quality, health, safety environmental (qhse) management ... · quality, health, safety &...

QUALITY, HEALTH, SAFETY

& ENVIRONMENTAL (QHSE)

MANAGEMENT SYSTEM

“QHSE MANUAL”

REVISION 9

DECEMBER 13, 2013

PCR HOLDINGS, INC. 500 PENN CENTER BOULEVARD

PENN CENTER EAST, BUILDING 5, SUITE 100 PITTSBURGH, PENNSYLVANIA 15235 USA

CONTROL COPY NO.: EXTRANET

Quality, Health, Safety and Environmental (QHSE) MANAGEMENT SYSTEM MANUAL

REVIEWED AND ApPROVED By:

Originator(s)

Corporate QHSE Officer

Dee M. Xenakis

Reviewer(s)

Vice President, Administration

Rachelle Rizzo

Verifier(s)

Margaret A. Pelcher, P.E.

Responsible Manager

President

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

"QHSE MANUAL"

PCR HOLDINGS, INC. (PCR)

REVISION 9 DECEMBER 13, 2013

Approval of the Responsible Manager signl ..... · ~"'r the document is released for use.

QHSE Manual Rev. 9

© peR Proprietary and Confidential Work Product

Verification method: Independent

Review

QHSE Manual Rev. 9

© PCR Proprietary and Confidential Work Product

CHANGE MANAGEMENT RECORD

Document Name: Quality, Health, Safety, and Environmental Management System Manual

REVISION NO.1

DATE DESCRIPTIONS OF CHANGES/AFFECTED PAGES

0 04/09/1996 N/A

1 01/25/2002 Revised page 2‐2 to include a definition of Principal‐in‐Charge. Revised page 7‐7 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 to Section 1.0. Deleted chart at end of Section 1.0 and replaced with new Table 1‐1. Deleted reference to ANSI/ISO/ASQC 9001‐1994. Revised Section 2.0 to: address roles of Vice President of Domestic Operations and Business Unit Managers; revise responsibilities of President, Project Manager, and Director of Quality Assurance; remove references to the Technical Review Committee, and clarify the requirements for auditor qualification. Revised Section 3.2 to allow Vice President of Domestic Operations to approve procedures. Removed Section 5.2.5 which discussed archiving computer files. Removed requirement for Project Manager review of drawings at 65 and 90 percent completion in Section 5.3. Revised method of documentation for field quality control check in Paragraph 6.2.3. Revised long‐term file storage location in Paragraph 7.1.2. Revised Paragraphs 7.1.3 and 7.1.4 to addresses changes in storage of electronic files.

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). Revised Sections 2.7.1 and 2.7.2. Added Sections 5.1 to 5.4 and revised numbering throughout remainder of Section 5.0. In Section 6.0, added reference to QP‐6 and discussed Commercial Grade Dedication. Updated Section 7.2.1 to discuss Project Work Plans. Clarified that Section 8.1 applies to project audits. Added Section 8.2 to discuss internal audit of overall QA Program. Revised Section 9.0 text and added references to QP‐4 and QP‐5.

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.

CHANGE MANAGEMENT RECORD

(CONTINUED)

QHSE Manual Rev. 9


REVISION NO.1

DATE DESCRIPTIONS OF CHANGES/AFFECTED PAGES

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. Revised first paragraph and added fourth paragraph in Section 1.0. Revised Section 1.2.1, 1.2.2 1.6, first paragraph of Section 3.0, Sections 3.1 to 3.6, and 3.8.1. Revised introduction to Section 4.0, Section 4.6 and 4.8. Added Section 7.1 and 7.4. Revised Section 7.3, 10.4, 10.5, 11.4 11.5, 12.2.7, 17.1, 17.4 to 17.6, 18.2, 18.3 and Table 17‐1. Minor editorial changes throughout.

7 04/04/2012 Fourth paragraph in the “Introduction” includes a revised discussion of the applicability of previous revisions of the Quality Manual. Added reference to QP‐36 under Section No. 3 on Page 2. Revised Figure 1‐1, Organization Chart. Revised Sections 1.1, 1.3, 1.4 and 1.5. Revised fifth paragraph in Section 2.1. Added reference to QP‐36 in Section 3.2. Revised second paragraph in Section 4.8. Added reference to QP‐29 to describe the process for acceptance of commercial grade calibration services in Section 7.9. Revised Table 17‐1 and Section 17.4.

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 in Introduction and Table 2. Added Sections 2.4 and 3.3.1 and expanded Section 7.10. Revised introductory paragraphs in Section 8.0 and 13.0. Revised Section 16.0. Revised Table 17‐1.

9 12/13/2013 Expanded requirements to include IAEA GS‐R‐3, 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.

QHSE�Manual�Rev.�9�

©�PCR�Proprietary�and�Confidential�Work�Product�

�

TABLE�OF�CONTENTS�PAGE�

INTRODUCTION�...................................................................................................................�1�

1.0� MANAGEMENT�RESPONSIBILITY�&�ORGANIZATION�............................................�1�3�

FIGURE�1�1,�PCR�TYPICAL�ORGANIZATIONAL�CHART�.......................................................�1�3�

1.1� PRESIDENT�...................................................................................................�1�4�

1.2� MANAGEMENT�REPRESENTATIVE�......................................................................�1�4�

1.3� ADMINISTRATION�..........................................................................................�1�4�

1.3.1� Quality,�Health,�Safety,�and�Environmental�(QHSE)�Department�...............................................................................�1�5�

1.3.2� Human�Resources�Department�.................................................�1�6�

1.3.3� Records�Management�...............................................................�1�6�

1.4� FINANCE�......................................................................................................�1�6�

1.4.1� Accounting�Department�............................................................�1�6�

1.4.2� IT�Department�...........................................................................�1�6�

1.4.3� Equipment�Department�.............................................................�1�6�

1.5� PROJECT�EXECUTION�......................................................................................�1�7�

1.6� BUSINESS�DEVELOPMENT�................................................................................�1�7�

1.7� GLOBAL�BUSINESS�OPERATIONS�.......................................................................�1�7�

1.8� MANAGEMENT�COMMITMENT�........................................................................�1�7�

1.8.1� Client�focus�................................................................................�1�8�

1.8.2� QHSE�Policy�................................................................................�1�8�

1.8.3� Objectives�..................................................................................�1�8�

1.8.4� Measurement,�Analysis�&�Improvement�..................................�1�8�

1.8.5� Continual�improvement�............................................................�1�9�

1.8.6� QHSE�Planning�...........................................................................�1�9�

1.8.7� Internal�communication�............................................................�1�9�

1.9� INTERFACE�CONTROL�.....................................................................................�1�9�

2.0� QUALITY,�HEALTH,�SAFETY,�AND�ENVIRONMENTAL�(QHSE)�PROGRAM�.............�2�1�

2.1�� QHSE�SYSTEM�.............................................................................................�2�1�

2.2�� QHSE�MANAGEMENT�SYSTEM�(LEVEL�1)�..........................................................�2�1�

TABLE OF CONTENTS (CONTINUED) PAGE

QHSE Manual Rev. 9


FIGURE 2‐1, QHSE PROCESS INTERACTIONS .................................................................... 2‐2

2.3 RESOURCE MANAGEMENT (INDOCTRINATION AND TRAINING) ............................... 2‐3

2.4 QUALIFICATION REQUIREMENTS ....................................................................... 2‐4

2.4.1 Technical Project Personnel ...................................................... 2‐4

2.4.2 Inspection and Test Personnel .................................................. 2‐4

2.4.3 Lead Auditors ............................................................................. 2‐5

2.4.4 Auditors ..................................................................................... 2‐6

2.4.5 Technical Specialists .................................................................. 2‐7

2.4.6 Records of Qualification ............................................................ 2‐7

2.5 MANAGEMENT REVIEW (ASSESSMENTS)............................................................ 2‐8

2.5.1 Management Review Input ....................................................... 2‐8

2.5.2 Management Review Output .................................................... 2‐8

2.6 SAFETY CULTURE ........................................................................................... 2‐8

2.7 GRADED APPROACH ...................................................................................... 2‐9

2.8 CONTRACT REVIEW........................................................................................ 2‐9

2.8.1 Planning ..................................................................................... 2‐9

2.8.2 Negotiation ................................................................................ 2‐9

2.8.3 Contract Order Entry ............................................................... 2‐10

2.8.4 Client Communication ............................................................. 2‐10

2.8.5 Control of Client‐Supplied Product ......................................... 2‐10

3.0 DESIGN CONTROL ................................................................................................ 3‐1

3.1 DESIGN AND DEVELOPMENT PLANNING ............................................................. 3‐1

3.2 DESIGN INPUT .............................................................................................. 3‐1

3.3 DESIGN PROCESS .......................................................................................... 3‐2

3.4 DESIGN ANALYSIS .......................................................................................... 3‐3

3.4.1 Design Output ............................................................................ 3‐4

3.5 DESIGN VERIFICATION .................................................................................... 3‐4

3.6 DESIGN VERIFICATION METHODS ..................................................................... 3‐5

3.7 DESIGN VALIDATION ...................................................................................... 3‐6

3.8 DESIGN CHANGE CONTROL ............................................................................. 3‐6


QHSE Manual Rev. 9


3.9 DESIGN INTERFACE CONTROL .......................................................................... 3‐7

3.10 SOFTWARE DESIGN CONTROL .......................................................................... 3‐7

3.10.1 Software Design Process ........................................................... 3‐7

3.10.2 Software Configuration Management ....................................... 3‐8

3.11 DESIGN DOCUMENTATION AND RECORDS .......................................................... 3‐9

3.12 QHSE ROLE IN DESIGN AND ANALYSIS .............................................................. 3‐9

4.0 PROCUREMENT DOCUMENT CONTROL ............................................................... 4‐1

4.1 SCOPE OF WORK ........................................................................................... 4‐2

4.2 TECHNICAL REQUIREMENTS ............................................................................. 4‐2

4.3 QHSE PROGRAM REQUIREMENTS .................................................................... 4‐2

4.4 RIGHT OF ACCESS .......................................................................................... 4‐2

4.5 DOCUMENTATION REQUIREMENTS ................................................................... 4‐2

4.6 NONCONFORMANCES .................................................................................... 4‐2

4.7 SPARE AND REPLACEMENT PARTS ..................................................................... 4‐3

4.8 PROCUREMENT DOCUMENT REVIEW AND APPROVAL ........................................... 4‐3

4.9 PROCUREMENT DOCUMENT CHANGES .............................................................. 4‐3

5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS ................................................. 5‐1

5.1 QUALITY PROCEDURES ................................................................................... 5‐1

5.2 FIELD PROCEDURES........................................................................................ 5‐1

5.3 PROJECT WORK PLANS ................................................................................... 5‐2

5.4 QUALITY ASSURANCE PROJECT PLANS ............................................................... 5‐2

5.5 HEALTH & SAFETY MANUAL, AND HEALTH, SAFETY, & ENVIRONMENTAL (HSE) PLANS ......................................................................................................... 5‐2

