ML21076A495
| ML21076A495 | |
| Person / Time | |
|---|---|
| Site: | 07000925 |
| Issue date: | 02/26/2021 |
| From: | Environmental Properties Management, Enercon Services, Burns & McDonnell Engineering Co, Veolia Nuclear Solutions Federal Services |
| To: | Office of Nuclear Material Safety and Safeguards, Cimarron Environmental Response Trust, NRC Region 4 |
| Shared Package | |
| ML21076A479 | List:
|
| References | |
| Download: ML21076A495 (51) | |
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LC Document No. QAPP-001 Rev. 4.0 Effective date:
Page i Approvals Approved by Quality Assurance Coordinator: Charles Beatty Jr.
Signature: Date:
Approved by Radiation Safety Officer: Jay Maisler, CHP Signature: Date:
Approved by Trustee Project Manager: Jeff Lux Signature: Date:
Approved by Administrator, Cimarron Environmental Response Trust: Bill Halliburton Signature: Date:
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envi ronmenta
- Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 Rev. 4.0 Effective date:
Page ii Summary of Changes Revisions to this document will be identified, and revisions or addenda will be issued as needed. The Trustee Project Manager maintains the signed original of this document; no controlled copies are issued.
The end user is responsible to verify with the Trustee Project Manager that any hard copy being referenced is the current revision. A summary description of each revision or addenda will be noted in the following table.
Revision Number Date Comments Rev.0 April 11, 2011 Original Rev. 1 February 29, 2012 Changes Assigned Leader to Activity Leader, other editorial changes Rev.2 September 19, 2013 General review of Plan incorporating editorial changes, Revised Section 2.2 and added Section 2.6.
Rev. 3 April 7, 2016 General revisions per triennial QA program review Rev 4 February 22, 2021 Revisions and reorganization throughout in anticipation of expanded project scope.
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environm*enta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management, LLC Document No. QAPP-001 Rev. 4.0 Effective date:
PaQe iii TABLE OF CONTENTS 1.0 QUALITY ASSURANCE PROGRAM ............................................................... 1-1
1.1 INTRODUCTION
.............................................................................................................. 1-1
1.2 BACKGROUND
................................................................................................................ 1-2 1.3 PURPOSE AND APPLICABILITY ................................................................................... 1-3 1.4 REGULATORY REQUIREMENTS .................................................................................. 1-4 1.5 PLAN CONTENTS .................................... ....... ................................................................. 1-4 2.0 GLOSSARY ...................................................................................................... 2-1 3.0 ORGANIZATIONAL STRUCTURE AND RESPONSIBILITIES ........................ 3-1 3.1 ORGANIZATION CHART ................................................................................................ 3-l 3.2 DUTIES AND RESPONSIBILITIES .......................................................................... ....... 3-l 3 .2.1 Trust Administrator ................................................................................................ 3-1 3.2.2 Trustee Project Manager ........................................................................................ 3-2 3 .2.3 Project Manager ..................................................................................................... 3-2 3.2.4 Radiation Safety Officer ........................................................................................ 3-2 3.2.5 Quality Assurance Coordinator .............................................................................. 3-3 3.2.6 Subject Matter Expert ............................................................................................ 3-3 3.2.7 Activity Leader ...................................................................................................... 3-3 3.2.8 Radiation Monitoring Personnel ............................................................................ 3-4 3.2.9 All Project Personnel ............................................................................................. 3-4 3.3 EXISTING ORGANIZATIONAL UNITS ......................................................................... 3-4 3.3.1 Radiation Protection ............................................................................................... 3-5 3.3.2 Safety and Health ................................................................................................... 3-5 3.3.3 Quality Assurance .................................................................................................. 3-5 3.3.4 Groundwater Remediation Design ......................................................................... 3-5 3.3.5 Groundwater Treatment Design ............................................................................. 3-5 3.3.6 Environmental Media Sampling ............................................................................ 3-6 3.4 FUTURE ORGANIZATIONAL UNITS ............................................................................ 3-6 4.0 QUALIFICATIONS AND TRAINING OF PERSONNEL .................................... 4-1 4.1 PERSONNEL TRAINING ........ ................................................................ ......................... 4-l 4.1.1 Management Personnel .................................................. ........................................ 4-1 4.1.2 Field Supervisors and Activity Leaders ................................................................. 4-1 4.1.3 Technical Personnel ........................................................................................ ....... 4-2 4.1.4 Radiation Protection Personnel .............................................................................. 4-2 Verify Current Version Prior to Use
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 Rev. 4.0 Effective date:
Page iv 4.1.5 All Site Personnel. .................................................................................................. 4-2 4.1.6 Retraining ............................................................................................................... 4-2 4.2 QUALIFICATIONS ........................................................................................................... 4-3 4.2.1 Lead Auditors and Inspectors ................................................................................. 4-3 4.2.2 Technical Personnel ............................................................................................... 4-3 4.2.3 Radiation Protection Personnel .............................................................................. 4-3 4.2.4 Personnel Performing Quality-Critical Work ....................................................... .4-4 4.3 DOCUMENTATION OF TRAINING ............................................................................... 4-4 4.4 EVALUATION OF WORK PERFORMANCE ................................................................. 4-4 5.0 OPERATING PROCEDURES AND INSTRUCTIONS ...................................... 5-1 5.1 RADIATION PROTECTION PROGRAM PROCEDURES ............................................. 5-1 5.2 SAFETY AND HEAL TH PLAN ........................................................................................ 5-1 5.3 SAMPLING AND ANALYSIS PLAN .............................................................................. 5-1 5.4 SAMPLING AND ANALYSIS PROCEDURES (SAPS) .................................................. 5-2 5.5 STANDARD OPERATING PROCEDURES (SOPS) ....... ................................................ 5-2 5.6 ACTIVITY PLANS ............................................................................................................ 5-2 5.7 QUALITY ASSURANCE IMPLEMENTING PROCEDURES (QAIPS) ......................... 5-2 5.8 CONSTRUCTION ACTIVITY PLANS ............................................................................ 5-2 5.8.1 Construction Execution Specifications .................................................................. 5-2 5.8.2 Construction Drawings .... ...................................................................................... 5-3 5.9 INDEPENDENT REVIEW ................................................................................................ 5-3 5.10 PLAN AND PROCEDURE APPROVAL. ......................................................................... 5-3 5.11 PROGRAM CHANGE ....................................................................................................... 5-4 6.0 DESIGN ............................................................................................................. 6-1 6.1 CONTRACTOR AND SUBCONTRACTOR (VENDOR) DESIGN ................................ 6-1 6.2 DESIGN INTERFACES ..................................................................................................... 6-1 6.3 DESIGN INPUTS AND OBJECTIVES ............ ................................................................. 6-2 6.4 DESIGN OUTPUTS ........................................................................................................... 6-2 6.5 DESIGN REVIEW .............................................................................................................. 6-2 6.6 DESIGN CHANGES .......................................................................................................... 6-2 7.0 PROCUREMENT AND CONTROL OF MATERIALS, EQUIPMENT, PARTS AND SERVICES .................................................................................. 7-1
- 7. 1 PROCUREMENT ............................................................................................................... 7-1 7 .1.1 Procurement of Materials, Equipment, and Parts ................................................... 7-1 7 .1.2 Procurement of Services ........................................................................................ 7-1 7.1.3 Requisition ............................................................................................................. 7-1 7.1.4 Vendor Qualifications ............................................................................................ 7-2 Verify Current Version Prior to Use
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management, LLC Document No. QAPP-001 Rev. 4.0 Effective date:
