PREFACE PART II: KEY POINTS IN PHARMA ENG. PROJECTS … · apollo Executive Leadership Project...
Transcript of PREFACE PART II: KEY POINTS IN PHARMA ENG. PROJECTS … · apollo Executive Leadership Project...
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郭红星 医药工程项目及管理经验分享
Pharmaceutical engineering project and management experience sharing
Reliable, Effective project management
The 5th Vogel Pharmaceutical Engineering International ForumMay 13th . 2013, Beijing, China
Horch Guo, [email protected] Roche Pharmaceutical Ltd.
VOGELVOGEL Content
PART I: PHARMA ENG. PROJECT MGMT
PREFACE
PART II: KEY POINTS IN PHARMA ENG.
PROJECTS MGMT
PART III: PRACTICAL APPROACHES & CASE
STUDY TO PHARMA ENG. PROJECTS
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PART I: PHARMA ENG. PROJECT MGMT
PREFACE
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Project & Project Management
Project:“A temporary endeavor undertaken to create a unique product, service or result”Program:
“A group of related projects managed in a coordinated way to obtain benefits and control not available from managing them individually.”
Operation:
“An organizational function performing the ongoing execution of activities that produce the same product or provide a repetitive service ”
Project Management:“ The application of knowledge , skills, tools and techniques toproject activities to meet the project requirements”
PMI PMBOK Fourth Edition
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Facility /Equipments projects
New builds ,Retrofit Facilities
New Equipment or Equipments line
Decommissioning and Demolition
Improvement projects
Product, Facility, Process and Equipment improvements
Audit preparation and subsequent improvement
Product Portfolio projects
New product and product transfer
Technology Transfer
IT & Automation projects
ERP implementation
System Functionality Upgrade
Process Control System (MES)VOGELVOGEL5
Pharma Eng. Project Classification Pharma Eng. Project Classification
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CriteriaSmall-scale
projectProject Facility
RetrofitNew BuildGreenfield
NewProductTransfer
NewProduction
line
Organizationalcomplexity(Departments)
2~3 > 3
Technical Complexity(Quality, Process, etc)
Noaffect Impacts
Human resource requirements(Manpower Days)
80~200 > 200
Costs(K CNY) 300
~8,000 > 8,000
Duration(Months) > 2 >6
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C DPharma Eng. Project Life Cycle Model
Project Initiation (PI)
Feasibility study
Conceptual development (CD)
CAPEX planning
Project Planning (PP)
Basic design (BD)
Project Planning
Project Execution (PE)
Detailed design (DD)
Procurement
Construction & Commissioning (CC)
Qualification
Project Handover (PH)
Validation & Start-up
1.Feasibility 2.CD
4.BD 5. Planning
3. CAPEX
6.DD 7.Procur. 8.CC 9.Quali
10.Validation & Start up
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PART II: KEY POINTS
IN PHARMA ENG. PROJECT MGMT
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Pharma Project Management Framework –classic triangle to 9 knowledge areas
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Time
Cost QualityPMI 9 knowledge areas
Classic Triangle
Pharma Project Management Framework –9 Knowledge Areas ,Mgmt Process & Life Cycle
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Mgmt Process
Knowledge area
Quality Mgmt
Risk Mgmt
Time Mgmt
Cost Mgmt
Scope Mgmt
HR Mgmt
Integration Mgmt
Communication Mgmt
Procurement Mgmt
Initiating Planning Execution Controlling Closing
MA
INSU
PPO
RT
CO
RE
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World Tier
State Tier
Organization Tier
Bureau Tier
Company & Peers Tier
Pharma Project Quality Management–Quality & Compliance tiers
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FDA Foreign Inspections in China, Y2010
cGMP Deficiencies Percent
Inadequate Lab controls 23%
Buildings/Facilities 7%
Control components, Intermediates, Raw material 7%
Records/Reports 7%
Invalidated Lab test methods 5%
QA systems 5%
EquipmentCleaning/Maintenance, CV 5%
Equipment design, size, etc. 5%
Packaging/labeling 5%
Lack of inadequate SOPs 5%
Deviation from DMF/ANDA 4%
FDA Foreign Inspections in Europe, Y2010
cGMP Deficiencies Percent
Inadequate Lab controls 13%
QA systems 11%
Lack of inadequate SOPs 10%
Equipment cleaning/Maintenance and CV 8%
Records and Reports 8%
Process Validation 8%
Production process control 7%
System Qualification (IQ/OQ) 5%
Invalidated Lab test methods 5%
Inadequate Environmental Control 4%
Pharma Project Quality Management–cGMP Deficiencies Focused
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Pharma Project Quality Management–Poor Quality& incompliance results
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Pharma Project Quality Management
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QMS: ISO 9001:2005 Project lifecycle Quality management
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魏文王问扁鹊曰:’子昆弟三人其孰最善为医?’扁鹊曰:’长兄最善,中兄次之,扁鹊最为下。’魏文侯曰:’可得闻邪?’扁鹊曰:’长兄於病视神,未有形而除之,故名不出於家。中兄治病,其在毫毛,故名不出於闾。若扁鹊者,镵血脉,投毒药,副肌肤,闲而名出闻於诸侯。’
《鶡冠子·卷下·世贤第十六》。
Pharma Project Risk Management –Case 1: Bian Que & brothers
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ICH Q9- Quality Risk Assessment ModelICH Q8/9/10- Patient linked risk assessment
Pharma Project Risk Management –Quality based Risk Assessment Model
PM & Stakeholder
Team Members
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Pharma Project HR Management –Case 2: The Journey to the West
Cos
t and
sta
ffing
leve
l
Time
Initial phase Intermediate phase Final phase
Planning Implementation
Costof Scope Changes
Curveof Life Cycle
Impactof Scope Changes
Pharma Project Schedule & Cost & Scope Magement
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Take high level view of the project from start to finish.
