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CHUCK WEBBER[ASUG INSTALLATION MEMBER
MEMBER SINCE:2008
MALCOM POULIN[ASUG ASSOCIATE MEMBER
MEMBER SINCE:1998
DENISE MISSONAK[SAP POINT OF CONTACT
MEMBER SINCE: 1998
]QM at Perrigo: A Continuous Improvement Process
Carl Dunlap
Andrea Loman
[
Real Experience. Real Advantage. 2
Carl Dunlap is the President of Cohesion, Inc. - an SAP Services company focused on
software & services for PLM & the Life Sciences Industry. Carl has 15 years of
experience with Enterprise Applications, including 14 years of SAP Quality
Management (QM) experience.
Andrea Loman is a Senior Business Analyst at the Perrigo Company. Andrea has 5
years of experience with Enterprise Applications, including 4 years of SAP Quality
Management (QM) experience. Prior to Perrigo, Andrea was a Sr. Deployment Analyst
employed by Whirlpool Corporation implementing QM at new manufacturing facilities.
Speakers:
[
Real Experience. Real Advantage. 3
Learning Points
� Who is Perrigo?
� Best Practices & Lessons Learned for loading QM Master Data (using MS Excel and LSMW)
� Design of Physical Sample Process and flow (QA, QC)
� Using the Flexible nature of QM to build an infrastructure that can allow future growth
� What to expect in an FDA regulated environment
[
Real Experience. Real Advantage. 4
4
Who is Perrigo?
A comprehensive generic pharmaceutical business providing healthcare solutions to consumers
[
Real Experience. Real Advantage. 5
5
Perrigo Statistics
� Founded in 1887
� Largest Manufacturer of Over the Counter Pharmaceutical and Nutritional Private Label
� Began selling Generic Pharmaceuticals in 2004.
� Over 2.5 million square feet
� Publicly held since 1992 - PRGO
� Over 6,000 employees worldwide
� Make more than 25 Billion tablets per year
[
Real Experience. Real Advantage. 7
Perrigo’s use of SAP QM
� Continuous Improvement
� Using SAP QM since 1998
� QM Functionality Used
� Quality Notifications
� Incoming
� Sample Management
� Extensive Batch Management
� External LIMS in Michigan
� Locations / Facilities live on SAP
� Perrigo New York (PNY)
[
Real Experience. Real Advantage. 8
Moving from Paper to SAP
� Current “Monograph” was Paper
� Scope included Raw materials, Bulk materials and Finished Goods
� Move to MS Excel first
� Sort and Analyze Data
� Utilization of LSMW
� Lessons Learned
[
Real Experience. Real Advantage. 13
LSMW – Inspection Plan Spreadsheets
Header (Total = 447) Material Assignment (Total = 450)
Operation (Total = 447) Characteristic (Total = 4566)
[
Real Experience. Real Advantage. 15
Physical Sample & Flow
� Sample Drawing Procedure (Insp Plan Header)
� Inspection Points (Insp Plan Header)
� Sampling Procedures (Insp Plan – Char level)
� Physical Sample
� Release, Print Label
� Results Recording for Sample
� Retain Sample
� Usage Decision (enforce storage)
[
Real Experience. Real Advantage. 16
SAP Demo
� Create/Release Process Order
� Inspection Lot (04 Early Lot Creation)
� Sample Drawing / Inspection Instruction
� Physical Sample (Release / Print Labels)
� Results Recording for Sample
� Process Order Confirmations
� Goods Receipt
� Usage Decision (function to ensure sample stored)
� Display Batch
[
Real Experience. Real Advantage. 18
Before
� Paper hard to track and control
� Administration/Transcription errors
� No way to analyze data
� Lack of organization (systematic control)
� Lots of data – but no easy way to retrieve/report
� No way to Quantify
� “If you can’t measure it – you can’t manage it
[
Real Experience. Real Advantage. 19
After
� Improved Visibility � Measure & Quantify (calculate metrics)
� Easy to retrieve
� Improved Accuracy & Discipline
� Integration with Supply Chain
� Ability to focus on Important Issues
� Continuous Improvement � Ensure scalable, repeatable, compliant and reliable
processes for future projects
[
Real Experience. Real Advantage. 20
Key Learning's
� Scrub and Validate Master Data as much as possible
� Add validations to spreadsheet to prevent errors
� Validation/Compliance - plan for extra time surrounding documentation and validation/verification due to FDA regulated environment
� Business Resources – Dedicated Master Data & Business Resources
� K.I.S.S. – Use SAP Standard as much as possible!
� Test, Test, Test, Train, Train, Train…..