FUNCTIONAL AREA: QUALITY ASSURANCE...FUNCTIONAL AREA: QUALITY ASSURANCE BGS-QAP-01 REV. NO. 12 TITLE: CORPORATE QUALITY ASSURANCE PLAN EFFECTIVE DATE: 03/08/2019 Page 2 of 85 Electronic

FUNCTIONAL AREA: QUALITY ASSURANCE BGS-QAP-01 REV. NO. 12

TITLE: CORPORATE QUALITY ASSURANCE PLAN

EFFECTIVE DATE: 03/08/2019 Page 2 of 85

Electronic documents once printed are uncontrolled and may become outdated. Contact the Document Control Administrator (DCA) for the correct version and the current revision.

Revision History

Rev. No. Effective

Date Preparer Type1 Changes 0 07/08/2013 T. Graben-Galyon M Original document. 1 08/14/2013 H. Boston M Added QA Managers requirements 2 07/11/2014 S. Chappelle M Added SQA and NQA-1 flow downs for implementation 3 07/25/2014 S. Chappelle M Administrative Changes: revision to Organizational Chart

(Attachment 2) 4 09/08/2014 T. Graben-Galyon M Added DOE EM-QAP-001 requirements 5 10/10/2014 T. Graben-Galyon M Revision to resolve DOE-EM comments 6 02/20/2015 S. Lambert M Revised to incorporate BGS graded program approach,

address DOE Audit findings and updates for RADCALC Phase 1.

7 04/03/2015 R. Lambert M Revised to incorporate informal comments from DOE EM. Changes included; Section 1.2 C; added paragraph on Spent Nuclear Fuel and High-Level Work exclusion. Section 1.5 C and D; updated definitions between BGS two-level QA Program. Section 1.6 B 1 and 4 c); moved part of 4. c) to President RR section. Section 1.6 B 4; added G) for assessment schedule. Section 1.6; added additional position RRs. Section 2.3; added additional qualification requirements and section 2.4. Section 3.3 A-C detailing SCAQ and other corrective action functions. Section 4.2 clarify temporary storage and maintenance requirements Section 5 B; added SQAP. Section 7.0; updated. Section 9.0; updated per comments. Section 10.0; updated per comments. Section 12.8; updated to address acceptance and testing of procured software. Attachment 2 revised Organizational Chart Attachment 3 (QIP); Added reference to the DOE EM QAP Management Expectation sections. Appendix D; updated per comments.

8 03/01/2016 R. Lambert M Revision includes changes noted in CAR-15-03, and noted section changes (listed below), miscellaneous minor editorial changes and prior BGS change tracking list items. All Sections – general updates Section 1.3 – Project Specific Quality Assurance Plans – removed. Section 12 – Rewrite Section 13 –-Added Attachments D and E removed.

1 M = major change, mc = minor change, N = new





Rev. No. Effective

Date Preparer Type1 Changes 9 05/13/2016 R. Lambert M Revision includes changes noted during the DOE

Qualification Audit EM-PA-16-40; BGS internal editorial comments noted during required reading; BGS internal comments identified during the revision process (Rev. 8 to 9); changes that incorporate actions to address DOE Audit (EM-PA-16-40) Finding #3 (Removed Sections 1.2.B.10 and 1.2.B.11; Revised Section7.5.G; and Updated Section 12.3) and updated Attachment 2 Organizational Chart to latest.

10 3/31/2017 J. Hendricks M Revision includes: Formatted to comply with BGS-AD-01 requirements for plan template. Reformatting resulted in the addition of required sections (e.g., Section 1 Purpose and renumbering of previous sections and references to the renumbered sections.) Throughout the document, changed the title of Vice President of Operations to Vice President of Information Management. Also, the term “Design verification” was changed to “verification” to match NQA-1 changes that will be included in future editions. Section 3.4: added responsibility for Senior Vice President. Section 3.4: added responsibility for Records Manager. Section 4.5: added Training and Qualification of Auditors. Section 10.1: deleted the word “hardware.” Section 11.1.C.6: removed web site and replaced with text. Section 12.1.B.5: removed web site and replaced with text. Section 12.3: revised BGS Quality Program Assessment. Section 14.11.B.3: added clarification safety software. Section 14.13.E: added clarification software testing. Section 15.1: deleted redundant statement. Section 16: deleted reference 10CFR 50…& 10CFR 21. Attachment 1: added definition of Audit. Attachment 2: revised Organizational Chart. Attachment 3: revised Quality Implementation Plan.





Rev. No. Effective

Date Preparer Type1 Changes 11 10/17/2018 R. Lambert M Revision includes:

General minor editorial changes which are not tabulated. Acronyms: Added SSCs Section 2.0, 3.2 B, 33 C., added Engineering Design scope of work. Section 3.2 2), Updated Requirement basis. Section 3.3 D) Added the definition of Quality Level #1, revised the definition of Quality Level #2, and removed the note that was before the section. Section 3.4 D.

2), Added QA Manager role on an interim basis to Senior Vice President responsibilities. 3) Removed VP of Information Management and moved function under Functional Manager Section 3.4 4). 5) added responsibility for Senior Vice President and Chief Engineer.

Section 3.4.5) a. Noted PM report to the Senior Vice President. Section 3.4. 6). Removed SIPM. Role falls under general PM responsibilities. Section 3.4 7) b. removed VP and deleted d. Section 3.4. 17). Removed Department Managers. Section 3.6 B. Added project specific Quality Assurance Plan may be utilized to identify, communicate and track external interfaces. Section 6. Added introduction paragraphs to address Engineering Design and other administrative document control items. Section 8. Updated to include Engineering Design requirements. Section 14.15. Updated to remove reference to one specific BGS client. Attachment 1-3 Updated as appropriate for addition of Engineering Design.

12 03/01/2019 S. Painter M Revision includes: General minor editorial changes which are not tabulated. Acronyms: Added PAAA and PQAP Sections 1.0 and 3.3 G: Added commercial non-nuclear project QA approach. Section 3.2 F: Noted use of external supplier’s QA Program audits/assessments are utilized to meet triennially program review. Section 3.9: Added section on Price-Anderson Amendment Act compliance and implementation. Attachment 2: Updated organization chart.





TABLE OF CONTENTS

ACRONYMS .............................................................................................................................. 8

BOSTON GOVERNMENT SERVICES, LLC QUALITY POLICY ................................................ 9

1. PURPOSE ........................................................................................................................10

2. APPLICABILITY ...............................................................................................................10

3. QUALITY ASSURANCE PLAN .........................................................................................11

3.1 Management Expectations ...................................................................................11 3.2 Quality Assurance Plan .........................................................................................11 3.3 Tier 1 Nuclear Facility QAP Implementation ..........................................................12 3.4 Tier 2 Standard Commercial-Industrial QAP Implementation ................................13 3.5 Graded Approach .................................................................................................14 3.6 Organization Structure and Responsibility ............................................................16 3.7 Delegation of Work ...............................................................................................22 3.8 Interface Control ...................................................................................................22 3.9 Stop Work Authority Policy....................................................................................23 3.10 Management Reviews ..........................................................................................23 3.11 Price-Anderson Amendment Act ...........................................................................23

4. PERSONNEL TRAINING AND QUALIFICATION .............................................................24

4.1 Management Expectations ...................................................................................24 4.2 Indoctrination and Training....................................................................................25 4.3 Qualification ..........................................................................................................26 4.4 Training and Qualification Records .......................................................................26 4.5 Training and Qualification of Auditors ...................................................................27

5. QUALITY IMPROVEMENT ..............................................................................................29

5.1 Management Expectations ...................................................................................29 5.2 Non-Conforming Items and Services Control ........................................................31 5.3 Corrective Action ...................................................................................................32

6. DOCUMENTS AND RECORDS .......................................................................................34

6.1 Management Expectations ...................................................................................34 6.2 Quality Assurance Records...................................................................................35

7. WORK PROCESSES .......................................................................................................38

7.1 Management Expectations ....................................................................................38

8. DESIGN CONTROL .........................................................................................................39

8.1 Management Expectations ...................................................................................39 8.2 Design Input .........................................................................................................39 8.3 Design Process .....................................................................................................40





8.4 Design Analysis ....................................................................................................41 8.5 Design Verification ................................................................................................42 8.6 Design Verification Methods .................................................................................43 8.7 Design Change Control .........................................................................................44 8.8 Configuration Management ...................................................................................45 8.9 Interface Control ...................................................................................................45 8.10 Software Design Control .......................................................................................45 8.11 Design Documentation and Records .....................................................................46

9. PROCUREMENT .............................................................................................................46

9.1 Management Expectations ....................................................................................46 9.2 Procurement Documents ......................................................................................46 9.3 Procurement Document Review ............................................................................48 9.4 Procurement Document Changes .........................................................................48 9.5 Control of Purchased Items and Services .............................................................48

10. INSPECTION AND ACCEPTANCE TESTING ..................................................................53

10.1 General .................................................................................................................53

11. MANAGEMENT ASSESSMENT .......................................................................................53

11.1 Management Expectations ...................................................................................53

12. INDEPENDENT ASSESSMENTS ....................................................................................55

12.1 Management Expectations ...................................................................................55 12.2 Independent Assessments ....................................................................................56 12.3 BGS Quality Program Assessment .......................................................................57

13. SUSPECT/COUNTERFEIT ITEMS ..................................................................................58

13.1 Management Expectations ...................................................................................58 13.2 BGS Suspect/Counterfeit Items Program ..............................................................58

14. SOFTWARE QUALITY ASSURANCE ..............................................................................59

14.1 Management Expectations ...................................................................................59 14.2 General Software Requirements ...........................................................................60 14.3 Software Acquisition .............................................................................................61 14.4 Software Configuration Management ....................................................................62 14.5 Problem Reporting and Corrective Action .............................................................63 14.6 Software Verification and Validation ......................................................................64 14.7 Reviews ................................................................................................................65 14.8 Software Engineering Method ...............................................................................65 14.9 Software Planning .................................................................................................66 14.10 Software Requirements Definition .........................................................................66 14.11 Software Design ...................................................................................................67 14.12 Implementation .....................................................................................................68





14.13 Software Testing ...................................................................................................68 14.14 Installation and Acceptance ..................................................................................71 14.15 Operation ..............................................................................................................71 14.16 Maintenance .........................................................................................................72 14.17 Retirement ............................................................................................................72 14.18 Standards, Conventions, and Other Work Practices .............................................72 14.19 Support Software ..................................................................................................73

15. COMPUTER MODEL DEVELOPMENT, USE, AND VALIDATION ...................................73

15.1 Management Expectations ...................................................................................73

16. REFERENCES .................................................................................................................75

17. ATTACHMENTS ..............................................................................................................76

ATTACHMENT 1 – DEFINITIONS ...................................................................................77 ATTACHMENT 2 – BOSTON GOVERNMENT SERVICES, LLC ORGANIZATION

CHART .................................................................................................................80 ATTACHMENT 3 – QUALITY IMPLEMENTATION PLAN ................................................81





ACRONYMS

ASME American Society of Mechanical Engineers

BGS Boston Government Services, LLC

CAQ Condition Adverse to Quality

CFR Code of Federal Regulations

COC Certificate of Conformance

DCA Document Control Administrator

DOE U.S. Department of Energy

FM Functional Manager

IAEA International Atomic Energy Agency

ISMS Integrated Safety Management System

ISO International Organization for Standardization

NQA Nuclear Quality Assurance

QA Quality Assurance

QAP Quality Assurance Plan

QIP Quality Implementation Plan

QL Quality Level

PAAA Price-Anderson Amendment Act

PQAP Project Quality Assurance Plan

PM Project Manager

S/CI Suspect/Counterfeit Item

SCAQ Significant Conditions Adverse to Quality

SIPM Software Implementation Project Manager

SME Subject Matter Expert

SQA Software Quality Assurance

SQAP Software Quality Assurance Plan

SRP Standard Review Plan

SSCs Systems, Structures, Components

TM Training Manager





BOSTON GOVERNMENT SERVICES, LLC QUALITY POLICY

Quality is a Boston Government Services, LLC (BGS) core value. Quality is essential for performing BGS work that consistently meets or exceeds the needs and expectations of BGS clients. Each BGS employee and associate has important contributions to make toward ensuring BGS provides quality services and deliverables. We understand each of us is responsible for quality, and quality is essential for BGS success.

The BGS Quality Assurance Plan (QAP) places emphasis on the principle that quality is a fundamental aspect of work performed by BGS employees and associates (staff). BGS personnel are expected to perform their duties safely and in a manner that provides value to our clients. Following the procedures established to implement the QAP is key to doing work correctly and the delivery of quality products.

Quality expectations for BGS staff are communicated as part of BGS’ policies and overarching philosophy to conduct activities that meet or exceed the standards of performance stated herein. BGS’ personnel are responsible and accountable for the quality of work they perform and/or supervise.

Staff roles, responsibilities, accountabilities, and authorities for specific project positions and assignments are established to meet the contract needs for which they are providing support and/or the corporate functions to which they are assigned. Performance criteria specific to BGS’ commitment to quality and continual improvement are as follows:

• Provide and continually improve services, products, and management systems of the highest quality consistent with the needs, expectations, and resources of our clients.

• Provide a safe and healthy workplace by developing and implementing work processes and controls that abate hazards, operating in a manner that protects and restores the environment, and integrating pollution prevention into planning and decision-making.

• Comply with applicable requirements for performing work and work-related activities on and off site.

• Communicate appropriate information to staff, subcontractor personnel, clients, and other stakeholders.

• Comply with legal, contractual, and other applicable requirements.

• When quality related activities are delegated to others, management retains responsibility for the overall effectiveness of the QAP.

• Establish policies to provide the basis for identification of quality objectives for management and staff that are applicable to the activities supported.

• Review policies periodically to determine suitability.





1. PURPOSE

The purpose of the BGS Quality Assurance Plan (QAP) and flow-down procedures conform and commit to the requirements, as applicable, specified by BGS’ clients. To support multi-client BGS work base a two-tier quality assurance program is utilized by BGS to implement the Corporate QA Plan. The two tiers are Tier 1) Nuclear Facilities and Tier 2) Standard-Commerical-Industrial. The QA program tier is determined for individual contracts or projects. The tier selected determines how this QAP is applied.

Tier 1) Nuclear Facilities tier is assigned for a contract or project which invokes any of the following nuclear quality assurance regulations, directives or standards:

• Title 10 Code of Federal Regulations, Part 830, Quality Assurance, Subpart A;

• American Society of Mechanical Engineers (ASME) Nuclear Quality Assurance (NQA)-1, Quality Assurance Requirements for Nuclear Facility Applications (2008 Edition with 2009 Addenda) (NQA-1);

• U.S. Department of Energy (DOE) Order (O) 414.1D, Change 1, Quality Assurance, Attachment 2, Contractor Requirements Document (CRD); and

• U.S. Department of Energy Office of Environmental Management (DOE EM) EM-QA-001 Revision 1, EM Quality Assurance Program (QAP).10 CFR 820, Procedural Rules for DOE Nuclear Activities

Tier 2) Standard Commercial-Industrial tier is assigned for a contract or project which invokes standard industrial quality control and assurance requirements and/or a consensus non-nuclear QA standard (i.e., ISO 9001, etc.).

The requirements of this QAP apply to projects that require quality-related contract work performed by BGS. A graded approach to the implementation of this program is applied based on the contract requirements of the project and the scope of work.

2. APPLICABILITY

This document is the BGS corporate program document applying to:

1. General technical and professional services such as Engineering Design, Technical and Engineering Consulting Services, Information Management, Safeguards and Security, and Program and Project Management support and services.

2. Specialty support such as operational efficiency and cost reduction assessments, program compliance and performance reviews, and contract management support.

3. Management consulting and performance improvement such as strategic planning, performance plans, and management training.

4. Management, technical, and specialty support associated with computer software development and change control.





BGS staff, including staff augmentation, performs work in accordance with this QAP and implementing procedures.

