Dr.

Willmar Schwabe
Group of Companies
System Specification [PP] [Production Execution Process] Code: PP05
(Process) Version: 001
[SAP] Date: 09.02.2015
Page: 1 of 13

Change to Previous Version

Initial Generation

Filing Original:
Distribution List: No Distribution

Approval
Function Name Date Signature Function Name Date Signature
Author Nanhe Babu Mr.Unnikrishnan

Quality Assurance Mr. Sunil

Vishwakarma
Process Owner Mr.Unnikrishnan
System Owner Mr.Sanjay Agrawal
Mr. S. Tyagi

This document contains proprietary material and is released by a company of Dr. Willmar Schwabe Group of Companies on a confidential basis. It may not - even in part - be copied, published or forwarded to third parties - including authorities - without
express permission. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, is authorized to exercise and enforce all rights pertaining to this document.
Dr. Willmar Schwabe
Group of Companies
System Specification [PP] [Production Execution Process] Code: PP05
(Process) Version: 001
[SAP] Date: 09.02.2015
Page: 2 of 13

Table of Contents

1 Process Assessment...............................................................................................................................................................................................3

2 Glossary..................................................................................................................................................................................................................3

3 Process Overview / Graphical Illustration of the Process.......................................................................................................................................3

4 Process Description................................................................................................................................................................................................6

4.1 Triggering Process / Requirements.........................................................................................................................................................................6

4.2 Process Description................................................................................................................................................................................................6

4.3 Subsequent Process.............................................................................................................................................................................................13

This document contains proprietary material and is released by a company of Dr. Willmar Schwabe Group of Companies on a confidential basis. It may not - even in part - be copied, published or forwarded to third parties - including authorities - without
express permission. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, is authorized to exercise and enforce all rights pertaining to this document.
Dr. Willmar Schwabe
Group of Companies
System Specification [PP] [Production Execution Process] Code: PP05
(Process) Version: 001
[SAP] Date: 09.02.2015
Page: 3 of 13

1 Process Assessment

This Process is GxP relevant

non GxP relevant

2 Glossary

3 Process Overview / Graphical Illustration of the Process

This document contains proprietary material and is released by a company of Dr. Willmar Schwabe Group of Companies on a confidential basis. It may not - even in part - be copied, published or forwarded to third parties - including authorities - without
express permission. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, is authorized to exercise and enforce all rights pertaining to this document.
Dr. Willmar Schwabe
Group of Companies
System Specification [PP] [Production Execution Process] Code: PP05
(Process) Version: 001
[SAP] Date: 09.02.2015
Page: 4 of 13

This document contains proprietary material and is released by a company of Dr. Willmar Schwabe Group of Companies on a confidential basis. It may not - even in part - be copied, published or forwarded to third parties - including authorities - without
express permission. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, is authorized to exercise and enforce all rights pertaining to this document.
Dr. Willmar Schwabe
Group of Companies
System Specification [PP] [Production Execution Process] Code: PP05
(Process) Version: 001
[SAP] Date: 09.02.2015
Page: 5 of 13

This document contains proprietary material and is released by a company of Dr. Willmar Schwabe Group of Companies on a confidential basis. It may not - even in part - be copied, published or forwarded to third parties - including authorities - without
express permission. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, is authorized to exercise and enforce all rights pertaining to this document.
Dr. Willmar Schwabe
Group of Companies
System Specification [PP] [Production Execution Process] Code: PP05
(Process) Version: 001
[SAP] Date: 09.02.2015
Page: 6 of 13

4 Process Description
4.1 Triggering Process / Requirements
Production Execution process is triggered from Material Requirements Planning however in some cases manual process order will be created. For finished and
semi-finished products; Process order will be created by converting planned order to process order. In case of reprocessing; Manual process orders will be
created.