Page v 7.1.5 Periodic Vendor Assessment.. ... ............................................................................. 7-2 7.2 INSPECTION OF ITEMS .................................................................................................. 7-3 7.3 CONTROL OF MATERIALS ............................................................................................ 7-3 8.0 SAMPLING, ANALYSES, MEASUREMENTS, AND PROCESSES ................. 8-1 8.1 RADIATION PROTECTION ............................................................................................. 8-l 8.2 QUALITY CONTROL IN ENVIRONMENTAL AND EFFLUENT SAMPLING .......... 8-1 8.3 LABORATORY QUALITY CONTROL ........................................................................... 8-2 8.3.1 Verification and Validation (V &V) ....................................................................... 8-2 8.4 CONSTRUCTION QUALITY CONTROL ....................................................................... 8-2 8.4.1 Construction Submittals ......................................................................................... 8-3 8.4.2 Documentation of Construction Controls .............................................................. 8-4 8.5 PROCESS CONTROL ........................................................................................................ 8-4 8.6 DATA QUALITY CONTROL ........................................................................................... 8-5 8.6.1 On-site Data ........................................................................................................... 8-5 8.6.2 Geodetic Data ......................................................................................................... 8-6 8.6.3 Radiological Survey Data ...................................................................................... 8-6 8.6.4 Field Measurements ............................................................................................... 8-6 9.0 CONTROL OF MEASURING AND TEST EQUIPMENT ................................... 9-1 9.1 CALIBRATION .................................................................................................................. 9-l 9.2 ADJUSTMENT .................................................................................................................. 9-2 9.3 EQUIPMENT INVENTORY ............................................................................................. 9-2 9.4 OUT-OF-SERVICE EQUIPMENT ........................................................................ ............ 9-2 10.0 HANDLING, STORAGE, AND SHIPPING ...................................................... 10-1 11.0 CONTROL OF NONCONFORMING ITEMS AND EQUIPMENT .................... 11-1 12.0 DOCUMENTS AND RECORDS ...................................................................... 12-1 12.1 QUALITY ASSURANCE RECORDS ............................................................................. 12-l 12.1.1 Records of Analytical Data .................................................................................. 12-2 12.2 QUALITY ASSURANCE DOCUMENTS ...................................................................... 12-3 12.3 DOCUMENT CONTROL ................................................................................................ 12-3 12.4 DOCUMENT AND RECORD STORAGE ...................................................................... 12-4 12.4.1 Hard Copies of Controlled Documents ................................................................ 12-4 12.4.2 Electronic Copies of Controlled Documents ........................................................ 12-4 12.4.3 Trust Document Repository ............................................................................... .. 12-4 Verify Current Version Prior to Use
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management, LLC Document No. QAPP-001 Rev. 4.0 Effective date:
Paoe vi 12.4.4 Retired Documents ............................................................................................... 12-4 12.4.5 Redundant Storage ............................................................................................... 12-4 13.0 AUDITS AND ASSESSMENTS ...................................................................... 13-1 13.1 AUDITS AND SURVEILLANCES ................................................................................. 13-1 13.2 ASSESSMENTS ............................................................................................................... 13-2 13.3 AUDIT RECORDS ...................... ..................................................................... ................ 13-2 14.0 CORRECTIVE ACTIONS ................................................................................ 14-1 14.1 NOTICE OF DEFICIENCY ............................................................................................. 14-1 Verify Current Version Prior to Use
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envi ronmenta f Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 1.0 Page 1-1 1.0 QUALITY ASSURANCE PROGRAM
1.1 INTRODUCTION
As Trustee of the Cimarron Environmental Response Trust (CERT), Environmental Properties Management LLC (EPM) is committed to the decommissioning and remediation of the Cimarron site in accordance with all license and regulatory requirements. EPM requires the development and implementation of a Quality Assurance Program that provides for the assurance of the required level of quality in the planning, execution, and documentation of quality-critical work performed at the site.
This Quality Assurance Program Plan (QAPP) documents the program that will be implemented at the Cimarron site.
The QAPP provides for:
- Products and services that comply with license and regulatory requirements.
- Quality management systems and procedures that are documented, communicated, controlled, and effectively put into practice.
- Opportunities to identify and improve the organization and the quality, compliance and cost effectiveness of work performed.
- Timely evaluation of personnel resources, needs, skills and performance to stress the importance of, and identify opportunities for, continual quality improvement.
- Data quality needed to support Cimarron decommissioning goals and assure compliance with nuclear and environmental compliance requirements.
- Documented management reviews indicating concurrence with quality-affecting procedures.
- Triennial management reviews of the effectiveness of the quality assurance program.
- Management of changes to the quality assurance program in accordance with License Condition 2 7( e ).
EPM retains contractors to perform work at the site. This QAPP establishes a program requiring that quality be incorporated in the planning, performance, and documentation of work. For contractors performing quality-critical work, EPM management will review quality assurance and quality control Verify Current Version Prior to Use
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 1.0 Page 1-2 programs to assure that controls meet the requirements of the Cimarron program. This QAPP also establishes a program for the evaluation and qualification of contractors and subcontractors, communication of quality requirements to contractors and subcontractors, and the monitoring of contractor and subcontractor performance and product quality. Acceptance of contractors' qualifications to perform quality-critical work must be documented before the work begins.
1.2 BACKGROUND
The Cimarron facility operated as a nuclear fuel production facility under Licenses SNM-928 (for uranium processing) and SNM-1174 (for mixed oxides processing) until the facility was closed in 1975. Decommissioning began in 1976. License SNM-1174 was terminated in 1993; decommissioning in accordance with the requirements ofNRC License SNM-928 is ongoing. The decommissioning of equipment, structures, and soil is complete.
The current mission at the Cimarron Site (Site) is the remediation of groundwater to criteria established by the US Nuclear Regulatory Commission (NRC) and the Oklahoma Department of Environmental Quality (DEQ). Groundwater remediation requires planning, data collection and management, and decision-making; all of which are subject to NRC- and DEQ- established quality requirements. Quality requirements are met through implementation of the Site Quality Assurance Program (inclusive of the QAPP, implementing procedures, and supporting documents). This quality program is periodically revised to reflect changes associated with ongoing decommissioning activities.
The Cimarron Environmental Response Trust (Trust) was established in accordance with the January 26, 2011 Consent Decree and Environmental Settlement Agreement executed by the former licensee, the Department of Justice (DOJ), the Nuclear Regulatory Commission (NRC) and the State of Oklahoma (among others). The NRC license was transferred to the CERT, which owns the Cimarron Site and manages the accounts that provide the funding for the remediation of the Site.
Environmental Properties Management LLC (EPM) is the Trustee for the CERT; because the CERT has no employees, the Trustee functions as the licensee.
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environmentai Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 1.0 Page 1-3 1.3 PURPOSE AND APPLICABILITY The Quality Assurance Program ensures that technical and quality assurance procedures required to implement the QA program are consistent with regulatory, licensing, and QA program requirements and are properly documented and controlled.
The Cimarron Quality Assurance (QA) program shall be documented by written policies and procedures. Sufficient records of conduct and performance are required to demonstrate program adherence. Contractors or subcontractors performing support activities (e.g., sampling, analysis, data evaluation, design, and record generation) shall retain records sufficient for the licensee to review to demonstrate compliance with applicable program elements.
The purpose of this QAPP is to document QA Program requirements for the Cimarron Decommissioning Project. Implementation of this QAPP is through written procedures and instructions as described in Section 5.0.
Activities affecting the quality of site decommissioning will be subject to the applicable controls of the QA program.
As the document defining the quality assurance program implemented at the Cimarron Site, the QAPP describes what will be done to provide for acceptable quality. Quality Assurance procedures implement the program; they describe how quality objectives will be identified and quality documented in the performance of quality-critical work.
The Quality Assurance Program applies to all quality-critical work performed at the Site, which is work intended to satisfy regulatory and/or license requirements, including, but not limited to:
- Groundwater monitoring well drilling, installation, and development
- Sampling and analysis of environmental media
- Design and evaluation of groundwater characterization and remediation plans
- Design of groundwater treatment processes
- Groundwater remediation activities Verify Current Version Prior to Use
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 1.0 Page 1-4
- Packaging and transportation of waste
- Other activities directly affecting license termination and site closure decision-making, if so designated by the Trustee PM or QAC The Quality Assurance Program does not apply to activities such as mowing, fence repair, building maintenance, or other activities not related to regulatory requirements.
1.4 REGULATORY REQUIREMENTS This QAPP establishes a quality assurance program meeting the applicable requirements of the following:
- NRC Regulatory Guide 1757, Consolidated Decommissioning Guidance, Decommissioning Process for Material Licenses
- NRC Regulatory Guide 4.15 (NUREG 4.15), Quality Assurance for Radiological Monitoring Programs (Inception Through Normal Operations to License Termination) - Effluent Streams and the Environment
- NRC License SNM-928 In addition, quality requirements not required by NUREG 4.15 or NUREG 1757 were included in this QA program; these were obtained from various sources including NQA-1, Quality Assurance Requirements for Nuclear Facility Applications.
