Kraft Information Systems

Stability Studies
Overview, Setup, Setup, Creation,
Special Scenarios and Opportunities

August 2009

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Agenda

• Definition & Process

• Roles & Responsibilities
Overview • Transaction view

• Stability Study
• Begin, Record Results, Finish
End to End
Scenarios • Cancel

• Material Master
• Inspection Plan
• Strategy
Master
Data Setup • Linkages
• Building Blocks

• BI
• ECC
Reports

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Background

Stability Study:
• The objective of a stability study is to determine the shelf-life, the
time period of storage at a specified condition within which the
product still meets its established specifications.

The business need for stability studies:

– Consumer Products Industry
• Expiry date determination
• Keeping quality tests of daily production batches
• Retest samples (in case of complaints)

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Stability Study
Roles & Responsibilities
Catalyst
ADT/Deployment Initial Setup
Team

Stability Study Plant Lab

Creation Team

Maintenance QM Master
Data
Steward

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Setup Stability Study

Overview

Create Create
Material
Inspection Strategy Linkages Building
Master
Plan Block

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Setup Stability Study

Transactions
SAP
Plant Competency Plant
Center

Create Inspection
Plan CBWBQM
•MM02 Insp Types: QP01
•16, 1601, 1602,
•Insp Plan,
Z89NA006
•Strategy (Header)
•Maint. Package
(Operation)
QST09
MM02 Strategy IP11
Create Building Block

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Setup Stability Study Steps

1. MM02
1. Inspection Types – 16, 1601, 1602, Z89NA006
2. QP02 – Create Inspection Plan
3. IP11 – Strategy
4. CWBQM – Inspection Plan, Strategy (Header), Maint. Package
(Operation)
5. QST09 – Create Building Block

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Material Master
MM02
Inspection type setup for stability studies in the material master:
16, 1601, 1602, Z8NA006

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Create Insp Plan

QP01
Task list for Stability Study
Inspection Plan Group Y* for
Stability Studies

Naming convention:
Y+plant+XXX where XXX is the
shelf life padded by leading 0.

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Strategy
IP11

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Strategy
IP11

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Create Linkages
CWBQM

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Building Blocks
QST09

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Material Master

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Create Stability Study

The end user process for day to day creation of stability studies.

Create Create Initial Create Initial

Notification Sample Inspection (Opt)

• [Notes] • [Notes] • [Notes]

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Create Stability Study

Transaction QM01

Type QM01 and enter or

Select from Favorites
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Enter QT.
Press enter.
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1. Select the Stability Study

BB. This is the shelf
life/SLED of the sample:
- Y90
- Y95
- Y100

2. Enter:
• Cycle Start (Day sample
was produced)
• Material number
• Plant number

3. Click check
mark/enter
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1. Enter batch number

2. Enter Description
3. Enter
• Room temp
• Meat temp
• Type of sample
(routine, ext
runs, etc)
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1. Click on create
initial sample

2. Notification/ Lab
number can be
viewed
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CLICK on Initial
Test Inspection Lot
Creates an inspection lot
for immediate results recording

1. Click on
specify storage
conditions

2. Click on
perform test
scheduling
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1. Click on start
study

If the printout does not work, write the

Batch# on the box with a marker.
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Hit the save button

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Other Scenarios
Cancel
• When you want to stop a study
– Method one:
– Inspection lot with results, reject, defect, cancel study
– Method two:
– Cancel without results

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Cancel
Method 2: No results ever recorded
• Only use this method if no inspection lots were created yet for
the study
• If cancelling after initial inspection lot, do it from usage decision
of initial inspection lot.
• If results have been entered on an initial lot or more use the
previous method to do so with a usage decision - there is a
special UD for cancelling which will record the reason why the
study was canceled.

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QM02 – Cancel Stability Study

Type in QM02 and Enter, or

Select from Favorites
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Type in Notification
number

NOTE: To view Notification number go to: QM11

transaction, fill in Notification Date, Notification
type and Material # (if known), then click execute
to view Notifications
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Click on Notification box

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Under Action
box, click on
Cancel Study
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1. Click Yes
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1. Click on the Save icon

2. The Study status is now

indicated as canceled as
displayed next to the blue
exclamation mark.
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Other Scenarios
Age Based Dynamic Specifications
• 8333 Kirksville Example
• Different specifications based on age of sample

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Reports

BI Reports
• X
• X

ECC Reports
• X
• X

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Suggested Improvements

• X

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