Vessel/Date/Time

In the process industry, liquids are produced in vessels. This operation can take several days. A sample is taken on an
hourly basis (a time-based inspection interval, interval = 1 hour).
This can be be shown by the following inspection point identifier:

Predefined field dependent on inspection type (' ')

Field active Key word

User fields Field active Key word

Text Length 18

Text Length 10

No. Length 10

No. Length 3 1 Vessel

Date 2 Date

Time 3 Time

Test equipment
Test equipment is monitored in calibration inspections. Choose inspection point type 1 (inspection point for equipment).
The equipment number 1 must be entered as an identifier. Since the equipment is test equipment, use 'test equipment'
as the key word.

This can be be shown by the following inspection point identifier:

Predefined field dependent on inspection type ('1')

Field active Key word

Equipment 1 Test equipment

User fields Field active Key word

Text Length 18

Text Length 10

1
No. Length 10

No. Length 3

Date

Time

Note

Even if the test equipment type allows for certain fields, you can define additional user fields.

If you enter a value for the field combination in the task list header, this value is copied to the inspection lots.

SAP Documentation for FM QAPP_CUST_IP_CREATE

2
Stability study:

Purpose

Stability studies or shelf-life studies are conducted to track and examine how different environmental conditions (for
example, temperature, brightness, moisture) affect a compound, a material, or a batch over a specified period of time.
For this purpose, you create physical samples of the material or batch and store them under controlled conditions for the
duration of the study. At specified intervals during the study, you remove these physical samples or parts of these
samples from the various conditions and test them according to predefined inspection plans. You can then use the
results of these tests which have accumulated over the course of the study, for example, to check and confirm whether
the desired or guaranteed life expectancy of the product conforms to the predefined recommendations for storage.

The overall stability study process is made up of the following subordinate process stages:

The process steps described below depict a typical process sequence. Since the stability study is a solution
that can be flexibly adapted to meet the needs of different users, other process sequences that differ from
the one described below are also possible.

1. Initiating the Stability Study

You initiate the stability study by creating a quality notification (type QS or QR, depending on whether or not you
are conducting a study with reference to a material). You then perform the following additional activities in any
desired sequence:
o You create a physical-sample record for the initial sample to be delivered to your laboratory. *
o You assign a stability bill-of-material to the stability study (only if the study is being conducted with
reference to a material). *

o You confirm the receipt of the initial sample when it arrives in your laboratory. *

Many of the process steps in the stability study are performed using follow-up functions in the action box of
the quality notification or stability study. In the process description, all steps that are triggered by follow-up
functions are marked with an asterisk ( * ).

2. Initial Testing

You test the initial sample. Depending on the results of this test, you decide whether or not to continue the
stability study. During the initial test, you perform the following activities:
a. You create an inspection lot for the initial sample. *
b. You perform the initial test by inspecting the initial sample and recording your test results.

3
 c. You complete the initial test by making the usage decision for the inspection lot.

3. Stability Planning

If you decide to continue the stability study based on the results of the initial test, you begin planning the
extended series of stability tests.

If necessary, you can begin the stability planning activities during the initial testing phase.

In the stability planning phase, you perform the following activities:

a. You specify the storage conditions under which the stability samples will be stored in this stability study.
*
b. You create a testing schedule to plan the scope and frequency of the stability tests. *

c. You create separate inspection plans for each storage condition.

d. You process the testing schedule to assign the inspection plans to the respective storage conditions. *

e. You complete the testing schedule. *

f. You print the storage list.

The system automatically calculates the quantities needed for the stability samples and prints these
quantities on the storage list.

g. You maintain the storage data for the stability samples in the system. *

h. You physically create the stability samples, print and affix the physical-sample labels, and place the
samples in storage under the predefined storage conditions.

i. You define a start date for the stability study.

The system automatically calculates all test dates for the duration of the study. *

4. Stability Testing

You perform the stability tests.

This process phase may last several weeks or months, or as much as several years. During this phase, you
perform the following activities:
a. You monitor the testing dates.
If necessary, you can influence the test dates (for example, by creating additional test dates, skipping
certain test dates, restarting the scheduling process, and so on).
b. You schedule a background job that periodically creates the inspection lots on the scheduled testing
dates.
You can flexibly create a work list of inspection lots in advance by specifying a lead time before the test
dates.

c. You remove the stability samples from storage on the specified test dates and perform the stability
tests. Following each test, you return each stability sample to storage.

d. You analyze the stability study process by performing evaluations.

5. Completing the Stability Study

4
 Once all planned stability tests have been performed, you complete the stability study.

You do not have to complete the stability study as you originally planned at the beginning of the study. If
necessary, you can:
 Cancel the stability study for all storage conditions or for selected storage
conditions at any time *
 Deactivate the stability study for all storage conditions or for selected storage
conditions, for an indefinite period of time (for example, if you want to resume testing at a later
date) *

In this scenario the material SS001- TuSAPin (100 ml) is subject of stability studies.

Material master set up:

. The inspection plan:

5
The dynamic modification rule:

6
SS01:

Mic: op2 and 2

Sampling procedures used:

FIX_1AUT

7
SMPL0002:

FIX_1:

Process steps for stability study:

8
1. Initiating the Stability Study
In this first phase of the stability study process, you create a record in the system to document your intent of conducting a
stability study, and you prepare to receive and manage the physical samples to be tested

Creating a Stability Study

In this process stage a stability study is created for the material SS001:

T/Code: QST01

Create notification for stability study:

Notification type QS : stability study with material

2. Creating Physical Sample Record for the Stability Study

In this procedure, you plan the receipt of the initial sample by creating a corresponding physical sample-record in the system. When
you create the record for the initial sample, the system automatically:

 Sets a status in the physical-sample record indicating that the initial sample has been created
 Retrieves the following information from the stability study and proposes it for entry in the physical-sample record:

o Physical-sample type (sample for stability study)

o Physical-sample category (stability sample - initial)

When the initial sample has been created, the action is documented as a task in the quality notification.
T/code: QM02

9
Save initial sample record:

Display the Tasks for the stability study:

Task tab in QM02:

10
The initial sample for the stability study has been created.

The notification is controlled by status profile :

3 Assigning a Stability BOM

In this procedure, you assign a stability bill-of-materials (BOM) to the stability study.

This step is optional and can be performed anytime after you have created the stability study.

In a stability bill-of-material (BOM), you document the components, substances, or ingredients that make up the material
or product to be tested, from a stability or shelf-life perspective. In a stability study for a self-produced drug, for example,
the laboratory is usually more interested in the proportion of active ingredients and chemical composition of the
compound, rather than the material BOM associated the process order or production order. The stability BOM is used for
documentation purposes only. In a BOM, you can also describe the compound or product using text components, which
can be especially important for newly developed products.

QM02:

We are just showing the screen as no BOM with usage 8 (Stability ) exists :

11
4. Confirm the receipt of the Initial Sample
In this procedure, you confirm the receipt of the initial sample in the laboratory for testing. To confirm the initial sample, you execute a
corresponding follow-up function in the action box. This causes the system to automatically:

 Confirm the physical-sample drawing

 Change the physical-sample record for the initial sample (a change document is created)

 Release the initial sample (a corresponding status is set in the physical-sample record)

You can only confirm the receipt of the initial sample once. Confirming the initial sample is a prerequisite for recording inspection results during the
initial test. When you confirm the initial sample, the action is documented as a task in the quality notification

T/code :QM02 :ACTION :Confirm initial sample:

Enter data as follows and save :

12
The results are: receipt of the initial sample for the stability study was confirmed. After this process step the initial
testing can be processed.

