Final Quality Management Plan

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TABLE OF CONTENTS

1 INTRODUCTION ...................................................................................................... 1
1.1 Commitment to Quality........................................................................................ 1
1.2 QA Program Principles ........................................................................................ 1
1.2.1 Client Satisfaction ......................................................................................... 1
1.2.2 Employee Participation ................................................................................. 2
1.2.3 Problem Prevention ....................................................................................... 2
1.2.4 Continuous Quality Improvement................................................................. 2
1.3 Quality Assurance Program Components ............................................................ 3
1.4 QMP Objectives ................................................................................................... 3
1.5 QMP Scope and Organization .............................................................................. 4
2 QUALITY MANAGEMENT SYSTEM .................................................................... 5
2.1 General ................................................................................................................. 5
2.2 Management Commitment ................................................................................... 5
2.3 Management Organization and Responsibilities .................................................. 6
2.3.1 President ........................................................................................................ 6
2.3.2 Quality Assurance Officer ............................................................................ 6
2.3.3 Project Manager ................................................................................................ 7
2.3.4 Project Quality Control Reviewer ................................................................. 8
2.3.5 Task Manager................................................................................................ 9
2.4 Personnel Qualifications, Development, and Training ........................................ 9
2.4.1 Internal Programs .......................................................................................... 9
2.4.2 External Programs ....................................................................................... 10
2.5 Project Management ........................................................................................... 10
2.6 Subcontractor Management................................................................................ 11
2.7 Document Control and Records Management ................................................... 12
2.8 Computer Hardware and Software Systems....................................................... 12
2.9 Work Processes and Systems ............................................................................. 13
2.10 Quality Control Review .................................................................................. 14
2.10.1 Project Scope and Objectives...................................................................... 15
2.10.2 Report Outline ............................................................................................. 16
2.10.3 Data Collection Rationale ........................................................................... 16
2.10.4 Data Collection Methods ............................................................................ 16
2.10.5 Factual Conclusions/Findings ..................................................................... 16
2.10.6 Opinions and Recommendations ................................................................ 17
2.10.7 Technical Reviews and Professional Registrations .................................... 17
2.10.8 Standard of Practice .................................................................................... 17
2.10.9 The Client's Perspective .............................................................................. 17
2.11 Management Assessment ............................................................................... 17
2.11.1 Quality Assurance Audits ........................................................................... 18
2.11.2 Corrective Actions ...................................................................................... 19
3 DATA ACQUISITION AND MANAGEMENT ..................................................... 20
3.1 General ............................................................................................................... 20
3.2 Planning and Scoping ......................................................................................... 20

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3.3 Data Collection Systems Design ........................................................................ 22
3.4 Planning Documents .......................................................................................... 23
3.4.1 Work Plan ................................................................................................... 23
3.4.2 Field Sampling Plan (FSP) ............................................................................. 24
3.4.3 Quality Assurance Project Plan .................................................................. 24
3.4.4 Health and Safety Plan (HASP) .................................................................. 25
3.5 Implementation of Data Acquisition Activities ................................................. 25
3.5.1 Sample Custody .......................................................................................... 26
3.5.2 Calibration Procedures ................................................................................ 26
3.5.3 Internal Quality Control Procedures ........................................................... 26
3.5.4 Preventive Maintenance .............................................................................. 27
3.5.5 Procurement Control ................................................................................... 27
3.5.6 Geospatial Data ........................................................................................... 27
3.6 Assessment of Data Usability ............................................................................ 28
3.6.1 Data Reduction............................................................................................ 28
3.6.2 Data Validation ........................................................................................... 29
3.6.3 Data Reporting ............................................................................................ 30
3.6.4 Data Assessment ......................................................................................... 30
3.7 Performance and System Audits ........................................................................ 30
3.8 Corrective Actions.............................................................................................. 32
4 DESIGN, CONSTRUCTION, OPERATION OF ENGINEERED SYSTEMS ....... 33
4.1 Project Planning and Scoping ............................................................................ 33
4.2 Project Organization ........................................................................................... 34
4.3 Design Phase Quality Control Reviews ............................................................. 34
4.3.1 Design Document QC Checking................................................................. 35
4.3.2 Quality Control Reviews............................................................................. 35
4.3.3 Value Engineering Reviews ........................................................................ 36
4.3.4 Constructibility/Biddability Reviews.......................................................... 36
4.4 Construction Phase Quality Control Reviews .................................................... 37
4.5 Operations and Maintenance Procedures ........................................................... 37
4.6.1 Procedures/Responsibilities for Inspection and Acceptance Testing ......... 39
4.6.2 Procedures for Tracking Inspection and Acceptance Test Results ............. 39
4.6.3 Tracking Deficiencies ................................................................................. 40
4.6.4 Field Reporting System............................................................................... 40
4.6.5 Testing Procedures ...................................................................................... 40
4.6.6 Calibration and Control of Measuring and Testing Equipment .................. 41
4.7 Corrective Actions.............................................................................................. 41
5 REFERENCES ......................................................................................................... 43

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LIST OF TABLES
Table 1 - Comparison between QMP and EPA Requirements for Quality Management
Plans

LIST OF FIGURES
Figure 1 - Functional Organization Structure

APPENDIX A – STANDARD OPERATING PROCEDURES


Document Control Procedures
Control of External Documents
General Checking and Review Procedure

APPENDIX B
Form B-1: Project Planning and Scoping Checklist
Form B-2: Quality Control Review Checklist
Form B-3: Quality Assurance Audit Checklist
Form B-4: Quality Assurance Audit Form

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LIST OF ACRONYMS

ANSI American National Standards Institute


ASQC American Society for Quality Control
ASTM American Society for Testing and Materials
CQAP Construction Quality Assurance Plan
DQO Data Quality Objective
EPA U.S. Environmental Protection Agency
FSP Field Sampling Plan
HASP Health and Safety Plan
EMSI Engineering Management Support
O&M Operation and maintenance
PARCC Precision, accuracy, representativeness, comparability, and completeness
PPM Project Procedures Memorandum
QA Quality Assurance
QMP Quality Management Plan
QAPP Quality Assurance Project Plan
QC Quality Control
SAP Sampling and Analysis Plan
SOP Standard Operating Procedure
UST Underground storage tank

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1 INTRODUCTION

1.1 Commitment to Quality

Since its founding in 1994, Engineering Management Support (EMSI) has had a strong
commitment to quality. EMSI is dedicated to the achieving technical and management
excellence and to delivering professional environmental and engineering services that
meet or exceed our clients' needs. Our Quality Assurance (QA) Program has evolved in
response to client needs, an evolving state of the practice, and concerns regarding
liability.

This Quality Management Plan (QMP) describes EMSI's QA Program, which is based on
four principles: client satisfaction, employee participation, problem prevention, and
continuous quality improvement. These principles are discussed below and embodied in
our corporate quality vision, which states:

Commitment to client needs and expectations,


from all EMSI team members,
provides technically competent, timely and
cost-effective solutions.

1.2 QA Program Principles

EMSI's QA Program establishes minimum quality standards for performance and


procedures for assuring that our clients receive quality service. EMSI's QA Program
requires the participation of employees at every level. It encourages Project Managers
and technical staff to take pride in their work and responsibility for ensuring that the
work is done correctly the first time. The program is designed to reduce the incidence of
problems related to quality and result in implementation, where necessary, of corrective
actions and modification of work procedures, where necessary, to reduce the incidence of
future problems.

1.2.1 Client Satisfaction

Client satisfaction is achieved when EMSI meets or exceeds the expectations of the
client. Quality standards are typically established for each project based on the client's
industry or business practice, regulatory requirements affecting the industry and project,
and the professional standard of care. In addition to the technical aspects of a project,
EMSI Project Managers concentrate their management efforts on responsiveness, timely
delivery, and cost effectiveness.

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A proactive approach to the client's needs and expectations is the key to client
satisfaction. The Project Manager is the primary point of contact: EMSI's Project
Managers are urged to work closely with their clients to assess client needs and receive
feedback on project performance.

1.2.2 Employee Participation

EMSI recognizes the value of having its employees at all levels participate in the QA
program. Opportunities are continuously sought for encouraging employees to improve
the quality of their work. EMSI's President encourages participative management by
soliciting input from project managers and staff before issuing company policies and
procedures.

1.2.3 Problem Prevention

Through its QA Program, EMSI reduces the potential for problems to occur. The
procedures in EMSI's QA Program are, therefore, based on the principles of problem
prevention, liability reduction, risk management, and loss prevention.

The steps necessary to assure the quality of EMSI work products and services are
summarized below:

 Make sure the work performed will satisfy the client's objectives;

 Perform work correctly the first time;

 Have all work checked;

 Correct errors where they occur;

 Modify work processes to reduce or eliminate future errors; and

 Demonstrate that the QC procedures have been followed through QC review


signatures and QA audits.

1.2.4 Continuous Quality Improvement

The final principle of EMSI's QA Program is continuous quality improvement. The QA


Program advocates systematic planning, implementing, assessing, and correcting in an
incremental process that results in a net long-term improvement. Continuous
implementation of activities designed to achieve this principle results in higher value to
our clients over time.

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1.3 Quality Assurance Program Components

EMSI's QA Program consists of the following related components, summarized below:

 Assignment of Responsibilities - The Company designates personnel with the


responsibility and authority to implement the QA Program. Roles and authorities
are clearly defined. All staff levels have responsibilities under the program.

 Training and Development - Quality awareness seminars are part of the EMSI
employee training program. Topics covered include project planning, QC
procedures, client relationships, liability issues, and loss prevention. In addition,
training on the fundamentals of project management problem/loss prevention is
available to Project Managers.

 Written Policies and Guidance - The company maintains written guidance


including procedures for many commonly performed work activities. These
documents serve to assist project managers and staff to provide a quality of
service that meets or exceeds the standard of practice.

 Quality Control Review - EMSI projects are assigned a QC reviewer responsible


for assuring that project processes and documents have been properly reviewed by
qualified professionals. Problems are communicated to the Project Manager and
corrected.

 Quality Assurance Audits - EMSI projects are subject to unannounced audits to


assure project procedures including QC review are followed at all times.

 Work Process Analysis - Where a need for improvement is identified, EMSI staff
will analyze the problem and develop ways to improve EMSI management and
project systems. Efforts to simplify work processes, while maintaining high
quality standards, are ongoing.

 Change Management - Recommended quality improvement measures identified


by work process analysis are communicated to EMSI staff.

1.4 QMP Objectives

The QA Program described in this QMP is designed to monitor the effectiveness of


EMSI's engineering and environmental data collection operations; report preparation; and
the design, construction, operation, and monitoring of engineered systems. Where
necessary, the QA Program is designed to correct situations where corrective actions are
required.

This QMP was developed to achieve three primary objectives.

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 It defines EMSI's QA Program. The QMP is designed to be responsive to federal
government agency quality standards, while addressing industry standards. See
Table 1 for a comparison between this QMP and EPA Requirements for Quality
Management Plans (EPA QA/R-2). The EMSI QA Program will be consistent
with EPA Order 2105 (Mandatory Agency-Wide Quality System), EPA 2105P
(EPA Quality Manual), EPA Order 2106 (Quality Policy) and QA/R-2 (EPA
Requirements for Quality Management Plans). These documents are referenced as
the foundation for implementing quality assurance for the Vasquez Boulevard I-
70 Operable Unit 2 project.

 It is a “bridging document” between EMSI’s QA policy, our procedures and


guidelines, standard operating procedures (SOPs), and project Quality Control
(QC) procedures.

 It establishes a framework for planning and implementing EMSI projects so that


quality standards of the client and relevant regulatory agencies are met.

To assure that EMSI’s QA Program remains adequate for the type of work being
performed by EMSI, this QMP and attached QA documents will be reviewed annually by
EMSI’s QA Manager.

1.5 QMP Scope and Organization

The scope of the plan encompasses the QA aspects of EMSI's science and engineering
operations. The manual follows a three-part format used by ANSI/ASQ-E 2014 for
Quality Assurance of Environmental Programs:

 Quality Management System - Common QA Program elements, regardless of the


type of project, are described in Section 2.

 Data Acquisition and Management Program elements related to planning,


implementing, and assessing operations to collect, analyze, and evaluate physical,
chemical, biological, geological, ecological, and engineering data, are described
in Section 3.

 Design, Construction, and Operation of Engineered Systems Program elements


that pertain to the design, construction, and operation of engineered processes or
systems are described in Section 4.

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2 QUALITY MANAGEMENT SYSTEM

2.1 General

Implementation of any quality program requires a management system available to all


Project Managers, regardless of the client, project type or phase of project operations.
Elements of this system include:

 Management commitment;

 Management organization;

 Written policies, procedures, and guidance;

 Personnel qualifications, development, and training;

 Project management;

 Subcontractor management;

 Document control and records management;

 Computer hardware and software systems;

 Work processes and systems;

 Quality control review; and

 Management assessment.

This section describes these key elements of EMSI's Quality Management System. Some
of these elements are addressed in more detail in Sections 3 and 4 as they pertain to
project execution.

2.2 Management Commitment

EMSI management is committed to the principles and practices of its QA Program at the
highest level. Senior management recognizes and accepts its responsibility to identify the
quality requirements that will meet client needs and expectations and create the business
and professional environment where all employees take responsibility for the quality of
their work. EMSI's QA Program focuses on preventing quality problems.

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2.3 Management Organization and Responsibilities

The QA management system is independent of EMSI administrative and project


management systems: it receives its authority directly from the President.

An organization chart showing key QA positions is presented on Figure 1. The following


sections describe QA personnel roles and responsibilities.

2.3.1 President

The President is ultimately responsible for all quality-related functions. The President's
QA responsibilities are to:

 Authorize the issuance of the QA Policy;

 Direct the implementation of QA objectives, plans, and policies;

 Approve the issuance of this QMP;

 Appoint the Quality Assurance Officer who directs the QA Program; and

 Approve the QA implementation strategy.

2.3.2 Quality Assurance Officer

The QA Officer manages the QA Program and is responsible for the technical quality of
all work products in the company and the development and maintenance of a sufficient
level of technical resources to support the company's quality objectives. The QA Officer
reports to the President and has the authority to halt the transmittal of any work product
that in his or her opinion is not consistent with the Company’s quality or loss prevention
standards. The QA Officer's primary duties are to:

 Provide a central point of responsibility for assessing company-wide technical


strengths, needs and direction in order to maintain a consistent Company-wide
quality of work that meets or exceeds the current standard of practice;

 Develop the Company-wide QA Policy and QMP;

 Coordinate QA training;

 Provide guidance to the QC Reviewers in carrying out QC-related functions;

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 Inform project personnel of QA policies, procedures, and other guidance
documents;

 Schedule and/or conduct quality awareness seminars for project personnel;

 Assist in preparation of Quality Assurance Project Plans (QAPPs) or review


QAPPs, to become familiar with the QA activities at the project level and to
understand the lines of communication between the QC Reviewer (described
below), the QA officer, and the Project Manager (described below). These lines
of communication are necessary for the QA Officer to be informed of the
project’s QC activities and to effectively work with the QC reviewer to address
QA concerns in a timely manner;

 Audit selected EMSI projects and monitor general compliance with the QA
Policy;

 Advise Project Managers of deficiencies based on peer reviews or audits and


identify corrective action needs. Review the effectiveness of the QA Program
with the President; and

 Maintain corporate/office QA files, including any audit and QA Program progress


reports.

2.3.3 Project Manager

Each EMSI project is directed by a Project Manager who has overall responsibility for
the project, including client liaison, planning document preparation, technical quality of
work performed, data acquisition, report preparation, and presentations, as well as budget
and schedule management. The Project Manager is also responsible for determining that
staff assigned to the project understand and comply with the QC procedures that apply to
their activities. The Project Manager's QA-related responsibilities are to:

 Review and approve project controlling documents, including QAPPs, Work


Plans, Sampling Plans, standard operating procedures (SOPs), and contract
documents;

 Select additional technical reviewers with the project QC Reviewer, if needed;

 Communicate project scope requirements to project team members;

 Communicate with the client for feedback on service satisfaction;

 Ensure that project deliverables and activities are in accordance with project
controlling documents;

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 Respond to corrective action requests and assure that deficiencies are corrected in
a timely manner; and

 Communicate with the project QC Reviewer on quality issues.

2.3.4 Project Quality Control Reviewer

At a minimum, a QC Reviewer is assigned to each project. The QC Reviewer has overall


responsibility for all project QA issues. The QC Reviewer reports to the Project
Manager, but also maintains a direct communication link and reporting relationship with
the QA Officer on quality-related matters. Any audits performed by the QC Reviewer
are circulated to the Project Manager and QA Officer. As well, any non-conformance
with QC procedures identified by the QC Reviewer are reported to the Project Manager
and QA Officer, along with recommended corrective measures and timeframes for
implementation. Progress on resolving a non-conformance is shared with the Project
Manager and QA Officer. The QC Reviewer's responsibilities are to:

 Work with the Project Manager to select additional QC reviewers or qualified


professionals to check design documents, as appropriate, to assure compliance
with all applicable Standard Operating Procedures listed in Appendix A;

 Review validation of field and subcontractor laboratory data with respect to QC


criteria;

 Review and approve all project QA documents;

 Conduct project QA audits of field operations and subcontracted laboratories;

 Review project documents;

 Communicate review comments to project team members;

 Develop, with the Project Manager, corrective actions when appropriate; and

 Follow up to assure planned corrective actions have been completed.

Standard Operating Procedures that are applicable to the VB/I70 project are PRO-QA-
004 (Document Control Procedures and Control of External Documents) and PRO-QA-
012 (General Checking and Review Procedures). They are presented in Appendix A.
If the project becomes sufficiently large or complex, QC Reviewers may be assigned to
specific portions of the project and the EMSI QA Officer may be assigned to the project
to have overall responsibility for all project QA issues and the coordination of all project
QC Reviewers.

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2.3.5 Task Manager

A Task Manager is a professional responsible for a particular project task. The Task
Manager's responsibilities are to:

 Prepare project technical memoranda for the project task(s);

 Oversee data collection and analysis and determine that appropriate procedures
are employed;

 Prepare reports or report sections related to the project task(s);

 Ensure that all task deliverables are in accordance with project controlling
documents;

 Correct deficiencies and nonconformities identified for the project task(s);

 Keep the Project Manager and QC Reviewer informed of project requirements


and changes in requirements; and

 Coordinate technical review requirements with the Project Manager and QC


Reviewer.

2.4 Personnel Qualifications, Development, and Training

All EMSI employees must meet a minimum requirement of a master’s degree for
education, have 15 years of relevant professional experience, and have professional
registration(s) where appropriate. EMSI's project managers are responsible for assigning
only qualified personnel to project activities.

EMSI provides for and encourages professional development through professional


development and training programs. These activities are planned and monitored by
EMSI's President and can include internal and external programs.

2.4.1 Internal Programs

 Quality Awareness Seminars: Seminars and informal presentations on the scope


and implementation of EMSI's QA Program and other quality management topics.

 Health and Safety Training: Training required to meet federal statutes for
employees performing work under specific conditions.

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 Project Management Training: Training workshops, focused seminars, and
continuing education for EMSI's Project Managers.

 Loss Prevention Training: Seminars and training workshops for all EMSI staff.

 Technical Training: On-the-job training for specific job responsibilities, seminars


on specific technical subjects, workshops focused on specific service areas.

2.4.2 External Programs

 Continuing Education: Funding of college level course work;

 Seminars/Short Courses: Selectively funded by EMSI for individuals requiring or


desiring specific technical training through a non-degreed program;

 Publications: EMSI encourages its staff to publish articles in peer-reviewed


journals and trade magazines and to prepare and present technical papers at
technical conferences;

 Membership in Professional Societies/Organizations: EMSI encourages


membership in relevant professional societies and provides professional fees for
membership; and

 Professional Licenses: EMSI pays for professional licenses for individuals based
on the requirements of our clients, projects, or the states within which we operate.

2.5 Project Management

The Project Manager is the primary link between EMSI and its clients and is responsible
for furnishing the client a work product or service that meets the functional, technical,
cost, and schedule requirements of the project. The Project Manager is assisted by
technical staff, the designated QC Reviewer, and other Technical Reviewers.

EMSI recognizes the importance of strong project management skills and their
applications. EMSI's project management training activities provide Project Managers
with tools to help perform effectively through all stages of a project. The training is
designed to hone their interpersonal, time management, business, and communication
skills, help them be responsive to clients, manage budgets and schedules, lead project
teams, and meet the desired quality standards of the work.

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2.6 Subcontractor Management

Requirements to ensure adequate quality of subcontractor products or services are


included or referenced in EMSI's procurement documents; these include bid requests,
purchase orders, and contracts. Changes to a procurement document are subject to the
degree of control used in preparing the original document.

Procurement documents state applicable requirements for technical performance, quality,


acceptability, and documentation, as follows:

Technical Performance:

 General requirements (scope of work);

 Appropriate codes and standards;

 Material composition, or physical/chemical requirements;

 Quantity and scheduling requirements;

 Work procedures;

 Testing and calibration requirements;

 Performance and accept/reject criteria; and

 Reporting requirements.