3. QUALITY ASSURANCE PLAN

3.1 Management Expectations

A. BGS management expectations are included for each section of this QAP.

B. Line management for execution of the work extends from the BGS President and Vice President(s) (senior management), through Functional Managers (FMs), Project Managers (PMs), staff, and subcontractors. BGS management expectations include:

1. Using a graded approach that is consistent with Integrated Safety Management System (ISMS) principles, BGS management ensures resources are planned, scheduled, and allocated to accomplish work.

2. The Functions, Responsibilities, and Authorities are documented to ensure requirements are identified and associated responsibilities are assigned.

3. Lines of communication, feedback mechanisms, and interfaces are established and documented.

4. Personnel at each level (including subcontractors, as applicable) are familiar with and facilitate achievement of the QA processes.

5. Management establishes and implements QA processes and procedures in a controlled manner.

C. These management expectations are implemented via BGS-QAP-01, Corporate Quality Assurance Plan, and noted procedures in BGS’ Quality Implementation Plan (QIP) (Attachment 3).

3.2 Quality Assurance Plan

A. The following office work activities associated with BGS administrative systems that do not contain quality related functions are excluded activities from the requirements of this QAP:

1. Accounting

2. Business Development

3. Human Resources (but not training, qualifications, and Human Resources records)

4. Procurement of office supplies and office equipment





B. BGS uses random sampling as part of acceptance or review processes. When sampling is utilized, sampling plans are developed or the sampling method utilized is summarized within a document (i.e., report, assessment) as detailed in BGS-QA-03, Graded Approach.

C. BGS conducts independent assessments at a frequency such that all elements of the QA Program are addressed at least triennially to accommodate changes in the program, incorporate new or revised requirements, and to ensure effective implementation of the QAP. Results of these assessments are documented and maintained, and any necessary changes are made through revision of this QAP. BGS may utilize external supplier’s audits and assessments to satisfy this review.

3.3 Tier 1 Nuclear Facility QAP Implementation

A. The Nuclear Facility Tier is applied to contracts or projects that require conformance with the requirements, as applicable, specified in Title 10 Code of Federal Regulations, Part 830, Quality Assurance, Subpart A; American Society of Mechanical Engineers (ASME) Nuclear Quality Assurance (NQA)-1, Quality Assurance Requirements for Nuclear Facility Applications (2008 Edition with 2009 Addenda) (NQA-1); DOE O 414.1D, Change 1, Quality Assurance, Attachment 2, CRD; DOE EM-QA-001 Revision 1, EM Quality Assurance Program (QAP); and International Organization for Standardization (ISO) 9001:2008, Quality Management Systems – Requirements.

B. All sections of this QAP and associated implementing procedure apply to this tier using a graded approach detailed in section 3.5.





C. BGS is a mission support company for federal programs and facilities. BGS provides Engineering Design, Technical and Engineering Consulting Services, Information Management, Safeguards and Security, and Program and Project Management support and services for government programs and government contractors. Therefore, the following sections of NQA-1 requirements are not applicable to the work performed by BGS and are excluded from the BGS QAP and implementing procedures. (Additional clarification is also provided in Attachment 3, Quality Implementation Plan [QIP] Notes section.)

1. Requirement 2, (Qualification Requirements) Paragraphs 301, Nondestructive Examination, and 302, Inspection and Test

2. Requirement 3, Design Control (Paragraph 601, Configuration Management of Operating Facilities)

3. Requirement 8, Identification and Control of Items (All)

4. Requirement 9, Control of Special Processes (All)

5. Requirement 10, Inspection (All)

6. Requirement 11, Test Control, (Paragraphs 300 and 400b)

7. Requirement 12, Control of Measuring and Test Equipment (All)

8. Requirement 13, Handling, Storage, and Shipping (All)

9. Requirement 14, Inspection, Test, and Operating Status (All)

D. BGS does not participate in the design, fabrication, procurement, use, maintenance, or shipment of hazardous materials packaging. Therefore, the requirements in EM-QA-001, Rev. 1, Attachment A, Certified Type B Fissile Packaging Quality Assurance Program, are not applicable to the work performed by BGS and are excluded from the BGS QAP and implementing procedures.

3.4 Tier 2 Standard Commercial-Industrial QAP Implementation

A. The Standard-Commerical-Industrial tier is applied on Non-Nuclear projects that invoke other QA requirements or other QA consensus standards (e.g., ISO 9001, etc.). Performance of work under this tier includes projects that may not contractually require special controls to ensure success of the customer project/program mission. Certain provisions of this QAP may not apply to Non-Nuclear Projects.





B. For Standard Commerical-Industrial projects, BGS will develop and issue a Project specific Quality Assurance Plan (PQAP). The PQAP identifies and selects:

1. Applicable QAP section (or criterion) based on the contract quality requirements and project’s scope and services;

2. Specific management controls to be applied to applicable QAP sections (criterion). Management controls are selected from the QAP implementing procedures and listed by project/section(s), as necessary, in the PQAP.

3. When BGS elects to adhere to customer’s QA Plan provisions and associated procedures versus selected provisions of this QAP and BGS’s procedures.

C. The following sections of the QAP are not applicable to Tier 2 Standard-Commercial-Industrial projects;

• Section 3.5, Graded Approach;

• Section 3.11, Price-Anderson Amendment Act;

• Section 13, Suspect/Counterfeit Items

• Section 14, Subsection 14.2 – 14.19, Software Management

• Section 15, Computer Model Development, Use, and Validation

3.5 Graded Approach

A. For Tier 1 contracts or projects the Corporate QA Program is applied using a graded approach. The graded approach provides a process of ensuring that the levels of analyses, documentation, and actions used to comply with requirements are commensurate with the level of associated risk. The QAP provides for a graded approach taking into consideration the following:

1. The relative importance to safety, safeguards, and security.

2. The magnitude of any hazard involved.

3. The life cycle stage of a facility or item.

4. The programmatic mission of a facility.

5. The particular characteristics of a facility or item.

6. The relative importance to radiological and nonradiological hazards.

7. Any other relevant factors.





B. The graded approach does not allow for a requirement identified in this QAP to be waived, but rather allows for varying levels of managerial controls to be applied to provide adequate assurance, commensurate with risk, that the requirement is being met. As such, for all BGS work activities the expectation is that all areas of the QAP are addressed. However, the methods used to implement the requirements can vary commensurate with the risk of the activity.

C. BGS defines work scope as a segmented list of activities that are clearly defined, bounded, and controllable. Work scope can encompass a specific set of activities at the contract level, individual contract tasks, specific projects, or unique sets of activities. Examples of potential segmented work scope include: Help Desk functions; software acquisition, development, maintenance and retirement; technical and engineering consulting services; engineering design, procurement activities, etc.

D. BGS applies a graded approach to projects or individual contract tasks (work scope) by establishing three Quality Levels (QL) as follows.

• Quality Level #1 (QL-1): BGS high risk work scope that is important to the safety and health whose preventive or mitigative function is necessary to limit radioactive hazardous material exposure to the public, as determined from safety analyses. Work scope activities that have a high-risk level where quality controls are needed to verify critical attributes and provide a high level of assurance that expectations associated with additionally quality controls are being met. QL-1 work scope requires implementation of all applicable requirements of this QAP (see Section 3.2 for a description of applicable QA elements the QAP addresses).

• Quality Level #2 (QL-2): BGS medium to high risk work scope that is important to the safety and health of the public, the workers, or the environment and BGS’ mission success. Work scope activities that have a moderate to high risk level where quality controls are needed to verify critical attributes and provide a moderate level of assurance that expectations associated with additional quality controls are being met. QL-2 work scope requires implementation of all applicable requirements of this QAP (see Section 3.2 for a description of applicable QA elements the QAP addresses).

• Quality Level #3 (QL-3): BGS work scope that is important to safety and health of the public, the workers, or the environment and BGS’ mission success. Work scope activities that have a low to moderate risk level where quality controls are needed to verify critical attributes.





• Quality Level #4 (QL-4): BGS work scope that has minimal, if any, impact on safety and health of the public, the workers, or the environment and BGS’ mission success. Work scope activities that have a low risk where no additional quality controls beyond general acceptance quality practices are utilized to ensure item or service requirements are met.

E. For QL-1, -2, -3, and -4 work scopes, the varying levels of managerial quality controls are established and detailed in BGS individual procedures.

F. Where the graded approach (assignment of QL) is utilized by BGS on work scope, a quality level determination risk analysis is performed to determine the QL as detailed in BGS-QA-03, Graded Approach.

3.6 Organization Structure and Responsibility

A. BGS defines the responsibilities for establishment and implementation of the QA Program through this QAP and flow-down procedures. BGS’ organizational structure, functional responsibilities, levels of authority, and lines of communications for activities affecting quality are documented. BGS is structured to focus on client activities while maintaining rigor in safety- and quality-related activities.

B. The President can contract QA subject matter expert (SME) support to assist with QA functions as needed to support project specific requirements.

C. Persons verifying activities affecting quality have sufficient authority, direct access to responsible level of management, organizational freedom, and access to work to perform assigned QA function(s), including sufficient independence from cost and schedule.

D. The responsibilities below are presented at an upper level. Additional details on responsibilities are presented in individual procedures and plans.

1. President

a. BGS is headed by the President (see Attachment 2, Organizational Chart) who provides overall direction and accountability for BGS performance, including quality. The President is a Senior Manager and is head of Line Management and FMs.

b. The President is responsible for ensuring organizational structure and responsibilities are such that senior management establishes overall expectations for effective implementation of the QA Program and is responsible for obtaining the desired end result.





c. The President is responsible for ensuring quality is achieved and maintained by those assigned responsibility for performing work and for ensuring quality achievement is verified by those not directly responsible for the work.

d. The President is responsible for providing strategic direction for BGS and approving corporate policies and commitments. The President provides leadership and commitment to quality achievement and improvement within a framework of public, worker, and environmental safety, and ensures adequate planning, scheduling, and financial resources are provided for work to meet policies and commitments successfully.

e. The President is responsible to the client for ensuring contractual quality requirements are met.

f. The President provides line management accountability for all aspects of BGS performance, retains responsibility for the scope and implementation of the QAP, and promotes effective achievement of performance objectives throughout the organization.

g. The President is responsible for ensuring those verifying activities affecting quality have sufficient authority, direct access to responsible levels of management, organizational freedom, and access to work to perform the quality function, including sufficient independence from cost and schedule when opposed to safety and quality function considerations.

h. The President identifies and assigns functional areas of responsibility within the BGS organization.

2. Senior Vice President

a. The Senior Vice President performs all the duties of the President as delegated to him. This delegation may be verbal.

b. The Senior Vice President may serve as the Quality Assurance Manager on an interim basis.

3. Functional Manager (FM)

a. BGS FMs have authority and responsibility over an organization unit, such as a department within BGS that carries out company functions (Functional Areas) such as Accounting, Contract Management, Engineering, Human Resources, and Quality Assurance.





b. FMs are responsible for work execution and ensuring quality is achieved and maintained by those assigned within an organizational unit.

c. FMs are responsible for requiring and cultivating achievement and improvement of quality within their organizations and within BGS.

d. The Information Management Functional Manager is responsible for establishing and maintaining the baseline software list (i.e., software inventory) and configuration status accounting information.

4. Project Manager (PM)

a. PMs report to either the BGS President or Senior Vice President.

b. PMs manage staff and activities providing services and are responsible for project performance and on-time delivery of quality products.

c. PMs are responsible for work execution and ensuring quality is achieved and maintained by those assigned responsibility for performing work.

d. PMs are responsible for requiring and cultivating achievement and improvement of quality within BGS.

e. PMs are responsible to clients for ensuring quality requirements are met.

f. PMs work with senior management and FMs for the development and execution of work plans and management of applicable staff.

g. PMs are responsible for ensuring project staff personnel are trained and/or qualified and empowered to perform their duties including implementation of applicable elements of this QAP.

5. Chief Engineer

a. The Chief Engineer reports directly to the President and ensures that engineering design processes and activities are performed to the requirements of this plan and associated implementing procedures.





6. Quality Assurance (QA) Manager

a. The QA Manager reports directly to the President and ensures quality achievement is verified by those not directly responsible for performing the work. The QA Manager provides oversight for all BGS quality-related activities.

b. The QA Manager is responsible for development and maintenance of this QAP. The QA Manager provides guidance and assistance to the President, Senior Vice President, FMs, PMs, and QA personnel deployed to BGS off-site projects.

c. The QA Manager ensures the QAP complies with BGS’ quality commitments. The QA Manager’s verification functions include:

• Identifying quality problems.

• Initiating, recommending, and/or providing solutions to quality problems.

• Verifying implementation of solutions.

• Assuring further processing, delivery, installation, and/or use of an item or service is controlled until proper disposition of a nonconformance, deficiency, or unsatisfactory condition has occurred.

d. The QA Manager is responsible for preparing, reviewing, and approving all QA procedures to ensure compliance with requirements.

e. The QA Manager is responsible for establishing and maintaining the BGS overall assessment schedule (internal and external).

f. The QA Manager provides interpretation of QA Program requirements and overview of implementation of this QAP by:

• Ensuring compliance with the QA Program through reviews, surveillances, and assessment/audits.

• Identifying, recommending, and/or providing solutions to quality problems through the FM or PM with responsibility for the areas affected and verifying implementation of solutions.

• Implementing continuous improvement for the QAP.





• Ensuring sub-tier supplier QA Programs meet applicable requirements imposed by governing contracts or the BGS QA Program.

7. Records Manager

a. The Records Manager reports directly to the President and is responsible for establishing records management compliance with DOE O 243.1B, Records Management Program.

b. The Records Manager may also serve as the Document Control Administrator (DCA).

8. Document Control Administrator (DCA)

a. The DCA reports to the Records Manager and is responsible for receiving, verifying, protecting, storing, controlling, recording, and maintaining records submitted for inclusion in the BGS Records Management System.

b. The DCA maintains the QA records on behalf of the Records Manager.

9. Contracts Manager (Administrator)

a. The Contracts Manager reports directly to the BGS President. The Contracts Manager is responsible for identifying requirements and deliverables in contracts BGS enters into with clients (including the DOE). The Contracts Manager supports development of contract management plans as requested by the BGS President. The Contracts Manager supports the BGS President in the following:

• Developing subcontracts and consulting agreements.

• Assuring that BGS client (Prime Contract) requirements are flowed into subcontracts and consulting agreements.

• Assuring BGS requirements or expectations are incorporated into subcontracts and consulting agreements.

10. Training Manager (TM)

a. The TM reports directly to the BGS President. The TM is responsible for coordinating the BGS Training and Qualification Program.

b. The TM interfaces with BGS FMs and PMs to identify training needs.





c. The TM ensures that the training notification, tracking, and records program requirements are implemented.

11. Cyber Security Manager

a. The Cyber Security Manager reports directly to the BGS President. The Cyber Security Manager is responsible for ensuring BGS’ internal computer network (general office systems) is safe from cyber-attacks. These responsibilities include securing BGS’ networks by installing or overseeing the installation of the software programs needed to protect the computer network.

b. The Cyber Security Manager is responsible for staying current on the latest issues affecting the industry.

c. The Cyber Security Manager consults with BGS client cyber security personnel related to client-owned software products not hosted on the BGS internal computer network.

12. Lead Auditor2

a. Lead Auditors are responsible for organizing and directing audits, reporting audit findings, and evaluating corrective actions.

13. Auditor1

a. Auditors are participants in an audit. The QA Manager ensures Auditors have, or are given, appropriate training or orientation to develop their competence for performing audits.

14. Subject Matter Expert1 (SME)

a. The BGS management establishes the qualifications and requirements for use of an SME to accomplish assessments, audits, surveillances, or other specific support.

