Instrumentation & Controls US Quality Manual · ICQ Instrumentation & Control Quality Procedure...

Instrumentation & Controls US Quality Manual Doc # 500-9600000-10 ICQ-005-C June 2009

Review Approval Approval

Brad Mabry I&C Product Mgr

Leslie A. Ward I&C US QA Manager

C. David Thompson I&C US Vice President

Instrumentation & Controls US Quality Manual

Copyright ©2009 Data Systems & Solutions, LLC

The information in this document is the property of Data Systems & Solutions, LLC, and may not be copied, or communicated to a third

party, or used for any purpose other than that for which it is supplied, without the express written consent of Data Systems & Solutions,

LLC.

While the content of this document is given in good faith, based on the latest information available to Data Systems & Solutions, LLC, no

warranty or representation is given concerning it. This content does not establish any contractual or other commitment binding on Data

Systems & Solutions, LLC or any of its subsidiary or associated companies.

Disclaimer of Warranties. Data Systems & Solutions, LLC, hereby disclaims all warranties, express or implied, including, but not limited to

the implied warranties of title, merchantability, fitness for a particular purpose, and against infringement upon the rightful claim of any third

party, as well as any warranty alleged to have arisen from custom usage or past dealings with the intended recipient of this document.

Notwithstanding anything to the contrary in this agreement, in no event shall Data Systems & Solutions, LLC, be liable for consequential,

indirect, special, incidental or similar damages, including but not limited to damages resulting from loss of actual or anticipated revenues or

profits, or loss of business data, customers or good will, regardless of whether these damages were reasonably foreseeable.

DS&S, PMS, PMS/Win, SMS, SDS, SDS/DV, SDS/X and SDSedit are trademarks or registered trademarks of and Data Systems &

Solutions, LLC. All other brand and product names contained herein may be trademarks or registered trademarks of their respective

companies.

Bureau Veritas Certification Mark for ISO 9001:2000 is an indication that the Civil Nuclear business of Rolls-Royce has achieved and

currently holds certification to the International Organization of Standards for 9001:2000 Quality Management Systems. The Civil Nuclear

business of Rolls-Royce (legal entity DS&S, LLC), has achieved this certification for all locations as defined within Bureau Veritas scope as

stated within the ISO 9001:2000 Certificate.

90000CN

REVISION HISTORY

Table is utilized for revision history and annual review of policies.

Revision Date Description of Change 0 August 2004 Superseded:

Quality Manual, doc #500-9600000-01

Software CM, doc #500-9600000-02

Software QA Manual, doc #500-9600000-03

CM Program Manual, doc #550-9600000-02

QA Procedures, doc #550-9600000-04 1 Oct 2006 Updated to reflect current QMS program and policies 2 June 2007 Updates to reflect current RTS QMS 3 June 2008 Updated to DS&S logo

References to PMS and new company organization changes to I&C US

Addition of new I&C policies A 30-April-2009 Initial Release

New format & Cover

New company – Rolls-Royce Civil Nuclear

Restarted numbering as such B 4-May-2009 Added detailed revision history

Added Document Review and Signature box

Added ISO logo

Updated section after detailed review of old Rev 3 I&C US Program Handbook to ensure proper incorporate of all items covered within the older version (into new QA Manual or as new policies)

C June-2009 Changed references from DS&S to the Civil Nuclear business of Rolls-Royce

Updated ISO Registrar Marks

This document has been written by Data Systems & Solutions, LLC, I&C Business Operation doing business as the Civil

Nuclear business of Rolls-Royce.

DOCUMENT REVIEW & PUBLICATION

Document Review Process (utilization of Workflow when possible) Assigned Signature Date Disposition Review Brad Mabry

June 2009

Approve

Owner Verification Leslie Ward

June 2009 Approve

Approval C. David

Thompson

June 2009

Approve

Quality Group Actions to complete Approval and Distribution Process Uploaded to I&C US Share Point site on: June 30, 2009 Communication

Distributed to Staff: June 30, 2009

90000CN

Civil Nuclear Business of Rolls-Royce Instrumentation & Controls US Quality Manual

I&C US Quality Manual, Rev. C Page 4

Table of Content

INTRODUCTION................................................................................................ 8 MANAGEMENT COMMITTMENT ............................................................................10 QUALITY PROGRAM .........................................................................................11 CRITERIA I: ORGANIZATION ..............................................................................12

1.1 GENERAL STATEMENT ....................................................................................................................12 1.2 NQA-1.........................................................................................................................................12 1.3 ROLES AND RESPONSIBILITIES..........................................................................................................13 1.4 DS&S QUALITY CHART IN RELATION TO I&C BUSINESS UNIT ............................................................14 1.5 CLASS 1E CONSIDERATIONS ............................................................................................................14 1.6 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................14 1.7 ASSOCIATED CORPORATE POLICIES..................................................................................................15

CRITERIA II: QUALITY ASSURANCE PROGRAM.........................................................16 2.1 GENERAL STATEMENT ....................................................................................................................16 2.2 NQA-1.........................................................................................................................................16 2.3 DOCUMENTATION...........................................................................................................................19 2.4 CLASS 1E CONSIDERATIONS ............................................................................................................20 2.5 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................20 2.6 ASSOCIATED CORPORATE POLICIES..................................................................................................21

CRITERIA III: DESIGN CONTROL...........................................................................23 3.1 GENERAL STATEMENT ....................................................................................................................23 3.2 NQA-1.........................................................................................................................................23 3.3 SUBPART 2.7 ................................................................................................................................27 3.4 ROLES AND RESPONSIBILITIES..........................................................................................................31 3.5 DOCUMENTATION...........................................................................................................................31 3.6 CLASS 1E CONSIDERATIONS ............................................................................................................31 3.7 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................32 3.8 ASSOCIATED CORPORATE POLICIES..................................................................................................33

CRITERIA IV: PROCUREMENT DOCUMENT CONTROL.................................................34 4.1 GENERAL STATEMENT ....................................................................................................................34 4.2 NQA-1.........................................................................................................................................34 4.3 ROLES AND RESPONSIBILITIES..........................................................................................................35 4.4 CLASS 1E CONSIDERATIONS ............................................................................................................35 4.5 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................35 4.6 ASSOCIATED CORPORATE POLICIES..................................................................................................36

CRITERIA V: INSTRUCTIONS, PROCEDURES AND DRAWINGS ........................................37 5.1 GENERAL STATEMENT ....................................................................................................................37 5.2 NQA-1.........................................................................................................................................37 5.3 CLASS 1E CONSIDERATIONS ............................................................................................................38 5.4 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................38 5.5 ASSOCIATED CORPORATE POLICIES .................................................................................................39

CRITERIA VI: DOCUMENT CONTROL .....................................................................40 6.1 GENERAL STATEMENT ....................................................................................................................40 6.2 NQA-1.........................................................................................................................................40



6.3 ROLES AND RESPONSIBILITIES..........................................................................................................41 6.4 CLASS 1E CONSIDERATIONS ............................................................................................................41 6.5 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................42 6.6 ASSOCIATED CORPORATE POLICIES..................................................................................................42

CRITERIA VII: CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES...............43 7.1 GENERAL STATEMENT ....................................................................................................................43 7.2 NQA-1.........................................................................................................................................43 7.3 ROLES AND RESPONSIBILITIES..........................................................................................................47 7.4 CLASS 1E CONSIDERATIONS ............................................................................................................47 7.5 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................47 7.6 ASSOCIATED CORPORATE POLICIES..................................................................................................48

CRITERIA VIII: IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS ..49 8.1 GENERAL STATEMENT ....................................................................................................................49 8.2 NQA-1.........................................................................................................................................49 8.3 CLASS 1E CONSIDERATIONS ............................................................................................................50 8.4 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................50 8.5 ASSOCIATED CORPORATE POLICIES..................................................................................................50

CRITERIA IX: CONTROL OF SPECIAL PROCESSES ......................................................51 9.1 GENERAL STATEMENT ....................................................................................................................51 9.2 NQA-1.........................................................................................................................................51 9.3 CLASS 1E CONSIDERATIONS ............................................................................................................52 9.4 APPLICABLE BUSINESS OPERATIONS POLICIES ...................................................................................52 9.5 ASSOCIATED CORPORATE POLICIES..................................................................................................52

CRITERIA X: INSPECTION ..................................................................................53 10.1 GENERAL STATEMENT ....................................................................................................................53 10.2 NQA-1.........................................................................................................................................53 10.3 CLASS 1E CONSIDERATIONS ............................................................................................................55 10.4 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................55 10.5 ASSOCIATED CORPORATE POLICIES .................................................................................................56

CRITERIA XI: TEST CONTROL .............................................................................57 11.1 GENERAL STATEMENT ....................................................................................................................57 11.2 NQA-1.........................................................................................................................................57 11.3 CLASS 1E CONSIDERATIONS ............................................................................................................59 11.4 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................59 11.5 ASSOCIATED CORPORATE POLICIES..................................................................................................60

CRITERIA XII: CONTROL OF MEASURING AND TEST EQUIPMENT ...................................61 12.1 GENERAL STATEMENT ....................................................................................................................61 12.2 NQA-1.........................................................................................................................................61 12.3 CLASS 1E CONSIDERATIONS ............................................................................................................62 12.4 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................63 12.5 ASSOCIATED CORPORATE POLICIES..................................................................................................63

CRITERIA XIII: HANDLING, STORAGE AND SHIPPING..................................................64 13.1 GENERAL STATEMENT ....................................................................................................................64 13.2 NQA-1.........................................................................................................................................64 13.3 CLASS 1E CONSIDERATIONS ............................................................................................................65 13.4 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................65 13.5 ASSOCIATED CORPORATE POLICIES..................................................................................................66

CRITERIA XIV: INSPECTION, TEST AND OPERATING STATUS........................................67



14.1 GENERAL STATEMENT ....................................................................................................................67 14.2 NQA-1.........................................................................................................................................67 14.3 CLASS 1E CONSIDERATIONS ............................................................................................................68 14.4 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................68 14.5 ASSOCIATED CORPORATE POLICIES..................................................................................................69

CRITERIA XV: NONCONFORMING MATERIALS, PARTS AND COMPONENTS........................70 15.1 GENERAL STATEMENT ....................................................................................................................70 15.2 NQA-1.........................................................................................................................................70 15.3 ROLES AND RESPONSIBILITIES..........................................................................................................71 15.4 CLASS 1E CONSIDERATIONS ............................................................................................................71 15.5 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................72 15.6 ASSOCIATED CORPORATE POLICIES..................................................................................................73

CRITERIA XVI: CORRECTIVE ACTION.....................................................................74 16.1 GENERAL STATEMENT ....................................................................................................................74 16.2 NQA-1.........................................................................................................................................74 16.3 CLASS 1E CONSIDERATIONS ............................................................................................................75 16.4 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................75 16.5 ASSOCIATED CORPORATE POLICIES..................................................................................................76

CRITERIA XVII: QUALITY ASSURANCE RECORDS.......................................................77 17.1 GENERAL STATEMENT ....................................................................................................................77 17.2 NQA-1.........................................................................................................................................77 17.3 CLASS 1E CONSIDERATIONS ............................................................................................................79 17.4 APPLICABLE BUSINESS OPERATION POLICIES.....................................................................................79 17.5 ASSOCIATED CORPORATE POLICIES..................................................................................................79

CRITERIA XVIII: AUDITS ....................................................................................80 18.1 GENERAL STATEMENT ....................................................................................................................80 18.2 NQA-1.........................................................................................................................................80 18.3 CLASS 1E CONSIDERATIONS ............................................................................................................81 18.4 APPLICABLE POLICIES.....................................................................................................................81 18.5 ASSOCIATED CORPORATE POLICIES..................................................................................................82

INSTRUMENTATION & CONTROL BUSINESS OPERATION SPECIFIC ..................................83 19.1 GENERAL STATEMENT ....................................................................................................................83 19.2 CLASS 1E CONSIDERATIONS ............................................................................................................83 19.3 APPLICABLE POLICIES.....................................................................................................................83 19.5 ASSOCIATED CORPORATE POLICIES..................................................................................................83

DISTRIBUTION ................................................................................................84



Glossary

I&C US Organization Abbreviations

PDM Product Manager Has direct access to QA Mgr PM Project Manager Has direct access to QA Mgr BOM Business Operation Manager Has direct access to QA Mgr GRI Goods Receipt Inspector Has direct access to QA Mgr ILI In-Line Inspector Has direct access to QA Mgr ST System Tester Has direct access to QA Mgr I&C Abbreviations

DS&S Data Systems & Solutions, LLC (legal entity) Currently doing business as Civil Nuclear of Rolls-Royce

C of C Certificate of Conformance CM Configuration Management FAT Factory Acceptance Testing HS&E Health, Safety and Environment ICQ Instrumentation & Control Quality Procedure NCAS Nonconformance Affecting Safety NC Nonconformance PQP Project Quality plan QAP Quality Assurance Program QA Quality Assurance QAM Quality Assurance Manual QAP Quality Assurance Program WI Work Instruction WF Work Flow Diagram



INTRODUCTION

Instrumentation & Controls Business Unit is composed of two operations, with individual office locations listed below:

I&C France Grenoble, France – Sales, Manufacturing, Projects, Maintenance Prague, Czech Republic – Sales, Projects I&C US Chattanooga, Tennessee – Sales, Integration, Projects Huntsville, Alabama – Sales, Integration, Projects

Instrumentations & Controls is part of the Civil Nuclear business of Rolls-Royce. DS&S, LLC is the legal entity doing business as Rolls-Royce. The Quality Manual is established as a common reference to applicable standards for the I&C US Business Operation. All products and services are required to conform to these standards.

This manual will address each of the 18 criteria within 10CFR Part 50 Appendix B as implemented according to ASME NQA-1 2004. Considerations for Class 1E applications are noted in separate sections within the 18 Criteria.

The I&C quality assurance policies and processes are consistent with the Civil Nuclear business of Rolls-Royce, and contain detailed process descriptions, rules, provisions, that are appropriate to the I&C business.

This manual contains references to applicable local business operation policies.

All common statements, rules, provisions are written in the General Statement sections; whereas NQA-1 and Class 1E considerations have their own sections.

The I&C US Quality Manager is directly responsible for establishing and maintaining this document. Revisions require both the Quality Manager and Business Operation Manager approval for distribution.

The I&C US Quality Assurance Program complies with NQA-1 2004, 10CFR Part 50 Appendix B and 10CFR Part 21.