5.6 PROJECT‐SPECIFIC PROCEDURES ....................................................................... 5‐2

5.7 PUBLISHED TEST PROCEDURES ......................................................................... 5‐2

5.8 FORMS AND WORK INSTRUCTIONS ................................................................... 5‐3

6.0 DOCUMENT CONTROL ......................................................................................... 6‐1

6.1 MAJOR CHANGES TO DOCUMENTS ................................................................... 6‐1

6.2 MINOR CHANGES TO DOCUMENTS ................................................................... 6‐1

7.0 CONTROL OF PURCHASED ITEMS AND SERVICES ................................................ 7‐1


QHSE Manual Rev. 9


7.1 PROCUREMENT PLANNING .............................................................................. 7‐1

7.2 SUPPLIER EVALUATION AND SELECTION ............................................................. 7‐2

7.3 BID EVALUATION ........................................................................................... 7‐2

7.4 SUPPLIER PERFORMANCE EVALUATION .............................................................. 7‐3

7.5 CONTROL OF SUPPLIER‐GENERATED DOCUMENTS ............................................... 7‐3

7.6 ACCEPTANCE OF AN ITEM OR SERVICE ............................................................... 7‐4

7.7 CONTROL OF SUPPLIER NONCONFORMANCES ..................................................... 7‐6

7.8 COMMERCIAL GRADE ITEMS AND SERVICES ........................................................ 7‐6

7.9 QUALIFICATION AND ACCEPTANCE OF COMMERCIAL GRADE CALIBRATION SERVICES ..................................................................................................... 7‐7

7.10 COUNTERFEIT AND FRAUDULENT MATERIALS, ITEMS, AND COMPONENTS ................ 7‐8

8.0 IDENTIFICATION AND CONTROL OF ITEMS .......................................................... 8‐1

8.1 IDENTIFICATION METHODS .............................................................................. 8‐1

8.2 SPECIFIC REQUIREMENTS ................................................................................ 8‐1

9.0 CONTROL OF SPECIAL PROCESSES ....................................................................... 9‐1

10.0 INSPECTION ........................................................................................................ 10‐1

10.1 INSPECTION REQUIREMENTS .......................................................................... 10‐1

10.2 INSPECTION HOLD POINTS ............................................................................ 10‐1

10.3 INSPECTION PLANNING ................................................................................. 10‐1

10.4 IN‐PROCESS INSPECTION ............................................................................... 10‐2

10.5 FINAL INSPECTIONS ...................................................................................... 10‐2

10.6 INSPECTIONS DURING OPERATIONS ................................................................ 10‐2

10.7 INSPECTION RECORDS .................................................................................. 10‐2

11.0 TEST CONTROL ................................................................................................... 11‐1

11.1 TEST REQUIREMENTS ................................................................................... 11‐1

11.2 TEST PROCEDURES (OTHER THAN FOR COMPUTER PROGRAMS) ........................... 11‐2

11.3 COMPUTER PROGRAM TEST PROCEDURES ....................................................... 11‐2

11.4 TEST RESULTS ............................................................................................. 11‐3

11.4.1 General Requirements............................................................. 11‐3


QHSE Manual Rev. 9


11.4.2 Additional Requirements for Compliance with NQA‐1, Subpart 2.20 ............................................................................ 11‐3

11.5 TEST RECORDS ............................................................................................ 11‐4

12.0 CONTROL OF MEASURING AND TEST EQUIPMENT ........................................... 12‐1

12.1 SELECTION AND APPLICATION ........................................................................ 12‐1

12.2 CALIBRATION AND CONTROL ......................................................................... 12‐1

12.2.1 Calibration Frequency ............................................................. 12‐1

12.2.2 Reference Standards ............................................................... 12‐1

12.2.3 Procedures ............................................................................... 12‐2

12.2.4 Corrective Action ..................................................................... 12‐2

12.2.5 Application ............................................................................... 12‐3

12.2.6 Handling and Storage .............................................................. 12‐3

12.2.7 Environmental Controls ........................................................... 12‐3

12.2.8 Pre‐calibration Checks ............................................................. 12‐3

12.2.9 Identification and Status Indication ........................................ 12‐3

12.2.10 Commercial Devices ................................................................ 12‐3

12.3 RECORDS ................................................................................................... 12‐3

13.0 HANDLING, STORAGE AND SHIPPING ................................................................ 13‐1

13.1 SPECIAL REQUIREMENTS ............................................................................... 13‐1

13.2 PROCEDURES .............................................................................................. 13‐1

13.3 TOOLS AND EQUIPMENT ............................................................................... 13‐1

13.4 OPERATORS ............................................................................................... 13‐1

13.5 MARKING OR LABELING ................................................................................ 13‐1

14.0 INSPECTION, TEST, AND OPERATING STATUS ................................................... 14‐1

15.0 CONTROL OF NONCONFORMING ITEMS ........................................................... 15‐1

15.1 IDENTIFICATION .......................................................................................... 15‐1

15.2 SEGREGATION ............................................................................................. 15‐1

15.3 DISPOSITION .............................................................................................. 15‐1

15.4 NOTIFICATION REQUIREMENTS ...................................................................... 15‐2

16.0 CORRECTIVE AND PREVENTIVE ACTIONS .......................................................... 16‐1


QHSE Manual Rev. 9


17.0 QHSE RECORDS .................................................................................................. 17‐1

17.1 GENERATION OF RECORDS ............................................................................ 17‐1

17.2 AUTHENTICATION OF RECORDS ...................................................................... 17‐1

17.3 CLASSIFICATION OF RECORDS ......................................................................... 17‐2

17.4 RECEIPT CONTROL OF RECORDS ..................................................................... 17‐5

17.5 STORAGE ................................................................................................... 17‐5

17.6 RETENTION AND DISPOSITION ........................................................................ 17‐6

17.7 MAINTENANCE OF RECORDS .......................................................................... 17‐7

17.8 ELECTRONIC RECORDS .................................................................................. 17‐7

18.0 AUDITS ............................................................................................................... 18‐1

18.1 AUDIT SCHEDULES ....................................................................................... 18‐1

18.1.1 Regularly Scheduled Internal Audits ....................................... 18‐1

18.1.2 Regularly Scheduled External Audits ....................................... 18‐1

18.1.3 Annual Evaluations of Suppliers .............................................. 18‐2

18.1.4 Project Audits .......................................................................... 18‐3

18.1.5 Audit Schedule Compliance ..................................................... 18‐3

18.2 AUDIT PREPARATION ................................................................................... 18‐3

18.3 AUDIT PERFORMANCE .................................................................................. 18‐4

18.4 AUDIT REPORTING ....................................................................................... 18‐4

18.4 AUDIT RESPONSE ........................................................................................ 18‐4

18.5 FOLLOW‐UP ACTION ................................................................................... 18‐4

18.6 AUDIT RECORDS .......................................................................................... 18‐4

18.7 SURVEILLANCE ............................................................................................ 18‐4

19.0 TABLE 1, COMPLIANCE WITH THE REQUIREMENTS, OF 10 CFR 50 APPENDIX B AND NQA‐1, 1994, 2008, 2009A .................................................... 19‐1

20.0 TABLE 2, COMPLIANCE WITH REQUIREMENTS OF 10 CFR 830, SUBPART A AND DOE O 414.1D ............................................................................................ 20‐3

21.0 TABLE 3, PCR PROCEDURES COMPLIANCE MATRIX WITH REQUIREMENTS ...... 21‐1

QHSE Manual Rev. 9


QHSE MANUAL

PCR HOLDINGS, INC. (PCR) REVISION 9

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 PCR world‐wide operations. The QHSE Manual describes the PCR commitments to the requirements of ISO 9001; 10CFR50 Appendix B; ASME NQA‐1 Edition; and other national/international regulatory requirements.

APPLICABILITY This QHSE Manual applies to activities that affect the Quality, Health, Safety, and Environmental elements of items and services supplied by PCR. It 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 PCR for applicable locations and projects, as well as applicable local or country specific regulations:

● ISO 9001:2008, “Quality Management Systems – Requirements”

● ISO/IEC 17025:2005, “General Requirements for the Competence of Testing and Calibration Laboratories”

● International Atomic Energy Agency (IAEA) GS‐R‐3:2006, “The Management System for Facilities and Activities”

● ISO 14001:2004, “Environmental Management Systems Requirements”

● OHSAS 18001:2007, “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.

● ASME NQA‐1‐1994

Part I – Basic Requirements and Supplementary Requirements for Nuclear Facilities.

QHSE Manual Rev. 9


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 and Quality Assurance Project Plans (QAPPs) 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 Work Plans and QAPPs, including any document revisions, until completion of activities controlled by those documents. Table 1 indicates the applicable sections of 10 CFR 50 Appendix B, NQA‐1‐1994, NQA‐1‐2008 and the NQA‐1A‐2009 Addenda, and references the associated implementing Quality Procedures (QPs). Table 2 lists applicable QHSE Manual sections and implementing procedures for the applicable criteria presented in 10 CFR 830, Subpart A and DOE O 414.1D. Table 3 lists compliance matrix of the Implementing procedures with the QHSE Manual sections, 10 CFR 50 Appendix B, NQA‐1‐1994, NQA‐1‐2008 and the NQA‐1A‐2009 Addenda, and ISO 9001 references.

QHSE Manual Rev. 9


1‐3

1.0 MANAGEMENT RESPONSIBILITY & ORGANIZATION The PCR Holdings (PCR) President defines the overall QHSE policy and objectives, and promotes a culture of conformance to requirements, client satisfaction and continual improvement. The PCR President authorizes and endorses the PCR 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 PCR operational organizations 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.

FIGURE 1‐1, PCR TYPICAL ORGANIZATIONAL CHART

QHSE Manual Rev. 9


1‐4

1.1 PRESIDENT

The PCR 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.

Reviews and approves implementing procedures or assigns this review and approval to the Vice President, Administration.

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 Management and 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).

1.2 MANAGEMENT REPRESENTATIVE

The PCR Corporate QHSE Officer has been appointed the designated Management Representative who, irrespective of other responsibilities, has the responsibility and authority for:

ensuring that processes needed for the QHSE are established, implemented and maintained

ensuring that the performance and effectiveness of the QHSE is being reported to management for review and as a basis for improvement.

ensuring the promotion of awareness of client requirements throughout PCR

resolving matters pertaining to QHSE. 1.3 ADMINISTRATION

The management position responsible for the administration functions within PCR is the Vice President, Administration. Responsibilities include records control (per Section 17.0 of this QHSE Manual), corporate oversight of the QHSE Department, the Human Resources Department, and administrative personnel. The Vice President, Administration reports directly to the President.

QHSE Manual Rev. 9


1‐5

1.3.1 Quality, Health, Safety, and Environmental (QHSE) Department The QHSE Staff administer the PCR QHSE Program. The PCR Corporate QHSE Officer reports to the Vice President, Administration, but has direct access to the President for quality, health, safety, and environmental related matters. QHSE Management and Staff are independent of individuals performing project work and have Stop Work Authority. Responsibilities include:

Development, review, and document control of the QHSE Manual.

Development, review, and document control of the PCR Health & Safety Manual

Development, review, approval and document control of implementing procedures, work instructions, and forms.

Review and approval of Field Procedures, project‐specific Work Plans, project‐specific procedures, QA Project Plans, and Health, Safety, & Environmental (HSE) Plans.

Conducting training on the QHSE Manual and procedures as required.

Preparation of the audit schedule (at least once per year) and review and revision of the audit schedule periodically (as necessary) to assure that coverage is maintained current.

The audit and surveillance programs.

Administration of the nonconformance and corrective action programs.

Has Stop Work Authority on non‐compliant aspects.

Develops and maintains an Approved Supplier List per QP‐6, “Procurement Source Evaluation, Selection, and Control.”

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

Reviews the quality requirements provided in subcontractor procurement documents, per Procedure QP‐30, “Procurement Documents.”

Maintains general Quality records as described in Procedure QP‐25, “Records Control.”

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 shall be independent of any direct responsibility for performance of the activities which they will audit. Personnel having direct responsibility for performing the activities being audited shall not be involved in the selection of the audit team. Auditors have the authority, access to work areas, and organizational freedom to:

QHSE Manual Rev. 9


1‐6

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.

Assure that further processing, delivery, installation, or use is controlled until proper disposition of a nonconformance, deficiency, or unsatisfactory condition has occurred.

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

1.3.2 Human Resources Department The Human Resources Department is responsible for maintaining position descriptions for PCR personnel, as described in Procedure QP‐3, “Personnel Qualifications.”