15. BGS Staff Personnel

a. BGS personnel (employees and associates) are responsible for achieving quality in performing their work assignments in accordance with client requirements and approved controlling procedures or other documents, identifying and participating in

2 These positions can be subcontracted by BGS. The QA Manager will ensure in procurement documents that the Lead Auditor, Auditor, and SME roles, responsibilities, and qualification/certification are defined per the scope of support services to be provided.





quality improvement opportunities, and maintaining their qualifications and competency.

16. QA Representative

a. QA Representatives report to the QA Manager and are responsible for verification of the implementation of the QA Program, inspection activities, and other duties as assigned. When QA implementing procedures and other BGS procedures or work instructions refer to a QA Representative, the QA Manager may perform those activities.

3.7 Delegation of Work

A. The QA Manager is responsible for establishing, maintaining, and verifying execution of the BGS QAP. The QA Manager delegates any or all of this work to other qualified QA personnel, but shall retain overall responsibility. Delegation other than BGS can be to a qualified third party, the client, or the client’s delegate.

B. The QA Manager is responsible for specifying which requirements (both BGS and Client), or portions thereof, apply and appropriately relating them to BGS suppliers through procurement documents. The QA Manager ensures supplier(s) working as staff augmentation, upon which BGS invokes the standard(s) or portions thereof in this QAP, comply with the specified requirements. However, BGS retains overall responsibility for the QA Program. The QA Manager ensures suppliers working to the supplier's QA Program comply with specified requirements through routine oversight.

3.8 Interface Control

A. Organizational interfaces are identified, communicated, and controlled through the applicable lower-tiered procedure(s) for effective work integration. Interfaces are identified as:

1. Between organizations within BGS.

2. Between BGS and its client(s).

3. Among other organizations (e.g., suppliers) with related responsibilities.

B. External interfaces between BGS and the client, and the internal interfaces among organizations, including changes, are documented, as appropriate. Interface responsibilities are defined and documented. BGS may develop a PQAP that identifies, communicates and tracks external interfaces.

C. Interface controls include the establishment of procedures for the identification, review, approval, release, distribution, and revision of





documents crossing organizational boundaries on an as needed project basis.

3.9 Stop Work Authority Policy

BGS Stop Work authority extends to all BGS personnel (employees and associates) to prevent any work, activity, or process that jeopardizes personnel safety and health, quality, or has the potential to cause significant environmental impact. Stop Work authority is one of the mechanisms used to ensure planning or scheduling considerations do not degrade safety, quality, or environmental performance. After a work stoppage of BGS managed work due to safety, quality, or environmental concerns, appropriate reviews, critiques, and/or assessments are planned, performed, and documented. Prior to restart of BGS managed work, BGS verifies conditions warranting the work stoppage are understood and were resolved and necessary remedial/corrective/preventive actions were completed. Responsibilities for work stoppage, resolution, and independently verifying corrective actions are identified and documented in the applicable lower-tiered procedure(s).

3.10 Management Reviews

Management reviews are conducted at planned intervals to ensure the continuing suitability, adequacy, and effectiveness of program resources. Management reviews include, but are not limited to, assessing opportunities for improvement in the quality policy and quality objectives. Management reviews follow a structured format for inputs and outputs and results are documented. Management review can be documented per BGS-QA-26, Surveillances.

3.11 Price-Anderson Amendment Act

A. The purpose of PAAA and associated reporting requirement is to assist in promoting and protecting the radiological health and safety of the public and workers at Department of Energy (DOE) facilities by:

1. Ensuring compliance by DOE contractors with applicable DOE Nuclear Safety Requirements.

2. Providing positive incentives for a DOE contractor’s:

a. Timely self-identification of nuclear safety deficiencies,

b. Prompt and complete reporting of such deficiencies to DOE,

c. Casual analysis of nuclear safety deficiencies,

d. Prompt correction of nuclear safety deficiencies in a manner which precludes recurrence, and





e. Identifications of modifications in practices or facilities that can improve public and worker radiological health and safety.

3. Deterring future violations of DOE requirements by a DOE Contractor.

4. Encouraging the continuous overall improvement of operations at DOE nuclear facilities.

B. Project activities that have potential to result in an exposure of an individual to radiation or radioactive materials are subject to the Price-Anderson Amendments Act, Section 234A of the AEA of 1954, as amended, and DOE's implementing regulations at 10 CFR Part 820, Procedural Rules for DOE Nuclear Activities.

C. BGS personnel as detailed in BGS-QA-16, Corrective Action, shall report to the Quality Assurance Manager those issues which may result in noncompliances requiring reporting in accordance with client’s Radiological Protection Plan and this QAP. Verbal notification of noncompliances shall be provided immediately upon discovery, followed by timely written notification as detailed within BGS-QA-16.

D. The procurement process includes a determination of the applicability of project specific quality and PAAA requirements to subcontractors, suppliers and their subtier suppliers. When applicable, procurement documents and contracts for items and services include a clause(s) informing the supplier that they are subject to these requirements. This compliance is clearly indicated in applicable contracts and procurement documents.

4. PERSONNEL TRAINING AND QUALIFICATION

The BGS QA Program provides for indoctrination, training, and qualification, as necessary, of personnel performing or managing activities affecting quality to ensure suitable proficiency is achieved and maintained.


A. The success of any organization requires members of the organization to be competent in the work they perform. Initial and continuing training is provided to employees to develop new skills, maintain or improve job performance, and enhance existing skills. Managers are responsible for ensuring personnel are fully qualified for their positions. Training identified by the FMs or PMs is made available to improve knowledge or skills specific to the job and/or organization. BGS management expectations associated with Personnel Training and Qualification include the following:

1. Qualifications for specific job categories are based on requirements established by the organization’s personnel management, DOE directives, other requirement documents, or management.





Management reviews the positions within their organization to determine:

a. If critical and unique job functions or tasks require highly technical, specialized skills.

b. Whether competency is demonstrated before performance or within a specified timeframe after entering the position.

c. Whether a specialized certification is required.

d. Whether a practical, physical, and/or written examination process can be established for qualification requirements that provide evidence of employee proficiency.

B. Employee-specific training needs are documented and updated as required to ensure the maintenance of competence required by the position.

C. These management expectations are implemented via BGS procedure BGS-TR-01, Qualification and Training.

4.2 Indoctrination and Training

A. Indoctrination and training are commensurate with the scope, complexity, activity importance, and BGS staff education, experience, and proficiency. Staff personnel performing or managing activities affecting quality receive indoctrination in their job responsibilities and authority including general criteria, technical objectives, requirements of this QAP and BGS procedures, applicable codes and standards, and regulatory requirements/commitments.

B. Indoctrination and training implementation records take the form of attendance sheets, training logs, or BGS staff training records.

C. For personnel performing or managing activities affecting quality, the need for formal training is determined. PMs or FMs designate activities requiring qualification of personnel and minimum training requirements. PMs or FMs ensure that personnel meeting the requirements are permitted to perform activities.





D. Training is provided, if needed, to achieve initial proficiency, maintain proficiency, and adapt to changes in technology, methods, or job responsibilities. On-the-job training shall be used if direct hands-on applications or experience is needed to achieve and maintain proficiency.

This on-the-job training documentation shall be attached to the BGS Qualification Verification Form, BGS-TRF-01.2. All training and relating documentation shall be definded in sufficient detail for a knowledge prsonnel to follow through task completions.

4.3 Qualification

A. Certain positions, whether BGS employees or subcontract staff, require specific qualifications to perform their duties. These positions include: QA Manager, Software QA SMEs, Training Manager, DCA, Auditors, Audit/Assessment SMEs, Lead Auditors, Inspection and test, Engineers and Technical Specialists, and Suspect/Counterfeit Items (S/CI) prevention personnel, etc. Written procedures delineate the specific activities those personnel are qualified to perform and the criteria used to qualify personnel in each activity. Additionally, as applicable, BGS identifies special physical requirements or restrictions required to perform these activities.

B. When subcontractors perform duties requiring specific qualifications, evidence of these qualifications will be provided by the subcontractor and maintained by BGS.

C. The QA Manager has demonstrated experience managing at the professional level and demonstrated experience in a nuclear quality-related function. Professional certification such as Certified Quality Auditor, Manager of Quality/Organizational Excellence, or Quality Engineer is preferred and encouraged but not required.

4.4 Training and Qualification Records

A. Appropriate indoctrination training records are maintained by BGS for BGS employees and subcontract staff in the form of (1) attendance sheets, (2) training logs/plans, or (3) personnel training records.

B. Appropriate training records are maintained by BGS for BGS employees and subcontract staff requiring certification in the form of (1) attendance sheets, (2) training logs/plans, (3) personnel training records, (4) performance checklists and/or written exams, or (5) other suitable evidence that the required qualifications have been accomplished.

C. Records, administration and maintenance of qualification, and requalification for noted activities in this section are established in implementing procedures.





4.5 Training and Qualification of Auditors

A. The Lead Auditor organizes and directs audits, reports audit findings, and evaluates corrective action. An individual shall meet the requirements of paragraphs B through I of this section prior to being designated a Lead Auditor.

B. The prospective Lead Auditor shall be capable of communicating effectively, both in writing and orally. These skills shall be attested to in writing by the Lead Auditor’s employer.

C. Prospective Lead Auditors shall receive training to the extent necessary to assure auditing competence including:

1. Knowledge and understanding of NQA-1 and other nuclear-related codes, standards, regulations, and regulatory guides, as applicable.

2. General structure of quality assurance programs as a whole and applicable elements as defined in NQA-1.

3. Auditing techniques of examining, questioning, evaluating, and reporting; methods of identifying and following up on corrective action items; and closing out audit findings.

4. Planning audits of activities affecting quality.

5. On-the-job training to include applicable elements of the audit program.

D. Prospective Lead Auditors shall participate in a minimum of five quality assurance audits within a period of time not to exceed 3 years prior to the date of qualification, one audit of which shall be a nuclear quality assurance audit within the year prior to qualification. Participation in independent assessments including team assessment activities such as operations readiness reviews and regulatory inspections/surveys may be used to satisfy up to four of the five required quality assurance audits, provided that the activities can demonstrate the following:

1. Independence from the functional areas being assessed.

2. Planning that establishes the scope of the activities and associated evaluation criteria.

3. Performance by technically qualified and experienced personnel.

4. Results that are documented and reported to management.

5. Appropriate corrective action initiated and tracked to resolution.





E. Such participation shall be subject to review and acceptance by the organization responsible for quality assurance audits and/or the certifying authority prior to their use for qualification.

F. Prospective Lead Auditors shall pass an examination that shall evaluate comprehension of and ability to apply the body of knowledge identified above. The examination may be oral, written, practical, or any combination thereof.

G. Lead Auditors shall maintain their proficiency through one or more of the following:

1. Regular and active participation in the audit process.

2. Review and study of codes, standards, procedures, instructions, and other documents related to quality assurance program and program auditing.

3. Participation in training program(s).

H. Based on annual assessment, management may extend the qualification, require retraining, or require requalification.

I. Lead Auditors who fail to maintain their proficiency for a period of 2 years or more shall require requalification. Requalification shall include retraining in accordance with the requirements of paragraph C of this section, reexamination in accordance with paragraph F of this section, and participation as an Auditor in at least one nuclear quality assurance audit.

J. Auditors are participants in an audit. Auditors shall have, or be given, appropriate training or orientation to develop their competence for performing audits. Competence of personnel for performance of the various auditing functions shall be developed by one or more of the following methods:

1. Orientation to provide a working knowledge and understanding of NQA-1 and the auditing organization’s procedures for implementing audits and reporting results.

2. General and specialized training in audit performance where the general training shall include fundamentals, objectives, characteristics, organization, performance, and results of quality auditing and the specialized training shall include methods of examining, questioning, evaluating, and documenting specific audit items and methods of closing out audit findings.

3. On-the-job training, guidance, and counseling under the direct supervision of a Lead Auditor. Such training shall include planning,





performing, reporting, and follow-up action involved in conducting audits.

K. The BGS QA Manager and/or the Lead Auditor shall establish the qualifications and requirements for use of technical specialists to accomplish the auditing of QA programs.

5. QUALITY IMPROVEMENT

The BGS process for quality improvement incorporates methodologies to promote the identification of candidate processes for improvement. Senior management, FMs, and PMs assess their processes and are provided access to various operational experience results (e.g., event reports, lessons learned, best management practices information) as resources from which they identify candidate areas for improvement associated with activities under their purview.

Quality improvement encompasses not only detection, correction, and continual improvement efforts, but problem prevention or preventive actions as well. Preventive actions include the use of procurement reviews, work control processes, and the conduct of management reviews and assessments to identify problems before they become significant.

BGS provides performance monitoring to promote and effectively achieve quality improvement initiatives. The monitoring process provides the appropriate means for the identification, cause and corrective action determination, and reporting of issues that result from defects, non-compliances, or inefficient practices.

BGS provides quality improvement activities and processes that support the ISMS philosophy. Those activities interface with QA requirements intended to provide assurance that BGS’ performance, potential risks, and information garnered from both event-related and assessment-related results are managed effectively.


A. In order for quality improvement to occur, it is necessary to have systems that identify problems. Problem identification can occur as a result of self-assessments, independent or external assessments, inspections, audits, benchmarking, failure to achieve performance goals or accomplish improvement plans, or as a result of the occurrence of an event. Problem identification can also result from unfulfilled expectations of clients served by the organization. In most cases, problems are associated with deviations, inconsistencies with a requirement, or failure to meet client or management expectations. The insights and results provided by the contractor assurance system should be leveraged to the extent possible to facilitate continuous quality improvement. BGS management expectations associated with quality improvement include the following.

1. Management sets performance goals and standards.





2. Management establishes metrics that monitor project/program performance to identify QA processes needing improvement.

3. Corrective actions are developed and implemented for problems/findings related to item characteristics, products, process implementation, or services.

4. Corrective Action Programs utilize and are consistent with:

a. DOE O 226.1B, Implementation of Department of Energy Oversight Policy.

b. DOE O 227.1A, Independent Oversight Program.

c. DOE G 414.1-2B, Quality Assurance Program Guide.

5. A process to determine the significance of identified problems/findings is developed.

6. In the case of significant conditions adverse to quality, causes of problems are identified, and prevention of recurrence is included as a part of corrective action planning.

7. Management identifies the causes of problems and takes corrective actions to address the problems. Formal root cause analysis is considered based on the complexity of the identified significant issue. Root causes when performed are identified and documented using an authoritative methodology for root cause identification and are performed by root cause analysis-trained personnel. Reference DOE O 232.2, Occurrence Reporting and Processing of Operations Information.

8. An Extent of Condition determination is considered for significant conditions adverse to quality (SCAQ).

9. In the case of SCAQ, proposed corrective actions are evaluated to ensure they will effectively address the underlying QA performance issues.

10. Completed corrective actions are independently verified for implementation and the verification documented to indicate closure.

B. These management expectations are implemented via BGS procedures, including:

1. BGS-MG-01, Customer Satisfaction Assessments

2. BGS-MG-02, Continuous Improvements





3. BGS-QA-15, Nonconformances

4. BGS-QA-16, Corrective Action

5.2 Non-Conforming Items and Services Control

BGS ensures that items or services not conforming to specified requirements are controlled to prevent inadvertent installation or use. Controls for nonconforming items provide for the identification, documentation, evaluation, segregation when practical, and disposition, and for notification to affected organization(s). The following processes that BGS employs once a nonconformance item or service is identified is defined in BGS-QA-15, Nonconformances, and BGS-QA-16, Corrective Action. An overview of the process is provided below.

A. Non-Conforming Items and Services Control

1. Items or services not conforming to specified requirements are controlled to prevent inadvertent installation or use. Controls provide for identification, documentation, evaluation, segregation (when practical), and disposition of nonconforming items and services, and for notification to affected organization(s).

B. Identification

1. Nonconforming items are identified by legible marking, tagging, or other methods not detrimental to the item, on the item, container, or package containing the item.

