Project Management in the Pharma Industry Based on PM SBT A6V10084371 Hq En
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Transcript of Project Management in the Pharma Industry Based on PM SBT A6V10084371 Hq En
Project Managementin the Pharma Industry based on PM@SBT
Building Technologies s
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Project Management in the Pharma Industry based on PM@SBT
The pharmaceutical industry is one of the most regulated industries in the world. The main purpose of this regula-tion is to protect the public health. There are special procedures (GMP or GxP) for all processes, which could have an impact on the drug quality. Often the building infrastructure also has an impact on the drug quality, e.g. the air treated in a HVAC system, the flow of people controlled with an access control system or through an environmental monitoring system, which provides the information if a drug can be released or not. The plants in the pharmaceutical industry usually are running 7/24. So each shut down e.g. from a HVAC system not only causes a business harm worth up to millions, it can also result in a down time of a week or more. Due to these reasons the pharmaceutical indus-try requires a special way of project exe-cution and operation of the sites.
Siemens has established an excellent project management procedure with PM@Siemens and the application PM@SBT. This document provides you with an overview, how to apply PM@SBT for Pharma projects, where the special issues are and where should be taken care during the execution of projects
Successful project management relies on adherence to certain basic principles. Clearly defined project workflows (“phase model” and “milestones”) as well as the specification of clear and unam-biguous responsibilities for the various project phases and tasks (“roles”) of the project together with comprehensible targets for all of those involved are the key factors for success. Project management thus involves lea-dership tasks, organization, techniques and means for performing the project flow in such a way that the cost, dead-line and functionality targets can all be met satisfactorily.
These PM guidelines aim to define and implement a consistent, high standard of project management and qualification in all sections (national and regional companies). This process is supported significantly with the electronic validation tool EVT, provided from the Center of Competence Pharma. It applies equally to large and complex projects as well as for small and straightforward projects.
To reduce the project risks for our custo-mers and for us, the Center of Compe-tence Pharma has established a certifi-cation process for the local GxP project execution. Based on a comprehensive assessment we support the local organi-zations to establish the proper processes, to acquire the required knowledge and to pass the audit successfully.
By applying PM@SBT for Pharma, con-sistent processes can be optimized and risks minimized; efficiency, quality and planning security are all increased simul-taneously.
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in the Pharma Industry.
PM@SBT Pharma – Sales
Pro
ject
Acq
uis
itio
n
Acq
uis
itio
n-P
has
e
Pre-
Aq
uis
itio
n
Acq
uis
itio
n-P
has
e
Qualify Lead Source
Select Leads
Perform Go/ No GoDecision
Identify Opportunities
Analyze Opportunities
Cover the Buying Center
Perform Bid/ No BidDecision
Communicate Bid/ NoBid Decision to customer
and HQ
Stop
Project Risk Ass.(LOA)
PM020-1
PM 010Acquisition Go/No Go
Decision
Sales SupportEngineering
Customer (RFQ)
Guideline 2140Calculation Scheme
Risk Assessment of the Project
Project managementassessment PMA
Project > 750 000 €
PM 020Bid/No Bid decision
(Quality Gate)
Calculation SchemePM010-2
Sales FunnelTool
PM010-1
Pharma BuyingCenter
PM020-3
Lifecycle ProfitabilityTool (LOA)PM020-5
Bid/No Bid Tool(LOA)
PM020-2
Account PlanPM020-4
Management ControlGuideline 2110;
2120; 2130; 3600
Project Risk ReviewReport (LOA)
PM021-1
Classification ProjectPM020-7
Inform HQ & localPharma Manager
ContractingSales
Manager
Sales Support
ContractingSales Manager
Sales RepresenterProject Controller
Sales Representer
Sales RepresenterProject Controller
Sales Representer
Sales Representer
Project > 20'000 EUR
Integration of HQ
National project
Involve CoC Pharma forsupport and assistance
International project/more divisions
involved
Involve Pharma Managerfor review
Local Pharma Manager
Local Pharma Manager
Sales Representer
Local Pharma Manager
Local Pharma Manager
Local Pharma Manager
Local Pharma Manager
Sales Representer
Checklist Handoversales Back office
PM020-8
Local Pharma Manager
BlockschemataPM020-6
Sales RepresenterProject Manager
LocalPharma Manager
ContractingSales Manager
Local Pharma Manager
Local Pharma Manager
COC Pharma HQ
Local Pharma Manager
ReviewPerformingFunctionReporting OutputProcess
Sales Version 2.9
Aquisition-Phase Offering-Phase
Pre-Aquisition
PM010 PM020
Bid-PreparationProject-Aquisition Contract-Negotiation Project-Handover
PM050 PM070 PM080
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Bid
Pre
par
atio
n
Off
erin
g-P
has
eO
ffer
ing
-Ph
ase
Co
ntr
act
Neg
ota
tio
n
Outline Sales Offering
Additional dataneeded?
no
Produce Bid
Review Bid
Bid complete/correct?
