INTERIM DRAFT
   EPA REQUIREMENTS FOR
QUALITY MANAGEMENT PLANS
          EPA QA/R-2
          Region 6 U.S. EPA
         Office of Quality Assurance

          Dallas, Texas 75202
            MAY 1994

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                         QUALITY MANAGEMENT PLANS
Introduction

       This document incorporates the national U.S. EPA Requirements for Quality Management
Plans and the Region 6 policy requirements into one document for ease of use by our customers.

       It is both a Regulatory requirement and policy of EPA that all environmental programs
conducted by or on behalf of EPA shall establish and implement effective Quality Systems.  EPA
policy  requires that all organizational units  document their  Quality  System in a Quality
Management Plan (QMP), formerly called a Quality Assurance Program Plan (QAPgP). Region
6 EPA policy requires submission of Quality Management Plans prior to any approval for EPA
funding. Quality Systems encompass the management and technical activities necessary to plan,
implement, and assess the effectiveness of quality assurance (QA) and quality control  (QC)
operations applied to environmental programs.  This plan provides  the blueprint for how an
individual organization or organizational component will plan, implement, and assess its Quality
System for the environmental work to be performed  as part of its mission.

       Approval of a QMP by the accountable official for the organizational unit preparing the
plan and by the senior  management official at the next higher level in the organization is
required prior to submission. Any QMP received without the required approval signatures will
be returned without being reviewed.  The EPA Region 6 Office of Quality Assurance will review
the QMP concurrently with the Region 6 program  office(s) and, if fully compliant with  all
Agency and Regional QA requirements listed in this document, will be approved.   Final
approval of a QMP  for Region 6 is made by the Region 6 Quality Assurance Manager.

       Contractors that perform work for or on behalf of EPA must provide a QMP as evidence
of their own established Quality System. Such QMPs are submitted, reviewed and approved by
the same process as described in the paragraph above, as part of the contract procurement. The
process used by grantees and contractors to review and approve QMPs from outside their own
organizational units, whether by contract or sub-contract, agreement or sub-agreement, must be
described in the organization's  QMP.

       The QMP is  management's statement of the process governing the QA/QC activities for
a given organization.  That is,  the QMP describes how the organization will conduct  its
business.  The QMP defines an organization's QA-related:

       •      policies,

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       •     criteria for and areas of application, and,

       •     definition of roles, responsibilities, and authorities.

       The QMP, therefore, is a management tool that should be appropriately tailored to the
needs of its organization and that defines how its quality management objectives will be attained.
The QMP must  be sufficiently inclusive and explicit to allow subordinate  managers and
supervisors to understand the  priority which management places on QA, the established QA
policies and procedures, and their respective QA roles. The QMP must be so constructed and
so written that an assessment of its implementation should be able to determine whether or not
the Quality System is  being  managed in  a way  that guarantees successful  environmental
programs.  In practice, the QMP should be focused on  the processes used to plan, implement,
and assess the programs to which it is applied. The level of detail should be based on a graded
approach1 that establishes  QA  and QC requirements commensurate with the importance of the
work and the unique needs of  the organization.

       The specifications  presented in  this  Chapter are based on  principles of organizational
flexibility so that the plan can be tailored to individual requirements and modified as the require-
ments change. This document describes the key QA management elements which are normally
considered to be important in a quality system.  Some  elements are  mandatory to ensure
consistency across EPA Region 6 Grantee/Contractor Quality Systems.  Other elements may be
mission-specific and may  not apply to every organization. Each organization should evaluate
these key elements  to see if they are applicable to their quality system.  Where a  particular
element is not relevant, a brief explanation of why it is not relevant should be provided in the
quality management document. On the other hand, if additional quality management elements
are deemed useful or necessary for an adequate Quality System, that group is encouraged to
develop these elements and discuss them in their Quality System documents.
       Quality Management Plan Preparation. Submission. Review, and Approval

              QMP Preparation Responsibility

       Each  senior  manager  is  responsible for the preparation of  a  QMP to cover  all
environmental programs for which the manager is accountable. The term senior manager refers
to managers  who are responsible and accountable for  mission  accomplishment and overall
operations.   The term management or line management refers  to those individuals directly
responsible and accountable for planning, implementing, and assessing environmental programs.
Several levels of senior management may exist and may include, but are not limited to, Office
Directors, Laboratory Directors, Division Directors, and Bureau Chiefs. "Environmental data"
       'A graded approach to QA/QC bases the level of managerial controls on the intended use of the results and
the degree of confidence needed in the quality of the results.

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include all field and laboratory measurements of chemical, physical, and biological parameters
in or pertaining to the environment as established by  the definition in  Chapter 1.   Senior
management is responsible for ensuring that the Quality System documented in the QMP meets
all compliance requirements with this Quality Manual.

       While senior management is responsible for the preparation of the QMP, the physical
preparation may be assigned to the organization's staff so long as it is assured that all line
managers participate in and support the effort.  It is essential that line management understand
fully the content of the QMP and concur with its implementation. It is recommended and highly
desirable that this concurrence be documented by  line managers signatures  as "Concurring
Officials" on the approvals page of the QMP. The preparation of the QMP may be directed by
the Quality Assurance Manager (QAM).

       Drafts of a QMP are not acceptable, due to resource constraints on the Region 6 Office
of Quality Assurance.  Assistance will be  provided and questions answered by the Region 6
Office of Quality Assurance staff to support the writing and reviewing process.  Call (214) 665-
2217 to receive such assistance.

       The Region 6 Office of Quality Assurance has committed to a 10 working day turnaround
time for reviewing QMPs.  This is a goal we strive to meet, as we recognize the need to provide
prompt feedback to our customers.
             Internal Approval and Submission

       The QMP must be approved by the accountable manager of the organization preparing
the QMP. This will certify that the organization has conducted an internal review of the QMP
and that line management has concurred with its contents and supports its implementation.
The senior manager should indicate his/her approval of the QMP on the signature page of the
document.  The  senior manager may require the concurrence of appropriate subordinate line
managers on the QA documentation if he/she believes this to be beneficial to the group's Quality
System. It is recommended that three sets of approval/concurrence pages be submitted, all with
original signatures.
             Region 6 QA Office Review and Approval of the QMP

       Following the internal review and approval, the QMP must be submitted to EPA Region
6 for review for compliance with EPA Quality System requirements.  Within 10 days of receipt
of a QMP (Received in the QA Office), the QA Office will either approve or disapprove and
provide detailed comments and suggestions for improving the QMP so that it can be revised and
approved upon resubmission.  An approval by Region 6 Office of Quality Assurance is valid for
a period not to exceed one year.  Each year after the initial approval of a QMP a revision and
update of the QMP is required.  Many organizations make changes to their internal processes

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which need to be documented.  Personnel change over time through promotion, attrition and
reassignment, and these changes require documentation.

