, as applicable, the same process, approvals and notifications as the original Purchase Order.

4.02 Project Quality Planning

4.02.00 Scope

Project Quality Planning applies to Project Quality Plans developed, revised, and implemented specifically for an individual order.

Project Quality Plans are required on all orders subject to the scope of this Manual.

4.02.01 Purpose

The purpose of Project Quality Planning (and of controlling the process) is to ensure that all applicable quality, statutory, and contractual requirements of a project are fulfilled.

4.02.02 Determination of Requirements and Implementation

The Quality Assurance Manager is responsible for maintaining a form for the preparation of Project Quality Plans.

The Project Quality Manager is responsible for determining the quality requirements applicable to his project, completing and maintaining a Project Quality Plan, and directing the implementation thereof.

4.03 Design Control

4.03.00 Scope

Design Control does not apply within the scope of this Manual because ATS does not presently seek to be qualified to provide nuclear safety related design services or to manufacture nuclear safety related equipment.

4.04 Design Documents

4.04.00 Scope

Design Documents applies to any documents used to present design process or results.

Within the scope of this Manual, design documents does not apply because ATS does not presently seek to be qualified to provide nuclear safety related design services or to manufacture nuclear safety related equipment.

4.05 Controlled Documents

4.05.00 Scope

Controlled Documents applies to any significant document, subject to revision, to which distribution needs to be controlled. Controlled Documents may or may not be produced by ATS.





4.05.01 Purpose

The purpose of Controlled Documents (and of specifying the process) is to:

a. ensure that only the appropriate approved version of a controlled document (generally the latest revision) subject to revision will be used, and

b. provide a means of tracking dissemination of proprietary and sensitive documents.

4.05.02 Identification of Controlled Documents

The Quality Assurance Manager is responsible for maintaining guidelines for identification of Controlled Documents and for identifying Controlled Documents that apply to multiple projects (e.g. this Manual).

4.05.03 Drafts

For documents authored by ATS, draft copies will be clearly marked with the word “DRAFT” on every page and will be identified as the next sequential revision number. (New documents are Revision 0; a draft change to Revision n would be Revision n+1.) Copies of documents marked “DRAFT” will not be used for project work.

The Quality Assurance Manager will verify conformance with this requirement.

4.05.04 Revisions

For documents authored by ATS, the Quality Assurance Manager will maintain a system by which documents are tracked that assures proper approvals and availability for distribution of each revision thereto.

4.05.05 Distribution of Controlled Documents

The Quality Assurance Manager is responsible for implementing, documenting, and maintaining a system of distribution of Controlled Documents that assures that all applicable personnel are using the proper approved version of each applicable document.

4.05.06 Release from Control

If and when there is no longer a need to maintain control of a particular document, said document may be released from document control according to a documented process prescribed by the Quality Assurance Manager.

4.06 Logbooks

4.06.00 Scope

Logbooks applies to bound contemporaneous record books typically maintained by Project Technical Managers.

4.06.01 Purpose

The purpose for maintaining Logbooks is to ensure that all aspects of a project are recorded accurately. On major projects several different employees may perform activities required by the project and record their activities in the project Logbook.





The purpose of controlling the use of Logbooks is to ensure that all required data is recorded in a complete, consistent, and traceable manner.

4.06.02 Application

The Project Technical Manager will maintain a Project Logbook of notes, calculations, and measurements pertinent to the technical aspects of the subject project per guidelines maintained by the Quality Assurance Manager.

Except during periods of project inactivity, the Project Quality Manager will periodically review the Logbook to assure that it is being contemporaneously maintained.

4.06.03 Disposition

Upon completion of a project, the original of the Project Logbook will remain in ATS custody and will be handled as a Quality Assurance Record per §4.19.

4.07 Procurement Control

4.07.00 Scope

Procurement Control applies generally to any materials and services ATS obtains from external suppliers to conduct its business.

Within the scope of this Manual, procurement control (to nuclear safety related standards as detailed below) applies only to the procurement of:

a. Calibration services,

b. Sub-contractors performing nuclear safety related testing (e.g. radiation aging or seismic testing),

c. Shipping of DUT, and

d. Data acquisition software (see also §4.14.04).