Related reference documents used to structure this manual include:

ASME NQA-1, Copyright 2004, Quality Assurance Program Requirements for Nuclear Facilities

10CFR Part 50 Appendix B, Quality Assurance Criteria for Nuclear Power Plan and Fuel Reprocessing Plants

10CFR Part 21, Report of Defects and Noncompliances

I&C US Policies and Procedures

Rolls-Royce Corporate Quality Policies and Procedures

ISO 9001:2008, Quality Management Systems Requirements International Standard

The TickIT Guide, January 2001, Issue 5.0

This Quality Assurance Manual (QAM) describes and summarizes the implementing procedures comprising the Quality Assurance (QA) Program for Instrumentation & Controls US (I&C US) Business Unit, a part of the Civil Nuclear business of Rolls-Royce. The Quality Assurance Program (QAP) is designed to provide administrative measures for assuring and documenting quality in services and turn key systems, in conjunction with corporate-wide policies and procedures.



The policies and requirements of the QAM are evoked to the extent described in this document as determined by the I&C US Business Unit Manager, the I&C US QA Manager, and the I&C QA Manager. The policies and requirements stated herein are mandatory for all products and services required to conform to applicable standards. These regulations and laws were used as a guide in developing the QAP for products produced for commercial and nuclear utility customers.

Overall quality policies, goals and objectives are established and documented in the on-Line I&C US QA Share Point site.



MANAGEMENT COMMITTMENT

The Rolls-Royce Quality Program and lower level Business Operation Quality Programs are endorsed by Executive Management. This endorsement demonstrates top management’s commitment to quality. The I&C US Quality Manual clearly defines the responsibilities and authorities for each element of this Business Operation.

The I&C QA Managers report directly to the Rolls-Royce Corporate Management for all quality activities, thereby assuring that the quality requirements are not compromised or influenced by project personnel, sales personnel, schedules or goals. The I&C QA Manager oversees the various Business Operation Quality Representatives and the respective Business Operation QAP.

The I&C US QA Manager is responsible for the evaluation of the quality of, and adherence to, software-related standards and procedures as they apply to the I&C US Business Unit. Software quality assurance activities are performed using the implementing procedures and additional standards documented in the project specific Project Plan. The I&C US QA Manager has the authority to stop all work or stop the release and issuance of any project and product documents and materials, with organizational freedom.



QUALITY PROGRAM

As indicated in the online Quality Policies (on I&C US Share Point and the Rolls-Royce intranet), Rolls-Royce, the Civil Nuclear business, and I&C US business operation is committed to its staff, its customers and society at large.

The Vision, Mission and Values Statement and the Code of Ethics and Business Conduct, which are posted on the Company intranet and communicated to all staff, document the company’s commitment to customers, employees, parent company and the proper conduct of business. This policy establishes a framework for subordinate policies, procedures, work instructions and other documented and undocumented processes for performing the business of the company while fully implementing and adhering to the established values. These documented values comprise the Company Quality Policy.

The scope of this manual encompasses the processes required by Rolls-Royce and the I&C US Business Unit to effectively design, develop, and integrate turnkey systems. The I&C US Business Unit primarily provides off-the-shelf hardware and field-proven software (turn-key systems) for nuclear power plants and commercial customers.

The I&C US solution is made up of our own software (designed and developed for our customer’s specific applications and needs) and off-the-shelf software and hardware. Using the very latest techniques, I&C US is able to advise commercial, technical, and corporate users on how to take advantage of emerging architectures and hardware platforms and is able to incorporate these changes. I&C US delivers advanced computer systems and software applications to meet customer’s demands and future needs.

Quality Performance is two-fold. First, products and services must meet or exceed their specified requirements at the agreed price within schedule. Second, the company and its employees must continuously improve the processes by which we provide our products and services, so that our work meets requirements without error and is done right the first time.

Quality performance is emphasized as a highly visible, important corporate goal, as evident by the corporate intranet’s dedication to quality. Any policy or procedure stated at a corporate level is not reiterated in this manual.

To ensure that quality performance is achieved, we rely on the integrity of each employee, insist that our managers meet contractual requirements, place responsibility for quality with those who do the work, and assure through a system of independent peer review and quality improvements that we meet our commitments.

The primary responsibility for the quality of these services and products produced by I&C US resides with the individuals performing the work. All departments and employees within these departments are responsible for being fully aware of the quality assurance practices of the I&C US QAP that are applicable to their work. Each employee of I&C US has the authority, and indeed the responsibility, to notify any QA Manager of any condition affecting the quality, reliability or safety of any products covered by this program.



CRITERIA I: ORGANIZATION

1.1 GENERAL STATEMENT

I&C Business Unit Manager accepts responsibility for the implementation of the I&C Quality Program. This responsibility is then delegated to the I&C QA Manager and then further to the individual Business Operation QA staff.

Business Operation QA managers report directly to the I&C Quality Manager and I&C Business Unit Managers. There is a direct path to the DS&S COO and DS&S CEO for relevant quality matters or issues.

Overall quality policies, goals and objectives are established and documented in the On-Line I&C US QA Policies. The I&C US Quality Assurance Program (QAP) is endorsed by Executive Management and demonstrates top management’s commitment to quality. The I&C US QAP clearly defines the responsibilities and authorities for each element of the organization.

Quality Independence

The QA Managers report directly to the Managing Executives. They have a direct path to the DS&S Quality Director for relevant quality matters or issues. The DS&S Quality Director reports to the COO, and indirect reports to CEO for corporate Quality issues. Any individual of the company has direct access to QA and or Management to report any concern relating to nuclear safety.

1.2 NQA-1

1.2.100

The organization for the I&C Business Unit is depicted in Figure 1.

The organization for the I&C US Business Operation is depicted in Appendix A.

Responsibilities for the establishment and implementation of the quality assurance program shall be defined. The organizational structure, functional responsibilities, levels of authority, and lines of communications for activities affecting quality shall be documented.

1.2.200

The organizational structure and responsibility assignments shall be such that

• senior management establishes overall expectations for effective implementation of the quality assurance program and is responsible for obtaining the desired end result

• quality is achieved and maintained by those assigned responsibility for performing work

• quality achievement is verified by those not directly responsible for performing the work

• those responsible for verifying quality achievement have sufficient authority, direct access to management, organizational freedom, and access to work to perform their function.

The Quality Assurance Group is:

• organizationally independent from the departments responsible for cost and schedule

• granted all access to documents, personnel, work areas and project materials to perform their required functions



The Quality Assurance Group can delegate any or all of their required functions, but the Quality Manager retains overall responsibility. Delegations shall be documented with specific responsibilities and authorities.

1.2.300

Where more than one organization is involved in the execution of activities, the responsibilities, interfaces, and authority of each organization shall be clearly defined and documented.

The external interfaces between organizations and the internal interfaces between organizational units, and changes thereto, shall be documented.

External interfaces will be controlled as such:

• The Project Manager and Lead Engineer (Hardware and Software) are the primary interface with the customer and vendors on technical issues

• The Quality Manager is the primary interface with the customer and vendors on quality assurance issues

Internal Interfaces will be controlled as such:

• Project teams will communicate as necessary to perform required tasks • Quality officials will communicate as necessary with project team for inspections,

monitoring, auditing, acceptance and other activities • All personnel have access to the Quality Manager, COO and CEO on matters of

quality

1.3 ROLES AND RESPONSIBILITIES

I&C Quality Manager:

o Ensure consistency and integrity of the Quality Programs within the I&C Business Unit

o Ensure business flow and process improvements are engaged at the proper level of operations

o Report critical quality issues to highest levels of management in DS&S

o Ensure the application and integrity of the Quality Program within the individual Business Operations, while in compliance with 10CFR Part50 Appendix B and 10CFR Part 21

o Ensure business processes are verified throughout the life cycle by appropriate means and methods

o Guarantee correct execution of Safety-Related projects through independent oversight with appropriate authority for rejection/acceptance and with organizational freedom

o Ensure quality resources are allocated across the business units in response to projects and other company activities, consistent with the importance of safety-related functions

o Identify the proper personnel to perform activities related to quality and safety, ensuring they are adequately skilled

QA Inspectors (Goods Receipt, Manufacturing, Repair and Site):

o Perform inspections based on pre-determined criteria of developed plans or activities

o Delegated authority for rejection/acceptance and with organizational freedom



1.4 DS&S QUALITY CHART IN RELATION TO I&C BUSINESS UNIT

Figure 1

1.5 CLASS 1E CONSIDERATIONS

Quality staff has the authority to stop any nonconforming activity or situation which could alter the quality of the product and compromise nuclear plant safety, without restriction due to cost or planning considerations.

QA tasks and resources are budgeted separately.

1.6 APPLICABLE BUSINESS OPERATION POLICIES

I&C US

I&C Business Unit Manager

I&C US Operations

Mgr

I&C France Operations

Mgr

DS&S COO

DS&S CEO

I&C Quality Manager

I&C France Quality Mgr

I&C US Quality Mgr

QA Inspectors & Verifiers

QA Team QA Team

QA Inspectors & Verifiers

Note: Although the function roles may remain static, the actual titles may by dynamic with organizational changes. This document may not reflect the most current titles in function roles as noted above.



Policy Ref. Name & Description NQA-1 Ref.

QPP 01-1 Name: Organization

Description: Assigns the Policy Owner, describes the organization structure of DS&S I&C US and interfaces both internal and external

BR 1

QPP 01-2 Name: Roles, Responsibilities and Authority

Description: Assigns the Policy Owner, describes staff positions, their responsibilities and authorities within I&C US

BR 1

WF 01-1 Name: I&C US Organization Chart BR 1

ICQ-005 Name: I&C US Quality Manual

Description: Assigns the Policy Owner, mandatory timeline requirements for reporting Safety-Related Problems, details authorities and responsibilities, details requirement for documentation, expected input and outputs listed

BR 1

ICQ-006 Name: Quality Oversight Board

Description: Assigns the Policy Owner, details how quality concerns or incidents will be rolled the organization for resolution. Expected input and outputs listed

BR 1

BR 2

BR 3

BR 15

1.7 ASSOCIATED CORPORATE POLICIES

N/A



CRITERIA II: QUALITY ASSURANCE PROGRAM


The Quality Assurance Program (QAP) is documented, and is applicable to all activities. All I&C US employees, including temporary and others working on behalf of Rolls-Royce Civil Nuclear and DS&S, must follow the QAP.

The QAP is documented and is intended to assure that all materials and services will perform and meet quality standards in accordance to all applicable codes and standards within the I&C US QAP and Customer Procurement documents. Policies, Work Instructions, Forms and Templates were written inclusive of safety-related requirements.

The Business Operations VP or designee is responsible for the infrastructure and work environments, ensuring projects are not affected by adverse conditions.

I&C staff are skilled to perform job functions, with additional job specific training (mechanical, technical) provided.

The QAP is assessed annually by the following activities:

o Management Review of the Quality Management System

o Audits (QA responsibility)

o Policy and Process Reviews (as assigned to participate)

o Corrective/Preventative Action (as assigned to participate)

o Process Improvements (as assigned to participate)

All Class 1E projects/initiatives will identify all relevant documents and materials to assure a clear distinction between Class 1E and non-Class 1E items.

ICQ policies written will apply to the Instrumentation & Controls Business Unit and shall be implemented by the individual Business Operations.

ICQ Policies written by one QA Manager will be reviewed and approved by the opposite QA Manager. (I&C France or I&C US QA Manager)

I&C US Quality Program consists of a five tier documentation system:

Tier 1: I&C US Quality Manual – established the basis for the Quality Assurance Program

Tier 2: QPP Policies – implementing procedures to support the Quality Program and its requirements

Tier 3: Work Instruction and Work Flow Diagrams – lower level implementing support instructions or visual flows of work to be completed supporting the Quality Program and its requirements

Tier 4: Records and Artifacts developed to provide objective evidence of program implementation.

Tier 5: Guides – establish best practice and potential tier 2 or 3 development. Not subject to external auditing

2.2 NQA-1

2.2.100

The I&C US Quality Assurance Program applies to all nuclear safety-related and non safety-related items, services and activities provided or performed by Rolls-Royce Civil



Nuclear I&C US.

The Quality Assurance Program is implemented and applies to all staff.

The Quality Manual provides details on how the Quality Assurance Program is implemented, along with local level implementing policies (as noted in associated tables per criteria).

The Quality Assurance Program is compliant to ASME NQA-1-2004, 10CFR Part 50 Appendix B, 10CFR Part 21, and ISO 9001:2000 for all work.

The Quality Assurance program is documented and implemented to assure all items and services provided are in compliance and of quality established by the above mentioned codes and standards.

The Quality Manager and Business Operations VP are responsible for implementing and maintaining the Quality Assurance Program.

The program monitors and measures all activities against acceptance criteria to assure technical and quality requirements are performed satisfactorily.

The program shall provide control over activities affecting quality to an extent consistent with their importance.

The program shall provide for the planning and accomplishment of activities affecting quality under suitably controlled conditions. Controlled conditions include the use of appropriate equipment, suitable environmental conditions for accomplishing the activity, and assurance that prerequisites for the given activity have been satisfied.

The program shall provide for any special controls, processes, test equipment, tools, and skills to attain the required quality of activities and items and for verification of that quality.

The program details what records and artifacts shall be retained as objective evidence of program implementation and quality objectives.

The program implements a Corrective Action process to identify, document, review and resolve all quality problems.

The program provides for indoctrination, training and qualification of I&C US staff. The training and qualification will be in accordance to industry standards and all records will be retained.

The Quality Assurance Program is audited annually by an independent certified Lead Auditor other than the I&C US Quality Manager.

The Quality Manager chairs quarterly management review of the Quality Assurance Program, assessing the adequacy and effective implementation.

2.2.200

Indoctrination and training shall be commensurate with scope, complexity, importance of the activities, and the education, experience, and proficiency of the person.

Personnel performing or managing activities affecting quality shall receive introductory indoctrination in their job responsibilities and authority.

Additional Indoctrination shall include the following topics;

• Business operation applicable codes and standards • regulatory commitments • company procedures • quality assurance program requirements and program • health, safety and environmental requirements and program • company benefits

I&C US issues an annual Training Plan for all staff. The plan includes at least the following:



• Annual Quality Program Training • Annual Quality Policy Training • Annual Health, Safety & Environment Program Training • Annual System Tester Certification Training • Annual Goods Receipts Inspector Training • Annual In-Line Inspector Training • Annual QA Inspector Official Training

Training Plan is developed based on required annual training, training requests from individuals, business needs for additional proficiencies and on monitored process results.

Training is performed for any program changes/updates.

Focused training sessions are provided for focus groups that utilize specific policies/processes such as:

• Nonconformances • Calibration

Training is additionally planned on an individual basis as determined by the Business Operations VP and requests for training.

2.2.300

The Quality Manager shall designate those activities that require qualification of personnel and the minimum requirements for such personnel.

