On the Job Training (OJT) Skill Demo Sub-Curriculum. Knowledge Summit June 5-7, Philadelphia, PA

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1 On the Job Training (OJT) Skill Demo Sub-Curriculum UL and the UL logo are trademarks of UL LLC 2013

2 Agenda Company Information Business Need Solution Implementation Results Conclusion 2

3 Grifols is a global healthcare company with a 70-year legacy of improving people s health and well being through the development of life-saving plasma medicines, hospital pharmacy products and diagnostic technology for clinical use. As a leading producer of plasma medicines, Grifols has a presence in more than 100 countries and is the world leader in plasma collection, with 150 plasma donation centers across the U.S. Grifols is committed to increasing patient access to its life-saving plasma medicines through significant manufacturing expansions and the development of new therapeutic applications of plasma proteins. The company is headquartered in Barcelona, Spain and employs more than 12,000 people worldwide. Clayton Grifols Therapeutics Manufacturing Site, 1700 employee Some of our life-saving products include: Gamunex -C, Prolastin -C, Albumin, Thrombate III, and Hypermunes. 3

4 Business Need We had a paper On-the-Job Training (OJT) system in place that required manual data entry and needed to create a process with an electronic system that would capture the qualification information in a timely fashion including: Employee Name, ID #, Department Course Code, Course Title, Revision # Steps and Time in Minutes Signatures of Trainee/Trainer/Supervisor Data Migration required from a legacy system. 4

5 Information in ComplianceWire Steps/Time Signatures Employee Trainer Supervisor 5

6 Solution We created OJT/Skill Demo Sub-curriculum which may include: Controlled Documents/Job Aids E-learnings Instructor-led courses Dual Signature Form for Trainee/Trainer (TR) Dual Signature Form for Trainee/Supervisor (SUP) 6

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8 Implementation Create Skill Demo (SD) Equivalency form, TR and SUP Dual Signature Forms Used Copy Form feature with Grifols verbiage SD - Equivalency for historical data from legacy system Sequencing 8

9 Implementation TR Form SUP Form 9

10 Implementation Manage Signers: Signers list for TR and SUP Curriculum Assignment: OJT Sub-curriculum were placed in larger curriculum 10

11 Results Over 2000 Qualifications Over 1000 OJT signers and Over 200 Supervisor signers Manufacturing, Quality Laboratories, Validation, and Engineering Departments have OJT/Skill Demo Compliance Benefits: Auditors have accepted printed reports from ComplianceWire Completion is recorded in Real Time Automatic notification to trainer/supervisor for signatures Visible Process for employee and supervisor Time saving Transparency for the organization in reports 11

12 Conclusion ComplianceWire is user friendly. Employees prefer to document the OJT process in the system instead of on paper. Skill Demonstration completion reports are a better management tool. Skill Demos are documented faster with electronic signatures. With the use of various tools within ComplianceWire, Grifols was able to develop a innovative solution. 12

13 Thank You! Questions?