Submit bid
no
Prepare NegotationStrategy
Strategic Selling Pharma
Negotiate Bid
Generate Final Conctract
Obtain Agreement OnContract
Customeracceptance?
Changes inContract?
Analyze Win/Loss& inform HQ
yes
no
Subcontract Proc.Sales Support Eng.
yes
PM 050Bid Approval
PM 070Project win/lost
Bid Preparation
yes
High riskstep
Get URS
Impact Analysis
Support CoCPharma
Risk Assessment
Inform Pharma Manageror HQ for review and
approval
Project > 20'000 EUR
approval
Sales RepresenterProject Controller
Management ControlGuideline Appendix 3
Contract reviewchecklist 2110
Strategic AnalysisBlue sheet PM070-1
Checklist HandoverRequirements
PM020-9
Sales RepresenterCustomer
Project Manager
CustomerLocal Pharma /
Validation Manager
Sales Representer Local Pharma /Validation Manager
CoC Pharma HQ
Sales Representer Local Pharma Manager
Sales Representer Local Pharma Manager
Local Pharma ManagerProject Controller
Sales Representer Contracting Manager
Sales Representer Project Controller
Local Pharma ManagerCoC Pharma HQ
Sales RepresenterProject Manager
Local Pharma /Validation Manager
Sales Representer
Local Pharma Manager
Stop
Stop
no
Involving Project /Validation Manager
yes
no approval
URSVA050-1 (draft)
Milestone PlanningPM050-1
Checklist URSVA050-3
Checklist 21 CFRPart 11
VA050-6
SBT SoftwareApplication in
regulated industryVA050-7
Checklist Val.Documents
VA050-3
Checklist ImpactAnalysisVA050-4
Validationcalculation tool
VA050-5
ReviewPerformingFunctionReporting OutputProcess
Gather Data for Offer
Sale
sEx
ecu
tio
nSe
rvic
e
5
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Pro
ject
Han
do
ver
Off
erin
g P
has
eCompile Handover
Documents
Verify Handover Documents & Address
Changes out of Negotiaton
Conduct HandoverMeeting/Submit
Handover Checklist
Documents o.k.?
Handoverto PEx
accepted?
yes
no
no
PM 080Start Project
handover to PExchecklistPM080-1
Sales Representer
Project Manager Project Manager
ProjectManager
Sales Representer
ReviewPerformingFunctionReporting OutputProcess
Process StepPM@SBT
Pharma specificStep
SoftwareCategory 5 Decision point
Project Milestone
Quality Gate
Ongoing SubprocessOriginal Document
of PM@SBTPharma specific
Document
yes
User Requirement Specification (URS)This describes what the equipment or system is supposed to do, and as such is normally written by the pharmaceutical manufacturer. This links to performance qualification, which tests these user requirements.
Any project within the pharmaceutical industry that requires Validation, should have an available URS, User Requirement Specification. The URS is a prerequisite for Validation, and must include details of the scope of the Validation and is required to qualify the project and pro-vide an accurate quotation. In the event that the customer does not have the capacity or skills to produce a URS, Sie-mens can assist in the production of a URS, or even produce a URS on behalf of the customer.
Impact AnalysisThe scope of the impact assessment is to evaluate the impact of a system on product quality. Those systems having a direct impact on product quality are subject to qualification practices in addi-tion to Good Engineering Practice (GEP). Indirect impact or no impact systems are designed, installed and commissioned according to GEP only. This allows appropriate effort and focus to be con-centrated on the quality impact systems.Siemens provides a service to support the impact analysis for the customer.
Bid Preparation
Risk AssessmentThe Risk Assessment will be used to assess systems (these can be a building management system, a HVAC, a project risk, etc.) which due to a failure can lead to a risk that can have an impact on pro-duct quality or data integrity. It will provide a base for decision that determines the amount of measures and tests during the validation process to beware or minimize potential risks. Siemens provides a service to support the risk assessment for the customer.