The Quality Manager shall establish written procedures for the qualification of personnel, and for the assurance that only those personnel who meet the requirements are permitted to perform these activities.

I&C US does not utilize Nondestructive Examination.

Visual examination is utilized for inspection by QA Inspection Officials. The QA Inspection Officials shall have an annual eye examination.

I&C US staff performing inspection or testing shall be trained, qualified and certified utilizing local certification policies.

Training and Certification is performed by the Quality Manager.

Certified staff shall be re-evaluated, receive updated training and re-certified on an annual basis.

The initial capabilities of individual staff members shall be determined by an evaluation of the candidate's education, experience, training, and either test results or capability demonstration.

If during this annual evaluation or at any other time, it is determined by the Quality Manager 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.

The Quality Manager must maintain certification as a Nuclear Lead Auditor.

The Lead Auditor organizes and directs audits, reports audit findings, and evaluates corrective action. An individual shall meet the requirements of paras. 303.1 through 303.6 of NQA-1 prior to being designated a Lead Auditor.

Auditors and Lead Auditors are qualified to Corporate and Local qualification policies. Qualification shall include:

• Communication skills (written and oral)

• Training

• Audit Participation



• Examination (this may be subcontracted)

Lead Auditors and Nuclear Lead Auditors shall maintain their proficiency and will be recertified on an annual basis.

The Quality Manager has the authority to qualify auditors, lead auditors and nuclear lead auditors. The Business Operation VP has the authority to qualify the Quality Manager.

2.2.400

The qualification of inspection, test, and Lead Auditor 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

o education, experience, indoctrination, and training o test results, where applicable o 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

The Quality Manager shall identify any special physical characteristics needed in the perform-ance of each activity, including the need for initial and subsequent physical examination.

I&C US may subcontract personnel qualification. The subcontractor shall be on the Approved Vendors List and qualified as a supplier of training and certification. I&C US will retain the overall responsibility and shall require qualification documentation from the subcontractor via Purchase Order requirements.

2.2.500

Indoctrination & Training Records shall include: • Attendance sheets • Training Matrix • Certification Status Reports • Personnel training records

Records of qualification, including requalification, for Auditors, Lead Auditors, System Testers, Goods Receipt Inspectors, In-Line Inspectors and QA Inspection Officials shall be established and maintained by the Quality Manager.

2.3 DOCUMENTATION

Quality Assurance Manual

o Overall description of the Quality Assurance Program

o References supporting quality materials

Quality Policies

o Written description of “WHAT” are applicable activities to meet requirements

Work Instructions



o Written steps of “HOW” the tasks/activities shall be performed to meet the requirement and gain acceptance

o Includes description of necessary skills, equipment, control, inspections, acceptance criteria and special processes (when necessary)

o Relevant prerequisites are identified and conformity recorded

Forms/Templates

o Tools used to assist the Work Instructions to establish documents, records and artifacts

Quality Records

o Document that is produced from a Work Instruction or Process that contains proof of acceptance/compliance of an item

o Produced as outputs, but may be used an inputs to additional processes

Quality Plan

o Specific to individual projects

o Documents any additional provisions as noted in the Contract/PO or as necessary for compliance to requirements/specification

o When required, changes on PQP are notified to the customer prior to their application.


Provisions are made within the QAP identifying Class 1E and non-Class 1E distinctions. The individual documents shall clearly identify Class 1E tasks, actions and records.

Infrastructure provisions are identified and budgeted for maintenance in relation to their impact upon conformity of safety-related items.

Employee training and indoctrination records are retained as lifetime records.

Quality Job Commitment – individuals recognize their assigning duties, responsibilities and authorities when performing activities affecting nuclear safety. They demonstrate this commitment via signatures. This commitment cannot be in conflict with the QAP provisions.


I&C US Policy Ref. Name & Description NQA-1 Ref.

QPP 02-1 Name: Quality Assurance Program

Description: Assigns Policy Owner, describes the scope and intent of the I&C US Quality Assurance Program

BR 2

QPP 02-2 Name: Management Review

Description: Assigns Policy Owner, details the mandatory items to cover during a review and the frequency of reviews

BR 2

QPP 02-3 Name: Documents and Vocabulary

Description: Assigns Policy Owner, defines the documents and vocabulary associated with I&C US projects and QAP

N/A



QPP 02-4 Name: Signature Log

Description: Assigns Policy Owner, Administration and Maintenance of staff signatures and alpha-numeric assignment for qualified roles (such as System Testers, Inspectors, etc.)

N/A

Aids in identification and traceability

QPP 02-5 Name: Identification Tag Authority

Description: Assigns Policy Owner, Describes authority to affix and remove identification tags

BR 8

BR 10

BR 12

BR13

BR 14

BR 15


QPP 02-6 Name: Customer Satisfaction

Description: Assigns the Policy Owner, details the process for obtaining, documenting and reporting customer satisfaction

BR 2

WF 02-6 Name: CSA Process BR 2

QPP 05-4 Name: I&C US Share Point

Description: Assigns the Policy Owner, details update process of current content, describes content available.

BR 2

BR 5

QPP 10-1 Name: Certification – Inspectors

Description: Assigns the Policy Owner, details the certification process and levels of certification

BR 2

BR 10

QPP 10-3 Name: Certification – QA Inspection Officials

Description: Assigns the Policy Owner, details the certification process and levels of certification, details the authority for final acceptance

BR 2

BR 10

QPP 11-1 Name: Certification – System Testers


BR 2

BR 11

QPP 14-1 Name: Certifications – In-Line Inspectors

Description: Assigns the Policy Owner, details certification process and levels of certification

BR 2

BR 14

QPP 18-1 Name: Certification – Lead Nuclear Auditors

Description: Assigns the Policy Owner, provides guidance and direction on the initial and annual certification process for Nuclear QA Lead Auditors

BR 2

BR 18

QPP 18-4 Name: Certification – Auditor Approval

Description: Assigns the Policy Owner, provides guidance for the review and approval of Auditors

BR 2

BR 18


Policy Number Name of Policy



CPP00/016 Standards of Business Ethics & Conduct Policy CPP00/009 Management Review CPP00/017 International Business and Export Control CPP00/024 Risk Management Policy CPP02/005 Bid/No Bid Review CPP02/006 Mobilisation of Bid Manager and Team CPP02/007 Bid Preparation, Review and Submission CPP02/007a Review and Approval of Bids and Sales of Standard Products CPP02/008 Rough Order of Magnitude (ROM) Proposals



CRITERIA III: DESIGN CONTROL (ENCOMPASSING OF SUBPART 2.7 QUALITY ASSURANCE REQUIREMENTS FOR COMPUTER SOFTWARE FOR NUCLEAR FACILITY APPLICATIONS)


The Contract/PO is used as the initial input to the design process. This is the output from the Bid & Proposal process as awarded to DS&S.

Requirements are extracted from the customer specification, examined and converted into project design and specification documents. Review and verification of adequacy is performed. This same process is repeated during the life cycle of the design process and covers all relevant design documents (drawings, procedures, instructions, test plans, etc.).

Design documents are developed under the applicable quality standards per the Contract/PO. Design interfaces (physical, software, hardware and internal design) shall be identified, documented, reviewed and verified. Design interfaces will be placed under Configuration Management (control of document modifications, review, approval, revision and distribution).

Design modifications undergo sufficient review, verification and validation prior to implementation and document updates.

Design adequacy is verified through review, data analysis, feedback experience, calculation tools, testing and special process (seismic, radiation, non-destructive, etc.) validation. This review is completed by staff member(s) independent from the designer but cognizant of the design and its requirements.

When testing is used to verify design, test execution will include all identifiable adverse situations. The test plan will include design testing, with considerations for adverse conditions and acceptance criteria.

Post Installation design modifications will follow the same Configuration Management process as the initial design.

3.2 NQA-1

3.2.100

The design shall be defined, controlled, and verified. Software and Hardware staff are responsible for design activities.

Design inputs shall be documented, reviewed by Project Engineers, and translated into design documents. Design inputs include specifications/requirements, drawings and other documents provided by customer or purchase order.

Design interfaces shall be identified and controlled.

Design adequacy shall be verified by cognizant individuals independent from those who designed the item or computer program. Design is approved by the customer for project related activities and by the Product Manager for product enhancements.

Formal design shall be placed under configuration management. Design changes shall be requested, reviewed and approved according to document control policies.

3.2.200

Applicable design inputs shall be identified and documented, and their selection reviewed and approved.

The 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.

3.2.300

The responsible design organization shall prescribe and document the design activities 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. Design documents shall support facility design, construction, and operation.

The 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 approved by the customer • Be documented and under configuration management • Be available to engineers for design verification • Be traceable to customer requirements • Specify required inspections and test and acceptance criteria • Identify items to be assembled and note applicable drawing numbers • Identify critical characteristics, verification and acceptance criteria, if

commercially dedicated

Critical characteristics must provide assurance that the item will perform the intended function. If the intended function is unknown, the critical characteristics shall provide reasonable assurance the item will perform to manufacturer’s specifications. If the item must perform to more restrictive requirements than the manufacturer’s, these new requirements must be documented.

3.2.400

Design analyses shall be sufficiently detailed such that an independent person technically qualified can review and understand the analyses, verifying the adequacy of the results.

I&C US does not utilize computer programs for programming and mathematical design and analysis.

Documentation produced during design analyses shall include the following:

• Identification of items being analyzed • Purpose or objective of analysis • Procedure or method used for analysis • Design inputs (traceable to customer requirements, industry standards, codes) • Assumptions (indicating those that must be verified) • Results • Internal independent review and signature approval

3.2.500

Software or hardware engineers responsible for the original design shall identify and document the appropriate design verification method utilized with the design verifier identified. Design methods utilized may be:

• Design review • Review of design analysis compared to design inputs and verification requirements • Alternate calculations • Testing

Design verification shall be performed by any competent individual(s) or group(s) other than those who performed the original design but who may be from the same organization. The Product Manager, immediate supervisor or Project Manager may perform the verification provided they:



• did not specify a singular design approach or rule out certain design considerations • did not establish the design inputs used in the design • are the only individual in the organization competent to perform the verification

(cursory supervisory reviews do not satisfy the intent of proper verification)

Design verification is documented by the verifier.

Design verification shall be performed prior to releasing the design for procurement, fabrication, or for use by another internal organization for design activities, except where project timing prohibits this. In this case, the unverified portion of the design shall be identified and controlled.

Design verification shall be completed prior to:

• Use of the item in its intended function • Issuance of Certificates of Conformance

If design verification results in verification findings, the findings must be addressed and the modified design shall be verified prior to release or use.

Design verification shall be based on the complexity of the design, degree of standardization, similarity to previous designs, and importance to safety-related use.

The verification process does not need to be repeated for identical designs, although the design inputs shall be verified for each application. Original design verification documentation shall be included in the current project documentation. ]

Known problems or enhancements from previously verified designs and their effects shall be considered.

Design Changes shall be evaluated, documented and reviewed.

Design reviews shall provide assurance that the final design is correct and satisfactory by addressing, where applicable:

• are design inputs correct? • are assumptions documented and reasonable? • were the appropriate design methods utilized? • were the design inputs correctly incorporated into the design? • is the design output reasonable compared to design inputs? • have 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.

Testing shall demonstrate adequacy of performance under conditions that simulate the most adverse design conditions. Where the test is intended to verify only specific design features, the other features of the design shall be verified by other means. I&C US does not utilize prototypes or models for testing.

3.2.600

The original project engineer is responsible for changes to design.

Changes to approved designs shall be evaluated and documented.

Design changes will be documented in an Engineering Change Order.

Preparation, review, approval and control of design changes will be commensurate with the processes utilized for 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 evaluation shall include facility configurations that occur during operation, maintenance, test, surveillance, and inspection activities.



The design organization approving the change shall have technically competent individuals with 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.

3.2.700

Design information shall be formally transmitted in a controlled manner.

Informal transmission of design information shall be followed up with formal transmission, as soon as possible.

Incomplete information and information requiring verification must be identified.

3.2.800

The software design process shall be documented, approved by the responsible design organization, and controlled.

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 program.

The software design shall be documented and shall define 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 rela-tionships 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 computer program(s) using the I&C US Coding standards and conventions.

Software Design verification shall be performed by any competent individual(s) or group(s) other than those who performed the original design but who may be from the same organization. The Product Manager, immediate Supervisor or Project Manager may perform the verification provided they:

• did not specify a singular design approach or rule out certain design considerations • did not establish the design inputs used in the design • are the only individual in the organization competent to perform the verification

(cursory supervisory reviews do not satisfy the intent of proper verification)

Software design verification is documented by the verifier.

Software engineers responsible for the original design shall identify and document the appropriate design verification method utilized with the design verifier identified. Design methods utilized may be any one or combination of:

• Design review • Review of design analysis compared to design inputs and verification requirements • Alternate calculations • Testing

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 and shall be in accordance with Requirement 11.



Software configuration management includes, but is not limited to: configuration identification, change control, and status control.

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 labeling system for configuration items shall be implemented that

• uniquely identifies each configuration item • identifies changes to configuration items by revision • 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 • 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 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 product 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.

3.2.900

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

Design documentation must be legible.

3.3 SUBPART 2.7

3.3.100

Software engineering activities include the following elements:

• Software acquisition methods for controlling the acquisition process for software and software services

• Software engineering methods used to manage the software life-cycle activities • Application of standards, conventions and other work practices that support the

software life-cycle • Controls for support software used to develop, operate and maintain computer

programs 3.3.200

Software engineering documentation shall include:



• Procurement documentation specific to acquisition of software of software services • Software analysis conducted prior to purchasing software • Supplier analysis conducted prior to purchasing software services • Descriptive methods utilized to manage software life-cycle • Coding standards and conventions • Policies, procedures and work instruction supporting the software life-cycle • Tools utilized to develop, operation and maintain software programs

Reviews of software shall ensure compliance with approved software design requirements (see 3.2.800).

Software reviews may be conducted and documented separately or combined with other software design activities.

Required software reviews shall be:

• Requirements for preparing the software for acceptance testing. This review can be combined with the software design verification.

• Verification of satisfactory completion of software development including acceptance testing. This review can be combined with the software design verification.

Reviewers shall be familiar with the design detail and the intended use of the computer program and software.

Software reviews shall:

• Identify the participants • Identify participant responsibilities • Document review comments and findings • Document findings dispositions • Verification of software incorporation of comments

If software review is not adequate, alternate calculations or testing may be utilized.

Tests performed in support of a review can be used to complement acceptance testing. The test and test results shall be included in the acceptance testing documentation. Such test shall be subjected to the same criteria as the acceptance tests. These tests do not substitute for performing the comprehensive, end of development, acceptance test.

