Page 70 - Binder

Nomination Recognition 2017

Report by Cross Functional Team

CATEGORY: CROSS FUNCTIONAL TEAM AWARD

PROJECT: Wooster Label Room Project

CATEGORY: CONTINUOUS IMPROVEMENT

NOMINATOR: Thomas Scarberry
SPONSOR: 7879

LEADER: 7476

PROFILE:
Describe the situation or event related to the individual's or team's performance.
They came together to be high performing in a very fast manner in order to create a
viable cGMP and FDA compliant label control process in an extremely tight
timeframe. After registering with the FDA in anticipation of running CL1, a group of
individuals realized that the starting label control process by routing everything
through LC was not workable to scale up operations. The initial label control
process was inefficient with significant time lag and manually burdening to execute.
This team identified the need and the appropriate team members, self-organized
and got to work in a very efficient manner. They then not only came up with a better
way to manage labels on site, but did so in an incredibly short time frame.
Additionally, they began the planning process that will assist Wooster with
expanding label management capability in the future.

Describe in detail the individual's or team's notable behaviors.
? Project management - worked through a complex regulatory challenge in an
expedited manner to implement a superior method of handling OTC labels
? Process management - identified better processes necessary to get things done,
successfully organized people and activities into efficient work flows and processes
to manage label movement within the manufacturing environment
? Perseverance - pursued everything with energy, drive, and a quick pace to cross
the finish line

What were the results of the individual’s or team’s behaviors?
? Documents: Necessary documents revised and/or created for all processes (WIS-
OPP-1079, WIS-OPP-1082, WIS-OPP-1086, WIS-OPP-1093, WIS-OPP-1094, WIS-
OPP-1095, WIS-OPP-1096, SOP-OPP-1232) in order to meet all cGMP and FDA
regulations for traceability, reconciliation, and control of labels.
? Training: All affected employees trained and provided hands on training of the
new processes for label receipt, staging, issuance, return and reconciliations at
Plant 1060.
? Timing: Labels will be able to be transported on the mail truck/van and received
in by the Logistics department and then taken to the WLCC for put-away. Labels
will then reside in the WLCC after running on CL1 and inventory will build up at
Plant 1060 for future orders. In addition, labels from Plant 1000 can be sent to
Plant 1060 as forecast demands.
? Requested and received a mock audit conducted by Rich King on 11/29/17, was

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