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Enter Order/EstablishPM Goals
Early MaterialRequirements?
Initiate / Set up Project
Obtain Deliverables fromEnabling Processes
no
Effect of Offer
Release Work Packages(Design)
Audit Suppliers &Audit of customer
Audit Report SuppliersVA100-2
Master Validation Plan(customer)
VA100-1
PSQPVA100-4
Validation GuidelineCM1 10820
Work PackagePM100-6
PM 100Entry Order Clarified
(Quality Gate)
Finance
Monitoring & Controlling
Training- GxP compliant
Risk Assessmentof the Projct
Logisticsyes
RevisionRisk Assessment
Kick off meetingwith the customer
Refine URS
Minutes of themeetingPM100-5
Audit ReportSiemensVA100-3
ContractingExecutionManager
Project ManagerProject Controller
Project Manager
Project Manager
Pharma SpecialistProject Manager
CoC Pharma
Target agreementPM100-1
Project SchedulePM100-2
Issue listPM100-3
Time schedulePM101-4
Define Project Organization &Responsibility Matrix- check education status- perform required education
Create Project & Quality Plan“Define” Work Packages
Local Pharma Manager
Local Pharma Manager
Local Pharma /Validation Manager
Customer
Project Manager Local Pharma /Validation Manager
Project ManagerPharma Specialist
Local Pharma /Validation Manager
Project Manager Local Pharma /Validation Manager
Project/ValidationManager
Material RequirementsResourcing Planning
EngineeringSubcontract Procurement
ProjectChange Management
Claim Management”Contract Management”
Pro
ject
Op
enin
g
Exec
uti
on
-Ph
ase
yes
ReviewPerformingFunctionReporting OutputProcess
Installation Commissioning Acceptance Warranty
PM650PM600PM590PM550 PM580 PM700
PM670
Execution Version 2.9
Execution-Phase
Project-Opening Dispatch
PM100
Detail Planning Purchasing Manufacture
PM300PM200 PM400
no
Execution-Phase Operating-Phase
PM570
PM@SBT Pharma – Execution
Sale
sEx
ecu
tio
nSe
rvic
e
7
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Obtain Approval
Perform Design Review
Release Work Packages(Technical Execution)
Ready to submitto customer?
ContractManagementyes
no approval
no
Code ReviewVA300-1
PM 200Approval of detailed
planning
Factory acceptance Test(FAT)
Functional Spec.VA200-1
HW TestSpecification
VA202-3
Factory AcceptanceTest Specification
VA200-7
Site AcceptanceTest Specification
VA200-8
Traceability matrixVA200-2
DQVA200-9
Work PackageVA200-2
HW DesignSpec.
VA200-3
HWCLVA201-3
SW DesignSpec.
VA200-4
SWCLVA201-4
SW ModuleDesign
SpecificationVA200-5
SW ModuleTest
SpecificationVA201-5
SW ModuleIntegrationTest Spec.VA200-6
SystemIntegrationTest Spec.VA201-6
Project Manager Local Pharma /Validation Manager
Customer
Project ManagerPharma Specialist
Local Pharma /Validation Manager
Customer
Project ManagerPharma Specialist
Local Pharma /Validation Manager
Customer
Project ManagerPharma Specialist
Project ManagerPharma Specialist
Local Pharma /Validation Manager
Customer
SW TestSpecification
VA202-4
Project Manager Local Pharma /Validation Manager
Customer
Project Manager Local Pharma /Validation Manager
Customer
Project Manager
Project Manager
Local Pharma /Validation Manager
Customer
Project Manager Project /Validation Manager
Project Manager Project /Validation Manager
Project Manager Project /Validation Manager
Field ServiceEngineer
Project Manager
Service Engineer
Service Engineer
Project /Validation Manager
Project Manager Customer
Exec
uti
on
-Ph
ase
Exec
uti
on
-Ph
ase
Create FunctionalSpecification
Create Acceptance Test Specification
(FAT, SAT)
Create Hardware
DesignSpecification
HardwareTest
Specification
Create SoftwareDesign
Specification
SW TestSpecification
Establish & maintaintraceability matrix
SoftwareModuleDesign
Specification
SoftwareModule TestSpecification
Det
aille
d P
lan
nin
gPu
rch
asin
g M
anu
fact
ure
Test HW/Peripherals
Test SWmodules
Test SWModul /System
Integration
Test integratedSW code
Purchasing &Manufacture
Build/assemble
HW/Peripherals
Code SWmodules
Perform SWcode reviews
SW Module Test Report
VA300-4
Signature ListVA300-11
Training ListVA300-10
Deviation ListVA300-9
SW Module IntegrationTest ReportVA300-5
SW IntegrationTest ReportVA300-6
Test integrated SWcode Report
VA300-8
Factory Test Report(FAT)
VA300-3
HW Test ReportVA300-7
ReviewPerformingFunctionReporting OutputProcess
8
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Initiate Completed WorkReview
Review Completed Workwith Customer
Generate Punch List
Punch list items?