4.2 Process Description

Process Description Risk Analysis
No. Process Step Description Room / Responsi- T-Code Reference Possible Failure (F) / D O I RA

RPN

Cat.
bility / Record to SSF Consequence (C)

1. Create Process  Process Orders will be created either from MRP gen- Production in COR1 / F: Wrong data entry / 2 3 2 12 A Very criti-
Order erated Planned Orders or manually for the Semi-fin- charge / Planning in COR7 selection. cal
ished or Finished Product to be Produced. charge C: Not Manufactured as
per production plan.

 Process Orders will be created daily / Weekly /

Monthly for the production quantity.

 Reprocessing Orders will be created manually for ex-

port purpose.

 Reprocessing Order will consume same Finished

Goods (from warehouse) with same batch number
and will produce stock with exact same batch num-
ber and details. User will enter the input / packing
material details with batch number in component
screen of process order manually.Goods Receipt lo-
cation will be entered manually in process order/
This document contains proprietary material and is released by a company of Dr. Willmar Schwabe Group of Companies on a confidential basis. It may not - even in part - be copied, published or forwarded to third parties - including authorities - without
express permission. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, is authorized to exercise and enforce all rights pertaining to this document.
Dr. Willmar Schwabe
Group of Companies
System Specification [PP] [Production Execution Process] Code: PP05
(Process) Version: 001
[SAP] Date: 09.02.2015
Page: 7 of 13

No. Process Step Description Room / Responsi- T-Code Reference Possible Failure (F) / D O I RA

RPN

Cat.
bility / Record to SSF Consequence (C)

component screen while doing process order confir-

mation.

 There are three types of Process Order Types will be

defined.

PI01 : Process Order-Packed Products

PI02 : Process Order-Semi Finished Products
PIR1 : Reprocessing Order

Order Descrip- No Range To

Type tion from
PI01 Process 10000000 19999999
Order-
Packed
Products
PI02 Process 20000000 29999999
Order-
Semi Fin-
ished
Products
PIR1 Repro- 30000000 39999999
cessing
Order
2. Release Process  Process Order will be released basis on user deci- Production in COR1/ F: Wrong Order is re- 2 3 2 12 A Very criti-
Order sion in case of material unavailability. charge / Planning in COR2 leased cal
 Batch numbers of raw materials / BOM items will be charge C: Not as per plan
assigned in process orders based on first in first out
(FIFO) strategy.

This document contains proprietary material and is released by a company of Dr. Willmar Schwabe Group of Companies on a confidential basis. It may not - even in part - be copied, published or forwarded to third parties - including authorities - without
express permission. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, is authorized to exercise and enforce all rights pertaining to this document.
Dr. Willmar Schwabe
Group of Companies
System Specification [PP] [Production Execution Process] Code: PP05
(Process) Version: 001
[SAP] Date: 09.02.2015
Page: 8 of 13

No. Process Step Description Room / Responsi- T-Code Reference Possible Failure (F) / D O I RA

RPN

Cat.
bility / Record to SSF Consequence (C)

 Batch Number will be GxP relevant.

 Batch number will be activated for Raw Material;
Semi finished Goods, Finished Goods and Packing
Material.
 System Generated Batch number will be of 7 digits.

 Batch Number :
Batch Number will be automatically generated at the time
of Process Order Release. Manufacturing date, Expiry
date & MRP will be calculated at the time of Process Or-
der Release and Excise Batch Number will be entered
manually at the time of Label printing and Excise Batch
number will be automatically flown to the batch classifica-
tion.
o Bulk Batch (MT) :
Batch Number will be automatically generated at the time
of Process Order Release. Manufacturing date & Expiry
date & MRP will be automatically captured during
process order. Alcohol % , Excise Batch Number and Ag-
ing completion date will be entered manually after Goods
Receipt is done against Process.

o MT Filling from Bulk batch :

