QUALITY, HEALTH, SAFETY AND ENVIRONMENTAL (QHSE ...

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Transcript of QUALITY, HEALTH, SAFETY AND ENVIRONMENTAL (QHSE ...

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QUALITY, HEALTH, SAFETY AND ENVIRONMENTAL (QHSE)

MANAGEMENT SYSTEM MANUAL

“QHSE MANUAL”

RIZZO INTERNATIONAL, INC. (RIZZO) REVISION 14

DECEMBER 18, 2020 REVIEWED AND APPROVED BY: Originator(s) Signature Effective Date:

Corporate QHSE Officer

Mike Mayer

December 18, 2020

Reviewer(s) Signature

Vice President of Finance

John Paul Giunta, P.E., PMP

December 18, 2020

Chief Technology Officer

Paul C. RIZZO, Ph.D., P.E.

December 18, 2020

Verifier(s) Signature Verification method: Independent Review

Chief Operating Officer

Michael J. Edwards, P. E.

December 18, 2020

Responsible Manager Signature

President/Chief Executive Officer

Rachelle Rizzo

December 18, 2020

Approval of the Responsible Manager signifies that the document and all required reviews are complete, and the document is released for use.

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CHANGE MANAGEMENT RECORD REVISION

NO.1 DATE DESCRIPTIONS OF CHANGES/AFFECTED PAGES

0 04/09/1996 N/A

1 01/25/2002 Revised to include a definition of Principal-in-Charge. Revised to allow the Principal-in Charge to review and approve proposals and reports.

2 07/07/2005 Added references to NQA-1-2004 and 10 CFR 21. Revised to address Senior Management Roles. Revised long-term file storage location. Revised to addresses changes in storage of electronic files. Editorial changes throughout.

3 03/26/2007 Revised Section 1.0 text. Revised Table 1-1 to update references to Quality Manual sections and added references to Quality Procedures (QP). Revisions included Commercial Grade Dedication, Project Work Plans, internal audit, nonconformances, and corrective actions.

4 09/11/2007 Overall revision of Quality Manual to more closely align with 10 CFR 50 Appendix B. Manual updated to meet requirements of NQA-1-1994 and additional TMI-related requirements provided in 10 CFR 50.34(f)(3)(iii)(C), 10 CFR 50.34(f)(3)(iii)(F), and 10 CFR 50.34(f)(3)(iii)(H). All pages affected.

5 01/27/2011 Reformatted Quality Manual to the 18 criteria of 10 CFR 50 Appendix B. Revised to meet requirements of NQA-1-2008 and the NQA-1a-2009 addenda. All pages affected.

6 04/01/2011 Revised Introduction to include commitment with NQA-1-1994 and provide grandfather clause with respect to Revision 4 of the Quality Manual. In the table included in the Introduction, reference to QP-3 added, revised title of QP-14 in the list of QPs that apply to NQA-1 Subpart 2.20. Editorial changes throughout.

7 04/04/2012 The “Introduction” includes a revised discussion of the applicability of previous revisions of the Quality Manual. Added reference to QP-36. Revised Organization Chart. Added reference to QP-36, added reference to QP-29 to describe the process for

1 Revisions are with respect to 04/09/96 version of the QA Manual. Earlier versions of the RIZZO QA Manual were not considered in the revision number sequence.

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CHANGE MANAGEMENT RECORD REVISION

NO.1 DATE DESCRIPTIONS OF CHANGES/AFFECTED PAGES

acceptance of commercial grade calibration services. Editorial changes throughout.

8 07/31/2013 Expanded scope of QA Program to include all of PCR, with minor changes throughout remainder of document. Expanded the QA group to include Quality, Health, Safety, and Environmental (QHSE). Addressed conformance to 10 CFR 830, Subpart A and DOE O 414.1D.

9 12/13/2013 Expanded requirements to include IAEA , ISO 9001, ISO 17025, and Health, Safety, and Environmental requirements, thereby consolidating the ISO 9001 QM Revision 3 and NQA-1 Manual Revision 8 into one QHSE Manual.

10 09/18/2015 Added reference to “Condition Report” records used to document the identification of an unexpected / unwanted conditions, risks and/or opportunities in lei of NCR and CPARs. Described the process for acceptance of commercial grade calibration and laboratory services consistent with ML14322A535 and NEI 14-05A. Updated the organizational chart and authorities. Referred to qualification requirements established in formal procedures for Inspection and Test personnel and Auditors. Added reference to International NMIs in section 12. Added electronic record storage in Section 17. Editorial changes throughout. Revised Tables 1, 2, 3 to Addendums 1, 2, 3 separate from the QHSE Manual.

11 10/06/2017 Editorial changes to address ISO 9001:2015 and other International requirements. Changes include removing text addressed in lower level procedures.

12 01/12/2018 Revised Company Name and editorial changes.

13 05/10/2020 Added Appendix A Non-Applicability Clauses Added revised Organizational Chart Updated company logo

14 12/18/2020 Added to 1.6.9 corporate office and laboratory office legal addresses. And removed 1.1 references to ISO 17025 and ISO 14001.

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TABLE OF CONTENTS PAGE

1.0 INTRODUCTION ..................................................................................................... 10

1.1 APPLICABILITY AND SCOPE ....................................................................... 10

1.2 CLIENT FOCUS ............................................................................................... 11

1.3 MANAGEMENT COMMITMENT ......................................................................... 12

1.4 QHSE POLICY ............................................................................................... 12

1.5 QHSE OBJECTIVES ......................................................................................... 13

1.6 MANAGEMENT RESPONSIBILITY & ORGANIZATION ............................................... 13

1.6.1 President ..................................................................................... 15

1.6.2 Management Representative ..................................................... 15

1.6.3 Quality, Health, Safety, and Environmental (QHSE) Department ................................................................................ 15

1.6.4 Human Resources Department .................................................. 16

1.6.5 Accounting Department ............................................................. 16

1.6.6 Business Development & Marketing .......................................... 17

1.6.7 IT Department ............................................................................ 17

1.6.8 Project Execution ........................................................................ 17

1.6.9 Inspection and Testing................................................................ 17

1.7 INTERNAL COMMUNICATION ............................................................................ 17

1.8 INTERFACE CONTROL ...................................................................................... 18

2.0 QUALITY, HEALTH, SAFETY, AND ENVIRONMENTAL (QHSE) PROGRAM .............. 19

2.1 QHSE PLANNING ........................................................................................... 19

2.2 QHSE SYSTEM .............................................................................................. 20

2.2.1 QHSE Management System (Level 1) ......................................... 20

FIGURE 2-1, QHSE PROCESS INTERACTIONS ..................................................................... 21

2.3 RESOURCE MANAGEMENT (INDOCTRINATION AND TRAINING) ................................ 23

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2.4 MANAGEMENT REVIEW (ASSESSMENTS)............................................................. 24

2.5 MEASUREMENT, ANALYSIS & IMPROVEMENT ...................................................... 24

2.6 CONTINUAL IMPROVEMENT .............................................................................. 24

2.7 SAFETY CULTURE ............................................................................................ 24

2.8 GRADED APPROACH – RISKS & OPPORTUNITIES ................................................... 25

2.9 CONTRACT REVIEW - OPERATION ...................................................................... 25

2.9.1 Planning and Control .................................................................. 25

2.9.2 Negotiation ................................................................................. 25

2.9.3 Contract Order Entry – Requirements for products and services ....................................................................................... 26

2.9.4 Client Communication ................................................................ 26

2.9.5 Control of Client-Supplied Product ............................................ 26

3.0 DESIGN CONTROL ................................................................................................. 27

3.1 DESIGN AND DEVELOPMENT PLANNING .............................................................. 27

3.2 DESIGN INPUT ............................................................................................... 27

3.3 DESIGN PROCESS ........................................................................................... 28

3.4 DESIGN ANALYSIS ........................................................................................... 29

3.5 DESIGN OUTPUT ............................................................................................ 29

3.6 DESIGN VERIFICATION ..................................................................................... 29

3.7 DESIGN VERIFICATION METHODS ...................................................................... 30

3.8 DESIGN VALIDATION ....................................................................................... 31

3.9 DESIGN CHANGE CONTROL .............................................................................. 32

3.10 DESIGN INTERFACE CONTROL ........................................................................... 32

3.11 DESIGN DOCUMENTATION AND RECORDS ........................................................... 33

3.12 SOFTWARE CONTROL ...................................................................................... 33

3.13 QHSE ROLE IN DESIGN AND ANALYSIS ............................................................... 33

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4.0 PROCUREMENT DOCUMENT CONTROL ................................................................ 34

4.1 REQUIREMENTS ............................................................................................. 34

4.2 PROCUREMENT DOCUMENT REVIEW AND APPROVAL ............................................ 35

4.3 PROCUREMENT DOCUMENT CHANGES ............................................................... 35

5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS .................................................. 36

5.1 QUALITY PROCEDURES .................................................................................... 36

5.2 FIELD PROCEDURES......................................................................................... 36

5.3 PROJECT WORK PLANS .................................................................................... 37

5.4 HEALTH, SAFETY, & ENVIRONMENTAL (HSE) MANUAL ......................................... 37

5.5 PROJECT-SPECIFIC PROCEDURES ........................................................................ 37

5.6 PUBLISHED TEST PROCEDURES .......................................................................... 37

5.7 FORMS AND WORK INSTRUCTIONS .................................................................... 37

6.0 DOCUMENT CONTROL .......................................................................................... 38

6.1 MAJOR CHANGES TO DOCUMENTS .................................................................... 38

6.2 MINOR CHANGES TO DOCUMENTS .................................................................... 38

7.0 CONTROL OF PURCHASED ITEMS AND SERVICES ................................................. 39

7.1 PROCUREMENT PLANNING ............................................................................... 39

7.2 COMMERCIAL GRADE ITEMS AND SERVICES ......................................................... 40

7.3 QUALIFICATION AND ACCEPTANCE OF COMMERCIAL GRADE CALIBRATION AND LABORATORY SERVICES .................................................................................... 40

7.4 COUNTERFEIT AND FRAUDULENT MATERIALS, ITEMS, AND COMPONENTS ................. 40

8.0 IDENTIFICATION AND CONTROL OF ITEMS ........................................................... 41

8.1 IDENTIFICATION METHODS ............................................................................... 41

8.2 SPECIFIC REQUIREMENTS ................................................................................. 41

9.0 CONTROL OF SPECIAL PROCESSES ........................................................................ 43

10.0 INSPECTION ........................................................................................................... 44

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10.1 INSPECTION REQUIREMENTS ............................................................................. 44

10.2 INSPECTION HOLD POINTS ............................................................................... 44

10.3 INSPECTION PLANNING .................................................................................... 44

10.4 IN-PROCESS INSPECTION .................................................................................. 44

10.5 FINAL INSPECTIONS ......................................................................................... 45

10.6 INSPECTIONS DURING OPERATIONS ................................................................... 45

10.7 INSPECTION RECORDS ..................................................................................... 45

11.0 TEST CONTROL ...................................................................................................... 46