Obtain CustomerAcceptance
Submit Certificate toFinance Department
Project 100%complete?
yes
no
no
Monitoring & Controlling
Finance
Dispatch
Erection/Installation
Punch listPM650-1
Project ClosureChecklistPM650-2
Request acceptanceReview
PM650-3
Supplier EvaluationAssessment
PM650-4
Final ValidationReport
(Customer)
AcceptanceTest Protocol
PM650-5
AcceptanceCertification
PM650-6
TransmittalConfirmation
PM650-7
PM 400Material & Resources at
Site
PM 300Dispatch approval
PM 550Erection Completed
PM 600Release to Acceptance
PM 580 IQ released
PM 570
Mechanical Completion
PM 590 OQ released
ConfigurationManagement Plan
VA550-1
Check Sheet tocomply with the
requirementsPM550-1
Install SW Install HW/Periperhals
Calibration
CalibrationDocumentation
VA550-2
Prepare ValidationReport
Project ManagerPharma Specialist
Local Pharma /Validation Manager
Customer
Project Manager
Project Manager
Field ServiceEngineer
Project Manager
Field ServiceEngineer
Project Manager
Pharma Specialist Project Manager
Field ServiceEngineer
Field ServiceEngineer
Project /Validation Manager
Field ServiceEngineer
Project /Validation Manager
Field ServiceEngineer
Project /Validation Manager
Project Manager LocalPharma Manager
Project Manager
Project Manager
Customer
LocalPharma Manager
Project Manager
Project Manager
LocalPharma Manager
Training- GxP compliant
Change Control
Training of Operator
Exec
uti
on
-Ph
ase
Dis
pat
chIn
stal
lati
on
Co
mm
issi
on
ing
Qu
alif
icat
ion
Acc
epta
nce
Exec
uti
on
Ph
ase
OQ – SpecificationVA550-4
IQ – SpecificationVA550-3
Perform SystemAcceptance Testing
(SAT)
TestHW/SW Peripherals
(IQ)
HW/SW PeripheralsOQ
Commissioning
IQ-Test Plan / protocol
VA580-1
IQ-ReportVA580-2
OQ-Plan /protocolVA590-1
OQ-ReportVA590-2
TestSAT ReportVA590-1
PM 650Customer Acceptance
ReviewPerformingFunctionReporting OutputProcess
Sale
sEx
ecu
tio
nSe
rvic
e
9
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Monitoring & Controlling
Compile Handover toService File
Conduct Site Visit
Handover to Service
Open Warranty Account Service Execution
PM 670PEx Handover Accepted
Meeting Customer(Lessons Learned)
- Punch list closed- handover service
checklistPM670-1
Demobilize Project Site
PM 700End of Warranty
Close Warranty Accountwarranty closurecommunication
Project Manager
Project Manager
Project Manager
Project Manager
Project Controller
Project Controller
LocalPharma ManagerProject Manager
Customer
War
ran
ty
Op
erat
ing
Ph
ase
Service LeadGeneration
Qualifying& Verification
yes
ReviewPerformingFunctionReporting OutputProcess
Process StepPM@SBT
Pharma specificStep
SoftwareCategory 5 Decision point
Project Milestone
Quality Gate
Ongoing SubprocessOriginal Document
of PM@SBTPharma specific
Document
Audit An activity to determine through investi-gation the adequacy of, and adherence to, established procedures, instructions, specifications, codes, and standards or other applicable contractual and licen-sing requirements, and the effectiveness of implementation of a vendor.
As an offer to our customers, Siemens can provide the customer access to an audit report of our development in Zug made by external auditors.