Quality. Quality requirements that a subcontractor must satisfy depend on the purpose of
the procurement, the degree of contractor independence, and client requirements. The
right to stop work for significant quality problems should be clearly stated in all contract
documents. The control of purchased items and services will include procurement source
evaluation and selection and subcontractor performance control, including inspections
and audits where appropriate.

Acceptability. Purchased items or services are controlled by invoking appropriate


quality-related requirements and elements of this QMP. To verify acceptability, the
procurement documents will provide for EMSI access to subcontractor facilities, work
areas, and records.

Documentation. The contract should specify EMSI rights and procedures the
subcontractor must follow for preparation, control, and retention of documentation.
Subcontractor submittals of nonconformance, work progress, and results will be specified
in the procurement documents.

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2.7 Document Control and Records Management

Documents developed and used by EMSI personnel, subcontractors, and vendors to


describe work processes and/or specify EMSI work activities are controlled in
accordance with the PRO-QA-004 (Document Control Procedures), PRO-QA-005
(Control of External Documents), and PRO-QA-012 (General Checking and Review
Procedures) in Appendix A. These policies and procedures address general requirements
for the preparation, review and approval, and issuance and revision of documents.
Project-specific procedures for preparing and approving documents are established by
Project Managers and distributed to all project personnel.

A document is considered a completed record when it has finished full processing and is
logged into the project file index. Completed project records should be maintained in a
secure location to facilitate retrievability and provide protection from deterioration.
Documents to be controlled include those documents and/or computer-generated records
that specify project requirements such as:

 Proposals;
 Contracts and subcontracts;
 Purchase orders;
 Cost estimates;
 Work plans, instructions and procedures;
 Calculations;
 Data quality standards;
 Technical reports;
 Drawings and specifications;
 Inspection and test reports;
 Correspondence; and
 Invoices and related backup.

The Project Manager is responsible for project document control. This responsibility
includes establishing a records management system to control both printed paper copies
and documents and data stored in electronic media. The records management system
should address procedures and responsibilities for the preparation, review and approval,
collection, custody and control, indexing, fling, distribution, safe storage, maintenance,
retrieval, and retention/destruction of company and project records. Written records
management and document control procedures should also be furnished by EMSI
subconsultants, subcontractors, and vendors.

2.8 Computer Hardware and Software Systems

All computer hardware used for the storage and manipulation of scientific or engineering
data shall be selected considering its intended use. Modifications or additions to

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computer hardware will be controlled and evaluated to confirm that the modifications
will not affect computer system performance or in any way alter the stored files.

Software used for data storage and manipulation, including all Geographic Information
Systems (GIS) [e.g., esri ArcGIS] and mapping (e.g., AutoCAD Map 3D) software,
should be validated, verified, and documented considering its intended use in accordance
with PRO-GE-015 (Verification and Validation of Computer Software Programs) in
Appendix A. Where possible, EMSI technical staff should use public domain software
that has been qualified, peer-reviewed, validated, and verified. Documentation for the
software used will be current.

Where software that is not considered public domain is used, the source of the software
will be specified and documented. EMSI project personnel will validate and verify the
software before its use on EMSI projects. Where EMSI project personnel develop
project-specific software, the code will be independently benchmarked, validated, and
verified prior to use. In addition, documentation of the code will be available and
maintained with the project file.

Modifications to software will be controlled, documented, and assessed to assure that


performance is not unacceptably altered.

2.9 Work Processes and Systems

EMSI projects are planned, implemented, and monitored following procedures described
in this QMP.

Project planning is conducted using established project management procedures and,


where applicable, the Data Quality Objective (DQO) process as defined by EPA and
interpreted by Project Managers. Planning procedures are designed to ensure that the
project scope of work will achieve the client's objective. Planning will be performed by
the EMSI Project Manager and Technical Reviewer before detailed work plans are
developed. This planning effort will determine the type and quality of data needed to
characterize environmental processes or conditions. Planning will include the
development of design criteria prior to design of any engineered system. The DQO
process is used where appropriate to identify specific data or interpretive requirements
and the level of QA commensurate with the intended use of the data.

Form B-1 (Appendix B) is a Project Planning and Scoping Checklist. This checklist can
be used to assist Project Managers, Technical Reviewers, or Task Managers to assure that
a comprehensive planning and scoping effort has been performed.

EMSI projects shall be implemented in accordance with written project documents (work
plan, plans, procedures, specifications, drawings) and the contract and implemented in a
sequence consistent with the project schedule.

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SOPs are available or are developed and implemented for some routine, standardized, or
specialized operations that are repetitive and require consistent controls. The Project
Manager will assure that requisite project SOPs are established prior to initiation of field
or design work, and that these SOPs are followed. SOPs that specify technical
requirements will be reviewed for adequacy by technically qualified personnel prior to
use.

The work process will be monitored using: inspections, tests, QC reviews, peer reviews,
and audits. Persons conducting QC reviews should be technically qualified and should
have previously received training to perform QC reviews. The QC reviewer must:

 Identify quality problems where present;

 Propose corrective actions as appropriate;

 Confirm that corrective actions have been implemented as necessary;

 Report to management (Project Manager and QA Officer) the nature of quality


problems, proposed corrective action(s), and the effectiveness of solution
implemented; and

 Control nonconforming or deficient work until quality problems are resolved and
provide information to all EMSI employees to assure future studies/investigations,
designs, or construction projects are satisfactorily performed.

2.10 Quality Control Review

All EMSI work products are required to undergo formal QC review in accordance with
EMSI’s General Checking and Review Procedure SOP (Appendix A). Each QC review
should address:

 Project scope and objectives;

 Report outline;

 Data collection rationale;

 Data collection methods;

 Factual conclusions/findings;

 Opinions and recommendations;

 Technical reviews and professional registrations;

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 Standard of practice; and

 The client's perspective.

Although these review elements were developed for report review, many also apply to
other EMSI work products. Form B-2 (Appendix B) is a Quality Control Review
Checklist designed to facilitate the QC review process. QC reviews of design
engineering documents should follow the general approach described in Section 4.

2.10.1 Project Scope and Objectives

The report should clearly state the project scope and objectives, as defined in the original
proposal, work plan, and contract. If the scope or objectives were modified during the
course of the project, the rationale for modification must be explained. A written record
that the client has acknowledged the changes must be part of the project file.

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2.10.2 Report Outline

The report should adhere to a logical outline, for example:

 Introduction;
 Methods;
 Data Presentation;
 Interpretations/Analyses;
 Conclusions; and
 Recommendations.

Reviewing the outline will provide the first assessment of whether the project includes
the necessary steps to fulfill the scope and achieve the project objectives.

2.10.3 Data Collection Rationale

Is the rationale used to establish data collection points, sampling intervals/frequencies,


and chemical analyses easily understood and well documented? Early establishment of
DQOs will aid in this documentation. For example, do the data need to be of sufficient
quality to estimate the size of an excavation for removal of an underground storage tank
(UST) or to establish human health risks to sensitive populations in support of litigation?

2.10.4 Data Collection Methods

The data collection methods should be sufficiently documented to allow a qualified


professional to repeat them. Methods need not be completely documented in a final
report if they are described in a previous document (e.g., a Sampling and Analysis Plan,
Remedial Action Plan, or Operations and Maintenance Plan). However, deviations from
methods referenced in previous documents should be clearly explained.

2.10.5 Factual Conclusions/Findings

Independent reviewers should be able to follow the logical progress from project plan
through execution and analysis or interpretation so that, using scientific or engineering
judgment and independent thought, they can reach the same conclusions, which should be
clearly stated in the report.

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2.10.6 Opinions and Recommendations

Our clients pay us as consultants to formulate opinions and make recommendations based
on professional judgment. These opinions should be supported by the data. The reviewer
should assess whether the recommendations are reasonable and if other reasonable
solutions have been overlooked. Opinions and recommendations should not be
interspersed throughout the report, but should be confined to a section clearly identified
as containing opinions and recommendations.

2.10.7 Technical Reviews and Professional Registrations

The QC Reviewer should confirm that the technical aspects of the project have been
checked or reviewed by technical personnel qualified in the appropriate disciplines. A
QC Reviewer is not expected to review the work of all scientific and engineering
disciplines, but is responsible for certifying that the proper technical reviews have
been performed. Appropriate registrations should be held by individuals signing reports
or stamping/sealing drawings.

2.10.8 Standard of Practice

Data collection and interpretive techniques should conform with the standard of practice
and applicable regulatory requirements. It is important to recognize that the standard of
practice is the ordinary skill and competence exercised by members of a profession in
good standing in the community at the time the work is undertaken. This is not to be
confused with the state of the art or an individual's perception of "excellence." Necessary
deviations from the standard of practice should be explained.

2.10.9 The Client's Perspective

Before completing any QC review, the reviewer should question whether the report meets
the client's needs or provided a solution to the client's problem. The magnitude of the
solution should be in line with the magnitude of the problem. The QC Reviewer should
discuss any concerns with the Project Manager.

2.11 Management Assessment

The management assessment process is a combination of client service assessments, QA


audits, management self-appraisals, and, where necessary, corrective actions. The
management assessment process is designed to identify quality problems, appropriate
response actions, and permanent changes to the practice that will improve quality.
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EMSI's President and QA Officer are responsible for regularly reviewing, documenting,
and where necessary correcting compliance with the QA Policy and this QMP. Elements
to be reviewed include:

 The organizational structure, including the qualifications and commitment of


personnel and resources;

 The degree to which EMSI's QA Program is being implemented and the


effectiveness of established management controls; and

 The results of QA audits, and peer reviews.

At a minimum, Management Assessments will be conducted annually if this QMP


extends beyond one year.

2.11.1 Quality Assurance Audits

Project QA audits may be performed to determine the degree to which a project is in


compliance with EMSI's QA Policy and procedures. Audits can be initiated by the
President, the Project Manager, or QA personnel. Audits may be performed by the QA
Officer or senior technical staff with training in performing project audits.

Typical steps in an audit include:

 Notify the Project Manager of the intent to perform an audit as well as the
objective and scope of the audit;

 Audit work processes;

 Review project files and deliverables;

 Interview the Project Manager and other key technical staff;

 Prepare a draft audit report for the Project Manager;

 Debrief the Project Manager and President; and

 Finalize the audit report with input from the Project Manager and President.

Audits may be conducted at EMSI office, project field sites, or at a subcontractor's or


vendor's location. Auditors usually use the QA Audit Checklist (Form B-3 in Appendix
B) and summarize results on the QA Audit Form (Form B-4 in Appendix B). Audit
reports are to be completed by the auditor within one week after completion of the audit
and be distributed to the Project Manager, QA Officer, and President. The President will
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ensure that corrective actions identified by the audits are implemented and documented.
The QA Officer and President will monitor the effectiveness of corrective actions.