Software configuration management shall include:

• Establishment of software baselines • Software design requirements • Utilized computer program identification and use description • Computer program instructions • Support software • Test plans • Test results

Software configuration change control shall include:

• initiation, evaluation, and disposition of a change request • Control and approval of changes prior to implementation • Requirements for retesting and acceptance of the test results

Problem Reporting shall include:

• description of the evaluation process for determining whether a report problem is a software error or other type of problem

• defining the responsibilities for disposition of the problem reports, including notifying the originator of the evaluation results

Software Problem Correction shall include a description of:

• how the error related to appropriate software engineering elements



• how the error impacts past and present use of the computer program • how the corrective action impacts previous development activities • how users are notified of the identified error, its impact, and how to avoid the error,

pending implementation of corrective actions

3.3.300

Software and software services purchases shall follow the standard Procurement process, supplier evaluation and selection, and acceptance criteria identification.

Procured software shall include provisions/requirements for problem reporting from Purchaser to Supplier and Supplier to Purchaser.

Software not previous approved (freeware, shareware, commercial off-the-shelf, etc) shall be evaluated. This software shall be identified and controlled prior to evaluation. The evaluation shall be performed and documented to determine adequacy to support operation and maintenance.

The evaluation shall document at least the:

• Capabilities and limitations for intended use • Test plans and test cases required to demonstrate the capabilities within the identified

limitations • Instructions for use within the identified limitations

Any exceptions and the justification shall be documented.

Once the evaluation and the actions necessary to accept the software has been is completed, the evaluation package shall be reviewed and approved. Once approved the software and evaluation package shall be established and included within the current baseline.

3.3.400

Software engineering method shall be documented. The software engineering method utilized shall ensure the software lifecycle activities are planned, performed, traceable and orderly.

Software design requirements shall address technical and software engineering requirements, as traceable through the software life-cycle.

Software design shall consider the computer program’s operating environment. Measure to mitigate the consequences of problems shall be an integral part of the design. These potential problems include external and internal abnormal condition and events that can affect the computer program.

Software design verification shall evaluate: • Technical adequacy of the design approach • Ensure internal completeness, consistency, clarity and correctness of the software design • Verify software design is traceable to the software requirements

Software design verification shall include testing results.

Software design verification shall be completed prior to approval of the computer program for use.

The requirements for the software design verification activity shall be documented in the software engineering method.

After review, implementation shall result in documented:

• Computer program listings

• Instructions for computer program use

Acceptance testing activity shall demonstrate that the computer program adequately and correctly performs all intended functions against the software design requirements. Acceptance testing shall demonstrate, as appropriate, that he computer program:

• Properly handles abnormal conditions and events as well as credible failures



• Does not perform adverse unintended functions • Does not degrade the system either by itself, or in combination with other functions or

configuration items

Acceptance testing shall be performed prior to approval of the computer program for use.

Configuration items shall be under configuration change control prior to starting acceptance testing.

Acceptance testing shall be planned and performed for all software design requirements.

Acceptance testing can be:

• Single test of software design requirements • Series of tests performed during development to assure proper function of individual

modules

Testing shall include a comprehensive acceptance test performed in the operating environment prior to use.

The test plans, test cases, and test results shall be documented, reviewed, and approved prior to use of the computer program. Observations of unexpected or unintended results shall be documented and dispositioned prior to test result approval.

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

After the software is approved for use and installed in the operating environment, the use of the software shall be controlled in accordance with approved procedures and instructions. These include, as appropriate:

• Application documentation • Access control specifications • Problem reporting and corrective action • In-use tests • Configuration change control process

Maintenance changes shall be identified and change control documented. Changes can arise from:

• Enhancement requests from user community • Revisions to software based on software design requirements • Changes to operating environment • Reported software problem corrections

During retirement, support for the software product is terminated, and the routine use of the software shall be prevented.

3.3.500

Standards, conventions and other software work practices supporting the software life-cycle (software engineering design/methods, software acquisition and software implementation) shall be documented.

3.3.600

Software engineering design/methods and software acquisition established the need for software tools.

Software tools shall be evaluated, reviewed, tested and accepted for use. Once established, these software tools shall be placed under configuration control and associated with the appropriate software product(s).



Software tools that do not affect the performance of the software product do not need to be placed under configuration control.

Software product(s) that are modified using the software tools shall be managed and include:

• Configuration of the software tool • Changes to the software tool

Any changes to the software tool must be evaluated for impact on the software product to determine the level of review and retesting required.

System software consists of the on-line computer programs used to provide basis or general functionality and facilitate the operation and maintenance of the application computer program. Examples include: lower level software layers, assemblers, interpreters, diagnostics, and utilities.

System software shall be evaluated, reviewed, tested and accepted for use as part of software development cycle of a new or revised software product. System software shall be placed under configuration change control. Changes to the system software shall be evaluated for impact on the software product to determine the level of review and retesting that will be required.


The Project Manager is responsible for coordinating the project team.

Within the project teams, there will be an identified Lead/Chief Software Engineer and Lead/Chief Hardware Engineer.

3.5 DOCUMENTATION

Design Test Plan – developed against relevant standards and includes adverse conditional scenarios


Class 1E projects/initiatives are clearly identified, including all relevant design documents.

Formal documented review of converted specification document is performed to ensure adequacy of customer requirements. This review is completed by staff member(s) independent from the preparer; with equal or higher level skill/knowledge. Signature acceptance required on the document.

Applicable quality standards are formally identified for each project/contract. These standards are documented in each related design document. Any deviations are recorded and communicated to the customer for consideration and acceptance, to the extent consistent with the importance to safety.

Project materials, parts, equipment and processes are selected as follows:

o Design and implement Class 1E items

o Commercially purchased items that are then Dedicated

Formal revision control at customer design acceptance is implemented for items affecting safety (documents, software, hardware and physical).

Design testing will include all identifiable adverse situations affecting safety and acceptance criteria.





QPP 03-1 Name: Process - Lifecycle

Description: Assigns the Policy Owner, describes the phases and subcomponents of each phase leading to the delivery of product/services. Expected inputs and outputs are defined and listed.

BR 3

SP 2.7

QPP 03-2 Name: Control - Design

Description: Assigns the Policy Owner. Details the design phase, design requirements review, design documentation. Expected inputs and outputs listed.

BR 3

SP 2.7

WI 03-2.1 Name: Configuration Control Board BR 3

SP 2.7

WI 03-2.2 Name: Software Configuration Management BR 3

SP 2.7

QPP 03-3 Name: Control - Development

Description: Assigns the Policy Owner, Details the development phase in which code is written and reviewed, how informal testing is conducted and documented. Expected inputs and outputs listed.

BR 3

WI 03-3.1 Name: Software Review BR 3

SP 2.7

WI 03-3.2 Name: PMS Product Test Procedures Review & Update BR 3

SP 2.7

WI 03-3.3 Name: Non-Product Test Procedure Review & Update BR 3

SP 2.7

WI 03-3.4 Name: Code Review BR 3

SP 2.7

QPP 03-4 Name: Control – Acceptance

Description: Assigns Policy Owner. Describes the acceptance of formal testing phases, reports generated and distributed. Expected inputs and outputs listed.

BR 3

SP 2.7

QPP 03-5 Name: Control – Project Data Management

Description: Assigns Policy Owner. Details how project data will be retained, project close-out activities and archival process. Expected inputs and outputs listed.

BR 3

WI 03-5.1 Name: Software Development Folders BR 3

WI 03-5.2 Name: Project Closeout BR 3

WF 03-5 Name: Backups BR 3

QPP 03-6 Name: Control – Product Releases

Description: Assigns Policy Owner. Describes process for creating product releases, proof of test and distribution to customers.

BR 3

SP 2.7

WI 03-6.1 Name: Error Notification BR 3

SP 2.7

WI 03-6.2 Name: Software Baseline Control BR 3



SP 2.7

WI 03-6.3 Name: Third Party Software Certification BR 3

SP 2.7

QPP 03-7 Name: Process – Maintenance & Support

Description: Assigns Policy Owner. Describes the various support contracts and the I&C US commitments to provide services.

BR 3

QPP 03-8 Name: Improvement – Product Delivery

Description: Assigns Policy Owner. Quarterly review of product delivery, accounting for problem change metrics, error trends and delivery improvements.

BR 3

SP 2.7



BR 1

BR 2

BR 3

BR 15


Policy Number Name of Policy CPP03/001 Contract vs. Proposal Analysis CPP03/002 Special Project Authorisation CPP03/003 Project Initiation CPP03/005 Contract Amendments CPP03/007 Project Review CPP03/011 Managing Changes to the Project Baseline CPP07/007 Warranty



CRITERIA IV: PROCUREMENT DOCUMENT CONTROL


Corporate Procurement process requires Supplier Evaluations for all vendors on the OSyS and I&C US Approved Vendor List (AVL). Supplier Evaluations occur on an annual basis and on a per project basis. Supplier Evaluation results are retained as a corporate record.

Suppliers are monitored at both the Corporate and Local Business Unit levels for acceptable delivery of goods, delivery time, product quality and nonconformities.

Relevant requirements, specifications and applicable standards/regulations are communicated to the Suppliers during the procurement process, as attached to the Purchase Order or stipulated in the Contract with the Supplier, including additional requirements I&C US considers necessary beyond the original Customer PO.

Contractors and Subcontractors are required to perform under or consistent with the I&C Quality Program.

Corporate Procurement will prepare and issue all Purchase Orders for I&C US.

Commercial Off the Shelf items can be purchased with less restrictive procurement requirements as these will be Commercially Dedicated.

4.2 NQA-1

4.2.100

Procurement documents shall include customer technical, quality and documentation requirements necessary to ensure proper items/services are procured and their conformance to the original requirements.

To the extent necessary, procurement documents shall require Suppliers to have a quality assurance program consistent with the applicable requirements of 10CFR 50 Appendix B and NQA-1.

4.2.200

Issued Procurement documents shall include provisions for the following:

• Statement of Scope of Work • Technical Requirements (documents, drawings, codes, etc) • Quality Requirements (Program, standards, Provision Document for Class 1E and

Special Provision) • Test, Inspection, and Acceptance Criteria for acceptability of item/service • Rights of access for I&C US personnel and I&C US authorized personnel (surveillance,

audit, inspection, etc) • Documentation Requirements (review and approval cycles, retention, format of

documents, etc) • Nonconformance Reporting to Purchaser • Spare and Replacement Parts (identification and ordering information) • Sub-Supplier Procurement Documentation Requirements (passing of appropriate

requirements to sub-suppliers)

4.2.300

A review of the procurement documents, and changes thereto, shall be made and documented prior to award to assure that documents transmitted to prospective Supplier(s) include appropriate provisions to assure that items or services will meet the specified requirements.



Technical or quality assurance 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.

Procurement document review shall be performed by personnel who have access to pertinent information and who have an adequate understanding of the requirements and intent of the procurement documents.

4.2.400

Procurement document changes affecting the technical or quality assurance program requirements shall be subject to the same degree of control as utilized in the preparation of the original documents.


Business Operation QA Managers or designee:

o Conduct corporate Supplier Evaluations

o Annual quality evaluation of local specific vendors to individual business operations


Supplier Evaluation results are retained in the local business operations.

All Class 1E and Special Provision Purchase Orders must be reviewed and approved by the Quality Manager.

A classification of suppliers is established, evaluated and maintained, including a specific label for those delivering safety related goods or services.

Nuclear quality requirements are forwarded to the subcontractors concerned by the means of a manual and/or procedure(s).

Review of Supplier Conformance to requirements shall occur before award or Purchase Order is issued.

The requirements cover:

Control of documents

Independence of verifications

Audits



QPP 04-1 Name: Procurement – Class 1E & Special Provision Purchases

Description: Assigns the Policy Owner, details the approval process for Class 1E and Special Provision items, details the use of the mandatory Provision Document on passing through quality requirements to Suppliers

BR 4

BR 7

QPP 04-2 Name: Procurement – IWO for Class 1E Purchases

Description: Assigns the Policy Owner, specific instructions on how to purchase Class 1E materials inter-company and how to pass the technical and quality requirements ensuring compliance.

BR 4

BR 7



QPP 04-3 Name: Procurement – Vendor Administration

Description: Assigns the Policy Owner, provides details on adding and removing vendors from the I&C US approved vendor list

BR 4

BR 7

QPP 04-4 Name: Procurement – Annual Vendor Evaluation

Description: Assigns Policy Owner. Allows for delegation of the process, provides direction for the annual evaluation of I&C US Vendors.

BR 4

BR 7


Policy Number Name of Policy CPP04/001 Create a Purchase Requisition CPP04/002 Purchase Requisition Approval CPP04/003 Generate PO/Subcontract Document CPP04/006 Supplier Evaluation Process



CRITERIA V: INSTRUCTIONS, PROCEDURES AND DRAWINGS


All activities related to projects, products and their processes and the related infrastructure/environment are considered as effecting quality; therefore included within scope of the I&C QAP.

The QAP is demonstrated through a series of policies, work instructions, forms/templates and workflow diagrams. QAP documents are controlled under Configuration Management.

The QAP is further detailed in the individual Business Operation Quality Manuals and policies.

Technical documents are those related to the product, from the specification to the FAT reports. This includes design, drawings, manufacturing & test documents.

5.2 NQA-1

5.2.100

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

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.

Instructions, Procedures and Drawings will be detailed enough so the results are consistent and acceptable. The level of detail these documents will be based on the complexity of the activity and the worker proficiency. Document types:

• QPP Policies – identify requirements to be met, staff involved, order of activities, expected input and output

• WI Work Instructions – identify requirements and step by step sequence of activities

• WF Workflow Diagrams – provide visual flow of the associated Policy or Work Instruction

• Guides – provide best practice guidance

• Drawings – will include materials, dimensions, fabrication and assembly details with review and approvals

• Forms – provide template for detailed information recording

The Hardware Group will be responsible for continued maintenance, updates and improvements to current engineering hardware related documents and drawings. The Hardware Group will provide a technical reviewer and the owner for document approvals. The Quality Group will provide final approval.

The Quality Group will be responsible for continued maintenance, updates and improvements to current quality documents. The Quality Group will provide a technical reviewer and the owner for quality related document approvals. The Business Operations Manager will provide final approval.

The Software Group will be responsible for continued maintenance, updates and improvements to current software documents (in particular related to the Product). The Software Group



will provide a technical reviewer and the owner for software related document approvals. The Quality Group will provide final approval.

The Project Managers will be responsible for developing, maintaining and controlling the current project management related project documents. The Project Managers will provide a technical reviewer and owner for approval. The Quality Group will provide final approval.

The Publications Coordinator will assist in with controlling all documentation.