      In  its reviews of QMPs,  the  QA Office staff focuses on  the substance  of the
organization's QA management process and not on format or technical details.  QA Office staff
will recommend approval for those QMPs it believes reflect acceptable QA policies,procedures,
administrative criteria, and management systems for key QA elements including Data Quality
Objectives, QA Project Plans, other QMPs (from organizations that are involved by contract,
agreement or sub-contract, sub-agreement), Standard Operating Procedures, assessments, and
oversight of delegated programs.  QA Office staff will review the QMPs for compliance with
current  Regional  and National  EPA  Quality System requirements  and the inclusion  of  all
mandatory program elements.
             QMP Revisions

       Region 6 and National EPA policy requires that all Quality Systems be reviewed at least
annually by their organizations to assure the effectiveness of the quality management practices
described in the QMP.  This assessment must also include an evaluation of the effectiveness of
the QMP. The process of developing and annually updating the QMP provides an opportunity
for management and staff to clarify roles and responsibilities, address problem areas,  and
acknowledge  successes  so that they may be fostered and rewarded.  Having an accurate QMP
at all times is  an  essential element in every Quality  System.   Changes in QA policy and
procedures should be documented in a timely fashion by QMP revisions.  In general, a copy of
any QMP revision(s) made during the year should be submitted as an attachment to or as part
of the QA Annual Report and Work Plan (QAARWP) if required as a grant condition, contract
deliverable or the QMP of the organization.  In some cases, however, it may be necessary to
re-submit the entire QMP if significant changes have been made to the Quality System.  If the
entire QMP is current,  valid and accurately reflects the organization's policy, at a minimum,
each year the organization will submit to EPA Region 6 a certification that the plan is current,
to include a copy of new, signed approval pages for the QMP.

       It is management's responsibility to assure that all changes to the Quality System and the
QMP are  distributed to all  personnel performing work for the organization,  including active
contractors, sub-contractors, and agreement, and sub-agreement parties.
       Quality Management Plan Requirements

              General Requirements

       The QMP is the blueprint for an organization's quality management process in support
of technical operations. That is, the QMP documents the entire framework and structure for the
QA/QC processes used by the organization.   In general, the QMP should describe how the

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organization plans and  implements the necessary quality management practices,  including
QA/QC, to ensure that the results of its technical work are of the type and quality needed for
their intended use. Accordingly, the QMP will contain discussions of such subjects  as:

             the quality policy and mission of the organization,

             the specific roles  and responsibilities of top management and employees for
             required QA/QC activities,

             the structure for effective communications,

             how measures  of  effectiveness will be  established and how frequently effec-
             tiveness will be measured, and

             how continual improvement will occur.

       The QMP reflects the organization's commitment to quality management principles and
practices,  tailored by  senior  management to meet the  organization's needs.   A  Quality
Management Plan, minimally, must address the topics addressed in subsequent sections of this
document.  It is preferable, but not necessary,  that the QMP cover the topics in the same order
as presented below.  If an existing QMP adequately addresses each of these topics, but  in a
different order, it should not be rewritten simply to conform to the outline provided here.  The
important  element here  is content, not format.  A  discussion is provided under each topic
heading to clarify the type of information that is expected to be presented in a QMP.

       Because the nature of the Quality System will vary among organizations, the content and
organization of QMPs will also vary. In general, the QMP should address all of the components
of the Quality System and discuss HOW they  should be carried out and by WHOM.

       The following Quality System elements  include the subjects listed above as well as others
and must be addressed by the QMP:

                    Management and Organization,
                    Quality System and Description,
                    Personnel Qualification and Training
                    Procurement of Items and Services,
                    Documentation and Records,
                    Computer Hardware and Software,
                    Planning,
                    Implementation of Work Processes,
                    Assessment and Response, and
                    Quality Improvement.

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       If an organization believes that an element or a sub-element is not applicable to its
Quality System, then it must state why this is the case.  In the discussions to follow, specific
requirements are presented on what  should be addressed or included within each of these
program elements.
1            Management and Organization

Specific Requirements:

       This section  of the QMP shall contain or address the following management  and
organizational items:

       •     a statement of the organization's policy on quality assurance, including:

                    the level of  importance of QA/QC to the organization and why,

                    the general objectives/goals for QA/QC, and

                    the commitment of resources for QA/QC;

       •     an organization chart that identifies all of the components of the organization and,
             in particular, the organizational position of the QA Manager/QA Officer;

       •     a discussion of the responsibilities and authorities of the QA Manager/QA Officer
             and any other QA staff, including:

                    the line of reporting to senior management, and

                    the means by which  management will be kept  informed about quality
                    issues;

       •     a discussion of the  mission of each organization component, functional responsi-
             bilities of management and staff, levels of accountability and authority, and lines
             of  communication  for planning,  implementing,  and assessing environmental
             programs;

       •     a discussion  of the  QA/QC roles and  responsibilities of line management,
             technical staff, and any other staff;

       •     identification of all activities to which QA/QC are to be applied;

       •     how management will assure that applicable elements of the Quality System are
             understood and  are implemented in all activities under their responsibility

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             involving environmental programs;

             an approval page  for the signatures of the accountable managers, senior line
             management (as appropriate), and the QA Manager/QA Officer of the organiza-
             tion, and for the Region 6 QA Officer, and appropriate Region 6 Program Office
             staff. This approval page may be part of a tide page or a separate sheet follow-
             ing the title page.
Rationale:
       The QMP represents an  opportunity for  the organization's accountable managers to
inform subordinates of the priority accorded to QA/QC and the reasons for that priority. The
QMP also represents an opportunity to document important broad quality policies such as the
need to incorporate QA in the up-front planning of activities entailing environmental data collec-
tion and the need for personal involvement of subordinate managers and supervisors in day-today
QA/QC activities.

