QUALITY MANAGEMENT PLAN

QUALITY MANAGEMENT PLAN COTTER CORPORATION (N.S.L.) CAÑON CITY MILLING FACILITY AND LINCOLN PARK SUPERFUND SITE OU1/OU2/OU3 CAÑON CITY, FREMONT COUNTY...
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QUALITY MANAGEMENT PLAN COTTER CORPORATION (N.S.L.) CAÑON CITY MILLING FACILITY AND LINCOLN PARK SUPERFUND SITE OU1/OU2/OU3 CAÑON CITY, FREMONT COUNTY, COLORADO EPA ID No. COD042167858

Valid for Five Years from Approval Date Prepared for: U.S Environmental Protection Agency Region VIII 1595 Wynkoop Street Denver, CO 80202-1129

Colorado Department of Public Health and Environment 4300 Cherry Creek Drive South Denver, Colorado 80246-1530

Prepared by: Cotter Corporation (N.S.L.) 7800 E Dorado Pl. Greenwood Village, CO 80111 (970) 554-6200

Wright Environmental Services Inc. 227 Jefferson St. Fort Collins, CO 80524 (970) 231-1160

SeptemberMay, 2015

Title and Approval Page Valid for Five Years from Approval Date Title:

Quality Management Plan, Cotter Corporation (N.S.L.) Cañon City Milling Facility and Lincoln Park Superfund Site OU1/OU2/OU3 Cañon City, Fremont County, Colorado

EPA Site ID No. COD042167858 Prepared by: Cotter Corporation (N.S.L.) 7800 E Dorado Pl. Greenwood Village, CO 80111 (970) 554-6200 Approval Date:

5/18/2015

Cotter Program Manager: John Hamrick

Signature Date

Cotter QA Manager: Frank Adamic

Signature Date

CDPHE Project Manager Jennifer Opila

Signature: Date

EPA Region VIII Project Manager: Mark Aguilar

Signature: Date

EPA Region VIII QA Manager: Linda Himmelbauer

Signature: Date

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CDPHE Project Manager Jennifer Opila Date

Signature: Formatted: Indent: Left: 0", First line: 0"

Site Name/Project: Cotter Corporation (N.S.L.) Cañon City Milling Facility and Lincoln Park Superfund Site Site Location:

Cañon City, Fremont County, Colorado

Operable Units:

OU1 Mill Facility OU2 Lincoln Park OU3 All other areas

Approval Entity:

EPA Region VIII, CDPHE

Dates of scoping sessions:

December 15, 2014; January 13, 2015

Dates and Titles of Quality Documents Written for Previous Site Work: Quality Assurance Program Plan for Environmental and Occupational Sampling and Monitoring Studies. Environmental Alternatives Inc, May 22, 2009. Quality Assurance Program Plan For the Cotter Corporation Canon City Mill Environmental Sampling and Monitoring Studies. Revised March 5, 1999. Quality Assurance/Quality Control Plan for the Cotter Corporation Canon City Mill Remedial Action Plan Technical Sampling and Monitoring Studies. Revised June 30, 1993. Quality Assurance/Quality Control Plan for the Cotter Corporation Canon City Mill Remedial Action Plan Technical Sampling and Monitoring Studies. Revised January 5, 1989. Cotter Corporation Canon City Mill Radiochemistry Quality Assurance Program. July, 1983, Revised November, 1985. Quality Assurance Plan for the Cotter Corporation Environmental and Occupational Monitoring Program Canon City Mi1l. November 1, 1984. Cotter Corporation Canon City Mill Radiochemistry Quality Assurance Program. July, 1983.

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Distribution List Document Recipients Mark Aguilar Vera Moritz Linda Himmelbauer Jennifer Opila Monica Sheets John Hamrick Craig Harlin Frank Adamic Jim Cain Mitch Abbate

Title EPA Project Manager Remedial Project Manager Regional QA Manager State Project Manager Program Manager Project Manager Technical Services Coordinator QA Manager Environmental Coordinator Laboratory Manager

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Organization EPA, Region VIII EPA, Region VIII

Telephone Number 303-312-6251 303-312-6981

[email protected] [email protected]

EPA, Region VIII CDPHE CDPHE Cotter Corporation (N.S.L.) Cotter Corporation (N.S.L.)

303-312-6020 303-692-3403 303-692-3439 719-275-7413 918-489-2222

[email protected] [email protected] [email protected] [email protected] [email protected]

Cotter Corporation (N.S.L.) Cotter Corporation (N.S.L.)

719-275-7413 719-275-7413

[email protected] [email protected]

Cotter Corporation (N.S.L.)

719-275-7413

[email protected]

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E-mail Address

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Document Revision Tracking Date Approved

Rev. No.

Prepared By

Approvals QA

0.0

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Project

Revision Description Original Draft

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TABLE OF CONTENTS Title and Approval Page................................................................................................................ i Distribution List .................................................................................................................. iviviviii Document Revision Tracking................................................................................................ vvviv Acronyms ........................................................................................................................... ixixixviii Introduction ................................................................................................................................... 1 1.0

Management and Organization ...................................................................................... 32

1.1 Importance of QA and QC Activities ........................................................................................... 32 1.2 Quality Program General Goals and Objectives ........................................................................... 32 1.3 Quality Assurance Policy Statement ............................................................................................ 32 1.4 Quality Assurance Implementation ............................................................................................... 43 1.5 Quality Program Organization ...................................................................................................... 54 1.5.1 Program Personnel Roles and Responsibilities ......................................................................... 54 1.5.1.1 1.5.1.2 1.5.1.3

Program Manager ........................................................................................................................54 Senior Department Heads .............................................................................................................65 Staff and Contractors ....................................................................................................................87

1.5.2 Technical Activities and Programs That Require QA Management ................................... 109 1.5.3 Assuring Understanding and Implementation in all Programs ............................................ 109 1.6 Process for Resolving QA System Disputes ............................................................................... 109

2.0

Quality System Components ....................................................................................... 1211

2.1 Description of Quality System ................................................................................................. 1211 2.1.1 Management Organization and Communication ............................................................... 1311 2.1.2 Quality System Documents ............................................................................................... 1312 2.1.2.1 2.1.2.2 2.1.2.3 2.1.2.4 2.1.2.5 2.1.2.6

2.1.3 2.1.4

Quality Management Plan ........................................................................................................ 1312 Site Quality Assurance Project Plan.........................................................................................1412 Task-Specific Quality Assurance Project Plans ........................................................................ 1413 Sampling and Analysis Plans .................................................................................................... 1514 Standard Operating Procedures ...............................................................................................1614 Document Control and Management ................................................................................ 16141415

Annual Reviews ................................................................................................................. 1615 Performance Assessments and Responses ......................................................................... 1715

2.1.4.1 2.1.4.2 2.1.4.3 2.1.4.4

Management System Reviews ................................................................................................... 1715 Technical Systems Audits ..........................................................................................................1715 Quality Assurance Status Reports .............................................................................................1716 Corrective Action ......................................................................................................................1716

2.1.5 Training ............................................................................................................................. 1816 2.1.6 Systematic Project Planning ............................................................................................. 1817 2.2 Principal Tools of the Quality Management System ................................................................ 1817

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3.0

Qualification and Training Requirements ................................................................. 2018

3.1 Training Policy.......................................................................................................................... 2018 3.2 Roles and Responsibilities ........................................................................................................ 2018 3.2.1 Identifying Training Needs ................................................................................................ 2018 3.2.2 Documenting Qualifications and Training ........................................................................ 2119 3.2.3 Implementation of Training Requirements ........................................................................ 2119

4.0

Procurement Of Items And Services ........................................................................... 2220

4.1 Procurement Process Description ............................................................................................. 2220 4.1.1 Material Items .................................................................................................................... 2220 4.1.2 Services.............................................................................................................................. 2321 4.2 Roles and Responsibilities in the Procurement Process ............................................................ 2321 4.2.1 Reviewing and Approving Procurement Documents ........................................................ 2321 4.2.2 Reviewing and Approving Solicitation Responses ............................................................ 2422 4.2.3 Assessing Procured Materials or Services ................................................................. 25232322

5.0 5.1 5.2

6.0

Quality Assurance-Related Documents and Records ........................................ 26242423 Confidential Documents ................................................................................................... 27252524 Process for Revising QA-Related Documents and Records ............................................. 27252524

Computer Hardware and Software ..................................................................... 28262625

6.1 Processes Associated with Software/Hardware Use ......................................................... 28262625 6.2 Processes Associated with Software/Hardware Maintenance ........................................... 28262625 6.2.1 Summary of Roles and Responsibilities .................................................................... 29272726

7.0

Planning ................................................................................................................. 30282827

7.1 Systematic Planning Process Description ......................................................................... 31292927 7.1.1 Process for Reviewing, Approving, Issuing, Systematic Planning Documents ........ 32303028 7.1.2 Process for Evaluating Data For Other Purposes or From Other Sources ................. 32303029 7.1.3 Planning Document Responsibilities ......................................................................... 33313129

8.0 8.1 8.2 8.3 8.4 8.5

9.0

Implementation Of Work Processes .................................................................... 34323230 Ensuring Work is Performed per Planning and Technical Documents ............................. 34323230 Identifying Operations Needing Procedures ..................................................................... 34323230 Preparation, Review, Approval, Revision, and Withdrawal of Procedures ...................... 34323230 Procedure Use Policy ........................................................................................................ 35333331 Summary of Roles and Responsibilities ........................................................................... 35333331

Assessment and Response ..................................................................................... 36343432

9.1 Assessing the Adequacy of the Quality System ................................................................ 36343432 9.1.1 Planning, Implementing, Documenting, and Report Assessments ............................ 36343432 9.1.1.1 9.1.1.2

Assessment Tools .............................................................................................................. 36343432 Assessment Planning......................................................................................................... 38363634

9.2 Response and Corrective Actions ..................................................................................... 39373735 9.2.1 Roles and Responsibilities for Assessments, Responses, and Corrective Actions .... 40383836 9.2.2 Dispute Resolution .................................................................................................... 41393936 Lincoln Park Superfund Site May, 2015

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10.0 10.1 10.2

11.0

Quality Improvement ........................................................................................ 42404037 Program Reviews ............................................................................................................ 42404037 Project Reviews .............................................................................................................. 42404037

References ............................................................................................................ 44424239