The I&C US Share Point (intranet) is utilized as the resource for staff to retrieve current documents. The Quality Group is responsible for all I&C US Share Point content, its availability and to assure the content is current.


The Quality Manager has ownership and approval of all Class 1E documents.

Appropriate criteria of acceptance are determined and documented in the relevant QAP documents.

All technical documents must be verified and approved before distribution and use.

Verification is made by a qualified person, independent from the author, having at least the same skills level as the author.

Signing off authority and approval for documents is described in a procedure.

When a contract requires the use of a language different of the official language of the I&C US office country, document translations are made by qualified in-house staff or specialized and approved vendors.



QPP 05-1 Name: Document Control - Quality

Description: Assigns the Policy Owner, details the steps during the development or modification of all quality documents, their review, approval and control. Expected inputs and outputs are listed

BR 5

BR 6

QPP 05-2 Name: Document Control - Drawings

Description: Assigns the Policy Owner, details the steps during the development or modification of all drawings, their review, approval and control. Expected inputs and outputs are listed.

BR 5

BR 6

WI 05-2.1 Name: Engineering Change Report BR 5

BR 6

QPP 05-3 Name: Drawing Numbering

Description: Assigns the Policy Owner, describes the numbering assignment and convention

BR 5

BR 6

QPP 05-4 Name: I&C US Share Point

Description: Assigns the Policy Owner, details update process of current content, describes content available.

BR 2

BR 5

QPP 05-5 Name: Policy and WI Development

Description: Assigns the Policy Owner, describes the content required when developing new Policies and Work Instructions, describes the

BR 2

BR 5



review and approval process, and final authorities. BR 6

BR 9


N/A



CRITERIA VI: DOCUMENT CONTROL


Documents are designed as either Technical or Quality. Technical documents are controlled by cognizant engineers and the CM process governed by the QAP. Quality documents are controlled by the QA Manager and the CM process.

All I&C US documents are identified, numbered and tracked for revision control.

Documents supplied by external sources relevant to projects/initiatives are identified, controlled and distributed to relevant personnel.

Modifications of documents are initiated through a Change request. Minor changes such as misprint, logo change, formatting do not require formal review.

The CM process for both technical and a quality document is:

o Original preparation of document(s)

o Modification of document(s)

o Review/Verification of documents for accuracy and acceptance

o Approval as final acceptance

Distribution and Posting of Quality documents include staff notification and posting of document in a consistent and secure location for access.

Distribution and Posting of Technical documents includes posting of documents in pre-determined locations, access provided to relevant personnel.

Both quality and technical documents produced are identified by a number and a revision index. This index changes with each update. The last revision of any document is the applicable document for use, unless specific notification is provided.

Document review is completed by staff member(s) independent from the preparer; with equal or higher level skill/knowledge. Document change reviews are performed by same organization as original reviewer.

Approver provides signature acceptance on the document.

Changes

Document changes are retained and recorded in the Change request form. Appropriate provisions in the document are identified as a description of change.

Updated documents are submitted for review by staff with the same skills and capabilities that had written, checked and approved the first version of the document. The sections modified are identified.

6.2 NQA-1

6.2.100

The preparation, issue, and change of documents that specify technical and quality requirements or prescribe activities affecting quality such as instructions, procedures, and drawings shall be controlled to ensure that correct documents are being utilized. Such documents, including changes thereto, shall be reviewed for adequacy and approved for release by authorized personnel. The Product or Project Manager has the authority to release documents for staff or customers.



6.2.200

Controlled documents are, but not limited to:

• Project deliverables (Project Manager has ownership and responsibility)

• Product documents (Product Manager has ownership and responsibility)

• Policies, Work Instruction and Forms (Quality Manager has ownership and responsibility)

• Customer Supplied documents and drawings (Project Manger has ownership and responsibility)

• Measuring & Test Equipment Calibration Records (Hardware Manager has ownership and responsibility)

• Class 1E documents and drawings (Quality Manager has ownership and responsibility)

Controlled documents are prepared, updated, reviewed and approved by the Owner mentioned above.

Controlled documents are distributed by either the Owner or with assistance from the Publications Coordinator.

Controlled documents are either posted on the I&C US Share Point site for all staff to utilize or on the appropriate access controlled project folders on the local servers.

6.2.300

Major document changes must undergo a formal review and approval cycle within the organization that developed the original document. The reviewing organization shall have access to pertinent background data or information upon which to base their approval.

Minor document changes, such as items listed below, do not require formal document review and approval. The Owner of the document can make Minor document changes and then approve the document for distribution. The Publications Coordinator is the only delegate that can make these Minor changes as directed by the Owner.

• Typographical changes

• Formatting changes

• Editorial changes that do not change the intent or scope of the original document


Preparer/Author – originator of the document

Reviewer/Verifier – reviews the document for accuracy

Approver – approves the document for distribution

The QA Manager is responsible for the QA documents release and distribution. The QA Manager ensures their consistency before distribution to staff.


Lifetime records are determined in the document control process.

Appropriate provisions are taken to ensure the document retrievability, whatever the storage media used.

Appropriate means to identify class 1E documents are visible and consistent.





QPP 05-1 Name: Document Control - Quality

Description: Assigns the Policy Owner, details the steps during the development or modification of all quality documents, their review, approval and control. Expected inputs and outputs are listed

BR 5

BR 6

QPP 05-2 Name: Document Control - Drawings

Description: Assigns the Policy Owner, details the steps during the development or modification of all drawings, their review, approval and control. Expected inputs and outputs are listed.

BR 5

BR 6

QPP 06-1 Name: Document Control - Technical

Description: Assigns the Policy Owner, details the steps during the development or modification of all technical documents, their review, approval and control. Expected inputs and outputs are listed

BR 6

QPP 06-2 Name: Document Numbering

Description: Assigns the Policy Owner, describes the numbering assignment and convention.

BR 6

QPP 06-3 Name: Document Changes

Description: Assigns the Policy Owners, describes the numbering assignment and convention

BR 6

WI 06-3.1 Name: Document Change Order BR 6

WI 06-3.2 Name: Document Review BR 6


N/A



CRITERIA VII: CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES


Procurement activities start during the Bid & Proposal phase of a project.

Quality Assurance is responsible for the preparation of the quality assurance related documentation in the procurement process.

Project Engineers are responsible for the preparation of the technical related documentation in the procurement process.

Procurement documents and records will be retained by the Procurement Department as a lifetime records.

The Proposal group will retain necessary copies of Procurement documents with project records.

The Goods Receipt process will ensure purchased items conform to Procurement requirements.

Relevant documentation as received during the Goods Receipt process will be retained.

7.2 NQA-1

7.2.100

The procurement of equipment, materials, items and services shall be controlled to ensure conformance with specified requirements. Controls will be implemented throughout the Procurement process, such as:

• Supplier Evaluation

• Source Evaluation, Inspection and Selection

• Evaluation of objective evidence of quality provided by the supplier

• Survey of supplier

• Audit

• Examination of items or services upon delivery or completion

Procurement activities start during the Bid & Proposal phase of a project.

Quality Assurance is responsible for interfacing with Supplier for Source Evaluation, Inspection, Audits and Surveys.

7.2.200

Prior to award of a contract, I&C US shall evaluate the Supplier's capability to provide items or services in accordance with the requirements of the procurement documents. Supplier evaluation and selection and the results thereof shall be documented and shall include one or more of the following:

• Supplier's history of providing an identical or similar product that performs satisfactorily in actual use. The Supplier's history shall reflect current capability

• Supplier's current quality records supported by documented qualitative and quantitative information that can be objectively evaluated

• Supplier's technical and quality capability as determined by a direct evaluation of the facilities, personnel, and the implementation of the Supplier's quality assurance program.



7.2.300

If bids are solicited, the bid evaluation shall be evaluated by Engineering and/or Quality Assurance to determine the Supplier's capability to conform to both the technical and quality assurance requirements.

Unacceptable technical and quality assurance conditions and Supplier exceptions will be resolved, or commitment to resolution obtained, prior to award of contract.

Solicitation of bids is not required.

7.2.400

Controls shall be established to ensure that Supplier generated documents are submitted evaluated and controlled in accordance to procurement document requirements.

These controls shall include provisions for the acquisition, processing, and recorded evaluation of the quality assurance, technical, inspection, and test documentation or data against acceptance criteria.

7.2.500

Prior to offering the item or service for acceptance, the Supplier shall verify that the item or service being furnished complies with the procurement requirements. 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.

Purchaser methods used to accept an item or service from a Supplier shall be a Supplier Certificate of Conformance, source verification, receiving inspection, or post-installation test at the nuclear facility site, or a combination of these methods.

When a Certificate of Conformance (C of C) is received, the certificate shall:

• Positively Identify the purchased material or equipment • Identify the specific procurement requirements met by the purchased material or

equipment, such as codes, standards, and other 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.

• Identify any procurement requirements that have not been met, together with an explanation and the means for resolving the nonconformances

• Be signed or otherwise authenticated by a person who is responsible for this quality assurance function and whose function and position are described in the Purchaser's or Supplier's quality assurance 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 certificates, shall be described in the Purchaser's or Supplier's quality assurance program.

Means shall be provided to verify the validity of Supplier 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 the Pur-chaser 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 Purchaser acceptance of source verification, documented evidence of acceptance shall be furnished to the receiving destination of the item, to the Purchaser, and to the Supplier.

Goods Receipt inspection is used to verify conformance to specified procurement requirements, taking into account source verification and audit activities and the



demonstrated quality performance of the Supplier. Receiving inspection shall verify by objective evidence and visual inspection:

• 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, providing traceability of items purchased.

When post installation testing is used, post installation test requirements and acceptance documentation shall be mutually established by the Purchaser and Supplier.

Services shall be accepted by the following methods:

• Technical verification of data produced

• Surveillance and/or audit of activity

• Independent review and verification of supplied information

• Objective evidence review for conformance to procurement document requirements

7.2.600

Nonconformances identified that do not meet procurement document requirements shall be controlled and dispositioned according to Criteria 15 of this manual and supporting policies.

7.2.700

I&C US commercially Dedicates only the PMS Product via integrated system testing and inspection. The PMS product (non safety-related) is composed of Commercial off-the-shelf items that once fully integrated and software installed, is tested both internally (via independent organization) and via customers, thus providing acceptance of the system and product in a deliverable state.

The Utilization of commercial grade items or services shall include the following:

• technical evaluation to determine that the item or service performs a safety function

• confirmation that the item or service meets the commercial grade definition criteria

• identification of the critical characteristics, including acceptance criteria • selection, performance, and documentation of the dedication method(s) for

determining compliance with acceptance criteria When one or more critical characteristics for acceptance cannot be verified by the dedication methods, the requirements of this section shall not be utilized to procure and accept the commercial grade item or service.

Critical characteristic selection for acceptance shall address the following:

(a) identifiable and measurable attributes or variables appropriate for the safety function (b) criteria related to the location of the item in the facility or criteria addressing the

most severe location of the item in the facility, unless controls are in place to prevent usage in undesignated locations

The Dedicating entity shall provide reasonable assurance that the commercial grade item or service meets the acceptance criteria for the identified critical characteristics by inspections, tests, or analyses performed after delivery, supplemented as necessary by one or more of the following:

• commercial grade survey of the Supplier • source verification of the item or service



• acceptable Supplier/item performance record

Prior to acceptance of the commercial grade item or service, the dedicating entity shall determine the following, as applicable:

• damage was not sustained during shipment • the item or service has satisfied the specified acceptance criteria for the identified

critical characteristics • specified documentation was received and is acceptable

A Commercial Grade Survey is performed as part of the Supplier Evaluation process for Class 1E and/or Special Provision Suppliers on or potentially on the I&C US Approved Vendors List.

A commercial grade survey is performed in accordance with a checklist or plan at the Supplier's facility and includes or addresses the following:

• identification of the item(s), or product line, or service included within the scope of the survey

• identification of the critical characteristics to be controlled by the Supplier • verification of the Supplier's processes and quality program controls are effectively

implemented for control of the critical characteristics • identification of the survey methods or verification activities performed with results

obtained • documentation of the adequacy of the Supplier's processes and controls

A commercial grade survey shall not be employed as a supplemental basis for accepting commercial grade items or services from Suppliers with undocumented quality programs or with programs that do not effectively implement the Supplier's own specified processes and controls. After a Supplier's processes and controls have been determined to be adequate, the dedicating entity shall invoke or reference the verified processes and controls as a part of the purchase order or control requirements for the commercial grade item or service and require the Supplier to provide a Certificate of Conformance attesting to the implementation of the identified processes and controls.

The dedicating entity shall establish the survey frequency for reconfirming the previous survey information for application to additional purchases.

Source verification shall apply to safety-related projects.

Source verification is only applicable to the actual item(s) or service(s) that are verified at the Supplier's facility or other applicable location. Source verification shall include a checklist or plan with the documented evidence of the source verification furnished to the dedicating entity and shall include or address the following:

• identification of the item(s) or service(s) included within the scope of the source verification

• identification of the critical characteristics, including acceptance criteria, to be controlled by the Supplier

• verification of the Supplier's processes and controls are effectively implemented for the identified critical characteristics

• identification of the activities witnessed during the source verification and the results obtained

• documentation of the adequacy of the Supplier's processes and controls

Acceptable Supplier/item/service performance record shall include the following:

• identification of the supplier/item/service being evaluated • identification of previously established critical characteristics specific to the

Supplier/item/service • identification of industry data examined to evaluate the Supplier/item/service • identification of basis for determining that industry data substantiates

acceptability of the Supplier/item/service



• documentation of the adequacy and acceptance of the Supplier/item/service performance record

An acceptable Supplier/item/service performance record shall not be employed unless

• the established historical record is based on industry-wide performance data that is directly applicable to the critical characteristics and the intended facility application, i.e., a single source of information is not adequate to demonstrate satisfactory performance

• the manufacturer/Supplier's measures for the control of applicable design, process, and material change have been accepted by the dedicating entity

Continued application of an acceptable Supplier/ item/service performance record shall include a documented periodic update and review to assure the Supplier/item/service maintains an acceptable performance record.

Deficiencies identified in the Supplier's processes and controls identified in the dedication process shall be corrected by the Supplier and verified by the dedicating entity, if the specified dedication process is to be used to verify an identified critical characteristic.

7.2.800

Records shall be established and maintained to indicate the performance of the following functions:

• supplier evaluation and selection • acceptance of items or services • supplier nonconformances to procurement document requirements, including their

evaluation and disposition • utilization and acceptance of commercial grade items


Goods Receipt Inspector(s) have the responsibility and authority for rejection/acceptance of incoming items.


C of C’s received by approved Suppliers are mandatory for all Safety-Related documents. Quality Assurance shall review, verify and accept these documents against the procurement requirements.