2.11.2 Corrective Actions

Conditions identified during QC reviews or QA audits as needing corrective action


should be addressed promptly. The President will follow up to verify that appropriate
and effective response actions were taken and that operating procedures, work processes,
or organizational responsibilities were modified, if necessary, to correct the concern.

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3 DATA ACQUISITION AND MANAGEMENT

3.1 General

The initial phase of an EMSI project typically entails the acquisition, interpretation, and
management of data. Data may be needed to characterize site conditions for planning
purposes, for engineering design and construction, or to identify the nature and extent of
chemicals of concern that require appropriate remedial action. Most of the data
acquisition for the VB/I70 project will be Environmental Data or Environmental
Technology.

Environmental Data is defined as any measurement of information that describes


environmental processes, location, or condition; ecological or health effects and
consequences, or the performance of environmental technology. Environmental data
include any information collected directly from measurements or obtained from any other
sources, i.e., exiting /secondary data, such as those compiled from databases, data reports,
literature, surveys, or produced from models.

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.

Any activity that involves the collection, generation, or use of environmental data or
environmental technology will require development and approval of a QAPP, which is
discussed later in this section. In all cases, EMSI follows specific procedures to
establish DQOs in compliance with client, federal, and state requirements. This section
of the QMP focuses on the general quality management procedures to be followed for
data collection. These process activities should take place within the quality management
systems described in Section 2.

3.2 Planning and Scoping

As a general rule, all EMSI projects involving the generation, acquisition, and use of data
must be planned prior to data collection. The foundation for the planning and scoping
process is the development of project DQOs. DQOs are specific statements developed by
the key data users and those responsible for activities affecting data quality (e.g., owners,
federal, state, and local regulatory agencies) to specify the type, quantity, and quality of
data needed to support site characterization conclusions and other project objectives.
DQOs can be formally developed following the steps described below or informally
addressed through a process by which project objectives are defined and data needs
specified. The DQO process and any associated planning activities should be

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documented to ensure that staff performing data acquisition activities are aware of and
have agreed to the project data quality requirements.

The DQO process consists of the seven basic steps described below.

Step 1: State the Problem

The scope, objectives, requirements, and activities associated with a program or task are
defined. A statement of the specific problem to be addressed or the question to be
answered is typically required. Additional scope definition activities include identifying
members of the scoping team and specifying resources available to address the problem.

Step 2: Identify the Decision

The key decisions to be made that require the collection of data are identified. The key
decision for a particular phase or stage of a project is defined, as well as alternative
actions that may be taken based on the results of the investigation. Any relationships
between the key decision and other associated or subsequent decisions are identified.

Step 3: Identify the Inputs to the Decision

The data needed to make or support decisions are identified. The sources of all data are
identified. Methods used to assess or manipulate collected data to arrive at project
decisions are described.

Step 4: Define the Study Boundaries

The spatial and temporal boundaries of the data acquisition activity are defined. These
boundaries ensure that the approach incorporates the time periods in which the data
should be acquired, areas that should be sampled, and the time period to which the results
should apply. This step includes defining the geographic areas for field investigations,
the population of interest, the scale of decision-making, the time frame for the decision,
the timing of sample collection, and any constraints on sampling or analysis.

Step 5: Develop a Decision Rule

A logical decision rule is formulated that defines conditions that would cause the
decision-maker to choose among alternative actions. First, the statistical parameter that
specifies the characteristic or attribute that the decision-maker needs to know about the
population or problem is defined. Next, the action level for the decision is defined.

Step 6: Specify Tolerable Limits on Decision Errors

The decision-maker's acceptable limits on decision errors are specified in order to


establish appropriate limits for uncertainty in the data. Activities include the following:

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 Establishing a possible range for each parameter of interest by estimating its
upper and lower bounds;

 Defining types of decision errors and identifying the potential consequences of


each;

 Defining a range of possible parameter values where the consequences of decision


errors are relatively minor; and

 Assigning probability values to points above and below an action level that define
the acceptable probability for the occurrence of decision errors.

Step 7: Optimize the Design

Evaluate information or data obtained from the previous steps and generate alternative
data collection designs. Choose the most resource-effective design that meets all DQOs.

3.3 Data Collection Systems Design

Once project objectives or DQOs have been established, the project data collection
system can be designed. The data collection system is designed to identify the most
effective and efficient approach to sampling and analysis that will satisfy project DQOs.
The data collection design process includes identification of the following:

 Personnel requirements and qualifications;

 Specifications for field sampling events;

 Health and safety considerations;

 Sample handling and custody;

 Selection of analytical methods;

 Analytical instrumentation requirements;

 Specification of calibration and performance evaluation samples for analytical


methods;

 Data reduction, validation, and verification methods;

 Specification of methods for evaluating data and assessing limitations on data use;

 Specification of statistical methods;

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 Data reporting requirements; and

 Required QC activities and oversight needs.

By following the data collection design process, data can be traced to sampling and
analytical procedures, performance standards, and measuring equipment.

3.4 Planning Documents

The data collection system design and other project criteria and parameters are specified
in project planning documents. These documents are reviewed and approved by the
Project and, as appropriate, Task Managers, as well as designated QC Reviewers. The
QC Reviewer shall be an appointed individual who was not involved in the design of the
data collection system. Any design or procedure changes are subject to the same review
and approval process as the original documents.

Different clients will have different requirements for planning documents. The general
intent of the planning documents is to communicate the scope and procedures for
intended activities so that these procedures can be reviewed and validated. The following
sections describe planning documents generally required for environmental projects
performed under U.S. EPA procedures (e.g., CERCLA, RCRA).

The type of data required for the VB/I70 project consists of environmental data and
environmental technology, as defined above. A Work Plan, Field Sampling Plan, QAPP,
and Health and Safety Plan that describe the objectives and acquisition protocol for
collecting these data types will be required, as discussed below. In addition, information
that originates from an external source, referred to as secondary data, will be required for
the VB/I70 project. This information includes, but is not limited criteria, codes,
standards, manuals, and customer-furnished documents. The procedures described in
PRO-QA-005 (Control of External documents) in Appendix A will be followed for
secondary data.

3.4.1 Work Plan

A Work Plan presents the structural design for a project and the strategy to be followed
for completing the project. In a stepwise fashion, duties are identified and described, and
milestones for their accomplishment are established. The resources to be used in the
course of work are elaborated upon.

Project personnel, including the Project Manager and QC Reviewer, are identified, along
with their respective responsibilities and anticipated levels of effort. Lines of interaction
between the staff are outlined. In addition, the plan specifies material resources to be
used, including laboratory and field equipment and computer software and hardware
systems (e.g., programs, information databases, communication network).

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3.4.2 Field Sampling Plan (FSP)

Under current U.S. EPA guidelines, data collection projects require a Sampling and
Analysis Plan (SAP), which consists of an FSP and a QAPP. The FSP:

 Describes sampling objectives including the phase of the sampling and the
ultimate use of the data;

 Identifies procedures for field activities and sampling protocols and procedures;

 Specifies the types, locations, and frequency of samples to be taken;

 Identifies procedures for sample analyses; and

 Identifies responsible individuals.

The FSP may also include pertinent instruction guides, SOPs, and operating manuals.
SOPs will be prepared in accordance with EPA’s Guidance for Preparing Standard
Operating Procedures (EPA, 2007). For multi-year projects, the FSP and SAP will be
reviewed annually for adequacy with the above-stated objectives, protocols, and
procedures. Annual reviews will be documented using EPA Region 8 Crosswalk
checklists.

3.4.3 Quality Assurance Project Plan

The QAPP is a written, comprehensive QA guidance document for a specific project. It


presents, in specific terms, the policies, organization, objectives, functional activities, and
QA/QC activities designed to achieve DQOs. Under EPA guidelines, the QAPP
comprises 16 elements as follows:

1. Title page;

2. Table of Contents;

3. Project Description;

4. Project Organization and Responsibility;

5. Precision, Accuracy, Representativeness, Completeness, and Comparability


(PARCC) Data Quality Objectives;

6. Sampling Procedures;

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7. Sample Custody and Documentation;

8. Calibration Procedures and Frequency;

9. Analytical Procedures;

10. Data Reduction, Validation, and Reporting

11. Internal Quality Control Checks;

12. Performance and System Audits;

13. Preventive Maintenance;

14. Specific Routine Procedures to Assess Data Precision, Accuracy, and


Completeness;

15. Corrective Actions; and

16. QA Reports to Management.

In addition, an analytical laboratory that is contracted by the project must maintain a


current QA Plan and hold a current certification from the National Environmental
Laboratory Accreditation Program (NELAP), or equivalent.

For multi-year projects, the QAPP will be reviewed annually for relevance and adequacy
with the above-stated elements. Annual reviews will be documented using EPA Region 8
Crosswalk checklists.

The QAPP must be approved by the EPA Regional Quality Assurance Manager or
designee prior to project initiation.

3.4.4 Health and Safety Plan (HASP)

EMSI administers a health and safety program for its employees in compliance with
Occupational Safety and Health Administration regulations in 29 CFR Part 1910. Site-
specific HASPs are generated for each project and provide detailed health and safety
information and guidelines for a project. A Site Safety Officer is assigned for each
sampling operation and is responsible for implementing the HASP.

3.5 Implementation of Data Acquisition Activities

Data acquisition activities are to be implemented according to project planning


documents and procedures for sample custody, calibration, internal QC, document

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control, preventive maintenance, and procurement control. Project planning documents
may include procedures or standards for each of these controls. If planning documents
do not contain such procedures, the following minimum quality requirements for these
procedures should be met.

3.5.1 Sample Custody

Sample custody procedures are to be followed throughout sample collection,


preservation, handling, packaging, shipping, storage, analysis, and ultimate disposal. The
purpose of these procedures is to maintain sample integrity, to prevent damage, loss,
deterioration, cross contamination and interferences, and to properly dispose of post-
analysis sample materials. U.S. EPA approved chain-of-custody and documentation
procedures should be used as a standard unless project criteria dictate otherwise.

3.5.2 Calibration Procedures

All tools, gauges, instruments, and other sampling, measuring, and test equipment used to
gather, generate or measure environmental and engineering data shall be calibrated by
subcontract laboratories or EMSI project personnel. These items should be calibrated at
specific intervals to maintain accuracy and reproducibility within specified limits as
defined by manufacturer specifications. Records of all calibration and maintenance
activities should be maintained. Equipment should be calibrated using certified
equipment and/or standards that are traceable to nationally recognized performance
standards such as the National Institute of Standards and Technology, if such standards
exist.

3.5.3 Internal Quality Control Procedures

Internal QC procedures and checks should be used throughout EMSI projects and should
include inspections and acceptance testing. The QC checks should include:

 Collection and analysis of QC samples for field and laboratory operations;

 Active involvement by Project Managers and QA personnel; and

 Use of document control procedures.