       It is appropriate  to begin the QMP with  a statement of the  organization's policy  on
quality assurance. It should convey senior management's views on the level of importance and
priority that the organization's personnel should give to quality assurance in environmental
sampling and analysis activities conducted by, or in support of the organization. Recognition
and support for senior management's policies should be affirmed by  subordinate managers  by
their inclusion as concurring officials on the approval page.  An explanation of why QA should
be afforded the indicated level of importance and priority is also appropriate. The QMP should
contain a statement of the general objective/goals that the organization intends to achieve through
its Quality System. This statement may be combined with the Policy Statement described above.
A commitment to assuring the availability of the time and resources needed to obtain the type
and quality of program results needed to satisfy mission objectives should be included. The
policy statement should emphasize  those requirements and activities needed  to  assure data
quality.  The specific policies and procedures addressed elsewhere in the QMP need not  be
repeated here. The basic objective of an organization's Quality System is to provide a  process
for management's review and oversight at the planning, implementation, and assessment stages
of environmental programs.
2            Quality System and Description

Specific Requirements:

       This section of the QMP shall contain or address the following items pertaining to the
Quality System and the technical mission to which it applies:

       •     A discussion of the principal components or "tools" comprising the organization's
             Quality System and the process and procedures for their use.  These

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             components include, but are not limited to:

                           Quality Management Plans
                           Management Systems Reviews
                           Data Quality Objectives Process
                           QA Project Plans
                           Standard Operating Procedures
                           Technical Assessments  (Self and Independent)
                           Data Quality Assessments

             The process discussion should include  the roles and  responsibilities  for  all
             management and staff in planning and implementing the Quality System.

             A discussion of the technical activities or programs that are supported by the
             Quality System and to which the QA/QC controls apply; that is, the specific pro-
             grams that require extensive  QA/QC controls; where oversight of delegated,
             contracted, or other extramural programs  is needed to assure data quality; and,
             where internal coordination of QA/QC among the group's organizational units
             need to occur.
Rationale:
       The QMP should describe the Quality System process used by the organization to plan,
implement,  and assess  the  effectiveness of QA/QC  activities applied  to  its environmental
programs.   Such a process  description  should include how key QA/QC functions are to be
performed, what "tools" or procedures are used,  and who is responsible for doing the work.

       The  QMP should identify the programmatic activities of the associated organizations
covered by  the Quality  System and describe its structure, policies and procedures, functional
responsibilities, levels of accountability and authority, and necessary interfaces.  By identifying
and describing these activities (i.e., projects, tasks, etc.), the organization specifies the necessary
foundation for defining and stipulating  the items that are  essential  to planning an effective
Quality System.  The  QMP should identify and briefly  describe  each  significant program
undertaken or supported by the group. Pertinent  information might include the nature and size
of each program  and the administrative vehicle by which they are implemented;  i.e., by the
efforts of internal organizational employees, by contract, by cooperative agreement, by grant,
or by delegation of responsibility through a inter-agency agreement to or from state government
agencies.

       The  QMP should define and  document how and when QA/QC  activities applied to
individual projects  and tasks  at the  technical/project level are planned, implemented,  and
assessed.  The QMP is  the formal means by which management documents how QA/QC will
be applied to environmental programs; that is, it  provides the "blueprint"  for how the Quality

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System will  operate.  Moreover,  the QMP provides  the basis or criteria for assessing  the
effectiveness of the Quality System.
3             Personnel Qualifications and Training

Specific Requirements:

       The QMP must reflect management's commitment to and describe its systems for:

       •      identifying certifications required to perform operations for the different programs
              for which the organization is responsible;

       •      establishing  training requirements for personnel;

       •      identifying and satisfying technical and project management training needs;

       •      identifying and/or designing training programs to meet these needs;

       •      performing introductory training and continuing training (or re-training);

       •      encouraging professional development beyond initial qualifications;

       •      documenting and maintaining training records for personnel;

       •      identifying qualified trainers;

       •      assessing the effectiveness  of training and  (where  applicable) establishing a
              program  for training and updating the instructors on  training techniques and
              technical changes; and

       •      reviewing and updating training materials and course content.

Included in the above is the responsibility of management  to identify what  qualifications or
certifications are necessary  for personnel to perform their work safely and effectively.

Rationale:

       As stated earlier, EPA policy requires that personnel performing work on environmental
programs shall be qualified to perform assigned work, including and according to any project-
specific requirements.  The QMP should include a description of the organization's process for
identifying and satisfying training  needs on a continuing basis. Accordingly, this section shall
describe the organization's  process for establishing training  requirements, identifying training
needs, assigning priorities to them, and satisfying them in priority order.

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       The training categories must be specified in the QMP or reference must be made to the
organization's formalized training program.  The following are examples of possible training
categories associated with environmental programs:
       •      fundamental principles of quality;
       •      the organization's QA policies and procedures;
       •      technical skills (e.g., statistics, experimental design);
       •      management and communication skills; and
       •      specialized topics (e.g., risk management).

       The selection of mandatory and optional topics within training categories should be based
on the results of a systematic evaluation of the organization's needs.  In addition to classroom-
style training, the organization should consider taking advantage of on-the-job training as  well
as innovative techniques such as computer-based training.

       Management should evaluate each position to determine what qualifications are necessary
for personnel to execute their quality-related responsibilities in a safe and effective manner.
These qualifications must be documented  in terms of education, experience, training, technical
knowledge,  or combinations  of the above.   Qualifications  should reflect the hazard  and  risk
associated with a specific position;  when appropriate,  qualifications  based on hazard and  risk
should be established  for individual projects, and required of personnel for the duration of the
project.
4             Procurement of Items and Services

Specific Requirements:

       This section of the QMP shall contain discussions of or address the following issues
pertaining to the procurement of items and services:

       •      the organization's process for assuring that QA/QC requirements are defined for
              all applicable acquisitions and that this assurance process is documented for each
              acquisition action;

       •      how changes to procurement documents will receive the same review approvals
              as the original documents;

       •      the organization's process for assuring that QA/QC requirements are adequately
              addressed in all responses to applicable solicitations and that QA/QC is an inte-
              gral criterion of the evaluation  criteria; and

       •      the organization's process for ensuring that contracted and subcontracted activities
              produce results of acceptable quality, including, as  appropriate:  procurement
              source evaluation and selection, evaluation of objective evidence


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              of quality furnished by the  supplier,  source inspections, supplier audits, and
              examination of deliverables.
Rationale:

        The procurement process must ensure  that approved suppliers continue to provide
acceptable items and services.  Procurement documents or financial assistance agreements shall
require suppliers (i.e., contractors, subcontractors, or financial assistance recipients) to have a
Quality System consistent with EPA QA requirements.  This requirement applies only to those
suppliers who provide services or items that directly affect the quality of results or products from
environmental programs. The management system should describe: the pre-award planning of
procurement needs  and activities; the identification,  documentation, review, and approval of
technical specifications; the selection  and documentation of evaluation criteria and necessary
certifications; the qualification and approval process of contractors and subcontractors; the
evaluation of contractor and subcontractor QMPs to ensure  compliance with the guidelines
presented  in this requirements document;  the identification of procedures for review and
approval of negotiations, compromises or changes regarding technical issues; documentation of
the procurement process; and  the evaluation and verification of post-award  quality versus
original pre-award acceptance criteria.