FIGURES Figure 1 Figure 1-1 Figure 2-1 Figure 9-1

Site Location Cotter Quality Assurance Program Organization General Quality Assurance Program Process Flow Chart Assessment and Response General Process Flow Chart

Appendix 1 (AOC/SOW)

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Acronyms ALARA AOC CAIR CDPHE DQO EPA MSR QA QAPP QAPjP QC QMP RI/FS SAP SOP SOW TSA

As Low As Reasonably Achievable Administrative Order on Consent Corrective Action – Improvement Request Colorado Department of Public Health and Environment Data Quality Objective U.S. Environmental Protection Agency Management System Review Quality Assurance Quality Assurance Project Plan (site) Quality Assurance Project Plan (task-specific) Quality Control Quality Management Plan Remedial Investigation/Feasibility Study Sampling and Analysis Plan Standard Operating Procedure Statement of Work Technical System Audit

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Introduction This document presents the Quality Management Plan (“QMP”) for the Remedial Investigation and Feasibility Study (“RI/FS”) at the Cotter Corporation N.S.L. (“Cotter”) Mill Facility and Lincoln Park Superfund Site (“Site”; EPA ID No. COD042167858) in Cañon City, Colorado (Figure 1). This QMP is intended to support the RI/FS process and is valid for five years from the Approval Date. The QMP will be reviewed annually by the QA Manager. The objective of the Cotter quality program is to provide sufficient and appropriate data to support defensible decision making regarding identification of potential alternative remedies followed by selection of the appropriate final remedies. This QMP describes how Cotter structures its quality program and related systems in support of the program objectives. It also describes the policies and systems for implementing and assessing the effectiveness of its quality program. This QMP has been prepared in accordance with the Environmental Protection Agency (“EPA”) document EPA QA/R-2 requirements (EPA, 2001). The purpose of this QMP is to establish the overall quality assurance systems, methods and criteria that will be followed for the RI/FS. This QMP is an “Umbrella” document that details in broad terms the strategies used to implement quality assurance (“QA”) and quality control (“QC”) activities during environmental data collection and for proper data management and subsequent use. This document is supported by and is intended to be considered in context with other quality assurance/quality control (“QA/QC”) documents such as the site Quality Assurance Project Plan (“QAPP”) as well as individual task-specific Sampling and Analysis Plans (“SAP”) and associated individual taskspecific Quality Assurance Project Plans (“QAPjP”). The site QAPP and individual task-specific QAPjP will be prepared in accordance with EPA documents EPA QA/R-5 (EPA, 2001) and EPA QA/G-5 (EPA, 2002) requirements. These QA/QC documents will be submitted to the EPA and Colorado Department of Public Health and Environment (“CDPHE”) (together the “Agencies”) for review and approval in accordance with the Administrative Settlement Agreement and Order on Consent for Remedial Investigation/Feasibility Study (“AOC”) and the attached Statement of Work (“SOW”), (together the “AOC/SOW”), attached as Appendix 1. The Region 8 Quality Management Plan Crosswalk (“Crosswalk”) will be completed and submitted with subsequent QAPjP’s for review by the Agencies under the AOC/SOW. The objective of this QMP is to ensure that appropriate and sufficient policies and procedures, criteria, areas of application, roles, responsibilities, and authorities are defined and in place to guide the necessary planning, design, and implementation of field studies to achieve the program objective in accordance with EPA requirements and guidance. Lincoln Park Superfund Site May, 2015

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1.0 Management and Organization 1.1 Importance of QA and QC Activities Cotter’s quality program is designed to ensure environmental data collected meet the objectives identified in the systematic planning process. The definition of environmental data is found is Section 7 of this document. In order to achieve the program objectives, data must be of appropriate quality for the intended use to support defensible decision-making regarding selection and successful implementation of corrective action remedies. The data and records resulting from QA and QC activities provide the defensible technical basis for site closure decision making. Therefore, robust QA and QC activities are essential to support remedy selection, successful site closure, and delisting from the National Priorities List.

1.2 Quality Program General Goals and Objectives The objective of the quality program is to ensure that all environmental data collection and processing activities, performed by Cotter or under Cotter’s oversight, will result in the production of data that are both of known quality and documented, and can be used with a high degree of certainty by the intended user to support specific decisions or actions, as required by the AOC/SOW. The goals of Cotter’s quality program are as follows:  Produce and use data that are of known quality, and are acceptable for the intended purpose, as verified through data assessments.  Document the use of QA/QC principles in the management of environmental projects.  Facilitate the timely identification of problems and implement effective corrective actions.  Assist in the identification of training needs.  Ensure that Cotter management, staff, and contractors work cooperatively and share lessons learned for system improvement.  Provide for continuous improvement in Cotter environmental data collection, management, and documentation operations.

1.3 Quality Assurance Policy Statement Cotter’s QA Policy includes several key points:  Programs generating, using, or requiring the collection of environmental data will be consistent with the intentions and guidance as outlined in this QMP, the site QAPP, taskspecific QAPjPs, SAPs, and standard operating procedures (“SOP”).  Individual task-specific QAPjPs are to be developed, as appropriate, for specific projects undertaken as part of the RI/FS. Task-specific QAPjPs developed for such projects shall be developed within the guidelines set forth in this QMP. Lincoln Park Superfund Site May, 2015

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Systematic planning of environmental data collection will be used. If the EPA data quality objective (“DQO”) process is selected as part of the planning process it should be implemented consistent with EPA’s Guidance for the Data Quality Objective Process, August 2004, EPA QA/G-4 or an equivalent document. Where applicable, DQOs or comparable quality and technical criteria need to be clearly stated for individual projects. However these criteria are often predetermined by regulatory criteria and action levels (i.e., promulgated protective table values) and should be identified as such. Technical System Audits (“TSA”) measure the conformance of a measurement system to defined criteria. TSAs may be conducted by the Cotter QA organization for Cotter projects involving environmental data collection, to ensure that compliance with QMP requirements. Management System Reviews (“MSR”) of the quality system are performed by Cotter management or qualified third-party personnel on behalf of Cotter. Deficiencies highlighted in these reviews will be addressed in a timely manner. All Cotter personnel and contractors have the responsibility to identify quality program issues with their immediate supervisors and to escalate those concerns upward through the program organization if those issues are not addressed in a reasonable manner and/or timeframe. The requirements of this QMP may be waived only under exceptional circumstances. The waiver request will be submitted to Cotter’s QA Manager and must address the requirement to be waived, the rationale, and the consequences of non-approval. Each waiver will be reviewed by both the QA Manager and the Program Manager on its own merits upon receipt of a written request. If found appropriate, the requirement may be waived. For activities that are under the jurisdiction of the Administrative Settlement Agreement and Order on Consent for Remedial Investigation/Feasibility Study (“AOC”), dated July 15, 2014, the request for a waiver must also be approved by the EPA and CDPHE, collectively the ”Agencies”. When a waiver is granted, the actual procedures for the data management activities will be documented and available for review and assessment during the decision-making process associated with the project.

Finally, it is Cotter’s policy that all required QA activities will be appropriately funded and staffed to ensure proper implementation and maintenance of the quality program.

1.4 Quality Assurance Implementation The Cotter quality program is implemented through several quality management systems, which include use of the following activities:  QA training.  Use of a site QAPP. Lincoln Park Superfund Site May, 2015

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    

Use of task-specific QAPjPs. Use of SAPs. Use of SOPs. Clearly defined QA organization responsibilities. Periodic assessments of program performance, including MSRs and TSAs.

Each component of this program is discussed in more detail in the appropriate section within this document. This document officially establishes the systems and activities as components of Cotter’s quality program.

1.5 Quality Program Organization The organizational structure of this quality program includes personnel who actively generate environmental data, develop QA/QC documents and/or perform QA/QC functions, and those who serve in a review and/or management capacity. The program organization is illustrated in Figure 1-1, showing lines of authority and lines of communication. The organization personnel are identified by the following general categories:  Program Manager.  Senior Department Heads.  QA Staff and Contractors Personnel identified in Figure 1-1 are to report to those individuals directly above them in the organization. All personnel have the responsibility to promptly identify quality program issues to their immediate supervisors and to escalate those concerns upward through the program organization if those issues are not addressed in a reasonable manner and/or timeframe. 1.5.1 Program Personnel Roles and Responsibilities The QA staff is authorized to access all levels of Cotter’s Management in execution of their QA functions. The QA staff and all personnel involved with QA functions should follow the organizational lines of communication identified in Figure 1-1 in addressing and, as necessary, escalating QA issues until resolution is achieved. 1.5.1.1

Program Manager

The Program Manager has overall responsibility for the conduct, direction and supervision of remedial activities as well as the other operational, health and safety, radiological, and environmental programs at the Site. The Cotter Program Manager is familiar with all aspects of the quality program as well as this QMP and other QA/QC activities at the Site. The Cotter Program Manager reviews QA status reports, performs MSRs, and, in conjunction with program personnel, takes appropriate action as necessary to insure compliance with this QMP. The Lincoln Park Superfund Site May, 2015

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Program Manager will ensure that tasks assigned to program personnel are performed in accordance with this QMP, the site QAPP, other relevant planning documents, and SOPs. The Program Manager will ensure that the QA Manager has organizational independence from groups generating, compiling, and evaluating environmental data, and that QA staff have access to the appropriate levels of management in order to plan, assess, and improve the organization’s quality program and related systems. 1.5.1.2

Senior Department Heads

Senior Department Heads that report directly to the Cotter Program Manager include the following personnel:  QA Manager.  Cotter Laboratory Manager.  Environmental Coordinator. These members of the organization provide the direct supervision of staff and contractors. In this regard, they assure that staff and contractors are properly trained to perform their tasks, that their work is performed in conformance with the appropriate planning documents, and that the work product generated through their efforts is of an acceptable quality. Senior Department Heads maintain familiarity with and update departmental or project documents, requirements, equipment, and procedures that are related to RI/FS environmental data collection or the site QAPP. In addition, these members are authorized and responsible for the following:  Assuring that activities under their control are performed correctly and on schedule.  Providing and verifying training of key individuals under their supervision including assuring that individuals are aware of and adhere to the as low as reasonably achievable (“ALARA”) radiation exposure policy.  Verifying qualifications of staff and contractors under their supervision.  Participating in the corrective action response system related to their area of supervision.  Acting upon and consulting with the QA Manager on items requiring corrective action or action for improvement.  Working with the QA Manager to ensure that communications material to the quality program are documented and maintained. Additional specific responsibilities of the Senior Department Heads are discussed below. QA Manager The QA Manager reports directly to the Program Manager, administers the quality program and has the authority and responsibility for managing the QA/QC activities within Cotter’s quality program. The QA Manager and his/her staff (“QA Group”) are organizationally independent of Lincoln Park Superfund Site May, 2015

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groups that generate, compile, and evaluate environmental data. The QA Group reports solely to the Program Manager. The QA Manager maintains familiarity with the environmental monitoring, remediation and quality programs, and related documents and requirements. The QA Manager may delegate duties and responsibilities to one or more members of the QA Group, collectively called the “QA Manager” in this document. The QA Manager is responsible for the following:  Ensuring all Cotter internal and external projects involving the generation of environmental data are performed in accordance with this QMP, site QAPP, and other QA-related documents.  Ensuring Cotter QA-related documents, such as QAPjPs, SAPs, and SOPs, are prepared and implemented in accordance with Cotter’s QMP and consistent with EPA requirements and guidance, as appropriate.  Reviewing and approving off-site laboratory QA documentation, compliance with the laboratory QAPjP, and performance.  Identifying activities requiring internal coordination of QA and QC and ensuring that the appropriate coordination is provided.  Ensuring periodic assessments of program performance (e.g. MSRs, TSAs) are coordinated and performed, the report of findings and proposed corrective actions, if any, are provided to Cotter management, and appropriate and approved corrective actions are appropriately implemented;  Ensuring QA status reporting and communication is timely, complete and accurate.  Ensuring personnel (staff and contractors) participating in the quality program are adequately qualified and trained to perform their functions, that personnel training is current, and that documentation of personnel qualifications and training is maintained.  Ensuring the required QA document reviews and revisions are implemented in a timely manner and within or before the frequency specified in this QMP.  Ensuring the Program Manager is informed of any action or omission related to quality that may require corrective action;  Ensuring oversight of the corrective action and response system. Cotter Laboratory Manager The Cotter Laboratory Manager reports to the Program Manager and has the authority and responsibility to ensure that laboratory activities are compliant with the technical and QA requirements in this QMP, the site QAPP, the laboratory QAPjP, and associated SOPs. The Cotter Laboratory Manager is responsible for the following:  Ensuring his/her assigned tasks are performed in accordance with this QMP, the site QAPP, and other relevant planning documents and SOPs.

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      

Ensuring all laboratory QA/QC objectives, policies, and procedures are followed according to this QMP, site QAPP and laboratory QAPjP. Reviewing and approving off-site laboratory QA documentation, compliance with the laboratory QAPjP, and performance, in consultation with the QA Manager. Managing Cotter laboratory sample handling, analyses, and active analytical records. Developing, reviewing, and approving laboratory SOPs and QA procedures, in consultation with the QA Manager. Overseeing laboratory QA and QC documentation. Determining how to implement laboratory corrective actions, if requested, in consultation with the QA Manager. Overseeing internal laboratory data review and production of laboratory analytical reports.

Environmental Coordinator The Cotter Environmental Coordinator reports to the Program Manager, and has the authority and responsibility to ensure that site-monitoring activities are compliant with the technical and QA requirements in this QMP, the site QAPP and associated QAPjPs. The Environmental Coordinator maintains familiarity with the environmental monitoring, remediation, and quality program and related documents and requirements. The Cotter Environmental Coordinator will work directly with the other Senior Department Heads and will be responsible for the following:  Ensuring his/her assigned tasks are performed in accordance with this QMP, the site QAPP, and other relevant planning documents and SOPs.  Ensuring compliance with environmental regulations, licenses, and permits.  Coordinating and managing all environmental data collection programs, except laboratory activities.  Managing implementation of environmental policies and practices.  Support auditing, analyzing and reporting of environmental data collection performance.  Ensuring that the records management system is implemented.  Writing environmental reports. 1.5.1.3

Staff and Contractors

Staff and contractors report to their respective Senior Department Heads and include the following personnel:  QA staff.  Laboratory staff.  Procurement Specialists.  Project Managers/Field Teams.

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 

Contract Laboratory. Contractors (environmental, engineering, etc.).

Staff and contractors are responsible for the first line of QA/QC on work within their areas of responsibility. In addition, these individuals are authorized and responsible for the following:  Ensuring their assigned tasks are performed in accordance with this QMP, the site QAPP, and other relevant planning documents and SOPs.  Reviewing the completeness and accuracy of all work products or data they generate.  Identifying issues that might affect work product or data quality to their immediate supervisor and/or the QA Manager in a timely manner.  Participating in corrective action and response activities, as needed. Staff and contractors assigned to conduct program tasks such as sample collection, sample analysis and data documentation, assure the quality of their work product through adherence to the documented planning documents and associated procedures. The following summarizes specific responsibilities for the QA staff. QA Staff The QA staff report to the QA Manager, and have the authority and responsibility to perform QA-related activities and maintain appropriate QA records for the efficient operation of the quality program. The QA staff will work directly with the Program Manager, Senior Department Heads, other staff, and contractors to implement the quality program. The QA staff has organizational independence from groups generating, compiling, and evaluating environmental data. In addition, by authority of the Program Manager, QA staff has access to the appropriate levels of management in order to plan, assess and improve the organization’s quality program and systems. QA staff is responsible for the following:  Ensuring his/her assigned tasks are performed in accordance with this QMP, the site QAPP, and other relevant planning documents and SOPs.  Verifying and validating environmental data and documenting such validation in conformance with this QMP, site QAPP, task-specific QAPjPs, SAPs and SOPs.  Supporting records and data management activities by providing administrative and clerical support to the members of the QA Group including maintaining and updating QA-related files.  Supporting quality program assessment and response efforts as directed by the QA Manager.

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1.5.2 Technical Activities and Programs That Require QA Management The four types of data generation and monitoring activities covered under this QMP include:  Data generated by field sampling and laboratory analysis.  Data generated and used for design, construction, and operation of engineered remediation/treatment systems.  Data acquired from sources outside Cotter through databases, publications, etc.  Data generated in response to AOC requirements. Health and Safety monitoring data are specifically not included and are not subject to the requirements herein. Cotter management will oversee all environmental data collection, even those activities performed by contractors, through the Laboratory Manager and/or the Environmental Coordinator and their staff. The Laboratory Manager shall oversee contract laboratory performance and compliance to applicable QA requirements while the Environmental Coordinator will oversee all other contractor performance to ensure compliance with applicable QA requirements. Internal coordination of QA and QC activities is needed for the field sampling teams, the analytical laboratory, and the QA Group to ensure that the task-specific quality objectives (e.g., DQOs) are known and achieved. This coordination is accomplished through including these groups in the systematic planning process, through distribution of the task-specific planning documents (e.g., QAPjPs and associated SOPs) to each group in advance of the task implementation, and through clear and direct communication. 1.5.3 Assuring Understanding and Implementation in all Programs Management will assure that all personnel have sufficient understanding of the technical and quality requirements for the RI/FS environmental data collection activities by ensuring the requirements of this QMP are implemented. Specifically, management will ensure that QA related training is provided and that personnel training remains current, that appropriate personnel are engaged in the systematic planning process, and that all personnel implementing QA related environmental data collection activities are provided with the appropriate plans and procedures. Management will assure implementation of the quality program through periodic assessments (e.g., MSRs, TSAs), reporting, and appropriate and timely corrective action.

1.6 Process for Resolving QA System Disputes All program personnel have the responsibility and authority to identify, report, and escalate quality program issues. Quality program issues and disputes should be reported to the direct supervisor of the identifying party and to the QA Manager. The identifying party will initiate Lincoln Park Superfund Site May, 2015

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corrective action and response activities. Corrective action and response activities are guided by the Corrective Action – Improvement Request (“CAIR”) system described in Section 9.2. The basic operation of the CAIR system is as follows:  A need for action/resolution is detected.  A request is sent through the QA Manager.  A responsible party is identified and notified.  The responsible party evaluates the request, determines a response, and gives a response through the QA Manager. The QA Manager and Department Supervisor or Project Manager, if necessary, are informed and approve or disapprove the request, response, and action.  The Program Manager reviews CAIR forms prior to filing. All completed CAIR requestresponse documentation is retained in the quality program files. The CAIR system process is described in more detail in Section 9.2.

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2.0 Quality System Components 2.1 Description of Quality System The quality program consists of systems that utilize program personnel, defined functions, tools, and procedures. The program includes documentation of how Cotter manages its quality systems and defines the primary responsibilities for managing and implementing each program component. QA responsibility is incorporated into performance standards. A general flow chart illustrating the quality program process is presented in Figure 2-1. Not shown on this figure is any review/approval cycle conducted by the Agencies under the AOC. Figure 2.1 depicts the general QA Program process flow. The figure is read from top to bottom, following the arrows. The process steps are presented in individual boxes and the individual steps are identified with a Step Number (e.g. Step A.1) on the far left of the figure. Assigning step numbers also facilities identification of specific steps when describing implementation or future review and possible revision of this general process.

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The colors of the individual boxes correspond to the broad process steps identified in bold on the far right hand of the figure (e.g. light yellow boxers correspond to the broad process step of “Systematic Planning” while the green colored boxes correspond to the broad process step of “Work Implementation”. The boxes for each process step are located under the individual responsible for the respective step. For example, Step A.2 (design and implementation of QA training) is the responsibility of the QA Manager. In Step A.3 (QA Training) the Senior Dept. Heads, QA Admin Assistant, Key Individuals and Staff, and the Program Manager all must receive QA Training. As a further example, in Step B.4, the Senior Dept. Head reviews the draft Planning Document (e.g., a SAP or QAPjP) and either has revisions made or passes it on to the QA Manager for review (Step C.1). When more than one arrow extends from a given step (box) such as in Step A.3 or Step B.4, either it means more than one action alternative or engagement of more than one individual is needed. There are several components of the quality program, which are implemented systematically to ensure that environmental data generated by Cotter, or its contractors/consultants, are of appropriate quality for their intended purpose. These quality program components are outlined below:  Management Organization and Communication.  Quality System Documents. o QMP. o Site QAPP. Lincoln Park Superfund Site May, 2015

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o Task-specific QAPjPs. o SAPs. o SOPs. Annual Reviews. Performance Assessments and Responses. o Management assessments. o Project and data assessments. o Quality assurance status reports. o CAIR system. Training. o QA training. o Technical training. Systematic Project Planning.