1.5 PLAN CONTENTS This QAPP includes the following sections:
1.0 Quality Assurance Program 2.0 Glossary 3.0 Organizational Structure and Responsibilities 4.0 Qualifications and Training of Personnel 5.0 Operating Procedures and Instructions 6.0 Design Verify Current Version Prior to Use
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties. management. LL.C Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 1.0 Page 1-5 7 .0 Procurement and Control of Materials, Equipment, Parts, and Services 8.0 Sampling, Analyses, Measurements, and Processes 9.0 Control of Measuring and Test Equipment 10.0 Handling, Storage, and Shipping 11.0 Control ofNonconforming Items and Equipment 12.0 Documents and Records 13.0 Audits and Assessments 14.0 Corrective Actions Verify Current Version Prior to Use
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environmental Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 2.0 Page 2-1 2.0 GLOSSARY Activity Plan: A document that describes the objectives of, the requirements for, and the process of implementing and documenting a non-routine quality-critical activity.
Cimarron Environmental Response Trust (CERT): The CERT is the NRC licensee, owns the Cimarron Site, and provides the funding for the remediation of the Site.
Cimarron Site (Site): The property owned by the CERT.
Contractor: Any organization or individual contracted directly to the Trustee.
Controlled Document: Any document the Trustee Project Manager or Quality Assurance Coordinator determines should be controlled so that the user possesses the most current revision of the document.
This includes the QAPP and all implementing procedures.
Decisions Affecting License Termination or Site Closure: Decisions that support the achievement of the objectives of the Trust as defined in the Trust Agreement for the Cimarron. The primary objectives are to decommission the site to achieve termination of the NRC license and to remediate groundwater to obtain a Notice of No Further Remediation from the State of Oklahoma.
Hold Point: A stopping point in a procedure or workplan requiring a signature or initials to verify that data has been recorded or that required actions are complete before proceeding. Hold Points are used as quality control measures in Activity Plans.
Quality-Critical Activity: Any activity that impacts the achievement of Trust objectives (see above) or compliance with applicable regulatory requirements.
Quality Data: Data that directly or indirectly support decisions affecting license termination or site closure. The collection, management, and evaluation of quality data are subject to the requirements of the QAPP.
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LlC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 2.0 Page 2-2 Quality Assurance (QA): Quality Assurance is the programmatic implementation of planned and systematic evaluations which provide confidence that the performance of quality-critical activities complies with all defined requirements.
Quality Assurance Program Plan (QAPP): The document which describes and governs the Quality Assurance Program.
Quality Assurance Program (QAP): The licensee's program for quality assurance, as described in the Quality Assurance Program Plan (QAPP).
Quality Assurance Records: Records that document that quality-critical work complied with the requirements specified in plans, procedures, drawings, or specifications.
Quality Control (QC): Quality Control (QC) consists of actions that measure and control the characteristics of equipment, processes, deliverables, and materials to meet established standards.
Subcontractor: Any organization or individual retained by a contractor.
Trustee: Environmental Properties Management (EPM), the Trustee identified in the January 26, 2011 Consent Decree and Environmental Settlement Agreement. The Trustee functions as the licensee on behalf of the Trust.
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 3.0 Page 3-1 3.0 ORGANIZATIONAL STRUCTURE AND RESPONSIBILITIES This section provides the structure of the organization as it relates to the Quality Assurance Program. The authorities, duties, and responsibilities of the positions within this organization, down to the first-line supervisory level, are described. These include (where applicable) responsibilities for review and approval of written procedures and the preparation, review, and evaluation of monitoring data and reports.
3.1 ORGANIZATION CHART The Organization Chart for the CERT is presented below:
Figure 3-1 The Cimarron Environmental Response Trust Organization Trust Administrator r-------------- --------------,
1 I I I I
I I I I
Trustee Project I Manager I I I I I I I I I I I I I I Radiation Safety Subject Matter Activity Leaders Project Managers Quality Assurance I Officer (RSO) Experts Coordinator (QAC)
I Radiation Safety Personnel Direct Report Accountability - - - -
3.2 DUTIES AND RESPONSIBILITIES 3.2.1 Trust Administrator The CERT Trust Administrator has overall responsibility for the administration of the Trust. This includes providing support for quality assurance and radiation safety functions at the Site. The Verify Current Version Prior to Use
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 3.0 Page 3-2 Trust Administrator is also responsible for the review and approval of the QAPP and the Radiation Protection Plan (RPP).
3.2.2 Trustee Project Manager The Trustee PM is responsible for overseeing the construction and operation of decommissioning systems, the implementation of radiation safety, industrial safety and health, quality assurance, and environmental compliance programs. The Trustee PM is responsible for ensuring that all personnel performing decommissioning activities, or working in radiation protection, safety and health, quality assurance, or environmental compliance functions receive training and have the skills and experience require to perform those functions.
The Trustee PM shall ensure that activities affecting quality are (a) prescribed by documented instructions, procedures, and drawings; and (b) accomplished through implementation of these documents. The Trustee Project Manager is also responsible for review and approval of quality-critical plans.
3.2.3 Project Manager Project Managers (PMs) are responsible for the preparation of plans, procurement of services and materials, and the execution of decommissioning projects. PMs ensure that all personnel working on projects have received all the training needed and are qualified to perform the tasks for which they are responsible to perform. PMs are responsible for monitoring the schedule, cost, and quality of the project work.
3.2.4 Radiation Safety Officer The Radiation Safety Officer (RSO) is responsible for maintenance and implementation of the radiation protection program. A list of the Radiation Protection responsibilities of the RSO is provided in the RPP.
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envi ronmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 3.0 Page 3-3 3.2.5 Quality Assurance Coordinator The Quality Assurance Coordinator (QAC) is responsible for the maintenance and implementation of the quality assurance program and has authority to go directly to the Trustee PM or the Trust Administrator to resolve quality issues if needed.
The QAC performs or schedules periodic and/or ad hoc audits and observations of all decommissioning and program management functions. The QAC is also responsible to perform periodic evaluations of the effectiveness of the quality assurance program and to ensure that all personnel performing quality-critical tasks have received the appropriate level of training on the Site-specific quality assurance program. The QAC attends the Site ALARA Committee.
3.2.6 Subject Matter Expert A subject matter expert (SME) is a knowledgeable and experienced individual who uses his or her expertise in a specific discipline to review and approve plans for quality-critical work from a technical perspective and to determine the qualification of personnel to perform quality-critical work. The SME assists in identifying and applying critical knowledge relevant to the project and works to ensure that project objectives are relevant and valid.
3.2.7 Activity Leader The Activity Leader is the person the Trustee Project Manager assigns to supervise work described in an Activity Plan. Activity Leader has the following responsibilities:
- Reviews and approves Activity Plans (and generates the plan if assigned).
- Performs pre-job briefs and post-job debriefs as necessary for purposes of incorporating worker suggestions and lessons learned.
- Trains personnel on the Activity Plan and compliance with Activity Plan requirements.
- Trains personnel under their direction on the radiological, environmental, and safety and health hazards associated with the activity and measures that will be implemented to mitigate those hazards.
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environmenta ,
Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 3.0 Page 3-4
- Ensures that all required documentation listed in the Activity Plan is compiled in the site paper files and electronic copies are provided to the Trustee PM.
3.2.8 Radiation Monitoring Personnel The qualifications of personnel needed to perform radiation monitoring functions are defined and documented in the Cimarron Radiation Protection Plan.
3.2.9 All Project Personnel All personnel are encouraged to be diligent in the performance of their work to maintain the level of quality required by plans, procedures, and instructions. In addition, personnel are encouraged to be attentive to any quality issues that may appear in the work of their peers, suppliers, contractors, and subcontractors. A consistent and exemplary level of quality can only be obtained through vigilant attention to the whole of the work, not just the pieces for which an individual is immediately responsible.
