PI sheet using X-Step for

Process Industries
[Type the document subtitle]
Bipin Shrivastav

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 PI Sheet Introduction & Detail procedure using X-STep

0.0 Table of Contents

1 PURPOSE 3
2 BACKGROUND 3
3 BUSINESS PROCESSES HANDLED 3
4 GENERAL INFORMATION -Process Message 4
5 GENERAL INFORMATION – PI Sheet 5
6 GENERAL INFORMATION –X Steps (Execution Steps) 5
7 APPLICATION-INDIPENDENT STANDARD X STEPS FOR STD.PROCESS MESSAGE 7
8 X-STEP PROCESS INSTRUCTIONS FOR PI SHEETS 11
9 BUSINESS BENIFITS 32

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1 Purpose

The purpose of this document is to describe business process related to manufacturing bulk
material & process industries including the process management (PI Sheets) and SAP X
Steps integration.

PI sheets are mainly used for Process industries like Pharmaceutical’s, Food, chemicals etc.
PI Sheets can be used by Continuous process manufacturing industries like Paper,
Cements, and polymers, also can be used by batch processing industries like
Pharmaceuticals, Distilleries.

The process flow is as below:

2 Background

H Lund beck, Glaxo, Jubilant Life Science is major Pharmaceutical companies presently
using X Steps to build their PI Sheets & Approval procedures.
Here we are dealing with some Standard PI sheet messaging processes using X Steps and
one example for the enhanced PI Sheet using X Step.

3 Business Process Handled

Normally we dealt with business processes like Goods receipts, Signature process for
approvals with Quality processes.
One enhancement for the decision making blocks.
Standard process messages categories (Example)
PI_BT_CR-- Batch Creation
PI_CONS-- Material Consumption Message
PI_CRST-- Message on Control Recipe Status

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PI_PHCON-- Time Ticket Confirmation for Phase
PI_PHST-- Message on Phase Status
PI_PROD-- Material Receipt Message
PI_QMSMR--Message on Insp.Charact. (Summ. Measured)
SIGN-- Message containing signature
We have created some commands for an enhancement.
PROC_INSTR.ACTVATE
PROC_INSTR.DEACTVATE

4 General Information (Process Messages)

When a process order is carried out; actual process data is needed that documents the
process and is available for further processing in other SAP application components and
external function modules such as process control systems. We can use this component to
send actual data from process control to predefined message destinations.
Definitions
Communication structure that is used to transfer actual process data from process control to
one or several destinations of the following types:
· Other SAP application components
· User-defined ABAP tables
· Users of the SAP office mail system:
· External function modules
Use
Depending on the destination to which the process message is sent, we can use the
Process message business object for the following:
· Triggering business transactions in the SAP System (for example, goods issue
posting)
· Documenting actual data from process control and evaluating this data using internal
or external functions
· Sending mails to certain employees and informing them about the process status
· Sending actual data from process control to an external system and triggering system
reactions (such as opening a valve), if required.
Structure
A process message consists of a message header and several message characteristics
as well as the characteristic values assigned to these characteristics
1] Header-The header of a process message contains general message data such as:
· Administrative data on the message
· The plant in which the message was created
· The message category to which the message belongs

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 · An indicator that specifies whether the message was created for test purposes or
whether it should actually be sent.
2] Characteristics-Which process data is to be contained in messages of a particular
category is defined by assigning characteristics.
Process message characteristics are defined and assigned to the message categories in
Customizing.
3] Characteristics Values-In the process message, a characteristic value can be assigned
to each characteristic contained in the message category. The value expresses the
process-specific data for the characteristics.
The format of a characteristic value as well as the value range to which it must
belong is defined in the characteristic in Customizing. Depending on the format, the
value of a message characteristic can be a date, a time, a numeric or alphanumeric
key, a short text or a long text.

In above section some standard process message categories have been mentioned which
are readily available with standard SAP system.

5 General Information (PI Sheet)

We can use PI sheets to exchange data between the partially or completely manually
operated production level and the SAP system (PP-PI). In manually operated production
lines, this usually involves a process operator who uses the PI sheet to transfer
production-relevant actual data to the SAP system and receives data from the SAP
System.
We can describe the entire production process of a product or only part of it in a PI sheet.
Apart from control information, the PI sheet can contain input fields and pushbuttons. We
can, for example, define fields into which you want the process operator to enter the
quantity of material components consumed for a phase. The material withdrawals must
then be posted as goods issues in inventory management. We can use process messages
to automatically carry out this function.
The PI sheet represents the result of a control recipe that was sent to a process operator
and whose content is displayed as text on the screen. This means the PI sheet is an
instruction for the process operator that describes how and in which order a product is
manufactured. The PI sheet can, for example, contain information about the picking of
raw materials as well as instructions about charging the mixer, filling silos, and so on.
Example-