The roles and implementation responsibilities of management and staff are described in the sections below. 2.1.1 Management Organization and Communication As described in Section 1.5, the management and organization system component is led by the Program Manager and implemented by the Senior Department Heads, staff, and contractors. Specific roles and responsibilities are summarized in Section 1.5.1. The essential value of this quality system component is derived from clear definition of roles and responsibilities, clear lines of authority, and clear lines for communications. 2.1.2 Quality System Documents Quality program documents record the policies, roles and responsibilities, procedures, and criteria for ensuring that the environmental data meet the program objectives. The following sections describe the documents within this system component. 2.1.2.1 Quality Management Plan This QMP describes the policies, procedures, and systems governing Cotter data collection activities. It serves as the “umbrella” document covering all QA/QC operations. This QMP will be reviewed internally at least annually and is valid for five years from the Approval Datefor a period of up to five years, after which it shall either be reissued without change, revised or withdrawn (EPA, 2001). Future revisions and updates to this QMP will be prepared at any other time that significant changes that affect this QMP are necessary and will be submitted by Cotter and reviewed by the Agencies in accordance with the AOC/SOW. The QA Manager will lead this process to gain concurrence from Cotter management and the Agencies. Revisions and/or updates will be completed and prepared for submission to the Agencies in as expeditious a manner as possible under the particular circumstances for each revision. Lincoln Park Superfund Site May, 2015

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The QA Manager is responsible for development of this QMP. The Program Manager is responsible for reviewing this QMP. Both the Program Manager and the QA Manager are responsible for approving this QMP. All management and program personnel are responsible for understanding and complying with the processes identified in this QMP. This QMP is implemented programmatically across the entire RI/FS process. 2.1.2.2 Site Quality Assurance Project Plan Section 6 of the Statement of Work (SOW), included as Appendix B of the AOC, identifies that Cotter shall revise the existing QAPP for Environmental and Occupational Sampling and Monitoring Studies for the Cotter Corp, Canon City Milling Facility and Lincoln Park, CO Superfund Site (Cotter, 2009) to comply with the EPA Requirements for Quality Assurance Plans QA/R-5 (EPA, 2001) and consider the guidance in EPA's Guidance for Quality Assurance Plans QA/G-5 (EPA, 2002). Because there are numerous and complex project tasks at the Site, the site QAPP will address QA/QC functions that are common to all of the projects to be undertaken as part of the RI/FS. The site QAPP describes the necessary quality assurance, quality control, and technical activities that must be included in subsequent task-specific QAPjPs to ensure that specific environmental data collection activities produce environmental data that meet task-specific objectives and performance or acceptance criteria for their intended use. The site QAPP also establishes acceptance and performance criteria for existing data that may later be used for individual projects as well as quality and technical criteria for existing routine environmental data collection that are relevant to the RI/FS. To the extent practicable, appropriate portions of the site QAPP may be referenced in subsequent task-specific QAPjPs. Each set of individual RI/FS tasks will then have a unique QAPjP that addresses the task-specific QA/QC functions and criteria. The QA Manager is responsible for developing the site QAPP. The Program Manager is responsible for reviewing the site QAPP. Both the Program Manager and the QA Manager are responsible for approving the site QAPP. All management and staff are responsible for understanding and complying with the processes and task-specific criteria identified in the site QAPP. The site QAPP is implemented across the entire Cotter program. 2.1.2.3 Task-Specific Quality Assurance Project Plans The QAPjP dictates the policies and procedures, project and task organization and objectives, QA requirements, and QC activities designed to achieve the desired type and quality of environmental data necessary to support specific task and project objectives. A QAPjP is utilized for collection and analyses of data to support the Cotter RI/FS. All Cotter QAPjPs shall be developed as specified in EPA QA/R-5, EPA Requirements for Quality Assurance Project Lincoln Park Superfund Site May, 2015

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Plans for Environmental Data Operations (EPA, 2001) and consider guidance in EPA QA/G-5, Guidance for Quality Assurance Project plans (EPA, 2002). Each project in the RI/FS (e.g., characterization of groundwater contamination or assessment of a particular remedial action technology) will have a task-specific QAPjP that is commensurate with project objectives and complexity (graded approach). The location and number of samples, type of sample, sample methodology, constituents of concern, type of analysis, detection limits, laboratory QA/QC, and the project documentation are among the items that are typically specified in task-specific QAPjPs. The task-specific acceptance criteria or performance criteria are determined during the planning stage of the QAPjP considering existing regulatory requirements (consent orders or promulgated water quality values, for example) or by using a systematic planning process. The QA Manager is responsible for approving all QAPjPs and for ensuring that all appropriate staff is engaged for the planning process that will result from the QAPjP. All management and staff are responsible for understanding and complying with the activities and methods identified in the QAPjPs. The QAPjPs are implemented through compliant execution of the task-specific activities. Cotter is committed to sound scientific practices during the generation of environmental data to ensure that data are technically appropriate for their intended use. Data quality objectives, or their functional equivalent, shall be developed in the systematic planning phase of all Cotter data collection activities before data collection goes forward. The Guidance on Systematic Planning Using the Data Quality Objectives Process, EPA QA/G-4 (EPA, 2006) is used, as appropriate, for the development of DQOs. In many situations, regulatory criteria and action limits are the basis for environmental decisions. In these situations, the appropriate planning document (i.e., QAPjPs) should state that regulatory limits are the driving force for the quality criteria, and that the formal EPA DQO process may not be extensively utilized. Although DQOs, or their functional equivalent, are an essential element of QAPjPs, these data objectives can be identified with regulatory limits and/or action limits that are already in existence, and do not necessarily need to be derived. 2.1.2.4

Sampling and Analysis Plans

Project SAPs include the specific information regarding the environmental data collection media, locations, and procedures and describe the actual activities to be performed to implement the planning established in task-specific QAPjPs.

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Senior Department Heads are responsible for assembling the team to develop the SAP. The QA Manager is responsible for reviewing, requiring revisions, as necessary, and approving the SAP. Program personnel are responsible for implementing the SAP. 2.1.2.5

Standard Operating Procedures

Procedures are one mechanism to ensure data quality and comparability between individual environmental data collection projects. Procedures must be incorporated, either in full or by reference, in the site QAPP and/or the task-specific QAPjPs. Cotter uses a variety of SOPs related to administrative, environmental data collection, and analytical activities. These SOPs are available for reference and can be incorporated into task-specific QAPjPs. Procedures can also be modified to develop specific procedures for a variety of tasks or projects. An SOP shall be developed to control the development, review, approval and control of all subsequent procedures related to RI/FS environmental data collection. Senior Department Heads and their personnel are responsible for developing SOPs for work tasks within their area of responsibility. The QA Manager is responsible for reviewing all SOPs. Both the QA Manager and the respective Senior Department Head are responsible for approving SOPs. Cotter Personnel are responsible for performing their work tasks in conformance with the applicable SOPs. 2.1.2.6

Document Control and Management

The overall Cotter document handling, management, and retention process shall be addressed in a document control procedure, which shall address a document control process for QA-related documents. The overall Cotter data management process shall be addressed with a data management procedure, which focuses primarily on management of environmental data records in both electronic and hard-copy document forms. This is described further in Section 5. The QA Manager is responsible for selecting and overseeing the document control procedure planning team that will be tasked with developing the document control procedure. The QA Manager is responsible for reviewing, requiring revisions, as necessary, and approving the document control procedure. Program personnel are responsible for implementing the document control procedure. 2.1.3 Annual Reviews Quality Assurance documentation requires periodic review to ensure that they remain current with program needs. Though this QMP is valid for five years and the site QAPP and taskspecific QAPjPs are valid for a period of one year after the official date of publication, the QArelated documents (QMP, site QAPP, QAPjP, SAP, and SOP) will be reviewed at least annually. Future revisions and updates to these documents will be prepared, prior to the end of the Lincoln Park Superfund Site May, 2015

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applicable validity period and as significant changes become necessary within Cotter’s quality program, to adapt to the program needs or to improve the performance of the quality program. Revisions and/or updates will be completed and prepared for submission to the Agencies in as expeditious a manner as possible under the particular circumstances for each revision. The QA Manager will lead this process to gain concurrence from Cotter management. The QA Manager is also responsible for maintaining the records of such reviews. Section 7.1.1 describes the process for reviewing, approving, and issuing systematic planning documents. 2.1.4 Performance Assessments and Responses 2.1.4.1

Management System Reviews

Management System Reviews will be performed periodically for all environmental data collection, management and analytical activities. Further details on MSRs are provided in Section 9.1.1. 2.1.4.2

Technical Systems Audits

All Cotter activities that employ environmental sample collection and analyses are subject to a TSA. Program TSAs are a principal tool of Cotter’s quality system and may include field TSAs and laboratory TSAs. Program TSAs are described more thoroughly in Section 9.1.1. 2.1.4.3

Quality Assurance Status Reports

QA status reports are generated at least annually by the QA Manager. These reports document the results of quality program assessments and the performance of the quality program components. The annual QA status report may be part of or supplant the Annual Report required by the Radioactive Materials License, which summarizes Site activities each year. The QA Manager prepares a formal summary of quality assurance and quality control activities in the form of a QA/QC section for the Annual Report. Non-routine QA/QC or miscellaneous related activities are also described. When auditors make findings or observations pertinent to the QA Department, the QA Manager prepares responses and forwards them to Cotter management for their approval. Audit report results are also addressed in the annual report. 2.1.4.4 Corrective Action The Cotter quality management system utilizes the CAIR system to document and implement corrective actions as well as to promote continuous improvement. Corrective actions must be documented and communicated to all parties involved. Lincoln Park Superfund Site May, 2015

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The basic operation of the CAIR system is as follows:  A need for action is detected.  A request is sent through the QA Manager.  A responsible party is identified and notified.  The responsible party evaluates the request, determines a response, and gives a response through the QA Manager.  The QA Manager and Senior Department Heads or Project Managers, if necessary, are informed and approve or disapprove the request, response, and action.  The Program Manager reviews CAIR forms prior to implementation. Corrective Actions are discussed in more detail in Section 9.2. 2.1.5 Training Technical and QA training help ensure that personnel know how to correctly and consistently execute their assigned tasks, promotes an understanding of the basics of the quality program as well as the underlying reasons for implementing the quality program. Personnel at all levels of the organization who are directly involved in any aspect of environmental data collection, sample analysis, data management and assessment, should receive training on the quality system. Training is described in more detail in Section 3.1. 2.1.6 Systematic Project Planning The purpose of the systematic planning process is to structure and document the complete planning process for collection, assessment and management of environmental data. The objective of the planning process is to ensure that data are of the appropriate type and quality to meet the program objectives. This QMP requires that systematic planning be performed of all environmental data collection activities related to the RI/FS but does not require one specific kind of systematic planning. Rather, this QMP allows for different variations to be adopted, depending on the focus of the study questions. The systematic planning process is described more fully in Section 7.