If materials and equipment are purchased as Commercial, the Class 1E Commercial Dedication process is applied.

Critical characteristics and acceptance criteria are documented and verified by the Goods Receipt Inspector through appropriate means.

To ensure conformity to requirements, acceptance may require quality inspections, source evaluation/inspection of contractors, subcontractors and vendors. Records of source verification are retained. Provisions are defined in a documented procedure.

Items will not be installed without proper evidence of conformity.

Contractors, Subcontractors and Vendors providing Class 1E materials and services affecting safety, will be evaluated for conformance through appropriate means.


I&C US



Policy Ref. Name & Description NQA-1 Ref.

QPP 04-1 Name: Procurement – Class 1E & Special Provision Purchases

Description: Assigns the Policy Owner, details the approval process for Class 1E and Special Provision items, details the use of the mandatory Provision Document on passing through quality requirements to Suppliers

BR 4

BR 7

QPP 04-2 Name: Procurement – IWO for Class 1E Purchases

Description: Assigns the Policy Owner, specific instructions on how to purchase Class 1E materials inter-company and how to pass the technical and quality requirements ensuring compliance.

BR 4

BR 7

QPP 04-3 Name: Procurement – Vendor Administration

Description: Assigns the Policy Owner, provides details on adding and removing vendors from the I&C US approved vendor list

BR 4

BR 7

QPP 04-4 Name: Procurement – Annual Vendor Evaluation

Description: Assigns Policy Owner. Allows for delegation of the process, provides direction for the annual evaluation of I&C US Vendors.

BR 4

BR 7

QPP 07-1 Name: Document Control - Vendor

Description: Assigns the Policy Owner, describes the receipt, identification and logging of vendor documentation. Expected inputs and outputs are listed

BR 7

QPP 07-2 Name: Control – Customer Supplied Items

Description: Describes the numbering assignment and convention.

BR 7

QPP 09-2 Name: Control - Commercial Dedication

Description: Assigns Policy Owner, discusses evaluation, plan, procurement, verification, review and approval process.

BR 7

BR 9


N/A



CRITERIA VIII: IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS


All materials, parts and components are tracked and identified with an individual and unique part number.

Materials, parts and components are identified at the functional level of use. Subcomponents are not individually identified or tracked.

Identification tags/stickers are legible and visible.

8.2 NQA-1

8.2.100

Controls shall be established to assure that only correct and accepted items are used or installed.

Identification shall be established and maintained on the items or in documents traceable to the items.

8.2.200

Project Deliverable Items (batch, lot, component, part) shall be identified and traceable from the initial receipt and fabrication of items up to and including installation and use.

This identification shall be traceable to an applicable design or other pertinent design document.

Physical identification shall be used to the maximum extent possible.

Where physical identification on the item is either impractical or insufficient, physical separa-tion, 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.

8.2.300

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


Identification logs are maintained as lifetime records ensuring traceability.

Subcomponents will be identified and marked when there is a direct correlation to their performance of safety functions. This correlation is determined in a documented process.

Limited life items are identified with the original manufacturing date and/or an expiration date.




Description: Describes authority to affix and remove identification tags

BR 8

BR 10

BR 12

BR13

BR 14

BR 15


QPP 08-1 Name: Control – Materials, Part and Components

Description: Assigns the Policy Owner, allows for delegation of process, describes the receiving process and proper identification of all materials received. Expected input and outputs are listed.

BR 8

QPP 08-2 Name: Control – Customer Returned Materials

Description: Assigns Policy Owner, details identification, interface with original Supplier and customer communications on items returned.

BR 8

QPP 10-2 Name: Inspections – Goods Receipt

Description: Assigns the Policy Owner, details the incoming goods process, recording of nonconformances, appropriate tagging and identification. Expected inputs and outputs are listed

BR 8

BR 10


N/A



CRITERIA IX: CONTROL OF SPECIAL PROCESSES


All special processes will be performed by approved skilled/knowledgeable personnel. Necessary skills to perform special process functions, training (mechanical, technical) will be provided.

Work Instructions are documented and provided for individual Special Processes.

Equipment used and appropriate acceptance criteria are documented within the Special Process.

Equipment used in a Special Process are evaluated for their critical characteristics and documented to ensure proper maintenance and the integrity of the equipment.

Other materials used in a Special Process are evaluated for their critical characteristics and controlled against these characteristics. (chemical products, liquids, physical elements)

Environmental conditions (temperature, humidity, pressure) are controlled as specified within the Special Process.

Appropriate risk and impact analysis is performed and documented prior to changes application on special processes.

9.2 NQA-1

9.2.100

Special Processes are defined as activities that affect, control or verify quality results of activities that cannot be readily determined by standard testing or visual inspection.

Processes classified as Special are, but not limited to:

• Welding

• Heat Treating

• Nondestructive examination

• Painting

• Electro Plating

• Seismic Qualification

• Particular manufacturing operations

Special Processes are dependant on the control of the process, the skill of the operator, or both. Special Processes shall be performed by qualified personnel using qualified procedures in accordance with specified requirements.

I&C US currently does not utilize any Special Processes; therefore there are no qualification procedures or qualified staff members.

9.2.200

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 or standards, the necessary requirements for qualifications of personnel, procedures, or equipment shall be specified or referenced in procedures or instructions.

9.2.300

It is the responsibility of the organization performing the special process to adhere to the approved procedures and processes.

9.2.400

Records shall be established within the relevant Special Process with retention requirements. Records will be maintained as appropriate for the currently qualified personnel, processes, and equipment of each special process. Records will demonstrate process monitoring and conformity to specified requirements.


All Special Processes are identified and logged on the Special Process List.

Periodic assessments and updated training are performed consistent with the importance of the skill required by the Special Process, as related to safety.

9.4 APPLICABLE BUSINESS OPERATIONS POLICIES


QPP 09-1 Name: Control - Special Process

Description: Assigns the Policy Owner, provides instruction for the development of special processes, the review and final approval of the special process. Expected input and outputs are listed.

BR 9

QPP 09-2 Name: Control - Commercial Dedication

Description: Assigns Policy Owner, discusses evaluation, plan, procurement, verification, review and approval process.

BR 7

BR 9


N/A



CRITERIA X: INSPECTION


Inspections include:

o Goods Receipt

o Source Verification

o In-Line

o Final Acceptance

Goods Receipt – inspector will be qualified/skilled and have authority to reject/accept items. The inspector is not involved in the Procurement process. Inspections are performed against the item specification, purchase order and other applicable standards. Acceptance records are retained.

Source Verification – inspector will be qualified/skilled and have authority to reject/approve for continuation of the item produced. This inspection occurs at the supplier/vendor location(s). Inspection will occur at various pre-determined steps during the production process. Inspection records are retained.

In-Line inspection – informal inspection, used to provide additional confidence and integrity of the production process. Inspections occur based on experience feedback or process improvement evaluations.

Final Acceptance – performed by QA Inspection Officials or Quality Manager. Occurs on tested and accepted goods prior to shipping. Ensure the following items are completed during this inspection:

o Cleanliness of materials

o Proper packaging is applied

o Relevant testing and conformance documents are available and completed

o Relevant legal and export documents are available and completed

Inspection will include Special Processes when inspection of items is not possible physically.

Differences between actual and expected results of inspections are recorded as nonconformities.

Quality Manager is responsible for final review of any relevant documents related to the inspections (nonconformance reports, testing reports, inspection reports, etc) and issuing approval. QA approval signifies the authority to ship/distribute items.

10.2 NQA-1

10.2.100

Inspections required to verify conformance of an item or activity to specified requirements or continued acceptability of items in service shall be planned and executed.

Critical Characteristics subject to inspection and inspection methods shall be specified in an Inspection Plan.

Inspection results shall be documented on the Inspection Report.

Inspection for acceptance shall be performed by qualified persons other than those who performed or directly supervised the work being inspected.

10.2.200



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.

10.2.300

Hold Points, if required, shall be identified during Inspection Planning.

Work cannot proceed beyond a Hold Point without the identified Inspector providing initials or inspection stamp as consent.

Hold points can be waived with documentation and approval from the Hardware Manager. Approval must be attained prior to reaching the Hold Point during fabrication.

10.2.400

An Inspection Plan shall be developed for each fabricated item/assembly, and include:

• Critical Characteristics to be inspected • Methods of inspection, • Acceptance criteria • Qualified Inspectors • Fabrication Activity • Identified Hold Points

I&C US does not utilize sampling for inspections. All items fabricated and assembled shall be inspected.

10.2.500

Inspection of items in process shall be performed as necessary to verify quality and conformance.

Fabrication process monitoring will be utilized if inspection of processed items is impossible or disadvantageous.

Process monitoring shall be performed by qualified personnel of equipment, fabricated items, and personnel performing fabrication and inspections.

Both inspection and process monitoring shall be provided when control is inadequate without both.

10.2.600

Final acceptance inspection shall include a review of the in-line inspection results and resolution of identified nonconformances.

All completed items shall be inspected for completeness, protection from damage, and critical characteristics required to verify the quality and conformance of the item to specified requirements.

Modifications, repairs, or replacements of items performed subsequent to final acceptance inspection shall require re-inspection or retest to verify acceptability.

10.2.700

Inspection records shall be established, maintained and include following:

• Inspection Plan • Inspection Report • Qualified Inspector(s) • Signature indicating Final Acceptance • Supporting records for inspection and nonconformance documentation




In-Line inspection – formal inspection. Inspections shall be conducted by the Quality Manager and the qualified Inspector listed on the Inspection Plan. The Inspectors have authority to reject/approve for continuation of the item being produced.

Critical characteristics and acceptance criteria are identified at pre-determined critical production stages, as during production there is limited availability/access for verification. Inspection occurs at these pre-determined stages for approval to continue production. In-Line Inspections and Hold Points cannot be waived.

At completion of the Final Inspection, QA will formally release the product for shipment.

Quality Manager will review and approve contract/subcontractor production plans for adequate inspection and hold points as determined by the requirements and critical characteristics of the items being manufactured.

The Contractor/Subcontracts will communicate the inspection and production status to the Quality managers for scheduling inspections. Results of the inspections are documented.

The Quality Manager will also issue the Final Certification of Conformance to accompany all materials.





BR 8

BR 10

BR 12

BR13

BR 14

BR 15




BR 2

BR 10

BR15

WF 10-1 Name: Inspector Certification BR 2

BR 10

QPP 10-2 Name: Inspections – Goods Receipt

Description: Assigns the Policy Owner, details the incoming goods process, recording of nonconformances, appropriate tagging and identification. Expected inputs and outputs are listed

BR 8

BR 10

WI 10-2.1 Name: Certification – Goods Receiving BR 2

BR 10

WI 10-2.2 Name: Discrepancy Report BR 2

BR 10

QPP 10-3 Name: Certification – QA Inspection Officials BR 2



Description: Assigns the Policy Owner, details the certification process and levels of certification, details the authority for final acceptance

BR 10

BR 14



BR 2

BR 10

BR 14

QPP 14-2 Name: Inspections – In-Line and Status

Description: Assigns the Policy Owner, details the in process inspections, including inspection planning, critical characteristic identification, hold point identification, assigned inspectors, and nonconformances. Expected inputs and outputs are listed

BR 10

BR 14

BR 15


N/A



CRITERIA XI: TEST CONTROL


Test Plans are developed and documented using test procedures, acceptance criteria with tolerance levels and design documents. The Test Plan is reviewed for adequacy and verification against the requirements.

Signature acceptance on the document indicates acceptance of the completed test procedure.

Testing results will be documented.

Quality Manager, Test Director or the Product Manager will evaluate the system test results against the requirements. After FAT is performed, the appropriate representative releases the system to the customer.

Test records are retained according to the contract.

Persons who perform activities related to the final conformity of the product are certified, and records of certification retained.

Testing performed by I&C US includes:

• Design

• Software verification and validation

• Integration

11.2 NQA-1

11.2.100

Testing shall be planned and then executed to the plan.

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.

Testing shall be conducted with written, reviewed and approved Test Procedures.

11.2.200

Test requirements and acceptance criteria shall be provided or approved by the responsible design organization.

Required tests, including, as appropriate, prototype qualification tests, production tests, proof tests prior to installation, construction tests, preoperational tests, operational tests, and computer program tests such as software design verification, factory acceptance tests, site acceptance tests, and in-use tests shall be controlled.

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.

All changes to testing environment during formal testing must be approved by the design authority prior to performing the test.

11.2.300



Test Procedures shall include:

• Acceptance Criteria • Test Configuration • Test Objectives • Test Scope, to include items or functions to be tested • Prerequisites identification • Environmental conditions • Calibrated Test Equipment necessary • Other equipment or instrumentation necessary • Qualified testing personnel • Additional documentation such as design documents, drawings, etc can be noted • Expected testing results with provision to collect data • Personnel qualified for acceptance

Test Procedure execution shall be monitored.

11.2.400

Test procedures developed specifically for computer program(s) shall demonstrate the adherence of the computer program to documented requirements (external customer requirements and internal product requirements).

I&C US does not utilize computer programs to aid in design.

I&C US software products are utilized for operational control and monitoring; therefore, computer program test procedures shall demonstrate the required performance over the range of operation of the controlled function or process.

The procedures shall also provide for evaluating 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.

Computer Program Test Procedures shall include:

• Requirements being tested • Acceptance Criteria • Test Configuration • Test Objectives • Test Scope, to include items or functions to be tested • Software module(s) being tested • Prerequisites identification • Environmental conditions • Calibrated Test Equipment necessary • Qualified testing personnel • Additional documentation such as design documents, drawings, etc can be noted • Expected testing results with provision to collect data • Test Results Evaluation, as necessary • Personnel qualified for acceptance of completion of test procedure • Test Director signature for acceptance of compliance to requirements

Test Procedure execution shall be monitored.

In-use test procedures shall be developed and documented to permit confirmation of acceptable performance of the computer program in the operating system.

In-use test procedures shall be performed after the computer program is installed on a different computer, or when there are significant changes in the operating 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.

Software verification and validation will be performed on a regular basis, as appropriate.



11.2.500

Test results shall be documented.

Test results shall be evaluated by the Testing Director or Product Manager to ensure that test requirements have been satisfied.

Test results for design qualification tests and software design verification shall be evaluated by the responsible design organization.

11.2.600

Test records shall include:

• Item or function tested • Date of test • Testing personnel • Test data/reports • Acceptance results • Problem & Correction notations • Signature of Compliance to test requirements


The Test Procedure development will be completed by staff member(s) independent from the designers; with equal or higher level knowledge.

Signature acceptance on the document indicates acceptance of the completed test procedure.