       The EPA recognizes  the concept of privity of the contract that applies between a prime
and a sub-contractor, and in theory, follows that concept in application to grants, cooperative
agreements and interagency agreements.  The EPA looks to the organization that was awarded
a grant, contract or interagency agreement to accept full responsibility for quality of all work
performed under that specific grant, contract or interagency agreement, regardless of whether
or not that organization actually performed the work or by some means had the work performed
by another entity. Each supplier/customer relationship requires each customer to be responsible
for fully and specifically informing a supplier of all quality expectations, and assuring that all
items and services provided by their subcontractors and suppliers meet those expectations.  How
this occurs,  and the process that assures it  is of acceptable quality must be delineated in this
section of the QMP.
5      Documents and Records

Specific Requirements:

       This section of the QMP must include:

       •     a  description  of  the organization's  process  for identifying  quality-related
             documents and records requiring control;

       •     a description of the organization's process for handling documents and records
             to assure their accessibility, protection from damage and deterioration, and means
             of retention, including discussion of the roles and responsibilities for


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             management and staff;

       •     a  description of the process by which all technical guidance documents are
             prepared, reviewed, approved, issued, used, and revised; and

       •     a description of the process that ensures compliance with all statutory, contrac-
             tual, and assistance agreement requirements for records from environmental pro-
             grams and that provides adequate preservation of key records necessary to support
             the mission of the organization.

Rationale:

       Organizations that perform environmental sampling, analysis, and project management
activities must establish and maintain procedures for the timely preparation,  review, approval,
issuance, use, control, revision and maintenance of documents and records.  For the purposes
of these requirements, a document is any volume that contains information which describes,
defines,  specifies,  reports, certifies,  requires, or provides  data  or results  pertaining to
environmental programs.  A record is a completed document that provides objective evidence
of an item or process.  A document which contains objective information can become a record
once it is complete and identified as a record.

       The QMP must define and establish a  management process  that controls preparation,
review, approval, issuance, use, and revision of all technical guidance documents, especially
planning documents; i.e., QA Project Plans,  Sampling and  Analysis  Plans,  and Standard
Operating Procedures (SOPs).   Such documents, including revisions, must be reviewed for
conformance with the Quality  System requirements and approved by authorized personnel for
general use.  To facilitate the use of documents, consistency in formats shall be encouraged for
similar types of documents, such as standard operating procedures (SOPs).

       The  QMP must also define a  management process for records  to ensure  that they
accurately  reflect  completed  work and/or fulfill statutory  and EPA  requirements.    The
maintenance of records should include requirements and responsibilities for record transmittal,
distribution, retention, protection, preservation,  traceability, disposition, and retrievability. To
facilitate their accessibility and use, records must comply with required formats such as that
required  for analytical data by Good Automated Laboratory Practices  (GALP) (Ref.  5).  The
QMP should also identify how  the disposition  of records,  in accordance  with regulatory
requirements, schedules, or directives from senior management, is accomplished.
6      Computer Hardware and Software

Specific Requirements:

       This section of the QMP shall address the use of computer hardware and software in


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the organization's operations.  Specifically, the QMP must:

       •     describe the process for ensuring that computer hardware used in environmental
             programs meets the requirements of these programs;

       •     describe how changes to hardware  shall be controlled to assess the impact of the
             change on performance;

       •     describe the process for developing computer software, for validating, verifying,
             and documenting the software for its use, and for assuring that the software meets
             the requirements of the user;

       •     describe how purchased software is evaluated to meet user requirements and to
             comply with applicable  organizational policy regarding software proliferation and
             configuration management standards; and

       •     describe the process for ensuring  that data and  information produced from or
             collected by computers  meet applicable organizational policy standards.

These descriptions shall include the roles and responsibilities assigned to management and staff.

Rationale:

       There is increasing  dependence  on computer  hardware  and software  to  support
environmental programs in a variety of ways.  Computer hardware must be appropriate for its
intended application.  Computer  programs used in environmental data  operations and for
environmental technology design,  construction,  and operation  should be developed using
software development methodology approved  by authorized  personnel.  Computer programs
covered by this policy include  but are not limited  to design, design analysis, modeling of
environmental processes  and conditions,  operations or process  control,  and data bases or
document control registers (when used as the  controlled source of quality information). The
QMP should document how the organization manages its computer hardware and software
operations that directly impact the quality of the results of environmental programs.
7      Planning

Specific Requirements:

       This section of the QMP shall document how and by whom work shall be planned by the
organization.  Minimally, the QMP shall describe the system or process used to:

       •     identify the customer for whom the work is to be performed,
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       •     identify the needs and expectations of the customer in terms of both technical
             and quality goals,

       •     translate the customer's needs into specifications to produce the desired result,

       •     consider any cost and schedule constraints within which project activities are
             required to be performed, and

       •     identify acceptance criteria for the result or measures of performance by which
             customer satisfaction will be determined.

       All projects involving the generation, acquisition and use of environmental data shall be
planned using a systematic planning process such as the Data Quality Objective process as
defined by the current revision of Guidance for Planning for Data Collection in Support of
Environmental Decision Making Using the Data Quality Objectives Process, EPA QA/G-4, or
acceptable alternate, and  shall be documented in a Quality Assurance Project Plan (QAPP), as
defined by the current  revision of EPA Requirements for Quality Assurance Project Plans for
Environmental Data Operations,  EPA QA/R-5, and approved by authorized QA personnel for
implementation.

Rationale:

       The planning process should ensure that all organizations and/or  parties who contribute
to the quality of the environmental program results are identified and that they participate in the
planning process.   The planning process should include direct communication between the
customer and the supplier to ensure that there is a clear understanding by all participants of the
needs and expectations  of the customer and the product or results to be provided by the supplier.
How this occurs and is documented must be specifically addressed in the QMP.

       Management should ensure  that the unique  planning requirements  for  different
environmental programs, projects or tasks are addressed and documented according to the needs
of the specific work to be performed.  Such  documentation may be in the form of work plans,
schedules, and QAPPs.

       The QMP should describe the interface between  the Quality System and the technical
activities conducted by the organization.  The following issues pertain to all  such activities and
should be addressed by the QMP.

       •      Communication -  The collection of environmental data is often a complicated
              process whose success is dependent upon the correct sequence and execution of
              a number  of related steps and  details by personnel  having  different areas of
              expertise.  The QMP should describe the system of communications to ensure that
              all personnel are aware of their roles and responsibilities in the overall project
              before project initiation. Communications should continue during


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             project implementation so that complications and necessary deviations can be
             addressed in a timely manner.