1.3.3 Records Management Personnel reporting to the Vice President, Administration are responsible for indexing and filing project records as described in Section 17.0 of this manual. 1.4 FINANCE

The management position responsible for finance oversees the Accounting Department and provides corporate oversight of the IT Manager and Equipment Manager. The management position responsible for finance reports directly to the President.

1.4.1 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 subcontractor agreements/purchase orders as described in Procedure QP‐30, “Procurement Documents.”

1.4.2 IT Department The IT Manager, or staff working under the supervision of the IT Manager, is responsible for software installation, maintenance, virus protection, and retirement as described in Procedure QP‐7, “Control of Design and Analysis Software.” The IT Manager and staff also support electronic records storage per Section 17.8.

1.4.3 Equipment Department The Equipment Department is responsible for maintaining measuring and test equipment and for implementation of the calibration control system as described in Procedure QP‐28, “Measuring and Test Equipment Control.”

QHSE Manual Rev. 9


1‐7

1.5 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 per Procedure QP‐3, “Personnel Qualifications.” 1.6 BUSINESS DEVELOPMENT

Business Development is responsible for the development of new business projects world‐wide, and implementation the QHSE Program for new project development. 1.7 GLOBAL BUSINESS OPERATIONS

Global Business Operations are responsible for the business development, marketing, project work and operations world‐wide, and implementation of this QHSE Manual and applicable procedures. 1.8 MANAGEMENT COMMITMENT

PCR Management is committed to the following:

1 The development and implementation of the QHSE program and to continually

improving its effectiveness.

2 Communicating the importance of meeting client as well as statutory and regulatory requirements within the company.

3 The QHSE policy and objectives are established. The QHSE Policy and Objectives are part of the corporate strategic focus of PCR Management and part of the day‐to‐day focus throughout the organization. PCR Management continues to be committed to the QHSE Policy and Objectives and pursues corporate strategies essential to the implementation of the QHSE Program.

4 Management reviews are established and regularly conducted.

5 Ensuring the availability of resources.

QHSE Manual Rev. 9


1‐8

1.8.1 Client focus The QHSE program is established and maintained to ensure that client requirements are determined and are met with the aim of enhancing client satisfaction. Processes are established to measure and monitor client perception with regards to PCR performance in meeting client requirements. The methods for obtaining and using this information include client visits, trip reports, results of client audits and surveys.

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

1.8.3 Objectives The PCR Goals, Plans, and Objectives involve short‐term and longer‐term issues identified by PCR management. The QHSE policy provides a framework for establishing and reviewing the company objectives. The objectives are 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.

1.8.4 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.

QHSE Manual Rev. 9


1‐9

1.8.5 Continual improvement PCR 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.

1.8.6 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. Controls are established to ensure that the integrity of the QHSE program is maintained when changes to the program are planned and implemented. Specific responsibilities for achieving and maintaining QHSE performance are stated in this manual and in the applicable implementing procedures. Personnel responsible for achieving and maintaining QHSE performance have the authority and responsibility to identify problems or issues which affect or have the potential to affect quality. Such problems and issues 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. PCR and the companies and individuals within PCR 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.

1.8.7 Internal communication Communication processes are established and implemented regarding the performance and effectiveness of the QHSE program within PCR. 1.9 INTERFACE CONTROL

Performance of project work may require interaction between various Project Execution and Business Development groups within PCR. 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 shall be described in a project Work Plan prepared, reviewed, approved, distributed, and revised per Procedure QP‐2, “Work Plan Preparation.”

QHSE Manual Rev. 9


2‐1

2.0 QUALITY, HEALTH, SAFETY, AND ENVIRONMENTAL (QHSE) PROGRAM The PCR QHSE program, as described in this manual and the implementing procedures, applies to the execution of technical and professional services provided by PCR. PCR implements applicable requirements of the QHSE for nuclear safety‐related items and services. PCR implements those requirements of the QHSE consistent with ISO 9001, for items and services that are not nuclear safety‐related, as a minimum. When requested by a client, the overall QHSE program may be supplemented or modified for a specific project by a QA Project Plan, prepared per Procedure QP‐31, “Quality Assurance Project Plans.” 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 PCR QHSE Program incorporates QHSE planning, provides a framework for managing the 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. 2.1 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 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, Work Plans (refer to Section 5.0)

● Level 3. Field procedures, work instructions, Records 2.2 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

QHSE Manual Rev. 9


2‐2

the supporting infrastructure to enable the direct processes to operate under the required controls, and continually improve. Figure 1 illustrates the continual improvement model of the PCR 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. The model illustrates the importance of Management Responsibility, Resource Management, Product Realization, and the Measurement System Analysis & Improvement Systems in achieving continual improvement. Product realization involves many individual processes that include (but are not limited to) the activities and functions shown in Figure 2‐1: Marketing; Contract Review; Project Management; Planning; Design & Development; Engineering; Consultants; Administration; Field Activities; Operations; Inspection, Measuring, & Testing; Construction Management; and Services.

and

Cl ients

Regulators

Requirements

Management Responsibility

Measurement System,

Analysis & Improvement

and

Cl ients

Regulators

Satisfaction

Product Realization Processes Product

Output

Continual Improvement

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

‐Marketing ‐Contract Review ‐Project Management

‐Planning ‐Design & Development ‐Engineering

‐ Consultants ‐ Administration ‐ Field Activities ‐ Operations

‐Inspection, Measuring, Testing

‐Construction Management ‐ Services

Input

Resource Management

Security, Finance, Information Technology

FIGURE 2‐1, QHSE PROCESS INTERACTIONS

QHSE Manual Rev. 9


2‐3

The QHSE program is the foundation for the overall continual improvement model. The Quality, Health, Safety, Environmental, Information Technology (including computer 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 PCR QHSE Manual, implementing procedures, and other applicable instructions, procedures, or drawings describe:

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

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

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.

Any 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 problems.

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. 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)

QHSE Manual Rev. 9


2‐4

evaluating these actions to confirm that personnel are adequately trained, competent and qualified to manage and perform assigned work activities. Each PCR staff member 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 PCR 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 shall 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. 2.4 QUALIFICATION REQUIREMENTS

Activities performed by PCR are accomplished by personnel qualified on the basis of education, experience, proficiency, and training. This section addresses the general qualifications of professional staff and the specific qualifications of staff members selected to perform inspection, test, or auditing duties.

2.4.1 Technical Project Personnel The qualifications of technical project personnel, such as engineers, geologists, scientists, and technicians, are documented by resumes which include academic credentials, employment history, and professional registrations. Personnel qualifications are documented, reviewed, and approved with respect to the requirements found in position descriptions developed by the Human Resources Department. The review and approval of technical project personnel qualifications is described in Procedure QP‐3, “Personnel Qualifications.”

2.4.2 Inspection and Test Personnel The initial capabilities of inspection and test personnel shall be determined by an evaluation of the candidate’s education, experience, training, and either test results or a

QHSE Manual Rev. 9


2‐5

capability demonstration. The job performance of inspection and test personnel shall be reevaluated at periodic intervals, not to exceed three years. Reevaluation shall be by evidence of continued satisfactory performance or redetermination of capability as described above. If during this evaluation, or at any other time, it is determined that the capabilities of an individual are not in accordance with the qualification requirements specified for the job, that person shall be removed from that activity until such time as the required capability has been demonstrated. Any person who has not performed inspection or testing activities in the qualified area for a period of one year shall be reevaluated. Procedure QP‐3, “Personnel Qualifications,” describes the process for qualification of inspection and test personnel.

2.4.3 Lead Auditors Lead Auditors shall be qualified in accordance with Procedure QP‐9, “Qualification of Auditors.” This procedure is based on the criteria listed below.

Communication Skills A prospective Lead Auditor shall be capable of communicating effectively, both in writing and orally. These skills shall be attested to in writing. Training Prospective Lead Auditors shall receive training to the extent necessary to assure auditing competence including:

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

General structure of QHSE Programs as a whole, and applicable elements defined in NQA‐1.

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

Planning audits of activities affecting QHSE.

On‐the‐job training to include applicable elements of the audit program. Audit Participation Prospective Lead Auditors shall participate in a minimum of five QHSE Audits within a period of time not to exceed three years prior to the date of qualification, one audit of which shall be a Nuclear QA Audit within the year prior to qualification. Participation in independent assessments, including team assessment activities such as operations readiness reviews and regulatory inspections/surveys, may be used to satisfy up to four of the five required QHSE Audits, provided that the activities can demonstrate the following:

Independence from the functional areas being assessed.

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

QHSE Manual Rev. 9


2‐6

Performance by technically qualified and experienced personnel.

Results that are documented and reported to management.

Appropriate corrective and preventive action initiated and tracked to resolution.

Such participation shall be subject to review and acceptance prior to their use for qualification.

Examination Prior to initial certification, prospective Lead Auditors shall pass an examination that evaluates comprehension of and ability to apply the body of knowledge described under the heading “Training”. The examination may be oral, written, practical, or any combination of the three types.

Maintenance of Proficiency Continued proficiency of Lead Auditors is maintained through one or more of the following:

Regular and active participation in the audit process.

Review and study of codes, standards, procedures, instructions, and other documents related to QHSE Program and program auditing.

Participation in training program(s).

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

Requalification Lead Auditors who fail to maintain their proficiency for a period of two years or more shall require requalification. Requalification shall include retraining and reexamination as described above, and participation as an Auditor in at least one Nuclear QA Audit.

2.4.4 Auditors Auditors may participate in an audit, under the direction of a Lead Auditor. Auditors shall have, or be given, appropriate training or orientation to develop their competence for performing audits. Competence of personnel for performance of the various auditing functions shall be developed by one or more of the following methods:

Orientation to provide a working knowledge and understanding of NQA‐1, the PCR QA Program, and Procedure QP‐22, “Audit Procedure.”

General and specialized training in audit performance where the general training shall include fundamentals, objectives, characteristics, organization, performance, and results of QHSE auditing, and the specialized training shall include methods of

QHSE Manual Rev. 9


2‐7

examining, questioning, evaluating, and documenting specific audit items and methods of closing out audit findings.

On‐the‐job training, guidance, and counseling under the direct supervision of a Lead Auditor. Such training shall including planning, performing, reporting and follow‐up action involved in conducting audits.

See Procedure QP‐9, “Qualification of Auditors” for the implementing procedure for Auditor qualification.

2.4.5 Technical Specialists Technical specialists participating in audits are qualified in the same manner as Auditors. Procedure QP‐9, “Qualification of Auditors” is the implementing procedure for qualification of technical specialists.

2.4.6 Records of Qualification The qualifications of inspection, test, and audit personnel shall be certified in writing and include the following information:

Employer’s name

Identification of person being certified

Activities certified to perform

Basis of qualification

Education, experience, indoctrination, and training

Test results, where applicable

Capability demonstration results

Results of periodic evaluation

Results of physical examinations, when required

Signature of employer’s designated representative who is responsible for such certification

Date of certification or recertification and certification expiration

Qualification records are controlled as described in Section 17.0. Physical examinations, as listed above, may be required when special physical characteristics are needed in the performance of an activity. If required, these shall be stated in a position description developed by the Human Resources Department and shall include the need for initial and subsequent physical examination. Qualification examination activities may be delegated to an independent certifying agency, but the PCR company will retain responsibility for conformance of the examination and its administration. Integrity of the examination shall be maintained by

QHSE Manual Rev. 9


2‐8

the PCR company or the certifying agency through appropriate confidentiality of files and, where applicable, proctoring of examinations. Copies of the objective evidence regarding the type(s) and content of examination(s) shall be retained in accordance with Section 17.0.

2.5 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 PCR Management.