2.2 Principal Tools of the Quality Management System Cotter uses a graded approach to the quality management system, as does EPA. The graded approach recognizes that different projects, depending on size or complexity, may require a greater or lesser degree of formal planning. The successful implementation of Cotter’s quality program requires a consistent and graded approach for QA practices commensurate with the intended uses of the data. This QMP requires that a variety of tools and procedures be utilized for planning, implementing, and evaluating the quality management system. Cotter personnel Lincoln Park Superfund Site May, 2015

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and contractors will be informed of the availability and appropriate use of these tools through training. These tools include but may not be limited those listed below:  Quality management plans and site QAPP (program-wide quality system documentation).  Quality systems audits, MSRs, field TSAs, laboratory TSAs (management assessments).  Training plans (training and documentation).  QA project plan (project-specific system quality documentation).  Data verification and validation (data assessments).

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3.0 Qualification and Training Requirements 3.1 Training Policy It is Cotter’s policy that quality program training should be provided at all levels of the organization and that everyone in the organization who is directly involved in environmental data collection, sample analysis, data management, and assessment, should receive training on the quality system. The amount of training and the topics to be included in the training should depend on each individual’s role in the organization and on their specific training needs. All personnel participating in QA-related activities will be trained on the basics of the quality system as well as the underlying reasons for implementing the quality system. Training will also include the procedures related to quality for specific jobs. However, personnel should only be required to participate in training for tasks they will be assigned to complete. As a result, just as with other types of training, the amount of training that each staff member is required to complete will be directly proportionate to the amount of QA-related tasks that staff member is expected to complete as part of their job. Therefore, all Cotter management and staff as well as contractors shall receive at least initial training about the importance of having a quality system, prior to and during the effective period of this QMP. Additional training will be based on the personnel category and specific QArelated work tasks as determined by the QA Manager.

3.2 Roles and Responsibilities The Program Manager has the overall responsibility to ensure that appropriate resources are available to support the QA training program. The QA Manager has overall responsibility for ensuring that appropriate QA training is effectively implemented and documented. Senior Department Heads have the responsibility for providing the QA Manager with personnel technical qualifications, statutory, regulatory, professional, or other certifications, accreditations, licenses, or other formal qualifications, and work area assignment information. 3.2.1 Identifying Training Needs Senior Department Heads are responsible for determining the task-specific technical qualification requirements of their staff and contractors, and for communicating these minimum requirements to the QA Manager. Determination of appropriate knowledge and skill may consider work experience as well as formal training. Senior Department Heads shall identify all new program personnel to be involved with environmental data collection, sample analysis, data management, and assessment to the QA Manager in a timely manner, including their areas of Lincoln Park Superfund Site May, 2015

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responsibility and existing qualifications and existing training. Further, Senior Department Heads shall inform the QA Manager in a timely manner of changes in personnel work requirements or work assignments that may change their training needs or status. The QA Manager is responsible for determining the task-specific QA training requirements for program personnel based on their area of responsibility. In addition, the QA Manager is responsible for assessing new and existing personnel technical qualifications and their QAtraining status. Further, the QA Manager shall inform Senior Department Heads when personnel re-training is necessary based on review of the training-status documentation. Program personnel have the responsibility to be aware of their training status through proactive communication with their Senior Department Head and the QA Manager. In addition, Program personnel have the responsibility to identify to their management any training deficiencies of which they are aware. 3.2.2 Documenting Qualifications and Training Ensuring that work proficiency and QA training are maintained is accomplished through assessment of staff work requirements, performance, and training documentation. Therefore, the QA Manager is responsible for maintaining training needs and training status documentation for program personnel. This includes maintaining documentation that program personnel have the appropriate knowledge, experience, skill, and statutory, regulatory, professional or other certifications, accreditations, licenses, or other formal qualification necessary to perform their respective work tasks to achieve the program objectives, based on the information provided by Senior Department Heads. The QA Manager shall require additional training as necessary to ensure personnel maintain quality-related qualifications. Initial staff proficiency in critical technical disciplines (e.g., environmental sampling, geologists, hydrologists, hydrogeologists, chemists, and microbiologists) may be determined within the hiring and/or contractor procurement process. 3.2.3 Implementation of Training Requirements Program personnel are required to participate in training for tasks they are assigned to complete. Training may include but is not necessarily limited to external training, internal training, and review of program documents such as task-specific SAPs, SOPs, task-specific QAPjPs, health and safety plans, Job Safety Analyses, and/or Radiation Work Permits.

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4.0 Procurement Of Items And Services Cotter procures items such as sampling equipment, instrumentation, field equipment, laboratory services, as well as consulting services. All items and services relating to environmental data collection and generation are obtained through the procurement process, which is guided by documented procurement procedures. Whenever appropriate, technical and quality requirements for equipment and services specific to individual projects will be detailed in the site QAPP or QAPjPs. Procurement activities may range from purchasing general supplies to highly sophisticated scientific instrumentation and consulting services that may directly affect the quality of environmental measurements or assessment.

4.1 Procurement Process Description In general, requests for procurement of items and services originate from technical groups and are documented in the form of purchase requisitions or statements of work. Preparation of these requests includes identification of the quantity and description of each item or service, identification of the specific technical and quality requirements and the planning document source (e.g., title and date of QAPjP and/or specific DQO, if applicable) for each item or a notation for each item that there are no specified QA or QC requirements. The Procurement Specialist duties are detailed in Section 4.2.1, below. The Procurement Specialist then assembles a procurement agreement or contract based on the purchase requisition or statements of work. For routine supplies and services, procurement may proceed with no additional review while draft agreements or contracts for non-routine supplies and services are routed back to the originating Senior Department Head or their designee for verification of accuracy and completeness, and to ensure that the quality system elements for which the supplier is responsible are described. Where applicable, the requesting group reviews bids, proposals and related QA documents (e.g., QAPjPs) and approves applicable responses to solicitations to ensure that they satisfy all technical and quality requirements in the planning documents. Both the department originating the request and the Procurement Specialist are authorized and responsible for identifying and documenting any technical or quality deficiencies in procured items or services. 4.1.1 Material Items Material item needs (e.g., supplies and equipment) are submitted to management, who then approve items for proposed procurement. This process allows Cotter to identify particular equipment needs, relative to other needs, in order to facilitate quality in measurement processes. Specific monitoring, sampling, and analytical equipment are procured only after quality Lincoln Park Superfund Site May, 2015

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requirements have been checked against the site QAPP or task-specific QAPjP requirements or discussed by management, program personnel, and when appropriate, Cotter’s QA Manager. 4.1.2 Services Contracted service for environmental data needs are (see Section 7 for the definition of environmental data) submitted to the Senior Department Head, either in the form of a purchase requisition form or statements of work, who approves items proposed for procurement. The purchase requisition form or statements of work will include a listing of performance periods, specific deliverables, deliverable schedule, and cost guidance with requested schedule for procurement. This process allows Cotter to identify particular equipment needs in order to facilitate quality in measurement processes. Specific services are procured only after quality requirements have been checked against the site QAPP or task-specific QAPjP requirements or discussed by management, program personnel, and when appropriate, Cotter’s Program and QA Manager. Contracts for services are not issued until the prospective contractor has been evaluated by the Agencies under AOC Paragraph 38 and SOW Section 14.1, and the contractor meets or exceeds Cotter’s commitment for QA as outlined in this QMP. At Cotter’s option, prospective contractors may either commit to the applicable provisions of Cotter’s QMP (if applicable) and QAPP or submit a QMP (if applicable) and a QAPP to Cotter for review. Cotter will evaluate any QMP or QAPP provided by prospective contractors under AOC Paragraph 38 and SOW Section 14.1.

4.2 Roles and Responsibilities in the Procurement Process Requests for procurement of items or services originate from technical groups and are processed by the Procurement Specialist. The Senior Department Heads of groups originating requests have the primary responsibility for the procurement requests but may delegate that role to program personnel who have the appropriate technical experience. The Procurement Specialist does not delegate his/her responsibilities. 4.2.1 Reviewing and Approving Procurement Documents The Procurement Specialist is responsible for the following:  Reviewing the purchase requisition or SOW for the following elements. o Documents are complete and accurate. o Documents clearly describe the item or service needed. o Technical and quality requirements are identified or explicitly noted that none apply. o The quality system components for which the supplier is responsible are clearly identified. Lincoln Park Superfund Site May, 2015

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Routing draft procurement agreements or contracts to the originating group Project Manager or their designee. Maintaining record of the approved procurement agreements or contracts.

Cotter’s Project Manager is responsible for establishing the contractual terms and conditions of procurement agreements or contracts with the suppliers based on the purchase requisition or statements of work and supplier input. The Senior Department Head is responsible for the following.  Drafting the scope, schedule and budget portions of the procurement agreements or contracts based on the purchase requisition or statements of work.  Ensuring that the procurement agreements or contracts shall identify how the supplier’s conformance to the technical and quality requirements will be verified.  Reviewing draft procurement agreements or contracts to ensure that they clearly describe the items or services needed and the associated technical and quality requirements.  Approving the procurement and routing the approved agreements or contracts back to the Procurement Specialist for transmittal to suppliers. 4.2.2 Reviewing and Approving Solicitation Responses The Procurement Specialist is responsible for receiving bids or proposals and routing them to the group originating the request. The Procurement Specialist is also responsible for maintaining a record of the selected and approved solicitation. The Senior Department Head reviews bids to ensure the supplier’s conformance to the technical and quality requirements including verifying that there is sufficient evidence (e.g., supporting QA-related documentation, as needed) of the supplier’s capability to meet the agreement or contract requirements. Where the procured material items or services require mandatory qualityrelated documentation (e.g., QAPjPs for contracted laboratory services), the Senior Department Head is responsible for ensuring that the review of the supplier quality-related documentation is delegated to individuals with expertise in those areas. This will ensure that the quality related documents are adequately assessed for conformance with the procurement agreements or contract requirements. Contract laboratory analytical service providers will comply with EPA Policy to Assure Competency of Laboratories, Field Sampling, and Other Organizations Generating Environmental Measurement Data under Agency-Funded Acquisitions, dated March 28, 2011. Review of service provider’s ability to meet this requirement will be conducted by the Program and QA Managers.