Manufacturing Date, Expiry Date, MT Alco-
hol %, and Excise Batch Number will be
fetched automatically from the consumed
Batch of MT Bulk. MRP will be automatically
This document contains proprietary material and is released by a company of Dr. Willmar Schwabe Group of Companies on a confidential basis. It may not - even in part - be copied, published or forwarded to third parties - including authorities - without
express permission. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, is authorized to exercise and enforce all rights pertaining to this document.
Dr. Willmar Schwabe
Group of Companies
System Specification [PP] [Production Execution Process] Code: PP05
(Process) Version: 001
[SAP] Date: 09.02.2015
Page: 9 of 13

No. Process Step Description Room / Responsi- T-Code Reference Possible Failure (F) / D O I RA

RPN

Cat.
bility / Record to SSF Consequence (C)

fetched from Material master classification

data.

o Reprocessing batch :
Reprocessing is done for the product for Ex-
port Products. In this case Original Batch
number and other batch classification de-
tails remain same. In label printing of repro-
cessed products additional text is printed.

In this case Batch Number and other Batch

classification details will be entered /se-
lected manually during release of process.

3. Print Process Or- Specialties , Tables , Bulk MT, Semi finished & Production in COR2/ ZSSF_PP01 F: Wrong Order is 1 1 1 1 C Not Criti-
der Sorted Herbs : charge / Planning in COPI/ printed. cal
Process Order and pick list will be printed after release. charge ZPP01 C: Not as per plan
Printout layout details are mentioned in the SSF template
Cumulative Process Order Print : Dilution , MT Filling COR2/ ZSSF_PP02
and LM : COPI/
Cumulative Process Order List will be printed after re- ZPP02
lease.
Printout layout details are mentioned in the SSF template
5. Print Pick List Cumulative Process Order Print : Dilution , MT Filling Production in COR2/ ZSSF_PP03 F: Wrong Order is 1 1 1 1 C Not Criti-
and LM : charge / Planning in COPI/ printed. cal
 Pick list will be printed after process order release charge ZPP03 C: Not as per plan
 Cumulative process order will be printed for calculat-
ing Total Alcohol qty required for the day.
 Printout layout details are mentioned in the SSF tem-
plate.
This document contains proprietary material and is released by a company of Dr. Willmar Schwabe Group of Companies on a confidential basis. It may not - even in part - be copied, published or forwarded to third parties - including authorities - without
express permission. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, is authorized to exercise and enforce all rights pertaining to this document.
Dr. Willmar Schwabe
Group of Companies
System Specification [PP] [Production Execution Process] Code: PP05
(Process) Version: 001
[SAP] Date: 09.02.2015
Page: 10 of 13

No. Process Step Description Room / Responsi- T-Code Reference Possible Failure (F) / D O I RA

RPN

Cat.
bility / Record to SSF Consequence (C)

 Users’ fills the requisition slip on paper and hand

over it to the Excise Dept. Excise dept then allow
transferring lot qty with Excise batch number for
whole of the lot qty.

6. Print Master Master sticker label will be printed for Liquid products. Production in ZPP04 ZSSF_PP04 F: Wrong Master label 1 1 1 1 C Not Criti-
Sticker Label. charge / Planning in is printed. cal
charge C: Not as per plan
7. Create Stock Stock transfer reservation will be created for transferring Production in MF60 F: Wrong Master label 1 1 1 1 C Not Criti-
Transfer Reserva- BOM items from Store to production location charge is printed. cal
tion C: Not as per plan
8. Post Stock trans- BOM items will be transferred to production location w.r.t Store in charge MB1B/ F: Wrong batch trans- 2 1 2 4 C not critical
fer from Store to transfer reservation LT03/ ferred
production loca- MF65 C: FIFO not followed.
tion.
9. Post Goods Issue Goods can be issued manually with reference to process
(Manually)-Op- order however this step is option since goods (BOM
tional items) will be consumed (backflushed) during process or-
der confirmation. This process can be used in two sce-
narios i) Extra Material Issue ii) Issue of Non Backflush
items.

i) Extra Material Issue against Process order :