       •     Documentation - Documentation is necessary to implement and validate sampling
             and analytical efforts, to detect problems, and to explain unexpected phenomena.
             Implementation of the work process will rely upon the documentation included
             in the QAPP as well as details documented in SOPs referenced by the Plan. The
             QMP should describe in  general what organizational and project information is
             be documented and how this information will be distributed, reviewed, and
             archived.

       •     Health & Safety - The QMP must emphasize the overriding importance of health
             and safety issues, and document mechanisms for review of all organizational and
             project activities for compliance with existing organizational health and safety
             requirements or for their  potential impact on the health and safety of personnel,
             prior to the initiation of activities.

       The QMP should describe how all work is accomplished in the proper sequence and in
accordance with approved planning documentation. All environmental programs do not require
the same degree of quality control. QMPs should define how to establish the needed level of
quality control.   QMPs define how to establish the needed level of quality control by selecting
data quality requirements using the Data  Quality Objectives (DQO) process or similar technique.
8      Implementation of Work Processes

Specific Requirements:

       This section of the QMP shall describe the process of how and by whom work shall be
implemented by or on behalf of the organization. Minimally, the QMP must describe:

       •     the procedures for ensuring that work is performed according to plan;

       •     the needed level of management oversight and inspection that will be commen-
             surate with the importance of the particular project and the intended use of the
             project results; and

       •     how procedures  for  appropriate  routine, standardized,  special, or  critical
             operations are developed and implemented, including the policies and procedures
             that address, but are not limited to:

                    identification of operations needing procedures;
                    preparation of procedures, including form, content,  and applicability;
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                    and
                    review and approval of procedures.

       The QMP must stress that environmental data operations project will be implemented in
accordance with the Quality Assurance Project Plan.  The QMP shall consider those activities,
policies, and procedures that are common to all projects of the specific organization.  It must
also emphasize the importance of documenting activities including any exceptions to the QA
Project Plan.

       The organization shall describe how appropriate measures for controlling the release,
change, and use of planned procedures are implemented.  These measures shall provide for the
necessary  approvals, specific times and points for implementing changes, removal of obsolete
documentation from work areas, and verification that the changes are made as prescribed.

Rationale:

       Line managers are responsible for implementing the approved QAPP and the QMP. This
includes   organizing and planning activities  to   meet quality  requirements  consistently;
coordinating work performance for specific projects; and training and qualifying personnel to
achieve and maintain proficiency. The mechanism for implementing these responsibilities should
be described in the QMP.

       The  QMP should describe how satisfactory performance will be determined from
established technical and quality specifications.  The work process should be monitored to ensure
continued satisfactory  performance.   The independence  of personnel  monitoring  work
performance should be demonstrated and be commensurate with the nature and importance of
the activity. Inspection, use of analytical QC  samples, and non-destructive  testing (NDT) are
examples  of measurement of work performance.

       Standard operating  procedures  (SOPs)  are encouraged   for appropriate  routine,
standardized, or special/critical operations.  If SOPs are to be utilized by the organization, and
referenced in the QMP or a QAPP for a specific project then the QMP should contain policies
and procedures for identifying and  addressing SOPs. The QMP should also describe the process
by  which  SOPs shall be reviewed  for adequacy by  technically qualified personnel before use.
9             Assessment and Response

Specific Requirements:

       Assessments are evaluations intended to increase the user's understanding of the program
or system being assessed, and to provide a basis for improving such programs or
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systems.  This section of the QMP must describe how and by whom assessments of environ-
mental programs  are planned, conducted,  and evaluated to measure the effectiveness of the
implemented quality system.  This section of the QMP shall also describe how management
determines  during planning which type of assessment activity is appropriate for a particular
project and which assessment tool is to be used.   The assessment tools for environmental
programs encompass:

                    management systems  reviews,
                    surveillances,
                    audits,
                    performance evaluations,
                    audits of data quality,
                    peer reviews and technical reviews,
                    readiness reviews, and
                    data quality assessments.

       This section shall contain or address the following items pertaining to management
assessment  of the effectiveness of the organization's Quality System:

       •     how the process for the planning, scheduling, and implementation of assessments
             works, as well as how the organization will respond to needed changes;

       •     definition of responsibilities,  levels of participation, and authorities for all
             management and staff for the assessment process; and

       •     discussion of how, when, and by whom actions will be taken in response to the
             findings of the assessment, and how the effectiveness of the response will be
             determined.

       Personnel  conducting  assessments  shall be qualified  based  on  project-specific
requirements to perform the assigned assessment.  The QMP must describe how the level of
competence, experience, and training necessary to ensure the capability of personnel conducting
assessments is determined. The QMP must document how persons conducting assessments must
have sufficient authority, access to programs and managers, access to documents and records,
and organizational freedom  to:

             identify quality problems;
             identify and cite noteworthy practices that may be shared with others to improve
             the quality of their operations and products;
             propose recommendations for resolving quality problems;
             independently confirm implementation and effectiveness of solutions; and
             provide documented assurance  to line management that,  when  problems are
             identified, further work performed is monitored carefully until the problems are
             suitably resolved.


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       The QMP must clearly define the responsibilities and authorities of personnel conducting
assessments,  particularly in regard to authority to suspend or  stop work in progress upon
detection and identification of an immediate adverse condition affecting the quality of results or
the health and safety of personnel.

       The QMP must describe  how management will respond to the findings  and recom-
mendations from assessments in a timely manner.  When conditions needing corrective action
are identified, the appropriate response must be made promptly. The QMP should indicate how
follow-up action shall be taken and documented to confirm the implementation and effectiveness
of the response action.

       Environmental data must be qualified according to the intended use of the data.  Data
obtained from sources that did not use, or fully comply with, a QA Project Plan (or equivalent
planning document) for data collection must also be qualified. Data shall be qualified according
to procedures documented in the QMP.  These procedures shall document the decision process
and factors used in arriving at the choice of the particular qualification method. This process
shall include the correct application of statistical methods during  the assessment process.  The
decision to qualify the data for their intended use shall be based on  reconciliation with  the
performance measures for the project defined by the data quality requirements. Any limitations
on data use shall be identified quantitatively to the extent practicable and fully documented.

       The QMP shall also describe how project reports containing data or reporting the results
of environmental data operations shall be reviewed independently to confirm that the data or
results are presented correctly.  The QMP shall describe the process used for these  reviews and
the approval  authority required  prior to  the publication or distribution of any reports.

