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10.3.
Response
Responses to adverse findings should be addressed within 10 working days after an assessment report is
completed. However, it is expected that findings that have a direct impact on the conduct of a verification
test will be corrected immediately following notification of the finding. Responses to each adverse
finding shall be documented in the assessment report. The response will indicate the corrective action
taken or planned to address the adverse finding. The response should be signed and dated by the staff
responsible for implementing the corrective action. The MERC Director reviews and approves the
responses to the assessments and thus ensures that responses are thorough, fully address the audit findings
and observations, and thoughtfully assess any impact to testing. Any corrective action that cannot be
immediately implemented should be verified following completion by the MERC QA Manager. Once all
corrective action associated with an assessment report has been taken, the MERC QA Manager will initial
the corrective action in the assessment report thus documenting verification of the corrective action. Any
impact that an adverse finding had on the quality of BWTS test data should be addressed in the test report.
10.4.
Corrective Action
Corrective action is implemented in response to any situation that compromises the quality of testing or
data generated by MERC. The need for corrective action can be identified by any MERC personnel and
implemented with the prior approval of the MERC Program Coordinator and/or Director, in consultation
with the QA Manager. Corrective action is required for all assessment findings and observations. The
Program Coordinator is responsible for determining appropriate corrective action to address an issue. The
corrective action should minimize the chance that a problem adverse to quality will re-occur. The
corrective action will be documented by the Program Coordinator on the assessment report.
The Program Coordinator is responsible for ensuring that corrective actions are implemented as
documented in the assessment report. The Program Coordinator provides a written response with
objective evidence of the effectiveness of the correction, and with specified time frames for those actions
in progress or planned for the future. Implementation of corrective actions must be verified by the MERC
QA Manager to ensure that corrective actions are adequate and have been completed. Verification of
corrective actions can be by re-assessment or examination of documentation. The assessment report
cannot be finalized until each corrective action has been identified and verified.
The corrective action process should include an assessment of the root cause of a problem so that
effective changes can be implemented to minimize reoccurrence. Once the root cause determination is
verified, appropriate actions can be planned, documented, and implemented by the MERC staff.
Any finding that is a QAPP or Test Plan deviation must be documented.
10.5.
Dispute
If an audit finding or response creates a dispute that cannot be resolved by the QA Manager and Program
Coordinator, the dispute will be elevated to the MERC Director.