11.1 TEST REQUIREMENTS ...................................................................................... 46

11.2 TEST PROCEDURES ......................................................................................... 46

11.3 TEST RESULTS ................................................................................................ 47

11.4 TEST RECORDS ............................................................................................... 47

11.5 COMPUTER PROGRAMS ................................................................................... 48

12.0 CONTROL OF MEASURING AND TEST EQUIPMENT .............................................. 49

12.1 SELECTION AND APPLICATION ........................................................................... 49

12.2 CALIBRATION AND CONTROL ............................................................................ 49

12.2.1 Calibration Frequency ................................................................ 49

12.2.2 Reference Standards .................................................................. 49

12.2.3 Procedures .................................................................................. 50

12.2.4 Corrective Action ........................................................................ 51

12.2.5 Application .................................................................................. 51

12.2.6 Handling and Storage ................................................................. 51

12.2.7 Environmental Controls .............................................................. 51

12.2.8 Pre-Calibration Checks ............................................................... 51

12.2.9 Identification and Status Indication ........................................... 51

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12.2.10 Commercial Devices ................................................................... 52

12.3 RECORDS ...................................................................................................... 52

13.0 HANDLING, STORAGE AND SHIPPING ................................................................... 53

13.1 SPECIAL REQUIREMENTS .................................................................................. 53

13.2 PROCEDURES ................................................................................................. 53

13.3 TOOLS AND EQUIPMENT .................................................................................. 53

13.4 OPERATORS .................................................................................................. 53

13.5 MARKING OR LABELING ................................................................................... 53

14.0 INSPECTION, TEST, AND OPERATING STATUS ...................................................... 54

15.0 CONTROL OF NONCONFORMING ITEMS .............................................................. 55

15.1 IDENTIFICATION ............................................................................................. 55

15.2 SEGREGATION ................................................................................................ 55

15.3 DISPOSITION ................................................................................................. 55

15.4 NOTIFICATION REQUIREMENTS ......................................................................... 56

16.0 CORRECTIVE & PREVENTIVE ACTION, AND IMPROVEMENT ................................ 57

17.0 QHSE RECORDS ..................................................................................................... 58

17.1 GENERATION OF RECORDS ............................................................................... 58

17.2 AUTHENTICATION OF RECORDS ......................................................................... 58

17.3 CLASSIFICATION OF RECORDS ............................................................................ 59

17.4 RECEIPT CONTROL OF RECORDS ........................................................................ 59

17.5 STORAGE ...................................................................................................... 60

17.6 RETENTION AND DISPOSITION ........................................................................... 60

17.7 MAINTENANCE OF RECORDS ............................................................................. 61

18.0 AUDITS .................................................................................................................. 62

18.1 AUDIT SCHEDULES .......................................................................................... 62

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18.1.1 Internal Audits ............................................................................ 62

18.1.2 External Audits for nuclear safety related items and services ....................................................................................... 62

18.1.3 Evaluations of Suppliers ............................................................. 63

18.1.4 Audit Schedule Compliance ........................................................ 63

Appendix A Non-Applicability Clauses……………………………………………………………….…….. 65

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QHSE MANUAL RIZZO INTERNATIONAL, INC. (RIZZO)

1.0 INTRODUCTION This Quality, Health, Safety, and Environmental Management System (hereafter known as the QHSE) Manual, has been developed to comply with regulatory, industry, statutory, and client requirements imposed by clients or regulatory agencies for items and services provided by RIZZO world-wide operations. The QHSE Manual describes the RIZZO commitments to the requirements of ISO 9001; 10CFR50 Appendix B; ASME NQA-1 Edition; and other national/international regulatory requirements.

1.1 APPLICABILITY AND SCOPE

This QHSE Manual applies to activities that affect the Quality, Health, Safety, and Environmental elements of items and services supplied by RIZZO, including (but not limited to) Engineering and Construction Management (Hydro-Nuclear-Fossil), Inspection & Testing Services, Geotechnical Engineering, Seismic & Structural Engineering, Hydrological & Hydraulic Engineering, Environmental Engineering & Permits. This Manual defines the requirements applicable to client contracts and is a commitment to our clients. It serves as a directive for organizations in establishing necessary policies and procedures that comply with the following requirements as approved by RIZZO for applicable locations and projects, as well as applicable local or country specific regulations:

• ISO 9001:2015, “Quality Management Systems – Requirements” • International Atomic Energy Agency (IAEA) GSR Part 2, “Leadership and

Management for Safety” • OHSAS 18001, “Occupational Health and Safety Standard” • Title 10 of the Code of Federal Regulations, Part 50 (10 CFR 50), Appendix B,

“Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants.”

• Title 10 of the Code of Federal Regulations, Part 21, “Reporting of Defects and Noncompliance”

• Title 10 of the Code of Federal Regulations, Part 830 (10 CFR 830), “Nuclear Safety Management”, Subpart A, “Quality Assurance Requirements” and applicable portions of U.S. Department of Energy (DOE) O 414.1D.

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• ASME NQA-1-1994 Part I – Basic Requirements and Supplementary Requirements for

Nuclear Facilities.

Subpart 2.7, “Quality Assurance Requirements for Computer Software for Nuclear Facility Applications.”

Subpart 2.20, “Quality Assurance Requirements for Subsurface Investigations for Nuclear Power Plants.”

• ASME NQA-1-2008, NQA-1A-2009 Addenda Part I – Requirements for Quality Assurance Programs for Nuclear

Facilities.

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.”

Subpart 2.20, “Quality Assurance Requirements for Subsurface Investigations for Nuclear Power Plants.”

Previous revisions of the QHSE (QA) Manual are still in effect for those active Project Work Plans that were prepared under those revisions of the Quality Manual and were reviewed and accepted by the client. Previous revisions of the QA Manual will continue to apply to those Project Work Plans, including any document revisions, until completion of activities controlled by those documents.

1.2 CLIENT FOCUS

Processes are established to measure and monitor client satisfaction with regards to RIZZO performance in meeting client requirements. The methods for obtaining and using this information include client visits, trip reports, results of client audits and surveys.

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1.3 MANAGEMENT COMMITMENT

RIZZO Management is committed to the following:

a) taking accountability for the effectiveness of the QHSE management system;

b) ensuring that the QHSE policy and objectives are established for the QHSE management system and are compatible with the context and strategic direction of the organization;

c) ensuring the integration of the QHSE management system requirements into the business processes;

d) promoting the use of the process approach and risk-based thinking;

e) ensuring that the resources needed for the QHSE management system are available;

f) communicating the importance of effective quality management and of conforming to the QHSE management system requirements;

g) ensuring that the QHSE management system achieves its intended results;

h) engaging, directing and supporting persons to contribute to the effectiveness of the QHSE management system;

i) promoting improvement;

j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

1.4 QHSE POLICY

The RIZZO QHSE Policy is that employees strive to: “Meet or exceed client requirements, and seek to continuously improve our Quality, Health, Safety and Environment (QHSE)”.

RIZZO Management is responsible for ensuring that this policy is communicated, understood, and implemented at all levels of the organization, and is regularly reviewed for continuing suitability. All employees are expected to perform their responsibilities in accordance with applicable QHSE requirements, and to strive for client satisfaction and continual improvement. Maintaining an atmosphere of integrity and responsiveness is one of the most important attributes of the work environment. All employees are encouraged to openly express all concerns for the safety and quality of RIZZO items and services. The quality policy is available to relevant interested parties, as appropriate.

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1.5 QHSE OBJECTIVES

The RIZZO Goals, Plans, and Objectives involve short-term and longer-term issues identified by RIZZO management. The QHSE policy provides a framework for establishing and reviewing the company objectives. The QHSE Objectives are documented, measurable and consistent with the QHSE policy. Methods are in place as required to track, update, revise and review the plans and objectives to ensure that the plans are adhered to and communicated throughout the organization as appropriate. The QHSE Objectives take into account applicable requirements, and are relevant to the conformity of products and services, and to the enhancement of client satisfaction.

1.6 MANAGEMENT RESPONSIBILITY & ORGANIZATION

The Rizzo International, Inc. (RIZZO) President defines the overall QHSE policy, objectives, and strategic direction and promotes a culture of conformance to requirements, client satisfaction and continual improvement. The RIZZO President authorizes and endorses the RIZZO QHSE Manual, and appoints and supports a Management Representative to coordinate development, implementation, and maintenance of the QHSE Manual. Figure 1-1 illustrates the typical RIZZO operational organization reporting structures that meet the requirements and commitments of this QHSE Program. Functional responsibilities, levels of authority and lines of communication for activities affecting quality are further described in this manual and the implementing procedures.

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FIGURE 1-1 RIZZO TYPICAL ORGANIZATIONAL CHART

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1.6.1 PRESIDENT/CEO

The RIZZO President approves the QHSE Program as documented in this manual. Other responsibilities include:

• Establishes the overall expectations for effective implementation of the QHSE Program and is responsible for obtaining the desired end results.

• Reviews and approves the QHSE Manual.

• Assesses the adequacy and effective implementation of the program on an annual basis or assigns this review to the Corporate QHSE Officer.

• Ensures that the personnel and resources of the QHSE organization are commensurate with its duties and responsibilities.

• Reviews audit schedules prepared by the QHSE Staff or assigns the review and approval to the Corporate QHSE Officer.

• Serves as Responsible Officer over work activities subject to 10 CFR 21 and 10 CFR 50.55(e).

1.6.2 MANAGEMENT REPRESENTATIVE

The RIZZO Corporate QHSE Officer is appointed the designated Management Representative who, irrespective of other responsibilities, has the responsibility and authority for ensuring that the QHSE system conforms to the requirements as described in this QHSE manual, QP-39 “QHSE Management Review” and implementing procedures.

1.6.3 QUALITY, HEALTH, SAFETY, AND ENVIRONMENTAL (QHSE) DEPARTMENT

The QHSE Staff administer the RIZZO QHSE Program. QHSE Staff are independent of individuals performing project work and have Stop Work Authority. Responsibilities include:

• Development, review, and document control of the QHSE Manual and lower

level implementing procedures. • Maintains the audit schedules and program. • Has Stop Work Authority on non-compliant aspects.

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• Reviews client-specified quality requirements, as described in client purchase orders, per the requirements of QP-1, “Order Entry and Contract Review.”

• Develops and maintains an Approved Supplier List and reviews quality requirements in supplier procurement documents per QP-6, “Purchasing.”

• Maintains general Quality records as described in Procedure QP-25, “Records Management System.”

• Coordinates audits conducted by external organizations. • Stays current with standards, guidelines, policies, and trends regarding

QHSE. • Assures that an appropriate QHSE Program has been established and

verifies that activities affecting QHSE have been correctly performed.

