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MERC+GSI – DRAFT Test Plan
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Corrective Action:
The MERC Program Coordinator, during the course of any assessment or audit, will
identify to the MERC staff performing experimental activities any immediate corrective action
that should be taken. If serious quality problems exist, the MERC Program Coordinator will
consult with MERC Primary Investigators and is authorized to stop work. Once the assessment
report has been prepared, the MERC Program Coordinator will ensure that a response is
provided for each adverse finding or potential problem and will implement any necessary follow-
up corrective action. The MERC Program Coordinator will ensure that follow-up corrective
action has been taken.
QA/QC Document Control:
It is the responsibility of the MERC Program Coordinator to maintain QA/QC records,
which shall include the following:
1)
records of the disposition of samples and data.
2)
records of calibration of instruments.
3)
records of QA/QC activities, including audits and corrective actions.
GSI -
Quality Assurance Project Plan (QAPP):
The GSI’s Quality Assurance Project Plan (QAPP) outlines the management activities the
GSI undertakes to assure the credibility of its biological research activities. The plan covers
QA/QC data quality indicators, evaluation processes, performance measures and acceptance
criteria; instrument certification and calibration; personnel training requirements; QA/QC of
documents and records; data management; and QA/QC assessments and response actions; etc.
The plan is updated annually, with a specific process used for review, comment, approval,
distribution and posting. It closely follows the format of the U.S. Environmental Protection
Agency’s (EPA’s) “
EPA Guidance for Quality Assurance Plans
”.
Quality Assurance/Quality Control Activities:
GSI QA/QC Officers regularly observe all aspects of the GSI’s biological research
activities and conduct technical reviews of these activities to ensure that all information is
complete, that SOPs are correctly followed, and that QA/QC objectives are met. The results of
these observations are documented on a QA/QC audit report form. It is the responsibility of the
GSI QAQC Officer undertaking the audit to maintain the form on file, create an electronic copy,
and post to the GSI Sharepoint website for storage. The GSI Senior QA/QC Officer also uses
these audits to help prepare an annual report describing all GSI QA/QC activities, including
results of QA/QC observations, corrective actions, etc. Corrective action reports help resolve any
identified deficiencies and non-compliance issues that relate to on-going activities and problems
of a systematic nature.
Standard Operating Procedures (SOPs)
:
GSI SOPs are developed by the relevant GSI senior personnel in conjunction with the PI
and GSI Senior QA/QC Officer. The SOPs follow a common format and all include specific
QA/QC procedures and metrics. The Senior QA/QC Officer is responsible for distributing the