2.5.1 Management Review Input The content of management review includes the following:

Performance and results of audits and surveillances

Client feedback

Process performance and product conformity

Status of preventive and corrective actions

Follow‐up actions from previous management reviews

Changes that could affect the QHSE Program

Recommendations for improvement

Nonconformances

QHSE policy and objectives

2.5.2 Management Review Output

The output from the management review of the QHSE Program includes decisions and

actions related to:

improvement of the effectiveness of the QHSE program and its processes

improvement of product related to client requirements

resource needs

2.6 SAFETY CULTURE

Free and open expression of safety concerns is an essential attribute of the PCR safety‐conscious work environment. It is the PCR policy that all employees and all personnel of PCR contractors working at PCR 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 PCR and personnel of its contractors

QHSE Manual Rev. 9


2‐9

without fear of discrimination, intimidation, harassment or retaliation and that those issues receive prompt and appropriate attention.

The PCR 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.

2.7 GRADED APPROACH

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.

2.8 CONTRACT REVIEW

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

2.8.1 Planning The planning and preparation of quality plans, health, safety and environmental plans, and/or 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.

2.8.2 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 requirements. During the review, marketing and/or

QHSE Manual Rev. 9


2‐10

designated organizations coordinate communication with the client. Records of the results of the reviews and actions arising from the reviews are maintained.

2.8.3 Contract Order Entry 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. 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.

2.8.4 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.

2.8.5 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.

QHSE Manual Rev. 9


3‐1

3.0 DESIGN CONTROL Design documents prepared by a PCR company 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. PCR companies also develop 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. 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 ● Industry codes and standards ● Regulatory and statutory requirements ● Technical requirements ● Other requirements essential for design and development ● Information derived from previous similar designs

QHSE Manual Rev. 9


3‐2

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, as described in the Procedures listed in Table 1. 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 shall review and concur with QHSE related procedures associated with design, construction, and installation. Procedures describing the design process shall be based on the following criteria:

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

Appropriate standards shall be identified and documented, and their selection reviewed and approved.

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

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

Applicable information derived from experience, as set forth in reports or other documentation, shall be 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 and the acceptance criteria for those characteristics shall meet the requirements of Subpart 2.14 to NQA‐1‐2008 and the NQA‐1a‐2009 Addenda. 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. If a commercial grade item, prior to its installation, is modified or selected by special inspection and/or testing to requirements that are more restrictive than the Supplier’s published product description, the component part shall be represented as different from the

QHSE Manual Rev. 9


3‐3

commercial grade item in a manner traceable to a documented definition of the difference.

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. The acceptability of computer programs used for design analysis shall be verified and validated (V&V) prior to use per Procedure QP‐7, “Control of Design and Analysis Software.” The V&V shall include:

Verification to show that the computer program produces correct solutions for the encoded mathematical model within defined limits for each parameter employed.

The encoded mathematical model shall be shown to produce a valid solution to the physical problem associated with the particular application.

As an alternative, software or spreadsheets that perform simple calculations may be controlled by treating the data and results presented as calculations, rather than performing V&V. Documentation of design analysis activities shall include the following:

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

Review and approval.

QHSE Manual Rev. 9


3‐4

3.4.1 Design Output Procedures describing the design output, including computer software, are listed in Table 1. Typical design output includes analyses, design reports, drawings, and specifications. PCR 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 shall also provide appropriate information for purchasing, production and service provision, contain or reference product acceptance criteria. A commercial‐grade item that is modified, inspected, and/or tested to demonstrate compliance to requirements more restrictive than the manufacturer’s original specifications is identified as different from the commercial‐grade item and traceable to the documented difference. 3.5 DESIGN VERIFICATION

Procedures describing the design process, which are listed in Table 1, are based on using the design review methodology for verifying a design. Where an alternative methodology is proposed, it shall meet the requirements of Section 3.5 and procedures shall be described in a 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 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

QHSE Manual Rev. 9


3‐5

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 shall be considered. The original design and associated verification documentation shall be referenced in records of subsequent application of the design. 3.6 DESIGN VERIFICATION METHODS

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

Design reviews

Alternate calculations

Qualification testing

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

QHSE Manual Rev. 9


3‐6

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. 3.7 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 of the design process using methods such as in‐process testing, prior to the delivery or implementation of the product. Software designed by RIZZO is validated prior to use per the requirements of RIZZO Procedure QP‐7, “Control of Design and Analysis Software.” Records of validation and any necessary actions shall be maintained. 3.8 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 in 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 a PCR company is controlled for the duration of a PCR company’s involvement with a nuclear power plant project. A PCR

QHSE Manual Rev. 9


3‐7

company role in a nuclear installation may involve the siting, design, and construction stages of the life cycle. 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 a PCR company involvement with a project. Measures are provided to ensure that changes that may affect the configuration are recognized and processed. 3.9 DESIGN INTERFACE CONTROL

Design organizations are responsible for establishing design interfaces with other organizations necessary to accomplish design project objectives and for documenting the identified interfaces. Design interfaces for safety related items, both within and external to PCR, are identified in Work Plans prepared per Procedure QP‐2, “Work Plan Preparation.” Interface controls shall include the assignment of responsibility and the establishment of procedures 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 letter 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 stamped 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 controlled document. 3.10 SOFTWARE DESIGN CONTROL

The requirements of this section apply to the design of software instead of Section 3.2, “Design Input,” Section 3.3, “Design Process,” Section 3.5, “Design Verification,” and Section 3.8, “Design Change Control.”

3.10.1 Software Design Process The software design process, meeting the requirements of Subpart 2.7 to NQA‐1 is described in Procedure QP‐7, “Control of Design and Analysis Software.” This process is based on the following criteria:

Software design requirements shall be identified and documented and their selection reviewed and approved.

The software requirements shall identify the operating system, function, interfaces, performance requirements, installation considerations, design inputs, and any design constraints of the computer system.

QHSE Manual Rev. 9


3‐8

The software design shall be documented and defines the computational sequence necessary to meet the software requirements. The documentation shall include, as applicable, numerical methods, mathematical models, physical models, control flow, control logic, data flow, process flow, data structures, process structures, and the applicable relationships between data structures and process structures. This documentation may be combined with the documentation of the software design requirements or the computer program listings resulting from implementation of the software design.

The software design shall be translated into the computer program(s) using the programming organization’s or design organization’s programming standards and conventions.

Software design verification shall be performed by a competent individual(s) or group(s) other than those who developed and documented the original design, but who may be from the same organization. This verification may be performed by the originator’s supervisor, provided:

a. 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

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

Cursory supervisory reviews do not satisfy the requirement for software design verification.

The results of the verification shall be documented with the identification of the verifier identified. Software verification methods shall include any one or combination of design reviews, alternate calculations, and tests performed during computer program development. The extent of verification and the methods chosen are a function of the complexity of the software, the degree of standardization, the similarity with previously proved software, and the importance to safety.

Computer program testing shall be performed as described in Section 11.0.

3.10.2 Software Configuration Management Software configuration management, including configuration identification, change control, and status control is addressed by Procedure QP‐7, “Control of Design and Analysis Software.” Configuration items shall be maintained under configuration management until the software is retired. A software baseline shall be established at the completion of each activity of the software design process. Approved changes created subsequent to a baseline shall be added to the baseline. A baseline shall define the most recently approved software configuration. A

QHSE Manual Rev. 9


3‐9

labeling system for configuration items shall be implemented that uniquely identifies each configuration item, identifies changes to the configuration items by revision, and provides the ability to uniquely identify each configuration of the revised software available for use. Changes to software shall be formally documented. The documentation shall include a description of the change, the rationale for the change, and the identification of affected software baselines. The change shall be formally evaluated and approved by the organization responsible for the original design, unless an alternate organization has been given the authority to approve the changes. Only authorized changes shall be made to software baselines. Appropriate verification activities shall be performed for the change. The change shall be appropriately reflected in the documentation, and traceability of the change to the software design requirement shall be maintained. Appropriate acceptance testing shall be performed for the change. The status of configuration items resulting from software design shall be maintained current. Configuration item changes shall be controlled until they are incorporated into the approved software baseline. The controls shall include a process for maintaining the status of changes that are proposed and approved, but not implemented. The controls shall also provide for notification of this information to affected organizations. 3.11 DESIGN DOCUMENTATION AND RECORDS

Design documentation and records shall 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 QHSE ROLE IN DESIGN AND ANALYSIS

QHSE Staff provide oversight of the QHSE design and analysis through audits and surveillances 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.

QHSE Manual Rev. 9


4‐1

4.0 PROCUREMENT DOCUMENT CONTROL Procedure QP‐30, “Procurement Documents,” 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 shall 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 and the NQA‐1a‐2009 Addenda. Examples of items and services typically procured by PCR companies, 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

Design and analysis software

The types of procurement documents issued by a PCR company include subcontractor agreements and purchase orders. 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 (see Section 4.1)

Technical Requirements (includes approval of product, procedures, processes, equipment and qualification of personnel; see Section 4.2)

QHSE Program Requirements (see Section 4.3)

Right of Access (see Section 4.4)

Documentation requirements (see Section 4.5)

Methods for reporting and approving disposition of nonconformances (see Section 4.6)

Spare and replacement parts (see Section 4.7)

QHSE Manual Rev. 9


4‐2

4.1 SCOPE OF WORK

Procurement documents shall include a statement of the scope of the work to be performed by a Supplier. 4.2 TECHNICAL REQUIREMENTS

Technical requirements shall be specified in the procurement documents that include requirements for approval of product, procedures, processes and equipment, as appropriate. These requirements shall be specified by reference to specific drawings, specifications, codes, standards, regulations, procedures, or instructions, including revisions thereto that describe the items or services to be furnished, as appropriate. The procurement documents shall identify requirements for qualification of personnel, appropriate test, inspection, and acceptance criteria for determining acceptability of the item or service. Design documents, which state the technical requirements, shall be prepared as described in Section 3.0. 4.3 QHSE PROGRAM REQUIREMENTS

QHSE Program requirements shall be specified in the procurement documents. These requirements shall be consistent with the importance and/or complexity of the item or service being procured. Procurement documents shall require subcontractors to incorporate appropriate QHSE and contract requirements in their sub‐tier procurement documents. 4.4 RIGHT OF ACCESS

Procurement documents shall provide for access by the PCR company or their client (for which the work is being performed) to the supplier’s and any sub‐tier supplier’s facilities and records for surveillance, inspection, or audit. 4.5 DOCUMENTATION REQUIREMENTS

Procurement documents shall identify the documentation required to be submitted for information, review, or approval by the PCR company. The time of submittal shall also be established. When a PCR company requires the supplier to maintain specific QA records, the retention times and disposition requirements shall be prescribed. 4.6 NONCONFORMANCES

The procurement documents shall include the PCR company requirements for reporting and approving disposition of nonconformances.

QHSE Manual Rev. 9


4‐3

4.7 SPARE AND REPLACEMENT PARTS

The procurement documents shall specify the supplier’s requirements to identify spare and replacement parts or assemblies (if applicable to an item being procured) and the related data required for ordering these parts or assemblies. 4.8 PROCUREMENT DOCUMENT REVIEW AND APPROVAL

Reviews of purchase orders and subcontractor agreements, and changes thereto, shall be 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 shall be incorporated into the procurement documents prior to their issuance to the supplier. This review shall include the following considerations:

Appropriate requirements as specified in Sections 4.1 through 4.7

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. Reviewers document their review per Procedure QP‐30, “Procurement Documents.” 4.9 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.