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The Program Manager will ensure that the agencies have been notified in writing of changes and additions to contractors and that no written disapproval of a contractor has been received. 4.2.3 Assessing Procured Materials or Services For the procurement of material items, the Senior Department Head of the material receiving group is responsible for verifying the material items and/or services are of acceptable quality, based on objective evidence. This evidence may be as simple as verifying the material item is the specified type or model requested or may include verifying conformance of the services provided against the quality requirements in the agreement of contract. It may also include verifying source selection, source inspections, supplier audits, and examination of deliverables.

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5.0 Quality Assurance-Related Documents and Records This section describes the general processes that document appropriate controls for qualityrelated records. Maintaining quality assurance-related records serves to assure that documentation of QA actions are preserved and that these QA records are accessible. In addition to managing QA records, the control of records ensures compliance with Section XII of the AOC as well as all statutory and contractual requirements for records involving environmental programs. “Records” are defined in Paragraph 52 a. of the AOC as records, reports, documents, and other information (including records, reports, documents, and other information in electronic form) including, but not limited to, sampling, analysis, chain of custody records, manifests, trucking logs, receipts, reports, sample traffic routing, and correspondence relating to the AOC or performance of the Work, as that term is defined in the AOC. Quality Assurance-related documents include those planning documents containing technical and quality requirements or criteria, and program documents that prescribe performance of activities intended to assure quality. The overall Cotter document handling process shall be addressed in a document control procedure. The document control procedure shall describe the process for identifying, preparing, reviewing, approving, issuing, using, authenticating, revising, transmitting, distributing, retaining, accessibility, traceability, and removal of obsolete records and QA-related documents from use. Quality-related documents include this QMP, the site QAPP, task-specific QAPjPs, SAPs, SOPs and the records specified in those documents. The QA Manager has primary overall responsibility for managing QA documents and records. The Environmental Coordinator is responsible for overall management of the documents and records as specified in the document control procedure. The Program Manager is responsible for assessment of the records management system through periodic MSRs and for review and approval of various QA–related documents as identified in the document control procedure. Records and documents pertaining to work completed by Cotter are developed by Cotter program personnel based on information and records generated during the work process. These documents and records are reviewed by the Senior Department Heads and the QA Manager to ensure they accurately reflect completed work. Corrections should be made based on these reviews, as appropriate, before the records and documents are finalized. In general, documents and records will be maintained and preserved in the Cotter Records Room. Records that require immediate retrieval for use in ongoing work activities or review purposes may be stored in individual offices or other areas as long as preservation of the records is not compromised. Additional storage areas may be utilized for records that do not require retrieval for audits or assessments as long as record preservation is not compromised. Lincoln Park Superfund Site May, 2015

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The QA Manager ensures that this QMP and the site QAPP are current through documented periodic reviews. Should one of these documents become outdated due to program changes, the QA Manager will notify the Program Manager who will notify the Agencies, in conjunction with the appropriate Cotter personnel. Cotter and the Agencies shall determine the status of the plan and initiate appropriate action.

5.1 Confidential Documents Confidential business information will be identified by Cotter in any submittal in accordance with Paragraph 52 of the AOC. If confidential business information exists, Cotter shall segregate and clearly identify all records for which business confidentiality claims are asserted. Records that are privileged under the attorney-client privilege or any other privilege will be segregated and marked with the appropriate designation.

5.2 Process for Revising QA-Related Documents and Records QA-related planning documents will undergo periodic review, which may result in the need for revision. All QA-related planning documents shall be reviewed at least annually and the review shall be documented by the QA Manager. Revisions to QA-related documents shall be assigned to the originating group and shall follow the process identified for preparation of QA-related documents in the document control procedure and Section 5, above. Similarly, the process for reviewing, approving, withdrawal, and issuing revised QA-related documents shall also be followed as described in the document control procedure.

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6.0 Computer Hardware and Software Cotter uses only commercially available computer hardware and software. Commercial off-theshelf hardware and software is standardized and used throughout the United States and the world. Cotter shall only use licensed copies of industry standard software on industry standard hardware platforms. Hardware and software compatibility and minimum performance requirements are verified during the procurement process. No independent verification and/or validation testing is planned for these standardized software and hardware products. Software is typically pre-loaded by the hardware provider or is manually loaded as per the supplier’s instructions by the end user. Cotter does not develop any hardware or software. Application-specific testing procedures and quality requirements will be established before any in-house software is developed for Cotter programs.

6.1 Processes Associated with Software/Hardware Use Cotter computer software and hardware use is typically limited to standard commercially available licensed software applications (e.g., Microsoft suite of office programs, etc.) and hardware platforms (e.g., laptop and desktop computers and printers such as Canon, Dell, etc.) to ensure compatibility and functionality. Cotter periodically assesses hardware and software impacts on user performance on a qualitative and informal basis. As user requirements change, appropriate computer hardware and/or software are identified by the user. Minimum quality and performance requirements are identified and documented in the procurement process. Contractors who propose to develop computer software, models or use calculations (other than standard commercially available licensed software applications) will be evaluated under AOC Paragraph 38 and SOW Section 14.1. Electronic records and data management shall be conducted in accordance with a standardized process to ensure that data and information produced from or collected by computers meet applicable requirements and standards. The process for ensuring that data and information produced from or collected by computers or electronic devices meet applicable requirements and standards is addressed through the relevant QA planning documents (e.g., QAPjPs).

6.2 Processes Associated with Software/Hardware Maintenance All hardware is purchased and owned by Cotter. Cotter only uses industry standard, commercially available licensed software. Software is upgraded with licensed upgrades on an asneeded basis when users identify unacceptable performance impacts. Hardware maintenance is Lincoln Park Superfund Site May, 2015

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provided by third party service providers procured with appropriate quality requirements (e.g., licensed and/or certified technicians), as described in the procurement process. 6.2.1 Summary of Roles and Responsibilities The Procurement Specialist is responsible for ensuring that the technical and quality criteria are provided on purchase requests as necessary, for executing the purchase, and for verifying that invoicing is accurate and complete. The Senior Department Heads and their staff are responsible for ensuring that appropriate technical and quality requirements are identified for computer hardware and software acquisitions, identifying and documenting any technical or quality deficiencies in computer or hardware performance or function and for informing the QA Manager of any such deficiencies through the CAIR system process. All program personnel have the responsibility of supporting the procurement process for computer and software items and for reporting performance or compliance issues with computer systems.

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7.0 Planning The EPA defines eEnvironmental data is defined as any measurement or information that describes environmental processes, location or conditions, ecological or health effects and consequences, or the performance of environmental technology.1, 2“information collected from measurements, produced from models, or compiled from other sources such as databases or literature” (EPA, 2006, Section 0.1). Environmental data include andany information collected directly from measurements or obtained from any other sources (i.e., existing/secondary data) such as those complied from databases, data reports, literature, surveys, or produced from models.3 Environmental technology is an all-inclusive term used to describe pollution control devices and systems, waste treatment processes and storage facilities, and site remediation technologies, and their components that may be utilized to remove pollutants or contaminants from or prevent them from entering the environment.2 1 3

universal definition; as defined in ANSI/ASQ E4-2014 EPA Quality Manual for Environmental Programs (CIO 2105-P-01-0)

The purpose of the systematic planning process is to structure and document the complete planning process for collection, assessment, and management of environmental data. The objective of the planning process is to ensure that data are of the appropriate type and quality to meet the program objectives. The program objective is to provide sufficient and appropriate data to support defensible decision-making during the RI/FS process. Project planning for environmental data collection shall address the planning elements identified in the following:      

EPA QA/R-5 (EPA, 2001); National Geospatial Data Policy (CIO2131.0); Guidance for Geospatial Data Quality Assurance Project Plans (QA/G-5G),EPA/240/R03/003, March 2003 (or latest version); FGDC-STD-001-1998, Content Standard for Digital Geospatial Metadata, Federal Geographic Data Committee, June 1998; FGDC-STD-007.1-1998, Geophysical Positioning Accuracy Standards Part 1: Reporting Methodology, Federal Geographic Data Committee, 1998;, aAnd shall consider the guidance in Guidance for Preparing Standard Operating Procedures (G-6), April 2007, EPA/600/B-07/001, EPA QA/G-5 (EPA, 2002) and EPA QA/G-4 (EPA, 2006), or will provide functionally equivalent information.

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Any ongoing environmental sampling and data generation will be considered secondary data. Upon signing the QAPP this secondary data will be evaluated as required by SOW Section 7.

7.1 Systematic Planning Process Description The systematic planning process will address the eight elements identified in the EPA QA/G-4 (EPA, 2006). Those elements are:  Organization.  Project goal.  Schedule.  Data needs (type and quantity, data use).  Performance and/or acceptance criteria.  Data collection.  QA and/or QC activities.  Analysis, evaluation, and assessment (also with respect to QA/QC criteria). This QMP does not require one specific kind of systematic planning, rather it allows for different variations to be adopted, depending on the focus of the study questions. The DQO Process (EPA, 2006), the Observational Method, and the Triad Approach (EPA, 2003a) are acceptable systematic planning methods. However, the DQO Process is recommended by EPA (EPA, 2006; Section 0.6). If the DQO Process is not used, a rationale shall be provided for the selection of other systematic planning processes. The systematic planning process is initiated by a Senior Department Head in coordination with the QA Group. The primary steps from the DQO Process that shall be incorporated into the Cotter systematic planning process include:  Identification of the project planning team including the project manager, necessary project personnel, and scientific experts.  Problem Statement. o Includes identifying and involving the Project Manager/decision maker, and project personnel, and possibly vendors and suppliers. o Includes identifying the project schedule, resources, milestones, and requirements.  Study Goals. o Describes the study goals and objectives.  Information Inputs. o Identifies the type of data needed.  Study Boundaries. o Identifies constraints to data collection.  Analytical Approach. o Identifies the technical methods for data collection. Lincoln Park Superfund Site May, 2015

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o Identifies the performance and/or acceptance criteria for data quality. Data Collection Plan. o Identifies how, when, and where the data will be obtained (including existing data) and identification of any constraints on data collection.  Includes identification of the type and quantity of data needed.  Includes identification of project schedule, resources (including budget), milestones, and any applicable requirements (e.g., regulatory and contractual requirements). o Specifies QA and QC activities to assess the quality performance criteria. o Describes the methods for data analysis, evaluation, and assessment against the intended use of the data and the quality performance criteria. o Identifies how the data will be evaluated and qualified, if necessary. o Describes the roles and responsibilities of project personnel.