13
5. Initial Testing

In the process phase initial testing, you inspect the initial sample. Based on the results of the initial test, you then decide
whether or not to continue the stability study. By performing the initial test, you can make sure that initial sample and
subsequent stability samples (which may be created from quantity of initial sample) will meet your specific requirements
for the stability study, before you proceed with the actual stability testing phase.

Creating the Initial Test Inspection Lot

This procedure describes how you can manually create an inspection lot for the initial sample, in order to perform the
initial test.

QM02:

In the flexible selection dialog box ,copy all spec from plan:

14
The inspection lot for the initial testing was created along with sample:

6. Result Recording

In this process step you perform the initial test by inspecting the initial sample and recording your test results.

15
 Record your inspection result in the template on the right for each operation. To do so choose the field Result.
For qualitative characteristics the possible codes can be displayed by choosing F4 and selected by double-clicking.
For quantitative characteristics the value may be entered directly in the result field.
By choosing Enter the results are valuated and completed.
After working off all characteristics of an operation, save the recorded results. A screen appears, whit a proposed valuation of
the physical sample . Choose Continue (Enter) to accept the proposed valuation and save the data.

The inspection lot for the initial testing has been processed. The results for the inspection lot have been saved. The usage
decision can now be made.

16
7. Usage Decision

You complete the initial test by making the usage decision for the inspection lot. This usage decision determines whether or not the
stability study will be continued. When you make the usage decision, you can choose between the following usage decision codes:

 Complete initial test: Stability study will be continued

If you choose and save this usage decision, the system automatically executes a follow-up action that sets the user status
Initial Test Completed in the stability study.
 Complete initial test: Stability study will not be continued

If you choose and save this usage decision, the system also executes a follow-up action automatically that sets the user status
Initial Test Completed in the stability study. Furthermore, the system will branch to the stability study in the change mode as
soon as you have saved the usage decision. In this way, you can manually trigger additional follow-up functions in the action
box (for example, to cancel or complete the stability study, to print lists, and so on).

17
8. Planning Stability Tests

In this process phase, you plan the stability tests, physically create the stability samples, place the stability samples into
storage, and define a start date for the stability study.

Specifying Storage Conditions

During a stability study, you examine what effects individual storage conditions will have on specific characteristics of a
product over an extended period of time (for example, in terms of shelf life or potency). When you specify the storage
conditions during the stability planning phase, you can only choose storage conditions that have previously been defined
in Customizing.

18
To prepare for the stability tests, you must select the storage conditions under which you intend to store and test the
stability samples. In this procedure, you select these storage conditions and assign them to the stability study.

Prerequisites

Storage conditions have been defined in Customizing.

Select all the storage condition and save.

Result
The Storage Conditions for the stability study and the sample quantity for each Storage Condition have been specified.
The system has saved the selected storage conditions in the Stability Study and has automatically created a physical-
sample record for each storage condition. Each physical-sample record identifies the physical sample that will later be
stored under the respective storage condition

9. Creating the Testing Schedule

The testing schedule specifies:

What will be tested (storage conditions)

When the stability tests will take place (testing dates)

How the tests will be performed (which inspection plans)

When you create the testing schedule, the system creates the testing schedule header and a testing schedule item for
each storage condition you specified in the stability study. In doing so, the system automatically uses the storage
condition short text as the short text for the testing schedule item.

19
Prerequisites

A strategy has been defined. A strategy defines the rules for the sequence of planned stability inspections. The strategy
QSTABI, which is provided as an example in the standard system, will be used for this scenario.

T/code QM02 and maintain data:

Testing schedule created:

20
10. Processing the Testing Schedule

Use

In this procedure, you assign an inspection plan to each storage condition or item in the testing schedule.

Prerequisites

Inspection plans for the different storage conditions have been created. The following inspection plans are delivered with
SAP Best Practices for Pharmaceuticals.

T/Code:QM02

Item data for a maintenance item for 530 for maintenance plan for stability study contains: if you create a maintenance
plan for stability study manually then you need to enter physical sample in maintenance item

21
The testing schedule for the stability study has been created. The system automatically creates an item in the testing
schedule for each storage condition in the stability study. The object entered for a testing schedule item is the physical
sample that is associated with the storage condition in this stability study

The following inspection plan will be used for all storage conditions :

Save the testing schedule and return to stability study:

22
11. Completing the Testing Schedule

Use

You complete the testing schedule to confirm that all scheduling activities have been completed for the storage
conditions.

A task Testing Schedule completed appears in the task list. This task was automatically created by the follow-up function
for completing the testing.

The testing schedule has been completed. Afterwards the storage list can be printed.

23
12. Printing the Storage List

Use
The storage list contains information on how to divide up the initial sample into the quantities for the stability samples
and it identifies the storage conditions under which the stability samples will be stored. The list gives you the following
specific information:

 A description of each storage condition

 A description of the physical sample associated with each storage condition

 The physical-sample quantity to be created for each storage condition (system proposal)

 The number of tests to be performed for each storage condition

In this list, you can also record the storage location of each stability sample, along with the actual physical-sample
quantity you created and stored for each storage condition.

T/code:

Choose Notification  Print  Notification. A dialog box for selecting the shop papers appears.
Select the row that specifies the storage list.
Enter a printer designation in the field for the output device.
Set the Print immediately indicator.
To view the storage list before you print it, choose Print preview. A print preview appears on the screen.

24
13. Maintaining the Storage Data

You now place the stability samples into storage under the predefined storage conditions and then maintain the storage
data for each stability sample in the system (for example, date of storage, location, and quantity of each stability sample
stored). Once you have entered and saved this data, the system automatically releases the stability sample for each
storage condition, allowing you to define a start for the stability study.

T/Code:QM02:

25
The storage data have been maintained

13.Defining the Start Date for the Stability Tests

Use

With defining the start date for the stability tests the system automatically calculates all test dates for the entire duration
of the stability study. The test dates are calculated on the basis of the data you maintained in the testing schedule

26
QM02:

Field name Description User action and values Comment

Define the start Click Start the follow-up function
date for stability for defining the start date.
tests
in the action box

3. A dialog box for entering a start date appears. The system proposes the earliest storage date for a stability
sample/storage condition.
Start of cycle Start date for the Current date
stability testing. A dialog box for entering a
start date appears. The
system proposes the earliest
storage date for a stability
sample/storage condition.
Save Data and Click
return to the
Stability Study

The system calculates all test dates for the entire duration of the stability study. The duration of the study corresponds to
the value you entered for the Scheduling Period when you created the testing schedule.

14.Performing the Stability Tests

In this phase of the stability study, you perform the stability tests for the storage conditions on the scheduled dates.

Procedure Deadline Monitoring

Use

Usually a background job that creates inspection lots for the impending test dates, is setup. In the present scenario we
will use the deadline monitoring function to create inspection lots for stability testing.

T/code : IP30

Maintain following data constellation:

27
Result

Inspection lots for each scheduled inspection date within the given time period have been created. Results can be
recorded and the usage decision can be made for this inspection lots, as described in the previous steps Initial Testing –
Results Recording and Initial Testing Usage Decision.

28
Inspection lot one each for each of the samples has been created:

When we created the testing schedule samples have been created and now after deadline monitoring inspection lots are
created for each sample.

We could have craeetd manual inspection lot for storage conditions from QM02 –Function module as follow up action

In action box:

29
Here the already created inspection lots are showing. We cannot create manual lot for lot origin 16 using QA01.

You can create inspection lot for samples by QPR5.For this inspection type for lot origin should be active in material
master.

15. Display Stability History

Recorded Results for all inspection lots related to the stability study, grouped by storage conditions, can be displayed.