2. Nonconforming services are identified using the Corrective Action Report process which identifies interim and corrective actions to address and correct the nonconforming services.

C. Segregation

1. Nonconforming items are segregated, when practical, by placing them in a clearly identified and designated hold area until proper disposition is identified.

2. When segregation is impractical or impossible due to physical conditions such as size, weight, or access limitations, other precautions are employed to preclude inadvertent use of a nonconforming item.





D. Disposition

1. Nonconforming items and services are evaluated, and recommended dispositions are proposed. Further processing, delivery, installation, or use of a nonconforming item is controlled pending the evaluation and an approved disposition by authorized personnel.

2. The responsibility and authority for evaluation and disposition of nonconforming items and the responsibility for control of further processing, delivery, installation, or use of nonconforming items and services is defined in procedure BGS-QA-15, Nonconformances.

3. Personnel performing evaluations determining dispositions are required to have demonstrated competence in the specific area they are evaluating, have an adequate understanding of requirements, and have access to pertinent background information.

4. A disposition, such as use-as-is, reject, repair, or rework of nonconforming items is made and documented per BGS-QA-15, Nonconformances. Technical justification for the acceptability of a nonconforming item with a repair or use-as-is disposition shall be documented. Nonconformance to design requirements with a repair or use-as-is disposition shall be subject to design control measures commensurate with those applied to the original design. Required as-built or as-delivered records shall reflect the use-as-is or repair condition.

5. Reworked items shall be reexamined according to applicable procedures and with the original acceptance criteria. Repaired items shall be reexamined according to applicable procedures with the original acceptance criteria unless the disposition has established alternate acceptance criteria.

5.3 Corrective Action

A. Corrective actions are initiated when conditions adverse to quality (CAQ) affect safety, health, the environment, or the reliability of BGS’ processes or activities. CAQs are those that exceed predetermined acceptability limits, deviate from required methods, fail to meet performance requirements or data quality objectives, or fail to meet client or regulatory requirements and expectations. Results of internal and external audits, assessments, reviews, noncomformance reports, etc., identify conditions that require corrective action. SCAQ is a condition that, if uncorrected, could have a serious impact on public or personnel health and safety, waste acceptance, the environment, facility operations, or the effective implementation of the BGS’ QA Program.





B. BGS-QA-16, Corrective Action, procedure establishes issue priority levels (P1-P3) which assists in determining the significance of identified issues, the expectation of actions to identify, and prepare corrective actions addressing the reported SCAQ/CAQ. Table 1 summarizes the required actions based on the BGS’ Issue Priority Level.

Table 1 – BGS Issue Priority Levels

Issue Priority Level

CAQ or SCAQ

Causal Analysis

Corrective Action

Effectiveness Review

Extent of Condition

Independent Review

P1 SCAQ Root Cause Yes Yes Yes Yes P2 CAQ Apparent

Cause Analysis (Case-by-Case Basis)

Yes Case-by-Case Basis

Case-by- Case Basis

Yes

P3 Observation No Yes No No No

C. BGS-QA-16, Corrective Action, ensures:

1. Establishment of a BGS Issue Priority Level (that assists in determining the expectations of actions to identify and prepare corrective actions addressing the reported finding).

2. CAQs are promptly identified and corrected as soon as practical.

3. The cause of the condition is determined, and corrective action is taken to preclude a recurrence for an SCAQ and/or CAQ.

4. The identification, cause, and corrective action for SCAQs and CAQs are documented and reported to appropriate levels of management.

5. Follow up action is taken to verify implementation of corrective actions resulting from a SCAQ and/or CAQ.

6. The root cause of SCAQs conditions are determined, corrected to prevent recurrence, properly documented, and reported in a timely manner.

7. Verification of corrective actions are performed by someone independent of the organization who developed and implemented the corrective action(s).

8. All corrective actions for all CAQs and SCAQs are verified.

D. BGS establishes performance goals and standards including metrics that monitor project/program performance (BGS-MG-02, Continuous Improvements) to help in the detection, communication, and prevention quality programs.





E. BGS encourages employees to identify lessons learned, offer suggestions, and propose solutions to eliminate ineffective systems and to improve service and performance. BGS fosters a “no-fault” policy wherein all employees are encouraged and expected to identify and report issues to management for evaluation, causal analysis, and correction.

6. DOCUMENTS AND RECORDS

The BGS document control system ensures documents are prepared, reviewed, approved, distributed, and used by personnel at their work locations. Documents specifying quality requirements or prescribing quality affecting activities are controlled in accordance with this section. Document control under the BGS Quality Assurance Program, includes procedures, design requirements documents, design basis documents, engineering specifications, instructions, drawings, calculations, procurement documents, computer codes, technical reports, and data.

The document control system identifies documents to be controlled and the specified distribution. Controls include identification of persons responsible for the preparation, review, approval, distribution, and revision of controlled documents. Controlled documents are prepared, reviewed, approved, issued, used, and revised to prescribe processes, specify requirements, and establish design. The document process specifies effectivity, timely release, distribution, and implementation. Controlled documents are made available on-line to BGS employees and subcontractors through appropriate implementing controls. Document control, distribution and use of documents, including changes and editorial corrections to documents, is implemented via BGS procedure BGS-AD-01, Document Preparation and Control, BGS-RM-01, Quality Assurance Records; BGS-RM-02, Office Records; and BGS-IM-03, Backup and Recovery Standards and BGS-EN-01, Engineering and Design Control.


A. BGS prepares, reviews, approves, issues, revises, controls, and uses documents to prescribe processes, specify requirements, or establish design. Documents that establish policy, prescribe work, or specify requirements are prepared, reviewed, approved, issued, used, and revised in a controlled manner using appropriate technical standards.

B. Activities affecting quality and services shall be prescribed by and performed in accordance with documented instructions, procedures or drawings that include or reference appropriate quantitative or qualitative acceptance criteria for determining that prescribed activities have been satisfactorily accomplished.

C. Procedures establish requirements or define how work is to be performed. New or revised requirements are analyzed to determine the impact on implementing procedures and/or contracts.





D. Policies, procedures, and plans are maintained current and deployed in a manner that makes them readily available to users.

E. Procedures that identify QA records are created and maintained in the implementation of the procedure.

F. Documents that describe the methods of implementing the requirements of this QAP are identified by BGS and maintained current. The list of procedures is noted in the attached QIP.

G. These management expectations are implemented via BGS administrative procedure BGS-AD-01, Document Preparation and Control.

6.2 Quality Assurance Records

A. General

1. QA records furnish documentary evidence that items or activities meet specified quality requirements. QA records are identified, generated, authenticated, and maintained, and their final disposition specified. Record control requirements and responsibilities for these activities are documented.

B. Generation of Records

1. Records shall be legible and traceable to associated items and/or activities and shall accurately reflect work accomplished or information required. Records to be generated, supplied, or maintained are specified in applicable documents, such as procurement documents, and procedures.

C. Authentication of Records

1. Documents are considered valid records only if stamped, initialed, or signed and dated by authorized personnel or otherwise authenticated. Corrections to records are reviewed and approved by a responsible individual from the originating or authorized organization.

2. Electronic documents are authenticated with comparable information as stated above, as appropriate with identification on the media, or with authentication information contained within or linked to the documents themselves.

D. Classification

1. BGS classifies all QA records generated as “lifetime” and they are maintained by BGS according to the requirements of this QAP and applicable client or regulatory requirements.





E. Lifetime Records

1. Lifetime records are those meeting one or more of the following criteria:

a. Those of significant value in demonstrating capability for safe operation.

b. Those of significant value in maintaining, reworking, repairing, replacing, or modifying an item.

c. Those of significant value in determining the cause of an accident or malfunction of an item.

d. Those providing required baseline data for in-service inspections.

2. Lifetime records are maintained by BGS for the length of the project (contract) and are submitted to the client at the completion of the project or as directed by the client via purchasing documents/task orders.

3. BGS creates and maintains vital records (i.e., rights and interest records) that are needed to protect BGS’ essential legal and financial functions and activities, and the legal and financial rights of individuals directly affected by BGS. BGS maintains vital records per DOE O 243.2, Vital Records.

F. Nonpermanent records are those required to show evidence an activity was performed according to applicable requirements but otherwise do not meet the criteria for lifetime records. BGS does not currently cateogorize QA records as “nonpermanent”. BGS may categorize and maintain nonpermanent records at a later date.

G. Receipt Control of Records

1. The BGS DCA is responsible for receipt of records and for organizing and implementing receipt controls for permanent and temporary storage. Receipt controls provide a method for identifying and inspecting incoming records, indexing the incoming records for future retrievability, and placing records in storage.

H. Storage

1. BGS records are stored at predetermined locations (e.g., facilities, containers, or a combination thereof) constructed and maintained in a manner minimizing the risk of loss, damage, or destruction from any of the following:





a. Natural disasters such as winds, floods, or fires.

b. Environmental conditions such as high and low temperatures and humidity.

c. Insect, mold, or rodent infestation.

d. Dust or airborne particles.

2. Activities detrimental to records are prohibited in the storage area. Access to processing and storage areas for records is limited to authorized personnel. Provisions are made to prevent damage from harmful conditions (e.g., excessive light, stacking, electromagnetic fields, temperature, and humidity) as applicable to the specific media used for record storage.

3. Records are stored according to either a single or dual storage methodology. Single storage consists of a storage facility, vault, room, or container(s) with a minimum two-hour fire rating the design and construction of which are reviewed for adequacy by a person competent in fire protection or that contains a certification or rating from an accredited organization. Where used, dual facilities, containers, or a combination thereof are at locations sufficiently remote from each other to eliminate the chance exposure to a simultaneous hazard.

4. When temporary storage of QA records is required, the storage facility or container provides a one-hour fire rating, unless dual storage requirements are utilized.

I. Retention

1. Record retention periods are specified and documented. Records are maintained for their required retention periods.

J. Maintenance of Records

1. Records are protected from damage or loss, and record controls provide for their retrieval within planned times based upon the record type or content. Provisions have been established ensuring no unacceptable degradation of electronic record media occurs during the established retention period.

2. The method(s) for control of record changes is documented.

3. Provisions have been established to ensure that when records are duplicated, substituted or restored (due to loss or damage of the





original QA record) or transferred to the same media or to different media for the purposes of maintenance or storage:

a. The duplication or transfer is appropriately authorized.

b. The record content, legibility, and retrievability are maintained.

4. Provisions are made to ensure QA records remain retrievable after hardware, software, or technology changes.

7. WORK PROCESSES

BGS activities and services affecting quality are prescribed by documented instructions, procedures, or drawings. These instructions, procedures, or drawings include or reference appropriate quantitative or qualitative acceptance criteria for determining whether prescribed activities have been satisfactorily accomplished. The activities are described to a level of detail commensurate with the complexity of the activity and the need to assure consistent and acceptable results. The need for, and level of detail in, written procedures or instructions is determined based upon complexity of the task, significance of the item or activity, work environment, and worker proficiency and capability (education, training, and experience).

BGS performs work in accordance with the documented instructions, procedures, drawings, or other appropriate means consistent with technical standards, administrative controls, and, where applicable, hazard controls adopted to meet regulatory or contract requirements.


A. Work performed by BGS employees focuses on completing the client project requirements through effective management. Procedures identified in the BGS QIP (Attachment 3) describe how work will be accomplished. BGS management expectations for work processes include the following:

1. Documents clearly establish the roles and responsibilities for employees.

2. Employees identify and assist in making changes that improve project processes and documents.

3. Safety and non-safety software have the appropriate controls in place as required by the DOE O 414.1D and NQA-1a-2008/2009.

B. These management expectations are implemented via BGS corporate procedures and BGS-SQ-02, Software Management (see Section 14 for additional details).





8. DESIGN CONTROL

BGS manages engineering and design activities to ensure designs are properly defined, controlled, and verified. Design inputs are specified on a timely basis and translated into design documents. Design interfaces are identified and controlled. Design adequacy is verified by individuals other than those who designed the item or computer program. Feedback and continuous improvement are used to aid in determination for the need of design changes. Design changes are governed by control measures commensurate with those applied to the original design.

The design control process is documented and implemented using approved procedures. Design documents incorporate or reference performance requirements and critical characteristics required for the function, reliability, interchangeability, life, and safety of systems, structures, and components (SSCs). Design activities, including changes, incorporate applicable requirements and design bases. The design control process provides the controls necessary to maintain the configuration of BGS’s clients’ facilities, documents, and products.

Design Control requirements and management expectations for computer software development and modification are included in Section 14 of this QAP and BGS-SQ-02, Software Management.


A. Designs are based on appropriate national standards and industry recognized engineering practices.

B. Applicable design bases are incorporated.

C. Design interfaces are identified and controlled.

D. Design reviews are implemented using individuals or groups other than those who performed the work.

E. Design work is verified before approval and implementation.

8.2 Design Input

Applicable design inputs, such as design bases, performance requirements, regulatory requirements, codes, and standards, are controlled as follows:

A. Design inputs are identified and documented, and selection is reviewed and approved, prior to the final design implementation.

B. Design inputs are specified and approved.

C. Design inputs provide the necessary details to permit design to be implemented in a manner that provides a consistent basis for making design





decisions, accomplishing design verification, and evaluating design changes.

D. Changes to design inputs receive the same level of review and approval as the original design input, and reasons for the changes are identified, approved, documented, and controlled.

E. Design inputs based on assumptions that require reverification are identified and controlled.

8.3 Design Process

The BGS design process is controlled as follows:

A. Design work is prescribed and documented to the level of detail to enable the design process to be implemented and permit verification that the design meets requirements.

B. Final design documents are adequate to support design, construction, and operation.

C. Designs provide a clear link between design inputs and design requirements, including production requirements and specifications.

D. Appropriate quality standards are identified and documented, and selection is reviewed and approved.

E. Design methods that apply sound engineering/scientific principles are selected and reviewed for suitability of application.

F. Calculations, modeling, and testing establish the design parameters and maintain the appropriate margins by taking into account uncertainties associated with the design envelope.

G. Materials, parts, equipment, and processes that are essential to the function of the item are selected and reviewed for suitability of application.

H. Applicable information derived from experience and documented in reports or other documentation is made available to design personnel.

I. Design drawings, specifications, or other design output documents are relatable to the design input by documentation in sufficient detail to permit design verification.

J. Design specifications are not more restrictive than essential for achieving required performance with appropriate margin.

K. Required inspections and tests, including appropriate acceptance criteria or reference to acceptance criteria, are specified.





L. The final design is relatable to the design input by documentation in sufficient detail to permit design verification, specify required inspections and tests, include or reference appropriate acceptance criteria, and identify assemblies and/or components that are part of the item being designed.

M. Design documents incorporate or reference performance requirements and critical characteristics required for the function, reliability, interchangeability, life, and safety of SSCs.

N. Identification of subassemblies, assemblies, or components is placed on final design documents that are part of the item being designed.

When BGS design contains a component of subassembly to be procured as a commercial grade item, the design output includes the identification of critical characteristics of the items to be verified for acceptance and the acceptance criteria for those characteristics.

8.4 Design Analysis

Design analyses are planned, controlled, and documented. Design analyses are prepared with sufficient detail such that a person technically qualified in the subject can review and verify the adequacy of the results without recourse to the originator.

Acceptability of computer programs used in design analysis is pre-verified and controlled. Computer programs utilized in design are verified to show that it produces correct solutions for the encoded mathematical model within defined limits for each parameter employed. The encoded mathematical model will be shown to produce a valid solution to the physical problem associated with the particular application. Preverified computer programs are controlled as specified in Section 14, Software Quality Assurance.

Design analyses documentation includes the following:

A. The objective of the analyses.

B. Design inputs and sources.

C. Results of literature searches or other applicable background data.

D. Identification of assumptions that are to be verified as the design proceeds.

E. Any computer calculation, including; identification of the computer type, computer program name, and revision, inputs, outputs, evidence of reference to computer program verification, and the bases (or reference thereto) supporting application of the computer program to the specific physical problem.