The Quality Manager will evaluate the system test results against the requirements and critical characteristics. After FAT is successfully performed, the Quality Manager issues the declaration of conformance, then release the system to the customer.

Test Records are retained are lifetime records.

Records of environmental conditions for test required are retained; they will be joined to the FAT report when required by contract.



QPP 11-1 Name: Certification – System Testers


BR 2

BR 11

QPP 11-2 Name: Testing – System in Development

Description: Assigns the Policy Owner, details the development testing phases and responsibilities during each phase. Expected inputs and outputs are listed

BR 11

QPP 11-3 Name: Testing – Integrated Systems

Description: Assigns the Policy Owner, details integrated testing and the responsibilities during this phase. Expected inputs and outputs are listed

BR 11

QPP 11-4 Name: Testing – Problem Reporting

Description: Assigns the Policy Owner, allows for delegation of the process, describes two types of problem reporting. Expected inputs and

BR 11

BR 15



outputs are listed

WI 11-4.1 Name: Hardware Problems BR 11

BR 15

WI 11-4.2 Name: Software Problems BR 11

BR 15


N/A



CRITERIA XII: CONTROL OF MEASURING AND TEST EQUIPMENT


Control, identification, monitoring and calibration of the tools, gauges, instrument s and equipment is the responsibility of the Hardware Group, specifically the Hardware Manager.

I&C US does not utilize any Special Processes; therefore there are no specialized tools required for these processes.

Measuring and test equipment will be controlled and calibrated against common industry acceptance criteria.

Calibration vendors will be certified against industry standards.

Staff shall be trained in the proper selection and use of Measuring and Test Equipment.

Calibration plans are documented. The Hardware Manager or designee is responsible for defining the following in the Calibration Plan:

o calibration cycles and intervals

o intended use of devices

o device identification number

o device maintenance

o proper storage and control

o proper labeling of calibrated devices

o calibration record retention

Devices not participating in the calibration plan are labeled accordingly.

Cognizant Engineers are responsible for identifying and selecting measuring and testing devices to be used during the testing process and documented in the Test Plan.

Devices found out-of-calibration will be segregated. The Hardware Manager will notify the project engineers, project manager and quality manager of devices found out-of-calibration.

Quality Manager will ensure proper steps are taken for resolution of the calibration device and its impact on acceptability of items previously inspected/accepted is evaluated. Appropriate corrective actions are taken.

12.2 NQA-1

12.2.100

All Measuring and Test equipment used for activities affecting quality shall be controlled, calibrated at specific periods, adjusted, and maintained to required accuracy limits and industry standards.

12.2.200

Measuring and Test equipment shall be selected for each individual test or inspection based on the type, range, accuracy, and tolerance needed to accomplish the required measurements for determining conformance to specified requirements.

Measuring and Test Equipment used shall be documented for each test and inspection.



12.2.300

Measuring and test equipment shall be:

• Calibrated on an annual basis unless manufacturer recommends a less frequent interval

• Calibrated when the accuracy of equipment is suspect

• Traceable to individual calibration reports, against recognized and accepted industry standards

Reference standards shall have a minimum accuracy four times greater than that of 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.

Calibration frequency can be changed based on equipment accuracy and performance.

Measuring and Test equipment found out of calibration or damaged shall be immediately identified with a red NONCONFORMANCE tag/sticker, removed from service, and segregated to prevent continued use.

Measuring and Test equipment shall be evaluated for impact to current testing or inspection and previous use back to the last calibration date. Evaluation shall include re-calibration of the Measuring and Test equipment, critical characteristic acceptance criteria, and customer impact for immediate notification. The evaluation and resulting actions shall be commensurate with the significance of the condition

Measuring or Test equipment consistently found to be out-of-calibration shall be repaired or replaced.

Measuring and Test equipment shall be properly handled and stored to maintain accuracy while not in use.

During use, Measuring and Test equipment shall be protected and handled to assure physical condition and accuracy of the equipment is not affected.

Calibration and calibration activities shall take place in environmentally controlled conditions.

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

All Measuring and Test equipment shall be tagged to indicate calibration status including calibration date, calibration due date and specific item identification with traceability to calibration records.

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

12.2.400

I&C US Hardware Group shall maintain calibration records indicating calibration status and the capability of measuring and test equipment to satisfactorily perform its intended function.

Calibration reports and certificates reporting the results of calibrations shall include the information and data necessary for interpretation of the calibration results and verification of conformance to applicable requirements.


Calibration records will be maintained as lifetime records.



When calibration is subcontracted, reports established by the subcontractor are checked and approved by the Hardware Manager and Quality Manager prior to release the device.





BR 8

BR 10

BR 12

BR13

BR 14

BR 15


QPP 12-1 Name: Calibration

Description: Assigns the Policy Owner, allows for delegation of process, describes the calibration process, device storage, process for equipment deviations. Expected inputs and outputs are listed

BR 12


N/A



CRITERIA XIII: HANDLING, STORAGE AND SHIPPING


Environmental conditions will be maintained and be adequate for system materials, parts and components by the HS&E representative. Environmental conditions will be adequate to prevent deterioration or damage to any system materials, parts and components.

Buildings and other work structures will be maintained to adequately provide acceptable working conditions.

Procedures are documented for proper storage and handling of materials, parts and components.

The method of shipping shall be such to protect the integrity of the materials, parts and components.

Shipping procedures are documented and include any specific requirements according to the contract.

Materials for shipment are verified against the packing lists by appropriate skilled personnel.

13.2 NQA-1

13.2.100

Handling, storage, cleaning, packaging, shipping, and preservation of items shall be controlled to prevent damage or loss and to minimize deterioration. These activities shall be conducted in accordance with established work and inspection instructions, drawings, specifications, shipment instructions, or other pertinent documents or procedures specified for use in conducting the activity.

During the final shipment review all items are verified for cleanliness, proper protection, proper identification and traceability, inclusion of customer supplied documents or equipment and proper shipping labels.

13.2.200

Special equipment and special protective environments shall be utilized when required. The use of special equipment and environments will be verified and documented, and if possible photographed. Examples include, but not limited to:

• Air ride trucks

• Special Containers

• Shock detectors

• Environmental requirements or constraints during shipment

• Critical straight to customer shipment

• Other customer purchase order special requirements

13.2.300

When required for critical, sensitive, perishable, or high-value items, specific procedures for handling, storage, packaging, shipping, and preservation shall be used and documented, and if possible photographed. Examples include, but not limited to:

• Shelf life requirements

• Electrostatic discharge (ESD) packaging and handling requirements for sensitive material

• Safety-Related secured packaging requirements



• Customer Purchase Order special requirements

13.2.400

I&C US does not currently utilize any special handling tools or equipment.

If required by customer purchase order any 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 periodically to ensure safe and adequate handling.

13.2.500

I&C US does not currently utilize any special handling tools or lifting equipment.

If required by customer purchase order, operators of special handling tools and lifting equipment shall be experienced or trained in the use of the equipment prior to use.

13.2.600

Identification and Traceability of all items will be maintained. Special controls or environments will be maintained in accordance to implementing policies and customer requirements.


Specific Environmental conditions (humidity, pressure, temperature, etc) will be provided and maintained in accordance to the requirements/specification of the contract.

Protective provisions of materials, parts and components are provided and verified during the life cycle of the project.





BR 8

BR 10

BR 12

BR13

BR 14

BR 15


QPP 13-1 Name: Control - Storage

Description: Assigns the Policy Owner, details the handling and storage of all products. Expected inputs and outputs are listed

BR 13

QPP 13-2 Name: Control – Pack & Ship

Description: Assigns the Policy Owner, details packing and shipping process of both individual items to large systems. Expected inputs and outputs are listed

BR 13




N/A



CRITERIA XIV: INSPECTION, TEST AND OPERATING STATUS


Components are identified and tracked during the life cycle of a project so inspection and status is available and known.

Goods Receipts items are accepted and forwarded to the project.

Physical Configuration is verified prior to entering the testing process.

Testing Status is verified through routing cards and/or test logs. Results from test/operations will be documented by the individual performing the test/operation.

14.2 NQA-1

14.2.100

A documented system will be maintained to assure that required inspections and tests are performed, and that inspection and test acceptance status is known and identified throughout applicable operational stages.

Identification of inspection and test status will be through the use of one or more of the following methods:

• Acceptance tags

• Stamps

• Labels

• Checklists

• Receipt Travelers

• Inspection/Test Reports

• Or other means acceptable to the Certified Inspector

Identification will show traceability of the inspection and test status to the item inspected.

The status indicators (listed above) are utilized to ensure that items which have not passed the required inspection are not inadvertently installed, used or operated. All items requiring specified inspections or tests will not progress beyond those specified hold points without proper authorization or acceptance.

The use of status indicators, their control, and their removal is documented. Personnel authorized to apply and remove the status indicator are documented.

Items that do not meet examination and test requirements will be identified as Nonconformances.




Provisions are documented to identify test/operational status to ensure that interruptions are prevented during the testing process. If an interruption occurs, the test/operations will be restarted from the beginning.

Travel forms identify the operations and the documents applicable to each. Forms are completed by the operator and operations tagged after completion. Non-conformances, deviations or technical changes are identified on those forms.

Marks of inspection, hold and witness points are written for the operations inspected.

Change requests that may impact status of the test/operation will be approved by Quality Manager prior to the application.





BR 8

BR 10

BR 12

BR13

BR 14

BR 15


QPP 10-3 Name: Certifications – QA Inspection Officials


BR 2

BR 10

BR 14



BR 2

BR 10

BR 14

WF 14-1 Name: Certification In-Line Inspectors BR 2

BR 14



BR 10

BR 14

BR 15

WI 14-2.1 Name: Inspection Planning BR 2

BR 14

BR 15



WI 14-2.2 Name: In-Line Inspection Report BR 2

BR 14

BR 15

WF 14-2 Name: In-Line Inspection BR 14


N/A



CRITERIA XV: NONCONFORMING MATERIALS, PARTS AND COMPONENTS


Any item that does not conform to requirements/specification is classified as a Nonconformance. Nonconformances are considered items that could alter the quality or affect the safety of a product, document, service or activity.

Nonconformances can be initiated by any employee working on quality related projects/initiatives. All Nonconformances will be reported to the appropriate Project Engineers, Project Manager and the Quality Manager or QA staff.

Nonconformances, item disposition, and final resolution will be recorded in the Nonconformance Report.

When a Nonconformance is identified, it will be tagged and segregated to prevent inadvertent use.

Resolved Nonconformance is reviewed and verified for conformance against the requirements/specification by the QA staff or designee.

Nonconformances not affecting safety and quality resolved as “use as is” are technically justified by relevant skilled design authority and documented.

15.2 NQA-1

15.2.100

Items that do not conform to specified requirements shall be controlled to prevent inadvertent installation or use. Nonconformance and Hardware Problem Reports will be prepared as applicable.

Controls shall provide for identification, documentation, evaluation, segregation when practical, and disposition of nonconforming items, and for notification to affected organizations.

15.2.200

Nonconforming items shall be identified by red NONCONFORMANCE tag/stickers. Tagging methods shall not be detrimental to the item, on either the item, the container, or the package containing the item. Tagging shall be visible at all times.

15.2.300

Nonconforming items shall be segregated by placing them in a clearly identified, access controlled 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.

15.2.400

Responsibility for the control of further processing, delivery, installation, or use of nonconforming items shall be designated in writing.

Evaluation of all nonconformances shall be as follows:

• Nonconformance report initiation

• Appropriate engineering, project management, quality, hardware and software engineers will rally together to evaluate and propose a disposition for the nonconforming item.



• The organization that has the best knowledge and experience is responsible for documenting the Nonconformance report and disposition. Staff performing these activities must be capable of making the evaluation, have adequate understanding of the requirements and access to pertinent background information.

• Quality Manager will review all supporting documentation and issue approval.

• Further processing, delivery, installation, or use of a nonconforming item shall be controlled pending the evaluation and an approved disposition by authorized personnel.

Disposition of all nonconformances shall be as follows:

• Nonconformance dispositions such as use-as-is, reject, repair, return, or rework of nonconforming items will be documented.

• Technical justification for the acceptability of a nonconforming item dispositioned as repair or use-as-is shall be documented.

• Nonconformances to design requirements dispositioned as 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.

• Nonconforming items dispositioned as use-as-is or repair will be submitted to the customer for approval, when required by contract.

• Nonconforming items dispositioned as use-as-is for typographical or documentation errors related to I&C US internal requirements need not be submitted to the customer for review and approval.

• Nonconforming items dispositioned as rework or repair will be re-examined in accordance with applicable procedures and contractual requirements unless the disposition has established alternate acceptance criteria.


Quality Manager – has the written authority to stop/halt production and/or testing where any Nonconformance can affect safety or quality.


Nonconformances affecting safety are identified according to a documented process and subject to 10CFR21 Reporting and Notification.

Nonconformances resolved by rework will be reviewed/verified by cognizant and independent staff other than the employee repairing the item.

Nonconformances affecting safety cannot be resolved as “use as is”.

Nonconformances affecting safety for delivered goods/systems will be communicated to:

o all affected installed locations

o appropriate levels of management

o relevant authorities

Nonconformances affecting safety for delivered goods/systems into the United States will comply with 10CFR Part 21 regulations.

Root causes analysis and documented corrective action plans are established for every Nonconformance affecting safety.



A member of QA staff is assigned to each of Nonconformance affecting safety (NCAS). This QA staff member ensures the appropriate reporting and coordinates the action of the skills involved. This staff member also ensures the quality of the resolution process, and monitors the corrective action plan and its closeout.





BR 8

BR 10

BR 12

BR13

BR 14

BR 15




BR 2

BR 10

BR15

QPP 11-4 Name: Testing – Problem Reporting

Description: Assigns the Policy Owner, allows for delegation of the process, describes two types of problem reporting. Expected inputs and outputs are listed

BR 11

BR 15



BR 14

BR 15

WI 14-2.1 Name: Inspection Planning BR 2

BR 14

BR 15

WI 14-2.2 Name: In-Line Inspection Report BR 2

BR 14

BR 15

QPP 15-1 Name: Nonconformances

Description: Assigns the Policy Owner, allows for delegation of process, details local process details and flow, expected inputs and outputs are listed

BR 15

WF 15-1 Name: Nonconformances BR 15

QPP 15-2 Name: Nonconformance Evaluation

Description: Assigns the Policy Owner, details the evaluation process and responsibility is assigned, expected inputs and outputs are listed

BR 15

BR 16

WI 15-2.1 Name: Nonconformance Report BR 15



BR 16

WI 15-2.1 Name: Material Review Board BR 15

BR 16

QPP 16-1 Name: Process Improvement – Corrective Action

Description: Assigns the Policy Owner, details the process for root cause identification, corrective action development, implementation of correction, and verification of effectiveness. Links Customer Satisfaction Assessment to the Process

BR 15

BR 16

ICQ-002 Name: 10CFR21 Reporting Safety-Related Problems

Description: Assigns the Policy Owner, mandatory timeline requirements for reporting Safety-Related Problems, details authorities and responsibilities, details requirement for documentation, expected input and outputs listed

BR 15

ICQ-003 Name: Class 1E Record Annual Review

Description: Assigns the Policy Owner, annual review process, items included in review, monitoring output.