T/code QM02:

16. Goods issue of samples

Consumption of samples is not posted automatically. Therefore this process step must be carried out manually.

T/code: MB1A:

30
The material document is posted. Document 70000160 has been saved and is stored in the database. Goods issue of samples
used for stability study carried out.

16. Completing the Stability Study

When you complete a stability study, you bring the study to a close (typically after all stability tests have been performed
as originally planned).

Prerequisites
You can only complete a stability study if no open test dates are pending in the testing schedule (for example, dates that
have not been called, confirmed, or skipped).

Here in QM02 when we try to complete the stability study the system does not allow as there are pending inspection lot:

So we proceed to complete the results recording (QE51N) and UD QA32 for the 5 lots first.

31
Also we skip calls for status on hold ,

Now we complete the stability study:

Select yes to complete stability study and then check status:

32
Complete the notification.

This completes the business cycle for stability study through action box and follow up functions

Related configurations :

1.Craete follow up actions for notification type :

Maintain following function module:

Create Initial Sample QST01_FT_CREATE_INITIAL_SAMPLE( QN7A

Change Initial Sample QST01_FT_CHANGE_INITIAL_SAMPLE

Confirm Initial Sample QST01_FT_RELEASE_INIT_SAMPLE QN7B

Assign Bill of Material QST01_FT_ASSIGN_BILL_OF_MAT QN7C

Initial Test Inspection Lot QST01_FT_INSPLOT_INIT_SAMPLE QN7D

33
Complete Initial Test QST01_FT_UD_INITIAL_TEST QN7E

Specify Storage Condition QST01_FT_DEFINE_STORAGE_COND QN7F

Change Storage Conditions QST01_FT_CHANGE_STABI_SAMPLES

(De)activate Storage Condition QST01_FT_LOCK_STORAGE_COND

Delete Storage Condition QST01_FT_DELETE_STORAGE_COND

Store Stability Samples QST01_FT_UPDATE_STORAGE_COND

Print Labels QST01_FT_PRINT_STORAGE_LABELS

Create Testing Schedule QST01_FT_CREATE_SCHEDULE_PLAN QN7H

Change Testing Schedule QST01_FT_CHANGE_SCHEDULE_PLAN

Complete Test Scheduling QST01_FT_FINISH_SCHEDULING QN7I

Define Start Date of Study QST01_FT_SET_START_OF_CYCLE QN7J

Manual Insp. Lot f. Stor.Cond. QST01_FT_INSPLOT_STORAGE_COND

Deactivate Stability Study QST01_FT_DEACTIV_STABI_STUDY QN7K

Activate Stability Study QST01_FT_ACTIVATE_STABI_STUDY QN7L

Cancel Stability Study QST01_FT_CANCEL_STABI_STUDY QN7M

Complete Stability Study QST01_FT_FINISH_STABI_STUDY QN7N C

Remove Stability Samples QST01_FT_REMOVE_STORAGE_COND QN7P

Specify Add. Storage Conds QST01_FT_DEFINE_STORAGE_COND QN7O

Display Objects for Study QST01_FT_DISPLAY_ATTACHED_OBJ

Display Stability History QST01_FT_DISPLAY_STABI_HISTORY

sampling schemes used in sampling procedure for sample management:

QDP1/2/3:

D00:

34
V2:

35
36
Sample drawing procedures:

37
38
Sample drawing procedure S2000

39
Master inspection characteristics:

40
Sample management:

The Sample Management component supplements the existing QM functions for processing
samples by allowing you to:
_ Flexibly plan the drawing of physical samples
_ Identify physical samples on the basis of unique, client-wide keys
_ Record inspection results for physical samples
_ Manage the physical-sample data in the system

The Sample Management component gives you increased flexibility and control in the following
areas:

41
Inspection planning
_ You can create sample-drawing procedures [Page 12] to define your strategy for creating
and drawing physical samples. For example, you can specify:
_ Which categories of physical samples should be drawn (for example, primary
samples, pooled samples, and reserve samples).
_ How many physical samples must be drawn
_ If your materials are delivered in different types of containers, you can define different
procedures for drawing physical samples from different container types.
_ To activate the functions for sample management, you must assign a sample-drawing
procedure to a task list. As a result, the information in the sample-drawing procedure
applies to all materials that are inspected with the task list.
Inspection processing
_ The system automatically creates physical-sample records [Page 30] for all planned
physical samples when it creates an inspection lot. A unique physical-sample number
identifies each physical sample.
_ The system assigns all physical samples that were created automatically for an
inspection lot to a unique physical-sample-drawing [Page 39] number. Using this
number, you can determine how many physical samples were drawn from an inspection
lot and how many pooled and reserve samples were created.
_ In addition to the planned, automatically generated physical samples, you can create
physical samples manually.
_ You can record inspection results for all automatically and manually created physical
samples.
_ When you make the usage decision for an inspection lot, you can display an overview of
all processed physical samples with their respective statuses.
_ You can track the physical samples after the inspection by recording the physical sample
location data in the physical-sample records.

when you are creating a Manual physical sample creation(QPR1 etc ) you do it with inspection type 15 -->here you have
to use the sampling procedure as sample management.Use of sampling scheme is not needed.
Whereas
when you are creating physical sample automatically you need to mention the sample drawing procedure in the task list
header.You again need to create sampling procedure as sample management.Use of sampling scheme is not needed in
the task list.But when you are creating the sample drawing procedure you may use the sampling scheme in the SDP.( Also
remember you can also create automatic sample in 01 inspection type)

wanted the sample to be created automatically. so I shd have the SDP assgined to Inspection plan. (If needed, I will attach
the sampling schema in SDP). As soon as the ins lot trigerred, samples should be calculated correct ? Is it calcuating
based on the formula given in SDP ? I heard we will have info on sample number along with info and also label will be
created as well. Where do I see all this info ? I checked with sampling drawing insts and it says...it will be printed as soon
as I leave the transaction but it didn't..is it becos of my printer issue ?

Steps :
Create material with ins type 01
Create sampling procudure with sample managment option (pls provide the sampling type and val mode)
Create sampling drawing procedure
Create inspection plan and assign SDP in header or char level
Lot automatically created based on GR
Sampling drawing insts printed ( how to see the preview ?)

42
I wanted the sample to be created automatically. so I shd have the SDP assgined to Inspection plan. (If needed, I will
attach the sampling schema in SDP). As soon as the ins lot trigerred, samples should be calculated correct ? Is it
calcuating based on the formula given in SDP ?
Agreed

I heard we will have info on sample number along with info and also label will be created as well. Where do I see all this
info ? I checked with sampling drawing insts and it says...it will be printed as soon as I leave the transaction but it didn't..is
it becose of my printer issue ?
If I remember correctly There is setting in defining the Inspection type-->QCC3-->inspection lot creation--->define
inspection type about automatic printing of sample drawing instruction.Along with this there is also setting in
customization.( I do not have system in-front of me so can't tell you correctly but you need to explore

Create sampling procudure with sample managment option (pls provide the sampling type and val mode)
sampling type can be fixed along with manual valuation mode.

Create inspection plan and assign SDP in header or char level SDP can only be assigned at header level.

Printing sample drawing instruction can be seen i in the physical Sample display overview

Questions:

I'm a bit lost on the sample management issue. I've configured sampling procedure for fixed sample, valuation mode(attr. inspection
non conforming/manual), with the dtermination rule '10' with sample management. Also, I've attached a sampling drawing-
procedure(for two characreristics in two operations) for primary samples with fixed number '5' with a size factor of '2'.
Now, when I create a manual lot, the system gives a sample size of 30 (PC) if the lot qty is greater than 30 or it will give a sample size
of equivalent to lot size if it (lot qty) is less than 30. My guess is that the sample size is determined by the function
module(QDRS_FIXED_SAMPLE) attached to the determinatin rule. Is this assumption correct? If yes, is there a way to know before
hand the sample size for any given lot qty.? If my basic assumption is wrong, then can somebody explain the logic behind the sample
size calculation?
The next question, the number of physical samples for the above example is 30/5 = 6, then what is the size factor used for and how?