F. Result of the analysis.





G. Names of personnel performing the analysis.

H. Review and approval.

8.5 Design Verification

The following design control requirements are to be applied to verify adequacy of design:

A. Design verification is required for design output documents.

B. The particular design verification method used is documented by the responsible design organization.

C. Results of design verification are documented and include the identification of the verifier(s).

D. Verification is performed by competent individuals or groups other than those that performed the original design (may be from the same organization). If necessary, the verification may be performed by the originator's supervisor provided:

1. The supervisor did not specify a singular design approach or rule out certain design considerations and did not establish the design inputs used in the design.

2. The supervisor is the only individual in the organization competent to perform the verification.

Design verification is performed at appropriate times during the design process. Verification is performed before release for procurement, manufacture or construction, or release to another organization for use in other design work. In some cases, such as when insufficient data exist, it may be necessary to release unverified designs to other engineering organizations or disciplines to support schedule requirements. Unverified portions of the design are to be clearly identified and controlled. If the design is modified to resolve verification findings, the modified design shall be verified prior to release or use. In all cases, design verification is completed before relying on the system, structure, component, or computer program to perform its function.

The extent of design verification required is a function of the importance to safety, complexity of design, degree of standardization, state of the art, and similarity with previously proven designs.





Use of previously standardized or proven designs is controlled according to the following requirements:

A. The applicability of standardized or previously proven designs is to be verified with respect to meeting pertinent design inputs for each application.

B. Known problems affecting standard or previously proven designs and the effects on other features are to be considered.

C. The original design and associated verification measures are to be adequately documented and referenced in the records of subsequent application of the design.

Where changes to previously verified designs have been made, design verification is required for the changes, including:

A. Evaluation of the effects of those changes on the overall design.

B. Evaluation of the effects on any design analyses upon which the design is based that are affected by the change.

8.6 Design Verification Methods

Acceptable verification methods include, but are not limited to design reviews, alternate calculations and qualification testing.

A. Design reviews.

Design reviews are critical reviews to provide assurance that the final design is correct and satisfactory. The following items are to be addressed, as applicable, during the review:

1. Were the design inputs correctly selected and incorporated?

2. Were assumptions necessary to perform the design activity adequately described, reasonable, and where necessary, were the assumptions identified for subsequent reverification before the detailed design activities were to be completed?

3. Were the appropriate design methods and approved computer programs used?

4. Was the design output reasonable, compared with the applicable design inputs?

5. Were the necessary design inputs and verification requirements for interfacing organizations specified in the design documents or in supporting procedures and instructions?





6. Were suitable materials, parts, processes, and inspection and testing criteria specified?

B. Alternate Calculations

Alternate calculations use alternate methods to verify correctness of the original calculations or analyses. The appropriateness of assumptions, input data used, the computer program, its associated computer hardware and system software, or other calculation method used, are also to be reviewed.

C. Qualification Tests

If design adequacy is to be verified by qualification testing, the tests are to be identified, controlled, and documented as follows:

1. Testing demonstrates the adequacy of performance under conditions that simulate the most adverse design conditions. Operating modes and environmental conditions in which the item must perform satisfactorily are considered in determining the most adverse design conditions.

2. If the tests verify only specific design features, the other features of the design are verified by other means.

3. Scaling laws are established, verified, and documented when tests are being performed on models or mockups.

4. The results of model test work are subject to error analysis, where applicable, before using the results in final design work.

8.7 Design Change Control

Changes to design inputs, final designs, and field changes are justified and subject to design control measures commensurate with those applied to the original design. BGS-EN-08, Design Change Control incorporates the following:

A. Evaluation of effects of the changes on the overall design and on any analysis on which the design is based. The evaluations include facility configurations that occur during operation, maintenance, testing, surveillance, and inspection activities.





B. Changes to approved design are reviewed and approved by the same affected groups or organization that reviewed and approved the original design documents.

C. If personnel originally responsible for review and approval of the original design documents are no longer available, BGS will ensure personnel responsible for the review and approval of design changes have;

D. demonstrated competence in the specific design area of interest,

E. an adequate understanding of the requirements and intent of the original design.

F. Measures, where appropriate, are put in place to incorporate design changes into affected final design documents when changes are approved by other than BGS’ formal design review process (i.e., field change orders, design change notices, etc.)

G. When a significant design change is necessary because of an incorrect design, the design process and verification procedures are reviewed and modified, as necessary.

8.8 Configuration Management

BGS current work scope does not involve the management of a nuclear facility. Therefore, BGS QAP does not include procedures that detail the establishment and maintenance of facility configurations.

8.9 Interface Control

BGS design control interfaces are identified and procedurally controlled. Design information transmitted across interfaces (BGS to/from client(s), and within BGS) identifies the status of the design information or documents provided, and identifies incomplete items that require further evaluation, review, or approval. Where it is necessary to initially transmit design information orally or by other informal means, the transmittal is confirmed promptly by a controlled document. Interface controls include the assignment of responsibility and the establishment of implementing documents among interfacing design organizations for the review, approval, release, distribution, and revision of documents involving design interfaces.

8.10 Software Design Control

When BGS develops software in support of design (i.e.: Development of Programmable Logic Controls codes for a piece of equipment to be manufactured) computer programs are controlled as specified in Section 14, Software Quality Assurance.





8.11 Design Documentation and Records

In addition to final design documents, such as drawings and specifications, and revisions to those documents, quality record controls are applied to documentation that identifies the important steps in the design process, including sources of design inputs that support final designs.

9. PROCUREMENT


A. The management expectation related to Procurement is that work performed under any of its contracts is in conformance with contractual requirements and specifications. This expectation is regardless of whomever under the contractor performs the activities, i.e., BGS employees, subcontractors, vendors, or consultants.

B. As such, an effective integrated procurement process (including development of a clear statement of work planned for subcontracting by BGS and associated QA requirements, subcontractor evaluation and selection process, and subcontractor work performance monitoring) is a critical BGS responsibility.

C. The acquisition strategy is developed and maintained to ensure work is accomplished in compliance with applicable laws, acquisition regulations, state/federal regulations, and DOE orders and directives, and is responsive to the project or facility specifications and needs.

D. The QA requirements and subsequent oversight imposed upon procurements is consistent with the importance and/or complexity of the item or service being procured.

E. Procurement procedures to implement the management expectations are defined in BGS-PC-01, Procurement and Contracts; BGS-QA-07, Control of Items and Services; BGS-QA-08, Review and Approval of Supplier Documents; and BGS-QA-23, Supplier Qualification.

9.2 Procurement Documents

Procurement documents issued at all tiers of procurement include provision for the following, as applicable to the procurement activity:

A. Scope of Work – Procurement documents include a statement of the scope of work to be performed by the supplier. The scope of work includes the item or service to be purchased and the quantity to be purchased (e.g., number of items or hours of service, as applicable). The scope of work shall be clear, precise, and in sufficient detail to ensure adequate communication of what is to be performed.





B. Technical Requirements – The appropriate PM ensures technical requirements are specified in procurement documents. These requirements are specified, as appropriate, by reference to specific drawings, specifications, codes, standards, regulations, procedures, or instructions, including revisions describing the items or services to be furnished. The procurement documents also identify appropriate test, inspection, and acceptance criteria for determining acceptability of the item or service.

C. QA Program Requirements – QA program requirements are specified in procurement documents and are consistent with the importance and/or complexity of the item or service being procured. Procurement documents require the supplier to include QA Program requirements in sub-tier procurement documents. As applicable, standard QA contract language in BGS contracts is included in subcontracts. This section will:

1. Define BGS expectations for the suppliers to either follow BGS’ QAP or require suppliers to have a QA program consistent with the BGS QAP.

2. Include applicable QA requirements, design basis, test, inspection, acceptance criteria, and hold points for determining the acceptability and quality of the items or services being procured. These requirements shall be consistent with importance and/or complexity of the items or services being procured. In addition, the following standard QA clauses will be incorporated into this section as deemed applicable by the QA Manager:

a. “The supplier shall incorporate appropriate QA program requirements in sub-tier procurement documents.”

b. “The supplier shall notify BGS when significant changes to their QA Program are made.”

c. “Suppliers shall have a system in place to identify potential suspect/counterfeit items (S/CI) and ensure S/CI are not used.”

3. Right of Access – Procurement documents provide for access to supplier and sub-tier supplier facilities and records for surveillance, inspection, or audit by BGS or its designated representative, and others as authorized by the QA Manager. Subcontract oversight activities will be commensurate with the project or task assigned QL, complexity, significance, and cost of the supplies and services.

4. Documentation Requirements – Procurement documents identify documentation required to be submitted for information, review, or approval by the QA Manager. The QA Manager establishes the time of submittal. When the QA Manager requires the supplier to maintain





specific records, retention times, and disposition requirements are prescribed.

5. Nonconformance – Procurement documents specify BGS’ QA Program requirements for supplier nonconformance reporting for items dispositioned as use-as-is or repair to BGS for approval of the disposition.

6. Spare and Replacement Parts – BGS does not purchase quality-related spare or replacement parts.

9.3 Procurement Document Review

A. The QA organization performs documented reviews of procurement documents and changes thereto prior to award to confirm documents transmitted to prospective suppliers include appropriate provisions to assure items or services will meet specified requirements.

B. Technical or QA Program changes made as a result of bid evaluations or negotiations are incorporated into procurement documents prior to their issuance to supplier.

C. Procurement document reviews are performed by personnel who have access to pertinent information and who have an adequate understanding of the requirements and intent of the procurement documents.

9.4 Procurement Document Changes

Procurement document changes affecting technical or QA Program requirements are subject to the same level of control as the original documents. Control of procurement documents are further defined in BGS-PC-01, Procurement and Contracts, and BGS-QA-08, Review and Approval of Supplier Documents.

9.5 Control of Purchased Items and Services

A. Item and service procurements are controlled to ensure conformance with specified requirements. Such control provides for the following, as appropriate: source evaluation and selection, evaluation of objective evidence of quality furnished by the supplier, source inspection, audit, and examination of items or services upon delivery or completion as detailed in BGS-QA-23, Supplier Qualification.

B. Supplier Evaluation and Selection

1. Prior to award of contract, the QA Manager evaluates the supplier’s capability to provide items or services according to requirements of the procurement documents. Supplier evaluation, selection, and results are documented and include one or more of the following:





a. Supplier’s history of providing an identical or similar product performing satisfactorily in actual use. The supplier’s history shall reflect current capability.

b. Supplier’s current QA records supported by documented qualitative and quantitative information that can be objectively evaluated.

c. Supplier’s technical and quality capability as determined by a direct evaluation of the facilities, personnel, and implementation of the supplier’s QA program.

C. Bid Evaluation

1. If bids are solicited, bid evaluation includes determination of the supplier’s capability to meet technical and QA requirements. Prior to award of contract, the QA Manager resolves or obtains commitments to resolve unacceptable technical and QA conditions resulting from bid evaluation.

D. Supplier-Generated Document Control

1. Controls are implemented to ensure submittal and evaluation of supplier-generated documents and changes are accomplished according to procurement document requirements. These controls provide for acquisition, processing, and recorded evaluation of the QA, technical, inspection, and test documentation or data against acceptance criteria and is detailed in BGS-QA-08, Review and Approval of Suppliers Documents.

E. Items and Services Acceptance

1. Prior to offering an item or service for acceptance, the supplier is required to verify the item or service being furnished complies with procurement requirements. The extent of BGS’ verification activities is a function of the relative importance, complexity, and quantity of the items or services procured and the supplier’s quality performance. Where required by code, regulation, or contract requirement, documentary evidence that verifies items conform to procurement requirements is required to be available at the facility prior to installation or use.

2. BGS accepts an item or service from a supplier through either a supplier certificate of conformance (COC), source verification, or receiving inspection method as detailed in BGS-QA-07, Control of Items and Services.

3. The following criteria are met as a minimum for COCs:





a. The certificate shall identify the purchased material or equipment, such as by the purchase order number.

b. The certificate shall identify specific procurement requirements met by the purchased material or equipment, such as codes, standards, and other specification. This can be accomplished by including a list of specific requirements or by providing, on-site, a copy of the purchase order and procurement specifications or drawings, together with a suitable certificate. Procurement requirements identified shall include any approved changes, waivers, or deviations applicable to the subject material or equipment.

c. The certificate shall identify any procurement requirements not met, together with an explanation and the means for nonconformance resolution.

d. The certificates shall be signed or otherwise authenticated by a person who is responsible for this QA function and whose function and position are described in the purchaser's or supplier's QA program.

e. The certification system, including the procedures to be followed in filling out a certificate and the administrative procedures for review and approval of the certificates, shall be described in the purchaser's or supplier's QA program.

f. Means shall be provided to verify the validity of supplier certificates and effectiveness of the certification system, such as during performance of supplier audits or independent inspection or test of the item(s). Such verification shall be conducted by BGS at intervals commensurate with the supplier’s past quality performance.

4. The following criteria are met at a minimum when source verification is used as the method for acceptance of items and services.

a. Source verification shall be performed at intervals consistent with the importance and complexity of the item or services.

b. Source verification shall include monitoring, witnessing, or observing selected activities.

c. Source verification shall be implemented in accordance with plans to perform inspections, examinations, or tests at predetermined points.





d. Upon acceptance of the source verification, documented evidence of acceptance shall be furnished to the receiving destination of the item, to BGS, and to the supplier.

5. The following criteria are met at a minimum when receiving inspections is used as the method for acceptance of items.

a. Purchased items shall be inspected as necessary to verify conformance to specified requirements (taking into account source verification and audit activities and the demonstrated quality performance of the supplier).

b. Receiving inspections shall verify by objective evidence such features as:

• Configuration

• Identification

• Dimensional, physical, and other characteristics

• Freedom from shipping damage

• Cleanliness

c. Receiving inspection shall be coordinated with the review of supplier documentation when procurement documents require such documentation to be furnished prior to receiving inspection.

6. For off-the-shelf items, BGS performs a receipt inspection as detailed in BGS-PC-01, Procurement and Contracts.

7. In cases involving procurement of services only, such as engineering, auditing, or third-party inspections, BGS accepts the service by any or all of the following methods:

a. Technical verification of data produced.

b. Surveillance and/or audit of the activity.

c. Review of objective evidence for conformance to procurement document requirements.

F. Supplier Nonconformance Control

1. Methods for control and disposition of supplier items and services not meeting procurement document requirements (i.e., nonconforming) include the following and as detailed in BGS-QA-07, Control of Items and Services.





a. Evaluation of nonconforming items.

b. Submittal of nonconformance notice to the BGS QA Manager by the supplier as directed by BGS. These submittals include supplier-recommended disposition (e.g., use-as-is or repair) and technical justification. Nonconformance with procurement requirements or BGS-approved documents, which consists of one or more of the following, shall be submitted to BGS for approval of the recommended disposition:

• Technical or material requirement violation.

• Requirement in BGS-approved supplier document violation.

• Nonconformance cannot be corrected by continuation of the original manufacturing process or by rework.

• Nonconformance with original requirements even though the item can be restored to a condition such that the capability of the item to function is unimpaired.

c. BGS disposition of supplier recommendation.

d. Verification of the implementation of the disposition.

e. Maintenance of records of supplier submitted nonconformances.

G. Commercial Grade Items and Services

1. BGS does not currently purchase commercial grade items and/or services for nuclear safety-related dedication.

2. BGS utilizes a Commercial Grade Dedication process for Computer Programs and Software Services as detailed in Section 14.3 of this document and within BGS-QA-28, Commercial Grade Dedication for Computer Programs and Software Services.

H. Records

1. Procurement records are established and maintained to indicate performance of the following functions:

a. Supplier evaluation and selection.

b. Acceptance of items or services.

c. Supplier nonconformance to procurement document requirements, including evaluation and disposition.





