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

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PURPOSE BACKGROUND BUSINESS PROCESSES HANDLED GENERAL INFORMATION -Process Messa e GENERAL INFORMATION " PI S#ee$ GENERAL INFORMATION "& S$e's (E)ec*$+o, S$e'sAPPLICATION-INDIPENDENT STANDARD & STEPS FOR STD/PROCESS MESSAGE &-STEP PROCESS INSTRUCTIONS FOR PI SHEETS BUSINESS BENIFITS

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2 Bipin Shrivastav

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 S!P " Steps integration# PI sheets are mainl$ used for Process industries like Pharmaceutical%s& 'ood& chemicals etc# PI Sheets can be used b$ (ontinuous process manufacturing industries like Paper& (ements& and pol$mers& also can be used b$ batch processing industries like Pharmaceuticals& )istilleries# The process flo* is as belo*+

ac!ground

H und bec!" #la$o" %ubilant ife Science is ma,or Pharmaceutical companies presentl$ using " Steps to build their PI Sheets & !pproval procedures# -ere *e are dealing *ith some Standard PI sheet messaging processes using " Steps and one e.ample for the enhanced PI Sheet using " Step#

"

usiness Process #andled

/ormall$ *e dealt *ith business processes like 0oods receipts& Signature process for approvals *ith 1ualit$ processes# 2ne enhancement for the decision making blocks# Standard process messages categories &'$ample( PI3BT3(455 Batch (reation PI3(2/S55 6aterial (onsumption 6essage PI3(4ST55 6essage on (ontrol 4ecipe Status 3 Bipin Shrivastav

PI3P-(2/55 Time Ticket (onfirmation for Phase PI3P-ST55 6essage on Phase Status PI3P42)55 6aterial 4eceipt 6essage PI316S64556essage on Insp#(haract# (Summ# 6easured SI0/55 6essage containing signature 7e have created some commands for an enhancement# P42(3I/ST4#!(T8!T9 P42(3I/ST4#)9!(T8!T9

) $eneral Infor%ation &Process 'essages( 7hen a process order is carried out: actual process data is needed that documents the process and is available for further processing in other S!P application components and e.ternal function modules such as process control s$stems# 7e can use this component to send actual data from process control to predefined message destinations# *efinitions (ommunication structure that is used to transfer actual process data from process control to one or several destinations of the follo*ing t$pes+ ; 2ther S!P application components ; <ser5defined !B!P tables ; <sers of the S!P office mail s$stem+ ; 9.ternal function modules +se )epending on the destination to *hich the process message is sent& *e can use the Process message business ob,ect for the follo*ing+ ; Triggering business transactions in the S!P S$stem (for e.ample& goods issue posting ; )ocumenting actual data from process control and evaluating this data using internal or e.ternal functions ; Sending mails to certain emplo$ees and informing them about the process status ; Sending actual data from process control to an e.ternal s$stem and triggering s$stem reactions (such as opening a valve & if re=uired# Structure ! process message consists of a message header and several message characteristics as *ell as the characteristic values assigned to these characteristics 1> -eader5The header of a process message contains general message data such as+ ; !dministrative data on the message ; The plant in *hich the message *as created ; The message categor$ to *hich the message belongs