QHSE staff and technical specialists are selected to perform and assist in the performance of audits, respectively, by QHSE Management. Selection is based on technical expertise and experience. Auditors are to be independent of any direct responsibility for performance of the activities which they will audit. Auditors have the authority, access to work areas, and organizational freedom to:

• Identify problems which affect or have the potential to affect QHSE. • Initiate, recommend, or provide solutions to QHSE problems through

designated channels. • Stop Work on non-compliant aspects. • Verify the implementation of corrective and preventive actions as a result of

internal audits. Auditors shall have direct access to management who can take appropriate actions.

1.6.4 HUMAN RESOURCES DEPARTMENT

The Human Resources Department is responsible for maintaining position descriptions for RIZZO personnel.

1.6.5 ACCOUNTING DEPARTMENT

When purchase orders are received from a client, the Accounting Department conducts a review of purchase orders per Procedure QP-1, “Order Entry and Contract Review.” Personnel in the Accounting Department are also responsible for reviewing supplier purchase orders as described in Procedure QP-6, “Purchasing.”

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1.6.6 BUSINESS DEVELOPMENT & MARKETING

Business Development & Marketing is responsible for the development of new business projects world-wide, and implementation the QHSE Program for new project development.

1.6.7 IT DEPARTMENT

The IT Manager, or staff working under the supervision of the IT Manager, is responsible for software installation, maintenance, and virus protection. The IT Manager and staff also support electronic records storage.

1.6.8 PROJECT EXECUTION

Project Execution is responsible for the project work described in the QHSE Manual and implementing procedures. Project Execution groups are led by an individual with the functional role of Project Manager, who has responsibility for general supervision of the project and its execution in accordance with the contract, the QHSE Manual, and applicable procedures.

The Project Staff includes members of the technical and support staffs assigned project tasks by the Project Manager. The Project Staff is responsible for performing activities in accordance with the QHSE Manual and other procedures applicable to the project. The Project Staff must be familiar with the project scope and project-specific requirements. Specific authorities and duties are further defined in position descriptions maintained by the Human Resources Department.

1.6.9 INSPECTION AND TESTING

Inspection and Testing are responsible for performing field and laboratory sampling, inspection, and testing that includes construction materials testing of aggregates, soils, concrete, rebar, and Roller Compacted Concrete (RCC), as well as Mix Design services and equipped with a Traveling Testing Laboratory for testing at client sites, and QHSE implementation in accordance with the contract, the QHSE Manual, applicable standards and procedures. The base laboratory office is located at: RIZZO International, Inc., 3538 Peoria Street, Suite 511, Aurora, CO 80010. The main corporate office is located at: RIZZO International, Intl., 500 Penn Center Blvd., Suite 100, Pittsburgh, PA 15235

1.7 INTERNAL COMMUNICATION

Communication processes are established and implemented regarding the performance and effectiveness of the QHSE program within RIZZO.

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1.8 INTERFACE CONTROL

Performance of project work may require interaction between various Project Execution and Business Development groups within RIZZO. There may also be interfaces with external organizations, such as a client or client’s supplier, during performance of project work. When applicable, the responsibility and authority of each organization and other interface controls are described in a Project Work Plan prepared, reviewed, approved, distributed, and revised per Procedure QP-2, “Project Work Plan.”

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2.0 QUALITY, HEALTH, SAFETY, AND ENVIRONMENTAL (QHSE) PROGRAM

The RIZZO QHSE program, as described in this manual and the implementing procedures, applies to the execution of services provided by RIZZO. RIZZO implements applicable requirements of the QHSE for nuclear safety-related items and services. RIZZO implements those requirements of the QHSE consistent with ISO 9001, for items and services that are not nuclear safety-related, as a minimum. This manual includes the following:

a) Scope of the QHSE Program b) Documented procedures established for the QHSE Program, c) Description of the interaction between the processes of the QHSE Program.

The RIZZO QHSE Program incorporates QHSE planning, provides a framework for managing the risks and opportunities (activities) that enable the company to create items and services which consistently satisfy the client, statutory, and regulatory requirements, and is a tool for achieving enhanced client satisfaction. The QHSE Manual also provides for the continual improvement by monitoring processes based on their significance, measuring their effectiveness against objectives, and management selection of processes for improvement and to prevent or reduce undesired effects. Understanding the Organization, It’s Context, and the Needs and Expectations of Interested Parties) are described in QP-39, Management Review.

2.1 QHSE PLANNING

This QHSE Manual defines and documents how the requirements for the QHSE program will be met. The planning of the QHSE program is carried out in order to meet the requirements defined in this manual, including the QHSE objectives. QHSE planning is consistent with all other requirements of the company's QHSE Program, taking into consideration the purpose of the changes and potential consequences. Controls are established to ensure that the integrity of the QHSE program is maintained when changes to the program are planned and implemented, including the availability of resources, and the allocation or reallocation of responsibilities and authorities.

Specific responsibilities for achieving and maintaining QHSE performance are stated in this manual and in the applicable implementing procedures. Personnel

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responsible for achieving and maintaining QHSE performance have the authority and responsibility to identify problems, issues, risks, or opportunities which affect or have the potential to affect the QHSE System. Such problems, issues, risks, or opportunities shall be brought either to the attention of the Project Manager and/or the QHSE Staff.

QHSE achievement is verified by the QHSE Staff. The organization provides sufficient authority, direct access to responsible levels of management, organizational freedom, and access to work to perform this function, including sufficient independence from cost and schedule considerations.

RIZZO and the companies and individuals within RIZZO that are responsible for establishing and executing the QHSE program under the applicable standards, may delegate any or all of the work to others, but shall retain responsibility therefore.

2.2 QHSE SYSTEM

Activities affecting the QHSE program are documented in accordance with written manuals, procedures, instructions, specifications, and drawings that contain appropriate criteria for determining risks and opportunities, and whether prescribed activities have been satisfactorily accomplished. The documentation is established in the following three distinct levels that integrate the policies, procedures, and working documents: • Level 1. QHSE Manual • Level 2. Quality Procedures, HSE Procedures, Project Work Plans • Level 3. Field procedures, work instructions, Records

2.2.1 QHSE MANAGEMENT SYSTEM (LEVEL 1)

The QHSE Management System is structured around interlinked processes that provide the necessary implementation controls to ensure client and regulatory requirements are met and continual process improvement. It provides the basis for policies and procedures that implement a comprehensive QHSE program. These processes are those that define activities that are directly necessary to create the item or service, and those that provide the supporting infrastructure to enable the direct processes to operate under the required controls, and continually improve.

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Figure 2-1 illustrates the continual improvement model of the RIZZO QHSE Program. This model is a process-based system that illustrates the process linkages as described in this manual to ensure that the operations and controls of the process are effective. The model emphasizes the important role of the client and regulator in defining the input requirements, and the importance of evaluating the product outputs and client satisfaction to ensure the requirements are met with the goal of continual improvement. Management of the processes and the system as a whole is achieved utilizing the Plan, Do, Check, Act (PDCA) cycle, with an overall focus on risk-based thinking aimed at taking advantage of opportunities and preventing undesirable results.

FIGURE 2-1, QHSE PROCESS INTERACTIONS The QHSE program is the foundation for the overall continual improvement model. The Quality, Health, Safety, Environmental, Information Technology (including computer

Output

Requirements

DO Processes, Indicators, Product

Realization Satisfaction

Continual Improvement

Management System Foundation Quality, Health, Safety, Environmental (QHSE)

Inputs

ACT Continual Improvement,

Nonconformity and Preventive / Corrective

Actions

Security, Finance, Information Technology

Inputs

RIZZO Services Engineering Design & Development

Inspection, Measuring, Testing

Construction Management Services

Output

CL IENTS

& REGULATORS

CL IENTS

& REGULATORS

CHECK Monitoring, Analysis, Evaluation,

Audits, Management Review

PLAN

Leadership, Policy, Objectives, Resources,

Roles & Responsibilities

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software), and Finance Systems are key aspects in the company to support the overall operation of the company. The Implementing policies and procedures (Levels 2 and 3) provide the details of interaction and sequence for the processes.

In case of conflict between an existing procedure or instruction and this QHSE Manual, the control provided by this QHSE Manual shall prevail.

The RIZZO QHSE Manual, implementing procedures, and other applicable instructions, procedures, or drawings describe:

• Control over activities affecting QHSE to an extent consistent with their importance.

• Assignment of the responsibilities and authorities for these processes, determining the inputs required and the outputs expected from these processes, the associated risks and opportunities, and the sequence and interaction of these processes

• Determining the criteria and methods (including monitoring, measurements and related performance indicators) applied to ensure the effective operation and control of these processes;

• Monitoring activities against acceptance criteria in a manner sufficient to provide assurance that the activities affecting QHSE are performed satisfactorily, and

• Suitably controlled conditions including the use of appropriate equipment, suitable environmental conditions for accomplishing the activity, and assurance that all prerequisites for the given activity have been satisfied.

• Determining the resources needed for these processes and ensuring their availability. These may include special controls, processes, test equipment, tools, and skills to attain the required QHSE activities and items and for verification.

• Processes to detect and correct QHSE issues.

• Improve the QSHE processes and implement changes to ensure that these processes achieve their intended results.

• Documented information to support and provide confidence that the processes are being carried out as planned

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2.3 RESOURCE MANAGEMENT (INDOCTRINATION AND TRAINING)

Necessary resources are provided to implement, maintain, and continually improve the effectiveness of the QHSE program, and to enhance client satisfaction. Competent, properly trained and/or qualified personnel are provided to accomplish work activities. Personnel are made aware how their activities support achievement of their organization’s QHSE objectives, including benefits of improved performance and the implications of not conforming. Adequate facilities, equipment, services, information and work environment are provided and managed to support the delivery of items and services in compliance with client and regulatory requirements. Managers of activities affecting QHSE are responsible for 1) determining the personnel competencies necessary for the assigned activities and assessing associated needs, 2) ensuring necessary actions (e.g., training) are taken to satisfy these needs and 3) evaluating these actions to confirm that personnel are adequately trained, competent and qualified to manage and perform assigned work activities, and maintained to ensure their continuing fitness for their purpose. RIZZO personnel performing or managing activities affecting QHSE receives indoctrination in their job responsibilities and authority that includes general criteria, technical objectives, requirements of applicable codes and standards, regulatory commitments, company procedures, QHSE requirements, applicable project specific requirements, and new or revised procedures / documents. This indoctrination includes training on the RIZZO QHSE Manual and those procedures relevant to the staff member's position. The extent of the indoctrination and training depends on the scope, complexity, and nature of the activities that they perform and on the education, experience, and proficiency of the person. Training is provided as needed to achieve initial proficiency, to maintain proficiency, and to adapt to changes in technology, methods, or job responsibilities. On-the-job training may be used if direct hands-on applications or experience is needed to achieve and maintain proficiency. Historical records of personnel education and experience serve as documentation of competency, and are supplemented by applicable training records. Actions to build or maintain necessary competencies are documented, and records are maintained in accordance with the applicable records procedures.

