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10.1.
Quality System Assessment
The MERC Director and MERC QA Manager assess the adequacy of the quality system formally during
the annual review and update of the QMP. As part of the review, they consider elements that are
adequate to achieve quality results, problems that need further control, and requirements that are obsolete
or superseded with other requirements. Systematic issues that require modification to procedures and
lessons learned are communicated to the MERC team.
10.2.
Quality Assessment Procedures
10.2.1.
General Requirements
Fundamental principles of the MERC assessment and response process include:
•
Each assessment must be fully documented. The MERC QA Manager will archive all assessment
reports generated on MERC.
•
Each assessment must be responded to by the appropriate level of the MERC team. MERC
quality assessment reports require a written response by the person performing the inspected
activity, and acknowledgment of the assessment by the MERC Director.
•
Corrective action must be documented and approved on the original assessment report, with
detailed narrative in response to the assessor’s finding. Initials and date are required for each
corrective action response. Acknowledgment of the response will be provided by the MERC
Director.
•
Implementation of corrective actions must be verified by the MERC QA Manager to ensure that
corrective actions are adequate and have been completed. This will be done in real-time if
corrective actions can be immediately performed and signed off on the assessment report.
10.2.2.
Assessment Planning
Assessment planning is performed by MERC’s Director and QA Manager prior to the actual performance
of any assessments. Planning the assessment scope helps provide the type of evaluation information
needed to determine whether procedural compliance and technical requirements are being met during
BWTS testing. Assessment planning by MERC includes a kickoff meeting with the testing team where
at least the following information may be discussed:
•
schedule of assessment(s);
•
proper completion of data records;
•
notification to affected parties;
•
specific assessment requirements (personnel lists, equipment lists, and availability of Test Plans);
•
follow-up procedures for corrective action, including debriefing and discussion of possible
resolutions;
•
corrective action guidelines to facilitate completion of the reported assessment;
•
appropriate management signature approval of the reviewed assessment report.