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Nomination Recognition 2017

Report by Cross Functional Team

CATEGORY: CROSS FUNCTIONAL TEAM AWARD

PROJECT: FDA Quality Metrics Submission Readiness

CATEGORY: INNOVATIVE WAYS OF WORKING

NOMINATOR: Gregory Sliwinski
SPONSOR: 4764

LEADER:

PROFILE:
Describe the situation or event related to the individual's or team's performance.
The team demonstrated effective whole systems thinking while developing an
approach that would result in an accurate and FDA defensible outcome. The team
was able to demonstrated new ways of working by examining how data is captured
in SAP and then mapped it across different systems, including customer complaints
and lab results and Quality Notifications.

Describe in detail the individual's or team's notable behaviors.

Team was focused on ensuring a high degree of accuracy in the face of paving new
territory for FDA while looking for insights that can be used for future continuous
improvement activities. One particular area was the rate of "invalidated lab OOS
results" for certain active ingredients. In some cases the lab OOS results are
invalidated 100% of the time; this would potentially be a big red flag during an FDA
inspection and could, possibly, result in market action being required. Through the
work of this team, high rates of invalidated lab OOS results will be examined to
determine root cause (such as questionable test methods) to ensure that GOJO
does not face FDA scrutiny in the future.

What were the results of the individual’s or team’s behaviors?
The team was able to sort through and effectively interpret the FDA Quality Metrics
guidance documents which have evolved over the past couple of years. Through
the team's efforts, GOJO is ready to submit the required data FDA is looking for in
the proper format the FDA requires. Due to the complex nature of our SKU's and
formats, there was an extensive amount of data scrubbing required to ensure that
our submittal accurately reflects GOJO's quality metrics in terms of unit doses
shipped, complaint rates and Out-of-specification (OOS) performance.

NOMINEE DEPARTMENT

Dennis Fuster (5542) Quality Assurance 204100
Richard King (8748) Quality Assurance 204100

Nathan Schaus (4506) Quality Assurance 204100
Frederick Wallace (7257) Quality Assurance 204100

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