All personnel are responsible to:
- Maintain familiarity with the applicable requirements of the QA Program, and maintaining a personal commitment to implementing the QA Program requirements in their everyday work.
- Identify opportunities for quality improvement.
- Conscientiously use stop work authority as needed to mitigate risks to safety, security, or quality.
3.3 EXISTING ORGANIZATIONAL UNITS As Trust Administrator, EPM delegates and manages work responsibility for the Cimarron project through contractors and subcontractors. Contractors and subcontractors who perform specific aspects of quality-critical work are considered "Organizational Units" per NUREG-1757. This section describes the unit-specific responsibilities and management structures that currently exist at the site.
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 3.0 Page 3-5 3.3.1 Radiation Protection The Radiation Protection unit is responsible for the implementation of the radiation protection program as defined in the Radiation Protection Plan and associated procedures and desk instructions. The Radiation Protection Unit reports to the RSO, who reports directly to the Trustee PM, with an indirect reporting responsibility to the Trust Administrator.
3.3.2 Safety and Health The Safety and Health unit is responsible for the implementation of the site-specific safety and health program as defined in the Safety & Health Plan. The Safety and Health unit reports directly to the Contractor's Director, with an indirect reporting responsibility to the Trustee PM.
3.3.3 Quality Assurance The Quality Assurance unit is responsible for the implementation of this Quality Assurance Program. The Quality Assurance unit reports to the QAC, who reports directly to the Trustee PM, with an indirect reporting responsibility to the Trust Administrator.
3.3.4 Groundwater Remediation Design The Groundwater Remediation Design unit is responsible for the design of groundwater extraction and delivery systems, treated water injection systems, in-process groundwater monitoring, and discharge monitoring. The Groundwater Remediation Design unit is also responsible for applying for and establishing procedures for operation of extraction and injection systems and for complying with all required environmental permits. The Groundwater Remediation Design unit reports to a Contractor Project Manager, who reports directly to the Trustee PM.
3.3.5 Groundwater Treatment Design The Groundwater Treatment Design unit is responsible for the design of facilities for groundwater treatment, water treatment systems that remove uranium from groundwater by ion exchange and nitrate by biodenitrification, systems for processing and packaging wastes produced by water treatment, and waste storage facilities. The Groundwater Treatment Design unit is also Verify Current Version Prior to Use
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~ Cimarron Environmental Response Trust environmenta Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 3.0 Page 3-6 responsible for establishing procedures for in-process treatment system operation and monitoring and waste processing and packaging. The Groundwater Treatment Design unit reports to a Contractor Project Manager, who reports directly to the Trustee PM.
3.3.6 Environmental Media Sampling The Environmental Media Sampling unit is responsible for the collection, packaging, and shipping of samples of environmental media for laboratory analysis. The Environmental Media Sampling unit also assists the Trustee PM in overseeing site maintenance performed by contractors and/or subcontractors, much of which may not be quality-critical work. The Environmental Media Sampling unit reports to the Trustee PM.
3.4 FUTURE ORGANIZATIONAL UNITS Before fabrication of water treatment systems and installation of groundwater remediation infrastructure begins, the roles and management structures of other organizational units will be defined. Examples of anticipated organizational units include, but are not limited to :
- Groundwater Extraction and Injection System Construction
- Groundwater Treatment System Construction
- Groundwater Extraction and Injection Operation and Monitoring
- Groundwater Treatment Operation and Monitoring
- Waste Management Verify Current Version Prior to Use
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties managemen . LL~
Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 4.0 Page 4-1 4.0 QUALIFICATIONS AND TRAINING OF PERSONNEL Personnel responsible for performing activities affecting quality shall be provided training and instruction as described in this section. Personnel will maintain proficiency by retraining, reexamining, and recertifying, or by periodic performance reviews, as appropriate. Continual training will be conducted as needed to ensure that personnel maintain awareness of events and issues that could affect quality.
Certain training will also be provided to site personnel who perform non-quality-critical work at the site (e.g. site maintenance).
Training and qualification records will be maintained by the QAC.
4.1 PERSONNEL TRAINING All training will be documented. Guidance for the content and frequency of QAPP training is provided in Quality Assurance Implementing Procedure QAIP 4.3. Instructions for documentation of training and task qualification is provided in QAIP 4.4.
4.1.1 Management Personnel Management Personnel will receive, at a minimum, training on the QAPP.
4.1.2 Field Supervisors and Activity Leaders Field Supervisors and Activity Leaders will be required to have the following training:
- QAPP
- Quality Assurance Implementing Procedures (QAIPs) (as applicable)
- Radiation Safety as required by the Radiation Safety Program
- Safety and Health Program as required by the Safety & Health Plan
- Sampling and Analysis Plan and Procedures (as applicable)
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Section 4.0 Page 4-2 4.1.3 Technical Personnel Persons performing technical work on quality-critical activities (e.g. sampling, data analysis, design) are consider Technical Personnel. Technical Personnel will receive training on the QAPP as well as any other specific training determined by the Trustee PM, RSO, or QAC.
4.1.4 Radiation Protection Personnel Training for individuals needed to carry out assigned radiological monitoring functions will be defined and documented in the RPP. Radiation protection personnel will also receive training on the QAPP as well as any other specific training required by the Trustee PM, RSO, or QAC.
4.1.5 All Site Personnel All personnel who perform quality-critical work on the Cimarron Site will receive safety and health training and QAPP training, and will provide documentation of HAZWOPER and OSHA Construction safety training required by the Trustee PM.
4.1.6 Retraining Retraining will be required as follows:
- Radiation Safety Training (all levels) - minimum annually; when plan is revised; or more frequent as determined by the RSO.
- Quality Assurance Program Plan - minimum annually; when plan is revised; or more frequent as determined by the Trustee PM or QAC.
- Safety and Health Program - minimum annually; when plan is revised; or more frequent as determined by the Trustee PM or QAC.
- Retraining requirements for procedures and desk instructions will be determined by the Trustee PM, QAC, RSO, or SME.
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Section 4.0 Page 4-3 4.2 QUALi FiCA TIONS The following sections define personnel qualification requirements. Section 7.1.1 of this QAPP establishes a program for the evaluation and qualifications of contractors and subcontractors (i.e.
Vendor Qualifications).
4.2.1 Lead Auditors and Inspectors Auditors for internal audits and assessments, as well as for external audits of laboratories and other service providers whose work is critical to quality, must be approved by the QAC or designee. The Trustee PM may designate personnel for these functions with a written justification of their qualifications for an audit or assessment.
Personnel performing inspections and/or observations need not be approved Auditors, and may be qualified based on their skills, experience, or task specific training, as approved by the QAC and/or the Trustee PM.
4.2.2 Technical Personnel Qualification requirements for Technical Personnel who work on quality activities may be determined by:
- Trustee Project Manager
- Quality Assurance Coordinator
- Subject Matter Expert 4.2.3 Radiation Protection Personnel The qualifications for radiation protection personnel will be defined and documented in accordance with the RPP.
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Section 4.0 Page 4-4 4.2.4 Personnel Performing Quality-Critical Work Qualification requirements for personnel working on the Cimarron Project will be verified by their supervisors. Other personnel qualification requirements may be provided in procurement documents (Section 7 .0).
4.3 DOCUMENTATION OF TRAINING Documentation of all formal training and job qualification programs shall include attendees, date of attendance, and the objectives and content of the program. Documentation of training to implement plans and procedures, as well as task qualification, must be documented and include the revision of the plan or procedure which the individual is qualified to perform.
4.4 EVALUATION OF WORK PERFORMANCE The Trustee PM will be responsible for evaluation of work performance through inspections or assessments. Inspections may include the review of records that demonstrate that items received, or work performed complied with requirements. Assessments may consist of observations of work performed to determine compliance with requirements. The Trustee may delegate inspections or assessments to Subject Matter Experts, as appropriate. Work performance evaluation will include consideration of the following:
- Safety performance
- Quality of work
- Maintenance of personnel qualifications
- Ability to meet deadlines
- Audits Verify Current Version Prior to Use
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Section 5.0 Page 5-1 5.0 OPERATING PROCEDURES AND INSTRUCTIONS Requirements for the performance of routine activities are provided in written operating procedures and instructions. The Trustee PM is responsible to determine when activities require specific procedures or other documentation to control the activity and maintain quality.
