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11.
QUALITY IMPROVEMENT
MERC is committed to a process of continuous quality system improvement. While every member of the
MERC team is encouraged to contribute to quality improvement initiatives, the MERC Director and the
MERC QA Manager are specifically responsible for identifying opportunities to improve the quality
system. The purpose of quality system improvement is to ensure that conditions adverse to quality are
prevented, identified, corrected, documented, and tracked.
11.1.
Annual QMP Review
An annual review of the MERC QMP will be conducted by the MERC QA Manager and research,
technical, and management staff in order to incorporate improvements to the quality system process. Any
revisions to the QMP will be compiled by the MERC QA Manager for review. Action items identified
during the review will be documented by inclusion in the revised QMP. The QMP review will be
documented by the MERC QA Manager and MERC Director by signing and dating the revised QMP
routed for review and approval.
11.2.
Problem Identification and Resolution
Detecting and correcting quality system problems is a result of qualified MERC technical and management
staff implementing not only this QMP, but also the QAPP, Test Plans, and other procedures. All staff is
encouraged to identify problems and offer solutions to problems in the following quality areas:
•
adequacy of the quality system, as defined in the QMP;
•
consistency of the quality system;
•
implementation of the quality system to specific BWTS tests;
•
correction of quality system procedures;
•
completeness of documented information;
•
quality of data;
•
quality of planning documents, such as the QAPP or Test Plans;
•
implementation of the work process.
Suggestions are received by the MERC Director and MERC QA Manager. No formal tracking system has
been developed because suggestions are typically implemented in near-real time. The process for
identifying and implementing improvements includes the following:
•
Improvements to Test plans, test reports, and audit reports are made on the next new document of
each type, which then becomes the template for future documents.
•
Suggestions for improving sampling designs or test logistics are communicated during MERC
team meetings.
•
The Program Coordinator communicates improvements, lessons learned, and new instructions to
the MERC team.
•
Any team member may request a corrective action, if an on-going problem or systematic issue is
identified.
11.3.
Assessments
TSAs and ADQs serve as tools to determine cause and effect relations of significant problems that might
require testing protocol, management system, or quality system changes. Monitoring and evaluation by
the MERC QA Manager, for example, may indicate trends or common and recurring problems for an