3.5.3.1 QC Samples

Field quality control samples consist of trip blanks, field blanks, equipment blanks,
duplicate samples, and matrix spike/matrix spike duplicate samples. Laboratory QC
samples include method blanks, reagent/preparation blanks, calibration standards,
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internal standards, surrogate standards, lab duplicates/replicates, and laboratory control
samples. The specific QC samples to be collected for each project and the frequency of
collection are defined during project planning and specified in project planning
documents.

3.5.3.2 Project and Quality Assurance Management

Project and quality assurance management for data operations shall be consistent with
general quality management procedures described in Section 2 of this QMP. QA
responsibilities are delegated by the Project Manager through the QC Reviewer.

3.5.3.3 Document Control

Document control for data acquisition activities shall be consistent with document control
and records management procedures described in Section 2.8 of this QMP.

3.5.4 Preventive Maintenance

A preventive maintenance program should be established for each data acquisition


activity to ensure that field and laboratory equipment are maintained according to the
specific procedures provided by the manufacturer so that the required sensitivity,
accuracy, completeness, representativeness, comparability, and precision are achieved.

For projects involving field and/or laboratory work, preventive maintenance procedures
and schedules for laboratory and/or field equipment should be described in the QAPP. If
maintenance procedures are simply referenced in the QAPP, the complete procedure
should be readily available to the field or laboratory staff using the equipment.

3.5.5 Procurement Control

Control over the procurement of purchased items and services shall be consistent with the
subcontractor procurement procedures described in Section 2.7, Subcontractor
Management. Subcontractors are subject to the same procurement requirements as
EMSI. Verification of subcontractor procurement procedures involves the performance
of field QC checks, receiving inspections, field inspections, verification tests,
subcontractor documentation reviews and onsite source audits.

3.5.6 Geospatial Data

Geospatial data may be associated with chemical constituent and physical geological-
related environmental data collected for the VB/I70 Globeville Landing Outfall Project.
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Geospatial data collection and data management activities will be planned and
implemented in accordance with the guidance policies and standards included in the
following documents:

 EPA, 2008, National Geospatial Data Policy, CIO 2131.0,


http://www.epa.gov/irmpoli8/policies/21310.pdf, August 24, 2008;

 EPA, 2003, Guidance for Geospatial Data Quality Assurance Project Plans
(QA/G-5G), EPA/240/R-03/003, March 2003;

 Federal Geographic Data Committee (FGDC), 1998, FGDC-STD-001-1998,


Content Standard for Digital Geospatial Metadata, June 1998; and

 FGDC, 1998, FGDC-STD-007.1-1998, Geospatial Positioning Accuracy


Standards Part 1: Reporting Methodology, 1998.

3.6 Assessment of Data Usability

All acquired data shall be managed, distributed, and preserved in order to substantiate
and document that the data are of known quality, are properly maintained, and meet the
intended project usability and objectives. Technical data, including field data and the
results of laboratory sample analyses, are tracked and validated. A project data storage
and information system will be developed for each project, as applicable, to facilitate and
manage data for tracking, data calculations, and data transfer to various forms, reports,
and data storage systems.

3.6.1 Data Reduction

Reduction of field measurement data and laboratory measurement data will be performed
in accordance with project data validation procedures that specify the required
documentation and technical criteria necessary to produce valid data. Laboratory data
must be:

 Quantitative and statistically significant in relation to the standard analytical


methods or procedures employed; and

 Satisfactory for custody and document control.

Field measurement data must meet criteria for:

 Complete documentation of sampling location, time, and personnel;

 Satisfactory documentation of field activities; and

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 Correct sampling methods.

3.6.2 Data Validation

Field measurement data validation procedures include reviewing the raw data and
supporting documentation generated during the field investigation. Data validation is
performed to meet the project's intended data uses by checking the procedures used in the
field and comparing the data to previous measurements.

Laboratory measurement data validation procedures are under the direction of the
laboratory QA coordinator. The objective is to review the analytical data to ensure that
the results for investigative and QC samples meet method-specified criteria prior to
submittal to EMSI. The laboratory QA coordinator is responsible for assessing data
quality and advising appropriate laboratory supervisors and EMSI's Project Manager of
any data that are unacceptable or that may be unreliable for use.

EMSI should perform independent data validation of data generated. The level of effort
and level of detail to which data will be validated will be in conformance with client
requirements and project objectives. The procedure for performing validation includes at
a minimum the following:

 Compiling a list of investigative samples;

 Compiling a list of QC samples;

 Reviewing the laboratory analytical procedures and instrument performance


criteria;

 Evaluating the completeness and integrity of the data;

 Preparing a data summary; and

 Reviewing the data summary for potential data quality problems.

EMSI data validation should be performed by identified personnel qualified and


experienced in laboratory data validation.

Field and laboratory measurement data will be validated where appropriate according to
EPA functional guidelines or using other appropriate criteria such as method-specific
statements of work or protocols.

Data are qualified according to the intended use of the data based on the performance
criteria originally established during the DQO process. The data qualifiers should be
consistent with method- or project-specific statements of work. Data qualifiers should be

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attached to the data whenever they appear in hard copy or computerized form to ensure
that data users are aware of the limitations and quality of the data.

3.6.3 Data Reporting

Documents are prepared and distributed which summarize the field activities and the
results of all data collected. These reports include the following:

 Presentation of results;

 Summaries of field data from field measurements;

 Field location of sampling points;

 Field measurement data logbooks;

 Laboratory deliverables; and

 Data validation reports summarizing the validation process used and the specific
results and comments pertaining to a sample or group of samples.

3.6.4 Data Assessment

After the laboratory and field data have been reduced, validated, and reported, the project
staff should assess the data with respect to the project DQOs. Field and laboratory data
are assessed in terms of precision, accuracy, representativeness, completeness, and
comparability (PARCC). Precision, accuracy, and completeness are evaluated
quantitatively, while representativeness and comparability are evaluated qualitatively.
The goals of this assessment are:

 To establish site-specific PARCC parameters;

 To use these parameters to develop a database with known limitations of data


usability; and

 To evaluate these limitations relative to the intended uses of the data.

Should the results of these assessments reveal that DQOs are not being met, the Project
Manager should assess the situation and initiate corrective action as appropriate.

3.7 Performance and System Audits

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Activities performed during data acquisition that may affect data quality may be assessed
through audits to verify that the requirements of the QAPP and other planning documents
are implemented as prescribed. Audits include performance evaluation audits and
technical systems audits. Both self-assessments and independent assessments should be
performed. The assessment results should be documented, reported to, and reviewed by
management. The purpose of these assessments is to provide management and clients
with an ongoing evaluation of the quality of the results produced by EMSI's data
collection activities and to indicate how well the objectives for a given project are being
met.

The QAPP will describe the procedures to be followed in conducting audits, and should
include an auditing plan and/or checklist. Designated QA audit personnel must be
experienced and knowledgeable about the activities which they are auditing and
completely independent of these specific activities audited. Several different types of
audits can be conducted: management audits, laboratory audits, field audits, and
performance evaluation audits.

 Management audits are designed to evaluate whether quality management


functions and responsibilities related to data acquisition and assessment are being
performed in accordance with the QAPP and company QA policy.

 Laboratory audits are performed to verify continuity of personnel,


instrumentation, and quality control requirements. A laboratory audit typically
consists of random data audits and review of laboratory quality control data. The
laboratory documentation normally examined during an audit includes sample
receiving, sample log-in, sample storage, chain-of-custody, sample preparation
and analysis records, instrument operating records, and any other documentation
related to the generation of analytical data by the laboratory.

 Field audits are performed to evaluate procedures for sample identification,


sample control, chain-of-custody, field documentation, sampling operations,
sample preservation, packaging, and shipping.

 Performance evaluation audits are performed periodically to determine the bias


of a total measurement system. These audits typically consist of a performance
evaluation sample that is submitted to and analyzed by the audited laboratory. In
some cases, the laboratory is made aware of the submittal of samples. At other
times, the samples are submitted to the laboratory in such a way that the
laboratory is necessarily unaware it is being audited.

The frequency of these audits and performance evaluations are project-dependent, and are
specified in project-specific QAPPs.

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3.8 Corrective Actions

A "closed-loop" corrective action system for data acquisition and assessment work
should be maintained for each project consistent with procedures described in Section 2.
Any issue requiring corrective action also requires verification that the corrective action
has successfully corrected the deficiency. Project mechanisms to suspend or stop
deficient activities and, if necessary, to issue restricted usage letters and labeling for
materials impacted by a corrective action requirement should be clearly specified in the
QAPP.

The general approach for defining corrective action requirements should involve:

 Identifying corrective action needs and causes;

 Establishing appropriate corrective action responses; and

 Verifying the timely implementation and effectiveness of the corrective action


taken.

Corrective action may require additional data collection activities. In the field, corrective
action is initiated by the Project Manager and/or Task Manager. All problems should be
identified and reported. Although corrective action for deviations from standardized field
procedures may not always be required, all deviations from project planning documents
should be noted in the field logbooks along with the field team leader's justification and
rationale for the changes. Corrective actions should be always implemented when SOPs
are not met, when non-representative conditions are indicated, and/or when specific tasks
have not been performed.

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4 DESIGN, CONSTRUCTION, OPERATION OF ENGINEERED SYSTEMS

This section describes QA Program elements that apply to the design, construction, and
operation of engineered systems. These elements should be applied in conjunction with
the quality management system described in Section 2. Engineered systems include
those facilities, structures, processes, mechanical and electrical devices designed by
EMSI to protect the environment from pollution or contamination, protect human health
and safety, and improve public infrastructure. QA Program elements include:

 Project planning and scoping;

 Project organization;

 Design phase quality control reviews;

 Construction phase quality control reviews;

 Operations and maintenance procedures;

 Construction inspection and acceptance testing; and

 Corrective actions.

It is the Project Manager's responsibility to see that the necessary QA documents are
provided to appropriate project staff and that the acceptability of design documents is
verified in a timely manner.

4.1 Project Planning and Scoping

Project activities for the design and construction of engineered systems must be planned
to define their implementation sequence and to identify the parties responsible for the
overall quality of the various system elements. A Project Procedures Memorandum
(PPM) should be prepared that establishes basic management criteria and applicable
project QA measures. The PPM should include:

 Description of the engineered system to be designed and constructed;

 Design objectives, design criteria, regulatory requirements, and performance and


quality standards;

 Scope of work and task breakdown structure;

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 Work schedule

 Project and task budgets;

 Expected rates of expenditure;

 Project team organization;

 Project requirements for equipment, travel and subsistence, and subcontractors;

 Project review requirements; and

 Quality Assurance Project Plan or Construction Quality Assurance Plan.

The EMSI Project Manager is responsible for preparing and distributing the PPM to the
appropriate members of the project team.

