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Agenda
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SAP QM
Sample Management
Calibrations
SPC
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Calibration
Reporting / SPC
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Compliance with
Regulations & Industry
Standards via general
and uniform approach
Common Audit
Trail and overall
traceability
Reduction of data
redundancy and
visibility of
information
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Bar codes
Stability studies
Digital signatures
Certificates handling
Calculated results
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Chemicals
Automotive
Pharmaceuticals
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Examples
Using QM with SAP as LIMS
Inspection
Lot
Lab 1
Lab 2
Lab 3
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Benefits:
For flexible adjustment of specification data before starting the actual test!
E.g. for service-based inspections.
Also applicable for results recording (adjustment of specs).
2011 SAP AG. All rights reserved.
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Stability Studies
GMP-Requirement: Stability test for new products
Continuous tests of durability
Research oriented tests
Bill of material
Flexible Assignment
of Specifications
First
Investigation
Inspection
Lot
manual
Initial Sample
Available Objects
Scheduling
Schedule
Strategy
3 Month
Sample at 8
Test plan 1
with
inspection
series of 3, 6,
9, ... months
Test plan 2
with
inspection
series (3, 9,
Sample at 21 12,... month)
2011 SAP AG. All rights reserved.
Inspection
Lot
6 Month
Inspection
Lot
3 Month
Inspection
Lot
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Planning
Scheduling
Sample
Dispatch
Planned
Test
Schedule
Inspection
Plan
Specification
Service
Entry
Inspection
Method
Unplanned
Request
Sales Order
Service Order
Sample
Management
CapacityPlanning
Sample
Execution
Results
Recording
Validation
Billing
and CoA
Certificate
of Analysis
Invoice
(or internal
activities)
Q-DataExchange
Flexible
Specifications
Inspection
Plan
Specification
Inspection
Method
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Calculated Results
SAP Solution:
Provided via an exchangeable program-part (Business Add-In)
Fields that can be changed: entered value, attribute, origin of results data, number
of decimal places
Entered value will be stored in the field original value.
SAP standard procedures
Output according to input
Output of significant digits
Input date
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Procedure: Date
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Calibration
Covered via Integration of QM and PM Functionality
Planning
Scheduling
Maintenance
task list
Equipment,
Functional
location
Maintenance
plan
Order
Release
Release !
Inspection
lot creation
Insp.lot
Calibration
inspection
Insp.lot
PM order
CS order
Including
Confirmation of used equipment => tracking of equipment (where used)
Update of equipment status incl. measurement info
Test before and after calibration
Audit trail and digital signature
2011 SAP AG. All rights reserved.
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Transfer Log
2011 SAP AG. All rights reserved.
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Change Management
Batch Traceability
Batch Information Cockpit
2011 SAP AG. All rights reserved.
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Supplier evaluation
Quality of purchased parts
Quality Scores
Audit Results
2011 SAP AG. All rights reserved.
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QM Evaluation Cockpit
Two Examples
Comparison of
characteristics
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Quality Notifications
Problem and Complaint Management CAPA Process
Problem and
Complaint
Management
Workflow
Classification
Quality-related costs
Follow-up actions with standard examples
Solution Database
Web-based entry via SAP MII
Corrective and
Preventive Action
Status Management
Tracking and Monitoring
Use of Catalogs
Quality
Analytics
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Certificate Process
Individual certificate profiles
Content and scope (characteristics)
Data origin (across supply chain)
Outbound certificates
For production batches
For deliveries (multi-level)
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(Plant Connectivity)
Connectivity
Framework for
external devices
(PCo)
Data Agents
QM-IDI
Interface
Enterprise Service
(SOA)
Complementary
Partner Product
(no full-blown LIMS,
e.g. IDOS,
Dr. Eilebrecht SSE *)
ES Bundles
Integration of QM
Systems (IQM) and
Easy Inspection
Planning (EIP)
Direct integration,
e.g. with CDS
Flexible Web
Services
Simple Data
Transfer
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Bar codes
Stability studies
Digital signatures
Certificates handling
Calculated results
SAP can!
2011 SAP AG. All rights reserved.
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Trigger
Inspection
Capture results
and issues
Decide on Usage
Digital signature
Processing configuration
Digital signature
Different inspection
types (goods
movement, order
release, scheduling,
stability study,
manual )
Preplanning of sample
drawing
Digital signature
Adjustment of specifications
Multiple specifications
Input processing
Follow-up actions
Results copy
Billing of analysis
Bundling of samples
Operation completion
Multiple specifications
Flexible inspections
Trigger CAPA
Draw additional samples
Complaints
Retest of reserved samples
Flexible evaluation of results
Copy results
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Human
Resources
Inventory Mgmt.
Batch Mgmt.
Change Handling
CAPA
Data Warehouse
Document Mgmt.
Logistics
Quality- Related
Costs
Revenues
Finance &
Controlling
Test Equipment
Management
Calibration,
Planning &
Execution
Enterprise
Asset
Management
Procurement
Stability Study
Inspection Planning
Flexible Specifications
Recipe Management
Goods Receipt
Inspection
Advanced Product
Quality Planning
(APQP/FMEA)
Production
In-/Post-Process Control
SPC-Statistical Process Control
Interfaces for Measurement
Devices
Deviation Management
Sample Management
Audit Management
Sales
Certificate of Analysis
(CoA)
Quality Data Exchange
Billing of Analysis
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Chemicals
Consumer Products
BASF
BASFAG
AG
Germany
Arla
ArlaFoods
FoodsAmba
Amba
Denmark
Clariant
Germany
Grammer AG
Germany
ZF Passau GmbH
Germany
IM&C
High Tech
Life Sciences
3M Espe
Germany
Abbott Laboratories
USA
Balluff GmbH
Germany
Qimonda
Germany
Molex Incorporated
USA
Roche Diagnostics
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Brochures
Quality Management with SAP ERP
SAP QM as Enterprise LIMS
Stability Studies with SAP ERP
Success Story with SPIMACO
Further brochures on QM and more
https://service.sap.com/qm
Media Library
(requires login credentials)
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Thank You!
Session Code: 2706
Contact information:
Mike Krug
QMS Inc.
mkrug@qmsinc.com
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