ACT pH Sensor Verification Protocols, PV12-01
15
on the conduct of the 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 ACT 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 ACT QA Manager. Once all
corrective action associated with an assessment report has been taken, the ACT 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.
8.2.3
Corrective Action
Corrective action is implemented in response to any situation that compromises the
quality of testing or data generated by ACT. The need for corrective action can be identified by
any ACT personnel and implemented with the prior approval of the ACT Chief Scientist, in
consultation with the QA Manager. The Chief Scientist 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 Chief Scientist on the assessment report. Implementation of corrective actions must be
verified by the 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 ACT staff. Any finding that is a deviation in the Verification Protocol must be documented.
9.
Summary of Verification Schedule
Note that the below schedule is provisional and actual dates for each milestone may vary.
•
Final Verification Protocols and ACT Verification Contract will be sent to Manufacturers
by October 5, 2012
•
Signed contracts are due back to ACT Headquarters by October 15, 2012
•
Testing facilities at HIMB set-up by October 26
•
Instruments shipped to HIMB by November 2, 2012
•
All dyes and buffers calibrated and shipped to HIMB by November 2, 2012
•
ACT staff will conduct an initial training period with each company representatives
during N
ovember 5-7, 2012.
