Kraft Information Systems

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

August 2009

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Agenda

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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

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Setup Stability Study

Overview

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Setup Stability Study

Transactions
Plant

SAP
Competency
Center

Plant

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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.

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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

2. Click on Ok for
print out

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

ECC Reports

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Suggested Improvements

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