QHSE Manual Rev. 9


5‐1

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)

QA Project Plans (see Section 5.4)

Health & Safety Manual, and Health, Safety, & Environmental (HSE) Plans (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 designated with the prefix “QP” and are developed, reviewed, approved, and revised per Procedure QP‐23, “Procedures.” Control of QPs is performed per Procedure QP‐24, “Document Control.” 5.2 FIELD PROCEDURES

Field Procedures provide field testing, data acquisition, documentation, or calibration procedures. These procedures are designated with the prefix “FP.” Field Procedures are developed, reviewed, approved, and revised per Procedure QP‐23, “Procedures.” Control of FPs is performed per Procedure QP‐24, “Document Control.”

QHSE Manual Rev. 9


5‐2

5.3 PROJECT WORK PLANS

Project Work Plans provide details on the project activities to be performed by PCR companies and their subcontractors. 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, “Work Plan Preparation.” Control of Project Work Plans is performed per Procedure QP‐24, “Document Control.” 5.4 QUALITY ASSURANCE PROJECT PLANS

When requested by a client, the overall QA Program may be supplemented or modified by a QA Project Plan. If a stand‐alone QA Project Plan is prepared, it shall meet the requirements of the client purchase order, this QHSE Manual, and applicable regulatory requirements. QA Project Plans are prepared, reviewed, approved, and revised per Procedure QP‐31 “Quality Assurance Project Plans.” Control of QA Project Plans is performed per Procedure QP‐24, “Document Control.” 5.5 HEALTH & SAFETY MANUAL, AND HEALTH, SAFETY, & ENVIRONMENTAL (HSE) PLANS

The PCR Health & Safety Manual applies to all activities, and states objectives which, when met, will prevent or reduce the risk of a harmful event. Where necessary based on project requirements, the overall HSE Program may be supplemented or modified by a HSE Plan. The HSE Plan shall meet the requirements of the client purchase order, this QHSE Manual, and applicable regulatory requirements. HSE Plans are prepared, reviewed, approved, and revised per Procedure QP‐2, “Work Plan Preparation.” Control of HSE Plans is performed per Procedure QP‐24, “Document Control.” 5.6 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‐23, “Procedures.” Control of project‐specific procedures is performed per Procedure QP‐24, “Document Control.” 5.7 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 shall be used.

QHSE Manual Rev. 9


5‐3

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 (see Section 5.3). 5.8 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”.

QHSE Manual Rev. 9


6‐1

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 shall be 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 background data or information upon which to base their approval. 6.2 MINOR CHANGES TO DOCUMENTS

Minor changes to documents, such as inconsequential editorial corrections, shall 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.”

QHSE Manual Rev. 9


7‐1

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 shall be planned and documented to assure a systematic approach to the procurement process. Procurement planning shall result in the documented identification of procurement methods and organizational responsibilities: Planning shall determine the following:

What is to be accomplished?

Who is to accomplish it?

How it is to be accomplished?

When it is to be accomplished?

Planning shall be accomplished as early as practicable, no later than the start of those procurement activities which are required to be controlled, to assure interface compatibility and a uniform approach to the procurement process. These aspects of the planning shall be addressed in a Work Plan prepared per Procedure QP‐2, “Work Plan Preparation.” Planning shall result 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 shall provide for the integration of the following:

Procurement document preparation, review and change control per Procedure QP‐30, “Procurement Documents.”

Selection of procurement sources per Procedure QP‐6, “Procurement Source Evaluation, Selection, and Control.”

Bid evaluation and award per Section 7.3.

Control of supplier performance per Section 7.4.

Verification (surveillance, inspection, or audit) activities by Purchaser, per Section 7.4, including notification for hold and witness points

QHSE Manual Rev. 9


7‐2

Control of nonconformances per Sections 4.6 and 15.0.

Corrective action per Section 16.0.

Acceptance of items or service per Section 7.6.

Quality Assurance records per Sections 4.5 and 17.0.

7.2 SUPPLIER EVALUATION AND SELECTION

Prior to the award of a contract, the supplier’s capability to provide items or services in accordance with the requirements of procurement documents is evaluated. The evaluation is performed and documented per Procedure QP‐6, “Procurement Source Evaluation, Selection, and Control” and includes one or more of the following:

Supplier’s history of providing an identical or similar product (or service) that performs satisfactorily in actual use. The supplier’s history shall reflect current capability.

Supplier’s current quality (including HSE, as applicable) records supported by documented qualitative and quantitative information that can be objectively evaluated.

Supplier’s technical and quality (including HSE, as applicable) capability as determined by a direct evaluation of the facilities, personnel, and the implementation of the supplier’s program.

QHSE Staff are responsible for the development and maintenance of an Approved Supplier List per Procedure QP‐6, “Procurement Source Evaluation, Selection, and Control.” Suppliers performing nuclear safety‐related work, approved based on their Quality Program meeting 10 CFR 50 Appendix B, are audited per the requirements of Section 18.1.2. 7.3 BID EVALUATION

If bids are solicited from potential suppliers prior to contract award, the bid evaluation shall include a determination of the supplier’s capability to conform to the technical and QHSE requirements. This evaluation shall be performed by individuals or organizations designated to evaluate the following subjects, as applicable to the type of procurement:

Technical considerations

Quality assurance requirements

Health, Safety, and Environmental considerations

Supplier’s personnel

Supplier’s production capacity

QHSE Manual Rev. 9


7‐3

Supplier’s past performance

Alternates

Exceptions

Prior to the award of the contract, PCR personnel shall resolve or obtain commitments to resolve unacceptable technical and quality (including HSE, as applicable) conditions resulting from bid evaluation. 7.4 SUPPLIER PERFORMANCE EVALUATION

Measures for interface with suppliers, including verification of supplier performance shall include the following:

Establishing an understanding between PCR and the supplier of the provisions and specifications of the procurement documents.

Requiring the supplier to identify planning techniques and processes to be utilized in fulfilling procurement document requirements.

Reviewing supplier documents which are generated or processed during activities fulfilling procurement requirements.

Identifying and processing necessary change information.

Establishing method of document information exchange between PCR and the supplier.

Establishing the extent of source surveillance and inspection activities.

Supplier performance verification methods are further described in Procedure QP‐6, “Procurement Source Evaluation, Selection and Control” and QP‐30, “Procurement Documents.” These verification activities shall be conducted as early as practicable. PCR verification activities, however, shall not relieve a supplier of his responsibilities for verification of quality (including HSE, as applicable) achievement. Activities performed to verify conformance to requirements of procurement documents shall be recorded. Source surveillances and inspections, audits, receiving inspections, nonconformances, dispositions, waivers, and corrective actions shall be documented. PCR personnel shall assure that this documentation is evaluated to determine the supplier’s quality (including HSE, as applicable) program effectiveness. 7.5 CONTROL OF SUPPLIER‐GENERATED DOCUMENTS

Controls shall be implemented to ensure that the submittal and evaluation of supplier‐generated documents and changes are accomplished in accordance with the procurement

QHSE Manual Rev. 9


7‐4

document requirements. These controls shall provide for the acquisition, processing, and recorded evaluation of the quality (including HSE, as applicable), technical, inspection, and test documentation or data against acceptance criteria. Controls are addressed in Procedure QP‐6, “Procurement Source Evaluation, Selection, and Control.” 7.6 ACCEPTANCE OF AN ITEM OR SERVICE

Prior to offering an item or service for acceptance, the supplier shall verify that the item or service being furnished complies with the procurement requirements. The extent of verification activities by PCR personnel shall be a function of the relative importance, complexity, and quantity of the item or services procured and the supplier’s quality (including HSE, as applicable) performance. Where required by code, regulation, or contract requirement, documentary evidence that items conform to procurement requirements shall be available at the nuclear facility site prior to installation or use. Methods used to accept an item or service shall be any of the following:

Supplier Certificate of Conformance

Source verification

Receiving inspection

Post installation test at the nuclear facility site

Combination of these methods

In cases involving procurement of services only, such as third‐party inspection; engineering and consulting services; auditing; and installation, repair, overhaul, or maintenance work, the service shall be accepted by any of the following methods:

Technical verification of the data produced

Surveillance and/or audit of the activities per Section 18.0

Review of objective evidence for conformance to procurement document requirements

Acceptable methods for accepting an item or service are discussed in Procedure QP‐6, “Procurement Source Evaluation, Selection, and Control” and Procedure QP‐32, “Receipt Inspection.” When a Certificate of Conformance is used, the minimum criteria listed below shall be met:

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

The certificate shall identify the specific procurement requirements met by the purchased material or equipment, such as codes, standards, and other

QHSE Manual Rev. 9


7‐5

specifications. This may be accomplished by including a list of the specific requirements or by providing, on‐site, a copy of the purchase order and the procurement specifications or drawings, together with a suitable certificate. The procurement requirements identified shall include any approved changes, waivers, or deviations applicable to the subject material or equipment.

The certificate shall identify any procurement requirements that have not been met, together with an explanation and the means for resolving the nonconformances.

The certificate shall be signed or otherwise authenticated by a person who is responsible for this quality function and whose function and position are described in the PCR or supplier’s quality program.

The certification system, including the procedures to be followed in filling out a certificate and the administrative procedures for review and approval of the certification shall be described in the supplier’s or the PCR program documents.

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

When source verification is used, it shall be performed at intervals consistent with the importance and complexity of the item or service and shall include monitoring, witnessing, or observing selected activities. Source verification shall be implemented in accordance with plans to perform inspections, examinations, or tests at predetermined points. Upon PCR acceptance of source verification, documented evidence of acceptance shall be furnished to the receiving destination of the item, to PCR, and to the supplier. When receiving inspection is used, purchased items shall be inspected as necessary to verify conformance to specified requirements, taking into account source verification, audit activities and the demonstrated quality (including HSE, as applicable) performance of the supplier. Receiving inspections shall verify by objective evidence such features as:

Configuration

Identification

Dimensional, physical, and other characteristics

Freedom from shipping damage

Cleanliness

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

QHSE Manual Rev. 9


7‐6

When post installation testing is used, post installation test requirements and acceptance documentation shall be mutually established by PCR and the supplier. 7.7 CONTROL OF SUPPLIER NONCONFORMANCES

The PCR company requirements for reporting and approving disposition of supplier nonconformances for items and services that do not meet procurement document requirements are described in Procedure QP‐4, “Control of Nonconformances” and Procedure QP‐30, “Procurement Documents.” Methods for control and disposition of supplier nonconformances shall include:

Evaluation of nonconforming items.

Submittal of nonconformance notice to PCR by the supplier as specified in the procurement documents. These submittals shall include the supplier‐recommended disposition (e.g., use‐as‐is or repair) and technical justification. Nonconformances to the procurement requirements or PCR‐approved documents, which consist of one or more of the following, shall be submitted to PCR for approval of the recommended disposition:

Technical or material requirement is violated.

Requirement in supplier documents, which has been approved by PCR, is violated.

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

The item does not conform to the original requirement even though the item can be restored to a condition such that the capability of the item to function is unimpaired.

Purchaser disposition of supplier recommendation.

Verification of implementation of the disposition.

Maintenance of records of supplier‐submitted nonconformances per Section 17.0.