Project construction phase activities should be planned during the preconstruction stage
with regard for quality and safety and to avoid project implementation problems while
the project is still in design. A project Construction Quality Assurance Plan (CQAP)
serves to establish project quality objectives and procedures for loss prevention, quality
control, and general coordination between EMSI and the construction contractor. The
CQAP includes the specific QC requirements of the contract documents, applicable
regulatory codes and requirements, EMSI corporate and professional standards, and loss
prevention considerations.

4.2 Project Organization

Adherence to project quality control procedures is the responsibility of the Project


Manager. The Project Manager may delegate responsibility for the quality of a design to
a QC Reviewer. The Project Manager may delegate responsibility for construction to a
Construction Services Manager.

4.3 Design Phase Quality Control Reviews

Design phase QC reviews are independent assessments of how engineered designs meet
project planning and scoping requirements. The Project Manager should select QC
Reviewers for their general knowledge of the technology chosen for the project and for
their objectivity in assessing liability issues. QC reviews should be scheduled at strategic
stages of the project design, such as after the concept design stage, after preliminary
design, and at scheduled points during the final design phase. The types of QC and
technical reviews required on a design project are described below.

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4.3.1 Design Document QC Checking

QC checking of design documents provides reasonable assurance that calculations, data


summaries or tabulations, design diagrams, process flow charts, drawings, cost estimates,
specifications, and material and equipment lists are accurate and consistent with technical
standards, criteria, and tolerances. Checking should be performed systematically by
project team members in accordance with the General Checking and Review Procedure
SOP included in Appendix A.

4.3.2 Quality Control Reviews

Quality control reviews are performed by the designated QC Reviewer in tandem with
ongoing QC checking of design documents by project staff. QC reviews of interim
designs are formal, systematic, and critical reviews conducted after various phases of
design development have been completed. The objectives of QC reviews are to identify
design irregularities and anticipate potential design implementation problems, and to
initiate appropriate corrective actions to ensure the final design meets client requirements.
A comprehensive approach to QC reviews should be taken so that all items pertaining to
meeting the needs of our clients are addressed. Typical components of a QC review for
design and/or construction projects should include review of:

 Clarity of project scope and objectives;

 Client needs expressed in the design criteria compared with the technical
specifications;

 Validation of the design data collection rationale and methods;

 Factual basis for design, conclusions, and findings;

 Relevance of technical opinions and recommendations to project scope;

 Professional registration verification;

 Conformance with local standards of practice;

 Items pertaining to process specifications and operations service requirements;


and

 Presentation of data conclusions and findings and construction contract


requirements.

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QC reviews are normally conducted at the conclusion of project development stages, i.e.,

 10 percent for conceptual design;

 30 and 60 percent for design development, and

 90 percent for final design.

4.3.3 Value Engineering Reviews

Value engineering evaluations are performed on EMSI projects at the request of, or with
the agreement of the client. These evaluations involve reviewing alternative design
options of relatively equal quality, with the result being a final design that serves the
client's required function at the lowest possible life cycle cost. These reviews are
conducted jointly with the client in a structured format that involves several
distinct phases:

 Information phase;

 Creative phase;

 Evaluation phase;

 Investigative phase; and

 Recommendation phase.

The degree of formality of a value engineering review varies with the type, size, and
complexity of the project, funding constraints, and operations and maintenance strategy.
Teams of three to five independent reviewers, who may include qualified personnel from
peer engineering firms, should become involved in the project at no later than the 30
percent stage. Recommendations from the value engineering review team are
communicated orally and in written form to the design team, which then makes the final
decision on implementation.

4.3.4 Constructibility/Biddability Reviews

Constructibility/biddability reviews are primarily intended to protect owners of


constructed facilities from damages due to defects in documents and to minimize
unnecessary changes to the design documents during construction. These reviews are
performed by qualified personnel experienced in construction management or
engineering at two design stages between the 30 and 60 percent stage and by the 95
percent stage. Typical items addressed include:
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 Construction sequencing and scheduling;

 Attention to existing site constraints;

 Temporary facilities needs;

 Practicality of construction; and

 Clarity of contract bid documents and drawings.

4.4 Construction Phase Quality Control Reviews

Construction phase QC consists of preparatory and follow-up actions that involve review
of construction specifications. Specifications must clearly describe to bidders the scope
of construction work and define the standards for technical performance and quality
acceptance. These standards become the basis for onsite construction QC activities such
as construction observation, inspection, and acceptance testing. Depending on contract
agreements, construction QC is performed by EMSI either as the owner's representative
or as the construction manager. Verification of the design intent and communication of
the contractor's understanding of the contract requirements and response by the engineer
are made through the submittal review and field clarification order process.

If EMSI is the site remediation contractor, the prime construction contractor on a


design/build contract, a qualified construction manager should be given the authority,
through the contract documents, to exercise control over the means and methods of
construction. These activities would include: prequalification of subcontractors to
perform the construction work, training, and certification of EMSI and subcontractor
personnel for hazardous waste work and for OSHA 1920.01 industrial hygiene and safety
compliance. Standardized subcontractor procurement procedures described in Section 2
of this QMP should be followed for hiring qualified subcontractors and equipment
vendors for construction. Construction materials purchasing, transport, storage, and
inspection are subjected to more direct QC when EMSI is the prime contractor. These
requirements are documented in various project-specific QC or site management plans.

At construction completion, the design engineer/construction manager should document


the completed work through preparation of contract record drawings. Results of
inspections and tests are documented in a final construction report to the owner and
interested agencies.

4.5 Operations and Maintenance Procedures

Operations and maintenance (O&M) procedures are prepared by EMSI for specific
elements of designed engineered systems for environmental remediation. These
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procedures are the responsibility of the Project Manager and are normally prepared in
three stages:

 Outline at the 50 percent design development stage;

 Final draft at 95 percent final design stage; and

 Final O&M manual at the 50 percent construction completion stage.

The O&M procedures address personnel qualifications and organizational


responsibilities, including operator certification requirements. Procedures are established
to assure that only qualified and accepted materials, equipment items, or services are used
in the operation of the engineered systems. Preventive maintenance schedules should be
included in accordance with the design and the manufacturers' specifications to ensure
that warranty provisions are met within established operating parameters.

A typical O&M procedures plan addresses the following items:

 Schematic operating diagrams;

 Pre-startup equipment settings;

 Startup procedures;

 Operating modes;

 Shutdown procedures;

 Post-shutdown procedures;

 Emergency operating procedures/contingency plan;

 Preventive maintenance; and

 Spare parts lists.

The O&M procedures should address system performance when inoperability of the
associated engineered systems could result in loss of monitoring data, decreased
treatment capacity or remediation efficiency, or safety hazards due to the release of
contaminants in excess of established limits.

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4.6 Construction Inspection and Acceptance Testing

4.6.1 Procedures/Responsibilities for Inspection and Acceptance Testing

Construction inspection and acceptance testing procedures should be described in the


project specific CQAP. As a minimum, a project CQAP should address procedures and
responsibilities for:

 Inspections and acceptance testing of installed systems and subsystem


components in accordance with approved design specifications;

 Verification under field conditions that the installed systems and subsystem
components meet operational performance requirements;

 Tracking of deviations from acceptance criteria and corrective actions and


deficiencies

 Documentation and reporting of inspections and acceptance testing;

 Calibration and control of measuring and test equipment against acceptable and
documented baseline standards.

4.6.2 Procedures for Tracking Inspection and Acceptance Test Results

The CQAP should describe procedures for tracking the work flow through the various
phases, including inspections and acceptance testing. The QC Reviewer for construction
should maintain records of all quality control operations, activities, and tests performed
for all project activities, including any of these for suppliers and subcontractors. These
records are maintained as part of the project history file. Records should include the
completed quality control inspection/test procedures to show evidence that required
activities or tests have been satisfactorily performed. Records of quality control activities
include:

 Procedures used for quality control inspection/tests;

 Procedures for quality control of any field engineering analyses activities;

 The results of inspections or tests or quality control reviews with authorized


signatures;

 Nature and extent of defects and causes of rejection, including corrective actions
taken; and

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 Results of quality control audits.

4.6.3 Tracking Deficiencies

Tracking construction non-conformances and corrective actions, including documenting


root cause analysis and measures taken to prevent reoccurrence, is the responsibility of
the EMSI Construction Manager. Once corrective actions have been completed, project
records should reflect actions taken to verify that the resulting work meets project and
client requirements.

4.6.4 Field Reporting System

A field reporting system should be developed to provide feedback of pertinent


information on performance deficiencies for all onsite work activities. The EMSI
Construction Manager is responsible for ensuring that daily quality control reports are
prepared. Standard EMSI test and inspection forms, together with the daily report,
should be used where appropriate for all reporting of daily activities. The reporting
system should reflect specific scope of work requirements and applicable project
regulations and be consistent with the project document control and records management
procedures described in Section 2.

4.6.5 Testing Procedures

Field testing procedures in the CQAP should specify that only approved laboratories
should be used for operational and/or acceptance testing. Project-specific lists of tests to
be performed for specific items of work should be described including:

 Test name;

 Approved test standard;

 Frequency and estimated number of required tests;

 Responsible personnel;

 Laboratory certification, if required;

 Test standard or protocol;

 Reference specification.

Data collection procedures should be consistent with Section 3.

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4.6.6 Calibration and Control of Measuring and Testing Equipment

CQAP procedures should be established to maintain sufficient control over all measuring
and testing equipment used for operational process monitoring and acceptance. Control
should be exercised over instruments, field gauges, sensors, and special test equipment to
ensure that the equipment is of the proper type, range and accuracy and is properly
calibrated according to the design specifications and nationally recognized performance
standards.

The control of measuring equipment and test equipment and test methods should take
into account the following factors, as appropriate:

 Correct specification, including range, precision, and serviceability under


specified environmental conditions;

 Initial calibration;

 Periodic recalibration, adjustment, and repair to maintain the required accuracy in


use;

 Documentary evidence covering identification of instruments, frequency of


recalibration, calibration status, and procedures for use, handling and storage; and

 Traceability to reference standards of known accuracy and stability.

Provisions should be made to recalibrate equipment found unsatisfactory for acceptance


testing and recertify the equipment to specified tolerances before using for acceptance
testing.

4.7 Corrective Actions

A "closed-loop" corrective action system for design and construction work shall be
maintained for each project consistent with the procedures described in Section 2. Any
issue requiring corrective action also requires verification that the corrective action has
successfully corrected the deficiency. Project mechanisms to suspend or stop deficient
activities and, if necessary, to issue restricted usage letters and labeling for materials
impacted by a corrective action requirement should be clearly specified in the PPM and
CQAP.

