Final Quality Management Plan
Final Quality Management Plan
Final Quality Management Plan
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
LIST OF FIGURES
Figure 1 - Functional Organization Structure
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
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:
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.
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.
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;
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.
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.
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.
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:
2.1 General
Management commitment;
Management organization;
Project management;
Subcontractor management;
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.
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.
2.3.1 President
The President is ultimately responsible for all quality-related functions. The President's
QA responsibilities are to:
Appoint the Quality Assurance Officer who directs the QA Program; and
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:
Coordinate QA training;
Audit selected EMSI projects and monitor general compliance with the QA
Policy;
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:
Ensure that project deliverables and activities are in accordance with project
controlling documents;
Develop, with the Project Manager, corrective actions when appropriate; and
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.
A Task Manager is a professional responsible for a particular project task. The Task
Manager's responsibilities are to:
Oversee data collection and analysis and determine that appropriate procedures
are employed;
Ensure that all task deliverables are in accordance with project controlling
documents;
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.
Health and Safety Training: Training required to meet federal statutes for
employees performing work under specific conditions.
Loss Prevention Training: Seminars and training workshops for all EMSI staff.
Professional Licenses: EMSI pays for professional licenses for individuals based
on the requirements of our clients, projects, or the states within which we operate.
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.
Technical Performance:
Work procedures;
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.
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.
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.
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
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.
EMSI projects are planned, implemented, and monitored following procedures described
in this QMP.
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.
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:
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.
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:
Report outline;
Factual conclusions/findings;
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.
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.
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.
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.
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.
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.
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.
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.
Notify the Project Manager of the intent to perform an audit as well as the
objective and scope of the audit;
Finalize the audit report with input from the Project Manager and President.
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.
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.
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
The DQO process consists of the seven basic steps described below.
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.
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.
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.
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.
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.
Assigning probability values to points above and below an action level that define
the acceptable probability for the occurrence of decision errors.
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.
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:
Specification of methods for evaluating data and assessing limitations on data use;
By following the data collection design process, data can be traced to sampling and
analytical procedures, performance standards, and measuring equipment.
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.
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).
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;
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.
1. Title page;
2. Table of Contents;
3. Project Description;
6. Sampling Procedures;
9. Analytical Procedures;
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.
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.
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.
Internal QC procedures and checks should be used throughout EMSI projects and should
include inspections and acceptance testing. The QC checks should include:
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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Engineering Management Support, Inc.
February 2016 – January 2017 26
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.
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.
Document control for data acquisition activities shall be consistent with document control
and records management procedures described in Section 2.8 of this QMP.
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.
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.
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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February 2016 – January 2017 27
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, 2003, Guidance for Geospatial Data Quality Assurance Project Plans
(QA/G-5G), EPA/240/R-03/003, March 2003;
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.
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:
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:
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
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;
Data validation reports summarizing the validation process used and the specific
results and comments pertaining to a sample or group of samples.
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:
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.
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.
The frequency of these audits and performance evaluations are project-dependent, and are
specified in project-specific QAPPs.
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:
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.
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 organization;
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.
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:
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.
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.
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:
Client needs expressed in the design criteria compared with the technical
specifications;
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;
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.
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.
Operations and maintenance (O&M) procedures are prepared by EMSI for specific
elements of designed engineered systems for environmental remediation. These
Quality Management Plan (Rev 0)
Engineering Management Support, Inc.
February 2016 – January 2017 37
procedures are the responsibility of the Project Manager and are normally prepared in
three stages:
Startup procedures;
Operating modes;
Shutdown procedures;
Post-shutdown procedures;
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.
Verification under field conditions that the installed systems and subsystem
components meet operational performance requirements;
Calibration and control of measuring and test equipment against acceptable and
documented baseline standards.
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:
Nature and extent of defects and causes of rejection, including corrective actions
taken; and
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;
Responsible personnel;
Reference specification.
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:
Initial calibration;
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.
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.
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.
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?
Table 1
EMSI QMP 1 of 6
Required Element from QA/R-2 EMSI QMP Location
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
20. Lists tools for implementing each component (e.g., QMPs, Quality Subsection 2.10
Systems Audits, Training Plans, QA Project Plans?
22. Identifies review and approval procedures for these internal QMPs? Subsection 2.10
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
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?
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
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
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
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?
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?
70. Are organizational units identified consistent with the most recent
reorganization?
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
Reviewer:
Status (circle)
1. Objectives and Scope
b. Are the objectives of the project clearly defined? 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
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
a. Have detailed cost estimates been prepared? Yes No Not Reviewed Not Applicable
Reviewer:
Status (circle)
1. Objectives and Scope
a. Are the objectives of the project clearly defined? Yes No Not Reviewed Not Applicable
d. Is there conformance to the contracted scope of work? Yes No Not Reviewed Not Applicable
a. Is the rationale for data collection adequately described? Yes No Not Reviewed Not Applicable
b. Were data collection procedures followed? Yes No Not Reviewed Not Applicable
4. Conclusions
c. Are conclusions adequately supported by facts? Yes No Not Reviewed Not Applicable
a. Are opinions supported by data and conclusions? Yes No Not Reviewed Not Applicable
c. Are recommendations clearly separated from conclusions? Yes No Not Reviewed Not Applicable
6. Professional Registrations
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
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
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
4. Chemical Analysis
a. Were data quality objectives established? Yes No Not Reviewed Not Applicable
Status (circle)
5. Calculations
6. Design
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
9. Contractual Procedures
6. Are there any significant quality assurance issues that need follow-up by
management? If so, please identify them below: