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Leveraging SAP QM as an eLIMS
Joe Weisburn – [email protected]
Mike Krug – [email protected]
April 16, 2014
2
The Scotts Miracle Gro Company Facts
The world's largest marketer of branded
consumer products for lawn and garden
care.
~$3B in Sales, 8000+ associates globally
The Company's Scotts®, Miracle-Gro®
and Ortho® brands are market-leading in
their categories in the US.
In Europe, the Company's brands include
Weedol®, Pathclear®, Evergreen®,
Levington®, Miracle-Gro®, KB®,
Fertiligene® and Substral®.
Scotts LawnService is our “Do It For Me”
segment.
SMG SAP History
▪ Implemented SAP 1998
▪ 2010 Upgrade to ECC6 using the following Modules
ECC 6.0
PLM Project
- EHS&S
- DMS
- PPM
- cFolders
QM Replace Labware LIMS and Spreadsheets Globally
- 40 Manufacturing Plants
- Notifications
- Vendor Defects
- Material Waivers
2010 PLM Project
QM Inspection Processes
▪ Material inspection and results recording at manufacturing plants
▪ Inspection for Goods Receipt of active/regulated materials
▪Certificate of Analysis recording and saving in DMS
▪ Inspection for R&D Materials
▪ Manufacturing In-Process inspection
▪ Mass Balance Calculations for Blending Plants
Challenges
▪ Organization Change Management
▪LIMS users used to interface and inspection flexibility
▪ Inspection results accessible to entire corporation
▪Record more information than before QM
▪Corporate means of controlling master data associated with inspections.
▪Hundreds of new SAP Users.
Challenges
▪ Fertilizer plant (~3000 Pallets/ day)
▪Serial process from raw materials to warehouse
▪ Inspect the intermediate material/ disposition the finished good material
▪Usage decision is after material is put in warehouse.
▪Quality controlled materials must be dispositioned with QM. (OCM for warehouse)
Challenges
▪ R&D Research Laboratory
▪OCM for Scientist to create Inspection Lots and Samples (20,000 samples/year)
▪Inspection Plans are different for most materials
▪Cannot change the inspection plan once results recording starts
▪Tabular Results Recording
▪Lab Technician inspects one characteristic for several samples and inspection lots
▪Monitoring service agreement performance for Lab
▪Stability Studies
Sample management - flexible
Bar codes
Stability studies
Supporting Laboratory processes
Worklist of their open inspections for lab
technician
Detailed documentation of results
Different ways of results recording (e.g.
across samples or inspection lots)
Calculated results
Interfacing with test equipments for
direct upload of results
Document management
Copy results from former tests
Change control and audit trail
Digital signatures
Flexible reporting capabilities
Detailed corrective and preventive actions
process for a detected issue
Certificates handling
Comprehensive authorization concept
Calibration of test equipments
…
Typical Requirements Towards a LIMS
Handling of Samples, Identification of Samples
Inspection Lots and Physical Samples in SAP
Lab 3 Lab 2 Lab 1
Different types of physical samples: primary,
pooled and reserve samples.
Results documentation for each physical
sample.
Sample records created with the inspection lot
or later.
Planned and unplanned physical samples.
Trigger additional inspection for existing
sample.
Bundling of samples via “physical sample
drawing”.
Dispatch of different samples to different labs.
Printing of barcode labels for further
identification.
Inspection
Lot
Sample Management at Goods Receipt Inspection
Physical Sample Labels
with barcodes for all physical
sample types
New Sample Drawing Instruction
with information about distribution
of samples
Flexibility in Triggering Laboratory processes
Service Entry
Request Flexible
Specifications
Sales Order
Service
Order
Planning Scheduling
Test
Schedule
Billing
and CoA
Sample
Executio
n
Inspection
Plan
Specification
Inspection
Method
Inspection
Plan
Specificatio
n
Inspection
Method
Sample
Management
Capacity-
Planning
Results
Recording
Validation
Certificate
of Analysis
Invoice
(or internal
activities)
Q-Data-
Exchange
Sample
Dispatch
Pla
nn
ed
U
np
la
nn
ed
Flexible Selection of Specifications During
Inspection Lot Creation
After assignment of inspection
plan manual sample calculation
to trigger flexible selection of
characteristics and
specifications.
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).
Bar Code Labels
Speed of Data Entry
Reduced Errors
Streamlined Process Flow
Stability Studies
Schedule
Strategy
Initial Sample
Test plan 1
with
inspection
series of 3,
6, 9, ...
months Test plan 2
with
inspection
series (3, 9,
12,...
month)
Inspectio
n Lot
Inspection
Lot
Inspection Lot manual
Bill of material
Inspectio
n Lot
Sample at 21°
Sample at 8°
GMP-Requirement: Stability test for new products
Continuous tests of durability
Research oriented tests
Available Objects
Scheduling
Flexible Assignment of
Specifications
3 Month 6 Month
3 Month
First
Investigation
Calculated Results
Idea of “Input Processing”:
Translation of entered results (average and single values) according to defined rules.
