qm at perrigo: a continuous improvement...

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

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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:

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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

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4

Who is Perrigo?

A comprehensive generic pharmaceutical business providing healthcare solutions to consumers

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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

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6

World Wide Presence

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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)

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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

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Master Spreadsheet – RAW, BULK, FERT

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Inspection Methods

Total = 379

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Master Insp. Characteristics (Qual.)

Total = 128

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Master Insp. Characteristics (Quant.)

Total = 204

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LSMW – Inspection Plan Spreadsheets

Header (Total = 447) Material Assignment (Total = 450)

Operation (Total = 447) Characteristic (Total = 4566)

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LSMW Example

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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)

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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

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Sample Label (Zebra Printer)

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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

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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

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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…..

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Questions?

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[

]� Thank you for participating.

SESSION CODE:

0810

Please remember to complete and return your

evaluation form following this session.

For ongoing education on this area of focus, visit the Year-Round

Community page at www.asug.com/yrc

qm at perrigo: a continuous improvement...

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