4.07.01 Purpose

The purpose of Procurement (purchasing) Control (and of specifying the process) is to ensure that the material and services ATS orders will be provided from ATS’ suppliers as specified. By ensuring that ATS’ suppliers can meet purchase order and quality requirements, ATS is capable of ensuring that ATS can meet its customer’s requirements.

4.07.02 General

The Quality Assurance Manager is responsible for maintaining an Approved Suppliers List (ASL) containing the names and approved scopes of supply for organizations qualified under §4.07.04 through §4.07.06 herein. The Project Quality Manager is responsible for verifying that applicable suppliers are on the ASL for the products or services being procured.

4.07.03 Purchase Orders and Change Orders

All orders by ATS of products or services subject to this Manual will be documented as a Purchase Order. Revisions to ATS Purchase Orders are made incrementally as Change





Orders. Applicable orders will be placed only with suppliers that have been qualified per §4.07.04 through §4.07.06, or that are to perform their work under direct ATS quality supervision per §4.07.07.

The Project Technical Manager, subject to oversight by the Project Responsible Engineer, is responsible for confirming that all necessary technical requirements are specified in the applicable Purchase Order.

The Quality Assurance Manager is responsible for confirming that the order invokes all necessary applicable quality requirements and verifying that these requirements are met.

The Project Responsible Engineer is responsible for verifying that Purchase Orders contain no terms or language that may create incentives to influence test results in a manner contrary to the interests of Public Health and Safety.

4.07.04 Qualification of Supplier by Exemption

The Quality Assurance Manager is responsible for verifying Supplier Qualification by Exemption. The following suppliers may be considered qualified without an audit or evaluation:

01. The Customer for any product unless specifically prohibited by the Customer.

02. NIST for calibrations.

03. Other recognized national standards for calibration (e.g. Satellite GPS for time).

04. Suppliers specifically approved in writing by an Authorized Customer Representative for any approved product or service

4.07.05 Qualification of Supplier by Audit

The Quality Assurance Manager is responsible for Qualification of Suppliers by Audit in conformance with the following requirements:

01. A satisfactory audit of the supplier has been performed per §4.22 within either:

a. 36 months if the Supplier has been approved via at least the last two consecutive ATS audits, or

b. 12 months otherwise.

02. The Supplier’s qualification covers the product to be procured.

03. The Supplier is not pending approval of Corrective Action that applies to the product to be procured.

04. The Customer will have the option to inspect the applicable Audit Report and, if so inclined, disapprove the supplier, provided notice is given in writing and includes the reason for disapproval.

4.07.06 Prequalification of Commercial Grade Calibration Suppliers by Evaluation

The Quality Assurance Manager is responsible for Prequalification of Calibration Suppliers (this includes suppliers of calibrated material measures, which, in turn,





includes suppliers of certified reference materials) by Evaluation in conformance with the requirements of SOP 4.07-01.

4.07.07 Performance by Supplier under ATS Quality Management

The Quality Assurance Manager is responsible for verifying and documenting supplier conformance with the ATS quality system, according to a Customer approved plan.

4.08 Commercial Dedication

4.08.00 Scope

Commercial Dedication applies to the process of elevating a commercial grade item from the Exempt or Basic quality grade to Special.

Within the scope of this Manual, Commercial Dedication applies only to the Commercial Dedication of Commercial Grade Calibration Suppliers as outlined in §4.07.03 and 4.07.06 of this Manual.

4.09 Control of Customer Supplied Product

4.09.00 Scope

Control of Customer Supplied Product applies, within the scope of this Manual, only to test specimens provided for testing by a Customer.

4.09.01 Purpose

The purpose of controlling customer supplied product is to:

a. provide confidence to the customer that the specimens they supply are used as intended,

b. ensure that any loss or (non test-related) damage is identified and reported, and

c. ensure that the specimens are handled in a manner to minimize the potential for loss or (non test-related) damage while the product is in ATS custody.