10. INSPECTION AND ACCEPTANCE TESTING

10.1 General

A. BGS does not currently and does not plan to receive, inspect, test, accept, control, store, ship, or operate items or SSCs. Inspection and acceptance testing are limited to computer software. See Section 3.2 B to view the list of NQA-1 requirements that are not applicable to the work activities performed by BGS and are not addressed in this QAP.

B. Inspection and acceptance testing requirements and management expectations associated with software are discussed further under Section 14 of this QAP and Attachment G of the QIP (Attachment 3).

11. MANAGEMENT ASSESSMENT


A. Management assessment is a method used by BGS to achieve continuous improvement and/or to identify barriers that hinder improved performance. BGS FMs and PMs periodically evaluate the performance of their organizations in comparison with their mission, responsibilities, and priorities. These evaluations are performed periodically and also in response to identified issues or concerns. Management assessments analyze snapshots of performance aspects to capture and create a total picture of how well the management systems and processes in place are meeting client requirements.

B. Management assessments include determining at least one or more of the following:

1. Verifying the roles and responsibilities are known and understood.

2. Processes and procedures are effectively implemented.

3. Appropriate measurement systems are in place and functional.

4. Evidence of continuous improvement process is available.

5. Procedures are being followed.

6. Organizational activities are consistent with the mission.

7. Client requirements and expectations are satisfied.

8. Adequacy of resources and the workers assigned to perform work in support of BGS activities.

9. Performance against technical and financial goals and objectives.





C. BGS management expectations associated with management assessments consist of:

1. Management assessments are one of the means for identifying areas needing correction and/or improvement.

2. Management assessments are performed by personnel knowledgeable in the subject area and trained in assessment techniques.

3. Managers within organizations assess their organization’s performance with regards to such things as safety, quality, mission completion, and performance against technical and financial goals and objectives. Management consolidates the ISMS and QA validation and declaration activities where possible and applicable.

4. Results of management assessments are documented, and deficiencies identified are tracked with corrective actions taken.

5. Management assessments use guidance provided in DOE G 414.1-1B, Management Assessment and Independent Assessment Guide for Use with 10 CFR, Part 830, Subpart A, and DOE O 414.1C, Quality Assurance.

6. The DOE Standard Review Plan (SRP) Modules can be used in the development of lines of inquiry for management assessments. The SRP modules can be found on the DOE EM website.

D. Assessments include evaluating available quality performance and trend analysis data, such as the results of independent or external assessments and data from issue tracking and corrective action systems.

E. Areas that present the greatest consequences of failure and the greatest benefit from improvements, if implemented, receive particular emphasis.

F. Management assessments include an introspective evaluation to determine if the Integrated Safety and Quality Management Systems effectively meet strategic goals. Therefore, significant personal participation by the manager in the assessment is an essential element.

G. Management assessments also identify opportunities for improving cost, schedule, safety, and/or quality of performance.

H. Assessment results are documented. Assessment results requiring corrective actions are tracked until corrective actions have been completed and verified.

I. Oversight plans and associated assessment procedures include requirements to:





1. Document improvement actions.

2. Process lessons learned, as applicable.

3. Provide a copy of the final assessment report so that follow-up improvement actions resulting from the assessment can be entered into an issues tracking system for tracking and a record of the assessment can be established.

J. Deficiencies (issues, findings, and observations) are documented and corrective action and causal analysis is considered as detailed in Section 5, “Quality Improvements,” and implemented in BGS-QA-16, Corrective Action.

K. These management expectations are implemented in BGS-MG-03, Management Assessments.

12. INDEPENDENT ASSESSMENTS


A. Independent assessments involve review, evaluation, inspection, surveillance, assessment, or audit to determine and document whether items, processes, systems, or services meet specified requirements and perform effectively. An independent assessment is conducted by individuals within the organization or from an external organization that are independent from the work or process being evaluated.

B. BGS management expectations associated with independent assessments include:

1. Organizations develop and implement a comprehensive plan and schedule to independently assess and conduct audits of reporting organizations against technical, programmatic, administrative, and quality program requirements.

2. Independent assessments are performed by personnel knowledgeable in the subject area and trained in assessment techniques.

3. Results of independent assessments/audits are documented, deficiencies tracked, corrective action plans reviewed, and corrective actions verified with the verification documented to indicate closure.

4. Independent assessments use guidance provided in DOE G 414.1-1B, Management Assessment and Independent Assessment Guide for Use with 10 CFR, Part 830, Subpart A, and DOE O 414.1C, Quality Assurance.





5. The SRP Modules can be used in the development of lines of inquiry for independent assessments The SRP modules can be found on the DOE EM website. In the course of issue identification, proposed solutions or alternative courses of action are brought forward with the objective of seeking to improve organizational excellence. Findings, observations, and recommendations are presented and documented in reports that are transmitted formally to the assessed/audited organization.

C. Deficiencies (issues, findings, and observations) are documented and corrective action and causal analysis is considered as detailed in Section 3, Quality Improvement, and implemented in BGS-QA-16, Corrective Action.

D. These management expectations are implemented in BGS-QA-25, Independent Assessments.

12.2 Independent Assessments

A. Independent assessments focus on performance of work with significant consideration given to performing activities in both a safe and compliant manner while achieving the goals of BGS.

B. Independent assessments are utilized to either improve performance and process effectiveness through assessing item and service quality, measuring adequacy of work performed, and promoting continual improvement.

C. Independent assessments are conducted by technically qualified and knowledgeable personnel who are not responsible for supervising or performing the work under review.

D. Independent assessments provide assurance to BGS management, clients, and regulatory agencies that BGS' QA Program is effective, identify candidate areas for improvement, and facilitate high value input to future business planning.

E. Independent assessments are scheduled and tracked by the QA Manager as part of the overall BGS Assessment Schedule.

F. An independent assessment plan is to be developed for each assessment. The plan will identify at least the following:

1. Assessment scope.

2. Assessed criteria (requirements, etc.).

3. Team members.





4. Activities to be assessed.

5. Organization to be notified.

6. Applicable documents, schedule, and written procedure or checklists.

G. Independent assessments are to be performed in accordance to written procedures or checklists.

H. Assessment results are documented, reported (in writing), and reviewed by responsible management.

I. Independent assessment report content includes (at a minimum):

1. Description of the scope (plan/checklist).

2. Identification of the assessor and personnel contacted during the assessment.

3. Activities assessed.

4. Summary of results including a statement on the effectiveness of the QA elements assessed.

5. Description of each reported finding.

J. Independent assessment findings are identified and tracked by the BGS corrective action process per BGS-QA-16, Corrective Action.

K. Reports are signed or otherwise endorsed by the Lead Assessor.

L. Independent assessment plans, reports, and written correspondence, are maintained as QA records per BGS-RM-01, Quality Assurance Records.

M. BGS may procure external SMEs to assist BGS in the performance of independent assessments of programs or products.

12.3 BGS Quality Program Assessment

A. As part of the independent assessment process, BGS ensures their QA Program is assessed to verify compliance and effectiveness of the quality requirements implementation at a frequency such that all elements of the QA Program are addressed at least triennially.

B. Independent assessments of BGS’ QA Program will be performed to BGS- QA-25, Independent Assessments.

C. Independent assessments of BGS’ QA Program will be performed by Lead Auditors, Auditors, and SMEs who are technically qualified and





knowledgeable in the areas to be assessed and are qualified as specified in NQA-1-2008/2009a, Requirement 2, Sections 303, 304, and 305.

D. BGS plans to use internal/outside personnel or qualified/certification agencies to conduct the performance of independent assessments of the BGS QA Program.

E. All auditors must be in compliance with BGS’ Lead Auditor/Auditor qualification program.

13. SUSPECT/COUNTERFEIT ITEMS


A. Guidance provided in DOE G 414.1-2B, Quality Assurance Program Guide, and International Atomic Energy Agency (IAEA)-TECDOC-1169, Managing Suspect and Counterfeit Items in the Nuclear Industry, is reviewed and utilized during the preparation process.

B. The latest information on S/CI awareness is used.

C. These management expectations are implemented in BGS procedure BGS-QA-24, Control of Suspect/Counterfeit Items.

13.2 BGS Suspect/Counterfeit Items Program

A. BGS implements the S/CI Program using a graded approach. BGS has established, documented, and implemented effective controls and processes that will: (1) ensure items and services meet specified requirements; (2) prevent entry of S/CI into BGS Clients’ supply chains; and (3) ensure detection, control, reporting, and disposition of S/CIs. Through the procurement planning process, S/CI control and prevention requirements are passed through to suppliers. BGS procurement documents require vendors or suppliers certify S/CIs are not contained in the items or materials they provide.

B. A standard S/CI clause directing the supplier to DOE G 414.1-2B, Quality Assurance Program Guide, and IAEA-TECDOC-1169, Managing Suspect and Counterfeit Items in the Nuclear Industry, is contained in procurement documents, regardless of the safety classification, for material requisitions (as applicable).

C. BGS or BGS-contracted third-party receipt inspection activities include checking for S/CI. BGS or BGS-contracted third-party receipt inspection personnel are required to have completed S/CI control and prevention training, and to be familiar with the governing DOE S/CI requirements.





14. SOFTWARE QUALITY ASSURANCE


A. Safety software QA processes use guidance provided in 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.

B. Software Validation Requirements

1. Software validation activities are planned, documented, and performed for software, software changes, or system configurations that are determined to impact the software.

2. The validation test plans, test cases, and test results are documented, reviewed, and approved prior to use of the software.

C. Software Verification Requirements

1. Software verification activities are planned, documented, and performed for software, software changes, or system configurations that are determined to impact the software.

2. Software verification is performed at the end of the requirements, design, and testing life cycle phases to ensure that the products of a given life cycle phase are traceable and fulfill the requirements still applicable from the previous phase(s).

3. Software verification evaluates the technical adequacy, ensures correctness of the software, and verifies that software is traceable to the software design requirements.

4. Tests and test results from reviews and verifications are included in the acceptance test documentation.

5. Tests conducted as reviews or verifications do not substitute for performing comprehensive, end-of-development acceptance tests.

6. Software verification includes review of the test results.

7. Software verification is completed prior to approval of the computer program for use.

8. Verification reviews identify the reviewer(s) and each reviewer’s specific responsibilities during the review.

9. Documentation of review comments and their disposition is retained as part of the records package.





10. Software verification and validation activities are performed by individuals not associated with the development of the software. In those instances where this level of independence cannot be achieved, an individual associated with the development of the software performs these activities with management approval and documented justification.

11. As part of the configuration change control, software verifications are performed for the changes, as necessary, to ensure the changes are appropriately reflected in software documentation and to ensure that document traceability is maintained.

14.2 General Software Requirements

A. BGS does not acquire software to operate nuclear safety software.

B. Sections 14.2 through 14.19 establish requirements for the acquisition, development, operation, maintenance, and retirement of software developed or acquired by BGS.

C. Requirements of this section are implemented through BGS plans, procedures, and work practices that provide the framework for software engineering activities. The scope of software engineering activities includes the following elements, as appropriate:

1. Software acquisition method(s) for controlling the acquisition process for software and software services.

2. Software engineering method(s) used to manage the software life cycle activities.

3. Application of standards, conventions, and other work practices that support the software life cycle.

4. Controls for support software used to develop, operate, and maintain computer programs.

D. Software acquisition, development, modification, and maintenance proceed in a planned, traceable, and orderly manner utilizing a defined software life cycle methodology. BGS’ program defines the software life cycle methodology and baseline documents for the following phases:

1. Software planning

2. Software requirements definition

3. Software design

4. Implementation





5. Software test

6. Installation and acceptance

7. Operations

8. Maintenance

9. Retirement

E. BGS’ program establishes the following life cycle quality activities that cross multiple life cycle phases above:

1. Software configuration management.

2. Verification and validation.

F. Software life cycles will identify control points that, when reached, ensure specified software is documented, reviewed, and baselined.

G. The requirements of Sections 14.2 through 14.19 are flowed down to suppliers of BGS subcontractors unless otherwise noted.

H. The following types of commercial off-the-shelf software are excluded from the processes detailed in this section: word processors, email, and other types of automated office support systems. Additional clarification of off-the-shelf software will be provided in BGS-SQ-02, Software Management.

14.3 Software Acquisition

A. Software acquisition includes software or software services (1) using BGS procurement processes, (2) through BGS initiated acquisition from third party entities, and (3) from clients supplying software to BGS. This section details the methods for controlling software and software services procured, acquired, or received from clients.

B. The software planning document(s) will include appropriate requirements of the software engineering method (i.e., Sections 14.9 through 14.14), including QA verification methods, upon acceptance of the software or related item.

C. Procured Software and Software Services

1. BGS procures software and software services utilizing the process defined in Section 9, “Procurement,” of this QAP. Procurement documents identify requirements for supplier’s reporting of software errors to BGS and, as appropriate, BGS reporting errors to the supplier. Section 9 details the process for the control of purchased items and services.





D. Otherwise Acquired Software

1. NQA-1 Part II Subpart 2.14 as it relates to commercial grade dedication for computer programs and services is applied where software or software services procured, acquired from third party entities, or supplied by clients, have not been developed under an NQA-1 program and are intended to be used to support a nuclear safety function, including the design of a nuclear safety structure, system or component or activities during operations that impact nuclear safety. This process is further detailed in procedure, BGS-QA-28, Commercial Grade Dedication of Computer Programs and Software Services.

E. Commercially Acquired Software

1. Prior to use, software and software services acquired that do not support a nuclear safety function are evaluated against BGS’ QAP requirements for software and software services. This evaluation is based upon the required QL, ensures adequate pedigree of the software or software service, and identifies any gaps required to be addressed prior to use. This evaluation process will assess the adequacy of the commercially acquired software life cycle documentation to maintain or use the software within its defined requirements and verification to ensure that the software performs its critical features correctly. This process is further detailed in procedure, BGS-SQ-02, Software Management.

14.4 Software Configuration Management

A. Software configuration management includes establishment of a software baseline at the end of each phase of the software process (i.e., life cycles). The software baseline includes computer programs (e.g., source, object, backup files), support software, and documentation (e.g., software design requirements, computer program instruction, test plans, and test reports). The software baseline defines the most recently approved software configuration.

B. Software planning document(s) identify a labeling system for configured items that uniquely identifies each configuration item, identifies changes to configuration item by revision, and provides the ability to uniquely identify each configuration of the revised software release. Configuration items are maintained under configuration management until the software is retired.

C. The software configuration change control process includes:

1. Initiating, evaluating, and dispositioning the requested change.





2. Controlling and approving any changes prior to implementation.

3. Identification of requirements for retesting and acceptance of test results.

D. Changes to software and other configured items are formally documented. The documentation includes:

1. A description of the change.

2. Justification/reason for the change.

3. Corrective actions which identify affected software baselines actions (changes) to be implemented.

4. Appropriate verification methods, activities, and testing.

E. The change is formally evaluated and approved per the software change control process. Only authorized changes are allowed to be made to software baselines. Verification and validation activities associated with the change are performed commensurate with those applied to the original configured item. If applicable, software documentation is modified to reflect the change. Traceability of the change to the software design requirements is maintained.

F. The status of changes to software and other configured items are maintained current. All configuration item changes are controlled until incorporated into the approved baseline. For those changes not incorporated, their status is maintained. The status of all changes is communicated to affected client and user organizations.

G. BGS-AD-01, Document Preparation and Control, and the BGS-SQ-02, Software Management, are utilized to implement software configuration management.

14.5 Problem Reporting and Corrective Action

A. BGS’ methods for documenting, evaluating, and correcting software problems are detailed in BGS-SQ-02, Software Management, and invoked procedures and plans. These methods describe the evaluation process for determining whether a reported problem is an error or other type of problem (e.g., user mistake). The process and responsibilities for disposition of the problem reports are documented, including notification to the originator (directly or by BGS clients) of the results of the evaluation.