Where applicable, all instructions, procedures, and drawings shall include quantitative acceptance criteria (such as those pertaining to dimensions, tolerances, and operating limits) and qualitative acceptance criteria (such as workmanship samples) for determining that important activities have been satisfactorily performed.
Monitoring for compliance with quality-critical documents may be conducted at any time by the QAC ( or designee).
5.1 RADIATION PROTECTION PROGRAM PROCEDURES Radiation protection procedures have been developed to provide consistent, effective performance of radiation protection activities. Desk Instructions provide guidance on radiation protection program implementation or to clarify program implementation expectations from the RSO.
5.2 SAFETY AND HEALTH PLAN The Safety and Health Plan (S&H Plan) describes the safety and health requirements for personnel who perform work on the Cimarron Site.
5.3 SAMPLING AND ANALYSIS PLAN The Sampling and Analysis Plan (SAP) specifies sample collection requirements for environmental media and includes sampling requirements for quality assurance quality control (QA/QC) programs.
It also specifies sampling equipment decontamination, documentation, sample preparation and shipment, and laboratory analytical methods. Finally, it specifies requirements for groundwater monitoring well installation and abandonment.
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 5.0 Page 5-2 5.4 SAMPLING AND ANALYSIS PROCEDURES (SAPS)
Quality requirements for repetitive routine sampling and analysis activities will be provided in Sampling and Analysis Procedures. This will include a procedure for discharge sampling.
5.5 STANDARD OPERATING PROCEDURES (SOPS)
Where practicable, Standard Operating Procedures will provide quality and other requirements for routine activities such as sampling and analysis and system operation.
5.6 ACTIVITY PLANS Quality requirements for non-routine activities not subject to specific contracts with contractors or subcontractors will be defined in Activity Plans. Activity Plans include:
- A unique identifier (name) of the activity.
- The objective of the activity.
- Radiological, environmental, and safety & health hazards associated with the work, and actions to mitigate those hazards.
- Step-by-step work instructions.
- Documentation required to demonstrate successful completion of the activity and compliance with quality requirements, and the distribution/destination of those documents.
5.7 QUALITY ASSURANCE IMPLEMENTING PROCEDURES (QAIPS)
Quality Assurance Implementing Procedures (QAIPs) provide instructions that tell personnel how to implement the Quality Assurance Program. A list of QAIPs is maintained by the QAC.
5.8 CONSTRUCTION ACTIVITY PLANS 5.8.1 Construction Execution Specifications Quality requirements (including quality control requirements) for contracted work, such as construction, will be provided in standard format such as MasterFormat or referenced to industry-Verify Current Version Prior to Use
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Section 5.0 Page 5-3 specific Standard Specifications. These requirements will be identified by the Contractor's Subject Matter Expert or Project Manager and communicated through Activity Plans or other written instructions.
5.8.2 Construction Drawings Quality requirements (including quality control) may be included on Construction Drawings.
These requirements will be identified by the Contractor's Subject Matter Expert or Project Manager and communicated through Activity Plans or other written instructions.
5.9 INDEPENDENT REVIEW All plans, procedures, instructions, specifications, and drawings must show evidence of independent review and approval. These documents must also bear a unique identifying number, date, and revision number.
Drawings must also identify the name of the preparer as well as the name of the independent reviewer and the date of the independent review.
5.10 PLAN AND PROCEDURE APPROVAL The following table provides the requirements for approval of plans and procedures:
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environmental Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management, LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 5.0 PaQe 5-4 Table 5-5 Plan and Procedure Approval Responsibility Safety & Subject Activity Document Trustee Trustee RSO QAC Health Matter Leader Description Administrator PM Manager Expert(s)
Radiation Protection X X X X Plan Radiation Protection X Procedure Radiation Protection X
Desk Instruction S&H Plan X X X X QAPP X X X X Standard Operating X As Applicable X X Procedure Sampling and X
Analysis Procedure Activity X X As Applicable X As Applicable Plan QAIP X As Applicable X As Applicable 5.11 PROGRAM CHANGE Editorial changes or personnel reassignments of a nonsubstantive nature do not require NRC notification. Where applicable, revisions to the QAPP will be evaluated and/or approved in accordance with License Condition 27(e).
Condition 27(e) ofNRC License SNM-928 provides flexibility for the licensee to make changes to the NRC-approved Decommissioning Plan (DP) and the Radiation Protection Plan (RPP), provided certain constraints are met. A Quality Procedure entitled "Program Change Evaluation Process",
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Section 5.0 Page 5-5 provides the process for the review and implementation of such changes to ensure that the license condition requirements have been met.
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LL Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 6.0 Page 6-1 6.0 DESIGN For the Cimarron Quality Assurance Program, design is defined as the process of planning and designing quality-critical systems, structures, components, or processes. Design examples include:
- Provisions for radiation protection control and measurement of water treatment and waste packaging operations.
- Facilities and processes for sampling and analytical requirements.
- Review of data for design purposes.
- Design of groundwater remediation system installation and operation for collection, transport, and injection of groundwater.
- Fabrication, and installation of groundwater treatment systems and operations.
The purpose of this section is to provide the quality requirements for controlling design work.
Designs must address applicable regulatory requirements and both qualitative and quantitative design requirements by establishing design standards in specifications, drawings, procedures, and/or instructions.
Deviation from such standards shall be reviewed and approved by qualified individuals, and approval of deviations shall be documented.
6.1 CONTRACTOR AND SUBCONTRACTOR (VENDOR) DESIGN EPM uses contractors and subcontractors to perform most design activities. These vendors must be approved in accordance with Section 7.0 of this QAPP. The quality assurance program of the individual vendor may be reviewed and approved by the Trust. The vendor's compliance with its quality assurance program will then constitute compliance with this quality assurance program.
6.2 DESIGN INTERFACES The Trustee PM will provide a vehicle for the identification and control of design interfaces and for coordination among participating design teams.
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Section 6.0 Page 6-2 6.3 DESIGN INPUTS AND OBJECTIVES The first step in design control is the identification of quality-critical objectives and design inputs (i.e., those inputs which must be known to develop a design that achieves the desired outcome). The identification of objectives and design inputs are captured in a Basis of Design generated by the contractor or subcontractor preparing the design.
The Trustee PM will provide for the review of the Basis of Design against the requirements of SNM-928, commitments to the NRC and ODEQ, and other applicable requirements and regulations.
6.4 DESIGN OUTPUTS Design outputs may consist of any combination of written plans or instructions, permits or permit applications, illustrations (e.g., figures), design drawings (including notes), and specifications.
6.5 DESIGN REVIEW All designs shall be are subjected to a documented independent review. This review will verify or check the adequacy of the design using alternate or simplified calculation methods, or by performance of a suitable testing program.
The verifying or checking process shall be performed by individuals or groups other than those who generated the original design, but who may be from the same organization. Design documents must be signed by both the preparer and the reviewer.
The Trustee PM (or a designated SME) must approve all designs.
6.6 DESIGN CHANGES Design changes, including field changes, shall be subject to the same requirements for review and approval as those applied to the original.
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties managemen . LL Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 7.0 Page 7-1 7.0 PROCUREMENT AND CONTROL OF MATERIALS, EQUIPMENT, PARTS AND SERVICES 7.1 PROCUREMENT 7 .1.1 Procurement of Materials, Equipment, and Parts Procurement of quality-related materials, equipment, and parts (a.k.a. items) from approved vendors requires inclusion of applicable quality requirements in procurement documents. These include the technical, quality, regulatory, and administrative requirements applicable to the items.
Acceptance requirements for inspection, or for test records that verify that an item is acceptable, must be clearly stated in procurement documents.
7.1.2 Procurement of Services Procurement of quality-critical contractors such as laboratory or engineering design may include adoption of the contractor's quality assurance program.
7.1.3 Requisition Material potentially affecting quality must not be requisitioned until it is determined that the supplier can ensure an appropriate level of quality. The requisitioner may require evidence of the supplier's quality assurance program, third party audits, assessments, or certifications of the supplier's capabilities. When this evidence is required, it will be reviewed by the QAC or designee. Satisfactory review of the supplier's documentation (and a physical audit of the supplier's facilities, if appropriate) will be documented and records will be maintained in the trust document repository (reference Section 12.0 of this QAPP).