Project Specific Quality Plan (PSQP)Document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract.This Project Specific Quality Plan PSQP) defines how Siemens Building Technolo-gies will fulfil both Siemens and custo-mer quality requirements of the project as they relate to the design, supply, installation, and commissioning of the Building Management System (BMS) for the customer plant. The PSQP defines the activities to be performed, their timing, which will perform them, the control mechanisms to be used, and the deliverable items.
Project Opening
10
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Detail Planning
Hardware Design Specification (HDS)The Hardware Design Specification is to specify and document the choice of con-trol and electric components. The Hard-ware Design Specification concerns design and construction which requires particular attention, including the choice of: ■ Servers and hardware configuration of
these■ Clients and hardware configuration of
these■ Network components ■ Printers and monitors■ External storage medias■ Controllers, I/Os, and sensors ■ Uninterruptible power supplyThe HDS, Hardware Design Specification, should be completed and signed off by the customer during this step.
Hardware Configuration List (HWCL)The purpose of the Hardware Configura-tion List is to have a detailed document of: The firmware versions, internal hard-ware settings through jumpers and swit-ches, used network IP addresses, serial numbers and computer hardware confi-
gurations; i.e. for the components that are assigned with a configuration item index number (CI) in the main configura-tion drawing in the document. This Hardware Configuration List is an appendix to the hardware design specifi-cation, but can also be used separately to make future hardware baselines.
Software Design Specification (SDS)The SDS describes how the software will be configured to achieve what the BMS is designed to do and provides a list of design objectives, as well as identifying system limitations, as detailed in the URS document and in sufficient detail to avoid any ambiguities. The SDS, Software Design Specification, should be completed and signed off by the customer during this step.
Software List (SWL)This SWL will list the software for Siemens BMS Pharma system. This software list is an appendix to the software design specification.
Test Plan / ProtocolA document describing the scope, approach, resources, and schedule of intended test activities. It identifies test items, features to be tested, testing tasks, who will do each task, and any risks requiring contingency planning.
Test ProtocolDetailed instructions for the set-up, execution, and evaluation of results for a given test case.After execution of the tests the test plan will be our protocol.
Design Qualification (DQ)Design Qualification, formal and syste-matic verification that the requirements defined during specification are comple-tely covered by subsequent specification or implementation.
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Qualification
Installation Qualification (IQ)This is a documented verification that all key aspects of hardware installation adhere to appropriate codes and appro-ved design intentions and that the recommendations of the manufacturer have been suitably considered.
IQ Protocols should include■ Documentation – introduction, objec-
tive, signature record, abbreviation and definitions, documentation checks, conclusions and approvals.
■ Hardware – drawing information, major hardware components, loca-tions, pre-start hardware checks.
■ Software – software version numbers, service pack number. Pre-start applica-tion software checks.
■ Installation procedures – installing the software on the target hardware plat-form.
■ Calibration – schedules, certificates.
Operational Qualification (OQ)This is a documented verification that the equipment-related system or sub-system performs as intended throughout representative or anticipated operating ranges.
OQ Protocols should include■ Documentation – introduction, objec-
tive, signature record, abbreviation and definitions, documentation checks, conclusions and approvals.
■ Hardware – digital input/output tests, analogue input/output tests.
■ Software – system security tests, com-puter functionality tests, operator con-trol tests, invalid input tests.
■ Systems – control system sequence tests, control system alarm tests.
■ General – stress/recovery tests, source code audit, software version tests.
■ Flow measurement devices■ Temperature/humidity devices■ Alarms and alarm messages■ etc.
Purchasing Manufacture
Factory Acceptance Test (FAT)The Factory Acceptance Test (FAT) is exe-cuted after completion of system imple-mentation at the system supplier’s site. At the end of the FAT the client should agree to the delivery of the system. An additional advantage of an extensive FAT is to detect possible faults in software programming early and to be able to cor-rect them prior to the installation of the system at the client’s site, so that the commissioning can be executed quickly. As far as possible the FAT should be exe-cuted with the original system equipment and can be supported with the help of simulated processes and test programs.
Installation
Change ControlA formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated status. The pur-pose is to determine the need for action which would ensure and document that the system is maintained in a validated state.