4.09.02 Raw Materials and Components does not apply

4.09.03 Work in Process does not apply

4.09.04 Devices Under Test (DUT)

The Project Quality Manager is responsible for tracking and documenting chain of custody of each DUT in conformance with the following requirements:

01. Each DUT will be inspected upon receipt and its condition and identity will be verified.

02. Each DUT will be clearly labeled or segregated from other devices as necessary to prevent confusion.

03. Efforts will be taken to protect each DUT from theft or damage, commensurate with its nature and value.





04. Any loss or damage to a DUT will be promptly reported to an Authorized Customer Representative and consequent corrections will be planned.

05. Each DUT will be subjected to the intended tests.

06. As applicable, each DUT will be returned to the Customer in the condition resulting from its last test.

07. ATS will ship the DUT per customer approved method.

4.09.05 Tools and Instruments does not apply

4.10 Inventory Control

4.10.00 Scope

Inventory Control applies to the control of raw materials, work in progress, and finished product, not supplied by the customer, in the custody of ATS.

Within the scope of this Manual, inventory control does not apply because ATS does not presently seek to be qualified to manufacture nuclear safety related equipment.

4.11 Process Control

4.11.00 Scope

Process Control applies to any manufacturing process performed by, or under the management of, ATS.

Within the scope of this Manual, Process Control (including Control of Special Processes) does not apply because ATS does not presently seek to be qualified to manufacture nuclear safety related equipment. The test process, which is in the scope of this manual, is controlled by §4.13

4.12 Inspection Control

4.12.00 Scope

Inspection Control applies to inspections performed by, or under the management of, ATS. Inspections of a customer’s device, process, or system performed as a contract deliverable are considered tests and are controlled under §4.13.

Within the scope of this Manual, inspection control applies to visual inspection of the DUT or other customer supplied items.

4.12.01 Purpose

The purpose for controlling inspections is to ensure that inspections are thorough and properly documented.

4.12.02 General

The Quality Assurance Manager is responsible for developing and maintaining inspection procedures.

The Project Quality Manager is responsible for performing necessary inspections.





4.13 Test Control

4.13.00 Scope

Test Control applies to tests performed by, or under the management of, ATS as a contract deliverable. Test Control applies to orders subject to the scope of this Manual.

4.13.01 Purpose

The purpose of controlling tests is to ensure that the tests ATS performs for its customers are conducted in a manner that meets all applicable quality, statutory, and contractual requirements. Controlling a test includes planning the test sequence, performing the test in accordance with the plan, recording all test results and anomalies accurately, and reporting the test and its results accurately.

4.13.02 General

The Project Responsible Engineer is responsible for conduct and control of all tests performed as part of his project(s).

The Project Quality Manager is responsible for verifying conformance with all applicable quality requirements and for verifying complete and proper documentation of activities and results.

All projects subject to this Manual will have a governing Test Plan and/or a Test Procedure subject to Document Control per §4.05.

4.14 Metrology

4.14.00 Scope

Metrology applies to all measurements and the instruments used to perform those measurements by, or under the management of, ATS.

4.14.01 Purpose

The purpose of controlling metrology is to:

a. meet all applicable statutory and contractual requirements for traceability of measurements,

b. ensure that all measurements made by ATS are as accurate as stated, and

c. ensure that all instruments calibrated by ATS are as accurate as stated.

4.14.02 Measurement Standards

The President is responsible for determining the requirements for, procuring, and maintaining in-house Measurement Standards.

The Quality Assurance Manager is responsible for procuring calibrations, and maintaining Calibration Records of, in-house Measurement Standards. Such records will enable an auditable and traceable documentation trail from recognized national standards to calibrations and measurements performed by ATS as deliverables under projects subject to this Manual.





4.14.03 Calibrations

The President is responsible for determining calibration guidelines, and for approving calibration procedures and forms.

The Quality Assurance Manager is responsible for organizing and uniquely identifying records of all applicable calibrations performed by ATS and treating these Calibration Records as Quality Records per §4.19.

The Project Responsible Engineer is responsible for the competent completion of all necessary calibrations on his project(s).

The Project Quality Manager is responsible for verifying that all necessary calibrations have been completed & documented, and that all applicable instruments are within their respective calibration durations, for any measurements that will be reported to the Customer on his project(s).

