The innovative approach supported by cME, starts with:
(1) identifying specific activities that are being performed by QA
techs (i.e., Batch record review, audit, clearance and general activities) than
(2) associate an expected duration for each of the define activities. Once the activity
(3) the QA techs record
the information leveraging tablet PC / desktop and
(4) compare the actual duration to its standard. With the information available in cME the project team is now able to
(5) measure the QA efficiency and cycle
time and provide the needed visibility to its management. Developing trends, inefficiency root causes by various events /
incidents are being recorded and reported on a regular basis.
cME General Flow
At the beginning of the shift, QA Techs log in and review pending
activities / batch records assignments, enter expected in-direct activities (i.e., meeting, training) Then,
the techs perform & record activities using Tablet PC (i.e., Audits, Inspections, Swabs etc.) or their desktop computer
for Batch Record review. While performing their assigned activities, they record observations / action items related to the
At the end of the shift, each tech updates completions, pass-down
notes and provides loss of efficiency reasons and receive an efficiency score.
§ Managers review current activity status, efficiency results and compliance trends via the cME dashboard
and initiate Operations Excellence/Lean/Sigma initiatives accordingly.