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Frequencies of customer complaints were increasing as well as the severity of the issues (including Patient Safety issues). Legal issues combined with how the clinical data was obtained were becoming problematic.

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The goal was to become a process-oriented organization. We identified the core processes of the organization. We used Business Process Mapping (BPM) to map the Current State of each process. Work Instructions were created where needed.

We then identified potential risk and established Control Plans for each process. This led to the establishment of an Operational Risk Management Program for continuous tracking of risk and improvement opportunities.

The documented processes created a foundation for a Quality Management System (QMS). The establishment of various quality processes such as: Corrective Actions, Preventative Actions and
Failure Modes Effects Analysis (FMEA) make up the QMS.

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• Stabilized core processes that are repeatable and reproducible
• Employee Training material
• Reduced Risk (including Patient Safety)
• Reduced legal issues
• Established Quality Management System (QMS)
• Full and Consistent utilization of accounting software
• Using software to generate reports
• Reallocated 1.5 people to improve efficiency
• Reduced cycle time from 15 days to 5 days (70%)
• Established procedure for sending files to permanent storage


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