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The general approach for defining corrective action requirements should involve:

 Identifying corrective action needs and causes;

 Establishing appropriate corrective action responses; and

 Verifying the timely implementation and effectiveness of the corrective action


taken.

In the field, corrective action is initiated by the Project Manager and/or Construction
Manager. All problems should be identified and reported. Although corrective action for
deviations from standardized field procedures may not always be required, all deviations
from project planning documents should be noted in the field logbooks along with the
field team leader's justification and rationale for the changes. Corrective actions should
be always implemented when SOPs are not met, when non-representative conditions are
indicated, and/or when specific tasks have not been performed.

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5 REFERENCES

American Society for Quality/American National Standards Institute (ASQ/ANSI)


E4:2014, Quality Management Systems for Environmental Information and Technology
Programs, 2014.

Federal Geographic Data Committee (FGDC), 1998, FGDC-STD-001-1998, Content


Standard for Digital Geospatial Metadata, June.

FGDC, 1998, FGDC-STD-007.1-1998, Geospatial Positioning Accuracy Standards Part


1: Reporting Methodology.

U.S. Environmental Protection Agency (EPA), 1984, EPA Order 2160, Records
Management Manual, U.S. Environmental Protection Agency, Washington, DC., July.

EPA, 1998, EPA Order 1900, Contracts Management Manual, U.S. Environmental
Protection Agency, Washington. DC., February.

EPA, 1999, EPA Directive 2100 (1999), Information Resources Management Policy
Manual, U.S. Environmental Protection Agency, Washington. DC.

EPA, 2000, EPA Order 5360 A1, EPA Quality Manual for Environmental Programs, U.S.
Environmental Protection Agency, Washington, DC., May.

EPA, 2000, EPA Order 5360.1 A2, Policy and Program Requirements for the Mandatory
Quality Assurance Program, U.S. Environmental Protection Agency, Washington. DC.,
May.

EPA, 2000, Guidance for the Data Quality Objectives Process (QA/G-4), EPA/600/R-
96/055, Office of Environmental Information, August.

EPA, 2001, EPA Requirements for Quality Management Plans (QA/R-2), EPA/240/B-
01/002, Office of Environmental Information, March.

EPA, 2001, EPA Requirements for Quality Assurance Project Plans (EPA QA/R-5),
EPA/240/B-01/003, Office of Environmental Information, March.

EPA, 2002, Guidance for Quality Assurance Project Plans (EPA QA/G-5), EPA/240/R-
02/009, Office of Environmental Information, December.

EPA, 2003, Guidance for Geospatial Data Quality Assurance Project Plans (QA/G-5G),
EPA/240/R-03/003, March.

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EPA, 2007, Guidance for Preparing Standard Operating Procedures (SOPs), EPA QA/G-
6, EPA/600/B-07/001, April.

EPA, 2008, National Geospatial Data Policy, CIO 2131.0,


http://www.epa.gov/irmpoli8/policies/21310.pdf, supercedes 2100 Information Resources
Management (IRM) Policy Manual Chapter 13: EPA National Locational Data Policy
1991, August 24.

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Tables
Table 1 – Relationship of EMSI QMP to EPA Requirements

Required Element from QA/R-2 EMSI QMP Location

MANAGEMENT AND ORGANIZATION


1. Signed and dated by senior manager? Cover

2. Signed and dated by senior line management? Cover

3. Signed and dated QA manager? Cover

4. Includes signature lines for Quality Staff approval? Cover

5. Includes signature lines for OEI approval? Cover (EPA)

6. Includes statement of the organization's QA policy? Section 1


6a. QA policy statement includes general objectives/goals? Section 1
6b. QA policy statement includes allocation of intramural, Section 1
extramural, and travel funds and personnel?

7. Includes organizational chart? Subsection 2.3


7a. Organizational chart identifies all components of Subsection 2.3
organization?
7b. Organizational Chart identifies position of QA manager? Subsection 2.3
7c. Organizational Chart identifies lines of reporting of the QA Subsection 2.3
manager?
7d. Organization Chart identifies any other QA staff? Subsection 2.3

8. Includes discussion of authorities of the QA manager and staff? Subsection 2.3

9. Documents the independence of QA manager? Subsection 2.3

10. Describes procedures to ensure QA staff have access to appropriate Subsection 2.3
levels of management?

11. Discusses technical activities or programs that require quality Subsections 2.5-2.8
management?

12. Discusses where oversight of delegated or extramural programs is Subsection 2.9


needed?

13. Identifies where internal coordination of QA and QC activities Subsection 2.10


among organizations is needed?

14. Discusses how management assures understanding and Subsection 2.10


implementation in all programs?

15. Describes process for resolving disputes? Subsection 2.10

Table 1
EMSI QMP 1 of 6
Required Element from QA/R-2 EMSI QMP Location

QUALITY SYSTEM COMPONENTS


16. Includes description of quality system? Subsection 2.10

17. Describes principal quality system components (e.g., quality system Subsection 2.10
documentation, annual reviews and planning, project specific quality
documentation?

18. Description of components includes how they are implemented? Subsection 2.10

19. Description of components includes responsibilities of management Subsection 2.10


and staff?

20. Lists tools for implementing each component (e.g., QMPs, Quality Subsection 2.10
Systems Audits, Training Plans, QA Project Plans?

21. Identifies internal organizations that develop QMPs? Subsection 2.10

22. Identifies review and approval procedures for these internal QMPs? Subsection 2.10

23. Includes assurance that QA responsibility is incorporated into Subsection 2.10


performance standards (consistent with Agency personnel policy)?

QUALIFICATIONS AND TRAINING


24. States policy regarding QA training for management and staff? Subsection 2.4

25. Describes process for identifying, ensuring, and documenting that Subsection 2.4
personnel have necessary quality-related qualifications?

26. Describes process for ensuring personnel maintain quality-related Subsection 2.4
qualifications?

27. Describes process for identifying the need for quality-related Subsection 2.4
retraining based on changing requirements?

28. Includes roles, responsibilities, and authorities in description of Subsections 2.2, 2.3,
above processes? 2.4

PROCUREMENT OF ITEMS AND SERVICES


29. Describes process for reviewing and approving all extramural Subsections 3.5.5, 4.3
agreements (grants, cooperative agreements and contracts)?
29a. Review process ensures documents are complete and accurate? Subsections 3.5.5, 4.3
29b. Review process ensures agreement clearly describes the item or Subsections 3.5.5, 4.3
service needed?
29c. Review process ensures agreement describes the associated Subsections 3.5.5, 4.3
technical and quality requirements?
29d. Review process ensures agreement describes the quality system Subsections 3.5.5, 4.3
elements for which the supplier is responsible?

Table 1
EMSI QMP 2 of 6
Required Element from QA/R-2 EMSI QMP Location

29e. Review process ensures that the supplier’s conformance to the Subsections 3.5.5, 4.3
customer’s requirements will be verified?

30. Describes process for reviewing and approving applicable responses Subsections 3.5.5, 4.3
to solicitations to ensure that they satisfy all technical and quality
requirements?
30a. Review process ensures the review of evidence of the supplier’s Subsections 3.5.5, 4.3
capability to satisfy EPA quality requirements?
30b. Review process ensures procured items and services are Subsections 3.5.5, 4.3
acceptable?

31. Describes process for review and approval of suppliers’ quality- Subsections 3.5.5, 4.3
related documentation (e.g., QA Project Plans and QMPs)?

32. Includes discussion of any policy and criteria for delegations of Subsections 3.5.5, 4.3
review of QA Project Plans and QMPs?

33. Describes process to ensure EPA extramural agreement policies Subsections 3.5.5, 4.3
satisfied?

34. Includes roles, responsibilities, and authorities in description of Subsections 3.5.5, 4.3
above processes?

DOCUMENTS AND RECORDS


35. Describes process for identifying quality-related documents and Subsection 2.9
records (including electronic) requiring control?

36. Describes process for preparing, reviewing, approving, issuing, Subsection 2.9
using, authenticating, and revising documents and records?

37. Describes process for ensuring that records and documents Subsection 2.9
accurately reflect completed work?

38. Describes process for maintaining documents and records including Subsection 2.7
transmittal, distribution, retention, access, preservation, traceability,
retrieval, removal of obsolete documentation, and disposition?

39. Describes process for establishing and implementing appropriate Subsection 3.2
chain of custody and confidentiality procedures for evidentiary records?

40. Above processes comply with EPA Order 2160 and EPA Directive Subsections 2.7, 2.9,
2100, Chapter 10? 2.10, 2.11
41. Includes roles, responsibilities, and authorities in description of Subsections 2.7, 2.9,
above processes? 2.10

Table 1
EMSI QMP 3 of 6
Required Element from QA/R-2 EMSI QMP Location

COMPUTER HARDWARE AND SOFTWARE


42. Describes process for developing, installing, testing, using, Subsection 2.8
maintaining, controlling, and documenting computer hardware and
software?

43. Describes process for assessing and documenting the impact of Subsection 2.8
changes to user requirements and/or the hardware and software on
performance?

44. Describes process for evaluating purchased hardware and software? Subsection 2.8

45. Describes process for ensuring that data and information produced Subsection 2.8
from or collected by computers meet applicable requirements and
standards?

46. Includes roles, responsibilities, and authorities in description of Subsections 2.9, 2.10
above processes?

47. Are the requirements of EPA Directive 2100 are addressed in the Subsections 2.8, 2.9,
above processes? 2.10

PLANNING
48. Includes a description of the systematic planning process for Section 3
environmental data operations?
48a. Does process include identification and involvement of all Subsection 3.2
customers and suppliers?
48b. Does process include description of the project goal, objectives, Subsections 3.2, 3.3,
and questions and issues to be addressed? 3.4
48c. Does process include identification of project schedule, Subsections 3.2, 3.3,
resources, milestones, and any applicable requirements? 3.4
48d. Does process include identification of the type and quantity of Subsections 3.3, 3.4,
data needed and how the data will be used to support the project’s 3.5
objectives?
48e. Does process include specification of performance criteria for Subsections 3.5, 3.6
measuring quality?
48f. Does process include specification of needed QA and QC Subsection 3.6
activities to assess the quality performance criteria?
48g. Does process include description of how, when, and where the Subsections 3.3, 3.4,
data will be obtained (including existing data) and identification of any 3.5
constraints on data collection?
48h. Does process include description of how the acquired data will Subsections 3.3, 3.6
be analyzed, evaluated, and assessed against its intended use and the
quality performance criteria?

49. Describes process for developing, reviewing, approving, Subsections 2.10, 2.11,
implementing, and revising QA Project Plans? 3.7, 3.8, 4.7

Table 1
EMSI QMP 4 of 6
Required Element from QA/R-2 EMSI QMP Location

50. Describes process for evaluating and qualifying data collected for Subsections 3.5, 3.6
other purposes or from other sources?

