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could be presented for review by our stakeholders. It is a preliminary working document without any
recommendation on future organization
1
Catalyst Central Europe
In Country Validation
EU SAP QM Design
January 2010
This document serves as a basis for Discussion and analysis to draft options
and hypothesis that could be presented for review by our stakeholders. It is
a preliminary working document without any recommendation on future
organization
Welcome
And you?
Meeting rules:
Mobiles must be switch off. At least in silence.
Please ask any question. I do not know all answers
3
Structure of Meeting
Timing
1 day and a half Demo/presentation
Aim
Introducing you our QM design
Will touch on each area at a high level
Starting the GAP Analysis in Quality Control
Attendants
Questions
4
Agenda
1. Introduction
2. STAR projects. In Country Validation
5
Catalyst CE
QM Project Team
Info?
6
In Country Validation
7
Catalyst CE Project Plan
Build Phase
(config - 19/2, dev-22/3)
Key User
Training
Milestone: 15
Jan Milestone: 29
Milestone: 21
Organstructure Jan
March
sign-off High-leveldesign
Allbuildcomplete
sign-off
(configanddev)
Build
TNATemplate
Authorization by Internal
Controls
8 Security tasks
In Country Validation
Objective
9
In Country Validation
Tools
Tool is Workshops
Workshops
Predefined KFI EU Business Template are used for
validation
Purpose of the workshop is to capture not solved gaps
Sign-off
The results are the findings where the business
requirements in the Enterprise Area were validated
against a KFI EU Business Template
The findings represent the proposed recommendations
where a gap was found between the business and the
KFI EU Business Template
1
In Country Validation
ExecutionofWorkshopsbaseduponreferenceTestCasesorU-
Perform
Workshop
Workshop
PostWorkshop
Creation of documents about differences between As-Is &
Common Design
Agreement for resolution to differences above
Documentation of details regarding agreed resolution to
differences above
Reviewagreedscopefor:
Completeness
Sign-off
Sign-off
Workshops documents
Plant design summary document
GAP analysis and
Business Change documents
Sign-off
TNA first approach
1
In Country Validation
Next steps
1
Business Change Analysis (BCA)
1
Current situation
15
Current situation
Today
SAP Quality Management is used combined with Excel
applications.
Tomorrow
STAR approach with SAP QM module
LegacySystem
Opava
Kolonda
Plonsk
Poland
Jaroslaw
Szekesfehervar
Hungary
Gyr
1
Basics SAP QM
17
Basics SAP QM Objects: 3 Steps
1
3BasicStepsofQM
Demo
Material:532781(Z004)ES02
19
QM. Bespoke fields for Inspection Lots
2
QM. Bespoke fields for Inspection Lots
Line and Equipment from which the sample was drawn. Lines and equipments are
Maintained in a separate bespoke table (ZQM_TABLES)
2
Inspectionlotinformation
Demo
22
Inbound Process
23
QM. Inbound Material General Process
Autoprint
Labels
g er Inspn. Autoprint
Goods trig Lot Sample Results
Usage
Decision
Receipt Created Drawing Recording
Recording
automatically Instruction
Exception Table to
create inspection lot
every time
2
Goods Receipt Decision Tree for Raw/Pack
Goods Receipt
Conditions:
(1) Batchmanaged
No Should (2) QMViewexist
STOP material be (3) Materialtype:Z002(SFG),Z003
inspected ? (RAW),Z004(PKG)
(4) InspectionTypeoforigin89
assignedandmarkedpreferred
Yes
Material
Yes Check if inspection lot
In
should always be created?
Customised Table: ZQM_MATNR
Table?
Mat/Vendor/Batch
No received in
Last
6 Months?
Yes
2
GR: Types of Inspection Lot (SRIL / NSRIL)
2 cases:
Non-Stock Stock
Relevant Relevant Lotorigin:01
Lotorigin:89
Inspection Inspection
Lot Lot
(NSRIL) (SRIL)
Logon to Stocks
decentralised Released
WM System Automatically in
To release stock Difference R/3 System
manually
Performanadjustment
ofquantitywithMB1B Performthe
orMB1Aifthereisa UsageDecision
differenceinqty.
Goodsarepostedautomatically
Real batch gets turned into tounrestricteduse.