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2.4 MANAGEMENT REVIEW (ASSESSMENTS)

Management reviews are conducted on (at least) an annual basis to assess the adequacy and effective implementation of the QHSE Program. This review is conducted by the Corporate QHSE Officer with the RIZZO Management as described in QP-39, “Management Review”.

2.5 MEASUREMENT, ANALYSIS & IMPROVEMENT

The QHSE system provides control over a system of interlinked individual processes. These processes are monitored and the resulting data is used to demonstrate conformance to specified requirements, to ensure conformity of the QHSE system, and support corrective, preventive or continual improvement actions. The management review process identifies the significant processes that are targeted for improvement and the associated objectives. This monitoring, measuring and analysis is used to support the management review process to evaluate the suitability and effectiveness of the QHSE program and where continual improvement of the effectiveness of the program can be made. Statistical techniques are incorporated into processes, to the extent necessary to ensure that acceptable items and services are provided in an acceptable manner. The procedures that describe this application are implemented when specified requirements, process capability, or item performance characteristics can be evaluated using statistical techniques to determine item or service acceptability or to identify improvement opportunities.

2.6 CONTINUAL IMPROVEMENT

RIZZO management strive to continually improve the effectiveness of the QHSE program through the use of the QHSE policy, objectives, audit results, analysis of data, corrective and preventive actions, and management review.

2.7 SAFETY CULTURE

Free and open expression of safety concerns is an essential attribute of the RIZZO safety-conscious work environment. It is the RIZZO policy that all employees and all personnel of RIZZO contractors working at RIZZO facilities or its client’s sites are free and encouraged to raise safety concerns and that such concerns are promptly reviewed, investigated as necessary and resolved with timely feedback to the concerned individual. Any issues relating to safety can be raised by employees of RIZZO and personnel of its contractors without fear of discrimination, intimidation,

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harassment or retaliation and that those issues receive prompt and appropriate attention.

The RIZZO management system is used to promote and support a strong QHSE culture by: • Ensuring a common understanding of the key aspects of the QHSE culture • Providing the means to support individuals and teams in carrying out their

tasks safely and successfully, taking into account the interaction between individuals, technology and the company

• Reinforcing a learning and questioning attitude at all levels of the company • Providing the means to continually seek to develop and improve the safety

culture.

2.8 GRADED APPROACH – RISKS & OPPORTUNITIES

The application of the QHSE Manual requirements is graded to ensure appropriate resources are assigned in consideration of the following:

• The significance and complexity of each product, project, or activity, • The hazards and the magnitude of the potential risks associated with the

quality, health, safety, environmental, security and financial elements of each product or activity,

• The possible consequences if a product fails or an activity is carried out incorrectly.

2.9 CONTRACT REVIEW - OPERATION

2.9.1 PLANNING AND CONTROL

Marketing, Project Managers, and other designated personnel are responsible for planning, coordinating negotiation and contract review activities as describe in Procedure QP-1, “Order Entry and Contract Review”.

2.9.2 NEGOTIATION

Marketing and/or designated organizations distribute copies of client specifications and subsequent changes regarding technical, administrative, and QHSE requirements to appropriate groups for review and comment prior to proposal submittal. This review is performed to ensure that client requirements are adequately defined and understood, and that the capability exists to meet these

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requirements. During the review, marketing and/or designated organizations coordinate communication with the client. Records of the results of the reviews and actions arising from the reviews are maintained.

2.9.3 CONTRACT ORDER ENTRY – REQUIREMENTS FOR PRODUCTS AND SERVICES

Client orders and amendments received are formally reviewed by Project Managers and other designated organizations at the time of entry. This review is performed to enhance client satisfaction by ensuring that 1) all stated client requirements are adequately defined and documented, 2) that other requirements, including those not stated by the client but necessary for the application (e.g. regulatory) are determined and considered where known, and 3) that the capability exists to meet the client requirements including delivery and post-delivery requirements. Requirements that differ from those in the final proposal are communicated to the client and resolved. Documentation of this review is maintained in accordance with established procedures. After acceptance, the client order and subsequent amendments are distributed to appropriate organizations. Records of the results of the review and actions arising from the review are maintained. The planning and preparation of Project Work Plans are developed for contracts, as needed, in order to establish the objectives, requirements, documentation, records, resources, processes, verification, validation, monitoring, inspection, and test activities needed to achieve the QHSE requirements.

2.9.4 CLIENT COMMUNICATION

Project Managers and other designated organizations determine and implement effective arrangements for communicating with clients in relation to a) product/service information, b) enquiries, contracts handling including amendments, and c) review, feedback, and complaints.

2.9.5 CONTROL OF CLIENT-SUPPLIED PRODUCT

When client items and material are supplied in accordance with contractual requirements, the applicable Project Manager or other designated organizations communicate the appropriate client requirements to the responsible organizations. The client’s items and material are identified, verified, protected, safeguarded, controlled and processed using the controls in this QHSE Program. Any client-supplied item or material that is lost, damaged, or otherwise unsuitable for use is documented and reported to the client.

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3.0 DESIGN CONTROL

Design documents prepared by RIZZO may include calculations, design reports, design drawings, regulatory submittals such as Safety Analysis Report (SAR) Sections, specifications, work procedures, responses to Requests for Information (RFI) from other design organizations, responses to Nuclear Regulatory Commission (NRC) Requests for Additional Information (RAI), commercial grade dedication plans and reports, and software verification and validation documentation. RIZZO also develops computer software as a design activity. These design documents and related activities are defined, controlled, and verified as described in this section and the referenced implementing procedures. Design inputs are specified on a timely basis, to support client schedule requirements, and correctly translated into design documents.

3.1 DESIGN AND DEVELOPMENT PLANNING

Design organizations are responsible for establishing and documenting a plan for a specific development or design activity of products. The plan shall provide a description of the design scope, verification and validation methodology, the identification of qualified personnel responsible for the design activity, key milestones, and design interfaces necessary to accomplish the design. Plans shall be maintained and implemented throughout the design activity. Design and development planning includes consideration of internal and external activities, as applicable, regarding a) resources, expected level of involvement and control of relevant interested parties for the design and development process.

3.2 DESIGN INPUT

Applicable design inputs, such as design bases, performance requirements, regulatory requirements, codes and standards, shall be identified and documented, and their selection reviewed and approved by the responsible design organization. Design input shall be specified to the level of detail necessary to permit the design activities to be carried out in a correct manner and to provide a consistent basis for making design decisions, accomplishing design verification measures, and evaluating design changes. The design organizations are responsible for the resolution of incomplete, ambiguous, or conflicting design inputs. Sources of design input may include, as applicable:

• Clients specifications

• Performance requirements

• Functional requirements

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• Industry codes and standards

• Regulatory and statutory requirements

• Technical requirements and other requirements essential for design and development

• Information derived from previous similar designs

3.3 DESIGN PROCESS

Design activities are prescribed and documented on a timely basis and to the level of detail necessary to permit the design process to be carried out in a correct manner and to permit verification that the design meets requirements.

These procedures may be supplemented or replaced by project-specific controls as described in documents prepared per Section 5.0. During the design and construction phases, QHSE personnel review and concur with QHSE related procedures associated with design, construction, and installation.

Procedures describing the design process are based on the following criteria:

• The resulting design documents support facility design, construction, and operation.

• Appropriate standards are identified and documented, and their selection reviewed and approved.

• Changes from specified standards, including the reasons for the changes, are identified, approved, documented, and controlled.

• Design methods, materials, parts, equipment, and processes that are essential to the function of the items are selected and reviewed for suitability of application.

• Applicable information derived from experience, as set forth in reports or other documentation, are made available to cognizant design personnel.

• The final design shall be relatable to the design input by documentation in sufficient detail to permit design verification.

• The final design shall specify any required inspections and tests and include or reference appropriate acceptance criteria.

• Assemblies and/or components that are part of the item being designed shall be identified. When such an assembly or component part is a commercial grade item, the critical characteristics of the item to be verified for acceptance

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and the acceptance criteria for those characteristics shall meet the requirements of the applicable NQA-1 standards. Critical characteristics to be verified are those that provide reasonable assurance that the item will perform its intended safety function. See Procedure QP-29, “Commercial Grade Dedication,” for additional information.

3.4 DESIGN ANALYSIS

Design analysis shall be performed in a planned, controlled, and documented manner. Design analyses shall be sufficiently detailed as to purpose, method, assumptions, design input, references and units, such that a person technically qualified in the subject can review and understand the analyses and verify the adequacy of the results without recourse to the originator.

Documentation of design analysis activities includes the following as applicable:

• The objective of the analyses.

• Design inputs and their sources.

• Results of literature searches or other applicable background data.

• Assumptions and indication of those assumptions that must be verified as the design proceeds.

• Identification of computer calculation, inputs, outputs, and supporting application of the computer program to the specific problem.

• Review and approval.

3.5 DESIGN OUTPUT

Typical design output includes analyses, design reports, drawings, and specifications. RIZZO management is responsible for ensuring that the design output complies with design input requirements, client and regulatory requirements, considers the safe and proper functioning of the designed items, and specify the characteristics of the product that are essential for its safe and proper use. Design outputs provide appropriate information for purchasing, production and service provision, and product acceptance criteria.

3.6 DESIGN VERIFICATION

Procedures describing the design process are based on using the design review methodology for verifying a design. Where an alternative methodology is

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proposed, it shall meet the requirements of Section 3 and instructions shall be described in documents prepared per Section 5.0.

The results of design verification shall be documented, with the identification of the verifier clearly indicated. Design verification shall be performed by competent individual(s) or group(s) other than those who performed the original design, but who may be from the same organization. If necessary, this verification may be performed by the originator’s supervisor, provided that 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, or the supervisor is the only individual in the organization competent to perform the verification.

Design verification is performed prior to releasing the design for procurement, manufacture, construction, or use by another design organization, except in those cases where this timing cannot be met, such as when insufficient data exists. In those cases, the unverified portion of the design shall be identified and controlled. In all cases, the design verification shall be completed prior to relying upon the component, system, structure, or computer program to perform its function. If the design is modified to resolve verification findings, the modified design shall be verified prior to release or use.

The extent of the design verification shall be a function of the importance to safety, the complexity of the design, the degree of standardization, the state of the art, and the similarity with previous proved designs. Where the design has been subjected to a verification process in accordance with this section, the verification process need not be duplicated for identical designs. However, the application of standardized or previously proven designs, with respect to meeting pertinent design inputs, shall be verified for each application. Known problems affecting the standard or previously proved designs and their effects on other features are considered. The original design and associated verification documentation are referenced in records of subsequent application of the design.

3.7 DESIGN VERIFICATION METHODS

The adequacy of designs prepared by RIZZO, including design input, processes, outputs, and changes, shall be verified by one or more of the following methods:

• Design reviews

• Alternate calculations

• Qualification testing

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When the design is verified using design reviews, the following items shall be addressed, where applicable:

• Were the design inputs correctly selected?