7.8 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 Subpart 2.14 to NQA‐1‐2008 and the NQA‐1a‐2009 Addenda. It is supplemented by guidance in NRC

QHSE Manual Rev. 9


7‐7

Generic Letter 89‐02 (dated March 21, 1989), “Actions to Improve the Detection of Counterfeit and Fraudulently Marked Products;” GL 91‐05 (dated April 9, 1991), “Licensee Commercial‐Grade Dedication Programs;” EPRI NP‐5652 (dated June 1988), “Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications, NCIG‐07;” EPRI TR‐102260 (dated March 1994), “Supplemental Guidance for the Application of EPRI Report NP‐5652 on the Utilization of Commercial Grade Items,” and NRC Inspection Manual, Inspection Procedure 43004 (dated October 3, 2007), “Inspection of Commercial Grade Dedication Programs.” Following the Commercial Grade Dedication of an item or service, PCR 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. 7.9 QUALIFICATION AND ACCEPTANCE OF COMMERCIAL GRADE CALIBRATION SERVICES

Suppliers of commercial‐grade calibration services for safety‐related applications may be qualified on the basis of accreditation to ANSI/ISO/IEC 17025, “General Requirements for the Competence of Testing and Calibration Laboratories.” This qualification method is limited to domestic calibration service suppliers. The accrediting body is the National Voluntary Laboratory Accreditation Program (NVLAP), the American Association for Laboratory Accreditation (A2LA), Laboratory Accreditation Bureau (L‐A‐B), ANSI‐ASQ National Accreditation Board (ACLASS), International Accreditation Service, Inc. (IAS), Perry Johnston Laboratory Accreditation, Inc., or other domestic based signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). The published scope of accreditation shall cover the services required, including the needed measurement parameters, ranges, and uncertainties. In this case, procurement documents shall include:

Technical and administrative requirements to satisfy necessary QA program and technical requirements.

Requirement to report as‐found calibration data when calibrated items are found to be out‐of‐tolerance.

Requirements to identify the laboratory equipment/standards used.

This method is applicable to sub‐suppliers of calibration service suppliers, provided the above conditions are met. The acceptance of calibration services as described above is required to be conducted per Procedure QP‐29, “Commercial Grade Dedication.”

QHSE Manual Rev. 9


7‐8

7.10 COUNTERFEIT AND FRAUDULENT MATERIALS, ITEMS, AND COMPONENTS

It is the policy of PCR to provide awareness to our employees of the potential risk for

Suspect and Counterfeit Items (S/CIs) to enter the supply chain. 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.

The following indications are typically employed to identify suspect (including counterfeit/fraudulent) materials, items, or components that may not be those ordered:

Altered manufacturer’s name, logo, serial number, manufacturing date.

Items differing in configuration, dimensions, fit, finish, color, or other attributes from that expected.

Markings on items or documentation from country other than that of the sub‐supplier.

Items, sold as new, exhibit evidence of prior use.

Performance inconsistent with specifications, certification or test data furnished.

Documentation that appears altered, incomplete, or lacks expected traceability, UL or manufacturer’s markings.

The following prevention barriers are used as applicable to a project:

Preventing introduction of S/CIs into the work by:

Engineering involvement (development of procurement specifications, during inspection and testing, and when maintaining, replacing, or modifying equipment)

Identifying and placing technical and QA requirements in procurement documents per Section 4.0

Accepting only those items that comply with procurement specifications, consensus standards, and commonly accepted industry practices, and

Inspecting inventory and storage areas to identify, control, and disposition S/CIs.

Inspection, identification, evaluation, and disposition of S/CIs that have been installed in safety applications and other applications that create potential hazards. Also address the use of supporting engineering evaluations for acceptance of installed S/CIs as well as marking to prevent future reuse.

QHSE Manual Rev. 9


7‐9

Conduct engineering evaluations to be used in the disposition of identified S/CIs installed in safety applications/systems or in applications that create potential hazards. Evaluations must consider potential risks to the environment, the public and workers along with a cost/benefit impact, and a schedule for replacement (if required).

Perform the evaluation to determine whether S/CIs installed in non‐safety applications pose potential safety hazards or may remain in place. Disposition S/CIs identified during routine maintenance and/or inspections to prevent use in these applications.

For DOE facilities, make a report to the DOE Inspector General per DOE O 414.1D, Attachment 3, Item 3, and per DOE O 221.1A, Reporting Fraud, Waste, and Abuse to the Office of Inspector General, dated 03‐22‐01 or latest version.

Collect, maintain, disseminate, and use the most accurate, up to date information on S/CIs and suppliers. Sources are identified on the DOE S/CI website.

Collect trend analyses for use in improving the S/CI prevention process.

QHSE Manual Rev. 9


8‐1

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 PCR, identification and control of items typically applies to samples of soil, rock, water and other materials that are collected during a site investigation or testing program. See QP‐26, “Sample Identification and Control,” for the procedure to identify samples such that the samples are traceable to the specific locations and sampling dates. 8.1 IDENTIFICATION METHODS

Items of production (e.g., batch, lot, component, part) shall be 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 shall be 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 identification or traceability of the item to applicable specification and grade of material; heat, batch, lot, part, or serial number; or specified 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.

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

Provisions for updating existing plant records.

QHSE Manual Rev. 9


9‐1

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.

QHSE Manual Rev. 9


10‐1

10.0 INSPECTION Inspection typically applies to the PCR scope of services as follows:

Receiving inspection may be applied as a method to accept supplier furnished items or services per Section 7.6. Procedure QP‐32, “Receipt Inspection,” provides the implementing procedure for this type of inspection.

Soil and rock samples may be inspected in the field to determine if they are suitable for their intended purpose. This type of inspection is addressed in a field investigation work plan prepared per Procedure QP‐2, “Work Plan Preparation.”

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. 10.1 INSPECTION REQUIREMENTS

Inspection requirements and acceptance criteria shall 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.

QHSE Manual Rev. 9


10‐2

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 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 shall be 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

QHSE Manual Rev. 9


11‐1

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 (other than for computer programs) including, as appropriate, prototype qualification tests, production tests, proof tests prior to installation, construction tests, preoperational tests, and operation tests shall be controlled. Computer program tests including, as appropriate, software design verification, factory acceptance tests, site acceptance tests, and in‐use 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. Test requirements and acceptance criteria for computer programs shall be provided by the organization responsible for the use of the computer program and shall include the following, as applicable:

Software design verification testing shall demonstrate the capability of the computer program(s) to provide valid results for test problems encompassing the range of documented permitted usage.

Computer program acceptance testing shall consist of the process of exercising or evaluating a system or system component by manual or automated means to ensure that it satisfies the specified requirements and to identify differences between expected and actual results in the operating environment.

In‐use computer programs testing shall demonstrate required performance over the range of operation of the controlled function or process.

QHSE Manual Rev. 9


11‐2

11.2 TEST PROCEDURES (OTHER THAN FOR COMPUTER PROGRAMS)

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

Within the PCR QA Program, test procedures are provided in Field Procedures (see Section 5.2), Project Work Plans (see Section 5.3), Project‐Specific Procedures (see Section 5.5) or published test procedures (see Section 5.6). 11.3 COMPUTER PROGRAM TEST PROCEDURES

The scope of services performed by PCR includes the use of computer programs for design activities. Procedure QP‐7, “Control of Design and Analysis Software,” provides the verification and validation (V&V) process used to assure that computer programs produce correct results, as previously described in Section 3.0. Procedure QP‐7, “Control of Design and Analysis Software,” describes the process to evaluate technical adequacy through comparison of test results from alternative methods such as hand calculations, calculations using comparable proven programs, or empirical data and information from technical literature. In addition to V&V, in‐use testing is performed to confirm acceptable performance of the computer program in the operating system, as described in Procedure QP‐7, “Control of Design and Analysis Software.” If a program is installed on a computer other than that in which the program V&V was performed, or if significant hardware or operation system configuration changes have been made since verification, in‐use tests shall be performed to confirm acceptable performance of the computer program on the new system. Periodic in‐use manual or automatic self‐check in‐use tests shall be prescribed and performed for those computer programs in which computer program errors, data errors, computer hardware failures, or instrument drift can affect required performance. Test procedures or plans shall specify the following, as applicable:

Required tests and test sequence

QHSE Manual Rev. 9


11‐3

Required ranges of input parameters

Identification of the stages at which testing is required

Criteria for establishing test cases

Requirements for testing logic branches

Requirements for hardware integration

Anticipated output values

Acceptance criteria

Reports, records, standard formatting, and conventions

11.4 TEST RESULTS

11.4.1 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.

11.4.2 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. Evaluation of the adequacy of the results shall be discussed in a Work Plan prepared per Procedure QP‐2, “Work Plan Preparation.”

QHSE Manual Rev. 9


11‐4

11.5 TEST RECORDS

Test records shall be established and maintained to indicate the ability of the item or computer program to satisfactorily perform its intended function or to meet its documented requirements. 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 (except for computer programs) shall 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

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

Computer program tests, including verification and in‐use tests, shall be documented on the forms provided in Procedure QP‐7, “Control of Design and Analysis Software.” These forms document the following information:

Computer program tested including system software used

Computer hardware used

Test equipment and calibrations, where applicable

Date of test

Tester or data recorder

Simulation models used, where applicable

Test problems

Results and applicability

Action taken in connection with any deviations noted

Person evaluating test results

Acceptability

QHSE Manual Rev. 9


12‐1

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

QHSE Manual Rev. 9


12‐2

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 in accordance with Section 5.0 and are 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)

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 Nonconformance Report (NCR)

QHSE Manual Rev. 9


12‐3

prepared and processed in accordance with Procedure QP‐4, “Control of Nonconformances.”

12.2.5 Application Measuring and test equipment shall be traceable to its application and use, as documented on test records prepared per Section 11.5.

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.

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

QHSE Manual Rev. 9


12‐4

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

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

QHSE Manual Rev. 9


13‐1

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.

QHSE Manual Rev. 9


14‐1

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.

QHSE Manual Rev. 9


15‐1

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, “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, “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. 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.

QHSE Manual Rev. 9


15‐2

The QHSE Management and 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) as defined in Appendix A. 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.

QHSE Manual Rev. 9


16‐1

16.0 CORRECTIVE AND PREVENTIVE ACTIONS Conditions adverse to quality (including HSE, as applicable) shall be identified promptly and corrected as soon as practical. A determination is made as to whether the condition adverse to quality meets the definition of significant condition adverse to quality. Conditions adverse to quality are evaluated to determine whether screening to assess the potential applicability of 10 CFR 21 or 10 CFR 50.55(e) is required. If a screening is required, it is conducted per Procedure QP‐8, “10 CFR 21 Program Procedure.” Conditions adverse to quality (including HSE, as applicable) are evaluated to determine the cause, develop subsequent corrective/preventive action plans, and assign expected completion date(s). Once agreed upon, the corrective/preventive action plans are then implemented, and appropriate corrective actions are to be instituted to preclude recurrence. The manager of the affected area is responsible for corrective / preventive action completion. Effective completion of corrective and preventive actions are reviewed and verified by the QHSE Staff as part of future auditing or QHSE activities. The implementing procedure for the activities described above is Procedure QP‐5, “Corrective Action, Preventive Action, and Continual Improvement.” This Procedure also describes the method for documenting these activities on Corrective/Preventive Action Reports (CPARs) and for reporting conditions adverse to quality (includes HSE, as applicable) to the appropriate levels of management. 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 CPAR forms per QP‐5 requirements.

QHSE Manual Rev. 9


17‐1

17.0 QHSE RECORDS The records control system is implemented to achieve the following objectives:

QHSE records shall 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 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 design specifications, 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.

QHSE Manual Rev. 9


17‐2

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 Table 17‐1, 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).

QHSE Manual Rev. 9


17‐3

TABLE 17‐1 CLASSIFICATION OF TYPICAL RECORDS FOR NUCLEAR SAFETY‐RELATED PROJECTS

Maintained as a General Record (not nuclear safety‐related)

General project correspondence, which is not otherwise listed below

Health and Safety Records

Phase Forms

Non‐Permanent Records (3‐year minimum)2

Requests for Proposals and Bids, both from and to RIZZO

Proposals and Bids, both from and to RIZZO

QA / QHSE Manual

Quality Procedures

Field Procedures

Project‐Specific Work Plans and Procedures

Commercial Grade Dedication Plans

Project‐Specific QA documents, such as QA Project Plans

Configuration Management Databases

Corrective/Preventive Action Reports

Equipment Maintenance and Calibration Records

Supplier Quality Manual and Procedures

Receipt inspection documentation

Reference Material, such as maps, papers, reports, articles

General QHSE Program documents such as Audit Schedules and records of Management Assessment

Audit plans, checklists, reports, responses and documentation of follow‐up action

Surveillance Records (Plans, Reports)

Auditor and Lead Auditor Qualification Records, including supporting documentation regarding education, experience, training, audit performance, and examination

2 Nonpermanent records shall be retained for a minimum of 3 years and at least until the date of issuance of the full‐power operating license of the unit.