B. If the problem is determined to be an error, the process detailed in the Software Quality Assurance Plan (SQAP) includes the following, as appropriate:





1. Determination of how the error relates to appropriate software engineering elements.

2. How the error impacts past and present use of the computer program.

3. How the corrective action impacts previous development activities.

4. How the users are notified of the identified error, its impact, and how to avoid the error pending implementation of corrective actions.

5. Detail how problem reporting, and the corrective action process are integrated with the BGS QAP.

14.6 Software Verification and Validation

A. Software verification methods include life cycle phase documentation reviews, computer program reviews, alternate calculations, and tests performed during computer program development. The extent of verification and the methods chosen are a function of the complexity of the software, the degree of standardization, the similarity with previously provided software, and the importance to safety.

B. Software verification is performed at the end of a life cycle phase to assure that the activities performed during that phase have been properly completed and that the software meets the desired level of quality for that phase.

C. Software validation is performed at the completion of implementation or as part of the acceptance of the software. It assures that the software meets the software requirements.

D. Software verification and validation activities are performed by competent individuals or groups not associated with the development of the software but can be from the same organization. In those instances where this level of independence cannot be achieved, these activities can be performed by the originator’s supervisor, provided:

1. The supervisor did not specify a singular design approach or rule out certain considerations and did not establish the design inputs used in the design, or

2. The supervisor is the only individual in the organization competent to perform the verification.

E. The results of the verification and validation are documented with the identification of the individual(s) performing the activities indicated.





F. Reviews are described in Section 14.7 and testing in Section 14.13. Software verification and validation activities associated with a particular life cycle are described within those phases.

14.7 Reviews

A. Review of software ensures compliance with the approved design requirements. Control points and associated reviews for the software elements identified in Sections 14.9 through 14.17 are identified and detailed in BGS-SQ-02, Software Management, and invoked procedures and plans. At a minimum the following reviews are performed by BGS as follows:

1. Software Test Readiness Review: This review includes the review of requirements related to the activities of preparing the computer program for acceptance testing.

2. Software Completion Review: The second review provides assurance of satisfactory completion of the software development cycle including acceptance testing.

B. These reviews can be combined with or be part of software verification . Individuals familiar with the design detail and the intended use of the computer program are involved in these reviews.

C. Reviews will identify the participants and their specific review responsibilities. Documentation of review comments and their disposition are retained until incorporated into updated software.

D. Alternate calculations are used, or tests developed and integrated into the appropriate activities of the software development cycle when the review(s) alone is not adequate to determine if requirements have been met.

E. Tests performed in support of a review are used to complement acceptance testing. Such tests are subject to the same criteria as the acceptance tests, but do not substitute for performing the comprehensive, end of development acceptance test. The tests and test results (see Section 14.14) are included in the acceptance testing documentation.

14.8 Software Engineering Method

A. The selected software engineering method (i.e., Sections 14.9 through 14.15) ensures that software life cycle activities are planned and performed in a traceable and orderly manner. Software engineering method(s) are documented in BGS-SQ-02, Software Management, and invoked procedures and plans and approved by the responsible PM.

B. The number of phases and relative emphasis placed on each phase of the software life cycle depend on the nature and complexity of the software. Life





cycle phases can be combined for documentation purposes; however, the combining of phases does not eliminate the requirement for addressing each life cycle element of the life cycle phase. Software life cycle activities can be performed in an iterative or sequential manner.

14.9 Software Planning

A. For all software projects either a project specific SQAP or one or more documents that contain equivalent content will be developed and documented at the start of the software life cycle.

B. The software planning document(s) will identify (as applicable):

1. A description of the overall nature and purpose of the software.

2. The software product(s) to which it applies.

3. The organizations responsible for performing the work, achieving software quality and their tasks and responsibilities, and approving the software planning document(s).

4. Required documentation.

5. Standards, conventions, techniques, or methodologies that guide the software activity.

6. Required software reviews.

7. Methods for error reporting and corrective action.

C. The software planning document(s) may include project management activities that include software activities to be performed for a particular software release, staffing resources, schedule, and technical or managerial approaches for the particular software release.

D. The software planning document(s) will be verified through a review as described in Sections 14.6 and 14.7 above. Changes to the software planning document(s) are controlled as described in Section 14.4.

14.10 Software Requirements Definition

A. The software requirements identify operating system, functions, interfaces, performance requirements, installation consideration, design input, and any design constraints of the computer program.

B. Software requirements specify technical and software engineering requirements, including security features (e.g., vulnerability protection, and cyber security). Identify applicable reference drawings, specifications, code, standards, regulations, procedures, or instructions that establish software





design requirement test, inspection, and acceptance criteria. Security requirements are specified commensurate with the risk from unauthorized access or use.

C. Software requirements are documented and traceable throughout the software life cycle stages. Software requirements provide enough detail to either design the software or make an acquisition decision.

D. Software requirements are reviewed and approved as described in Sections 14.6 and 14.7 above. Changes to the software requirements are controlled as described in Section 14.4.

14.11 Software Design

A. The software design is developed, documented, and reviewed based on the requirements depicted in the software requirements documentation. The software design considers the computer program’s operating environment. External interfaces are identified and controlled. Measures to mitigate the consequences of potential problems, as identified through analysis, are an integral part of the design. These potential problems include external and internal abnormal conditions and events that can affect the computer program.

B. The software design documentation includes as appropriate:

1. A description of the major components of the software design as they relate to the software requirements.

2. A technical description of the software design with respect to the theoretical basis, computational flow, numerical methods, mathematical models, physical models, control flow, data flow, control logic, process flow, process structures, data structures, and relationships between data structures and process structures.

3. For safety software, identify the consequences of potential problems with the computer program that can affect its safety function and how the design will incorporate applicable design concepts to mitigate those consequences.

4. A description of the inputs and outputs including their allowable or defined ranges.

5. Source(s) of input values.

6. Described in a manner that can be translated into code.





C. The design documentation can be combined with the software requirements documentation or computer program listings resulting from the implementation of the design.

D. Software verification evaluates the technical adequacy of the design approach and ensures internal completeness, consistency, clarity, and correctness of the software design is traceable to the software design requirements. The verification activities are performed in accordance with Sections 14.6 and 14.7 above.

E. Software verification includes review of the test results. Software verification is completed prior to approval of the computer program for use. The requirements for the software verification activity are documented in the software engineering method.

F. Changes to the software design are controlled as described in Section 14.4.

14.12 Implementation

The design is translated into source code and resulting executable(s) necessary to perform the functions required. The source code and resulting executable(s) adhere to BGS’ coding standards, conventions, and design specifications. The implementation process results in computer program listings and information to assist the user in running the computer program.

14.13 Software Testing

A. Software testing includes software verification and acceptance tests.

B. Tests to verify conformance to specified requirements or satisfactory performance of a service are planned. Characteristics to be tested and test methods are specified. Test results are documented and their conformance to requirements and acceptance criteria are evaluated.

C. Test requirements and acceptance criteria are provided by or approved by the client or responsible design organization and are based upon specific requirements contained in design documents or other pertinent technical documents that provide approved requirements. The test requirements and acceptance criteria includes at a minimum:

1. Software verification testing demonstrates the capability of the computer program to provide valid results for test problems encompassing the range of documented permitted usage.





2. Computer program acceptance testing consists of the process to exercise or evaluate by manual or automated means to ensure that the computer program satisfies the specified requirements and to identify differences between expected and actual results in the operating environment identified in the software or design specifications.

D. Testing activities demonstrate that the computer program adequately and correctly performs all intended functions (i.e., specified software design requirements). Testing demonstrates that the computer program:

1. Properly handles abnormal conditions and events as well as credible failures.

2. Does not perform adverse unintended functions.

3. Does not degrade the system either by itself, or in combination with other functions or configuration items.

E. Acceptance testing is performed prior to approval of the computer program for use. Configuration items are under configuration change control prior to starting acceptance testing. Acceptance testing is planned and performed for all software design requirements. Acceptance testing ranges from a single test of all software design requirements to a series of tests performed during computer program development. Performance of a series of tests provides assurance of correct translation between activities and proper function of individual modules. Testing includes a comprehensive acceptance test performed in the operating environment, prior to use. If temporary changes to the operating environment are needed for this testing, approval by the authorized manager for the operations environment is required prior to performing the testing

F. The acceptance testing of changes to the computer program will be subjected to selective retesting to detect unintended adverse effects introduced during the change. Such testing provides assurance that the changes have not caused unintended adverse effects in the computer program, and to verify that a modified system or system component still meets specified software design requirements.

G. The test plans, test cases, and test results are documented, reviewed, and approved. Observations of unexpected or unintended results are documented and dispositioned prior to test results approval.

H. All tests performed are controlled under the appropriate environment to fulfill test requirements and acceptance criteria. Tests performed obtain the necessary data with sufficient accuracy for evaluation and acceptance.

I. Computer Program Test Procedures





1. BGS computer program test procedure(s), as developed in the software planning document(s), demonstrate the adherence of the computer program to documented requirements. The procedure(s) provides for evaluating the technical adequacy through comparison of test results from alternative methods such as hand calculations, calculations using comparable proven programs, or empirical data and information from technical literature.

2. Test procedures specify the following, as applicable:

• Required tests and test sequence.

• Required ranges of input parameters.

• Identification of the stages at which testing is required.

• Criteria for establishing test cases.

• Requirements for testing logic branches.

• Requirements for hardware integration

• Anticipated output values.

• Acceptance criteria.

• Reports, records, standard formatting, and conventions.

J. Test results are documented and evaluated by a responsible authority to ensure that test requirements have been satisfied. Test records are established and maintained to indicate the ability of the item or computer program to satisfactorily perform its intended function or to meet its documented requirements.

K. BGS Computer Program Test Records, at a minimum, contain the following information:

1. Computer program tested, including system software used.

2. Computer hardware used.

3. Test equipment and calibration, where applicable.

4. Date of test.

5. Tester or data recorder.

6. Simulation model used, where applicable.

7. Test problems.





8. Results and applicability.

9. Action taken in connection with any deviations noted.

10. Person(s) evaluating test results.

11. Acceptability.

14.14 Installation and Acceptance

Installation and acceptance of the software product are initiated after the system test has been successfully completed and prior to approval of the software program for use. This stage involves the activities required to install the software, databases, or data that comprise the software product onto the hardware platform at the site(s) of operation. The objectives of the activities of this stage are to ensure the application executes properly in its production environment and to obtain the requester’s acceptance of the software product.

14.15 Operation

A. BGS may at times maintain a set of software for client(s). Software once approved for release, is distributed to the user through clients’-approved processes. The software is either executed on computer servers maintained by DOE or downloaded to the users’ environment. BGS does not have control or maintain configuration control of those systems. When a configuration change is made to a server that hosts BGS-maintained software, appropriate testing is performed to ensure the BGS-maintained software functions properly. BGS does not perform in-use testing for these environments.

B. After BGS-maintained software that is used internally is approved for use and installed in the appropriate computer environment, the use of this software is controlled in accordance with the approved procedures and instructions. These include, as appropriate:

1. Application documentation.

2. Access control specifications.

3. Computer system vulnerability protections.

4. Problem reporting and corrective action.

5. In-use tests.

6. The configuration change control process.





14.16 Maintenance

A. The appropriate software engineering methods, as described in Sections 14.4 through 14.15, are identified and performed to control changes to the software. The software maintenance activities are a result of the following:

1. Enhancements requests from the user community.

2. Revision to software in response to new or revised requirements.

3. Adapting the software to changes in the operating environment and changes to computer system vulnerability protections.

4. Correction of reported software problems.

5. Performing preventative maintenance to ensure long-term maintainability of the software.

14.17 Retirement

A. When software products are retired, support services are terminated and routine use of the software is prevented. The software version being retired is removed from any downloadable or other user accessible locations. BGS customers are notified that the software version or product is being retired.

B. When a software product (i.e., all versions) is being retired:

1. Ensure all user training material and software documentation that is specific to the retired software version are archived.

2. Identify and segregate all associated QA records that are specific to the retired software version.

3. Identify and segregate all retired software version source and executable code within the code management system(s).

4. If the product has been maintained or developed for a client, forward all associated QA records, source code and executable code for the retired software version to the client for permanent storage.

14.18 Standards, Conventions, and Other Work Practices

As appropriate, the software engineering method, software acquisition method, or both, as documented in the software planning document(s), establish the need for standards, conventions, and other required work practices to facilitate software life cycle activities.





14.19 Support Software

A. Support software includes software tools and system software. As appropriate, the software engineering method defined, the software acquisition method, or both establish the need for the software tools.

B. Software tools are evaluated, reviewed, tested and accepted for use, and placed under configuration control as part of the software development cycle of a new or revised software product. Software tools that do not affect the performance of the software are not placed under configuration control. Changes to software tools are evaluated for impacts on the software product to determine the level of reviews and retesting that will be required.

C. In cases involving modification of software products using software tools, if the software tool may impact performance of the software product, the configuration of the software tool associated with the modification is managed as part of the software configuration management.

D. System software consists of the on-line computer programs used that provide basic or general functionality and facilitate the operation and maintenance of the application computer program (e.g., lower-level software layers, assemblers, and utilities).

E. System software is evaluated, reviewed, tested, and accepted for use as part of the software development cycle of new or revised software products. System software is part of the software baseline and is placed under configuration control and changes to the software system are evaluated for impact on the software product.

15. COMPUTER MODEL DEVELOPMENT, USE, AND VALIDATION


A. Model development and approaches to validation are planned, controlled, and documented. BGS-SQ-03, Model Validation (when issued), will describe the approaches, validation criteria, quality requirements, and procedural steps to control the model validation process. There is a DOE technical Hold Point to approve the modeling methodology prior implementation. This procedure will include any work-planning activities associated with the validation activities that are required after the model has been documented. For a specific instance of performing model validation, a model validation technical report will be developed that documents the specific models.

B. Documentation of each model includes:

1. Definition of the objective (intended use) of the model.





2. Description of conceptual model and scientific basis, as well as alternatives for the selected conceptual model. Rationale for not selecting alternatives should also be included.

3. Results of literature searches and other applicable background information.

4. Identification of inputs and their sources.

5. Identification of, and rationale for, assumptions that are made to develop or apply the model, including model idealizations, as well as those assumptions that support the input to the model and impact model results.

6. Discussion of mathematical and numerical methods that are used in the model, including governing equations, formulas, and algorithms, and their scientific and mathematical bases.

7. Identification of any associated software used, computer calculations performed, and basis to permit traceability of inputs and outputs.

8. Discussion of initial and/or boundary conditions.

9. Discussion of model limitations (i.e., data available for model development, valid ranges of model application, and spatial and temporal scaling).

10. Discussion of model uncertainties (e.g., conceptual model, mathematical model, process model, abstraction model, system model, parameters) and how they affect the model.

11. Identification of the originator, reviewer, and approver.

C. The intended use of the model and the importance of the model is used to determine the appropriate level of confidence for a model (i.e., models of system components most relied upon are validated with the highest levels of confidence to the extent practical).

D. Model validation criteria addresses the following:

1. Criteria used to establish the adequacy of the scientific basis for the model are consistent with the model application and justified in the model documentation.

2. Criteria are used to demonstrate that the model is sufficiently accurate for its intended use. Model documentation provides an accounting for uncertainties and variability in parameter values and provides the





technical basis for parameter ranges, probability distributions, or bounding values used in process, abstraction, and system models.

3. The importance of the model for assessing performance is defined.

4. The relative level of confidence for the model is described.

5. The supporting information needed to substantiate validation is defined.

E. The usual progression of a model is from conceptual model to mathematical model to process model to abstraction model to system model. A conceptual model shall be validated when its implementation as a mathematical, process, abstraction, or system-level model is validated. Technical review through publication in a refereed professional journal or review by an external agency may be used to corroborate model validation when used in conjunction with one or more of the following:

1. Corroboration of model results with data acquired from field experiments, analogue studies, laboratory experiments, or subsequent relevant observations (i.e., refereed journals or literature). Data used to develop and calibrate a model shall not be used to validate a model.