Answer:

there are several ways to calculate the number of samples. If you work without pooled samples, SAP will create independent
inspection points for each primary sample (physical samples are actually inspection points, check table QAPP). As you defined the
sample quantitiy per MIC to 5 PC and defined a multipier of 2, you will get 10 pyhsical samples. If you get higher numbers it might be
related to the control indicator 'additive sample'. If you set this indicator at MIC level, to get additional 10 primary samples for each
MIC with this setting.

The problem you described may also be related to the inspection quantity defined per MIC. Pedning on the UoM you defined in your
inspection plan, and according to alternative UoM in you material master and/or applicable conversion factors (see TA: CUNI) you
might get a wrong number of samples. For e.g.: If you inspection plan says you need 100 g for a specific inspection, but the base unit
of measure of the material is PC, you might have a conversion between PC and g. So 1 Piece might be 10 g, and instantly you will
need 10 pieces to fulfill the requirement defined in ypur inspection plan.

43
Also check the inspection quantity in general. If you sample quantity is higher then the inspection lot quantity (also regard the
conversion!), it looks like a 100 % inspection.

Automatic creation of sample by quality plan

Set up data for sample management –

44
Material master:

45
Now ,

To perform sample management at GR:

1.Create PO for the material:

2.Perform MIGO for GR:

46
Material document posted

Material document 5000001599

Inspection lot generated:

47
Note:

You can control the recording of lot containers in a goods receipt posting with the help of the Lot container indicator in Settings at plant
level:

The sample created is shown below(QPR1/2/3)

48
Sample data is as per sample drawing procedure

QPR2

Storage data in the physical sample:

Task list:

Group PYRIDIN means using a sample drawing procedure for 2 primary and 1 Main sample and with lot container info at
GR:
49
Operations in the task list:

Master inspection char for the operations:

Now create PO and GR: for material 300-130 which uses the above task list:Th po has lot qty >121 to select the plan for
sample drawing procedure s2000:

50
GR:

Material document 5000001616 posted

Check the Iinspection lot created:

51
The sample overview shows:

The details of the samples created:

52
All physical-sample records are assigned to a physical-sample drawing [Page 39]. The physical
samples drawn together from the same inspection lot have the same physical-sample drawing
number. The system assigns manually created physical samples that do not reference an
existing physical-sample drawing number to a new physical-sample drawing number.

Similarly samples 100000402 (Primary ) and 100000403 (Pooled) Sample have been created and refre to the same
inspection lot: 3671

Sample size:

Sampling Scheme
Sampling plans grouped together on the basis of various determining criteria (for example,
acceptable quality level and inspection severity).In the R/3 System, the structure of the sampling scheme
is based on international standards (for example, ISO 3951 and 2859). However, you can also use sampling
schemes based on other sampling procedures in the R/3 System.
You can reference a sampling scheme in the sample-drawing procedure if you want the system
to determine the number of physical samples automatically. The system can determine the
number of physical samples using one of the following values:
_ Inspection lot quantity in the base unit of measure
_ Inspection lot quantity based on the number of containers and the container type

The status of sample Craeted and labal printed:

Nxt we have to confirm the physical drawing by:

Call the program "Process physical-sample drawing" and confirm the physical-sample drawing 000000000163:

We call the physical sample drawing in QPR4:

53
Release the 3 samples

Status of the physical sample drawing is now released:

Note:

The following table lists the system statuses that can be set for physical sample master records:
Status Meaning
CRTD Physical sample created
REL Physical sample released
DLFL Deletion flag set for physical sample master record
LKD Physical sample locked
LBPR Label printed for physical sample
STRD Physical sample stored
USED Physical sample no longer exists

Manual Creation of Physical Samples

Use
Beyond the planned, automatically generated physical samples, you can also create additional,
unplanned physical samples manually for an inspection lot. When you create a physical sample
manually, the system creates a corresponding physical-sample record.
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Activities
You can create a completely new physical sample or you can create one by using an existing
physical-sample record as a copy model.
_ Using a copy model
If you create a physical sample using a copy model, the system copies all information
from the copy model into the record for the new physical sample.
All physical-sample records that are created manually receive the initial status CRTD
(created). If the physical-sample record you are using as a copy model has a
different status, this status is not copied.
_ Creating a completely new physical sample
If you create a physical sample without a copy model, you must enter all of the physicalsample
data manually.
In addition to using a copy model, you can create physical samples with or without reference to
an existing physical-sample drawing number.
_ With reference to an existing physical-sample drawing number
If you specify an existing physical-sample drawing number when you create a new
physical sample, the system assigns the existing physical-sample drawing number to the
new physical sample. The new physical sample is assigned to the existing group of
physical samples with the same physical-sample drawing number.
_ Without reference to an existing physical-sample drawing number
If you do not specify an existing physical-sample drawing number, the system
automatically creates and assigns a new physical sample drawing number the new
physical sample.
See also:

Physical-Sample Drawing
Definition
A data record that serves as a reference object for all physical samples (primary samples, pooled
samples, and reserve samples) that were drawn from the same inspection lot. The system
automatically assigns a unique number to each physical-sample drawing when an inspection lot
is created.
Use
You can use the physical-sample drawing to collectively process all physical samples drawn from
the same inspection lot. The physical-sample drawing allows you to:
_ Release one or more physical samples and record comments for the sample drawing
(when you release a physical sample, the system changes the status from created to
released)
_ Lock one or more physical samples (prevents you from recording inspection results for
the physical samples)
_ Set a deletion flag for one or more physical samples (marks the physical-sample records
for deletion when the next reorganization run takes place)
Structure
The physical-sample drawing record consists of a header with the following information:
_ Physical-sample drawing number
_ Date and time physical-sample drawing was created and name of person who created
the record
_ Date and time physical-sample drawing was released and name of person who released
the record
_ Plant, material, and batch
_ Inspection lot number
Sample Management (QM-IM-SM) SAP AG
Automatic Assignment of Physical-Sample Drawing

Processing a Physical-Sample Drawing

Prerequisites
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The system must have created a physical-sample drawing when an inspection lot was created.
Procedure
1. Choose Logistics _ Quality management _ Quality inspection _ Sample management _
Phys. sample drawing _ Process.
The initial screen for processing a physical sample drawing appears.
2. Enter the key for a physical-sample drawing.
3. Choose Phys. samples.
A list of all physical samples that belong to the physical-sample drawing appears. The
physical samples are grouped and listed by physical sample category (primary samples,
pooled samples, and reserve samples).
4. You can process one or more physical samples in the list by selecting the desired samples
and choosing an appropriate function. The important functions and how you can use them
are listed in the table below:
Function Pushbutton / Menu path / Operation
Release one or more physical samples Choose Release and save
Lock one or more physical samples Choose Lock and save
Print physical-sample label Choose Print label
Set deletion flags for one or more
physical samples
Choose Edit _ Set deletion flag and save
Download a list of physical samples Choose PhysSampleDrawing/PhysSample _
Download
Print a list of physical samples Choose PhysSampleDrawing/PhysSample _
Print
Save a list of physical samples in PC file Choose PhysSampleDrawing/PhysSample _
Save in PC file
Display physical sample record Double-click a physical sample number