• Are assumptions necessary to perform the design activity adequately described and reasonable? Where necessary, are the assumptions identified for subsequent re-verifications when the detailed design activities are completed?

• Were appropriate design methods and computer programs used?

• Were the design inputs correctly incorporated into the design?

• Is the design output reasonable compared to design inputs?

• Are the necessary design input and verification requirements for interfacing organizations specified in the design documents or in supporting procedures or instructions?

• Have suitable materials, parts, processes, and inspection and testing criteria been specified?

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

Qualification testing shall demonstrate adequacy of performance under conditions that simulate the most adverse design conditions. Operating modes and environmental conditions shall be considered in determining the most adverse conditions. Where the test is intended to verify only specific design features, the other features of the design shall be verified by other means. If qualification testing indicates that modifications to the item are necessary to obtain acceptable performance, the modification shall be documented and the item modified and retested or otherwise verified to assure satisfactory performance. When tests are being performed on models or mockups, scaling laws shall be established and verified. The results of model test work shall be subject to error analysis, where applicable, prior to use in the final design.

3.8 DESIGN VALIDATION

Design and development validation, such as qualification or final product testing, is performed to ensure that the product conforms to the specified user requirements. Wherever practicable, validation is performed during earlier stages

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of the design process using methods such as in-process testing, prior to the delivery or implementation of the product.

3.9 DESIGN CHANGE CONTROL

Changes to design inputs, final designs, field changes, and temporary and permanent modifications to operating facilities shall be justified and subject to design control measures commensurate with those applied to the original design. These measures shall include evaluation of effects of those changes on the overall design and on any analysis upon which the design is based. The review of design changes shall include evaluation of the effect of the changes on product and services already delivered. These measures shall include assurance that the design analyses for the structure, system, or component are still valid. The evaluation shall include facility configurations that occur during operation, maintenance, test, surveillance, and inspection activities. Changes shall be approved by the same affected groups or organizations that reviewed and approved the original design documents. When the organization originally responsible for review and approval of the original design documents is no longer responsible, the owner or his designee shall have responsibility or designate a new responsible organization. The design organization approving the change shall have demonstrated competence in the specific design area of interest and have an adequate understanding of the requirements and intent of the original design. When a design change is approved other than by revision to the affected design documents, measures shall be established to incorporate the change into these documents, where such incorporation is appropriate. Where a significant design change is necessary because of an incorrect design, the design process and verification procedure shall be reviewed and modified as necessary.

The configuration of design documents prepared by RIZZO is controlled for the duration of involvement with a nuclear power plant project. Configuration management is implemented through Procedure QP-19, “Configuration Management.” The configuration is established upon the completion of design documents and is maintained for the duration of involvement with a project. Measures are provided to ensure that changes that may affect the configuration are recognized and processed.

3.10 DESIGN INTERFACE CONTROL

Design organizations are responsible for establishing design interfaces with other organizations necessary to accomplish design project objectives. Interface controls include the assignment of responsibility and the establishment of procedures

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among participating organizations for the review, approval, release, distribution, and revision of documents involving design interfaces.

The Project Manager shall perform a final review prior to transmittal of design information across interfaces. Design information shall be accompanied by a transmittal describing the documentation being transmitted, the status of the design information or documentation provided, and identification of incomplete items that require further evaluation, review, or approval. Design information issued as "preliminary" or "draft" is to be clearly marked as such and is not to be signed as approved prior to issue. Where it is necessary to initially transmit design information orally or by other informal means, the transmittal shall be confirmed promptly by a formal document.

3.11 DESIGN DOCUMENTATION AND RECORDS

Design documentation and records include not only final design documents, such as drawings and specifications, and revisions to those documents, but also the documentation that identifies the important steps in the design process, including sources of design input that support the final design, design reviews, verification, validation, and necessary actions.

3.12 SOFTWARE CONTROL

The acceptability of computer programs used for design analysis are controlled in accordance with Procedure QP-7, “Software.”

3.13 QHSE ROLE IN DESIGN AND ANALYSIS

QHSE Staff provide oversight of the QHSE design and analysis through audits conducted per Section 18.0. During the Design and Construction phases, design documents are reviewed by individuals knowledgeable and qualified in QHSE to ensure that the documents contain the necessary QHSE requirements.

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4.0 PROCUREMENT DOCUMENT CONTROL Procedure QP-6, “Purchasing,” describes the process for assuring that applicable design bases and other QHSE requirements are included or referenced in documents for procurement of items and services. To the extent necessary, procurement documents require suppliers to have a QHSE program consistent with the applicable client purchase order requirements, such as ISO 9001, NQA-1-1994 and/or NQA-1-2008 with NQA-1a-2009 Addenda. Examples of items and services typically procured by RIZZO, and requiring procurement document control, include:

• Consulting services • Audit services • Drilling services • Laboratory services • Monitoring equipment or services • Measuring and test equipment calibration services • Specialty testing equipment or services

The types of procurement documents issued by RIZZO include supplier agreements and purchase orders.

4.1 REQUIREMENTS

Procurement documents are to state applicable requirements for technical performance, quality, health, safety, environmental, acceptability, and documentation. As appropriate, the documents include the following requirements: • Scope of Work • Technical Requirements (includes approval of product, procedures, processes,

equipment and qualification of personnel; • QHSE Program Requirements • Right of Access • Documentation requirements • Methods for reporting and approving disposition of nonconformances • Spare and replacement parts

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4.2 PROCUREMENT DOCUMENT REVIEW AND APPROVAL

Reviews of purchase orders and supplier agreements, and changes thereto, are made prior to contract award to assure that documents submitted to prospective supplier(s) include appropriate provisions to assure that items or services will meet the specified requirements. Technical or QHSE Program changes made as a result of bid evaluations or negotiations are incorporated into the procurement documents prior to their issuance to the supplier. This review includes the following considerations:

• Appropriate requirements as specified in Section 4.1

• Determination of any additional or modified design criteria

• Analysis of exceptions or changes requested or specified by the Supplier and determination of the effects such changes may have on the intent of the procurement documents or QHSE of the item or service to be furnished.

Reviews of procurement documents shall be performed by personnel who have access to pertinent information and have an adequate understanding of the requirements and intent of the procurement documents. In addition, QHSE requirements included in procurement documents are reviewed by QHSE staff.

4.3 PROCUREMENT DOCUMENT CHANGES

Procurement document changes affecting the technical or QA Program requirements shall be subject to the same degree of control as was utilized in the preparation of the original document.

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5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS Activities affecting QHSE items 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. Monitoring and measuring equipment, validation requirements, use of suitable equipment, and product release and delivery methods shall be described, as necessary. The activity shall be 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 shall be determined based upon complexity of the task, the significance of the item or activity, work environment, and worker proficiency and capability (education, training, experience). Within the QHSE Program, the following types of instructions, procedures, plans, and drawings are typically used:

• Quality Procedures (see Section 5.1) • Field Procedures (see Section 5.2) • Project Work Plans (see Section 5.3) • Health, Safety, & Environmental (HSE) Manual (see Section 5.5) • Project-Specific Procedures (see Section 5.6) • Published Test Procedures (see Section 5.7) • Forms and Work Instructions (see Section 5.8)

5.1 QUALITY PROCEDURES

Quality Procedures provide details of the process to be used to implement the requirements within this QHSE Manual. These procedures are developed, reviewed, approved, and revised per Procedure QP-24, “Document Control.”

5.2 FIELD PROCEDURES

Field Procedures provide field testing, data acquisition, documentation, or calibration procedures. Field Procedures are developed, reviewed, approved, and revised per Procedure QP-24, “Document Control.”

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5.3 PROJECT WORK PLANS

Project Work Plans provide details on the project activities to be performed by RIZZO and their suppliers. Project Work Plans are used to document instructions related to the fulfillment of client purchase order requirements, as identified during a purchase order review conducted per Procedure QP-1, “Order Entry and Contract Review.” Project Work Plans are prepared, reviewed, approved, and revised per Procedure QP-2, “Project Work Plans.” Control of Project Work Plans is performed per Procedure QP-24, “Document Control.”

5.4 HEALTH, SAFETY, & ENVIRONMENTAL (HSE) MANUAL

The RIZZO Health, Safety & Environmental Manual applies to all activities, and states objectives which, when met, will prevent or reduce the risk of a harmful event.

5.5 PROJECT-SPECIFIC PROCEDURES

Where necessary based on project requirements, project-specific procedures may be used to prescribe work activities. Project-specific procedures are developed, reviewed, approved, and revised per Procedure QP-24, “Document Control.”

5.6 PUBLISHED TEST PROCEDURES

For appropriate situations, published test procedures (such as ASTM Standards) are used as reference documents and can be the prescribed work instruction. Test procedures shall include adequate instructions to assure the required quality of the work. Unless otherwise indicated, the current revision of the published test procedures that has been reviewed and implemented by RIZZO shall be used. Where published test procedures are used as the work instruction, a reference to the published test procedure should be included in the Project Work Plan.

5.7 FORMS AND WORK INSTRUCTIONS

Forms and/or Work Instructions may be used to document specific tasks required to meet procedural requirements. When required, these shall be controlled per Procedure QP-24, “Document Control”.

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6.0 DOCUMENT CONTROL The preparation, issue, and change of documents that specify QHSE requirements or prescribe activities affecting QHSE, such as instructions, procedures, and drawings (as described in Section 5.0) shall be controlled to ensure that the current revision status of documents are identified, relevant versions of applicable document are available at the points of use, and correct documents are being employed. Such documents, including changes thereto, shall be reviewed for adequacy and approved for release by authorized personnel. Procedure QP-24, “Document Control,” addresses the following controls applied to documents and changes thereto:

• The identification of controlled documents, including documents of external origin.

• The specified distribution of controlled documents for use at the appropriate location.

• The identification of the individuals responsible for the preparation, review, approval, and distribution of controlled documents.

• The review of controlled documents for adequacy, completeness and approval prior to distribution.

• A method to ensure that correct documents are being used. • Methods to prevent unintended use of obsolete documents, and identification

if obsolete documents are retained for any purposes.

6.1 MAJOR CHANGES TO DOCUMENTS Changes to documents, other than those defined below as minor changes, are considered as major changes and are reviewed and approved by the same organizations that performed the original review and approval unless other organizations are specifically designated. The reviewing organization shall have access to pertinent information upon which to base their approval.

6.2 MINOR CHANGES TO DOCUMENTS Minor changes to documents, such as inconsequential editorial corrections, do not require that the revised documents receive the same review and approval as the original documents. To avoid a possible omission of a required review, the type of minor changes that do not require such a review and approval and the persons who can authorize such decisions are delineated in Procedure QP-24, “Document Control.”