4.14.04 Instruments

The Project Responsible Engineer is responsible for determining the suitability of instruments to be used on his project. This includes validation of data acquisition systems including their embedded software.

The Project Quality Manager is responsible for verifying that instruments being used on his project are controlled as necessary to assure accurate, traceable, and properly documented measurements.

4.14.05 Measurements

The President is responsible for implementing, documenting, and maintaining standards that assure that measurements are traceable, as accurate as required, properly recorded, and auditable.

The Project Technical Manager is responsible for assuring that all measurements made in fulfillment of his project conform with the applicable test plan or procedure.

The Project Quality Manager is responsible for assuring that all measurements made in fulfillment of his project conform with the applicable project Quality Plan.

4.15 Identification of Product Status

4.15.00 Scope

Identification of Product Status applies to the tracking of work progress. This section applies to all orders subject to the scope of this Manual.

4.15.01 Purpose

The purpose of controlling the identification of product status is to:

a. ensure that all products are subject to all necessary processes, inspections, hold and notification points and tests in the intended order, and

b. provide a reliable means to ascertain in-process product status.





4.15.02 Application

The Project Quality Manager is responsible for creating, revising, and contemporaneously maintaining project tracking form(s). These forms will provide for dates and personnel identification upon completion of each significant point in fulfillment of the applicable order.

4.16 Control of Nonconforming Product

4.16.00 Scope

Control of Nonconforming Product applies to all products manufactured by, or under the management of, ATS.

Control of Nonconforming Product does not apply within the scope of this manual because ATS does not presently seek to be qualified to manufacture nuclear safety related equipment.

Within the scope of this manual, Deviations, described in §4.29, are analogous to Nonconformances.

4.17 Corrective and Preventive Action

4.17.00 Scope

Corrective and Preventive Action applies to the determination and implementation of corrective and preventive actions. Corrective Actions are Quality System improvements implemented in response to a Deviation, non-compliance, or a notice from a Customer of system defect. Preventive Actions are Quality System improvements implemented in response to a reported gap or defect in the system that did not (yet) cause a Deviation or non-compliance.

4.17.01 Purpose

The purpose of Corrective and Preventive Actions is to improve ATS products and systems. The purpose of corrective action is to provide a means of handling a known problem so that the problem will not occur again. The purpose of preventive action is to provide a means of preventing a problem from occurring that might occur if a change is not made.

4.17.02 Determination

The Quality Assurance Manager is responsible for documenting policies for determining circumstances that warrant opening an investigation into a Corrective or Preventive Action.

4.17.03 Investigation

The Quality Assurance Manager is responsible for directing and documenting an investigation into the need for and nature of Corrective and/or Preventive actions according to documented guidelines.

The President shall evaluate all corrective actions to determine whether 10CFR21 applies and if applicable, shall process per section §4.28.





4.17.04 Corrective Action

The Quality Assurance Manager is responsible for directing the timely implementation of, and validating the results of, Corrective Actions. If the Corrective Action was triggered by a finding or a notification from a Customer, or if it resulted from a defective product having been released to a Customer, the Corrective Action report will be made available to the applicable Customer’s quality organization.

4.17.05 Preventive Action

The Quality Assurance Manager is responsible for directing the timely implementation of, and, to the extent possible, validating the results of, Preventive Actions.

4.18 Handling, Storage, and Shipping

4.18.00 Scope

Handling, Storage, and Shipping applies to the receipt, handling, preservation, storage, packaging, and delivery of tangible products to customers. This section does not apply to handling, storage, or shipping of a DUT which is covered in §4.09.04.

Within the scope of this Manual, Handling, Storage, and Shipping does not apply because ATS does not presently seek to be qualified to manufacture nuclear safety related equipment.

4.19 Quality Assurance Records

4.19.00 Scope

Quality Assurance Records applies to any records documenting quality assurance activities generated by, or under the management of, ATS.

4.19.01 Purpose

The purpose of managing Quality Assurance records is to:

a. ensure that any records documenting Quality Assurance activities at ATS are recorded, maintained, and stored in a manner that ensures that the information will be authentic and retrievable, and

b. ensure that the records can only be disposed of appropriately.

