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SAP Quality Notifications - Beyond the Basics:

Leveraging Workflow, Digital Signatures, and Action Boxes to Manage Nonconforming Materials at Medtronic

Scott Heathcote, MedtronicCarl Dunlap, Cohesion/QMScdunlap@qmsinc.com

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Agenda

Introduction & Project ScopeElectronic NCMRNCMR Process & Demo

WorkflowDigital SignatureAction Box

BenefitsQ&A

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About Medtronic

Founded in 1949Global Leader in Medical TechnologyHeadquartered in Minneapolis, MNEmploys 38,000 people worldwideServes physicians, clinicians, and patients in more then 120 countriesKey Businesses

Cardiac Rhythm Disease ManagementCardioVascularSurgical TechnologiesNeuromodulationSpinal & BiologicsDiabetes

http://www.medtronic.com/about-medtronic/index.htm

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About Cohesion / QMS

Unparalleled experience in SAP Quality ManagementFocus on using SAP to meet Quality & Regulatory Deep Industry Experience

Discrete IndustryMedical DeviceSemiconductor & High Tech ElectronicsAerospace & Defense

Process IndustryConsumer Products, FoodPharmaceutical & BiotechChemicalIndustrial

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Electronic NCMR

Based on SAP ERP Quality Notifications

Scenarios: Non-conformance in RI (F2) Non-conformance in Production (Q3) Non-conformance in Inventory (Q3) Parent / Child Relationship

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ServiceSalesProductionProcurement

Quality Notifications in the Supply Chain

Complaint against vendor

Customer Complaint

Internal Problem Message

Notification: Defect/Damage

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NCMR Activities

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Structure of NCMR

Tasks

NCMRHeader

Tasks

ActivitiesFrom Action Box

NonconformanceItem

PartnerOrg. Structure

UserVendor

ActivitiesCauses

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NCMR Demonstration …

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NCMR Tasks (Flow)

Scope &Investigation

CorrectiveAction Plan Corrections Disposition Review

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Workflow

Assign Investigation OwnerDetermine ScopeEvent Classification (Defect Class)Perform Corrective ActionDisposition Approvals

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Email & Workflow

* Not actual data, example only

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Digital Signature

* Not actual data, example only

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Action Box: e-attachments

* Not actual data, example only

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Action Box: Associated NCMR

* Not actual data, example only

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NCMR: Document Flow

* Not actual data, example only

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Highlighted Enhancements

Assign Partner Functions to NCMR tasksZMP_NCMR_ASSIGN

Item Text TemplatesZMP_NCMR_ITEM_TX

Reminders – Task DeadlinesZQM_NCMR_REMIND

Prerequisite Tasks before DispositionZMP_NCMR_PREREQ

Approvals requiredZMP_NCMR_CHECK

Prerequisite Tasks before Disposition

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Before

* Not actual data, example only

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After – Header Data

* Not actual data, example only

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After – Item data

* Not actual data, example only

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After - Tasks

* Not actual data, example only

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Smart Form and PDF

* Not actual data, example only

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BenefitsMove from Paper to ElectronicEnhanced Levels of Data Accuracy Electronic Signatures & Routing vs. ManualIntegration to Critical Information in SAP• Material, Batch, Serial Number• Vendor, Purchase Order• Inventory & Status• Production Order, Routing

Ability to Track and Trend Using Harmonized Codes: Focus Both on Top Problems and Issues, While Also Enabling Specific Detailed Documentation Full Document Traceability and RetrievabilityLays Groundwork for Future MII Projects