Commissioning
Site Acceptance Tests (SAT)The Site Acceptance Test (SAT) demon-strates that the system is working in its operational environment and interfaces with instruments and equipment. The SAT normally constitutes a repeat of ele-ments of the FAT in the user’s operating environment plus those tests made pos-sible with all process, field instruments, interfaces and service connections esta-blished. The SAT may be combined with equipment and plant commissioning, and this will provide a basis for OQ.
Note: Siemens Building Automation is normally not directly involved in PQ.
IQ/OQ Report:After the tests of all test phases are exe-cuted according to their specification and the single test results are evaluated and no major deviations are left, the end of the qualification phases has to be documented. The Qualification Report is created by the client/system supplier. It summarizes the test results of all test phases, e.g. FAT, SAT, IQ, OQ.
Deviation List:To each test phase one Deviation List has to be included. It contains test points that were not evaluated as successful, i.e. the specified acceptance criteria were not fulfilled. The Deviation List is appended to the xQ-Report. Further on in the master exemplar (not in any copy!) of the Devia-tion List the correction of the defects has to be signed by the respective person and to be approved by the client.
Acceptance
Validation ReportWhatever the scale or scope of the pro-ject, there is always a requirement to issue a final Validation Report which summarizes the entire project, measures its ultimate success, and clearly signifies acceptance of a final solution by the user and quality assurance.This report should document the out-come of activities defined in the valida-tion plan.
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Assign Service SalesResource
Lead Approvalrequired?
Include Lead in ServiceSales Funnel
(Prospect List)
Check HandoverChecklist for Prospect /
Customer
Arrange Customer /Prospect
Contractor Visit
Indentify Key CustomerProspect Contacts
no no
Continue withbusiness
opportunity
Confirm Service offeringScope with customer
Check Compain Datafor Prospect / Customer
Obtain approval
Inform Customer
Inform Customerabout no go
Negotiation
SubcontractProcurement
yes
BT 420 Qualified profilereviewed & verifiedCustomer Offering
BT 410Target Leads Identified
Analyze businessopportunity & recognize
customer needsLinked with SBT capabilities
Cover the Customer/Prospect Buying Center
& Determine preliminaryscope
Scope confirmedSufficient
Data
Customer MappingPM420-1
Qualification ProfilePM420-2
Service ManagerHandover to ServicePEx checklist
PM410-1
Service SalesFunnel Tool
PM410-2
Outline Service offering&
Review/submitSBT capabilities
LocalPharma Manager
Service Support LocalPharma Manager
Service SupervisorSales Rep.
LocalPharma Manager
ServiceSales Rep.
LocalPharma Manager
ServiceSales Rep.
ServiceSales Rep.
LocalPharma Manager
ServiceSales Rep.
LocalPharma Manager
ServiceSales Rep.
LocalPharma Manager
ServiceSales Rep.
LocalPharma Manager
ServiceSales Rep.
LocalPharma Manager
ServiceSales Rep.
LocalPharma Manager
ServiceSales Rep.
ServiceSales Rep.
LocalPharma Manager
ServiceSales Rep.
LocalPharma ManagerComplete
Qualification Profile
Serv
ice
Lead
Gen
erat
ion
Serv
ice-
Phas
e
Qu
alif
yin
g &
Ver
ific
atio
n
Serv
ice-
Phas
e
yes
Prepare customer /prospect visitor contact
(in line with segment andopportunity)
yes
no
no
yes
ReviewPerformingFunctionReporting OutputProcess
Handover & Execution Service Execution Service Settlement
Service Version 2.9
Lead-Generation Service NegotiationQualifying & Verification Proposal Generation
BT410 BT420
BT450
BT430 BT440
Service-Phase
Service-Phase
PM@SBT Pharma – Service
Sale
sEx
ecu
tio
nSe
rvic
e
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Negotiation ServiceProposal Pharma
Review ServiceContract Signed by
Customer
Register ServiceContract in IT System
Analyze Win/Loss& inform HQ
On-Call
Service Planning
yes
Compile HandoverDocuments
US Service SalesFunnel Tool BAU
PM440-1
Service contractHandover checklist
PM440-2
Service handover toPEx checklist
Impact AnalysisVA-450-1
Risk AssessmentVA-450-2
PART11 AuditConsulancy
URS Consulancy
AdjustmentRequired
CustomerModifications
toProposal
ServiceSales Rep.
LocalPharma Manager
ServiceSales Rep.
ServiceSales Rep.
Service SupportSales Rep.
Service SalesRep.
Service SalesRep.