 For issuing extra material against process order, Production supervi- COR2 F: Wrong batch se- 3 3 3 27 A Very criti-
user will first add extra quantity of an item in process sor / in charge lected. cal
C: FIFO not followed.
order component screen.
 Extra Item added will then be transferred to Produc- Production supervi- MF60/ F: Wrong batch trans- 3 3 3 27 A Very criti-
tion location from store. sor / in charge LT03 ferred cal
This document contains proprietary material and is released by a company of Dr. Willmar Schwabe Group of Companies on a confidential basis. It may not - even in part - be copied, published or forwarded to third parties - including authorities - without
express permission. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, is authorized to exercise and enforce all rights pertaining to this document.
Dr. Willmar Schwabe
Group of Companies
System Specification [PP] [Production Execution Process] Code: PP05
(Process) Version: 001
[SAP] Date: 09.02.2015
Page: 11 of 13

No. Process Step Description Room / Responsi- T-Code Reference Possible Failure (F) / D O I RA

RPN

Cat.
bility / Record to SSF Consequence (C)

C: FIFO not followed.

 Once stock is available in production location, user Production supervi- MB1A/ F: Wrong batch con- 3 3 3 27 A Very criti-
can either post Goods Issue against process order sor / in charge COR6N sumed. cal
C: FIFO not followed.
manually or can be backflushed during process order
confirmation.
ii) Manual Goods / Non Backflush Material Is-
sue against Process order
 Material once transferred from Store to production lo- Production supervi- MB1A F: Wrong batch con- 3 3 3 27 A Very criti-
cation can be consumed manually against process sor / in charge sumed. cal
C: FIFO not followed.
order. These are the materials which are not marked
as Backflush indicator in material master hence need
to be consumed manually.
16. In process Quality Will be mapped in QA32
Inspection by QA QM
17. Print Label Sticker Label Stickers will be printed for Finished Goods packing Production supervi- ZPP05 ZSSF_05 F: Wrong label are 1 1 1 1 C Not Criti-
in bottles. Specifications of Printing labels are mentioned sor / in charge printed. cal
in SSF template. Printing of Unit carton will continue as C: Not as per plan
per existing method outside SAP. If unit carton printing is
required form SAP, new printing equipment has to be
procured.
18. Process Order Process order will be confirmed at each milestone opera- Production supervi- COR6N F: Wrong batch con- 3 3 3 27 A Very criti-
Confirmation tion. During process order confirmation; System post sor / in charge sumed, Wrong data cal
goods consumption automatically for the BOM items de- entry.
fined as “Backflush”and Operation times/ data is cap- C: FIFO not followed,
tured. If confirmation is done at last operation, system will not produced as per
post goods receipt automatically. plan.

This document contains proprietary material and is released by a company of Dr. Willmar Schwabe Group of Companies on a confidential basis. It may not - even in part - be copied, published or forwarded to third parties - including authorities - without
express permission. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, is authorized to exercise and enforce all rights pertaining to this document.
Dr. Willmar Schwabe
Group of Companies
System Specification [PP] [Production Execution Process] Code: PP05
(Process) Version: 001
[SAP] Date: 09.02.2015
Page: 12 of 13

No. Process Step Description Room / Responsi- T-Code Reference Possible Failure (F) / D O I RA

RPN

Cat.
bility / Record to SSF Consequence (C)

Backflusing: During Process Order Confirmation, Batch

Managed materials are consumed based on consumption
strategy (First in first out) however user can alter the re-
quired batch number in Goods Movement tab of confir-
mation screen.

Goods Receipt: During Process Order Confirmation at

last phase, system automatically posts the Goods receipt
of the product for the Quantity entered as yield.

Activity: During Process Order Confirmation at each

phase, Activity actual time can be entered by user how-
ever system calculates these times based on the yield
quantity produced.
Activity actual time and BOM items consumed accumu-
late the total actual cost of the process order.