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7.0 CONTROL OF PURCHASED ITEMS AND SERVICES The procurement of items and services shall be controlled to ensure conformance with specified requirements. Such control shall provide for the following, as appropriate: source evaluation and selection; evaluation of objective evidence of QHSE furnished by the supplier; and source inspection, audit, and examination of items or services upon delivery or completion.

7.1 PROCUREMENT PLANNING

Procurement activities are planned and documented to assure a systematic approach to the procurement process. Procurement planning addresses the following activities as appropriate:

• What is to be accomplished? • Who is to accomplish it? • How it is to be accomplished? • When it is to be accomplished?

Planning is accomplished as early as practicable, no later than the start of procurement activities which are required to be controlled, to assure interface compatibility and a uniform approach to the procurement process.

Planning results in the documented identification of methods to be used in procurement activities, sequence of actions and milestones indicating the completion of these activities, and the preparation of applicable procedures prior to the initiation of each individual activity listed below. Planning provides for the integration of the following:

• Selection of procurement sources, procurement document preparation, review and change control per Procedure QP-6, “Purchasing.”

• Bid evaluation and award

• Control of supplier performance

• Verification (surveillance, inspection, or audit) activities by Purchaser including notification for hold and witness points

• Control of nonconformances.

• Corrective action

• Acceptance of items or service

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7.2 COMMERCIAL GRADE ITEMS AND SERVICES

Controls for commercial grade items and services are described in Procedure QP-29, “Commercial Grade Dedication.” These controls include the process for evaluating a commercial grade item or service to provide reasonable assurance that the item or service will perform its safety function.

Procedure QP-29, “Commercial Grade Dedication,” is based on 10 CFR 21 and NQA-1-2008 and the NQA-1a-2009 Addenda. It is supplemented by NEI 14-05A “Guidelines for the Use of Accreditation In Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration And Test Services,” Revision 0.

Following the Commercial Grade Dedication of an item or service, RIZZO is responsible for identifying and evaluating deviations, reporting defects, and failures to comply associated with substantial safety hazards for a dedicated item. See Procedure QP-8, “10 CFR 21 Program Procedure,” for additional information.

7.3 QUALIFICATION AND ACCEPTANCE OF COMMERCIAL GRADE CALIBRATION AND LABORATORY SERVICES

Suppliers of commercial-grade calibration and laboratory services for safety-related applications may be qualified on the basis of accreditation as described per Procedure QP-29, “Commercial Grade Dedication.”

7.4 COUNTERFEIT AND FRAUDULENT MATERIALS, ITEMS, AND COMPONENTS

It is the policy of RIZZO to provide awareness to our employees of the potential risk for Suspect and Counterfeit Items (S/CIs) to enter the supply chain as described in QP-38, “Suspect and Counterfeit Items Prevention”. This awareness and barriers are instituted to 1) preclude introduction of such items into our organization, 2) ensure items and services meet specified requirements, and to 3) ensure detection, control, reporting, and disposition of S/CIs.

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8.0 IDENTIFICATION AND CONTROL OF ITEMS Procedures are established to specify the methods and extent of identification and traceability of items to ensure that only correct and acceptable items are installed or used in items and services. Within the scope of services performed by RIZZO, identification and control of items typically applies to aggregate and bulk soil samples, concrete samples, and samples of soil, rock, water and other materials that are collected during a site investigation or testing program. Refer to Procedure QP-26, “Sample Identification and Control”.

8.1 IDENTIFICATION METHODS

Items of production (e.g., batch, lot, component, part) are identified from the initial receipt and fabrication of items up to and including installation and use. This identification shall relate an item to an applicable design or other pertinent specifying document.

Physical identification shall be used to the maximum extent possible. Where physical identification on the item is either impractical or insufficient, physical separation, procedural control, or other, appropriate means shall be employed. Identification markings are applied using materials and methods that provide a clear and legible identification and do not degrade the function or service life of the item. Markings shall be transferred to each part of an identified item when subdivided and shall not be obliterated or hidden by surface treatment or coating unless other means of identification are substituted.

8.2 SPECIFIC REQUIREMENTS

When codes, standards, or specifications include specific identification or traceability requirements (such as grade of material; heat, batch, lot, part, serial number; inspection, test, or other records), the program shall provide such identification and traceability control. Items having limited calendar or operating life or cycles shall be identified and controlled to preclude use of items whose shelf life or operating life has expired.

Provisions shall be made for the control of item identification consistent with the planned duration and conditions of storage, such as: • Provisions for maintenance or replacement of markings and identification

records due to damage during handling or aging.

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• Protection of identifications on items subject to excessive deterioration due to environmental exposure.

• Provisions for updating existing plant records.

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9.0 CONTROL OF SPECIAL PROCESSES Special processes are those in which the results are highly dependent on the control of the process or the skill of the operator, or both, and in which the specified quality cannot be readily determined by inspection or test of the product. Special processes that control or verify quality, such as those used in welding, heat treating, and nondestructive examination, shall be performed by qualified personnel using qualified procedures in accordance with specified requirements. Special processes shall be controlled by instructions, procedures, drawings, checklists, travelers, or other appropriate means. Special process instructions shall include or reference procedure, personnel, and equipment qualification requirements. Conditions necessary for accomplishment of the process shall be included. These conditions shall include proper equipment, controlled parameters of the process, specified environment, and calibration requirements. The requirements of applicable codes and standards, including acceptance criteria for the process, shall be specified or referenced in procedures or instructions. For special processes not covered by existing codes and standards or where quality requirements specified exceed those of existing codes and standards, the necessary requirements for qualifications of personnel, procedures, or equipment shall be specified or referenced in procedures or instructions. It is the responsibility of the organization performing the special process to adhere to the approved procedures and processes. Records shall be maintained as appropriate for the currently qualified personnel, processes, and equipment of each special process.

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10.0 INSPECTION Inspections required to verify conformance of an item or activity to specified requirements or continued acceptability of items or services shall be planned and executed. Characteristics subject to inspections and inspection methods shall be specified. Inspection results shall be documented. Inspection for acceptance shall be performed by qualified persons other than those who performed or directly supervised the work being inspected. Receiving inspection may be applied as a method to accept supplier furnished items or services. Procedure QP-32, “Inspection and Test,” provides the implementing procedure for this type of inspection.

10.1 INSPECTION REQUIREMENTS

Inspection requirements and acceptance criteria include specified requirements contained in the applicable design documents or other pertinent technical documents approved by the responsible design organization.

10.2 INSPECTION HOLD POINTS

If mandatory inspection hold points are required beyond which work shall not proceed without the specific consent of the designated representative, the specific hold points shall be indicated in appropriate documents. Consent to waive specified hold points shall be recorded prior to continuation of work beyond the designated hold point.

10.3 INSPECTION PLANNING

Characteristics to be inspected, methods of inspection, and acceptance criteria shall be identified during the inspection planning process. Sampling procedures, when used, shall be based upon standard statistical methods with engineering approval.

10.4 IN-PROCESS INSPECTION

Inspection of items under construction or otherwise in process shall be performed as necessary to verify quality (including HSE, as applicable). If inspection of processed items is impossible or disadvantageous, indirect control by monitoring of processing methods, equipment, and personnel shall be provided. Process monitoring shall be performed by qualified personnel or qualified automated

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means. Both inspection and process monitoring shall be provided when control is inadequate without both. A combination of inspection and process monitoring methods, when used, shall be performed in a systematic manner to assure that the specified requirements for control of the process and quality of the item are being achieved throughout the duration of the process. Controls, where required, shall be established and documented for the coordination and sequencing of these activities at established inspection points during successive stages of the conducted process or construction.

10.5 FINAL INSPECTIONS

Final inspections shall include a records review of the results and resolution of nonconformances identified by prior inspections. The final inspection shall be planned to arrive at a conclusion regarding conformance of the item to specified requirements. Completed items shall be inspected for completeness, markings, calibration, adjustments, protection from damage, or other characteristics as required to verify the quality and conformance of the item to specified requirements. Quality records shall be examined for adequacy and completeness if not previously so examined. Any modifications, repairs, or replacements of items performed subsequent to final inspection shall require re-inspection or retest, as appropriate, to verify acceptability. The acceptance of the item shall be approved by authorized personnel.

10.6 INSPECTIONS DURING OPERATIONS

Periodic inspections (e.g., in-service inspections) or surveillances of structures, systems, or components are planned and executed to assure the continued performance of their required functions.

10.7 INSPECTION RECORDS

Inspection Records shall, at a minimum, identify the following:

• Item inspected • Type of observation • Date of inspection • Results or acceptability • Inspector • Reference to information on action taken in

connection with nonconformances

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11.0 TEST CONTROL Tests required to collect data, such as for siting or design input, to verify conformance of an item or computer program to specified requirements, or to demonstrate satisfactory performance for service shall be planned and executed. Characteristics to be tested and test methods to be employed shall be specified. Test results shall be documented, and their conformance with test requirements and acceptance criteria shall be evaluated.

11.1 TEST REQUIREMENTS

Test requirements and acceptance criteria shall be provided or approved by the responsible design organization. Required tests including, as appropriate, prototype qualification tests, production tests, proof tests prior to installation, construction tests, preoperational tests, and operation tests shall be controlled. Required tests shall be controlled under appropriate environmental conditions using the tools and equipment necessary to conduct the test in a manner to fulfill the test requirements and acceptance criteria. The tests performed shall obtain the necessary data with sufficient accuracy for evaluation and acceptance. Test requirements and acceptance criteria shall be based upon specified requirements contained in applicable design documents, or other pertinent technical documents that provide approved requirements. If temporary changes to the approved configuration of a facility are required for testing purposes, approval by the design authority is required prior to performing the test.

11.2 TEST PROCEDURES

Test procedures shall include or reference the test configuration and test objectives. Test procedures shall also include provisions for assuring that prerequisites and environmental conditions are met, adequate instrumentation is available and used, appropriate tests and equipment are used, and necessary monitoring is performed. Prerequisites shall include the following, as applicable:

• Calibrated instrumentation

• Appropriate equipment

• Trained personnel

• Condition of test equipment and the item to be tested

• Suitable environmental conditions

• Provisions for data acquisition

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Within the RIZZO Program, test procedures are provided in Field Procedures, Project Work Plans, Project-Specific Procedures, or published test procedures.

11.3 TEST RESULTS

11.3.1 General Requirements Test results shall be documented and maintained. Test results shall be evaluated by a qualified individual to demonstrate that test requirements have been satisfied.

11.3.2 Additional Requirements for Compliance with NQA-1, Subpart 2.20

For projects requiring compliance with NQA-1, Subpart 2.20, field activities and test results shall be documented in suitable test reports and data sheets. Each report shall identify the activity to which it applies, the procedures or instructions followed in performing the task, and the identification of the following: • Pertinent test data such as identification of sample giving boring or test pit

number, depth and elevation, test results, testing equipment identification, and description of sample

• Significant dates and times • Test completion signatures • Results of test • Unusual conditions encountered

The signature of an approving reviewer constitutes a certification that the techniques utilized met the field and laboratory procedures.