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
Input Processing: Example
Procedure: Date
Results Copy Functionality
Option 1: Copy results automatically during
sample calculation
Option 2: Copy results automatically during
results recording
Transfer Log
Option 3: Manual selection of an inspection lot
during results recording
Test Equipment Interfacing
Possible Ways with SAP ERP
Simple Test Equipments (e.g. balances, colorimeter etc.
QM Data Exchange with consumer applications (e.g. SAP MII, 3rd party systems)
Complex Test Equipment (e.g. HPLC)
Steinwald interface box; Simple Test Equipments
QM with SAP ERP used as Enterprise LIMS
PCo
(Plant Connectivity)
QM-IDI
Interface
Enterprise Service
(SOA)
Simple Data
Transfer
Connectivity
Framework for
external devices
(PCo)
Data Agents
Complementary
Partner Product
(no full-blown LIMS,
e.g. IDOS,
Dr. Eilebrecht SSE *)
Direct integration,
e.g. with CDS
ES Bundles
“Integration of QM
Systems (IQM)” and
“Easy Inspection
Planning (EIP)”
Flexible Web
Services
RS232 serial interface
File transfer
Interface Boxes
(e.g. Steinwald)
Keyboard Wedges
Test Equipment Interfacing
Possible Ways with SAP ERP
Keyboard Wedge RS-232 & USB
Robust Interface
Web Based Results Recording - eQMS-RЯ
eQMS-RЯ Features
Web Based User Interface (Web Dynpro)
Visual Color based cells for Pass/Fail
Configurable Tabs
DMS Integration for Displaying Documents
SPC Charts
Ability to Change Texts
Leverages standard SAP functionality
Copy Down Function
Mobile
And more!!!
eQMS-RЯ - Selection Screen
eQMS-RЯ - Recording Screen
Calibration (QM/PM)
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
Planning Scheduling Calibration
inspection
Inspection
lot creation
Order
Release
Release !
Maintenance
task list
Equipment,
Functional
location
Maintenance
plan
Insp.lot Insp.lot
PM order
CS order
Supporting regulatory compliance
▪ Digital Signature in QM
▪ Sample Drawing
▪ Results Recording
▪ Usage Decision
▪ Quality Notifications
▪ Multiple Signature Methods
▪ Signature Strategies
▪ Electronic Batch Record (EBR)
▪ Deviation Analysis
▪ Audit Trail Functionality
▪ Cross-Application
▪ Change Management
▪ Batch Traceability –
Batch Information Cockpit
Flexible Reporting Capabilities
Ad-hoc evaluations of quality notifications and results
Specific graphics types:
—Pareto Chart
—Scatter Plot
—Control Chart …
QM Cockpit for Evaluations
Analyze data from…
Notifications / Tasks
Audits
inspection lots
Predefined queries
Queries & figures via SAP NetWeaver BI
Quality of purchased parts
Quality Scores
Audit Results
Supplier evaluation
QM Evaluation Cockpit
Two Examples
Pareto Chart to show
defect frequencies
Comparison of
characteristics
Quality Notifications
Problem and Complaint Management – CAPA
Process
Status Management
Tracking and Monitoring
Use of Catalogs
Workflow
Classification
Quality-related costs
Follow-up actions with standard examples
Solution Database
Web-based entry via SAP MII
Problem and
Complaint
Management
Corrective and
Preventive Action
QM Evaluation cockpit for ad-hoc reporting
Predefined queries and key figures in SAP NetWeaver BI
Supplier evaluation
Full-text search
Quality
Analytics
Certificate Process
Individual certificate profiles
Content and scope (characteristics)
Data origin (across supply chain)
Outbound certificates
For production batches
For deliveries (multi-level)
Inbound certificates from suppliers
Electronic quality data exchange options
Integrated with customer/supplier data
Archiving
Implementation Best Practices
April 23,
2014 l Company Confidential © 2013 32
Organizational Change Management
Denial
Anger
Bargaining
Support Convert the Opinion Formers
Sell the Benefits
Sell the Rewards
Emotional
Response
to Change
Staff Response
Communication Training Coaching
Information Learning on the job
Monitoring
Enhanced Steady State
Trust Established
New Tools & Training
Experimenting with new
ways of working
Acknowledgement
& Reinforcement
Competence
& Confidence
Acceptance
of Change
Uncertainty &
Disorientation Stimulus
for Change
Activities Provide the Resources
Train and Develop
Provide the Evidence
Change Emotional Cycle
Source: A.T. Kearney analysis
Activities
Whats Next?