TABLE 17‐1 (CONTINUED)

QHSE Manual Rev. 9


17‐4

Documentation of Personnel Qualifications, including supporting documentation regarding education, experience, certifications, training, position descriptions, examinations, etc.

Lifetime Records3

Design input, including Requests for Information received by RIZZO

Records documenting review and approval of internet data, when this data is used as an input to a RIZZO design document

Procurement Specifications

Approved Supplier Lists and Supporting documentation

Design Reports prepared by RIZZO

Responses to Requests for Information prepared by RIZZO and submitted to another design organization

Design Reports prepared by others and referenced in a RIZZO Lifetime Record

Specifications

Design Drawings

Calculations.

SAR and COLA section input and RAI responses prepared by RIZZO and documentation of review and approval.

Commercial Grade Dedication Reports

Contracts and Purchase Orders

Applicable codes and standards used in design

Field Investigation Records

Laboratory Testing Results

Field Testing Records including test deviation or exception records and results of checks

Other records prepared in accordance with NQA‐1, Subpart 2.20

Nonconformance Reports (including those from suppliers)

Verification and Validation Packages, Software Configuration Control documents, and other documentation referenced in Procedure QP‐7

3 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.

QHSE Manual Rev. 9


17‐5

The PCR 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 records, and for having copies of these records filed per Procedure QP‐25, “Records Control.” If revised versions of externally prepared records are subsequently received, the documentation is to be updated to reflect the revision per procedure. 17.5 STORAGE

Records shall be stored in predetermined location(s) in facilities, containers, or a combination thereof, constructed and maintained in a manner that minimizes the risk of loss, damage, or destruction from:

Natural disasters such as wind, flood, or fires.

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

Infestation of insects, mold, or rodents.

Dust or airborne particles.

Activities detrimental to the records shall be prohibited in the storage area. Access to the processing, storage, and retrieval of records shall be limited to authorized personnel. These measures shall guard against larceny and vandalism. Measures shall be taken to provide for replacement, restoration, or substitution of lost or damaged records. Provisions shall be made to prevent damage from harmful conditions (such as excessive light, stacking, electromagnetic fields, temperature, and humidity), as applicable to the specific media utilized for record storage. There are two equally satisfactory methods of providing storage for nuclear safety‐related records, single or dual. Storage facilities shall meet the requirements of Supplement 17S‐1, Paragraph 4.4 of NQA‐1‐1994. Additional storage requirements for these methods are as follows.

Single storage consists of a storage facility, vault, room, or container(s) with a minimum two‐hour fire rating. The design and construction of a single storage facility, vault room, or container shall be reviewed for adequacy by a person competent in fire protection or contain a certification or rating from an accredited organization.

QHSE Manual Rev. 9


17‐6

Dual facilities, containers, or combination thereof shall be at locations sufficiently remote from each other to eliminate the chance exposure to a simultaneous hazard. Dual facilities are not required to meet the single storage requirements listed above.

When temporary storage of nuclear safety‐related records (such as for processing, review, or use during performance of field work) is required, the storage facility or container shall provide a one‐hour fire rating, unless the dual storage requirements listed above are met. 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 PCR company or a designated alternate (e.g. the Owner or PCR client). 17.6 RETENTION AND DISPOSITION

Records for nuclear‐safety related projects shall be maintained per retention periods described in Section 17.3 and Table 17‐1. 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. After six years or the designated duration, the PCR company determines if the records may be discarded, and the final disposition of the records is mutually agreed upon by the client and the PCR company. Records accumulated at various locations, prior to transfer, shall be made accessible to the Owner directly or through the procuring organization. The custodian shall inventory the submittals, acknowledge receipt, and process these records in accordance with Part 1 of NQA‐1. 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

Purchaser’s requirements are satisfied

QHSE Manual Rev. 9


17‐7

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

17.8 ELECTRONIC RECORDS

If electronic records are used to satisfy any of the records control requirements listed in this section, they shall be identified, generated, authenticated, stored, and maintained per procedures meeting the following guidance, as applicable:

Non‐mandatory Appendix 17A‐2, “Guidance for Electronic Records” of NQA‐1‐2008 and the NQA‐1a‐2009 Addenda.

Regulatory Issue Summary (RIS) 2000‐18, “Guidance on Managing Quality Assurance Records in Electronic Media,” dated October 23, 2000, and applicable documents referenced in Attachment 1 to RIS 2000‐18.

Generic Letter 88‐18, “Plant Record Storage on Optical Discs,” October 20, 1998.

Applicable implementing procedures shall describe the associated controls.

QHSE Manual Rev. 9


18‐1

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 subcontractors 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 Regularly Scheduled 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, whichever is shorter. Also, if the QHSE program is modified because of significant changes in the requirements of regulations or industry standards, or because of a new service provided by PCR, an internal audit will be conducted to verify implementation of the necessary changes.

18.1.2 Regularly Scheduled External Audits Procurement audits that are non‐safety related are accomplished as follows:

Audits may not be necessary for procuring the following items, based on the evaluation of supplier conducted per Section 18.1.3:

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.

QHSE Manual Rev. 9


18‐2

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 Annual Evaluations of Suppliers Evaluations of suppliers are documented per Procedure QP‐6, “Procurement Source Evaluation, Selection, and Control” and take into account the following, where applicable:

Receipt inspection, operating experience, and supplier evaluation programs are reviewed on an ongoing basis as the information becomes available. The results of the review are promptly considered for effect on a supplier’s continued qualification and adjustments made as necessary (including corrective actions, adjustments of supplier audit plans, and input to third party auditing entities, as warranted).

Additionally, results are reviewed periodically to determine if, as a whole, they constitute a significant condition adverse to quality (includes HSE, as applicable) requiring additional action.

If there is no ongoing receipt inspection or operating experience with which to analyze the supplier for a period of twelve months, an annual evaluation shall be performed as follows:

Review of supplier‐furnished documents and records such as certificates of conformance, nonconformance notices, and corrective actions.

Results of previous source verifications, audits, and receiving inspections.

QHSE Manual Rev. 9


18‐3

Operating experience of identical or similar products furnished by the same supplier.

Results of audits from other sources (e.g., client, NUPIC, NRC inspection reports).

The results of the evaluation shall be reviewed by the QHSE Staff and appropriate corrective action shall be taken. Adverse findings resulting from these evaluations shall be periodically reviewed in order to determine if, as a whole, they result in a significant condition adverse to quality and to provide input to the supplier audit program. Adverse findings shall be documented in accordance with Procedure QP‐5, “Corrective Action, Preventive Action, and Continual Improvement.”

18.1.4 Project Audits Project‐specific audits may be conducted, if specified in a QA Project Plan (see Section 5.4) or as directed by the QHSE Staff. The scope of these audits shall be based on the status and scope of the audited activity. Subsurface investigations for nuclear power plants, subject to Subpart 2.20 of NQA, shall be audited in accordance with QP‐14, “Quality Assurance Verification to Meet NQA‐1, Subpart 2.20.”

18.1.5 Audit Schedule Compliance A grace period of 90 days may be applied to the scheduled audit and annual evaluation intervals, but the periodicity of these activities shall be based on the original schedule. 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. 18.2 AUDIT PREPARATION

An audit plan shall be prepared prior to conducting the audit. This plan shall identify the audit scope, requirements, audit personnel, activities to be audited, organizations to be notified, applicable documents, schedule, and written procedures or checklists. Audit personnel shall have sufficient authority and organizational freedom to make the audit process meaningful and effective. An audit team shall be identified prior to the beginning of each audit. The team shall contain one or more Auditors, one being designated Lead Auditor who organizes and directs the audit. The Lead Auditor shall, prior to commencing the audit, concur that assigned personnel collectively have experience or training commensurate with the scope, complexity, or special nature of the activities being audited. Audit team members shall be qualified per Section 2.2.

QHSE Manual Rev. 9


18‐4

18.3 AUDIT PERFORMANCE

Auditing shall begin as early in the life of the activity as practical and shall be continued at intervals consistent with the schedule for accomplishing the activity. Elements selected for audit shall be evaluated against specified requirements. Objective evidence shall be examined to the depth necessary to determine if these elements are being implemented effectively. Conditions requiring prompt corrective action shall be reported immediately to management of the audited organization. 18.4 AUDIT REPORTING

The audit report shall be signed or otherwise endorsed by the Lead Auditor and issued to the audited organization. The contents of the report shall:

Describe the audit scope.

Identify Auditors and persons contacted.

Summarize audit results, including a statement on the effectiveness of the elements audited.

Describe each reported adverse audit finding.

18.4 AUDIT RESPONSE

Management of the audited organization or activity shall investigate adverse audit findings, schedule corrective action, including measures to prevent recurrence of the significant conditions adverse to quality (includes HSE, as applicable), and notify the appropriate organization in writing of action taken or planned. Audit responses shall be evaluated by or for the auditing organization. 18.5 FOLLOW‐UP ACTION

Follow‐up action shall be taken to verify that corrective and preventive action is accomplished as scheduled. 18.6 AUDIT RECORDS

Audit records shall include audit plans, audit reports, checklists, written replies, and the record of completion of corrective action. 18.7 SURVEILLANCE

Surveillance is the act of monitoring or observing to verify whether an item or activity conforms to specified requirements. Surveillances are conducted as described in Procedure QP‐21, “Surveillance Procedure.” The results of the surveillance shall be documented and reported to the individual or organization requesting the surveillance.

QHSE Manual Rev. 9


19‐1

19.0 TABLE 1, COMPLIANCE WITH THE REQUIREMENTS, OF 10 CFR 50 APPENDIX B AND NQA‐1, 1994, 2008, 2009A

SECTION NO.