2. Peer review or independent technical review.

3. Performance confirmation studies using validation test model predictions prior to comparison with field or laboratory data.

4. Comparison of model results with other results obtained from the implementation of an alternative validated model.

16. REFERENCES

1. ASME NQA-1, Quality Assurance Requirements for Nuclear Facility Applications, (2008 with Addenda through 2009)

2. Department of Energy (DOE) Environmental Management QA Program (EM-QA-001, Revision 1)

3. DOE Guide (G) 414.1-4, Safety Software Guide for Use with 10 CFR 830, Quality Assurance Requirements and DOE O 414.1C, Quality Assurance

4. DOE G 414.1-1B, Management Assessment and Independent Assessment Guide for Use With 10 CFR, Part 830, Subpart A, and DOE O 414.1C, Quality Assurance; DOE M 450.4-1, Integrated Safety Management System Manual; and DOE O 226.1A, Implementation of Department of Energy Oversight Policy

5. DOE G 414.1-2B, Quality Assurance Program Guide





6. DOE Order (O) 226.1B, Implementation of Department of Energy Oversight Policy

7. DOE O 227.1A, Independent Oversight Program

8. DOE O 232.2, Occurrence Reporting and Processing of Operations Information

9. DOE O 243.1B, Records Management Program

10. DOE O 243.2, Vital Records

11. DOE O 414.1D, Change 1, Quality Assurance

12. IAEA-TECDOC-1169, Managing Suspect and Counterfeit Items in the Nuclear Industry

13. ISO 9001:2008, Quality Management Systems – Requirements

14. 10 CFR Part 830 Subpart A, Quality Assurance Requirements

15. 10 CFR 820, Procedural Rules for DOE Nuclear Activities

17. ATTACHMENTS

• Attachment 1 – Definitions

• Attachment 2 – BGS Organizational Chart

• Attachment 3 – Quality Implementation Plan (QIP)





ATTACHMENT 1 – DEFINITIONS Page 1 of 4

1. Audit. A planned and documented activity performed to determine by investigation, examination, or evaluation of objective evidence the adequacy of and compliance with established procedures, instructions, drawings, and other applicable documents, and the effectiveness of implementation. (NQA-1-2008)

2. BGS Staff. Employees, contractors, and staff augmentation personnel supporting the BGS mission or assigned to support BGS clients.

3. Commercially Acquired Software. Software acquired outside of the BGS procurement process that does not support a nuclear safety function.

4. Condition Adverse to Quality (CAQ). An all-inclusive term used in reference to any of the following: failures, malfunctions, deficiencies, defective items, and nonconformanaces. A significant condition adverse to quality is one that, if uncorrected, could have a serious effect on safety or operability. (NQA-1-2008)

5. Critical Characteristics. Important deisgn, material, and performance characteristics of a commercial grade item or service that, once verified, will provide reasonable assurance that the item or service will perform its intended saftey function (NQA-1-2008)

6. Design Process. Technical and management process that commence with identification of design input and that leads to and include the issuance of design output documents. (NQA-1-2008)

7. Document. Any written, pictorial, or electronic information describing, defining, specifying, reporting, or certifying activities, requirements, procedures, or results. A document is not considered to be a quality assurance record until it satisfies the definition of a quality assurance record as defined in this Standard. (NQA-1-2008)

8. Functional Manager. A person who has management authority over an organization unit, such as a department, within BGS.

9. Functional Areas. BGS identifies and assigns individuals (Functional Managers) to the following functional areas. Additional areas may be identified as needed.

Accounting Human Resources Quality Assurance Administrative Information Management Records Management Business Development Management Safeguards and Security Cyber Security Procurement/Contracts Software Quality Assurance Engineering Project Management Training






10. Graded Approach. The process of ensuring the level of analysis, documentation, and actions used to comply with a requirement are commensurate with: (DOE O 414.1D)

• the relative importance to safety, safeguards, and security.

• the magnitude of any hazard involved.

• the life cycle stage of a facility.

• the programmatic mission of a facility.

• the particular characteristics of a facility.

• the relative importance of radiological and non-radiological hazards.

• any other relevant factor.

11. Item. An all-inclusive term used in place of any of the following: appurtenance, assembly, component, equipment, material, module, part, product, software, structure, subassembly, subsystem, system, unit, or support systems. (10 CFR 830.3)

12. Independent Assessment. An assessment conducted by individuals within the organization or company but independent from the work or process being evaluated, or by individuals from an external organization or company (DOE G 414.1-1B)

13. Management Assessment. A periodic introspective self-analysis, conducted by management, to evaluate management systems, processes, and programs ensuring the organization’s work is properly focused on achieving desired results. (DOE G 414.1-1B)

14. Nonconformance. A deficiency in the characteristics, documentation, or procedure, which renders the quality of an item or activity unacceptable or indeterminate.

15. Otherwise Acquired Software. Software procured, acquired from third party entities, or client supplied that has not been developed under an ASME NQA-1 program and are intended to support a nuclear safety function.

16. Project Manager. A person assigned to manage staff and activities providing services and is responsible for project performance and on-time delivery of quality products.

17. Quality. The condition achieved when an item, service, or process meets or exceeds the user’s requirements and expectations. (10 CFR 830.3)

18. Quality Assurance. All those actions that provide confidence that quality is achieved. (10 CFR 830.3)






19. Quality Assurance Program. The overall program or management system established to assign responsibilities and authorities, define policies and requirements, and provide for the performance and assessment of work. (10 CFR 830.3)

20. Quality Assurance Record. A completed document that furnishes evidence of the quality of items and/or activities affecting quality. Types or record media may include paper, electronic (magnetic or optical), or specially processed media such as radiographs, photographs, negatives, and microforms. (NQA-1-2008)

21. Quality Levels. Process utilized by BGS to apply a graded approach for varying levels of managerial controls to provide adequate assurance, commensurate with risk, that the quality requirement is being met.

22. Reasonable Assurance. A justifiable level of confidence based on objective and measurable facts, actions, or observations which infer adequacy. (EPRI Report TR-102260, “Supplemental Guidance for the Application of EPRI Report NP-5652 on the Utilization of Commercial Grade Items”)

23. Senior Management. BGS senior management consist of the President and Senior Vice President.

24. Significant Condition Adverse to Quality (SCAQ). An SCAQ is a condition that, if uncorrected, could have a serious impact on public or personnel health and safety, waste acceptance, the environment, facility operations, or the effective implementation of the quality assurance program.

25. Software. Computer programs and associated documentation and data pertaining to the operation of a computer system. (NQA-1-2008 with the NQA-1a-2009 addenda)

26. Supplier. Any individual or organization who furnishes items or services in accordance with a procurement document. An all-inclusive term used in place of any of the following: vendor, seller, contractor, subcontractor, fabricator, consultant, and their sub-tier levels.

27. Technical Requirement. Characteristics, performance capabilities, etc., that define the parameters to ensure that an item will meet functional requirements. Technical requirements for a service describe the conditions for the service or deliverable to be provided.

28. Work Scope. A segmented list of activities that are clearly defined, bounded, and controllable.





ATTACHMENT 2 – BOSTON GOVERNMENT SERVICES, LLC ORGANIZATION CHART

Page 1 of 1





ATTACHMENT 3 – QUALITY IMPLEMENTATION PLAN Page 1 of 5

EM-QA-001 Requirement (1) Corresponding NQA-1 Section (1)

BGS QAP Section(s) BGS Procedure(s)

7.1 Management/Program (Criterion 1) Establish an organizational structure, functional responsibilities, levels of authority, and interfaces for those managing, performing, and assessing the work. Establish management processes, including planning, scheduling, and providing resources for the work.

Req. 1, Organization Req. 2, Quality Assurance Program

3, Quality Assurance Plan App. 2, Organization Chart

All BGS procedures (see Section 3.2.B for exclusions)

7.2 Management/Personnel Training and Qualification (Criterion 2) Train and qualify personnel to be capable of performing their assigned work. Provide continuing training to personnel to maintain their job proficiency.

Req. 2, Quality Assurance Program

4, Personnel Training and Qualification

BGS-TR-01, Qualification and Training BGS-QA-30, Quality Assurance Auditor and Lead Auditor Qualification and Certification Program (when issued)

7.3 Management/Quality Improvement (Criterion 3) 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 recurrence as a part of correcting the problem. Review item characteristics, process implementation, and other quality related information to identify items, services, and processes needing improvement.

Req. 2, Quality Assurance Program Req. 15, Control of Nonconforming Items Req. 16, Corrective Action

5, Quality Improvement BGS-MG-02, Continuous Improvements BGS-QA-15, Nonconformances BGS-QA-16, Corrective Action

7.4 Management/Documents and Records (Criterion 4) Prepare, review, approve, issue, use, and revise documents to prescribe processes, specify requirements, or establish design. Specify, prepare, review, approve, and maintain records.

Req. 5, Instructions, Procedures, and Drawings Req. 6, Document Control Req. 17, Quality Assurance Records

6, Documents and Records

BGS-AD-01, Document Preparation and Control BGS-RM-01, Quality Assurance Records BGS-RM-02, Office Records BGS-IM-03, Backup and Recovery Standards




ATTACHMENT 3 – QUALITY IMPLEMENTATION PLAN

Page 2 of 5




7.5 Performance/Work Processes (Criterion 5) Perform work consistent with technical standards, administrative controls, and other hazard controls adopted to meet regulatory or contract requirements, using approved instructions, procedures, or other appropriate means. 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.

Req. 5, Instructions, Procedures, and Drawings Req. 8, Identification and Control of Items (2) Req. 9, Control of Special Processes (2) Req. 12, Control of Measuring and Test Equipment (2, 3) Req. 13, Handling, Storage, and Shipping (2) Req. 14, Inspection, Test, and Operating Status (2) Subpart 2.7, Quality Assurance Requirements for Computer Software for Nuclear Facility Applications

7, Work Processes Project specific Software Quality Assurance Plan(s) BGS-IM-01, Application Development and Coding Standards BGS-SQ-01, Software Change Requests BGS-SQ-02, Software Management

7.6 Performance/Design (Criterion 6) 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 or validate the adequacy of design products using individuals or groups other than those who performed the work. Verify or validate work before approval and implementation of the design.

Req. 3, Design Control Subpart 2.7, Quality Assurance Requirements for Computer Software for Nuclear Facility Applications

8, Design Control Project specific Software Quality Assurance Plan(s) BGS-IM-01, Application Development and Coding Standards BGS-SQ-01, Software Change Requests BGS-SQ-02, Software Management BGS-EN-01, Engineering/Design Control BGS-EN-02, Design Interface Control and Plans BGS-EN-03, Design Analysis and Calculations BGS-EN-04, Drawing Development





Page 3 of 5




BGS-EN-05, Design Specifications BGS-EN-06, Design Reviews BGS-EN-07, Design Verification BGS-EN-08, Design Change Control BGS-EN-09, Determination of Setpoints BGS-EN-10, System Design Descriptions BGS-EN-11, Design Record File

7.7 Performance/Procurement (Criterion 7) 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.

Req. 4, Procurement Document Control Req. 7, Control of Purchased Items and Services (2) Subpart 2.7, Quality Assurance Requirements for Computer Software for Nuclear Facility Applications Subpart 2.14, Quality Assurance Requirements for Commercial Grade Items and Services (4)

9, Procurement BGS-PC-01, Procurement and Contracts BGS-QA-23, Supplier Qualification BGS-QA-07, Control of Items and Services BGS-QA-08, Review and Approval of Supplier Documents

7.8 Performance/Inspection and Acceptance Testing (Criterion 8) Inspect and test specified items, services, and processes using established acceptance and performance criteria. Calibrate and maintain equipment used for inspections and tests.

Req. 3, Design Control Req. 8, Identification and Control of Items (2) Req. 10, Inspection (2) Req. 11, Test Control (6) Req. 12, Control of Measuring and Test Equipment (2, 3)

10, Inspection and Acceptance Testing

Project specific Software Quality Assurance Plan(s) BGS-IM-01, Application Development and Coding Standards BGS-SQ-01, Software Change Requests BGS-SQ-02, Software Management BGS-EN-01, Engineering/Design Control





Page 4 of 5




Req. 14, Inspection, Test, and Operating Status (2) Subpart 2.7, Quality Assurance Requirements for Computer Software for Nuclear Facility Applications

7.9 Assessment/Management Assessment (Criterion 9) Ensure managers assess their management processes and identify and correct problems that hinder the organization from achieving its objectives.

Req. 2, Quality Assurance Program Req. 16, Corrective Action Req. 18, Audits

11, Management Assessment

BGS-MG-03, Management Assessments BGS-QA-26, Surveillances BGS-QA-16, Corrective Action BGS-QA-29, Quality Assurance Audits

7.10 Assessment/Independent Assessment (Criterion 10) Plan and conduct independent assessments to measure item and service quality, to measure the adequacy of work performance, and to promote improvement. Establish sufficient authority, and freedom from line management, for the group performing independent assessments. Ensure persons who perform independent assessments are technically qualified and knowledgeable in the areas to be assessed.

Req. 1, Organization Req. 2, Quality Assurance Program Req. 10, Inspection (2)

Req. 11, Test Control (6) Req. 15, Control of Nonconforming Items Req. 16, Corrective Action Req. 18, Audits

12, Independent Assessment

BGS-QA-25, Independent Assessments BGS-QA-29, Quality Assurance Audits (When issued)

Attachment A • Certified Type B and Fissile

Packaging Quality Assurance Program

Req. 13, Handling, Storage, and Shipping (5)

3, Quality Assurance Plan

N/A

Attachment C • Quality Assurance Implementation

Plan

N/A Attachment 3, Quality Assurance Implementation Plan (QIP)

N/A

Attachment D • Graded Approach

N/A 3, Quality Assurance Plan 3.4, Graded Approach

BGS-QA-03, Graded Approach

Attachment E Integrated Management System

N/A 3, Quality Assurance Plan

BGS-MG-02, Continuous Improvements





Page 5 of 5




NOTES:

1. Includes applicable sections of the DOE EM QAP EM-QA-001, Revision 1 requirement, associated sections management and implementation expectations and NQA-1 requirements.

2. This NQA-1 Part 1 Requirement is not applicable to BGS scope of work and is excluded under Section 3.2 of the QAP.

3. BGS does not currently and does not plan to construct, fabricate, manufacture, receive, inspect, or test items of “hardware” and does not use any special processes or measuring and test equipment.

4. BGS does not currently and does not plan to procure commercial grade items or services; however, BGS does have a commercial grade dedication process for computer programs and software services.

5. BGS does not currently and does not plan to design, fabricate, procure, use, maintain, or ship hazardous materials Type A or Type B packaging.

6. NQA-1 Part I Requirement 11, Test Control, Sections 100, 200, and 400-600 are applicable.

5, Quality Improvement

BGS-QA-15, Nonconformances BGS-QA-16, Corrective Action

Attachment F Suspect/Counterfeit Items Prevention

None 13, Suspect/Counterfeit Items

BGS-PC-01, Procurement and Contracts BGS-QA-24, Control of Suspect/Counterfeit Items

Attachment G Software Quality Requirements

Req. 3, Design Control Req. 11, Test Control (6) Subpart 2.7, Quality Assurance Requirements for Computer Software for Nuclear Facility Applications Subpart 2.14, Quality Assurance Requirements for Commercial Grade Items and Services (4)

14, Software Quality Assurance

Project specific Software Quality Assurance Plan(s) BGS-IM-01, Application Development and Coding Standards BGS-SQ-01, Software Change Requests BGS-SQ-02, Software Management BGS-QA-28, Commercial Grade Dedication for Computer Programs and Software Services

Attachment H Model Development, Use, and Validation

N/A N/A BGS-SQ-03, Model Validation (when issued)