Dummy batch 1 Abatchistransferred
toadummybatchinbackground
2
Standard Decentralise Inbound Processing
(Non-Stock Relevant Inspection Lot)
UnderstandingofQMwithinade-centralisedwarehouseenvironment
withoutHandlingUnit
Inbound
Purchase Inbound Delivery
Order Delivery
Pack
1stScan
ERP(R/3) Transfer
Order
Confirm 2ndScan
Auto creation
Inspection
GR
Idoc GR
Lots
WMS
Results UD Manual Releasebatch
Recording Recording QI->Unrestr.
byQMpersonnel ZQM_HUMO
2
QM.GRInboundMaterialProcess
Demo
Bulk(SRIL)503517/ES02
Bulk(SRIL)11114/SE03
RM(NSRIL)532781/ES02
29
In-Process, SFG & FG
30
Quality Management: In-Process, SFG, FG
SFG
Inspection lots for SFG are manual
FG
Very few products are performed at FG level. Most FG are
decentralised WM managed. WM system has a program to auto
release stock after x number of days from QI stock. During that time,
QM would have taken a sample and completed the analysis. Any
blocking will be performed manually.
In-Process
In-processarenotrepresentedasamateriallevelinabillofmaterial
Thereforeweuseaphantommaterialtypetorepresentthein-processmaterial
andtheinspectionlotsarecreatedmanuallybystaffinthelab
3
QM.InspectionLotsforFG,SFG&WIP
Demo
SFG (Insp. Type Z030) AT01 / 400592-400596, 407273
FG (Insp. Type Z040) ES02 / 87093, BE02 / 26292, NO02 / 20681
SFG (Insp. Type Z020) AT01 / PHAT1PA001-009
32
Environmental
33
Environmental Master Data
Maintain
Environmental
Master Data
ZQM_ENV
Link Material,
Materials Maintain Lines Line and
(type phantom) And Equipment Equipment to
Inspn. Plan
Representing what
is to be inspected
Transaction: Transaction:
ZQM_TABLES ZQM_ENV
3
QM tables
Lines
Equipment
3
Environmental Process
Run Environmental
Program
ZENV
Print
Physical Labels
Collection of samples
from the lines
3
QM.EnvironmentalProcess
Demo
DE01 / FPDE10109, FPDE10121, FPDE10122
37
Micro Analysis
38
Micro-biology Processes
Physical depending on
Sample product group
Preparation Date
Coliforms Yeast Count Mould Count ZQM_PREP
Count
4
QM.Microbiologicalprocesses
Demo
QS23: MIC HM140000 / DE02 (HM13*)
QA01: DE02 / 26454, 95494, 103225
ZQM_PREP: Group F9001103 (1 & 2), Date 11.01.2010
41
QM Labels
42
QM Labels.
Structure of Inspection Plan impact into samples
Inspection
Workcenter Physical
Plan Operations (ChemicalLab)
Characteristics
Sample2
4
QM. Types of physical labels
4
QM Label printing
4
QM. Raw and pack labels
Material Number
and Description
4
QM. SFG and FG labels
Material Number
and Description
4
QM. In-process labels
Material Number
and Description
Line Description
Production Date and Time Preparation Date
Equipment Description
4
QM. Environmental labels
Material Number
and Description
Line Description
Production Date and Time Preparation Date
Equipment Description
4
QM. Micro labels
Incubation Temperature
Preparation Date
5
R&D Inspection Lots
51
Quality Management for R&D
5
R&D Inspection lot creation
5
QM.R&Dinspectionlots
Demo
BE01/MtlRBE01001
Insp.PlanBE1RD001
Insp.Lot890000493314
54
Other QM Bespoke Functions
55
Quality Management
QM bespoke transactions
5
Quality Management
Tabular results recording
Usage:
Allows fast entry of results by characteristics. This is
used mostly for micro characteristics and any other
characteristics setup as summarised results. Users scan
the barcode on the label to find the physical sample
they want to record results for
Note: The system prohibits results entry for
characteristics which are not due yet for results
recording
5
QM.Tabularresultsrecording
Demo
DE02/Daterange:30/12to15/01
SelectionbyMIC:HM030002,HM030003Date05/01/2010
58
Quality Management:
QM Grouping
Usage:
Assign several materials to one generic code
5
Quality Management:
QM Grouping
QM Group Eg.SaladCreamor
Mass/Formula TomatoKetchup
FG 1 FG 2 FG 3
6
Quality Management:
QM Grouping
Usage:
For FG made from the same mass, the dynamic
modification can be set at the Mass/Formula material
level.
