SAP-ECM and PPPI Integration-Solution

SAP R/3 4.6C / 4.7 / ECC 5 0 / ECC 6 0ECC 5.0 / ECC 6.0

E i i Ch M &Engineering Change Management & Process Order Integration

Solution

Index

Synopsis11

Risk22 Risk22

Business Requirement 33

SAP Standard (As-Is) Functionality44

IT Sapiens’ Solution55

Solution Merits66

O r Val e Proposition77

2 ©2007 IT Sapiens, Inc.Proprietary and Confidential

Additonal Info88

Our Value Proposition77

Synopsis11

• FDA and cGMP requirements, mandate the use of – "Only Releasedstandards, features, materials and products" – in the manufacturing process

• Material BOMs and Master Recipes are usually changed using Engineering ChanqeMaterial BOMs and Master Recipes are usually changed using Engineering Chanqe Management (ECM) – Change Masters or Change Requests

• During Process/Production Order Creation for manufacturing, the system based on configuration settings is capable of automatically selecting thebased on configuration settings, is capable of automatically selecting the Material List/BOM/Recipe as master data into the Process/Production Order. However:

• If the Material List/BOM/Recipe is undergoing an engineering change that is relevant for the horizon in which the process/production order is to beis relevant for the horizon in which the process/production order is to be executed:

• The system adopts the BOMs/Recipes "as-is" and :• does not prevent the unreleased, unapproved, work in process

changes from being adopted into the Process Order This functionalitychanges from being adopted into the Process Order. This functionality does not exist in Standard SAP and is a GAP


Risk22

• A potential major change – such as component discontinuity, component Qty. change, BOM deletion, etc – to the Product BOM, would be adopted into the Process Order Execution process, even though the change has not been Released for Manufacturing, thus resulting in process order being created with “NOT approved”Manufacturing, thus resulting in process order being created with NOT approvedstandards.


Business Requirement33

• During Process Order Creation for manufacturing, the system based on configuration settings, should :

• Should automatically select ONLY “Valid, Approved and Released”Material List/BOM/Recipe as master data into the Process Order.Material List/BOM/Recipe as master data into the Process Order.

• If the Master Data (e.g. BOM) relevant for Process Order is undergoing an engineering change, the system:

• MUST check if the subject “in process” change has an effectivity dateless than the Finish date of the Process Orderless than the Finish date of the Process Order

• If the effectivity date of the Master Data change is less than the Finishdate of the Process Order, then the system:

• MUST check if the change for the object has been completed and releasede eased

• If the change for the object has NOT been released, then the system MUST issue an error message “Material BOM/List # <BOM #> for Object <Material #>/<Plant #>/<Usage> is being changed with EC# <Change Master#>” and the system MUST prevent the g g y pProcess Order from being created


SAP Standard (As-Is) functionality – ECM-Process Order IntegrationMaterial BOM – Showing Header and Item 0030 – Before Change44


SAP Standard (As-Is) functionality – ECM-Process Order IntegrationProcess Order Creation – Showing Item 0030 – Before Change44

• BOM Item 0030 has qty : 15 PC b t f 1000 PCPC per base qty of 1000 PC

• Process Order Item 0030 has qty : 30 PC for an order qty of 2000 PC


SAP Standard (As-Is) functionality – ECM-Process Order IntegrationEngineering Change Order – Header Status – Before Execution of Change-

44


SAP Standard (As-Is) functionality – ECM-Process Order IntegrationEngineering Change Order – Showing Change Objects44


SAP Standard (As-Is) functionality – ECM-Process Order IntegrationEngineering Change Order – Showing BOM Change “To Be Processed”44


SAP Standard (As-Is) functionality – ECM-Process Order IntegrationMaterial BOM – Being Changed via Master Recipe using Change Order44






SAP Standard (As-Is) functionality – ECM-Process Order IntegrationMaterial BOM – Item 0030 Qty Changed using Change Order44

• BOM Item 0030 qty being changed from 15 PC per base qty of 1000 PC to 30PC per base qty of 1000 PC