Results Recording for Physical Samples

When you inspect each physical sample, you must record inspection results for all required
characteristics to determine whether the materials meet the predefined quality requirements. On
the basis of the inspection results, you valuate and close each characteristic and then valuate
each physical sample. The valuation specifies whether you accept or reject the physical sample.
You can record inspection results for physical samples using one of the following functions:
_ Work list for results recording
This is the recommended method for recording the inspection results for physical
samples if you want to process several inspection lots. Using this function, for example,
you can generate a list of inspection lots for each work center or laboratory. You can
then drill down each inspection lot to display a hierarchical list of operations, physical
sample numbers, and characteristics.
_ Record inspection results for physical sample
You can use this function to record inspection results for a physical sample that was
created manually for an inspection lot.
Integration
Depending on how you valuated the inspection characteristics during results recording, the
system proposes a valuation for the physical sample. You can store proposals for these
valuations in Customizing for Inspection Planning (Define inspection point identification) as
follows:
_ A code proposal if all characteristics are accepted
_ A code proposal if at least one characteristic is rejected
Prerequisites
You can only record inspection results for physical samples whose records have been released.
All automatically or manually created physical-sample records receive this status if the
confirmation requirement was not set in the sample-drawing procedure. If you set the indicator for
the confirmation requirement, you must confirm the drawing of the physical samples before you

56
can record the inspection results.
For more information about confirming the drawing of physical samples, see Processing a
Physical-Sample Drawing [Page 43].
Activities
When you record inspection results for a physical sample, you:
1. Record an inspection result for each required characteristic
2. Valuate and close each characteristic
3. Valuate each physical sample after all required characteristics for each physical sample have
been valuated and closed You can valuate the physical samples manually or the system can valuate them
automatically. You set the valuation mode for the inspection points in the inspection
plan on the operation detail screen.If you create or assign a new batch while valuating a physical sample,
the batchnumber is automatically updated in the physical-sample record.

Usage Decision for Inspection Lot

The usage decision for an inspection lot confirms that all physical samples have been valuated
and the inspection has been completed. It also specifies whether the goods in the inspection lot
have been accepted or rejected for use. You can make the usage decision manually or the system can
make the decision automatically.The usage decision can be made using one of several functions:
_ You can make the usage decision manually for a single inspection lot.
_ You can make the usage decision manually for several inspection lots using the work listfunction.
_ The system can make the usage decision automatically for one or more inspection lots by means of
preplanned, periodically executed jobs.
Prerequisites
You can make the usage decision for an inspection lot if:
_ You have the user authorization to make the usage decision.
_ The inspection lot is released.
_ You have recorded inspection results for all required inspection characteristics.
_ You have closed all characteristics and valuated all physical samples during results
recording.
_ No active status exists that blocks the usage decision.
Activities
When you make the usage decision for an inspection lot, you can also:
_ Display an overview of all physical samples with their respective statuses.
_ Make stock postings
_ Activate quality notifications
_ Record defects
When you make the usage decision, the system can also execute the following functions
automatically:
_ Calculate the quality score
_ Update the quality level
_ Trigger automatic follow-up actions (provided they are linked to the usage decision code)

Processing Unplanned Physical Samples

This scenario describes how to process physical samples that were not planned in advance
using a sample-drawing procedure. In this situation, you create the physical samples manually
after the inspection lot has been created.
Prerequisites
In the field for inspection points in the inspection plan header, you must have entered a value that
specifies the inspection points for physical samples.
Process Flow
1. The system creates the inspection lot automatically or you create the inspection lot manually.
When the inspection lot is created, the system creates a physical-sample drawing [Page
39]. It does not, however, create physical-sample records or inspection points.

57
2. You create one or more physical samples manually with reference to the physical-sample
drawing that was created with the inspection lot. You can determine the physical-sample
drawing on the basis of the inspection lot number.
3. You release each manually created physical sample (change status from created to
released).
4. You distribute the physical samples to the work centers or laboratories and inspect each
physical sample.
5. You record inspection results for each physical sample using one of the following functions:
_ Work list (inspection point 999999)
_ Results recording for a specific physical sample (physical sample number)
When you record inspection results, you must valuate and close each characteristic, and
then valuate each physical sample.
6. You complete the inspection by making the usage decision for the inspection lot.
7. You can store the physical samples for further testing, if necessary.

QA 52 –Results recording and Usage decision:

Inspection results are entered for the characteristics:

58
Usage decision for lot:

Inspection lot status after UD:

59
Process: Deadline monitoring of batches

Recurring Inspections for Batch Materials

Purpose

The system can automatically create inspection lots at predefined intervals for selected batch materials. You can plan
such inspections by having the system monitor the date for a recurring inspection.

Recurring inspections are triggered by a report that you can execute manually or that the system can execute
automatically (provided it has been planned as a background job). When recurring inspections are triggered
automatically, the background job executes the report, which in turn selects the batches and creates the inspection lots
according to your processing parameters.

The report does not consider, for example, storage locations with HU requirement. This means that the
report cannot be used to generate inspection lots for storage locations that require HUs. Therefore, recurring
inspections are not possible.

60
 Instead, the Business Add-In (BAdI) implementation BIC_REC_INSPECTION is available via the Batch
Information Cockpit for the BAdI BIC_FOLLOW_UP_ACTION. This BAdI implementation allows you to open
recurring inspection lots.

Inspection for Deadline Monitoring of Batches

In this step, you plan the creation of inspection lots by monitoring the deadlines of materials whose stocks are managed in
batches.

The monitoring of deadlines involves two activities:

 changing the batch status when the following deadlines are reached:

 shell life expiration date

 date of the next recurring inspection

 creating an inspection lot before the date of the next recurring inspection expires and posting the materials to
inspection stock

To create inspection lots automatically, the system starts a job that triggers the monitoring of deadlines at certain intervals:

 on a one-time basis

 at predefined intervals

Requirements

You must maintain the stocks of the monitored materials in batches.

An inspection type for inspection lot origin 09 must be active in the material master.

Activities
1. Plan the jobs to create the inspection lots.

a) Define report variants for triggering the inspections with the help of the deadline monitoring function.

b) For each plant and material, define the intervals in which the deadlines are to be monitored.

Further Notes

If the interval for the recurring inspection is defined in the material master, the date of the next recurring inspection is
recorded when a batch is created.
You can enter the expiration date manually when you create a batch or the system can determine the date on the basis
of the shelf life specified in the material master.
If the inspection type for inspection lot origin 09 (recurring inspection) is active in the material master, then a periodically
executed program can identify all batches that qualify for the creation of an inspection lot, a status change or a transfer
posting.

Jobs do not have a transport link; you must therefore plan the jobs in the production system.

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interval for the recurring inspection
Definition

Specifies the interval between different quality inspections.

Use

If the interval for the recurring inspection has been defined in the material master record, the date of the next recurring
inspection is entered automatically when creating a batch.

For more information on planning deadline monitoring for materials whose stocks are managed in batches, please refer to
the Implementation Guide for QM.

next recurring inspection

Definition

Defines the date for the next recurring inspection for the batch.

Dependencies

There is a program that runs on a cyclical basis for monitoring the date. If necessary, this program creates an inspection
lot.
You can also use the following functions for deadline monitoring:

 The job overview display function

 The job planning maintenance function

expiration date
Dependencies

The date is set upon goods receipt in one of the following ways:

 You enter it yourself.

 You enter a date of production, and the system calculates the shelf life expiration date from the date of production
plus the shelf life in days (from the material master record).

Note
This date can still be changed upon receipt of the usage decision for an inspection

shelf life
Definition

Period for which the material will keep in total, that is, from the date of production to the shelf life expiration date.