If an item is an "off the shelf' item of commercial grade, but has performance characteristics deemed important to quality, those characteristics must be specifically listed on the requisition.
The requisitioner will also note on the requisition whether receipt inspection or testing is required prior to acceptance of the item (inspection should be required at a minimum to verify that quality requirements established by the purchase requisition have been met). Cut sheets or specifications Verify Current Version Prior to Use
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Section 7.0 Page 7-2 used to select the item, and any specifications or instructions delivered with the item(s), should become part of the procurement file and distributed to the end user as necessary.
7.1.4 Vendor Qualifications Vendors are qualified on an as-needed basis when products or services are required to complete quality-critical work. Qualification may be based on the vendor's submitted statement of qualifications, third party audits, referrals, professional certifications or licensure, or by the review of other information deemed relevant to establish the vendor's qualifications to perform a required scope of work. This may include contract-related requirements (e.g. required minimum insurance or EMR rating).
Records of vendor qualification are maintained by the QAC. Vendor qualification records are retained in the Trust document repository.
A Trustee representative may access vendor facilities to perform assessments and inspections.
Specific procurement requirements established by the requisitioner may also require the vendor to submit documentation and records that demonstrate the acceptability of the service or equipment provided.
7.1.5 Periodic Vendor Assessment Each approved vendor's performance is assessed periodically to maintain the vendor's qualification status. Documented vendor reviews are valid for up to three years.
Assessments of the vendors may include reviewing assessment reports conducted by regulatory agencies or other customers. Internally, the assessment may be based on vendor performance, or by physical audit or receipt of a vendor performance questionnaire. Approved vendors may also be re-evaluated when:
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Section 7.0 Page 7-3
- A vendor's performance is considered unacceptable by the Trustee PM or QAC.
- At the discretion of the Trustee PM or QAC, based on a trend of non-conformances, prolonged periods of inactivity, or significant and documented problems with other clients or regulators.
- At the discretion of the Trustee PM or QAC, vendors whose performance is unacceptable may be disqualified or maintained on hold pending successful implementation of corrective action.
7.2 INSPECTION OF ITEMS The level of inspection required for an item is specified in procurement documents or an Activity Plan. The QAPP does not establish specific inspection or assessment requirements or frequencies, but all items are subject to inspection or assessment by the Trustee PM or QAC (or personnel designated by either individual).
A vendor may provide required documentation, or independent inspections may be performed, to verify conformance with procurement requirements. When inspection evaluates conformance of an item to specified requirements, the inspection must be documented. Inspection records contain at a minimum the item inspected, date of inspection, inspector, type of observation, results, and either acceptability or, if not acceptable, a description of the nonconformance.
7.3 CONTROL OF MATERIALS Control of quality-critical materials is required. Examples of these materials include resin and chemicals used in the remediation process, partially processed and processed waste, and contaminated equipment.
Where possible, quality-critical materials must be properly labeled and easily identifiable. The status of such materials must be designated. For instance, spent resin must be identified as such and must be segregated from unused resin to prevent its misuse. Drums of dewatered biomass that has not yet been blended with absorbent must be identified as such so it is not stored for shipment prior to blending.
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Section 7.0 Page 7-4 Additionally, all materials should be stored properly in designated locations appropriate for that material. Storage areas should be clearly demarcated and labeled to prevent inadvertent misplacement and/or misuse of quality-critical materials.
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Section 8.0 Page 8-1 8.0 SAMPLING, ANALYSES, MEASUREMENTS, AND PROCESSES 8.1 RADIATION PROTECTION Radiation control requirements are addressed in the Radiation Protection Program.
8.2 QUALITY CONTROL IN ENVIRONMENTAL AND EFFLUENT SAMPLING Quality requirements for sampling of environmental media (e.g., solids, liquids, or gases) will vary based on the purpose for conducting the sampling. Quality requirements will be established during design or activity planning. Methods for determining and demonstrating compliance with quality requirements will be addressed in any combination of:
- Design documents
- The Sampling and Analysis Plan and associated procedures
- Activity Plans Quality requirements for sampling effluent (e.g., discharged or injected treated water) will be established during design. Methods for determining and demonstrating compliance with quality requirements will be addressed in the Sampling and Analysis Plan and associated procedures.
Quality control procedures for both environmental and effluent sampling systems shall address the following, as applicable:
- The frequency of duplicates and replicates.
- Chain of custody procedures.
- Calibration of instruments and equipment.
- Measurement and documentation of field parameters as applicable.
- Collection efficiencies based on the physical configuration of the sampling point (sample port, well, etc.) and the type of collector.
- Volumes of containers, preservation, and holding times.
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Section 8.0 Page 8-2 8.3 LABORATORY QUALITY CONTROL Analytical laboratories used by the Trustee will be subject to vendor qualification requirements provided in Section 7.0 of the QAPP.
Analytical laboratory qualifications will include the following:
- Quality Assurance Program approved by the QAC
- Accreditation by the Oklahoma Department of Environmental Quality (if applicable)
- Certification by National Environmental Laboratory Accreditation Program (NELAP) ( or equivalent)
Vendor qualifications for other laboratories, such as instrument calibration or dosimetry, will be determined by the RSO.
8.3.1 Verification and Validation (V&V)
The V& V of certain aspects and support activities related to radiological or environmental measurements monitoring are essential to the QA program.
- V &V requirements for standard analytical methods will be included in the contracted analytical laboratory's Quality Assurance Program.
- Additional data quality review will be performed by an independent party in accordance with established data quality assessment procedures.
- Requirements for verification of on-site measurements (e.g. field parameters) will be determined by the SME, Trustee PM and/or QAC.
8.4 CONSTRUCTION QUALITY CONTROL Construction quality will be controlled using the three-phase quality system described below. The purpose of the three-phase system is to require the contractor to plan and schedule quality-critical work to ensure that he is prepared to start each subsequent task.
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Section 8.0 Page 8-3 8.4.1 Construction Submittals Submittals are required by the contractor to regulate the timely flow of materials to be incorporated into construction work. They are necessary to demonstrate that the proposed materials, etc., comply with the drawings and specifications. All required submittals must be submitted by the contractor in time to allow for the review, approval, procurement, delivery, and performance of the preparatory phase of the Three Phases of Control for an item before it is needed for construction.
First Phase - Pre-Construction Meeting The Pre-Construction Meeting will be performed prior to any construction work, as determined by the Trustee PM or the QAC. The following topics will be reviewed:
- Contract plans and specifications.
- Status of submittal approvals.
- Physical examination of materials.
- Status of preliminary work.
- Procedure/plan for accomplishing work.
- Safety hazard assessment.
- Radiation protection assessment.
- Testing - number of tests; when; where; and nature of recording.
- Identify individuals with QA/QC responsibility.
Second Phase - Initial Inspection The Initial Inspection will be conducted at the beginning of any phase of construction work and will include the following:
- Check preliminary work (e.g. from previous phase) - verify full compliance.
- Establish level of workmanship.
- Resolve all differences.
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Section 8.0 Page 8-4
- Check safety compliance.
- Check radiation protection compliance.
Third Phase - Follow-up Inspections Follow-up inspections will be performed daily to ensure that controls continue to provide work which conforms to the drawings and specifications.
8.4.2 Documentation of Construction Controls All construction quality control activities will be documented as follows:
- Submittals will be classified as: Approved; Approved, Except as Noted; or Disapproved;
- Pre-Construction Meetings will be documented with an agenda and meeting minutes.
- Initial Inspections will be documented on the Daily Construction Quality Control Form.
- Follow-up inspections will be documented on the Daily Construction Quality Control Form.