       The QMP shall also describe the process by which periodic assessments of environmental
programs  are planned, scheduled and  implemented.  Line  management  is responsible  for
overseeing assessments and for responding to their findings.   Scheduling of assessments and
allocation of resources are to be based on the  status, risk and complexity of the sampling and
analytical activities.

Rationale:

       Assessments should include an evaluation to determine whether technical requirements,
not just procedural compliance,  are being met effectively.  Assessments should be performed ac-
cording to approved written procedures  from management, based on careful planning of scope
of the assessment and the information needed. The QMP should describe how assessment results
shall be documented, reported to, and reviewed by management.

       The type of assessment is determined by management.  Four general types of assessments
are described below:
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       •      management self-assessment:  the qualitative assessment of a particular program
              operation and/or organization(s) by those immediately responsible for overseeing
              and/or performing  the  work  to  establish  whether  the  prevailing quality
              management structure, policies, practices, and procedures are  adequate  for
              ensuring that the type and quality of results needed are obtained.

       •      management independent assessment: the qualitative assessment of a particular
              program operation and/or organization(s) by someone other than the group per-
             forming the work to  establish  whether  the  prevailing quality management
              structure, policies, practices, and procedures are adequate for ensuring that the
              type and quality of results needed are obtained.

       •      technical self-assessment:  the evaluation process used  by those immediately
              responsible for overseeing and/or performing the work to measure the perfor-
              mance  or effectiveness of a technical system and its elements with respect to
              documented specifications  and objectives.   Such assessments  may  include
              qualitative and quantitative evaluations.

       •      technical independent assessment:  the evaluation process used by someone
              other than  the group  performing  the work  to measure the performance  or
              effectiveness of a technical  system and its elements with respect to documented
              specifications and objectives.  Such assessments may  involve qualitative and
              quantitative evaluations, and may include peer reviews and audits.

       Management  is responsible for  choosing  the assessors,  defining acceptance criteria,
approving audit check lists, and identifying goals prior to initiation of an assessment.  Assessors
are technically knowledgeable people with no  real or perceived conflict of interest.  If the
assessors are chosen from within the organization, they must have no involvement or responsi-
bility for the work being assessed.  Personnel conducting independent assessments  should  be
qualified,  certified when necessary,  and have sufficient authority to  conduct  the assessment
activities.   The QMP should  detail how the assessors are selected and how the limits of their
authority will be determined.

       Senior management is required to regularly assess (at least annually) and document the
adequacy  of the  framework and infrastructure of the Quality System for which  they  are
responsible  and to ensure its effective  implementation.  The organization's approved QMP
provides the primary criteria for these  assessments.  Such assessments shall provide a means for
determining and taking necessary response actions regarding:

       •      Effectiveness of the system of management controls that are established to achieve
              and assure quality, and

       •      Adequacy of resources  and  personnel provided to achieve quality objectives  in
              all  activities to which the  Quality System applies.


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      These planned and periodic management assessments, or Management Systems Reviews
(MSRs), are to be established and implemented according to procedures detailed in the QMP.
Management assessments focus on how well the integrated Quality System is working, and
identify and correct management barriers that  hinder  the organization  from achieving its
objectives.   Management assessments address the effectiveness of management controls to
achieve and assure quality, the adequacy of resources and personnel, the effectiveness of training
and assessments, and  applicability of data quality requirements and software.   Management
assessments  consider  both noteworthy accomplishments and significant QA  problems, and
identify opportunities for improvement.
10                  Quality Improvement

Specific Requirements:

       This  section of the QMP shall include a description of the organization's management
system  for detecting and preventing quality problems  and  for ensuring continuing quality
improvement.  Accordingly, this section shall describe:

       •     the management process and identify who (organizationally) is responsible for
             identifying, planning, implementing, and evaluating the effectiveness of quality
             improvement activities;

       •     a corrective  action  program to ensure that conditions adverse to quality are
             identified promptly and corrected as soon as practical.

       Corrective actions shall include the identification of root causes of problems, determining
if the problem is  unique or has more generic implications, and recommending procedures to
prevent recurrence.

Rationale:

       The process of continuous quality improvement leads to the development of a better and
more responsive quality system.  Quality problems are often inherent in existing management
and technical systems, and workers may have little or no control over eliminating these problems
or improving performance. Lessons learned from assessments and from operating experiences
may be used to augment or enhance  an organization's systems and technical operations.  In
environmental programs, quality improvement results from processes that:

       •     prevent  or  minimize  problems  (during planning,  sampling,
             analysis, project management, and data handling) that may affect
             the quality of environmental data;
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       •     detect and correct these problems when they do occur; and

       •     review existing performance and identify opportunities for qualify
             improvement.

       The QMP should describe how the use of the following program elements will help to
prevent the occurrence of problems that can affect the quality of environmental data:

             SOPs,
             personnel training,
             QC samples, checks, and inspections,
             documentation of implementation activities,
             documentation of personnel responsible for sampling and analytical activities.

However, specific planning,  sampling, analytical, and program management activities that do
not meet established  requirements (i.e., deficiencies, nonconformances) should be identified,
controlled, documented, reported, and corrected.

       The QMP should describe how staff at all levels are encouraged to identify customers and
suppliers, identify process improvement opportunities, identify problems, and offer solutions to
those problems.  Motivation of staff begins with their understanding of the tasks  they are
expected to perform and how those tasks support the  overall mission of the organization. The
QMP should identify how employees are made aware of the advantages of proper job perfor-
mance at all levels and of the effects of poor job performance on other employees, customer
satisfaction, and costs. The QMP should show how management encourages continuous quality
improvement and encourages staff and other managers to exceed the expectations of their
customers whenever possible as a quality improvement goal.
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                                    APPENDIX A

                             TERMS AND DEFINITIONS
Activity - an all-inclusive term describing a specific set of operations or related tasks to be
performed, either serially or  in  parallel (e.g.,  research and  development, field sampling,
analytical operations, equipment fabrication), that in total result in a product or service.

Assessment - the evaluation process used to measure the performance or effectiveness of a
system and its elements. In this Standard, assessment is an all-inclusive term used to denote any
of the following: audit, performance evaluation, management  systems  review, peer review,
inspection or surveillance.

Audit - a planned and documented investigative evaluation of an item or process to determine
the adequacy and effectiveness as well as compliance with established procedures, instructions,
drawings,  QAPPs, and other applicable documents.

Characteristic - any property or attribute of a datum, item, process, or service that is distinct,
describable, and measurable.