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Use
 Value entered in the material master record

The system assumes that the date entered upon goods receipt is the material's date of production. It then calculates a
shelf life expiration date from the date of production plus the total shelf life.
 No value entered in the material master record

The system assumes that the date entered upon goods receipt is the material's shelf life expiration date.

In both cases, the system updates the shelf life expiration date in the batch master record and in the material document if
the goods receipt is accepted.

Dependencies

The period (day, week, month, year) depends on the entry in the Period indicator field.

The shelf life is checked upon goods receipt only if this check has been activated in Customizing for Inventory
Management in the activity Set expiration date check

Deadline Monitoring of Batches - Transaction

Technical Data

Provider/homepage SAP
Type of application ITS/SAP GUI for HTML
Technical name com.sap.pct.erp.qltyinsp.13.deadline_monitoring_of_batches
Available for portal (release) See Business Package
Data origin Transaction: QA07
Languages See Business Package
Support EP-PCT-MAN-QI

Features
You can use this iView to monitor the deadlines of batches. The basis can be the expiration date, a planned inspection
interval, or a specified date of inspection. A transaction in the ERP system is called when you access this iView.

Material master set up:

63
64
We are using following material as the above material is not having batch:

Please see MM02 and BMBC screen for batch and inspection set up details:

65
Create 3 Batches for the material –100 qty each with 501:

Material master self life data:

66
Result after creation of batches:

(old batches have been set deletion flag)

67
The Following is the deadline monitoring screen (QA07) with all the options:

Initial Run in Days

Use

The opening period is calculated using the initial run in days.

68
If the batch expiration date or the next inspection date is in the opening period, the chosen action is executed.

Initial run in days Status of batches

10 No action on any of the options –lot creation or post to

inspection stock or block batch etc as no check against self
life date is checked

11 No action on any of the options –lot creation or post to

inspection stock or block batch etc as no check against self
life date is checked

20 No action on any of the options –lot creation or post to

inspection stock or block batch etc as no check against self
life date is checked

Work with t-aq599 as Inspection lots are getting created at GR for other batches with material QS8X30(Due to other
inspection types)

Log:

69
Bmbc FOR t-aq599:

Initial screen in QA07 for T-AQ599:

70
Log for T—AQ599

Log:

71
The no of days entered (30 days) in initial run days is > self life date for both batches ,so inspection lot has been created
for both batches.

Below are the results for testing with various options in QA07:

Please note:

The Red Mark portion with 5 options has been explained below.

The run days in these section only checks against the next inspection date and not self life expiration date

And effects stock posting and lot creation when the run days +today’s date >next inspection date.

Self life check is not performed in this section

Option 1:Batch 100 :run days 21 :current date 26.11.2011:

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Option 1:Batch 200 :run days 21 :current date 26.11.2011:

Now process the lots for RR and UD.

Option 2::

Batch 100 :run days 21 :current date 26.11.2011:

Batch 200 :run days 21 :current date 26.11.2011:

Transfer posting doc for Batch 100(generated on 26.12.2011 )

Similarly for batch 200:

73
Next process and release the lot.

1 RR for the lots.

2. UD for the lots

3. Stock posting on acceptance from QI to unrestricted (321) documents no 70000178

4. At UD you have the option of changing the self life date and also batch status –restricted to unrestricted

74
Option 3:

Batch 100 :run days 21 :current date 26.11.2011:

Batch 200 :run days 21 :current date 26.11.2011:

Also transfer posting takes place:

Batch Status at BMBC:

75
Batch stock is showing in restricted use:

Now process the lots:

1.RR

2.UD-accept

3.POP UP comes-change batch status to unrestricted :

76
4.Post to unrestricted.

5. The material doc generated:

Reversal of 341 I,e 342-unrestricted to restricted reversal:

77
Option 4:

To inspection stock on inspection date:

Inspection lots created when the date (run day 21 ) for inspection is within planning horizon(26.11.2011+21 days > next
inspection date 16.01.2012.The inspection date is 26.12.2011.Here the batches have not reached there inspection date
and hence are not transferred to QI stock .Only inspection lot has been created for today I,e 26.12.2011 as in option 1-lot
creation only,had the date of inspection 16.01.2012been reached stock transfer to QI would have taken place along with
lot creation.

Option 5:

Block Batch at Inspection Date

Defines that a batch is blocked, if the next inspection date has been reached.

If you choose this option, batches that have reached their next inspection date are blocked.

 If the batch status management is active in the corresponding plant, the batch status is changed to "restricted".

 If the batch status management is not active in the corresponding plant, the batch stocks are transferred to the blocked stock.
When the batch status is changed or a transfer posting takes place for each storage location a new inspection lot is created, if
no corresponding inspection lot already exists.

 Inspection lots created when the date (run day 21 ) for inspection is within planning horizon(26.11.2011+21 days
> next inspection date 16.01.2012.The inspection date is 26.12.2011.Here the batches have not reached there
inspection date and hence are not transferred to blocked stock and restricted status.
78
  Only inspection lot has been created for today I.e. 26.12.2011 as in option 1-lot creation only, had the date of
inspection 16.01.2012been reached stock transfer to blocked (batch status restricted) would have taken place
along with lot creation.

The following screen shot shows the setion with respect to expiration date check:

BMBC screen for SLED:

When we run QA07 with inintial run days 10 as shown:

79
The result is expiration days reach for Batch 100 and batch status changed to restricted.

For Batch 200 the expiration date is not reached and hence its status remains same

When run days is set as 15 days ,for batch 200 also the expiration date is reached and status is changed:

80
But no inspection lot is generated.

Please note:

Block Batch at Expiry Date

Defines that a batch is blocked, if its expiration date lies within the opening period.

81
If you set this indicator, batches are blocked if their expiration date lies within the opening period:

 If the batch status management is active in the corresponding plant, the batch status is changed to "restricted".

 If the batch status management is not active in the corresponding plant, the batch stocks are transferred to the blocked stock.

If the next inspection date has been reached, the blocking of the batch has priority over the next scheduled inspection.

Inspection for a Delivery

Use
The system can create an inspection lot automatically if a delivery is created in the Sales & Distribution (SD) component
for a inspection-relevant material. You can create a delivery in the system as follows:

 With reference to a sales order (inspection lot origin 10)

 Without reference to a sales order (inspection lot origin 11)

 As a general delivery (inspection lot origin 12)

An inspection lot for a delivery is not stock relevant because the goods to be delivered correspond to a consumption
posting.

Using customer info records for a customer/material combination, you can specify whether or not an
inspection lot is created before or after the goods are shipped, or whether the quality inspection will be
carried out by the customer.

Prerequisites
The system automatically creates an inspection lot for a delivery if:

 You have made all required settings in Customizing for Inspection Lot Creation (Inspection in SD)
 QM is active for the movement type in Customizing for Inspection Lot Creation (Define inspections for goods
movements)

 QM is active for the material to be delivered This means that in the inspection settings of the material master:

o An inspection type is active for inspection lot origin 10, 11, or 12

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 o The remaining control indicators for the inspection type are set to meet your requirements for inspection
processing

Process Flow
1. The system creates an inspection lot automatically when a delivery is created in the Sales & Distribution (SD)
component for a inspection-relevant material.
2. If the inspector will record results for inspection characteristics (controlled by the inspection settings in the
material master), the system assigns an inspection specification (for example, a task list or material specification)
to the inspection lot. If the system cannot find an inspection specification or if more than one inspection
specification is assigned to the material, you must assign a specification to the inspection lot manually.