BR 15

BR 17

ICQ-004 Name: 10CFR21 Posting Notice Review

Description: Assigns the Policy Owner, details quarterly review of postings, items mandatory to be posted, and locations of postings for all offices.

BR 15



BR 1

BR 2

BR 3

BR 15


N/A



CRITERIA XVI: CORRECTIVE ACTION


Corrective Actions are identified as items initiated to resolve conditions adverse to quality.

Corrective actions can effect:

o Product

o Process

o Infrastructure

o Skills

o Organization

Corrective actions can be identified by:

o Testing

o Inspection

o Audit

o Customer feedback

o Process Improvement

o Preventative

Corrective, Preventative and Business Process Improvement actions are documented in the Corrective Action Log.

Corrective action resolution will include root cause determination and actions to prevent recurrence.

16.2 NQA-1

16.2.100

All I&C US staff have the responsibility to identify conditions adverse to quality and nonconformities, reporting them immediately to the Quality Manager and/or Business Operations Manager.

Conditions adverse to quality shall be identified promptly and corrected as soon as practical, including all nonconformities.

Immediate action will be taken to correct/resolve the current condition, although further actions may be necessary based on the formal review.

In the case of a significant condition adverse to quality, the cause of the condition shall be formally reviewed with root cause determined and documented. A corrective action plan shall be developed to correct and preclude recurrence.

Quality Manager will review the formal corrective action plan and then later verify implementation and its effectiveness.

Corrective/Preventative actions will be monitored, measured and reported to Management.

Corrective action requirements will be extended to vendors and subcontractors, as necessary.



Nonconformances shall be reviewed for applicability for Corrective and Preventative Action. These actions will be identified in the Corrective Action log for implementation.

Any Safety-Related Class 1E conditions adverse to quality shall be reviewed for applicability for Correction and Preventative Action. These actions will be identified in the Corrective Action log for implementation.


Corrective Actions that result from a Class 1E project/initiative will be maintained as a lifetime record.

Corrective Actions that result from a Class 1E project/initiative must be reported to the I&C Quality organization.

The I&C Quality Manager will assign a Quality representative to govern the Corrective Action process and ensure the proper the final resolution. This Quality representative will ensure the process is documented and reported to the appropriate level of management.



QPP 02-6 Name: Customer Satisfaction

Description: Assigns the Policy Owner, details the process for obtaining, documenting and reporting customer satisfaction

BR 2

QPP 15-2 Name: Nonconformance Evaluation

Description: Assigns the Policy Owner, details the evaluation process and responsibility is assigned, expected inputs and outputs are listed

BR 15

BR 16

WI 15-2.1 Name: Nonconformance Report BR 15

BR 16

WI 15-2.1 Name: Material Review Board BR 15

BR 16

QPP 16-1 Name: Process Improvement – Corrective Action

Description: Assigns the Policy Owner, details the process for root cause identification, corrective action development, implementation of correction, and verification of effectiveness. Links Customer Satisfaction Assessment to the Process

BR 15

BR 16

BR 17

WF 16-1 Name: Corrective Actions BR 16

QPP 16-2 Name: Process Improvement – Preventative Action

Description: Assigns the Policy Owner, guides for the method to identify and track potential occurrences and potential implementation of actions taken by the organization.

BR 16

BR 17

WF 16-2 Name: Preventative Actions BR 16

QPP 16-3 Name: Process Improvement – Business Process Improvements

Description: Assigns the Policy Owner, details the process for identification of improvements, internal discussion on value to implement, development of effective plan for implementation and verification of effectiveness.

BR 16

BR 17



WF 16-3 Name: Process Improvement Review BR 16

QPP 16-4 Name: Root Cause Analysis

Description: Assigns the Policy Owner, details the process developing and investigating an issue to determine the root cause, findings, plan for correcting the root cause and prevention against recurrence.

BR 16

BR 17


Policy Number Name of Policy CPP00/004 Corporate Improvement Action CPP03/009 Customer Complaint & Quality Concern Process



CRITERIA XVII: QUALITY ASSURANCE RECORDS


Records are identified and defined in each procedure, work instruction, form and template. Personnel are also identified and given responsibility for archiving and retaining quality records.

Records are retained according to the contract requirements/specification and local QAP requirements.

Records are legible, retrievable and traceable. Records must be supported by media using current technology (non obsolete), and protected as appropriate.

A procedure is documented for protection and security of quality records.

Records of qualification and training of inspectors, test and manufacturing personnel will be maintained by QA during the employee's tenure, plus one year.

Labeling, storage requirements and disposition/destruction are documented in relevant procedures.

Provisions are taken to ensure appropriate access to the records, with consideration to criteria such as confidentiality or risk of data modification.

17.2 NQA-1

17.2.100

Quality assurance records shall furnish documentary evidence that items or activities meet specified quality requirements. Quality assurance records shall be identified, generated, authenticated, and maintained, and their final disposition specified. Requirements and responsibilities for these activities shall be documented. The term records, used throughout this section, is to be interpreted as quality assurance records.

17.2.200

Records shall be legible and easily retrievable.

Records shall be traceable to associated items and activities and accurately reflect the work accomplished or information required.

17.2.300

Documents shall be considered valid records only if stamped, initialed, or signed and dated by authorized personnel or otherwise authenticated.

Electronic documents shall be authenticated by either:

• identification on the media • authentication information contained within or linked to the document itself

17.2.400

Records shall be classified as either lifetime or nonpermanent. Records are those documents required to show evidence that an activity was performed in accordance with the applicable requirements.

Lifetime records are:

1. All Safety-Related Class 1E records, such as but not limited to:

• Hardware or Software related • Design specifications • Design output • As-built drawings and documentation



• Nonconformance reports • Testing Records • Inspection Records • Significant value in demonstrating capability for safe operation • Significant value in maintaining, reworking, repairing, replacing or modifying

an item • Significant value in determining cause of an accident or malfunction or an

item • Provide required data for in-service inspection

2. Maintained by the Quality Manager on behalf of the Owner, or authorized agent, for the life of the particular item while installed in the plant or stored for future use.

3. Indexed and reviewed on an annual basis for control, proper protection and continued legibility.

4. Transferred to the Owner, or authorized agent, when formally requested.

Nonpermanent records are:

1. Not required to be maintained as lifetime records as they do not meet the criteria above

2. Maintained by the staff member generating the record

3. Required to be retained per governing policy for the identified retention period

4. Required by the contract requirements

5. Required or directed by appropriate levels of company management

17.2.500

Each organization responsible for the receipt of records shall designate a person or organization responsible for receiving the records. The designee shall be responsible for organizing and implementing a system of receipt control of records for permanent and temporary storage.

17.2.600

Records shall be stored in facilities, containers, or a combination thereof, constructed and maintained in a manner that minimizes the risk of damage or destruction from the following:

• natural disasters such as winds, floods, or fires • environmental conditions such as high and low temperatures and humidity • infestation of insects, mold, or rodents

Dual facilities, containers, or combination thereof shall be provided for records storage if a single facility, container, or combination thereof is not capable of providing adequate protection.

17.2.700

Record retention periods shall be documented.

Records shall be maintained for their retention periods.

17.2.800

Records shall be:

• protected from damage or loss • retrievable • legible

Provisions for records shall include:

• Methods for record changes, proper indexing, per the same manner as the original version. This method must be documented.



• Methods for retention that include damage prevention, protection from harmful conditions (excessive light, stacking, electromagnetic fields, temperature, humidity, pests)

• Methods to ensure readability and retrievability of media, specific provisions ensuring current media is utilized preventing degradation or loss or readability based on technology

• Methods 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


Class 1E lifetime records and documents are:

o Evidence of conformity of the product

o Evidence of the skills of personnel

o Evidence of conformity of the process and equipment

o Technical Documents

o Nonconformance Reports

o Corrective Action Reports

o Legal and Contract documents

o 10CFR Part 21 documents

Records of indoctrination of inspectors, test and manufacturing personnel will be maintained by QA as a lifetime record.



QPP 17-1 Name: Records

Description: Assigns the Policy Owner, details records for retention, discusses storage of records onsite and off-site, and disposition of records.

BR 17

WI 17-1.1 Name: Dual Storage BR 17

ICQ-003 Name: Class 1E Record Annual Review

Description: Assigns the Policy Owner, annual review process, items included in review, monitoring output.

BR 15

BR 17


Policy Number Name of Policy CPP00/014 Control of Records



CRITERIA XVIII: AUDITS


I&C US will have an audit program that includes but not limited to development of an annual audit schedule, approved auditors, audit implementation with appropriate documentation, audit follow-up and monitoring/maintenance of the program. The I&C US Quality Manager is responsible for developing, implementing, and monitoring the effectiveness of the I&C US Audit Program.

Auditor acceptance and approval is documented and implemented. Approved auditors are on an I&C US approved auditor list and they are re-evaluated every three years for current qualification status.

The I&C US audit schedule must be approved by I&C US Business Operation Manager.

Audits and surveillances are conducted against an individual audit plan, relevant checklist or assessment program. These audits are documented and the audit artifacts are retained or referenced as audit records.

Audit reports are distributed to the relevant managers of the area(s) audited and supervisors for review prior to approval for final distribution. Any Audit findings are recorded and actions assigned within the Corrective Action Log and Nonconformance Log, as necessary.

The Lead Auditor will ensure the all audit findings are resolved and documented. Findings are evaluated for effectiveness, as determined, by the auditor prior to closure.

18.2 NQA-1

18.2.100

Audits shall be performed to verify that performance criteria are met and to determine the effectiveness of the program. These audits shall be performed in accordance with written procedure or checklists by personnel who do not have direct responsibility for performing the activities being audited. Audit results shall be documented and reported to and reviewed by responsible management. Follow-up action shall be taken where indicated.

18.2.200

The I&C US QAP must be audited annually by a Qualified Auditor other than the I&C US Quality Manager.

I&C US Audit Schedule shall forecast and assure external audits are conducted at least once every three years.

18.2.300

I&C US Quality Manager shall schedule internal audits based on the importance of the activity, business demand and load, and historical process performance.

I&C US Audit Schedule shall forecast and assure internal audits based on the importance of all activity, business demand and load, and historical process performance. All internal processes must be audited at least annually.

Individual Audit plans (developed by the Quality Organization) will identify the audit scope, applicable requirements and standards, performing personnel, activities to be audited, organizations that need notification, applicable documents, schedule, policies and checklists.

The audit team shall have at least a Lead Auditor and additional qualified auditors, as necessary, for the scope of audit. The audit team shall have sufficient authority and organizational freedom to make the audit process meaningful and effective.

Audits may be both internal and external (supplier, subcontractor, etc).



18.2.400

Elements selected for audit shall be evaluated against pre-determined requirements as identified in the Audit Plan. Objective evidence will be examined to the depth necessary to determine the effectiveness of implementation.

Any conditions identified requiring prompt Corrective Action will be reported immediately to the responsible/managing parties of the area being audited.

18.2.500

Lead Auditor shall approve, sign and issue the final audit report.

The Audit Report shall note the audit scope, auditors and participating personnel, summarize the audit results and its effectiveness of the elements audited and identify with descriptions of any adverse findings.

18.2.600

Audits shall be documented and reported to appropriate managers. Managers shall review and ensure any follow-up actions are taken where indicated, and prevent recurrence. Managers shall provide an audit response to the auditing organization for review, detailing actions taken and planned. Lead Auditor shall evaluate corrective.

18.2.700

Lead Auditor shall ensure corrective actions undertaken have been accomplished, and then close the audit.

18.2.800

Audit records shall include but are not limited to audit plans, audit reports, audit responses and records of completed corrective actions.


Written response and commitment will be provided to the audit team by the relevant Manager in response to each Corrective Action and/or Nonconformance as assigned by the Lead Auditor.

If there are two ore more safety related non conformances, a plan for re-audit and project / process monitoring is required.

18.4 APPLICABLE POLICIES


QPP 18-1 Name: Certification – Lead Nuclear Auditors

Description: Assigns the Policy Owner, provides guidance and direction on the initial and annual certification process for Nuclear QA Lead Auditors

BR 2

BR 18

WF 18-1 Name: Lead Nuclear Auditor Qualification BR 2

BR 18

QPP 18-2 Name: Program - Audits

Description: Assigns the Policy Owner, provides additional details on the local activities in relation to the distribution of audits and audit findings.

BR 16

BR 18



WF 18-2 Name: Audit Flow BR 18

QPP 18-3 Name: Audit Report


BR 18

QPP 18-4 Name: Approving Auditors


BR 18

WF 18-4 Name: Auditor Approval BR 18


N/A



INSTRUMENTATION & CONTROL BUSINESS OPERATION SPECIFIC


I&C US develops policies and work instruction to support the basic operations of the business, such as I&C Capital Equipment backups, HS&E concerns, etc.


N/A

19.3 APPLICABLE POLICIES


QPP 19-1 Name: Backups

Description: Assigns the Policy Owner, describes the actions necessary to backup I&C US Capital Assets and Staff Laptops

QPP 19-2 Name: Disaster Preparedness

Description: Assigns the Policy Owner, describes the Business Continuity development and planning, including Phone Trees, Disaster Recovery Plans, etc.

QPP 19-3 Name: Certification – Fire Marshals

Description: Assigns the Policy Owner, provides details to appointed Fire Marshals the duties during an emergency


N/A



DISTRIBUTION

The primary means of distribution of this document is the I&C US Intranet for internal staff purposes.

Hard copies are held by the Quality representatives and other as necessary office locations.

The document is available for external distribution as an Adobe .pdf file format. External distribution copies may be requested from the Quality Department. An Adobe .pdf copy for external company use will be posted on the company intranet.

Name Position Location

Leslie Ward I&C US QA Manager Chattanooga – I&C

Philippe Paillat I&C QA Mgr, I&C France QA

Manager

Grenoble – I&C

C. David Thompson I&C US BOM, VP Chattanooga – I&C

Instrumentation & Controls US Quality Manual · ICQ Instrumentation & Control Quality Procedure...

Documents

Transcript of Instrumentation & Controls US Quality Manual · ICQ Instrumentation & Control Quality Procedure...