8.5 PROCESS CONTROL The Cimarron remediation system - consisting of groundwater extraction, treatment, and injection systems - will be equipped with a fully-integrated control system providing continuous automated operation under normal conditions. The control system will provide the permissives, trips, and interlocks, along with appropriate redundancies, necessary for safe and reliable operation. Programmable logic controllers (PLCs) will process inputs associated with process instrumentation, equipment status signals, operator commands, and other data sources. The PLCs will also execute automated and manual process commands using analog control loops and binary control functions, in accordance with the control logic established by PLC software programming. Critical interlocks and other functions will be executed via hardwired connection and/or failsafe hardware configurations. A single PLC located in the Western Area Treatment Facility (WATF) control room will serve as the Balance of Plant (BOP) controller, with other PLCs located on self-contained equipment skids serving as distributed process controllers. These PLCs will be subordinate to the BOP controller but will be capable of safely operating their respective processes Verify Current Version Prior to Use
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Section 8.0 Page 8-5 independently. A PLC located in the Western Area (WA) well field will serve as remote terminal unit, routing data and control commands to and from select groundwater extraction wells and the BOP controller. The PLCs will also execute alarm functions and collect data for logging purposes. All operational data will be transmitted back to the BOP controller for logging via a central database consisting of a server equipped with a historian software package.
The control system will include human-machine interfaces (HMis) in the WATF control room and select equipment skid locations to facilitate operator command execution and display the status of process control operators and alarms. The HMis will also display key operational data. The central (BOP) HMI will provide a geospatial display of well field operational information for both the WA and Burial Area #1 (BAI) systems. The BOP HMI will consist of a computer workstation with panel monitors while the remote HMis will consist of touchscreen thin clients. The control system will include remote telemetry providing alarm notification (via text message) and acknowledgement capability (via web-based interface). The web-based interface will also provide remote monitoring, control, and data download capabilities. Local and remote access to the control system will be managed via password-protected permissions established for various personnel roles and access levels.
8.6 DATA QUALITY CONTROL Data quality control typically applies to off-site testing of samples, material, etc. However, data quality control may also apply to the on-site generation of data, or installation of equipment. Control of tests will be included in Sampling and Analysis Procedures and Activity Plans, or other quality control documents.
Requirements for off-site laboratories are discussed in Section 8.4 above.
8.6.1 On-site Data Two main categories of laboratory analytical data are collected at the Site: geotechnical and chemical/radiological. Geotechnical data, when received, is stored in the electronic data repository (EDR).
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Section 8.0 Page 8-6 Chemical/radiological data may receive two types of review following receipt. The first is a standard quality review of analytical results. The second, as applicable, is a "reasonableness" review consisting of comparison with historical results from the same location (if applicable).
For radiological analytical data, reasonableness review may also consist of comparison with other laboratory analytical results. For example, isotopic concentration data may be compared to isotopic activity to evaluate data acceptability.
Following review, analytical data is uploaded to an EQuIS database. Review-assigned data qualifiers are manually entered in addition to laboratory-assigned data qualifiers.
8.6.2 Geodetic Data Geodetic data is collected by a licensed surveyor. New data points should tie in with existing locations, as determined by the licensed surveyor. For example, a survey of new monitoring wells should include surveys for one or more existing monitoring wells. New survey data is included in the Trust document repository. A monitoring well inventory and the ArcGIS database are updated based on the new data in the Trust document repository.
8.6.3 Radiological Survey Data Radiological survey data collected on site is managed in accordance with the Cimarron Radiation Protection Program. Electronic copies of radiological survey forms are maintained on the site computer and are uploaded to the EDR. Paper copies are maintained on site.
8.6.4 Field Measurements Examples of field measurements collected on site are ground water sampling field parameters and lithologic data obtained during drilling operations. Ground water field parameters are recorded on field parameter forms. Where applicable, field parameters are collected with instruments that are calibrated daily during field work. Boring logs and monitoring well completion diagrams are prepared by task-qualified personnel who are familiar with Site geology.
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Section 9.0 Page 9-1 9.0 CONTROL OF MEASURING AND TEST EQUIPMENT The purpose of this section is to assure that tools, gauges, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits.
Types of measuring and test equipment may include radiological instruments, groundwater level measurement gauges, and field chemical measurement equipment, as well as groundwater treatment system gauges and controls.
Details regarding control of the groundwater extraction and treatment system are included in Section 8.0 of the Decommissioning Plan and in Section 8.6 of this Plan.
Local and remote access to the control system will be managed via password-protected permissions established for various personnel roles and access levels.
Plant operations will be documented on daily logs.
9.1 CALIBRATION Measuring and test equipment requiring calibration must not be used unless the calibration is current.
Plans, procedures, and/or designs require verification and documentation of calibration.
Frequency of equipment calibration shall be in accordance with applicable procedures and instructions, as well as manufacturer's recommendations. Daily calibration checks shall be in accordance with applicable procedures and instructions, as well as manufacturer's recommendations.
Requirements for calibration and control of radiological instrumentation are provided in the Radiation Protection Program.
The adequacy of supplier controls on measuring and test equipment is subject to assessment.
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Section 9.0 Page 9-2 9.2 ADJUSTMENT Calibrated measuring and test equipment, subject to operation checks, may be adjusted by qualified personnel in accordance with procedures.
9.3 EQUIPMENT INVENTORY Equipment which impacts Quality Activities or Quality Data (e.g. calibrated instruments) must be marked with a unique identifier, such as a serial number. An inventory of equipment owned or controlled by the Trustee must be maintained on site, along with records of calibration.
9.4 OUT-OF-SERVICE EQUIPMENT When equipment is found to need calibration or repair, it must be taken out of service. Out-of-service equipment must be visibly marked (i.e. tagged) and physically separated from in-service equipment.
If the equipment is owned or controlled by the Trustee, the equipment inventory must be updated to reflect the status of the equipment and to maintain control of its use.
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Section 10.0 Page 10-1 10.0 HANDLING, STORAGE, AND SHIPPING The purpose of this section is to establish measures to control the handling, storage, and shipping of material and equipment in accordance with procedures and instructions.
Handling, storage, and shipping activities also includes the proper containerization, preservation, and shipping of environmental samples for analysis. These efforts are controlled through detailed work instructions in plans or procedures.
The Material Control and Accounting Plan will provide requirements regarding the determination of the mass of enriched uranium recovered and concentrated by the groundwater treatment operations.
Qualified contractors and/or subcontractors will provide handling, storage, and shipping services for low level radioactive waste (LLRW), contaminated materials, and some solid waste. Such contractors and/or subcontractors will be qualified as described in Section 7.0 of this QAPP.
Contaminated materials being shipped for disposal must comply with DOT regulations and Disposal Facility Waste Acceptance Criteria (WAC). Manifests, and/or bills of lading must document the appropriate packaging and transportation of such materials. A QAIP will be developed to provide instruction for classification and shipping papers for LLRW.
Handling and storage requirements also apply to materials which possess hazardous characteristics, or which have specific requirements for their handling or storage. For instance, flammable materials must be stored in fire-rated vented cabinets, and liquids which may spontaneously produce vapors may require the use of personnel protective equipment. Materials requiring special handling and/or storage requirements will be identified and labeled, and procedures or other instructions for their handling and/or storage must specify those requirements.
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Section 11 .0 Page 11-1 11.0 CONTROL OF NONCONFORMING ITEMS AND EQUIPMENT Section 9.0 above describes measures to assure that tools, gauges, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits.
When items or equipment are evaluated and determined not to comply with quality requirements, they are designated as "nonconforming". Nonconforming items or equipment will be controlled to prevent inadvertent installation or use by labeling, tagging, and/or isolation.
When procedures are not properly followed, that incorrect "performance" is considered a nonconformance. When errors are identified in documentation, those documents are considered nonconforming.
A nonconformance is defined as any deficiency in characteristic, performance, or documentation that renders the quality of an item or deliverable unacceptable or indeterminate. This includes data that is considered deficient or suspect through failure of sampling, analysis, or data processing procedures.
When any non-conformance affecting quality is identified, the non-conformance shall be documented on the Notice of Deficiency form. Section 14.0 provides requirements for corrective actions regarding identified program deficiencies. An example of a program deficiency would be the inadvertent use of nonconforming equipment.
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 12.0 Page 12-1 12.0 DOCUMENTS AND RECORDS This QAPP requires maintenance of a system that produces unequivocal, accurate records that document all quality-critical activities. The purpose of this section is to provide quality requirements for the management of Project documents and records.