3. If dynamic modification criteria are defined for the inspection lot origin or task list usage, the system checks the
existing quality level for the material (and the other criteria, if applicable).

o If a quality level is not available, the system creates one.

o If the dynamic modification rule specifies that the quality level must be updated when the usage decision
is made, the system does not update the quality level now.

o If the dynamic modification rule specifies that the quality level must be updated when an inspection lot is
created, the system updates the quality level now.

4. The system calculates the sample size.

If the sample calculation must be triggered manually (controlled by the inspection settings in the material master),
you must call up the inspection lot in the change mode and choose the function to trigger the sample calculation
manually.

5. If you are going to inspect the goods in an inspection lot using an inspection specification, you or the system can
print out the inspection instruction or sample-drawing instruction.

Result
You can use the information in the inspection instruction and sample-drawing instruction to:

 Draw and prepare the samples at the work centers specified in each operation
 Inspect the samples and record characteristic results and/or defects

When you have finished recording inspection results and/or defects, you can complete the inspection.

See also:

Effect of Delivery Processing on Inspection Lots

Results Recording

Defects Recording

Inspection Lot Completion

Effect of Delivery Processing on Inspection Lots

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When a delivery is created and processed in the SD component, the SD activities in the delivery note also affect the
processing of inspection lots in QM. The key events include the following activities:

 Creating the delivery

When a delivery note is created in the SD component for a material that must be inspected, the QM component
automatically creates an inspection lot for the material as soon as the plant is identified. The system displays a
message indicating that preparations are being made for a quality inspection.

 Batch split

If the material for a delivery is managed in batches, a responsible person in SD user must determine whether the
delivery item can be posted in a single batch or in several batches. The batch split function allows you to split a
single item into a desired number of smaller batches. If a batch is split and the delivery is saved, QM automatically
creates a partial lot for each batch.

 Changing a delivery item

If a delivery item is changed in SD, the inspection lot also reflects these changes:

o If the quantity of material for the delivery item is changed, the system also changes the actual lot quantity.
o If the plant number is changed, the system cancels the existing lot and, depending on the control settings
in the material master, creates a new lot.

o If a batch split is cancelled because the delivery item can be processed in a single batch after all, the
system cancels the existing lot and creates a new one.

 Deleting the delivery item

If you delete a delivery item, the system reacts in different ways. This depends on the status of the delivery and
the inspection. If the inspection lot or partial lots:

o Have not been saved, they are not written to the database
o Have been saved, but sample size has not yet been calculated, the inspection lot or partial lots are
cancelled

o Have been saved, the sample size has been calculated, but a usage decision has not yet been made, the
inspection lot or partial lots will be marked for cancellation (this means that you can still record results for
the inspection lot or partial lots)

o Have been saved with a usage decision, the inspection lot or partial lots are cancelled

A goods issue begins with a request for the delivery of goods or services. The request for a delivery can be initiated in one
of two ways:

 A customer requests the delivery of goods or services in the form of a purchase order or call-up order based on a
pre-arranged delivery plan. In this case, a delivery is created with a reference to a sales order. The sales order
may then trigger a production order or the withdrawal of material from the warehouse stock.
 The delivery note is created directly in Sales & Distribution (SD) without a reference to a sales order.

When the delivery note is created, the QM component creates an inspection lot in the background for the inspection-
relevant delivery note items. The control over the goods reverts to QM until the inspection has been completed. The
delivery can be released for the goods issue posting if you make a usage decision to accept the inspection lot.

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Features of a Quality Inspection for a Delivery
When you process an inspection for a delivery item, the inspection activities in QM are the same as for other types of
inspections (for example, goods receipt inspection or production inspection). There are several functions in an inspection
for a delivery, however, that are unique:

Inspection control for customer/material combinations

In the QM component, you can maintain default customer specifications for a customer or customer information records
for customer/material combinations. These info records contain inspection-related control indicators that you can use to
influence a quality inspection for a delivery (see QM control in Sales & Distribution).

Partial Lots

An inspection for a delivery supports the processing of batch materials. You can process a batch for a delivery item in a
single inspection lot or in several partial lots. If the person processing the delivery in SD determines that the delivery item
cannot be fulfilled with a single batch, the item can be divided into several batches. The QM component then creates a
partial lot for each batch automatically.

The partial lots are subordinate to the inspection lot at the delivery item level. The QM component processes each partial
lot separately. You must record inspection results and make usage decisions for the partial lots and the inspection lot.

Batch classification

The QM component can automatically transfer the inspection results for the individual lots to the respective batches in
order to classify the batches. In SD, a user can select a batch for a goods issue posting on the basis of specific attributes
(for example, expiration date, quantity or characteristic value).

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Quality certificates

The system can also create a quality certificate for a delivery item automatically. The quality certificate documents the
specifications, inspection results or properties of a material or batch.

See also:

LO - Batch Management

QM Control in Sales and Distribution

Use
You need QM control in Sales & Distribution so the QM component can automatically create inspection lots when delivery
items are created.

Using the function QM Control in SD in the screen for Quality Management in Sales and Distribution, you can influence
the quality inspection by:

 Defining default customer specifications

 Creating and maintaining customer information records

In SD, you can assign several partner functions to a customer in the customer master (for example, you
can identify a customer as a sold-to party, ship-to party, or bill-to party). If you define customer
specifications or want to create a customer info record, you must specify the ship-to party for the
customer number.

Prerequisites
Certain control parameters must be active and various master data records must be maintained in the QM and SD
components. The QM component automatically creates an inspection lot for a delivery item if the following conditions have
been met:

 Your system administrator has maintained the appropriate Customizing tables in the SD and QM.

 You have maintained the QM inspection data in the material master records for the materials to be inspected.

In addition, you can influence an inspection for a delivery by defining customer specifications and customer info records. To do
this, choose QM Control in SD in the Quality Management in Sales and Distribution screen. You do not have to maintain
customer specifications or customer information records for the system to create inspection lots automatically.

Customizing prerequisites in SD

 Maintain delivery type.

 Maintain delivery category.

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Customizing prerequisites in QM

 Maintain inspection lot origin.

 Maintain inspection type.

 Assign the delivery type to the inspection lot origin. The system supports the following inspection lot origins:

 Inspection lot origin 10 (delivery with reference to sales order)

 Inspection lot origin 11 (delivery without reference to sales order)

 Inspection lot origin 12 (general delivery; no customer reference)

 Assign the delivery category and delivery type to the inspection lot origin.

Together, the delivery category and the inspection lot origin specify the inspection type. If necessary, you
can use customer enhancement QVDM0003 to have the system select another inspection type to create
an inspection lot.

Assignments in the material master

Assign an inspection type to QM inspection data in the material master.

Default Customer Specifications

Use
Once a customer master record has been created for a customer in the SD component, you can define several
inspection-related default specifications for the customer. These specifications apply to all materials that are delivered to
this customer. The specifications include the following control parameters:

 Quality inspection

You use this parameter to specify whether a quality inspection will take place and when the inspection will occur:

o Before the goods issue is posted

o After the goods issue is posted

o To be performed by the customer (if you choose this option, the QM component will not create an
inspection lot for the delivery)

 Delivery category

With this parameter, you document the customer's release status (for example, whether the customer has
released you for a replacement, model, or production series delivery).

 Documents

With this parameter, you can create a link to quality documents (for example, quality assurance agreements and
technical delivery terms) with the help of the document management system.

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If a delivery item was created for a material, but a customer information record does not exist for this particular
customer/material combination, the system uses the default customer specifications to determine the requirements for the
quality inspection. The system also uses default customer specifications as default values when you create customer
information records.

You can only define default specifications for a customer if a corresponding customer master record exists in the SD
component. For more information about customer specifications, refer to the procedure Defining Customer Specifications.