11.4 TEST RECORDS

Test records shall be established and maintained to indicate the ability of the item to satisfactorily perform its intended function or to meet its documented requirements. Test forms shall be used to document the performance of the test. Test records vary depending on the test type, purpose, and application, but shall contain the following information, as a minimum, as listed below. Test records contain the following: • Project name and/or number • Item tested or, in the case of a field test, the location (e.g., boring, well,

coordinates, depth, etc.) • Date of test • Identification of test personnel • Type of observation and/or test data

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• Test data reduction (if applicable) • Results and acceptability • Action taken in connection with any deviations • Person evaluating test results • Identification and calibration due date for measuring and test equipment used

(if applicable) • Reference to test procedure

11.5 COMPUTER PROGRAMS

Computer software programs are controlled in accordance with QP-7 “Software”. controlled. Test requirements and acceptance criteria for computer programs are provided by the organization responsible for the use of the computer software as described in QP-7.

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12.0 CONTROL OF MEASURING AND TEST EQUIPMENT Tools, gages, instruments, and other measuring and test equipment used for activities affecting QHSE shall be controlled, calibrated at specific periods, adjusted, and maintained to required accuracy limits. Procedure QP-28, “Measuring and Test Equipment Control,” is the implementing procedure which addresses the requirements listed below.

12.1 SELECTION AND APPLICATION

Selection of measuring and test equipment shall be based on the type, range, accuracy, and tolerance needed to accomplish the required measurements for determining conformance to specified requirements.

12.2 CALIBRATION AND CONTROL

12.2.1 CALIBRATION FREQUENCY

Measuring and test equipment shall be calibrated at prescribed times or intervals and whenever the accuracy of the measuring and test equipment is suspect. For measuring and testing equipment used in one-time-only applications for nuclear safety related projects, the calibration shall be performed both before and after use.

Use of acceptably calibrated equipment does not relieve personnel of the responsibility for using properly functioning equipment. If a malfunction is suspected, the equipment is removed from service and recalibrated. If it fails recalibration, it is repaired or replaced. Previous results obtained from equipment found to be out-of-calibration are evaluated per Section 12.2.4.

12.2.2 REFERENCE STANDARDS

Calibration shall be against and traceable to certified equipment or reference standards having known valid relationships to nationally recognized standards, or to international standards known to be equivalent to and verified against corresponding nationally recognized standards. Where no such standards exist, the basis for calibration shall be defined.

Reference standards shall have a minimum accuracy four times greater than that required for the measuring and test equipment being calibrated to ensure that the reference standards contribute no more than one-fourth of the allowable

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calibration tolerance. Where this 4:1 ratio cannot be maintained, the basis for selection of the standard in question shall be technically justified.

12.2.3 PROCEDURES

Calibration procedures shall identify or reference required accuracy and shall define methods and frequency of checking accuracy. The calibration method and interval of calibration shall be based on the type of equipment, stability characteristics, required accuracy, intended use, and other conditions affecting performance.

Measuring and test equipment which is overdue for calibration or found to be out of calibration shall be tagged and/or segregated, removed from service, and not used until it has been recalibrated. Measuring or test equipment consistently found to be out of calibration shall be repaired or replaced.

When equipment is not continuously in use or must be recalibrated for each measurement, the scheduled periodic calibration may be disregarded. Such equipment is calibrated as needed prior to use and then at the required frequencies for as long as its use continues.

Documented and approved procedures are used for calibrating measuring and test equipment. Accepted procedures, such as those published by ASTM, or procedures provided by equipment manufacturers, are to be used whenever possible. If pre-established information is not available, calibration procedures are developed based on the type of equipment, stability characteristics of the equipment, required accuracy, and the effect of error on the quantities measured. As a minimum, the procedures include:

• Identification of the equipment to be calibrated

• Calibration equipment and reference standards to be used

• Accuracy requirements

• Calibration interval

• Checks, tests and measurements

• Sequence of calibration

• Data recording form/format

• Special instructions (when necessary)

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12.2.4 CORRECTIVE ACTION

When measuring and test equipment is lost, damaged, or found to be out-of-calibration, the validity of previous measurement, inspection or test results, and the acceptability of items previously inspected or tested shall be evaluated. This evaluation shall be from at least the last acceptable calibration of the Measurement and Test Equipment (M&TE). The evaluation and resulting actions shall be commensurate with the significance of the condition. This evaluation shall be documented on a Condition Report (CR) prepared and processed in accordance with Procedure QP-4, “Condition Reporting and Control of Nonconformances.”

12.2.5 APPLICATION

Measuring and test equipment shall be traceable to its application and use, as documented on test records.

12.2.6 HANDLING AND STORAGE

Measuring and testing equipment shall be properly handled and stored to maintain accuracy.

12.2.7 ENVIRONMENTAL CONTROLS

Measuring and test equipment shall be used and calibrated in environments that are controlled to the extent necessary to ensure that the required accuracy and precision are maintained.

12.2.8 PRE-CALIBRATION CHECKS

Measuring and test equipment and reference standards submitted for calibrations shall be checked and the results recorded before any required adjustments or repairs are made.

12.2.9 IDENTIFICATION AND STATUS INDICATION

Calibrated equipment is uniquely identified by using either the manufacturer's serial number or other unique identification number. This identification and a label indicating when the next calibration is due are attached to the equipment. If this is not possible, calibration records traceable to the equipment are to be available for reference. It is the responsibility of personnel using the equipment to check the calibration status prior to use.

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12.2.10 COMMERCIAL DEVICES

Calibration and control measures are not required for commercial equipment such as rulers, tape measures, levels, etc., if such equipment provides the required accuracy.

12.3 RECORDS

Records shall be established and maintained to indicate calibration status and the capability of measuring and test equipment to satisfactorily perform its intended function. Calibration records shall include the following:

• Type of equipment calibrated

• Serial or other unique identification number of M&TE

• Reference to calibration procedure used

• List of Reference Standards used during the calibration and calibration due dates of the Reference Standards

• Calibration date

• Identification of person and organization performing the calibrations

• Calibration data

• Calibration acceptance tolerances

• Conformance or nonconformance to required tolerances prior to and following adjustments

• Any limitations on use (if applicable)

• Traceability to certified equipment or reference standards having known valid relationships to nationally recognized standards, or to international standards known to be equivalent to and verified against corresponding nationally recognized standards, or to international National Metrology Institutes (NMI) that are signatories to the International Committee for Weights and Measures Mutual Recognition Agreement (CIPM MRA) with proven abilities and disciplines.

Calibration records for measuring and test equipment are filed per Section 17.0.

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13.0 HANDLING, STORAGE AND SHIPPING Handling, storage, cleaning, packaging, shipping, and preservation of items shall be controlled to prevent damage or loss and to minimize deterioration. Procedures require that items shipped from suppliers, items processed internally, and items shipped directly to clients are received in acceptable condition. Procedures also provide for:

• Storage requirements, such as shelf life and environmental control; • Special material handling requirements; and • Standard and nonstandard shipping requirements.

13.1 SPECIAL REQUIREMENTS

When required, special equipment (such as containers, shock absorbers, and accelerometers) and special protective environments (such as inert gas atmosphere, specific moisture content levels, and temperature levels) shall be specified and provided and their existence verified.

13.2 PROCEDURES

When required for critical, sensitive, perishable, or high-value items, specific procedures for handling, storage, packaging, shipping, and preservation shall be used.

13.3 TOOLS AND EQUIPMENT

Special handling tools and equipment shall be utilized and controlled where necessary to ensure safe and adequate handling. Special handling tools and equipment shall be inspected and tested in accordance with procedures at specified time intervals or prior to use.

13.4 OPERATORS

Operators of special handling and lifting equipment shall be experienced or trained in the use of the equipment.

13.5 MARKING OR LABELING

Marking or labeling shall be utilized as necessary to adequately maintain and preserve the item, including indication of the presence of special environments or the need for special controls.

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14.0 INSPECTION, TEST, AND OPERATING STATUS The organization responsible for a work scope ensures that the status of inspections, tests, and operations can be determined at any point throughout the process. Altering the sequence of tests, inspections or other operations requires the authorization of personnel responsible for the function being altered. The status of inspection and test activities shall be identified either on the items or in the documents traceable to the items where it is necessary to ensure that required inspections or tests are performed and to ensure that items that have not passed the required inspections and tests are not inadvertently installed, used, or operated. Status shall be maintained through indicators, such as physical location and tags, markings, shop travelers, stamps, inspection records, or other suitable means. The authority for application and removal of tags, markings, labels, and stamps shall be specified. Status indicators shall also provide for indicating the operating status of systems and components of the nuclear facility, such as by tagging valves and switches, to prevent inadvertent operation.

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15.0 CONTROL OF NONCONFORMING ITEMS A nonconformance is a deficiency in a characteristic, documentation, or procedure that renders the quality (including HSE, as applicable) of an item or activity unacceptable or indeterminate. Nonconformances shall be controlled to prevent inadvertent installation or use. These controls, as described in Procedure QP-4, “Condition Reporting and Control of Nonconformances,” provide for identification, documentation, evaluation, and segregation when practical, and disposition of nonconforming items, and for notification to affected organizations.

15.1 IDENTIFICATION

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

15.2 SEGREGATION

Nonconforming items shall be segregated, when practical, by placing them in a clearly identified and designated hold area until properly dispositioned. When segregation is impractical or impossible due to physical conditions such as size, weight, or access limitations, other precautions shall be employed to preclude inadvertent use of a nonconforming item.

15.3 DISPOSITION

Each nonconformance is to be documented by the personnel identifying the issue. This documentation is to clearly identify and describe the characteristics that do not conform to specified criteria. The responsibility and authority for the evaluation and disposition of nonconforming items is defined in Procedure QP-4, “Condition Reporting and Control of Nonconformances.” This procedure also defines the responsibility for control of further processing, delivery, installation, or use of nonconforming items. Personnel performing evaluations to determine a disposition shall have demonstrated competence in the specific area they are evaluating, an adequate understanding of the requirements, and access to pertinent background information.

The disposition, such as use-as-is, reject, repair, or rework, of nonconforming items shall be made and documented. Technical justification for the acceptability of a nonconforming item, dispositioned repair or use-as-is shall be documented.

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Nonconformances to design requirements dispositioned use-as-is or repair, shall be subject to design control measures commensurate with those applied to the original design. Required as-built records shall reflect the use-as-is or repair condition.

The Responsible Manager, in collaboration with QHSE Staff or designee is responsible for further review of nonconformances to determine if the nonconformance meets the definition of a significant condition adverse to quality (including HSE, as applicable). Significant conditions adverse to quality (including HSE, as applicable) are addressed as described in Section 16.0. An evaluation is also made as to whether the nonconformance requires screening to assess the potential applicability of 10 CFR 21 or 10 CFR 50.55(e). If required, this screening is performed per Procedure QP-8, “10 CFR 21 Program Procedure.”