19. Print Manufactur- Manufacturing record will be printed for Dilution , LM , Production supervi- ZPP06 ZSSF_PP06 F: 0 0 0 0 - Not GxP
ing Record and MT filling sor / in charge C: Relevant
Printout layout details are mentioned in the SSF template
20. QA after Goods Quality Inspection lot is created if GR after production is Will be mapped in QA32
receipt activated for the product and stock is moved to Quality QM
stock after final process order confirmation. This process
is applicable for Finished Product only.
21. Generate Transfer For finished Goods, transfer request will be generated in Production supervi- ZPP07 ZSSF_PP07 F: Wrong Transfer Re- 1 1 1 1 C Not Criti-
request system for transferring stock from production location to sor / in charge quest created cal
Finished goods warehouse location. C: Not as per plan
Details of Transaction are given in SSF template.
22. Print Transfer Re- Stock Transfer request will be printed and will be handed Production supervi- ZPP08 ZSSF_PP08 F: Wrong Stock Trans- 1 1 1 1 C Not Criti-
quest over to store person for acknowledging the receipt of sor / in charge fer Request printed. cal
This document contains proprietary material and is released by a company of Dr. Willmar Schwabe Group of Companies on a confidential basis. It may not - even in part - be copied, published or forwarded to third parties - including authorities - without
express permission. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, is authorized to exercise and enforce all rights pertaining to this document.
Dr. Willmar Schwabe
Group of Companies
System Specification [PP] [Production Execution Process] Code: PP05
(Process) Version: 001
[SAP] Date: 09.02.2015
Page: 13 of 13

No. Process Step Description Room / Responsi- T-Code Reference Possible Failure (F) / D O I RA

RPN

Cat.
bility / Record to SSF Consequence (C)

stock in warehouse. C: Not as per plan

23. Print Excise Slip Excise slip(Bonded / Non bonded) is also printed for Production supervi- ZPP09 ZSSF_PP09 F: Wrong Excise slip is 1 1 1 1 C Not Criti-
transferring Finished goods stock from production loca- sor / in charge printed. cal
tion to warehouse location. C: Not as per plan
Details of Print layout are mentioned in SSF Template.
24. Receive Stock in Warehouse Store person will post the stock transfer re- FG Store in charge MB1B F: Wrong Transfer re- 1 1 1 1 C Not Criti-
Finished Goods quest in SAP to update the stock in finished Goods ware- quest is posted cal
warehouse. house. C: Not as per plan
25. Order Technically Process Orders will be marked as Technically closed Planning in charge COR2/ F: 0 0 0 0 - Not Gx-
Closing (TECO) after final confirmation. CO- C: PRele-
HVPI vant
26. Order Settlement Process Orders will be settled after Technically closing to CO person KO88/ F: 0 0 0 0 - Not Gx-
settle the accumulated cost to inventory account. After Co88 C: PRele-
Settlement balance order becomes Zero. vant
27. Order Closing After settlement, Process Orders are marked as CLOSED Planning in charge COR2/ F: 0 0 0 0 - Not Gx-
(CLSD) to complete the full production cycle. CO- C: PRele-
HVPI vant
28. Production Report Thus report will be used to see the total produced qty. in Planning in charge ZPP11 ZSSF_PP12 F: 0 0 0 0 - Not Gx-
KG/L and in sales unit(No.) C: PRele-
vant
29. Plant Capacity This report is used to check the available and used ca- Planning in charge ZPP12 ZSSF_PP12 F: 0 0 0 0 - Not Gx-
Utilization pacity in KG. C: PRele-
vant

4.3 Subsequent Process

Quality Inspection, usage for in-house production and for sales.

This document contains proprietary material and is released by a company of Dr. Willmar Schwabe Group of Companies on a confidential basis. It may not - even in part - be copied, published or forwarded to third parties - including authorities - without
express permission. Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, is authorized to exercise and enforce all rights pertaining to this document.