4.19.02 Identification

The Project Quality Manager is responsible for the identification and collection of Quality Assurance Records of project specific activities. The Quality Assurance Manager is responsible for the identification and collection of Quality Assurance Records of activities that are not specific to one project.

4.19.03 Data Records

The Quality Assurance Manager is responsible for documenting policies for recording data.





The Project Quality Manager is responsible for verifying conformance with the ATS policies for record keeping on his project(s)

4.19.04 Storage

The Quality Assurance Manager is responsible for documenting policies for storage and surveillance of Quality Records and for implementing said policies.

Applicable quality records shall be stored as duplicates in two or more locations sufficiently remote from each other to minimize the chance of exposure to a simultaneous hazard.

4.19.05 Disposition

The Quality Assurance Manager is responsible for documenting policies for determining circumstances under which Quality Records may be disposed.

The Quality Assurance Manager is responsible for the disposition of quality records when applicable.

4.20 Internal Audits

4.20.00 Scope

Internal Audits applies to audits of the ATS quality system performed under the direction of ATS.

4.20.01 Purpose

The purpose of Internal Audits is to periodically check whether the ATS quality system is working and is being followed by ATS personnel. The purpose of controlling Internal Audits is to assure that they are effective and that any identified Corrective or Preventive Actions are initiated.

4.20.02 Implementation

The Quality Assurance Manager is responsible for documenting policies for planning, conducting, and reporting on periodic Internal Audits and for implementing said policies. Any findings will be addressed by a corrective action per §4.17.

Audits will be performed in accordance with written plans and checklists by an individual qualified as a Lead Auditor per §3.05. The Lead Auditor must not have direct responsibility for performing the activities being audited or other conflict of interest.

4.21 External Audits

4.21.00 Scope

External Audits applies to any audit of the ATS quality system performed under the direction of an organization other than ATS.

4.21.01 Purpose

The purpose of external audits is to verify that the ATS Quality System meets specified requirements and is being followed by ATS personnel. External audits are conducted by





either ATS customers or by independent auditing organizations for the purpose of qualifying ATS as a supplier of nuclear safety related testing services.

4.21.02 Customer Audits

The Quality Assurance Manager is responsible for documenting policies for Customer Audits and for implementing said policies. Any findings will be addressed by a corrective action per §4.17.

A Customer Audit will be permitted only upon authorization by the President. Upon authorization, it will be coordinated and hosted by the Quality Assurance Manager.

In no case will a visiting Customer auditor be allowed access to records containing confidential information owned by a different Customer unless authorized in writing by the Customer that owns the information.

4.21.03 Independent Audits

An independent audit may be ordered as a means of validating the effectiveness of the ATS quality system and/or securing certification.

The Quality Assurance Manager is responsible for coordinating and hosting Independent Audits. Any findings will be addressed by a corrective action per §4.17.

4.22 Supplier Audits

4.22.00 Scope

Supplier Audits applies to quality audits of ATS suppliers performed under the direction of ATS.

4.22.01 Purpose

The purpose of supplier audits is to verify that organizations supplying goods and services to ATS meet all applicable quality standards.

4.22.02 General

Each Supplier Audit will be planned and executed by an individual qualified as a Lead Auditor per §3.05 and verified to have no conflict of interest with the Supplier. Audits will be conducted to document objective evidence confirming the following elements for the subject scope of supply:

01. The supplier’s quality system documentation meets applicable requirements.

02. The supplier conforms with its documented quality assurance system.

03. The supplier is technically competent.

4.22.03 Planning

A copy of the Supplier’s Quality System Manual will be procured and evaluated for conformance with applicable requirements (e.g. 10CFR50 Appendix B). Based on this evaluation, an Audit Plan and checklist will be prepared and approved by a Lead Auditor and the Quality Assurance Manager prior to conducting each supplier Audit.





4.22.04 Implementation

Audits will be performed by, or under the direct supervision of, the same Lead Auditor who approved the Audit Plan and Checklist per the following requirements:

01. ATS audit team members will accept no gifts from the Supplier or its personnel.

02. The audit will be conducted in accordance with the Audit Plan and Checklist.

03. Findings of discrepancies will be communicated to the Supplier then schedules and responsibilities for implementation of necessary Corrective Actions will be agreed upon.