See also:

Customer Info Record

Defining Default Customer Specifications

1. Choose Logistics  Quality management  Quality planning Logistics master data  Q-info record (SD) 
Create.
2. In the initial screen for creating QM control data in SD, enter a customer number and sales organization, and then
choose Control data.

3. Choose Goto  Customer specifications. A dialog box for creating the customer specifications appears.

4. Proceed as follows in the dialog box:

o Enter the delivery category (if known)

o Set the indicator for the quality inspection.

o Choose Documents if you want to link the customer specifications to a quality document (for example, a
quality assurance agreement or technical delivery terms). A dialog box appears in which you can link the
customer specifications to a document. Use the possible entries help to select the desired document and
then choose Continue. The dialog box for creating the customer specifications reappears.

5. Choose Continue to return to the screen for creating the QM control data in SD.

6. Save the customer specifications.

To change the default customer specifications, repeat the above procedure and change the data as
necessary.

Customer Info Record

Definition
The customer info record defines the inspection requirements for a specific customer/material combination (per sales
organization). You can use the customer info-record to override the default customer specifications.

Use

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When a delivery is created in SD, the system first checks the inspection settings in the material master to determine if the
material should be inspected. If so, the system checks whether a customer info record exists for the customer/material
combination, to determine if any special inspection requirements apply. If a customer info record does not exist, the
system uses the default customer specifications. In the customer info record, you can:

 Specify the material for the customer/material combination

 Enter an additional short text for the customer info record

 Create a long text as additional documentation

 Change the default customer specifications (quality inspection, delivery category, or documents)

You normally create a customer info record after you have maintained the inspection settings in the material master and
the customer data in the customer master.

Structure
The customer info record consists of information retrieved from the customer master and material master records.

See also:

Process Customer Info Records

Process Customer Info Records

Creating a new customer info record

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 1. Choose Logistics  Quality management  Quality planning Logistics master data  Q-info record (SD) 
Create.
2. In the initial screen for creating QM control data in SD, enter a customer number and sales organization, and then
choose Control data.

3. Choose New info record. A dialog box for creating the QM control data in SD appears.

4. Proceed as follows in the dialog box:

o Enter a material.

o Enter the delivery category.

o Enter a short text for additional information (optional).

o Set the indicator for the quality inspection.

o Choose Documents if you want to link the customer info record to a quality document (for example, a
quality assurance agreement or technical delivery terms). A dialog box appears in which you can link the
customer info record to a document. Use the possible entries help to select the desired document and
then choose Continue. The dialog box for creating QM control data in SD reappears.

5. Choose Continue to return to the screen for creating the QM control data in SD.

6. Save the customer info record.

If you want to define a new material for an existing customer, call up the info record for the customer
using the Create function. When the record is displayed, choose Edit  New info record and then enter
the information listed in step 5 above.

Displaying or changing a customer info record

To display or delete a customer info record, perform the procedure described above. Instead of the change or display
function, however, choose the create function.

Deleting a customer info record

1. Choose Logistics  Quality management  Quality planning  Logistics master data  Q-info record (SD) 
Change.
2. In the initial screen for creating QM control data in SD, enter a customer number and sales organization, and then
choose Control data.

3. Select the desired material and choose Info record details. A dialog box for changing the QM control data in SD
appears.

4. Set the indicator for the deletion flag. Depending on the other system settings, the data record will be deleted
during the next reorganization run.

Processing and Completing Quality Inspections

Purpose
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After the system has created the inspection lot(s) for the goods issue and you have inspected the goods, you can:

 Record inspection results

 Make the usage decision

After you have recorded inspection results and made the usage decision (and the inspection lot has been accepted), the
goods issue can be posted in SD.

Process Flow

Record inspection results

You can record inspection results for inspection lots or partial lots using the following functions for quality inspections:

 Results  For delivery in SD

 Worklist  Results recording

If you want to record results for a single inspection lot, use the function Results  For delivery in SD. If you want to record
results for several inspection lots or partial lots, use the Worklist function. You can use the Worklist function to simplify the
repetitive steps involved in recording inspection results and making usage decisions.

Making a usage decision

You can make a usage decision for:

 Partial Lots
 Inspection lots

Making the usage decision for partial lots

You can make a usage decision for individual partial lots or for several selected partial lots collectively. You cannot make a
usage decision for a partial lot if:

 The status of the partial lot does not allow the inspection to be completed, a usage decision to be made, or the
usage decision to be changed
 Samples are currently being processed for the partial lot

If you decide to make a usage decision for the entire inspection lot instead of for a partial lot, the usage decision also
applies to the partial lots. You cannot define follow-up actions for partial lots.

Making a usage decision for a series of inspection lots

You cannot make a usage decision for an inspection lot if a batch split for a delivery item is incomplete (see Incomplete
Batch Split).

Posting the goods issue

The goods issue is posted in the SD component. If the customer info record specifies that the quality inspection must
occur before the goods issue, the goods issue can only be posted after the inspection lot has been accepted. The goods
issue cannot be posted if:

 An inspection lot or a partial lot has been rejected

 A usage decision has not been made yet for an inspection lot or partial lot
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If the customer info-record specifies that the quality inspection may occur after the goods issue, the goods issue can be
posted at any time.

Incomplete Batch Split

Assume, for example, that a delivery note item is to consist of 100 units of a material. You want to process these 100 units
in three batches. Up to now, you have created and assigned the following partial items to the delivery item:

 1st batch: 35 units

 2nd batch: 40 units

The third batch, consisting of the remaining 25 units, has not been assigned to the delivery item yet because the material
is still in production. In this case, you cannot make a usage decision for the inspection lot because the batch split is
incomplete.

Material master set up:

Inspection plan:

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The set up date of MIC:

1. Q-1010-Damage to packaging

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2. Q-1020-Missing Quantity

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3. Q-1030-ID of Property Class (Strength)—meant for qualitative result recording and defect recording

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4. Q-1040-Electroplating

Note: assignment of selected set /catalog type/Code group to MIC:

Catalog Type of Assigned Code Group or Selected Set

Main category by which code groups and codes are classified according to their contents (e.g. characteristic attributes, defect types,
usage decisions).If you are processing a quantitative characteristic or a qualitative characteristic for which the characteristic attributes
indicator is not set, you can assign up to 4 code groups or selected sets to describe the inspection characteristic or the inspection
method.You CANNOT assign selected sets from catalog type 1 to quantitative characteristics or to qualitative characteristics for which
the characteristic attributes indicator is not set.:

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The selected sets used:

Catalog type 1:characteristics attribute

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Defect catalog: catalog type 09

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Sampling procedures used:

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As per material master record in QM view for inspection type 10, inspection is carried out by material specification:

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Process :

1. Create a sales order:

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2.

Availability check:

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Schedule line for item:

Standard Order 13318 has been saved.

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Create a delivery for the sales order:

When you save the delivery before PGI the Inspection lot is generated.

Delivery 80016230 has been saved

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The inspection lot processing:

RR screen:

Usage decision:

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Post goods issue:

Note:

Please note that if materials are handled in batches the batch items must be picked. If there is a batch split, the delivery quantity of the
main item is equal to zero.

Procedure

Change the picking quantity to a value less than or equal to the delivery quantity or increase the delivery quantity before you enter the
picking quantity.

To pick batch split items, select + for the main item in the Batch split indicator column in the item overview. The system then displays
the item's batch structure.

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Picking(WM picking)

Create transfer order:

Transfer order 0000003131 created and confirmed in background on saving

So in VLO2N you can see that the picked qty appears for batch split item generated earlier:

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Now perform PGI

Material document posted.

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