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 Instructions for Operator Calculations Digital Signature

6 General Information (Execution Steps X-Steps)

Process Instructions
In the process instructions we can define processing steps, which:
· A process operator to execute manually at a production line
· A process control system to execute automatically
We can define the process instructions in the master recipe and in the process order. We
have the following options:
1. Characteristic-Based Process Instructions
In the process instruction overview, we define characteristic-based process
instructions. That is, we define the process instructions using characteristics and their
characteristic values. In doing so, we create process instructions for a phase.
2. XStep Process Instructions
First we need to define XSteps in the XSteps editor. Then we define XSteps process
instructions in the XSteps. Although XSteps process instructions are also based on
characteristics, we can create them without knowledge of the characteristic structure
using the context menu. When doing this we create XSteps independent of the
phases. We assign the XSteps to a phase by assigning a context.

X Steps (Execution Steps)

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 Using XSteps we can describe the precise execution of production processes and can
group and structure this information in the form of modules. XSteps can be structured
in hierarchical form. These form XStep trees.
Prerequisites
Maintenance of XSteps in the Master Recipe-- To ensure that we can maintain
XSteps in the master recipe, we must create a recipe profile when creating the recipe
group. The new recipe profile PI01_XS: Profile for Process Industry XSteps is
available in the standard delivery to assist we when maintaining XSteps.
To do this, access Customizing for the Master Recipe and choose Settings for the
Task List Type -> Define Profiles with Default Values.
Early Issue of Order Number-- As default, it is only possible to generate an XStep
tree in a process order once the order in question has been saved. We can also set that
an XStep tree is generated, even if it has not yet been saved.
To do this, access Customizing for process management and choose Execution Steps
(XSteps) -> Set Early Issue of Order Number.

7 Application-independent Standard XSteps for Std.Process Massages

Application-independent Standard XSteps- We define standard XSteps as master data in

the standard XStep repository (SXS repository).
Using the references to standard XSteps (SXS reference), WE can considerably reduce the
time required to maintain the data. If, for example, there are changes to the standard
processes, WE do not have to make these changes in each individual master recipe. Instead,
WE make the changes centrally in the SXS repository. All master recipes, which contain
references to these standard XSteps, are changed automatically.
Structure of a Standard XStep
A standard XStep can consist of several versions. Every version contains an XStep tree.
We can create XSteps within the XStep tree, which describe the precise contents of the
standard XSteps.

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Advantage -
We can drag & drop, copy and paste out XSteps
• Templates for process instructions as standard XSteps (SXS) in a SXS repository. They
can be referenced and reused
• The PI Sheets can be simulated in the master recipe, in the process order and in the SXS
repository. We’ll see the final layout of our PI Sheet just after pressing the F8 button.
• Various generation scopes exist; each of the XStep elements that belong to an XStep tree
can have an own generation scope.

Versioning--
Several versions with different validity periods can be created for a standard XStep. If we
explode an SXS reference either in the SXS repository or in an application, the system
searches for the SXS version that is valid and released for the key date and creates a copy
of it. We can select the description of the version we require. The version descriptions are
only unique within the standard XStep.

Versioning

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 Procedure for Creating SXS Folder-Use CMXSV Tcode

Creating a Standard XStep for a PI Sheet

The following example describes, how you can create a standard XStep for a PI sheet.

It is important to note the following points when navigating in the standard XStep
repository:

• You can execute several functions for each XStep node. You access all functions for an
XStep node using the context menu.
• You can store several different pieces of information and settings for each XStep node. You
access the dialog box by doubling-click on the particular node.

Case Study:

Instruction Data Input Signatu Comments

re (Y/N)
Operation 0010
Phase 0011 – Sterile Storage Equipment Check-In

Filling Pump Check-In See Table below 2 manufacturing

technician
Check in filling pumps prior to setup. SOP Button for signatures for Allow for data entry in all check-in steps in any order since
Verify product contact S numbers for 701.26 check in. (Do not equipment becomes available at different times.
each manifold per SOP 701.26. require
1.
SOP Button for concurrent If expiration date has already occurred, indicate date is
Perform Post-Sterilization Vacuum 706.17 signatures) expired and do not allow field to be entered.
Testing of pumps per SOP 706.17.
1 technician
Note: If pump test fails, describe signature for
action taken in comments section. pump testing.

Status Manifold Position Product Contact Code Sterilization CPR # Sterilization Exp Comment Performed by
Date
(MM/DD/YYYY)

Dropdown Dropdown Dropdown Text Field Date Text field 30 Manufacturing

Primary Front/Rear Set (default) • S-71 7 characters (entered by character technician or high
(default) Front only • S-72 (entered by technician; not technician; Date
Backup Rear only • S-73 verified against master data) entered must not
be prior to current
date.