A controlled document is any document the Trustee Project Manager or Quality Assurance Coordinator determines should be controlled so that the user possesses the most current revision of the document.
This includes the QAPP and all implementing procedures.
The Trustee PM is responsible for the maintenance of quality records. Quality records include any documentation of activity that produces data or otherwise supports decisions related to license termination and site closure.
Quality records also include records of personnel qualification, training, and radiation exposure. Records fitting this description are classed as Lifetime Records and must be maintained until license termination.
For exposure records, the retention period is indefinite.
12.1 QUALITY ASSURANCE RECORDS A system that produces unequivocal, accurate records that document all quality-critical activities will be maintained. Records of implementation or ongoing activities will be maintained, such as the following:
- Plan or procedure revision
- Deficiency Reports and Corrective Actions
- QA Inspections, Assessments, Surveillances, and Audits
- Completed Activity Plans
- Personnel training and qualification records
- Reports of analytical results
- Radiological Surveys Verify Current Version Prior to Use
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environmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 12.0 PaQe 12-2
- Procurement documents containing quality requirements and specifications, including laboratory analytical services
- Formal Regulatory Communications, Submittals, Permits, License documents
- Equipment Inventory and Calibration Records
- Uranium Inventory Logs
- Accident Reports
- Corrective actions
- Intermediate activities or calculations (as may be needed to validate or substantiate results)
- Records of tracking and control (chain of custody) throughout all processes from sample collection through analysis and reporting of results, including unique identifiers, descriptions, sources, dates/times, packaging/preparation/shipping, and required analyses
- Field logs with sufficient information describing environmental conditions and recording related information and data documenting the nature of the sample and where and how it was taken
- Laboratory notebooks recording related information and data, observations of analysts, and laboratory or other conditions potentially affecting the measurement process
- Electronic data collection and algorithms and QA documentation
- Calculations (including data reduction, analysis, and verification)
- Other records as determined by the Trustee PM or QAC 12.1.1 Records of Analytical Data Data obtained from laboratory analysis of collected samples affects decisions related to license termination and site closure. The Cimarron Data Management Procedure (QAIP 17 .1) establishes methods to:
- Specify electronic data deliverable formats,
- Establish data review parameters and methods, and
- Assure data are archived as quality records.
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envi ronmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 12.0 Page 12-3 This procedure applies to analytical data supplied by contract laboratories, geodetic data collected by licensed surveyors, and field measurements collected during ground water sampling and drilling. However, the procedure may be applied to other data at the discretion of the Trustee Project Manager.
12.2 QUALITY ASSURANCE DOCUMENTS The latest (i.e. current) version of a plan, procedure, or instruction which stipulate requirements which must be met, or which address Quality Activities are considered Quality Assurance (QA)
Documents. Quality Assurance Documents are developed, when required, by Subject Matter Experts, as delegated by the Trustee PM. The Trustee PM will coordinate distribution of QA Documents.
Documents are also "records".
12.3 DOCUMENT CONTROL Controlled documents specifically required to be maintained by this QAPP include:
- The Quality Assurance Program Plan and implementing procedures
- Radiation Protection Plan and implementing procedures
- Sampling and Analysis Plan and implementing procedures
- Safety and Health Plan and implementing procedures
- Material Control and Accounting Plan
- Standard operating procedures
- Activity Plans
- Other documents as determined by the Trustee PM or QAC The need for revisions to Quality-Critical Documents is often identified by personnel performing the work. The necessity for document revision will be determined by Subject Matter Experts with concurrence of the Trustee PM. Where applicable, revisions to the QAPP will managed in accordance with License Condition 27( e). Logs of current revisions for plans, procedures, and instructions will be maintained.
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envi ronmenta 1 Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management, LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 12.0 Page 12-4 End users are required to verify the latest approved version of a document with the Trustee PM or QAC.
Users rely on the revision number on the cover page of the controlled document to verify their printed version. Consequently, revision of individual pages within a document are not permitted. Document revisions shall be announced to likely users when they become available and the previous version will be "retired".
12.4 DOCUMENT AND RECORD STORAGE 12.4.1 Hard Copies of Controlled Documents A single hardcopy of controlled documents will be maintained at the Cimarron Site.
12.4.2 Electronic Copies of Controlled Documents Electronic copies of controlled documents are maintained on a digital data storage site ( e.g.
Share Point).
12.4.3 Trust Document Repository The Trust document repository contains electronic copies of controlled documents. The repository is maintained in a central location; files are in .pdf format so the document cannot be inadvertently changed by a user. An electronic copy of each controlled document must be stored in the Trustee document repository.
12.4.4 Retired Documents Retired documents will be removed from the SharePoint site and retained in the Trustee document repository.
12.4.5 Redundant Storage Redundant storage of records is required. This can take the form of remote electronic storage combined with onsite hardcopy storage. Records that do not need to be immediately accessible may be archived for storage at a remote location as determined by the Trustee PM or QAC.
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envi ronm enta l Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 13.0 Page 13-1 13.0 AUDITS AND ASSESSMENTS Assessments and audits evaluate the effectiveness of the Cimarron Quality Assurance Program. The Quality Assurance Coordinator (QAC) is responsible for the planning and execution of internal and external audits and assessments for the CERT Trustee. Subject to approval by the QAC, audits may be requested by the Trustee PM, a SMEs, or the RSO.
13.1 AUDITS AND SURVEILLANCES Planned and periodic audits will be conducted to verify compliance and determine the effectiveness of the Quality Assurance Program. The Trustee PM or the QAC will perform or schedule an audit of the Quality Assurance Program at least once every three years.
An annual audit of the Radiation Protection Program will be conducted by the QAC, as required by the Radiation Protection Plan. Radiation Protection Surveillances may be initiated by the RSO or Quality Assurance Coordinator.
Procedures for audits are in general accordance with NQA-1, and an audit report is issued to the Trustee PM (for internal audits) or to the supplier quality representative. The report will be transmitted with a request to identify corrective actions for reported findings. When applicable, a Notice of Deficiency may also be issued, in accordance with Section 14.0 below.
The QAC will schedule a return visit or review documentation to verify corrective actions are complete, after which the audit is closed. Desktop audits may be substituted for on-site audits depending on the complexity of the products and services being supplied.
Third party audits or independent certifications may also be reviewed in lieu of direct auditing.
Follow-up to corrective actions noted in audit and surveillances, and trending/tracking, shall be managed in accordance with Section 14.0 below.
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environmental Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan pro pert[es management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 13.0 Page 13-2 13.2 ASSESSMENTS Management (above or outside the QA organization) will regularly assess the scope, status, and adequacy of, as well as compliance with, the QA program. This will include formal triennial reviews.
13.3 AUDIT RECORDS Audit records shall include documentation in conformance with NQA-1, where applicable.
Management of audit records shall be in accordance with Section 12.0 above.
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envi ronmenta Cimarron Environmental Response Trust Cimarron Site Quality Assurance Program Plan properties management. LLC Document No. QAPP-001 DRAFT Rev. 4.0 Effective date:
Section 14.0 Page 14-1 14.0 CORRECTIVE ACTIONS 14.1 NOTICE OF DEFICIENCY Corrective action for non-conformances and incidents is implemented through the "Notice of Deficiency" reporting process. The Notice of Deficiency (NOD) is used to report conditions adverse to quality, and to report nonconformances related to quality requirements. NODs document stop-work actions initiated by anyone working at the Site, deficiencies in procured items or services, documents, procedure content, or adherence to procedures in the performance of work. NODs document failure to comply with specified requirements. NODs may also document certain safety-related issues.
The adoption of this single reporting mechanism simplifies deficiency reporting and the resolution of issues that impact safety or quality at the site.
This process provides for the prompt identification of conditions adverse to safety or quality, determination of their cause, resolution of the specific conditions adverse to quality, and follow-up. A log of deficiencies and corrective actions is maintained to permit trending analysis if appropriate. The trend analysis can be used to identify timely corrective actions to prevent recurring problems and improve performance, as well as determine effectiveness of the corrective action and need for follow-up. Deficiency reporting and documentation of the corrective action process are controlled by QA Procedure QAIP 15. I.
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