Computer Program  - a sequence of instructions suitable for  processing by  a computer.
Processing may include the use of an assembler, a compiler, an interpreter, or a translator to
prepare the program for execution. A computer program may be stored on magnetic media, and
be referred to as "software", or may be stored permanently on computer chips, and be referred
to as "firmware". Computer programs  covered  by this Standard are those used for design
analysis, data acquisition, data reduction, data storage (data bases), operation or control, and
data base  or document control  registers  when  used as the controlled  source  of quality
information.

Contractor - any organization or individual that  contracts to furnish services or items or
perform work.

Corrective  Action - measures taken  to rectify  conditions adverse to quality and,  where
necessary,  to preclude their recurrence.

Customer  - any individual or  organization for whom items or services are furnished or work
performed  in response  to defined requirements and expectations.

Data Quality Assessment (DQA) - a process of statistical and scientific evaluation that is used
to assess the validity and performance of the data collection design and statistical test, and to
establish whether a data set is adequate for its intended use.

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Data Quality Objectives (DQOs) - a statement of the precise data, the manner in which such
data may be combined, and  the acceptable uncertainty in those data in order to resolve an
environmental problem or condition.  This may also include the criteria or specifications needed
to design a study that resolves the question or decision addressed by the DQO process.

Data Quality Objectives Process  - a Total Quality  Management (TQM) tool, based on the
Scientific Method and developed by the U.S. Environmental Protection Agency to  facilitate the
planning of environmental data collection activities. The DQO process enables planners to focus
their planning efforts by specifying the use of the data (the decision), the decision criteria (action
level),  and the   decision maker's acceptable decision error rates. The products of the  DQO
process are the  DQOs (See also Graded Approach).

Data Usability  - the process of ensuring or determining whether the quality of the data produced
meets the intended use of the data.

Design Review  - a documented evaluation by a team, including personnel other than the original
designers, the responsible designers, the customer for the work or product being designed, and
a QA representative to  determine if a proposed design will meet the established design criteria
and perform as  expected when implemented.

Engineered Environmental Systems -  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 the environment.  Examples include wet scrubbers (air),  soil  washing (soil), granulated
activated carbon unit (water),  and filtration  (air,  water). Usually,  this  term will  apply to
hardware-based systems; however, it will also apply to methods or techniques used for pollutant
reduction or containment of contamination to prevent further movement of the contaminants,
such as capping, solidification or vitrification, and biological  treatment.

Environmental Conditions - the  description  of a physical  medium  (e.g., air,  water, soil,
sediment) or biological system  expressed in terms of its  physical,  chemical, radiological, or
biological characteristics.

Environmental Data -  any  measurements or information that describe  environmental processes
or conditions, or the performance of engineered environmental systems.

Environmental Data Operations  - work performed to  obtain, use, or report  information
pertaining to environmental processes and conditions.

Environmental Monitoring - the process of measuring or collecting environmental data.
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Environmental Processes - manufactured or natural processes  that produce discharges to or
impact the ambient environment.

Environmental Programs - an all-inclusive term pertaining to any work or activities involving
the environment, including but not limited to: characterization of environmental processes and
conditions; environmental monitoring; environmental research and  development;  the design,
construction, and operation of engineered environmental systems; and laboratory operations on
environmental samples.

Environmentally Related Measurements - the data collection activity or investigation involving
the assessment of chemical, physical or biological factors in the environment which affect human
health or the quality of life.

Financial Assistance - the process by which funds are provided by one organization (usually
government) to another organization for the purpose of performing work or furnishing services
or  items.   Financial assistance  mechanisms include grants,  cooperative agreements,  and
government interagency agreements.

Graded Approach - the process of basing the level of application of managerial controls applied
to an item or work according to the intended use of results and the degree of confidence needed
in the quality of the results.  (See Data Quality Objectives Process).

Hazardous  Waste - any waste materials that satisfies the definition of "hazardous waste" as
given in 40  CFR Part 261, "Identification and Listing of Hazardous Waste".

Independent Assessment - an assessment performed by a qualified individual, group, or
organization that is not a part of the organization directly performing and accountable for the
work being  assessed.

Inspection - examination or measurement of an item or activity to verify conformance to specific
requirements.

Item - an all-inclusive term used in place of the following:  appurtenance,  facility,  sample
assembly, component, equipment, material, module, part, product, structure, subassembly,
subsystem, system, unit, documented  concepts, or data.

Management -   those  individuals  directly responsible  and  accountable  for planning,
implementing, and assessing work.

Management System - a structured non-technical system describing the policies, objectives,
principles, organizational authority, responsibilities, accountability, and implementation plan of
an organization for conducting work and producing items and services.
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Management System Review (MSR) - the qualitative assessment of a data collection operation
and/or organization(s) to establish whether the prevailing quality management structure, policies,
practices, and procedures are adequate for ensuring that the type and quality of data needed are
obtained.

May - denotes permission but not a requirement.

Method - a  body of procedures and techniques for performing an activity (e.g., sampling,
chemical analysis, quantification) systematically presented in the order in which they are to be
executed.

Mixed Waste - hazardous waste material, as defined by 40 CFR part 261 (RCRA), mixed with
radioactive constituents.

Must -  denotes a requirement that has to be met.

Peer Review - a documented critical review of  work generally beyond the state of the art or
characterized by the existence of potential uncertainty. The peer review is conducted by qualified
individuals (or organization)  who are independent of those who performed the work, but are
collectively equivalent in technical expertise (i.e., peers) to those who performed the original
work.   The peer review  is conducted to ensure  that  activities  are technically adequate,
competently  performed, properly  documented,  and satisfy established technical and  quality
requirements.  The peer review is an in-depth  assessment of the assumptions, calculations,
extrapolations,  alternate  interpretations, methodology, acceptance criteria,  and conclusions
pertaining to specific work and of the documentation that  supports them. Peer reviews provide
an evaluation of a subject where quantitative methods  of analysis or measures of success are
unavailable or undefined, such as in  research and development.

Performance Evaluation (PE) - a type of audit in which the quantitative data generated in a
measurement system are obtained independently  and compared  with routinely obtained data to
evaluate the proficiency of an analyst or laboratory.

Procedure -  a documented set of steps or actions that systematically specifies  or describes how
an activity is to  be performed.

Process - an orderly  system of actions that are intended to  achieve a desired end or result.
Examples of processes include  analysis,  design, data  collection, operation, fabrication, and
calculation.
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QTRAK - is a Computer Program that contains database information on Quality Management
Plans and Quality Assurance Project Plans to the Program Managers, Project Officers, and the
OQA for planning and assessment of the status of regional Quality Management Plans and the
associated Project Plans.

