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3.2.1.1.
Quality Management Plan
The MERC Quality Management Plan (QMP) is a “living document” which presents a blueprint of the
organizational quality system. It covers all aspects of MERC’s commitment to quality including policies
and procedures; criteria for and areas of application; roles, responsibilities, and authorities; and
assessment and response. It is the framework for planning, implementing, documenting, and assessing
MERC’s QA activities.
The QA Manager is responsible for preparing the QMP and initiating annual reviews, which include input
from all end-users of the QMP. The MERC Director reviews drafts of the QMP and proposed revisions.
An approved final draft is distributed to MERC senior researchers and technical staff prior to preparation
of the final version. The QA Manager also is responsible for ensuring compliance with the QMP and
communicating compliance efforts to the MERC Director. Senior research personnel and technical staff
are required to follow QMP goals and strategies and are encouraged to actively participate in QMP
revisions.
3.2.1.2.
Quality System Annual Report and Work Plan
The Quality System Annual Report and Work Plan (QAARWP) is a summary of specific implemented
QA activities within MERC for the previous calendar year and the planned QA activities for upcoming
year, such as s project-specific audits, assessments and responses; quality system documentation and
SOPs; and training. It also includes a discussion on the status of the MERC quality system, including
strengths, weaknesses, successes and problems; an assessment of the adequacy of the MERC QMP; and
recommendations for improvements. The Annual Report is prepared by the QA Manager with inputs from
the senior researchers and technical staff. The report will follow the EPA document
Guidance for
Annual Reporting of Quality System Progress
, January, 2008, to the greatest extent possible. The report
is initially submitted electronically to MERC Director at the end of each year. The electronic submission
is then followed by a hard copy of the signature page signed by the QA Manager.
3.2.1.3.
Quality System Process Assessments
Quality system process assessments are conducted by performing a Quality System Review/Audit
(QSR/QSA). QSR is a qualitative evaluation of MERC to determine whether the current quality
management structure, policies, practices, and procedures are adequate for ensuring that the type and
quality of data needed to evaluate the performance of BWTS are obtained. QSR is a tool used to
determine the effectiveness of, and adherence to, the quality system and the adequacy of resources and
personnel provided to achieve and ensure quality in all activities. The focus of these assessments is on the
quality system process and not on evaluating the quality of specific products or the performance of
personnel. Depending on the availability of resources, external QA experts or the QA Manager will
perform an independent QSR of MERC’s quality system once every three-to-five years. QSR’s will
follow the EPA document
Quality System Assessment Guidance,
EPA QA/G3, March, 2003, to the
greatest extent possible.
3.2.1.4.
Quality System Training
Under its quality system, continued training is critical to ensure that all MERC personnel remain
proficient in their operational functions and meet QA requirements. Typical quality systems training
addresses the policies, processes, procedures, and written instructions related to operational activities.
The MERC training plan describes overall training requirements, training methods, training effectiveness
evaluation, training record retention and the periodic review of training. The QAPP and SOPs specify