04. A Lead Auditor approved report will be generated describing the results of the Audit, including, as attachments, the Audit Plan and completed checklist.

4.22.05 Follow-up

The Quality Assurance Manager is responsible for confirming that any Corrective Actions required due to findings of discrepancies are effectively implemented according to the agreed schedules.

4.23 Personnel Qualifications

4.23.00 Scope

Personnel Qualifications applies to personnel skill, aptitude, education, experience, and training as it affects quality.

4.23.01 Purpose

The purpose of defining how personnel are qualified is to:

a. meet any applicable statutory and contractual requirements for the documentation of personnel qualifications, and

b. ensure that work performed for and by ATS is done by qualified personnel.

4.23.02 Qualification Requirements

The Quality Assurance Manager is responsible for the following:

01. Ensure that all ATS personnel are trained for the work they perform.

02. Conduct regular training on quality system requirements and on 10CFR21 for all ATS personnel that will be working on projects subject to this Manual.

03. Maintain records of training for all ATS personnel.

4.24 Servicing

4.24.00 Scope

Servicing applies to any activity performed, or additional product delivered, as a supplement to a product that has been delivered to a customer.





4.24.01 Purpose

The purpose of controlling servicing is to ensure that ATS customers continue to be satisfied with ATS products after receipt.

4.24.02 Application

The Project Quality Manager will verify that any servicing performed in association with a nuclear safety related test program subject to this Manual is in compliance with the requirements of 10CFR21 and 10CFR50 Appendix B.

4.25 Statistical Techniques

4.25.00 Scope

Statistical Techniques applies to any non-trivial mathematical or graphical technique employed to analyze data or control a process.

4.25.01 Purpose

The purpose of controlling the use of statistical techniques is to ensure that techniques are developed and used appropriately. This will help prevent the misuse and misinterpretation of data and information.

4.25.02 Application

The President is responsible for prescribing organization-wide norms and guidelines for the use of Statistical Techniques developed and applied by ATS.

The Project Responsible Engineer is responsible for determining which Statistical Techniques will be applied and for their proper application. Original recorded data will be preserved, thereby providing fully auditable and reproducible results.

4.26 Hold & Notification Points

4.26.00 Scope

Hold & Notification Points applies to any specified point in the process of completing a project where work is required to stop pending notification of the Customer, whether specified verbally or in writing.

4.26.01 Purpose

Hold and Notification points are typically specified by the customer. The purpose of Hold and Notification points is to give the customer an opportunity to inspect product at specified points in the process. The purpose of controlling the implementation of Hold and Notification points is to prevent missing one inadvertently and, thus, not meeting a customer requirement.

4.26.02 Application

The Quality Assurance Manager is responsible for documenting policies for implementing Hold and Notification Points. The Project Quality Manager is responsible for including all applicable Hold and Notification Points in the Project Status Form and verifying implementation.





4.27 Intellectual Property

4.27.00 Scope

Intellectual Property does not apply under the scope of this Manual because the applicable quality assurance regulations do not address control of intellectual property.

4.28 Reporting of Defects and Noncompliance

4.28.00 Scope

Reporting of Defects and Noncompliance applies to any work subject to 10CFR21 or any other reasonably known statutory reporting requirements.

The requirements of 10CFR21 apply to work subject to this Manual. Pursuant to ORC 4733, these requirements apply regardless of the destination country of equipment being tested by ATS.

4.28.01 Purpose

The purpose of defining how to report defects and noncompliance is to ensure that public health and safety are safeguarded and that statutory reporting requirements are met.

4.28.02 Application

The Quality Assurance Manager is responsible for performing and documenting regular training and evaluation of ATS personnel on the requirements of 10CFR21 and for meeting all applicable posting requirements of that regulation.

All ATS personnel working on projects subject to this Manual will be responsible for noting any potential applicable instance of defect or noncompliance and promptly reporting same to management.

The President is responsible for evaluating the seriousness of each internal report of potential defect or noncompliance and making any necessary notifications to customers or applicable regulatory agencies (typically the NRC).