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!n indicator that specifies *hether the message *as created for test purposes or *hether it should actuall$ be sent# 2> (haracteristics57hich process data is to be contained in messages of a particular categor$ is defined b$ assigning characteristics# Process message characteristics are defined and assigned to the message categories in (ustomi@ing# 3> (haracteristics 8alues5In the process message& a characteristic value can be assigned to each characteristic contained in the message categor$# The value e.presses the process5specific data for the characteristics# The format of a characteristic value as *ell as the value range to *hich it must belong is defined in the characteristic in (ustomi@ing# )epending on the format& the value of a message characteristic can be a date& a time& a numeric or alphanumeric ke$& a short te.t or a long te.t# In above section some standard process message categories have been mentioned *hich are readil$ available *ith standard S!P s$stem# ) $eneral Infor%ation &PI Sheet( 7e can use PI sheets to e.change data bet*een the partiall$ or completel$ manuall$ operated production level and the S!P s$stem (PP5PI # In manuall$ operated production lines& this usuall$ involves a process operator *ho uses the PI sheet to transfer production5relevant actual data to the S!P s$stem and receives data from the S!P S$stem# 7e can describe the entire production process of a product or onl$ part of it in a PI sheet# !part from control information& the PI sheet can contain input fields and pushbuttons# 7e can& for e.ample& define fields into *hich $ou *ant the process operator to enter the =uantit$ of material components consumed for a phase# The material *ithdra*als must then be posted as goods issues in inventor$ management# 7e can use process messages to automaticall$ carr$ out this function# The PI sheet represents the result of a control recipe that *as sent to a process operator and *hose content is displa$ed as te.t on the screen# This means the PI sheet is an instruction for the process operator that describes ho* and in *hich order a product is manufactured# The PI sheet can& for e.ample& contain information about the picking of ra* materials as *ell as instructions about charging the mi.er& filling silos& and so on# '$ample-

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Instructions for 2perator

(alculations

)igital Signature

; ;

#eneral Information &+,ecution Steps X-Steps( Process Instructions In the process instructions *e can define processing steps& *hich+ ! process operator to e.ecute manuall$ at a production line ! process control s$stem to e.ecute automaticall$ 7e can define the process instructions in the master recipe and in the process order# 7e have the follo*ing options+ ,- .haracteristic-Based Process Instructions In the process instruction overvie*& *e define characteristic5based process instructions# That is& *e define the process instructions using characteristics and their characteristic values# In doing so& *e create process instructions for a phase# /- XStep Process Instructions 'irst *e need to define "Steps in the "Steps editor# Then *e define "Steps process instructions in the "Steps# !lthough "Steps process instructions are also based on characteristics& *e can create them *ithout kno*ledge of the characteristic structure using the conte.t menu# 7hen doing this *e create "Steps independent of the phases# 7e assign the "Steps to a phase b$ assigning a conte.t#

X Steps &'$ecution Steps(

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<sing "Steps *e can describe the precise e.ecution of production processes and can group and structure this information in the form of modules# "Steps can be structured in hierarchical form# These form "Step trees# Prere0uisites 1aintenance of XSteps in the 1aster 2ecipe-- To ensure that *e can maintain "Steps in the master recipe& *e must create a recipe profile *hen creating the recipe group# The ne* recipe profile PI01_XS: Profile for Process Industry XSteps is available in the standard deliver$ to assist *e *hen maintaining "Steps# To do this& access (ustomi@ing for the Master Recipe and choose Settings for the Task ist Type 5C !efine Profiles "ith !efault #alues# 'arly Issue of 3rder 4umber-- !s default& it is onl$ possible to generate an "Step tree in a process order once the order in =uestion has been saved# 7e can also set that an "Step tree is generated& even if it has not $et been saved# To do this& access (ustomi@ing for process management and choose $%ecution Steps &XSteps' 5C Set $arly Issue of (rder )um*er#

.pplication-independent Standard XSteps for Std.Process 'assages

5pplication-independent Standard XSteps- 7e define standard "Steps as master data in the standard "Step repositor$ (S"S repositor$ # <sing the references to standard "Steps (S"S reference & 79 can considerabl$ reduce the time re=uired to maintain the data# If& for e.ample& there are changes to the standard processes& 79 do not have to make these changes in each individual master recipe# Instead& 79 make the changes centrall$ in the S"S repositor$# !ll master recipes& *hich contain references to these standard "Steps& are changed automaticall$# Structure of a Standard XStep ! standard "Step can consist of several versions# 9ver$ version contains an "Step tree# 7e can create "Steps *ithin the "Step tree& *hich describe the precise contents of the standard "Steps#