• BOM Item 0030 changed• BOM Item 0030 changed from 15 PC per base qty of 1000 PC to 30 PC per base qty of 1000 PC


SAP Standard (As-Is) functionality – ECM-Process Order IntegrationEngineering Change Order – Showing BOM Change “In Process”44

• BOM Item 0030 qty has been changed, BUTh h NOT b d d


change has NOT been approved and released as yet, hence status of change order shows “Object in Preparation”

SAP Standard (As-Is) functionality – ECM-Process Order IntegrationProcess Order creation when Change is “ Object in Preparation(In Process)”44

C O S O ( )• Though Change Order is Status “Object in Preparation” (I.e. In Process), and though the change has not been Released as yet, note that the Process Order Item qty. adopted from BOM/Master Recipe is now showing 60 PC per Order Qty of 2000PC, as opposed to 30 PC per Order Qty of 2000PC prior to the change

b i d ( h i lid 8)


ever being made (as shown in slide 8).• Un-Released changes to BOM has been adopted into the Process Order, and

Standard SAP functionality allows for Process Order to be saved.

SAP Standard (As-Is) functionality – ECM-Process Order IntegrationProcess Order “Saved” when Change Order Status is “ Object in Preparation”

44

O• Un-Released changes to BOM has been adopted into the Process Order, and Standard SAP functionality allows for Process Order to be saved.


IT Sapiens’ Solution for ECM-Process Order Integration55

• During Process Order Creation for manufacturing:• For Master Data adopted into the Process Order, the system automatically

checks :• the latest “Change Order” for the Master Data Object (e.g. Matl.BOM)the latest Change Order for the Master Data Object (e.g. Matl.BOM)• the validity date of the “Change Order” found• if the Validity Date of the Change Order is less than Finish Date of

Process Order, then:• Status of Change Order is checkedStatus of Change Order is checked

• Error Message “Material BOM/List # <BOM #> for Object <Material #>/<Plant #>/<Usage> is being changed with EC#<Change Master#>” is raised if:

- Change Order Status is “ECO to be Processed”C a ge O de Status s CO to be ocessed- Change Order Status is “ECO Object in Preparation- Change Order Status is “ECO Processed” but NOT “ECO Released)

• If the Error Message is raised then the system prevents the• If the Error Message is raised, then the system prevents theProcess Order from being saved until the subjectChange Order has status “ECO Released”


IT Sapiens’ Solution for ECM-Process Order IntegrationProcess Order CANNOT be Saved when Change Order Status is “Object in Preparation”

55

• Un-Released changes to BOM has been adopted into the Process Order,

Error Message !!!


g p ,but, IT Sapiens’ solution prevents Process Order from being Saved when Change Order Status is “Object in Preparation”

IT Sapiens’ Solution – Merits66

• “Real Time Prevention” of the adoption of Invalid, Unapproved and NOT Released Master Data into the Process Order

• Ensures that FDA and cGMP Compliant Process Manufacturing requirements areEnsures that FDA and cGMP Compliant Process Manufacturing requirements are seamlessly adhered to at all times

• Ensures that only authorized changes can be made to Manufacturing Execution related Master DataMaster Data

• Configurable triggering of checks based on Plant and Process Order Type

• Configurable triggering of checks based on Process Order StatusConfigurable triggering of checks based on Process Order Status• e.g. Check can be performed during “Order Release” instead of “Order Creation”


Our Value Proposition – Our Differentiators !!!77

• Lowest TCO with highest quality thru’

• Cross Functional Expertise Rich Resources

• Experienced in Implementing cGMP compliant SAP Solutions for Regulated Environments

• Pre-configured Solutions and Knowledge Base to alleviate GAPs in SAPPre configured Solutions and Knowledge Base to alleviate GAPs in SAP Functionality

• HIGHEST First Pass Yield

• We Succeed where most Don’t


For Additional Info88

Kindly Contact Vijay PisipatyDirector-ERP Solutions & ConsultingIT Sapiens, Inc.e-mail: [email protected]


Technology

SAP-ECM and PPPI Integration-Solution