4.29 Deviations

4.29.00 Scope

Deviations applies to departures from any quality or technical requirement of any applicable manual, procedure, or contract document, whether planned in advance or recognized after its occurrence.

Note that a Deviation is not a Nonconformance as referred to in criterion XV of 10CFR50 Appendix B. (Nonconforming items shall be reviewed and accepted, rejected, repaired or reworked in accordance with documented procedures.) Deviations, as defined by ATS, cannot be rejected, repaired, or reworked in the sense applicable to Nonconformances.

4.29.01 Purpose

The purpose of defining how deviations are managed and authorized is to ensure that all instances of deviations are properly addressed.





Note that there is no objective to reduce or eliminate the occurrences of Deviations. Often, Deviations are pre-planned and pre-authorized as solutions to operational problems that arise during a project.

4.29.02 Application

The Quality Assurance Manager is responsible for implementing, maintaining, and documenting a system for managing Deviations. The system will ensure that all instances of deviations are properly documented and approved and that any indicated Corrective Actions are initiated per §4.17.

4.30 Software Control

4.30.00 Scope

Software Control applies to the control of computer software as it affects quality. Primarily, Software Control consists of Software Configuration Management as well as Software Verification and Validation.

Within the scope of this Manual, Software Control does not generally apply because ATS does not presently seek to be qualified to supply nuclear safety related software.

However, real world data collected during tests (e.g. temperatures, pressures, etc.) do serve a nuclear safety related purpose. Validation of computer based data acquisitions systems used by ATS is performed in an integrated system condition (software plus hardware). This issue is addressed in §4.14.04.





5 REFERENCES

The applicable sections of the following references were reviewed during the preparation of this Manual. Each reference is preceded in boldface by an abbreviated title. These abbreviated titles are used throughout this Manual for citations.

Copies of all references are available in ATS offices, for use or review whenever necessary.

10CFR21, Reporting of Defects and Noncompliance, U.S. Government Printing Office, the latest revision at: http://www.nrc.gov/reading-rm/doc-collections/cfr/part021/

10CFR50.49, Environmental Qualification of Electric Equipment Important to Safety for Nuclear Power Plants, U.S. Government Printing Office, latest revision at: http://www.nrc.gov/reading-rm/doc-collections/cfr/part050/part050-0049.html

10CFR50-App B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, U.S. Government Printing Office, latest revision at: http://www.nrc.gov/reading-rm/doc-collections/cfr/part050/part050-appb.html

ASME NQA-1-1994, Quality Assurance Program Requirements for Nuclear Facility Applications, ©1994, The American Society of Mechanical Engineers.

ATS QAS-Glossary, Quality Assurance System Glossary, Assurance Technical Services Inc.

IEEE 323-1974, IEEE Standard for Qualifying Class 1E Equipment for Nuclear Power Generating Stations, ©1974, The Institute of Electrical and Electronics Engineers, Inc.

IEEE 323-1983, IEEE Standard for Qualifying Class 1E Equipment for Nuclear Power Generating Stations, ©1983, The Institute of Electrical and Electronics Engineers, Inc.

IEEE 344-1987, IEEE Recommended Practice for Seismic Qualification of Class IE Equipment for Nuclear Power Generating Stations, ©1987, The Institute of Electrical and Electronics Engineers, Inc.

ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, 2005, International Organization for Standardization.

ISO 9001, Quality management systems – Requirements, 2008, International Organization for Standardization.

OAC 4733-35, Ohio Administrative Code, Chapter 4733, Part 35, Code of Ethics for Engineers and Surveyors, State of Ohio, latest revision at http://codes.ohio.gov/oac/4733-35.

ORC 4733, Ohio Revised Code, Chapter 4733, Professional Engineers and Surveyors, State of Ohio, latest revision at http://codes.ohio.gov/orc/4733.

http://www.nrc.gov/reading-rm/doc-collections/cfr/part021/

http://www.nrc.gov/reading-rm/doc-collections/cfr/part050/part050-0049.html

http://www.nrc.gov/reading-rm/doc-collections/cfr/part050/part050-appb.html

http://codes.ohio.gov/oac/4733-35

http://codes.ohio.gov/orc/4733

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