Setup:
(1) Material is created to represent each mass level
(2) Relationship between mass level and each FG is
made in table ZQMXX_MASS
(3) A user exit is used to check and update the
quality level
At the mass material level each time an inspection lot is
created
6
QM.QMGrouping
Demo
DE02/Mtl(FGPhilly)22629
GroupF0310907,Groupcounter1(PhantomPhilly)
62
Quality Management
Revoke Usage Decision: QA12
Usage:
6
Quality Management
Copy Inspection Lot Header Information
Usage:
6
QM.CopyInspectionLot
Demo
AT01/Mtl140005Insp.lot890000442998
65
Reports
66
Quality Management
List of QM Reports
Report names
QA32 Standard Interactive Housekeeping Report
MCXB Standard SAP Report showing number of analysis done in
Lab
Queries
skipped GR of Raw material (QM_SAME_BATCH)
relationships between SKU and Mass (QM Grouping)
maintained in the material master (QM_MASS)
Micro Prep Date Report (ZQM_PREP)
Single Results - shows all bespoke fields and can be downloaded
to excel
Similar Batch Received in same plant
Sample Drawing Instruction
Report by sample
6
Quality Management
QA32 Inspection Lot Selection
Usage:
This standard interactive report allows users to
perform their daily/weekly housekeeping on
inspection lots.
This report is especially useful to get a list of
inspection lots which have had some rejected
characteristics and require UD recorded manually
6
Quality Management
MCXB Analysis: Inspection Results
Usage:
This standard SAP report provides lab managers with
overviews of the amount of analyses done in the lab by
material, work center, characteristic
Transaction: MCXB
6
Quality Management
SAP QM Queries
7
QM.Queries
Demo
71
Quality Management
ZQM_PREP : Preparation Date Report
Usage:
Thisreportisusedbythemicrobiologicallabworkersasa
worklisttoshowallphysicalsamples(bycharacteristic)
thathavetobepreparedonthepetridisheseachday.
Thisreportisgeneratedbasedonthepreparationdate
bespokefieldinthephysicalsamples.
Note:onlymicrocharacteristicwillbeselectedforthis
report.
Microsoft Word
Document
Demo
See slide 39 for demo
7
Quality Management
Single Results Report
Usage:
This program provides results for all characteristic per
physical sample and inspection lot.
This is a customizable report by Users. They also can
download this report into excel spreadsheet for further
processing if required.
Transaction: ZQMXX_SINGLE_RESULTS
Microsoft Word
Document
Demo
ES02/Z003/01.12.0904.12.09Status5
7
Quality Management
Statistical Report
Statistical Report
Usage:
This program provides statistical calculation per QM Group or
Material for each characteristic per set of limit.
7
Quality Management
Similar Batch Received in same plant
Usage:
This program is setup to run in the background per plant once per day to
check if there are inspection lots created for the same plant which satisfy the
following conditions:
Same material, vendor and batch combination has been previously
received in the same plant in the last 6 months.
The material has to be goods receipted into quality stock for the plant
which the program is performing the checking for.
The check will only include inspection lot created in the past 6
months. The program will use both date and time to check this
condition.
If it finds records that satisfy the above conditions, it will then
generate a
notification via email. Outlook Item
7
Quality Management
Sample Drawing Instruction
Usage:
This report is printed automatically when the inspection lot
is created upon goods receipt. It shows information on
how sample should be collected. This report can be
printed in different languages.
Sample Drawing
Instruction
Config Transaction: ZQM_PRINT_LANG
7
Quality Management
Inspection Instruction Report (Report by Sample)
Usage:
This report is printed automatically when the inspection lot is
created upon goods receipt. It is used as a work list
Inspection Inspection
Instruction 1 Instruction
7
Certificate Of Analysis
78
Quality Management CoA
7
QM. CoA
8
QM.CoA
Demo
QC03. DE192079001/1/Z002 (go to Char. Screen)
ZQMXX_QCERT. DE01 / Insp. Lot 890000301493 / Mtl # 90857 /Cust. 6224591
81
Notifications
82
Quality Management
Quality Notifications
Function:
Adobe Acrobat
Document
8
Quality Management
Quality Notifications
Generalities
8
Quality Management
Quality Notifications
Notification types
8
QM.QualityNotifications
Demo
QE51N. Insp. Lot 890000479807 or
ES02, Lot created from 01.12.09 to 04.12.09 Insp. Type Z010
86
Function Summary
87
Quality Management
Functions summary by plant
Microsoft
Office Excel Worksheet
8
Add ins
89
Teammembers
Mobile
Name Department Site Country Direct phone number number
Production Czech
Jiri Mrazek Opavia Factory Opava Republic +420 553 825 811
Miroslaw
Abramczyk Production Jaroslaw Poland +48(016)621 28 41
BU-MFG/Pro
Competence
Miron Molcan Center Bratislava Slovakia
Czech
Dalibor Kuznik IT / IS Opava Republic +420 553 825 330
Marek Branny-
Rduch IS Cieszyn Poland +48 33 8519735
Umut Soydan Information Kucukyali - +90 216 489 52 00
Gltekin Systems Istanbul TURKEY Ext:102
9
This document serves as a basis for Discussion and analysis to draft options and hypothesis that
could be presented for review by our stakeholders. It is a preliminary working document without any
recommendation on future organization