51. Includes roles, responsibilities, and authorities in description of Subsections 3.2, 3.3,
above processes? 4.1, 4.2

IMPLEMENTATION OF WORK PROCESSES


52. Describes process for ensuring that work is performed according to Subsections 3.5, 4.4,
planning and technical documents? 4.6
53. Describes process for identifying operations needing procedures? Subsection 4.5

54. Describes process for preparation, review, approval, revision, and Subsection 4.5, 4.6, 4.7
withdrawal of these procedures?

55. Describes policy for use of these procedures? Subsections 1.2, 1.4

56. Describes process for controlling and documenting the release, Subsections 2.9, 2.10,
change, and use of planned procedures? 3.7, 3.8, 4.6, 4.7
56a. Process includes description of necessary approvals? Subsections 2.9, 2.10
56b. Process includes removal of obsolete documentation from work Subsection 2.10
areas?
56c. Process includes verification that the changes are made as Subsections 2.10, 2.11,
prescribed? 3.7, 3.8, 4.6, 4.7
57. Includes roles, responsibilities, and authorities in description of Subsections 2.3, 3.4,
above process? 4.2

ASSESSMENT AND RESPONSE


58. Describes the process for assessing the adequacy of the quality Subsection 2.11
system at least annually?

59. Describes the process for planning, implementing and documenting Subsection 2.11
assessments and reporting results to management?
59a. Process includes selecting an assessment tool, the expected Subsection 2.11
frequency, and the roles and responsibilities of assessors?
59b. Process includes determining the level of competence, Subsection 2.11
experience and training needed for assessment personnel?
59c. Process includes ensuring that personnel have no real or Subsection 2.11
perceived conflict of interest, and have no direct involvement or
responsibility for the work being assessed?
59d. Process includes ensuring that personnel conducting Subsection 2.11
assessments have sufficient authority, access to programs and
managers, access to documents and records, and organizational
freedom?

Table 1
EMSI QMP 5 of 6
Required Element from QA/R-2 EMSI QMP

60. Describes process for management’s review of, and response to, Subsection 2.11
findings?
61. Describes process for identifying how and when corrective actions Subsection 2.11
are to be taken in response to the findings of the assessment?
61a. Process includes ensuring corrective actions are made promptly? Subsection 2.11
61b. Process includes confirming the implementation and Subsection 2.11
effectiveness of any corrective action?
61c. Process includes documenting actions? Subsection 2.11

62. Describes process for addressing disputes encountered as a result of Subsection 2.11
assessments?

63. Includes roles, responsibilities, and authorities in description of Subsection 2.11


above processes?

QUALITY IMPROVEMENT
64. Describes process for ensuring that conditions adverse to quality are Subsection 1.2
prevented, identified promptly, corrected promptly and that actions are
taken toward prevention, documented and actions tracked to closure?

65. Describes process for encouraging staff to establish Subsection 1.2


communications between customers and suppliers, identify process
improvement opportunities, and identify and propose solutions for
problems?

66. Includes roles, responsibilities, and authorities in description of Subsection 1.2


above processes?

OTHER REVIEW CRITERIA


67. Are regulatory or other citations accurate?

68. Are there any inconsistencies in the text?

69. Is the writing clear?

70. Are organizational units identified consistent with the most recent
reorganization?

71. Are past QS management assessment findings resolved?

72. Are activities described in the QMP consistent with QA Annual


Report and Work Plans?

73. Are tasks proposed for other organizations not covered solely by
this QMP documented elsewhere (e.g., in another organization’s
QMP)?

Table 1
EMSI QMP 6 of 6
Figures
PRESIDENT
P. Rosasco, P.E.

CHIEF QUALITY
FINANCIAL ASSURANCE
OFFICER OFFICER
R. Jelinek, P.E. R. Jelinek, P.E.

PROJECT
PROJECT QUALITY CONTROL
MANAGER REVIEWER
T. Shangraw, P.E. (As Required)

TASK
MANAGERS
(As Required)

PROJECT
STAFF
(As Required)

Figure 1

Functional Organizational Structure


(February 2016)
Quality Assurance Management Plan

EMSI Engineering Management Support, Inc.


Appendix A
Appendix B
Form B-1
Project Planning and Scoping Checklist

Project Name: Project Number:

Project Manager: Date:

Reviewer:
Status (circle)
1. Objectives and Scope

a. Is there a signed contract? Yes No Not Reviewed Not Applicable

b. Are the objectives of the project clearly defined? Yes No Not Reviewed Not Applicable

c. Is the overall technical approach commensurate with the


objectives? Yes No Not Reviewed Not Applicable

d. Are the limitations of the proposed scope of work well


understood and conveyed to the client? Yes No Not Reviewed Not Applicable

e. Is there conformance to the contracted scope of work? Yes No Not Reviewed Not Applicable

f. Are the project members appropriately assigned and briefed? Yes No Not Reviewed Not Applicable

2. Methods and Procedures

a. Are the proposed methods and procedures technically sound


and adequately defined? Yes No Not Reviewed Not Applicable

b. Have competent subcontractors been identified? Yes No Not Reviewed Not Applicable

c. Have the permit issues been adequately considered? Yes No Not Reviewed Not Applicable

d. Are the QC requirements adequately identified? Yes No Not Reviewed Not Applicable

e. Is there a change order procedure documented? Yes No Not Reviewed Not Applicable

3. Deliverables

a. Have the client and the project manager agreed on the number
and scope of deliverables? Yes No Not Reviewed Not Applicable

4. Budget and Schedule

a. Have detailed cost estimates been prepared? Yes No Not Reviewed Not Applicable

b. Are cost estimates correct? Yes No Not Reviewed Not Applicable

c. Has detailed project schedule been prepared and discussed


with the client? Yes No Not Reviewed Not Applicable

d. Is the schedule reasonable? Yes No Not Reviewed Not Applicable

Engineering Management Support, Inc.


Form B-2
Quality Control Review Checklist

Project Name: Project Number:

Project Manager: Date:

Reviewer:
Status (circle)
1. Objectives and Scope

a. Are the objectives of the project clearly defined? Yes No Not Reviewed Not Applicable

b. Is the overall technical approach commensurate with the


objectives? Yes No Not Reviewed Not Applicable

c. Are the limitations of the proposed scope of work adequately


described? Yes No Not Reviewed Not Applicable

d. Is there conformance to the contracted scope of work? Yes No Not Reviewed Not Applicable

2. Data Collection Rationale

a. Is the rationale for data collection adequately described? Yes No Not Reviewed Not Applicable

b. Is a QAPP needed? Yes No Not reviewed Not Applicable

3. Methods and Procedures

a. Are the methods and procedures used technically sound and


adequately explained? Yes No Not Reviewed Not Applicable

b. Were data collection procedures followed? Yes No Not Reviewed Not Applicable

4. Conclusions

a. Is the data interpretation process logical, and can it be


followed? Yes No Not Reviewed Not Applicable

b. Are conclusions clearly stated? Yes No Not Reviewed Not Applicable

c. Are conclusions adequately supported by facts? Yes No Not Reviewed Not Applicable

5. Opinions and Recommendations

a. Are opinions supported by data and conclusions? Yes No Not Reviewed Not Applicable

b. Do recommendations and opinions reflect reasonable


professional judgment? Yes No Not Reviewed Not Applicable

c. Are recommendations clearly separated from conclusions? Yes No Not Reviewed Not Applicable

6. Professional Registrations

a. Have documents been reviewed and signed by registered


professionals where appropriate? Yes No Not Reviewed Not Applicable

Engineering Management Support, Inc.


Form B-3
Quality Assurance Audit Checklist

Project Name: Project Number:

Project Manager: Date:

Reviewer:
Status (circle)
1. Scope

a. Did proposal define work performed? Yes No Not Reviewed Not Applicable

b. Did work plan define work performed? Yes No Not Reviewed Not Applicable

c. Did project meet objectives? Yes No Not Reviewed Not Applicable

2. Budget and Schedule

a. Were all scope items budgeted? Yes No Not Reviewed Not Applicable

b. Were all equipment and support labor budgeted? Yes No Not Reviewed Not Applicable

c. Were cost estimates correct? Yes No Not Reviewed Not Applicable

d. Was the project completed within budget? Yes No Not Reviewed Not Applicable

e. Was the project completed on schedule? Yes No Not Reviewed Not Applicable

3. Field Investigation

a. Were field procedures audited? Yes No Not Reviewed Not Applicable

b. Were field notes reviewed? Yes No Not Reviewed Not Applicable

c. Were boring logs edited? Yes No Not Reviewed Not Applicable

4. Chemical Analysis

a. Were data quality objectives established? Yes No Not Reviewed Not Applicable

b. Were QC samples collected? Yes No Not Reviewed Not Applicable

c. Were QC data reviewed? Yes No Not Reviewed Not Applicable

Engineering Management Support, Inc.


Form B-3 (continued)
Quality Assurance Audit Checklist

Status (circle)
5. Calculations

a. Was methodology correct? Yes No Not Reviewed Not Applicable

b. Was math correct? Yes No Not Reviewed Not Applicable

6. Design

a. Was design in conformance with Project Procedures


Memorandum? Yes No Not Reviewed Not Applicable

b. Was design review completed? Yes No Not Reviewed Not Applicable

7. QA/QC Plan

a. Were separate QA/QC plans required? Yes No Not Reviewed Not Applicable

b. Did QC procedures conform to company policy? Yes No Not Reviewed Not Applicable

8. Report

a. Was a technical edit performed? Yes No Not Reviewed Not Applicable

b. Were graphics correct? Yes No Not Reviewed Not Applicable

c. Was draft report reviewed? Yes No Not Reviewed Not Applicable

d. Were signatures correct? Yes No Not Reviewed Not Applicable

9. Contractual Procedures

a. Was there a signed contract? Yes No

b. Did scope of work, budget, and schedule comply with


contractual obligations? Yes No

c. Are change orders properly documented for scope, budget, and


schedule changes? Yes No

d. Are subcontracts in accordance with company policy? Yes No

Engineering Management Support, Inc.


Form B-4
Quality Assurance Audit Form

Project Name: Project Number:

Project Manager: Date:

Audited by: Date:

Reviewed with President: Date:

Project Objective/Brief Scope Description:

1. Was a project management plan or PM procedures memo prepared? Yes No

2. Who is the professional in responsible charge of the work?


(This is the scientist or engineer of record, not necessarily the Project Manager)

3. List QC reviewer(s) names and their specialty areas.

4. What is the estimated physical project completion stage? %

5. Have QC reviews been completed and documented? Yes No

6. Are there any significant quality assurance issues that need follow-up by
management? If so, please identify them below:

cc: Project Manager


President

Engineering Management Support, Inc.

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