SAP Quality Notifications - Beyond the Basics:

Transcription

1 SAP Quality Notifications - Beyond the Basics: Leveraging Workflow, Digital Signatures, and Action Boxes to Manage Nonconforming Materials at Medtronic Scott Heathcote, Medtronic Carl Dunlap, Cohesion/QMS cdunlap@qmsinc.com Slide 1

2 Agenda Introduction & Project Scope Electronic NCMR NCMR Process & Demo Workflow Digital Signature Action Box Benefits Q&A Slide 2

3 About Medtronic Founded in 1949 Global Leader in Medical Technology Headquartered in Minneapolis, MN Employs 38,000 people worldwide Serves physicians, clinicians, and patients in more then 120 countries Key Businesses Cardiac Rhythm Disease Management CardioVascular Surgical Technologies Neuromodulation Spinal & Biologics Diabetes Slide 3

4 About Cohesion / QMS Unparalleled experience in SAP Quality Management Focus on using SAP to meet Quality & Regulatory Deep Industry Experience Discrete Industry Medical Device Semiconductor & High Tech Electronics Aerospace & Defense Process Industry Consumer Products, Food Pharmaceutical & Biotech Chemical Industrial Slide 4

5 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 Slide 5

6 Quality Notifications in the Supply Chain Procurement Production Sales Service Complaint against vendor Notification: Defect/Damage Customer Complaint Internal Problem Message Slide 6

7 NCMR Activities Slide 7

8 Structure of NCMR NCMR Header Partner Org. Structure User Vendor Tasks Activities From Action Box Nonconformance Item Causes Tasks Activities Slide 8

9 NCMR Demonstration Slide 9

10 NCMR Tasks (Flow) Scope & Investigation Corrective Action Plan Corrections Disposition Review Slide 10

11 Workflow Assign Investigation Owner Determine Scope Event Classification (Defect Class) Perform Corrective Action Disposition Approvals Slide 11

12 & Workflow * Not actual data, example only Slide 12

13 Digital Signature * Not actual data, example only Slide 13

14 Action Box: e-attachments * Not actual data, example only Slide 14

15 Action Box: Associated NCMR * Not actual data, example only Slide 15

16 NCMR: Document Flow * Not actual data, example only Slide 16

17 Highlighted Enhancements Assign Partner Functions to NCMR tasks ZMP_NCMR_ASSIGN Item Text Templates ZMP_NCMR_ITEM_TX Reminders Task Deadlines ZQM_NCMR_REMIND Prerequisite Tasks before Disposition ZMP_NCMR_PREREQ Approvals required ZMP_NCMR_CHECK Prerequisite Tasks before Disposition Slide 17

18 Before * Not actual data, example only Slide 18

19 After Header Data * Not actual data, example only Slide 19

20 After Item data * Not actual data, example only Slide 20

21 After - Tasks * Not actual data, example only Slide 21

22 Smart Form and PDF * Not actual data, example only Slide 22

23 Benefits Move from Paper to Electronic Enhanced Levels of Data Accuracy Electronic Signatures & Routing vs. Manual Integration 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 Retrievability Lays Groundwork for Future MII Projects Slide 23