Qualified Data - any data that have been modified or adjusted  as  part of  statistical or
mathematical evaluation, data validation, or data verification operations.

Quality - the sum of features and properties/characteristics of a process, item, or service that
bears on its ability to meet the stated needs and expectations of the user.

Quality Assurance (QA) -  an integrated system of management activities involving planning,
implementation, assessment, reporting, and quality improvement to ensure that a process, item,
or service is of the type and quality needed and expected by the customer.

Quality Assurance Management Staff (QAMS) - the U.S. EPA's headquarters staff element
that establishes and promulgates Quality Assurance Policy.

Quality  Assurance Officer (QAO)  - the designated  Region 6 staff  member that  has the
delegated authority  for approval of all Quality Management Plans in Region 6, Chief of the
Office of Quality Assurance.

Quality Assurance Program Description/Plan -see Quality Management Plan.

Quality Assurance Project Plan (QAPP) - a formal document describing in comprehensive
detail the necessary QA, QC, and other technical activities that must be implemented to ensure
that the results of the work  performed will satisfy the stated performance criteria.

Quality Control (QC) - the  overall system of technical activities that measures the attributes and
performance of a process, item, or service against defined standards to verify that they meet the
stated requirements established by the customer.

Quality Improvement  - a management program for improving the quality of operations.  Such
management  programs generally  entail  a  formal  mechanism  for  encouraging  worker
recommendations with timely management evaluation and feedback or implementation.

Quality  Indicators -  measurable attributes of the attainment of the necessary  quality for a
particular environmental decision. Indicators of quality include precision,  bias, completeness,
representativeness, reproducibility, comparability, and statistical confidence.
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Quality Management - that aspect of the overall management system of the organization that
determines and implements the quality policy. Quality management includes strategic planning,
allocation of resources, and other systematic activities (e.g.,  planning, implementation, and
assessment) pertaining to the quality system.

Quality Management Plan (QMP) - a formal document that  describes the quality system in
terms of the organizational structure, functional responsibilities of management and staff, lines
of authority, and required interfaces for those planning, implementing, and assessing all activities
conducted.

Quality System - a structured and documented  management system describing the policies,
objectives,   principles,   organizational   authority,  responsibilities  accountability,   and
implementation plan of an organization for ensuring quality in its work processes, products
(items), and services.  The quality system provides the framework for planning, implementing,
and assessing work performed by the organization and for carrying out required QA and QC.

Radioactive Waste - waste material containing radionuclides, or contaminated by radionuclides.

Readiness Review - a systematic, documented review of the  readiness for the  startup or
continued use of a facility, process, or activity.  Readiness reviews are typically  conducted
before proceeding beyond project milestones and prior to initiation of a  major phase of work.

Remediation - the process of reducing the concentration of a contaminant  (or contaminants) in
air, water, or soil media to a level that poses an acceptable risk to human health.

Research (Applied) - a process, the objective of which is to gain knowledge or understanding
necessary for determining the means by which a recognized and specific need may be met.

Research (Basic) - a process, the objective  of which is to gain  knowledge or understanding of
the fundamental aspect  of phenomena and of observable facts without specific applications
toward processes  or products in mind.

Research Development/Demonstration - Systematic use of the knowledge and understanding
gained from research and directed toward the production of useful materials, devices, systems,
or methods, including prototypes and processes.

Self-Assessment  - Assessments of work conducting by individuals, groups, or organizations
directly responsible for overseeing and/or performing the work.

Service - the category of economic activity that does not produce manufactured items.  In
environmental data operations or engineering projects, such activities include design, inspection,
laboratory and/or field analysis, repair, and installation.
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Shall - denotes a requirement that is mandatory and has to be met.

Should - denotes a guideline or recommendation.

Significant Condition - any state, status, incident, or situation of an environmental process or
condition of an engineered  environmental system in  which the work being performed will be
adversely affected in a manner sufficiently serious to require corrective action to satisfy quality
objectives or specifications and safety requirements.

Software Life Cycle - the period of time that starts when a software product is conceived and
ends when the software product is no longer available for routine use.  The software life cycle
typically includes a requirements phase, a design phase, an
implementation phase,  a test phase, an installation and check-out phase,  an operation  and
maintenance phase, and sometimes a retirement phase.

Standard Operating Procedure (SOP) - a written  document that details the method for an
operation, analysis, or action with thoroughly prescribed techniques and steps, and that is
Officially approved as the method for performing certain routine or repetitive tasks.

Supplier - any individual or organization furnishing items or services or performing work
according to a procurement document or financial assistance agreement. This is an all-inclusive
term used in place of any of the following: vendor, seller, contractor, subcontractor, fabricator,
or consultant.

Surveillance - the act of monitoring or observing a process or activity to verify conformance
to specified requirements.

Technical Review - a documented critical review of work that has been performed within the
state of the art.  The review is accomplished by one  or more qualified reviewers who are
independent of those who  performed  the work,  but are collectively  equivalent in  technical
expertise to those who performed the original work.  The reviews  are an in-depth analysis and
evaluation of documents, activities,  material, data, or items that require technical verification
or  validation  for  applicability, correctness, adequacy, completeness, and assurance  that
established requirements are satisfied.

Technical Systems Audit (TSA) - a thorough, systematic, on-site qualitative audit of facilities,
equipment, personnel, training procedures, record keeping, data validation, data management,
and reporting aspects of a system.

Total  Quality Management (TQM)  - the  process of applying quality management  to all
activities of the organization, including technical and administrative operations.  See Quality
Management and Quality System.
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Validation - an activity that demonstrates or confirms that a process, item, data set, or service
satisfies the requirements defined by the user.

Verification - the act of authenticating or formally asserting the truth that a process, item, data
set, or service is, in fact, that which is claimed.

Work - the process of performing a defined task or activity (e.g., research and development,
field sampling, analytical operations, equipment fabrication).
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                  IMPORTANT INFORMATION:



U.S. EPA Region 6 Quality Assurance Office Staff:

     Alva L. Smith, P.E. - Chief of QA Office, (214) 665-8347

     Charles Ritchey, (214) 665-8344

     Dr. Randall Romig, (214) 665-8346

     Dr. Kuenja Chung, (214) 665-8345

     Don Johnson, (214) 665-8343^

     Office Phone: (214) 665-2217/2218


Mailing Address:

     U.S. EPA Region 6
     1445 Ross Avenue (6E-Q)
     Dallas, TX 75202-2733
Call us for any assistance we can give you on QA matters, such as finding
out about the status of your QA Plans, advice on writing your QA Plans, or
attending one of our QA Courses.
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