TITLE IMPLEMENTING PROCEDURES

1 Management Responsibility & Organization

Organization is described in this manual. QP‐39, “Management Review”

2 QHSE Program QP‐1, “Order Entry and Contract Review” QP‐3, “Personnel Qualifications” QP‐9, “Qualification of Auditors” QP‐34, “Training” QP‐37, Information Control

3 Design Control QP‐7, “Control of Design and Analysis Software” QP‐11, “Preparation and Review of Regulatory Submittals for Licensing of Nuclear Power Plants” QP‐12, “Use of Internet Data” QP‐15, “Calculation Preparation” QP‐16, “Specifications” QP‐17, “Drawing and Figure Preparation” QP‐18, “RAI Process” QP‐19, “Configuration Management” QP‐20, “Report Preparation” QP‐29, “Commercial Grade Dedication” QP‐33, “Request for Information Process” QP‐36, “Qualification of Existing Data”

4 Procurement Document Control

QP‐1, “Order Entry and Contract Review” QP‐30, “Procurement Documents”

5 Instructions, Procedures, and Drawings

QP‐1, “Order Entry and Contract Review” QP‐2, “Work Plan Preparation” QP‐23, “Procedures” QP‐31, “Quality Assurance Project Plans”

6 Document Control QP‐24, “Document Control”

QHSE Manual Rev. 9


19‐2

Table 1

Continued 7 Control of Purchased Items

and Services QP‐6, “Procurement Source Evaluation, Selection, and Control” QP‐29, “Commercial Grade Dedication” QP‐32, “Receipt Inspection” QP‐38, “Suspect and Counterfeit Items Prevention”

8 Identification and Control of Items

QP‐26, “Sample Identification and Control”

9 Control of Special Processes

QP‐2, “Work Plan Preparation”

10 Inspection QP‐32, “Receipt Inspection”

11 Test Control QP‐7, “Control of Design & Analysis Software”

12 Control of Measuring and Test Equipment

QP‐28, “Measuring & Test Equipment Control”

13 Handling, Storage, and Shipping


14 Inspection, Test, and Operating Status


15 Control of Nonconforming Items

QP‐4, “Control of Nonconformances” QP‐8, “10 CFR 21 Program Procedure”

16 Corrective Action QP‐5, “Corrective Action, Preventive Action, and Continual Improvement” QP‐8, “10 CFR 21 Program Procedure”

17 Quality Assurance Records QP‐10, “Signature Authorization for Quality Records” QP‐25, “Records Control”

18 Audits QP‐21, “Surveillance Procedure” QP‐22, “Audit Procedure”

NQA‐1 Subpart 2.7

Quality Assurance Requirements for Computer Software for Nuclear Facility Applications

QP‐7, “Control of Design and Analysis Software”

NQA‐1a‐2009

Subpart 2.14

Quality Assurance Requirements for Commercial Grade Items and Services

QP‐29, “Commercial Grade Dedication”

QHSE Manual Rev. 9


19‐3

NQA‐1 Subpart 2.20

Quality Assurance Requirements for Subsurface Investigations for Nuclear Power Plants

QP‐2, “Work Plan Preparation” QP‐3, “Personnel Qualifications” QP‐14, “Quality Assurance Verification to Meet NQA‐1, Subpart 2.20”

QHSE Manual Rev. 9


20‐3

20.0 TABLE 2, COMPLIANCE WITH REQUIREMENTS OF 10 CFR 830, SUBPART A AND DOE O 414.1D

DOE Criteria Criteria

Applicable Section(s) of QHSE Manual

1 Management/Program. (1) Establish an organizational structure, functional

responsibilities, levels of authority, and interfaces for those managing, performing, and assessing the work.

(2) Establish management processes, including planning, scheduling, and providing resources for the work.

1.0, 2.0

2 Management/Personnel Training and Qualification. (1) Train and qualify personnel to be capable of

performing their assigned work. (2) Provide continuing training to personnel to maintain

their job proficiency.

2.1 and 2.2

3 Management/Quality Improvement. (1) Establish and implement processes to detect and

prevent quality problems (2) Identify, control, and correct items, services, and

processes that do not meet established requirements.

(3) Identify the causes of problems and work to prevent recurrence as part of correcting the problem.

(4) Review item characteristics, process implementation, and other quality‐related information to identify, items, services, and processes needing improvement.

2.0, 15.0, and 16.0

4 Management/Documents and Records. (1) Prepare, review, approve, issue, use, and revise

documents to prescribe processes, specify requirements, or establish design.

(2) Specify, prepare, review, approve, and maintain records.

5.0, 6.0, and 17.0

QHSE Manual Rev. 9


20‐4

TABLE 2, CONTINUED



5 Performance/Work Processes. (1) Perform work consistent with technical standards,

administrative controls, and other hazard controls adopted to meet regulatory or contract requirements, using approved instructions, procedures, or other appropriate means.

(2) Identify and control items to ensure their proper use. (3) Maintain items to prevent their damage, loss, or

deterioration. (4) Calibrate and maintain equipment used for process

monitoring or data collection.

5.0, 8.0, 12.0, 13.0

6 Performance/Design. (1) Design items and processes using sound

engineering/scientific principles and appropriate standards.

(2) Incorporate applicable requirements and design bases in design work and design changes.

(3) Identify and control design interfaces. (4) Verify or validate the adequacy of design products

using individuals or groups other than those who performed the work.

(5) Verify or validate work before approval and implementation of the design.

3.0

7 Performance/Procurement. (1) Procure items and services that meet established

requirements and perform as specified. (3) Evaluate and select prospective suppliers on the basis

of specified criteria. (4) Establish and implement processes to ensure that

approved suppliers continue to provide acceptable items and services.

4.0 and 7.0

QHSE Manual Rev. 9


20‐5

TABLE 2 CONTINUED



8 Performance/Inspection and Acceptance Testing. (1) Inspect and test specified items, services, and

processes using established acceptance and performance criteria.

(2) Calibrate and maintain equipment used for inspections and tests.

10.0, 11.0 and 12.0

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

2.3 and 18.0

10 Assessment/Independent Assessment (1) Plan and conduct independent assessments to

measure item and service quality, to measure the adequacy of work performance, and to promote improvement.

(2) Establish sufficient authority, and freedom from line management, for the group performing independent assessments.

(3) Ensure persons who perform independent assessments are technically qualified and knowledgeable in the areas to be assessed.

1.0, 2.2, 10.0, 11.0, 15.0, 16.0 and 18.0

§830.7 Where appropriate, a contractor must use a graded approach to satisfy the requirements of this part.

2.4

DOE 0 414.1D Attachment 3

Suspect/Counterfeit Items Prevention 7.10

QHSE Manual Rev. 9


21‐1

21.0 TABLE 3, PCR PROCEDURES COMPLIANCE MATRIX WITH REQUIREMENTS

PROCEDURE TITLE QHSE SECTION 10CFR50 APP B, NQA‐1: 1994, 2008, 2009A, AND

OTHER REGULATORY REQUIREMENTS

ISO‐9001:2008 SECTIONS

QP‐1 Order Entry and Contract Review

2.8 – Contract Review 4 – Procurement Document Control

5 – Instructions, Procedures, and Drawings

7.1 Planning Of Product Realization

7.2 Client‐Related Processes 7.5.1 Control of production

and service provision 7.5.4 Customer property

QP‐2 Work Plan Preparation 5 – Instructions, Procedures, & Drawings13 – Handling, Storage, and Shipping

5 – Instructions, Procedures, & Drawings

13 – Handling, Storage, and Shipping


4.2.3 Control Of Documents (External Origin)

5.4.2 Quality Management System Planning (Project Specific)


7.2 Client‐Related Processes 7.5.1 Control of production

and service provision 7.5.5 Preservation of product

QP‐3 Personnel Qualifications

2– QHSE Program

2– Quality Assurance Program


5.5.1 Responsibility and Authority

6.2 Human Resources

QP‐4 Control of Nonconformances

15 – Control of Nonconforming Items


8.3 Control of nonconforming product

8.4 Analysis of data

QP‐5 Corrective Action, Preventive Action, & Continual Improvement

16 – Corrective and Preventive Actions

16 – Corrective Action 5.2 Customer Focus8.2.3 Monitoring and

measurement of processes


8.4 Analysis of data 8.5 Improvement

QP‐6 Procurement Source Evaluation, Selection, and Control

7 – Control of Purchased Items & Services


7.4 Purchasing 8.4 Analysis of data

QP‐7 Control of Design and Analysis Software

3– Design Control11 – Test Control

3– Design Control11 – Test Control NQA‐1 Subpart 2.7

7.3 Design and Development7.5.1 Control of production

and service provision 7.5.2 Validation of Processes

for Production and Service Provision

8.2.4 Monitoring and measurement of product

Table 3, Continued

QHSE Manual Rev. 9


21‐2




QP‐8 10 CFR 21 Program Procedure

4 – Procurement Document Control 15 – Control of Nonconforming Items 16 – Corrective Action

4 – Procurement Document Control


16 – Corrective Action 10 CFR 21


QP‐9 Qualification of Auditors

2– QHSE Program18 ‐ Audits

2– Quality Assurance Program

18 ‐ Audits

6.2.2 Competence, Training And Awareness

8.2.2 Internal audit

QP‐10 Signature Authorization for Quality Records

17 – QHSE Records 17 – Quality Assurance Records

4.2.4 Control of Records

QP‐11 Preparation and Review of Regulatory Submittals for Licensing of Nuclear Power Plants

3– Design Control 3– Design Control 7.3 Design And Development

QP‐12 Use of Internet Data 3– Design Control 3– Design Control 7.3 Design And Development

QP‐13 Employee Concerns Program

15 – Control of Nonconforming Items 16 – Corrective Action 10 CFR 21


16 – Corrective Action 10 CFR 21


8.5 Improvement

QP‐14 Quality Assurance Verification to Meet NQA‐1, Subpart 2.20

3– Design Control NQA‐1 Subpart 2.20 7.3 Design And Development

QP‐15 Calculation Preparation


QP‐16 Specifications 3– Design Control 3– Design Control 7.3 Design And Development

QP‐17 Drawing and Figure Preparation


QP‐18 RAI Process 3– Design Control 3– Design Control 7.3 Design And Development

QP‐19 Configuration Management


QP‐20 Report Preparation 3– Design Control 3– Design Control 7.3 Design And Development

QP‐21 Surveillance Procedure 18– Audits

18– Audits NQA‐1 Subpart 2.20

7.4 Purchasing 8.2.2 Internal audit 8.4 Analysis of data

QP‐22 Audit Procedure 18– Audits

18– AuditsNQA‐1 Subpart 2.20

7.4 Purchasing 8.2.2 Internal audit 8.4 Analysis of data

QP‐23 Procedures 5 – Instructions, Procedures, and Drawings


7.1 Planning of Product Realization

QP‐24 Document Control 6 – Document Control 6 – Document Control 4.2.3 Control Of Documents

QP‐25 Records Control 17 – Quality Assurance Records

17 – Quality Assurance Records

4.2.4 Control Of Records7.5.3 Identification and

Table 3, Continued

QHSE Manual Rev. 9


21‐3




traceability7.5.5 Preservation of product

QP‐26 Sample Identification And Control

8 – Identification & Control of Items 13 – Handling, Storage, & Shipping

8 – Identification & Control of Items

13 – Handling, Storage, & Shipping


7.5.3 Identification and traceability

QP‐27 Field Activity Daily Logs



7.2 Client‐Related Processes7.5.1 Control of production

and service provision

QP‐28 Measuring and Test Equipment

12 – Control of Measuring and Test Equipment

12 – Control of Measuring and Test Equipment

7.6 Control of monitoring and measuring equipment

QP‐29 Commercial Grade Dedication

3– Design Control7 – Control of Purchased Items & Services

3– Design Control7 – Control of Purchased

Items & Services NQA‐1A 2009 Subpart 2.14

7.3 Design And Development7.4 Purchasing

QP‐30 Procurement Documents



7.4 Purchasing

QP‐31 Quality Assurance Project Plans



5.4.2 Quality Management System Planning (Project Specific)


QP‐32 Receipt Inspection 7 – Control of Purchased Items & Services 10– Inspection 13 – Handling, Storage, and Shipping


10– Inspection 13 – Handling, Storage, and

Shipping

7.4 Purchasing

QP‐33 Request for Information Process

3– Design Control 3– Design Control 7.2.3 Client Communication7.3 Design And Development

QP‐34 Training 2‐QHSE Program 2‐Quality Assurance Program

6.2.2 Competence, Training And Awareness

QP‐35 Project Performance Review

3‐Design Control 3‐Design Control 5.2 Customer Focus7.2.3 Client Communication 8.2.1 Client Satisfaction 8.2.3 Monitoring and

measurement of processes

8.4 Analysis of data

QP‐36 Qualification of Existing Data

3‐Design Control 3‐Design Control 7.3 Design And Development

QP‐37 Information Control 2‐QHSE Program 10 CFR 830 5.2 Customer Focus7.1 Planning Of Product

Realization

Table 3, Continued

QHSE Manual Rev. 9


21‐4




7.2 Client‐Related Processes7.5.4 Client Property

QP‐38 Suspect and Counterfeit Items Prevention

4 – Procurement Document Control 7 – Control of Purchased Items & Services



7.4 Purchasing

QP‐39 QHSE Management Review

2‐QHSE Program 2‐Quality Assurance Program

5.2 Customer Focus5.6 Management Review