A technical team will be assembled to prepare the systematic planning documents considering the EPA QA/G-4 Guidance (EPA, 2006). The Senior Department Head of the originating group or his/her designee shall identify and involve all the necessary and relevant personnel in the planning process. The Senior Department Head of the originating group will review the draft document for completeness, accuracy, and conformance to the elements in the EPA QA/G-4 guidance, as appropriate, and will ensure the document is revised accordingly prior to review by the QA Manager. 7.1.1 Process for Reviewing, Approving, Issuing, Systematic Planning Documents The QA Manager shall review the draft systematic planning document(s). Comments and request for revisions, if any, will be submitted back to the Senior Department Head of the originating group. This review cycle will continue until no further revisions are required. The final systematic planning document(s) shall be approved by the individuals listed in the document control procedure and issued by the QA Manager as defined in the document control procedure. A site QAPP, QAPjP, FSP or SAP will include the 24 elements presented in EPA QA/R-5. Evaluation of any of the preceding documents will follow the requirements of ACO Paragraph 38 and SOW Section 14.1 or SOW Section 8.3 or Section 10, as applicable. 7.1.2 Process for Evaluating Data For Other Purposes or From Other Sources Data collected from sources or for purposes other than those originally intended for a specific work task must still be assessed according to the performance or acceptance criteria for the taskLincoln Park Superfund Site May, 2015

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specific work effort. This data assessment will follow the same process as for the task-specific data assessment. 7.1.3 Planning Document Responsibilities The Program Manager is responsible for the overall conduct, direction, and supervision of remedial activities and environmental programs at the Site. In addition, the Program Manager reviews and approves certain QA-related documents, including this QMP, site QAPP, taskproject-specific QAPjPs, and SAPs as per the document control procedure. The Senior Department Heads are authorized and responsible for developing and drafting revisions of the planning documents including this QMP, site QAPP, task-specific QAPjPs, SAPs, and SOPs. In addition, Senior Department Heads are authorized and responsible for implementing the planning documents, including oversight of data collection and data evaluation or analysis. Third-party contractors may be retained to assist in this process as subject matter experts under the direct supervision of the Senior Department Heads. The QA Manager is authorized and responsible for review, approval, issuing, and control of QA planning documents consistent with the requirements of the document control procedure, for identifying internal QA/QC activities requiring coordination, and implementing that coordination. In addition, the QA Manager is authorized and responsible for the validation and, as needed, qualification of environmental data collected under this program. This includes how collected environmental data are assessed against their intended use and the quality performance criteria.

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8.0 Implementation Of Work Processes The quality management system will be implemented in all aspects of environmental data collection, analysis, evaluation, and management. Any changes to this QMP will be documented in revisions and will receive, at least, Program Manager and QA Manager level approval as well as approval by the Agencies. Implementation of QAPjPs, SAPs or other plans, and SOPs takes place at all levels of the program by all personnel. The quality management system will be implemented through the QA-related documents, which include this QMP, site QAPP, taskspecific QAPjPs, SAPs, and task-specific SOPs.

8.1 Ensuring Work is Performed per Planning and Technical Documents Program and project personnel will receive QA training and QA-related documents associated with their areas of responsibility. The implementation of work processes will be overseen by Project Managers or Field Team Leaders as well as Senior Department Heads, and periodically assessed (e.g., MSRs, TSAs) to ensure that work is performed according to planning and technical documents. Corrective actions will be promptly implemented to ensure program and project objectives are met.

8.2 Identifying Operations Needing Procedures Standard Operating Procedures are appropriate for the following activities:  Complex work processes that contain numerous steps and/or decisions to be made.  Work processes that require the participation of multiple persons.  Routine, standardized, or special sampling, analytical, and quality control activities or critical operations. Note that analytical activities will be performed under EPA Standard Methods or SOP’s evaluated under SOW Section 6. Senior Department Heads are responsible for identifying when work tasks within their area of responsibility need procedures to ensure consistency and quality in work products.

8.3 Preparation, Review, Approval, Revision, and Withdrawal of Procedures All SOPs shall be prepared in a standard format following a consistent process appropriate for the work to be performed. Procedures shall be developed by personnel involved with the specific work task under the oversight of a Senior Department Head. The Senior Department Head ensures that all applicable requirements, standards, and guidelines have been incorporated. The procedure is submitted to the QA Manager and Program Manager for review and approval.

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Procedures will be reviewed at least annually. Changes in program or project requirements, input from project personnel, or the results of performance assessments may result in the need to change an SOP. Revisions to SOPs shall be developed by project personnel who are responsible for the work task under the direction of the appropriate Senior Department Head. Revisions to an SOP will be reviewed and approved in the same manner new SOPs are reviewed and approved. This review will verify that the changes are made as prescribed.

8.4 Procedure Use Policy It is Cotter’s policy that all procedures will be followed and any deviation from approved procedures will be documented and considered during data verification, validation, analysis, or assessment.

8.5 Summary of Roles and Responsibilities As identified in Section 5.2, the QA Manager is responsible for withdrawing superseded SOPs, removal of obsolete documentation from work areas, and documenting that personnel receive the most recent SOPs. The SOPs are controlled QA-related documents and their release, control, and withdrawal will follow the requirements identified in the document control procedure. The QA Manager has the overall responsibility for managing QA documents and records and for review and approval of various QA-related documents. The Environmental Coordinator is responsible for overall implementation and management of document control as identified in the document control procedure. The Program Manager is responsible for assessment of the document control procedure through periodic MSRs and for review and approval of various QA-related documents as identified in the document control procedure.

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9.0 Assessment and Response This section describes how Cotter will assess the effectiveness of its quality program. Cotter will use a variety of internal management and technical reviews, performance evaluations, and QA audits to ensure that the procedures in this QMP are implemented successfully. This chapter also describes Cotter’s commitment to using the results of these evaluations to make any necessary operational adjustments to Cotter’s data collection and analytical procedures, as well as to other aspects of the quality program. Figure 9-1 illustrates the general flow of the QA assessment and response process. It is Cotter’s policy that all personnel are responsible for the credibility and quality of their work. Adherence to written procedures for each program ensures that the highest possible level of data QA/QC will be maintained and that the goals of the QA/QC program described in this QMP are being met. Verification that such procedures are effective and that they are followed is an important component of this QA/QC program. It is each individual’s responsibility to inform the appropriate supervisor and the QA Manager of any deficiencies or potential for improvements when recognized. Therefore, any person who performs work under Cotter quality program documents may initiate a request for action using the CAIR system.

9.1 Assessing the Adequacy of the Quality System The QA practices and procedures described in this QMP will be reviewed at least annually, and revised or updated as needed by the QA Manager. The QA Manager is responsible for coordinating this assessment, arranging meetings of appropriate and necessary personnel to assist with the review and revision, and for incorporating any recommended changes into this QMP or other QA-related documents. Imminent substantive changes to the program requiring revision to this QMP or other QA-related documents will be identified promptly to the QA Manager so review and necessary revisions can be implemented between annual reviews, if necessary. Proposed revisions to other QA-related documents will be presented to Cotter’s Program Manager, who will seek the appropriate approvals from the Agencies. 9.1.1 Planning, Implementing, Documenting, and Report Assessments 9.1.1.1

Assessment Tools

Cotter employs several QA assessment tools designed to assess and improve the components of quality program, including the Crosswalk. Auditing, both internal programmatic and external QA audits, is one of the principal tools for determining the effectiveness of the quality program components. QA audit frequency and scheduling will vary with the type of review conducted. The following paragraphs in this section provide a description of some of the evaluation tools.

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Tables 9-1 Summary of QA Document Reviews Frequency and 9-2 Summary of QA Assessments Frequency provide further information on assessments. The Crosswalk will be completed for assessments as previously stated in this QMP. Management System Reviews An MSR is an assessment of Cotter’s QA management practices and data collection procedures, and is generally performed by Cotter’s Program Manager and QA Manager, though a qualified third-party may assist or be delegated the review. An MSR will be conducted for each major program system on a four-year cycle. Cotter MSRs generally focus on adherence to this QMP, the site QAPP, as well as the implementation of QA practices within a quality program. The major program systems include the following:  Field data collection.  Laboratory analyses.  Data verification and validation.  Records and data management. The MSR will qualitatively assess a system to determine if Cotter’s quality management system is adequate to ensure the quality of the data. The MSR shall address the following elements:  Effectiveness of management controls in achieving and assuring data quality.  Adequacy of resources and personnel devoted to QA functions.  Effectiveness of training and assessments.  Applicability of data quality requirements. While MSRs can identify significant QA concerns and areas of needed improvement, they also point out noteworthy accomplishments. Management System Reviews will be conducted considering the Guidance on Assessing Quality Systems, EPA QA/G-3 (EPA, 2003b). Cotter may also make occasional use of independent, outside reviews of its quality assurance practices. When electing to use an outside source, the QA Manager, in consultation with the Program Manager, will make arrangements for such a review by selecting a qualified reviewer(s) and following the procurement process described in Section 4. The goals and objectives of this type of review will be the same as if the assessment were conducted internally. Technical Systems Audits A TSA is conducted to assess any portion of the environmental data collection, sample analysis, data management, and assessment systems. The QA Manager will use TSAs to evaluate Lincoln Park Superfund Site May, 2015

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laboratory and field procedures used by Cotter personnel and contractors. TSAs can entail comprehensive, on-site evaluation of the field equipment, sampling and analyses procedures, documentation, data validation, and training procedures for collecting or processing environmental data. A TSA will be conducted on at least one selected portion of each major system area at least annually. TSAs may be routinely planned by Cotter’s QA Manager, specifically requested by Cotter’s Program Manager or Senior Department Heads, or result from the findings of another audit or review. Cotter’s QA Manager is responsible for assembling the audit team. Results will be reported to the audited group in the form of a written report. Copies of the TSA audit final report will be stored in the project file and also with the QA Manager. Additional copies will be distributed as appropriate. Both laboratory and field TSAs may be performed, though a TSA can be performed on any system in the quality program. Laboratory TSA The TSA may be conducted on the Cotter Laboratory, contract laboratories, and contract laboratories of consultants and contractors who submit analytical data to Cotter. The TSA may be conducted on other state or federal agency laboratories that perform sample analysis for the Cotter RI/FS. The primary goals of the TSA will be to review the laboratory organization, operation, and capabilities, determine the reliability of data, and note corrective action for any apparent deficiencies. Auditors for TSAs will be selected by the Cotter QA Manager and Program Manager based on their technical proficiency in the subject area. The designated auditors will be responsible for planning and conducting the audit, and reporting the findings to the Cotter laboratory manager, QA Manager, and Program Manager. Field TSA Oversight of field operations is an important part of the quality assurance process, and the QA Manager may conduct QA audits of field sampling activities, both for its own field operations, and on those contractors and state and federal agencies that collect samples for the RI/FS or license termination process. Cotter will specify frequency and procedures for conducting field TSAs within specific program areas. During any MSRs or other QA audit or when QAPjP are reviewed, the QA Manager will determine the necessity of an associated field TSA. 9.1.1.2 Assessment Planning Assessment personnel will be selected by the QA Manager and Program Manager and shall have the following attributes:  No real or perceived conflict of interest.  No direct involvement or responsibility for the work being assessed. Lincoln Park Superfund Site May, 2015

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Demonstrated and/or documented competence, experience and/or training for assessment of the specific area of focus.