Service SalesRep.
Service Support
Pharma ManagerProject Controller
ServiceSales Rep.
Serv
ice
Ne
go
tiat
ion
Serv
ice
-Ph
ase
Pro
po
sal G
en
era
tio
n
Serv
ice
-Ph
ase
Serv
ice
Han
do
ver
Exe
cuti
on
Serv
ice
-Ph
ase
BT 430 Proposal Submitted
to customer
BT 440Signed Contract
Qualifying &Verification
no
yes
yes
no
Send Confirmationand Copy of Contract
to customer
Verify HandoverDocuments & Address
Changes out of Negotiation
Conduct HandoverMetting / Submitt
Handover Checklist
no
Submit/PresentService Proposal
ProposalComplete
Service Settlement(in case of
existing customer)
Request for Proposalfrom existing
customer's only
Service SalesFunnel Tool
PM430-1
Service ValueProposition Card
PM430-2
CustomerRequirements
Solution MatrixPM430-3
ServiceSales Rep.
LocalPharma Manager
ServiceSales Rep.
ServiceSales Rep.
Pharma /Validation Manager
Prepare ServiceProposal
incl. Quotation
ReviewService Proposal
Receive and Checkrequest for
Service Proposal
ReviewPerformingFunctionReporting OutputProcess
Process StepPM@SBT
Pharma specificStep
SoftwareCategory 5 Decision point
Project Milestone
Quality Gate
Ongoing SubprocessOriginal Document
of PM@SBTPharma specific
Document
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Service Lead Generation
The Lead Generation step in the service sales process includes activities that lead to prospecting for customers and cover-ing their potential needs. A strategy is planned based on these needs and quest-ions and implications are prepared for use during this phase.
Qualifying & Verification
The QUALIFYING step of the service pro-cess identifies the customer’s service needs and links them to Pharma service modules. The service salesperson relies on knowledge of our service capabilities, knowledge of the customer‘s market drivers and specific goals, and on sales skills and techniques to determine the needs of the customer.
Once needs are acknowledged in con-sultation with the customer, the Custo -mer Requirement Solutions Matrix is used to quickly highlight applicable solu-tions to address those needs.
The VERIFICATION step confirms the importance of the customer’s needs or requirements. Potential services are posi-tioned as solutions to meet their needs or satisfy their requirements.
Proposal Generation
In this step a proposal or a site specific contractual agreement (Service Level Agreement) is created to document the scope of recommended services.The customer-specific service concept not only covers the services from the Pharma Service Program but also includes “traditional” Advantage Services™ specially adapted to Pharma.
The program‘s modular structure allows us to offer an individual service program tailored to the customer‘s needs:
Each module specifically offers:■ Standard operating procedure (SOP)
for executing the service■ Required tools and processes■ Required checklists to support our
experts on-site■ Expert training
Service Negotiation
The NEGOTIATION step involves obtain-ing the approval of the customer and conforming acceptance of the terms and conditions identified within the service contract. The salesperson addresses the entire contract, including scope, price, terms and conditions and service dates.
Service Handover Execution
During the HANDOVER phase, the service team clearly understands and delivers the individual, customer specific service concept or standard service package identified in the service agreement.
When executing services in a critical environment, the service staff must be trained on how to operate in this en -viron ment and be fully aware of the customer‘s change management procedures.
A formal analysis of the possible impact of any planned changes to a validated system, combined with a risk assess-ment, is required.
All changes to existing systems must be formally approved from the customer prior to execution.
Pharma Service ConceptThe Pharma Service Concept for main-taining a validated state is divided into three main groups:■ Compliance consultancy
(URS Consultancy, Impact Analysis, Risk Assessment)
■ Business continuity (Backup Integrity, System Integrity, Archive Test)
■ Validation review (Part 11 Audit, Calibration, Baselining)
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www.siemens.com/buildingtechnologies-pharma
Siemens Switzerland LtdBuilding Technologies GroupInternational HeadquartersGubelstrasse 22CH-6301 ZugTel. +41 41-724 24 24Fax +41 41-724 35 22www.siemens.com/buildingtechnologies
The information in this document contains general descriptions of technical options available, which do not always have to be present in individual cases. The required features should therefore be specified in each individual case at the time of closing the contract.
Subject to change • Order no. 0-92004-en© Siemens Switzerland Ltd • Printed in Switzerland • 0,00000 Ni/Ah
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