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5dvantage 7e can drag & drop& cop$ and paste out "Steps E Templates for process instructions as standard "Steps (S"S in a S"S repositor$# The$ can be referenced and reused E The PI Sheets can be simulated in the master recipe& in the process order and in the S"S repositor$# 7e%ll see the final la$out of our PI Sheet ,ust after pressing the 'F button# E 8arious generation scopes e.ist: each of the "Step elements that belong to an "Step tree can have an o*n generation scope# 6ersioning-Several versions *ith different validit$ periods can be created for a standard "Step# If *e e.plode an S"S reference either in the S"S repositor$ or in an application& the s$stem searches for the S"S version that is valid and released for the ke$ date and creates a cop$ of it# 7e can select the description of the version *e re=uire# The version descriptions are onl$ uni=ue *ithin the standard "Step#

6ersioning

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Procedure for .reating SXS 7older-+se .1XS6 Tcode

Creating a Standard XStep for a PI Sheet

The follo*ing e.ample describes& ho* $ou can create a standard "Step for a PI sheet# It is important to note the follo*ing points *hen navigating in the standard "Step repositor$+
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

*ata Input

Signatu .omments re &894(

3peration ::,: Phase ::,, ; Sterile Storage '0uipment .hec!-In

Filling Pump Check-In Check in filling pumps prior to setup. erify product contact S numbers for each manifold per S!" #$1.%&. "erform "ost-Sterili'ation acuum (esting of pumps per S!" #$&.1#. Note: )f pump test fails* describe action taken in comments section. See (able belo+ S!" ,utton for #$1.%& S!" ,utton for #$&.1# % manufacturing technician signatures for check in. -.o not re/uire concurrent signatures0 1 technician signature for pump testing.

1llo+ for data entry in all check-in steps in any order since e/uipment becomes available at different times. )f expiration date has already occurred* indicate date is expired and do not allo+ field to be entered.

1.

Status

2anifold "osition

"roduct Contact Code

Sterili'ation C"3 4

Sterili'ation 5xp .ate -226..6YYYY0 .ate -entered by technician9 .ate entered must not be prior to current date.

Comment

"erformed by

.ropdo+n "rimary -default0 ,ackup

.ropdo+n 7ront63ear Set -default0 7ront only 3ear only

.ropdo+n S-#1 S-#% S-#8

(ext 7ield # characters -entered by technician9 not verified against master data0

(ext field 8$ character

2anufacturing technician or high

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Procedure
...

1. 7rom the SAP Eas2 Access Me,** choose Pro3*c$+o, " Process -: Mas$er Da$a -: S$a,3ar3 &S$e' Re'os+$or2. -(-Code : C2XS 0

5nter "lant ; execute

2. Create folder Select the S$a,3ar3 &S$e's folder and choose Crea$e -: Fo43er/ (he system creates the <Fo43er5 node. 5nter a description for the folder.

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"rovide the name to folder:

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3.

Create Standard XStep <&S$e'

Select the <Fo43er: and choose Crea$e -: S$a,3ar3 &S$e'/ (he system creates the <S$a,3ar3 &S$e': node +ith the <6ers+o,: and Tree: subnodes. (he status of the version is currently I, Process/ a. 5nter a description for the standard XStep. b. 5nter a description for the version and a validity period. See also: Standard XSteps

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5xpand the arro+ of displaying arro+:

Create XStep

Select <XStep (ree: and choose Crea$e -: &S$e'/ (he system creates a <Ne7 &S$e': node. See also: XStep

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!.

"ssign Control #ecipe $estination

.ouble-click <Ne7 &S$e': and enter the destination type PI s#ee$ or a precise destination that has type PI s#ee$ in the Des$+,a$+o,s dialog box.

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1ssign Control 3ecipe .estination

% Pre -re&uisite : Control #ecipe $estination need to 'e created in configuring through transaction code : SP#()

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*. $efine XStep Parameter .efine* if re/uired* XStep parameters for the contents of all XSteps* +hich have values that you +ant to reuse. .ouble-click <Ne7 &S$e': and create the parameters and their valuations in the Para8e$ers a,3 6a4*a$+o,s dialog box. See also : XStep "arameter and SXS 3eference and "arameteri'ation.