The Program Manager will ensure that assessment personnel have sufficient authority, access to programs and managers, access to documents and records, and a corporate mandate to ensure organizational freedom to candidly and objectively assess and report findings. Table 9-1 Summary of QA Document Reviews Frequency

Frequency QA Document Reviews1

QMP 5 yr

Site QAPP 1 yr

QAPjP

SOP

SAP

1 yr

1 yr

*

1

Specified frequency is a maximum interval between reviews, additional reviews & revisions as program changes necessitate. *As needed due to project changes but at least annually if work effort duration exceeds 1 yr.

Table 9-2 Summary of QA Assessments Frequency Assessment Type MSR TSA

Program Assessment RI Field Program

QA Status Report Annual

Annual Water Sampling Soil Sampling Air Sampling Other Data Collection

Annual Annual Annual Annual

Lab Program QA Program Data Verification & Validation Data & Records Management Training & Qualifications CIAR System FS Engineering/Design

Annual Annual Bi-annual Bi-annual Annual Annual Annual

9.2 Response and Corrective Actions The purpose of the response to identified technical or QA-related issues is to promote continuous improvement. Quality can only be maintained or improved if action is taken 1) to correct deficiencies when noted or 2) to improve the system when the potential for improvement is discovered. The need for correction or improvement may be detected through personal involvement, observation, communication, or formal assessments. The CAIR system is the Lincoln Park Superfund Site May, 2015

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primary system that Cotter’s quality program uses for initiating and documenting corrective actions and improvements. Management will review QA program assessment reports in a timely manner and develop appropriate responses to the assessment findings. Corrective actions, if any, will be implemented promptly, documented, and their effectiveness confirmed using the CAIR system process. Figure 92-1 illustrates the general flow of the QA assessment and response process. Figure 9-1 depicts the QA Program assessment and response general process flow, as stated in the title and is designed to be consistent with and as a continuation of the process identified in Figure 2-1. The figure is read in the same manner as described for Figure 2-1, discussed in Section 2.1. The operation of the CAIR system shall be documented in a procedure and is summarized below:  A need for action is detected.  A request of corrective action or improvement is sent to the QA Manager.  The QA Manager promptly investigates the request.  If the request is substantive, a responsible party is promptly identified and notified.  The responsible party promptly evaluates the request, determines a response, and establishes a response through the QA Manager.  The QA Manager and Senior Department Head and project personnel, if necessary, are informed of the request, response, and proposed action.  The QA Manager and Senior Department Head approve, disapprove, or comment on the request and/or proposed improvement or corrective action.  Once the proposed action is approved, the responsible person promptly oversees implementation of the approved action.  The QA Manager monitors the action and verifies its effective completion, and documents close out of the request.  Effectiveness of the action may be assessed using additional formal assessments, informal reviews, and direct observations.  The Program manager reviews CAIR system documentation prior to corrective action close out and filing of the documentation. 9.2.1

Roles and Responsibilities for Assessments, Responses, and Corrective Actions

The Program Manager is responsible for performing or assisting in a MSR and other QA assessments, as appropriate, reviewing QA-program assessments in a timely manner, and reviewing CAIR system actions prior to implementation and close out. The QA Manager is responsible for selecting the assessment tool(s), coordinating assessments, arranging meetings of appropriate and necessary personnel, and implementing the improvements Lincoln Park Superfund Site May, 2015

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or corrective action through the CAIR system process. It is the QA Manager’s responsibility to assure that the goals of the QA/QC program described in this QMP are being met. This includes managing the quality of work systems by coordinating improvement and corrective actions. The QA Manager does this by maintaining the CAIR system. The QA Manager also informs the Program Manager of requests and action taken and significant findings of any follow-up. The QA Manager has the authority to determine level of involvement of program personnel, depending on type of action requested. Senior Department Heads and other program personnel are responsible for promptly notifying the QA Manager of any needed changes to the program requiring revision of which they are aware. 9.2.2 Dispute Resolution The organization through which disputes will be escalated is depicted in Figure 1-1. The dispute resolution process is illustrated in a general manner in Figures 2-1 and 9-1 through the revision steps (e.g., Steps B.3 through C.1 and Steps D.3 through E.)1. The following language has been added to the QMP Section 9.2.2. Quality assurance dispute resolution will first be handled at the level at which it is identified between the identifying individual and the individual’s manager. If technical resolution at that level is not achieved, the QA dispute will be escalated to the manager’s Senior Dept. Head, or the QA Manager. The Program Manager has final authority over Cotter QA dispute resolution. Quality program disputes and their resolution will be addressed in QA status reports.Disputes regarding resolution of QA issues through the CAIR system will be escalated through the organization structure (Figure 2-1). The Program Manager has final authority over Cotter QA dispute resolution. Quality program disputes and their resolution will be addressed in QA status reports.

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10.0 Quality Improvement Cotter management actively supports quality improvement by encouraging Cotter personnel to implement the following behaviors:  Continually evaluate the effectiveness of current policies, procedures, and practices through proactive communication.  Apply innovative approaches while maintaining integrity and accuracy.  Conduct regular management reviews and assessments to define and acknowledge success while recognizing and eliminating undesirable processes or results. The above behaviors are achieved by continually communicating and assessing work performance, both formally and informally, and by committing appropriate resources to Cotter’s quality program efforts. Communication and assessments will enable the constant evaluation of Cotter activities, projects, and individual staff performance. All program personnel are encouraged to establish communications between work groups, identify process improvement opportunities, and identify and propose solutions for problems. Improvement can take the form of preventing quality problems from occurring by adjusting current work processes, or by seeking out better ways to do the work. The quality management system and processes seek to prevent quality problems from occurring, recognize challenges early, and acknowledge success. Continual improvement is achieved through consistent evaluations of program, project, and individual performances. Regular oversight allows Cotter to reshape the quality program systems to reflect changing methods or procedures.

10.1 Program Reviews It is the responsibility of Cotter management to assure appropriate staff participation in all program reviews (i.e., MSR, TSA) and to regularly review all QA activities of their staff, to determine that SOPs are in place and to revise them if necessary, to ensure that task-specific QAPjPs are written and approved in advance of project start-up, and to ensure that data quality assessments are made. All deviations and discrepancies noted during any external or internal assessment will be corrected promptly. Recommendations for modifications to this QMP will be forwarded in writing using the CAIR system to the QA Manager for investigation, implementation, and inclusion during regular review sessions, as described in Section 9.1.

10.2 Project Reviews It is the responsibility of Senior Department Heads and Project/Field Team Managers to request project reviews and/or QA audits when the need for such a review or audit is identified and to identify where improvements can be made. This process is started during the determination of DQOs and is finalized during the assessment of data quality. All corrective actions required Lincoln Park Superfund Site May, 2015

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during the life cycle of the project are to be filed with the QA Manager, who shall maintain them in the quality program files.

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11.0 References Cotter, 2009. Quality Assurance Program Plan for Environmental and Occupational Sampling and Monitoring Studies. Environmental Alternatives Inc, May 22, 2009. EPA, 2001. Requirements for Quality Management Plans; EPA QA/R-2; E PA/240/801/002; March, 2001 EPA, 2001. EPA Requirements for Quality Assurance Project Plans, EPA QA/R-5. EPA/240/B-01/003. March, 2001. EPA, 2002. EPA Guidance for Quality Assurance Project Plans, EPA QA/G-5. EPA/240/R02/009. December, 2002. EPA, 2003a. EPA Using the Triad Approach to Streamline Brownfields Site Assessment and Cleanup – Brownfields Technology Primer Series. June, 2003. EPA, 2003b. Guidance on Assessing Quality Systems, EPA QA/G-3. EPA/240/002. March, 2003. EPA, 2006. EPA Guidance on Systematic Planning Using the Data Quality Objectives Process, EPA QA/G-4. EPA/240/B-06/001. February, 2006. Quality Assurance Program Plan for Environmental and Occupational Sampling and Monitoring Studies. Environmental Alternatives Inc, May 22, 2009. Quality Assurance Program Plan For the Cotter Corporation Canon City Mill Environmental Sampling and Monitoring Studies. Revised March 5, 1999. Quality Assurance/Quality Control Plan for the Cotter Corporation Canon City Mill Remedial Action Plan Technical Sampling and Monitoring Studies. Revised June 30, 1993. Quality Assurance/Quality Control Plan for the Cotter Corporation Canon City Mill Remedial Action Plan Technical Sampling and Monitoring Studies. Revised January 5, 1989. Cotter Corporation Canon City Mill Radiochemistry Quality Assurance Program. July, 1983, Revised November, 1985. Quality Assurance Plan for the Cotter Corporation Environmental and Occupational Monitoring Program Canon City Mi1l. November 1, 1984. Lincoln Park Superfund Site May, 2015

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Cotter Corporation Canon City Mill Radiochemistry Quality Assurance Program. July, 1983.

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FIGURES

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Figure 1

Site Location

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Figure 1-1 Cotter Quality Assurance Program Organization

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Figure 2-1 General Quality Assurance Program Process Flow Chart

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Figure 9-1 Assessment and Response General Process Flow Chart

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APPENDIX 1 (AOC/SOW)

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