Professional Documents
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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#
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/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-
A Bipin Shrivastav
(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#
<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 $arly Issue of (rder )um*er#
5pplication-independent Standard XSteps- 7e define standard "Steps as master data in the standard "Step repositor$ (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#
D Bipin Shrivastav
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
F Bipin Shrivastav
Case Study:
Instruction
*ata Input
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
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
(ext 7ield # characters -entered by technician9 not verified against master data0
G Bipin Shrivastav
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
2. Create folder Select the S$a,3ar3 &S$e's folder and choose Crea$e -: Fo43er/ (he system creates the <Fo43er5 node. 5nter a description for the folder.
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3.
Select the <Fo43er: and choose Crea$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
12 Bipin Shrivastav
Create XStep
Select <XStep (ree: and choose Crea$e -: &S$e'/ (he system creates a <Ne7 &S$e': node. See also: XStep
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!.
.ouble-click <Ne7 &S$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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% Pre -re&uisite : Control #ecipe $estination need to 'e created in configuring through transaction code : SP#()
1A Bipin Shrivastav
*. $efine XStep Parameter .efine* if re/uired* XStep parameters for the contents of all XSteps* +hich have values that you +ant to reuse. .ouble-click <Ne7 &S$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.
1B Bipin Shrivastav
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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
1D Bipin Shrivastav
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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.
1F Bipin Shrivastav
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.
%.
1G Bipin Shrivastav
(ext 7ield # characters -entered by technician9 not verified against master data0
.ate -entered by technician9 .ate entered must not be prior to current date.
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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:
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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.
2A Bipin Shrivastav
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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'$pand all=
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5dvantages= The PI Sheets can be simulated in the master recipe& in the process order and in the S"S repositor$ 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