-"re-re/uisite: )f re/uired create characteristics to hold re/uired values: (-Code: !%#C

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+.

"ssign Scope of ,eneration <=e+ XStep: and

1ssign a scope of generation to the XStep if re/uired. .ouble-click enter a scope of generation in the scope of generation dialog box. See also: XStep >eneration -. Create Process Instructions

Select <Ne7 &S$e': and choose Crea$e -: Process I,s$r*c$+o,/ (he system creates a <Ne7 Process I,s$r*c$+o,: node. 5nter a description for the process instruction. See also: XStep "rocess )nstructions for ") Sheets

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..

Create (utput of a /ong 0e1t

Select <Ne7 Process I,s$r*c$+o,: and choose Crea$e -: O*$'*$ -: Lo, Te)$/ (he system creates the <Gro*': node +ith the sub node <Lo, Te)$:. .ouble-click <Lo, Te)$: and enter a description and a long text.

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7or Filling Pump Check-In Check in filling pumps prior to setup. erify product contact S numbers for each manifold per S!" #$1.%&. "erform "ost-Sterili'ation acuum (esting of pumps per S!" #$&.1#. Note: )f pump test fails* describe action taken in comments section.

%.

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7or (abular repeated re/uest:

Status 2anifold "osition "roduct Contact Code Sterili'ation C"3 4 Sterili'ation 5xp .ate -226..6YYYY0 Comment "erformed by erified by

.ropdo+n "rimary -default0 ,ackup

.ropdo+n 7ront63ear Set -default0 7ront only 3ear only

.ropdo+n S-#1 S-#% S-#8

(ext 7ield # characters -entered by technician9 not verified against master data0

.ate -entered by technician9 .ate entered must not be prior to current date.

(ext field 8$ character

2anufacturing technician or higher

2anufacturin technician o higher

2H Bipin Shrivastav

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?et us see fe+ validation ; function module use in ") sheet: alidation 7unction for date: a0 (o 3evie+ the document stored in .2S: Create process instruction @SA!BS!" .etermine the re/uirement as document type* document* document part as parameter Create those parameters in X-Step:

.o the valuation for the same: ,y click on create button

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Create ,utton to trigger .2S for S!":

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1$. Save 22. 31ecute Inspection Select an XStep node in the standard XStep and choose &S$e's -: C#ec9 from the menu bar. Correct any errors that may occur.

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22. 31ecute Simulation Select an XStep node in the standard XStep and choose &S$e's -: S+8*4a$e from the menu bar. (he XStep is simulated on the right of the screen. 1 previe+ of your ") sheet is displayed.

23. #elease Status of the 4ersion (o release your standard XStep for production* you must change the status of the version from I, Process to Re4ease3. Select <6ers+o,: and choose C#a, e S$a$*s -: Re4ease/ See also: Standard XSteps

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Standard X Steps saved in certain name can be referenced in process orders as <ell as in master recipe7or Process 3rder--

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Then .lic! on '$plode=

'$pand all=

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7or 1aster recipe--

usiness enefits & .d0antages

5dvantages= The PI Sheets can be simulated in the master recipe& in the process order and in the S"S repositor$ as *ell# 7e can see the final la$out of our PI Sheet ,ust after pressing the 'F button# 8arious generation scopes e.ist: each of the "Step elements that belong to an "Step tree can have an o*n generation scope Business Benefits for given X steps 7eatures 1 7e can define these " Steps in master recipe or in process orders# 'or this an$ one can build this " steps *ithout having basic kno*ledge for process characteristics *hich results into significant time saving# 31 Bipin Shrivastav

Benefits fast5to5build different combinations# 'or 9.ample+ eas$ signature procedures and reusabilit$ of the different Parameters# 3 7e can define templates for process instructions as standard "Steps (S"S in a S"S repositor$# The$ can be referenced and reused ? 7e can drag& drop& (op$ & paste the standard " steps# These benefits *ill be causing massive cost reduction & time consumption#

32 Bipin Shrivastav