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Procedure
...

1. From the SAP Easy Access Menu, choose Production – Process -> Master Data ->
Standard XStep Repository. (T-Code : CMXSV)

Enter Plant & execute

2. Create folder
Select the Standard XSteps folder and choose Create -> Folder.
The system creates the <Folder> node. Enter a description for the folder.

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 Provide the name to folder:

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 3. Create Standard XStep
Select the <Folder> and choose Create -> Standard XStep.
The system creates the <Standard XStep> node with the <Version> and <XStep
Tree> subnodes. The status of the version is currently In Process.
a. Enter a description for the standard XStep.
b. Enter a description for the version and a validity period.
See also: Standard XSteps

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 Expand the arrow of displaying arrow:

4. Create XStep
Select <XStep Tree> and choose Create -> XStep.
The system creates a <New XStep> node.
See also: XStep

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 5. Assign Control Recipe Destination
Double-click <New XStep> and enter the destination type PI sheet or a precise
destination that has type PI sheet in the Destinations dialog box.

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 Assign Control Recipe Destination

( Pre -requisite : Control Recipe Destination need to be created in configuring

through transaction code : SPRO)

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 6. Define XStep Parameter
Define, if required, XStep parameters for the contents of all XSteps, which have values that
you want to reuse. Double-click <New XStep> and create the parameters and their
valuations in the Parameters and Valuations dialog box.
See also : XStep Parameter and SXS Reference and Parameterization.

(Pre-requisite: If required create characteristics to hold required values:

T-Code: O27C

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 7. Assign Scope of Generation
Assign a scope of generation to the XStep if required. Double-click <New XStep> and
enter a scope of generation in the scope of generation dialog box.
See also: XStep Generation
8. Create Process Instructions
Select <New XStep> and choose Create -> Process Instruction.
The system creates a <New Process Instruction> node. Enter a description for the
process instruction.
See also: XStep Process Instructions for PI Sheets

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 9. Create Output of a Long Text
Select <New Process Instruction> and choose Create -> Output -> Long Text.
The system creates the <Group> node with the sub node <Long Text>.
Double-click <Long Text> and enter a description and a long text.

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 For
Filling Pump Check-In
Check in filling pumps prior to setup. Verify product contact S numbers for each manifold per SOP
701.26.
2. Perform Post-Sterilization Vacuum Testing of pumps per SOP 706.17.
Note: If pump test fails, describe action taken in comments section.

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 For Tabular repeated request:
Status Manifold Position Product Contact Sterilization CPR Sterilization Exp Comment Performed by Verified by
Code # Date
(MM/DD/YYYY)

Dropdown Dropdown Dropdown Text Field Date Text field Manufacturing Manufacturin
Primary Front/Rear Set • S-71 7 characters (entered by 30 technician or technician o
(default) (default) • S-72 (entered by technician; Date character higher higher
Backup Front only • S-73 technician; not entered must not
Rear only verified against be prior to current
master data) date.

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 Let us see few validation & function module use in PI sheet:
Validation Function for date:
a) To Review the document stored in DMS:
Create process instruction ZSHOWSOP
Determine the requirement as document type, document, document part as
parameter
Create those parameters in X-Step:

Do the valuation for the same: By click on create button

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 Create Button to trigger DMS for SOP:

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 10. Save
11. Execute Inspection
Select an XStep node in the standard XStep and choose XSteps -> Check from the menu
bar.
Correct any errors that may occur.

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 12. Execute Simulation
Select an XStep node in the standard XStep and choose XSteps -> Simulate from the menu
bar.
The XStep is simulated on the right of the screen. A preview of your PI sheet is displayed.

13. Release Status of the Version

To release your standard XStep for production, you must change the status of the version
from In Process to Released. Select <Version> and choose Change Status -> Release.
See also: Standard XSteps

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Standard X Steps saved in certain name can be referenced in process orders as well as
in master recipe.
For Process Order--

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Then Click on Explode:

Expand all:

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For Master recipe--

9 Business Benefits & Advantages

Advantages:
The PI Sheets can be simulated in the master recipe, in the process order and in the SXS
repository as well. We can see the final layout of our PI Sheet just after pressing the F8
button.
Various generation scopes exist; each of the XStep elements that belong to an XStep tree
can have an own generation scope

Business Benefits for given X steps Features

1) We can define these X Steps in master recipe or in process orders. For this any one
can build this X steps without having basic knowledge for process characteristics
which results into significant time saving.

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 2) Benefits fast-to-build different combinations.
For Example: easy signature procedures and reusability of the different Parameters.
3) We can define templates for process instructions as standard XSteps (SXS) in a SXS
repository. They can be referenced and reused
4) We can drag, drop, Copy & paste the standard X steps. These benefits will be
causing massive cost reduction & time consumption.

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