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

15.4 NOTIFICATION REQUIREMENTS

It is the responsibility of the Project Manager to notify appropriate personnel of the nonconformance. This would typically include anyone impacted by the nonconformance. In addition, the Project Manager shall notify the client of significant nonconformances which could impact the results of the work or as otherwise required by client purchase order requirements.

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16.0 CORRECTIVE & PREVENTIVE ACTION, AND IMPROVEMENT The purpose of the Corrective & Preventive Action Program is to promote continuous improvement through organizational learning and provide direction on the resolution and documentation of unexpected / unwanted conditions. A Condition Report is initiated for reporting of unexpected / unwanted conditions, risks, and opportunities as described in Procedure QP-4, “Condition Reporting and Control of Nonconformances”. Corrective actions are taken in accordance with Procedure QP-5, Corrective Action, Preventive Action, and Continual Improvement”. Conditions adverse to quality (including HSE, as applicable) are evaluated and subsequent corrective/preventive action plans are developed in accordance with Procedure QP-5. The manager of the affected area is responsible for resolution of the Condition Reports and implementation of required corrective / preventive actions. For significant conditions adverse to quality, the causes are determined and documented and the impact on items and services is evaluated in accordance with Procedures. Reports, including actions to prevent recurrence, are provided to the appropriate level of management. Effective completion of corrective and preventive actions are reviewed and verified by the QHSE Staff as part of future auditing or QHSE activities. Results of audits and surveillances, analysis of data, review of corrective actions and nonconformances, and management assessment of the QHSE Program are used to identify items, services, and processes needing improvements. These continual improvement opportunities are documented on Condition Reports per QP-5 requirements.

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17.0 QHSE RECORDS The Records Management System control is implemented to achieve the following objectives:

• QHSE records furnish documentary evidence that items or activities meet specified requirements.

• QHSE records shall be identified, generated, authenticated, stored, protected, retrievable, and maintained and their final disposition specified.

• Record control requirements and responsibilities for these activities shall be documented.

Procedure QP-25, “Records Management System Control,” is the implementing procedure for achieving these objectives.

17.1 GENERATION OF RECORDS

Records to be generated, supplied, or maintained shall be specified in applicable documents, such as procurement documents, or other documents as described in Section 5.0. Documents that are designated to become records shall be legible, traceable to associated items and activities, and accurately reflect the work accomplished or information required. Documents shall be in a form suitable for reproduction, filing and retrieval.

17.2 AUTHENTICATION OF RECORDS

Documents shall be considered valid records only if stamped, initialed, or signed and dated by authorized personnel or otherwise authenticated. Handwritten signatures are not required if the document is clearly certified or otherwise authenticated as a statement by the reporting individual or organization. Corrections to documents shall be reviewed and approved by the responsible individual from the originating or authorized organization. Pen shall be used to correct documents which are corrected by hand after completion. The person making the correction shall draw a single line through any incorrect information and shall initial and date any corrections.

Electronic documents shall be authenticated with comparable information as described above, as appropriate, with identification on the media or with authentication information contained within or linked to the document itself.

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17.3 CLASSIFICATION OF RECORDS

Records for nuclear safety-related projects shall be classified as lifetime or nonpermanent. Lifetime records are those that meet one or more of the following criteria: • Those that would be of significant value in demonstrating capability for safe

operation. • Those that would be of significant value in maintaining, reworking, repairing,

replacing, or modifying an item. • Those that would be of significant value in determining the cause of an

accident or malfunction of an item. • Those that provide required baseline data for in-service inspections. Lifetime records are required to be maintained by or for the Owner for the life of the particular item while it is installed in the plant or stored for future use. Nonpermanent records are those required to show evidence that an activity was performed in accordance with the applicable requirements, but need not be retained for the life of an item because they do not meet the criteria for lifetime records. Nonpermanent records shall be maintained for the identified retention period. Records classification shall be based on the requirements of the client as identified during purchase order review conducted per Procedure QP-1,”Order Entry and Contract Review.” In the absence of other specific client instructions, records associated with nuclear safety-related projects shall be classified and stored per Procedure QP-25, “Records Management System” until copies of the records are provided to the client and they assume responsibility for records storage. After the client assumes responsibility for records storage, the records shall be stored as general records (non-nuclear safety-related). The RIZZO company shall maintain responsibility for storage of records associated with the implementation of Procedure QP-8, “10 CFR 21 Program Procedure,” in accordance with the current revision of 10 CFR 21 and 10 CFR 50.55(e).

17.4 RECEIPT CONTROL OF RECORDS

Incoming project-related records such as correspondence, drawings, logs, or other information are routed by the recipient to the Project Manager. The Project Manager is responsible for identifying the records received, inspection of incoming

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records, and for having copies of these records filed per Procedure QP-25, “Records Management System.” If revised versions of externally prepared records are subsequently received, the documentation is to be updated to reflect the revision.

17.5 STORAGE

Records are to be stored electronically on Document Locator (DL) or to a designated Network Drive location that is secure and backed up by the IT Department as described in Procedure QP-25, “Records Management System”.

Storage systems shall provide for retrieval of information in accordance with planned retrieval times based on the record type. A list shall be maintained designating those personnel who shall have access to the files. Records maintained by a supplier at their facility or other location shall be accessible to the RIZZO company or a designated alternate (e.g. the Owner or RIZZO client).

17.6 RETENTION AND DISPOSITION

Records for nuclear-safety related projects shall be maintained per retention periods described in Section 17.3 and Procedure QP-25, “Records Management System”. Records for other types of projects (not nuclear safety-related) are retained for a minimum of six years following completion of the project, unless otherwise specified by the client purchase order or regulatory requirements. Records accumulated at various locations, prior to transfer, shall be made accessible to the Owner directly or through the procuring organization. Various regulatory agencies have requirements concerning records that are within the scope of Part 1 of NQA-1. The most stringent requirements shall be used in determining the final disposition. The supplier’s nonpermanent records shall not be disposed of until the applicable conditions listed below are satisfied:

• Items are released for shipment, a Code Data Report is signed, or a Code Symbol Stamp is affixed

• Regulatory requirements are satisfied

• Operation status permits

• Warranty consideration is satisfied

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• Purchaser’s requirements are satisfied

17.7 MAINTENANCE OF RECORDS

Record maintenance shall meet the following requirements:

• Records shall be protected from damage or loss

• Record controls shall provide for retrievability within planned retrieval times based upon the record type or content

• The methods for record changes shall be documented

• Provisions shall be established to ensure that no unacceptable degradation of the electronic record media occurs during the established retention period.

• Provisions shall be made to ensure that the records remain retrievable after hardware, software, or technology changes.

• Provisions shall be established to ensure the following when records are duplicated or transferred to the same media or to a different media for the purposes of maintenance or storage:

− Duplication or transfer is appropriately authorized

− Record content, legibility, and retrievability are maintained

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18.0 AUDITS Audits shall be performed to verify compliance to QHSE program requirements, to verify that performance criteria are met, and to determine the effectiveness of the program. Audits can be project-related audits, internal audits of the overall QA and/or QHSE Program, or external audits of suppliers to verify compliance and evaluate program effectiveness. These audits shall be performed in accordance with Procedure QP-22, “Audit Procedure,” by personnel who do not have direct responsibility for performing the activities being audited and who are qualified per Procedure QP-9, “Qualification of Auditors.” Audit results shall be documented and reported to and reviewed by responsible management. Follow-up action shall be taken when indicated.

18.1 AUDIT SCHEDULES

Internal or external audits shall be scheduled in a manner to provide coverage and coordination with ongoing activities, based on the status and importance of the activity. Scheduled audits shall be supplemented by additional audits of specific subjects when necessary to provide adequate coverage.

18.1.1 INTERNAL AUDITS

Internal audits shall be performed in a manner as to assure that an audit of applicable QHSE program elements is completed at least once each year or at least once during the life of the activity.

18.1.2 EXTERNAL AUDITS FOR NUCLEAR SAFETY RELATED ITEMS AND SERVICES

Procurement audits are accomplished as follows:

• Audits may not be necessary for procuring the following items, based on the evaluation of supplier: − Those that are relatively simple and standard in design, manufacturing, and

testing. − Those that are adaptable to standard or automated inspections or tests of

the end product to verify quality characteristics after delivery. • Audits are conducted as follows for procurement of items not covered by the

exceptions listed above: − The supplier’s QA program is audited on a triennial basis. − The triennial period begins when the first audit is performed.

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− An audit is initially performed after the supplier has completed sufficient work to demonstrate that its organization is implementing a QA program that has the required scope for purchases placed during the triennial period.

• If a subsequent contract or a contract modification significantly enlarges the scope of or changes the methods or controls for activities performed by the same supplier, an audit of the modified requirements is conducted, thus starting a new triennial period.

• If the supplier is implementing the same QA Program for other clients as that proposed for use on the auditors’ party’s contract, the pre-award survey may serve as the first triennial audit. Therefore, when the pre-award survey is used as the first triennial audit, it should satisfy the same audit elements and criteria as those used on other triennial audits.

• If more than one purchaser buys from a single supplier, a purchaser may either perform or arrange for an audit of the supplier on behalf of itself and other purchasers to reduce the number of external audits of the supplier. The scope of this audit should satisfy the needs of all of the purchasers, and the audit report should be distributed to all of the purchasers for whom the audit was conducted. When RIZZO relies on the results of an audit performed on behalf of several purchasers, RIZZO remains individually responsible for the adequacy of the audit.

18.1.3 EVALUATIONS OF SUPPLIERS

Evaluations of suppliers are documented per Procedure QP-6, “Purchasing”.

18.1.4 AUDIT SCHEDULE COMPLIANCE

A grace period of 90 days may be applied to the scheduled audit and annual evaluation intervals. The grace period does not allow the “clock” for particular activities to be reset forward. The “clock” for an activity is reset backward by performing the activity early.

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APPENDIX A

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Appendix A - Non-Applicability Clauses

As it applies to standard ISO 9001, Quality Management System – Requirements, the following have been identified as non-applicable to RIZZO core business model. 7.1.5.2 Measurement traceability - Non-applicable. Justification: This clause is non-applicable in that, while design and development and testing is done, the equipment is calibrated by external sources which is controlled under Purchasing requirements and the control of purchased items and services. 8.5.3. Property belonging to customers or external providers - Non-applicable Justification: This clause is non-applicable in that, while RIZZO may do on-site testing and project management, RIZZO does not take possession or control of customer's property or external provider's property. 8.7.1 Control of non-conforming outputs - Non-applicable Justification: RIZZO does not produce a product and the core service business is Design and Engineering and Consulting. Any deficient issues would be controlled under the design change processes. 8.7.2 Control of non-conforming outputs - Non-applicable Justification: RIZZO does not produce a product and the core service business is Design and Engineering and Consulting. Any deficient issues would be controlled under the design change processes.