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Table 1. Description of MERC Quality System Components and Tools
Quality System
Component
Quality System
Tool
Description
Roles and Responsibilities
Program Quality
System
Quality
Management
Plan (QMP)
Document describing the quality
system including organizational
structure, responsibilities and QA
assessment.
The QA Manager is responsible
for developing and revising the
QMP. The MERC Director
approves the QMP.
Quality System
Annual Report
and Work Plan
A summary of specific implemented
QA activities within MERC for the
previous calendar year and the planned
QA activities for upcoming year.
The report is prepared by the
QA Manager with inputs from
the senior researchers and
technical staff and submitted to
the MERC Director.
Quality System
Review/Audit
(QSR/QSA).
An evaluation of the integrated quality
system implementation (processes).
Results are used to improved quality
efficiency.
The MERC Director is
responsible for initiating
evaluations of the quality
system effectiveness. The
independent evaluation may be
done by external evaluators or
the QA Manager.
Training
Implementation
Plan
Document which identifies (1) specific
QA training needs for all levels of
management and staff, (2) priorities,
(3) strategies, (4) required resources,
and (5) the availability of the necessary
resources.
The QA Manager is responsible
for assessing QA training needs
and reporting to the MERC
Director.
Project-specific
Quality System
Systematic
Planning
Processes
Planning based on Data Quality
Objectives (DQO) process to determine
the type, quantity, and quality of data
needed to reach defensible decisions on
BWTS performance.
The MERC Director is
responsible for initiating the
development of DQOs.
Program Quality
Assurance
Project Plan
(QAPP)
An overarching plan that serves as an
umbrella under which multiple data
collect activities may be conducted
over an extended period of time.
The MERC Director and QA
Manager develop the Program
QAPP with input from senior
research and technical
personnel.
Test Plan
The plan developed for each individual
test of a technology. The Test Plan
provides the experimental approach
with clearly stated test objectives and
associated quality objectives for the
related measurements.
The MERC Director and senior
research and technical
personnel develop specific Test
Plans. The QA Manager
develops QA/QC activities with
the MERC team.
Standard
Operating
Procedures
(SOPs)
A set of written instructions that
document a routine or repetitive
activity that must be performed
consistently over time, such as routine
sampling, preparation and
analytical laboratory methods,
instrument service, data management,
etc.
MERC Director and senior
research personnel develop
SOPs; technical staff
implements SOPs.
Field and
Laboratory
Notebooks,
Forms and
Records
Documentation of all data and
information recorded in support of
analytical and process measurements
made during planning, testing, and
assessing BWTS technology.
Research personnel and
technical staff are responsible
for maintaining notebooks and
records on site, creating
electronic copies, archiving.