Consolidate and integrate many project activities and will make decision where to apply resources allocation in order to execute the project to achieve the goal.
“Integration” means changes made in any one area of the project must be integrated into the rest of projects.
Integration
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Project Integration Management Project Integration Management-Case 3: Ding Wei “kill three birds with one stone”
丁谓 - 一举三得
“一举而三役济,计省费以亿万计”
挖沟取土,解决土源 引水入沟,运输建材 废土建沟,处理垃圾
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Project Communication ManagementCase 4: Messager game
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Conflict Management
orange
arrange
arrow
apple opera
apollo
ExecutiveLeadership
ProjectLeadership
WorkingTeam
Internal Team
ProjectLeadership
WorkingTeam
External team from Vendors
SPOC
Qualified vendor List ! Sustainable vendor evaluation criteria!
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Project Purocurement Management-Lifecycle purocurement process
t+1
Projectsupport&tracking
t+2
Vendorrevaluation.
5 4 3 2 1 0
tProject-/DemandPlanning
BiddersSelection
Requestforproposal(RFP)/Invitationto Bid (ITB)
Bidevaluation,auditing& Final Negotiation
Award PurchaseOrder/contracts
t+3
Closing
PART III: PRACTICAL APPROACHES & CASE
STUDY TO PHARMA ENG. PROJECTS
MGMT
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Pharma Eng. Project- PI Phase-Case Study : State-of-art CIP tablet compression system - Created PM Manual, Integrated Org-chart & RACI matrix
24 Project Delegation tool -RACI Matrix
Created PM Manual
Integrated Org-Chart
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Pharma Eng. Project- PI Phase-Case Study : State-of-art CIP tablet compression system - Global alignment feasibility study
China
Italy
Brazil
Mexico
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Pharma Eng. Project- PI Phase-Case Study : State-of-art CIP tablet compression system -Occupational Exposure Limits’ Risks & Technology
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Pharma Eng. Project- PI Phase-Case Study : State-of-art CIP tablet compression system –Quantitative evaluation summary
DRIVERS Vendor A Vendor B Vendor C
High Containment
Max Output
Production Flexibility
WIP/CIP Level
Investment Budget
Delivery Time
After Sales Services Quality
Spare Parts management
References
Layout Study
Qualification & Validation supports
Automation level27
Pharma Eng. Project- PI Phase-Case Study : State-of-art CIP tablet compression system –CAPEX Finiancial Appraisel Project EVA evaluation
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Eng. project EVA breakdown Finiancial Appraisel
Pharma Eng. Project - PP Phase-Case Study: State-of-art CIP tablet compression system
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Pharma Eng. Project - PP Phase-Case Study : State-of-art CIP tablet compression system –Project Schedule
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Pharma Eng. Project - PP Phase-Case Study : State-of-art CIP tablet compression system –ICH Q9 Quality Risk Management (QRM) & RACI
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QRM Program SME Quality Decision Makers
QRMLead
Facilitator Site RMC
Initiate QRM Plan
- Develop Plan C C A/R I C
- Approve Plan R A/R R I I
Risk Assessment
-Plan for Risk Assessment C A/R R
-Execute Risk Assessment(Identify, Analyze, Evaluate)
R R A R
-Finalize Risk Assessment R R A R
-Approve Risk Assessment R
Risk Control
-Risk Control Decision (Reduce/AcceptRisk)
I R A/R R C
-Risk Reduction Implementation R R A R I
QRM Report I R A/R A I
Risk Review I R A R
QRM Documentation A/R R
Pharma Eng. Project - PP Phase-Case Study : State-of-art CIP tablet compression system –ICH Q9 Quality Risk Management (QRM) in V model
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Pharma Eng. Project - PP Phase-Case Study : State-of-art CIP tablet compression system –Project Execution Plan (PEP)
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Pharma Eng. Project - PE Phase-Case Study : State-of-art CIP tablet compression system –System Process P&ID
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Pharma Eng. Project - PE Phase-Case Study : State-of-art CIP tablet compression system
-Site construction
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3D simulation
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Pharma Eng. Project - PE Phase-Case Study : State-of-art CIP tablet compression system
-Cost tracking profile
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Down payment
2nd payment
3rd payment
Final payment
Add order
Cos
t
ScheduleM
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Pharma Eng. Project - PE Phase-Case Study : State-of-art CIP tablet compression system –Project Change Management
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Reasons:
System/Plant/Location:Brief Description of Change:
Initiator: Date: Signature:Change Type:□Scope □Incident □Design □Execution □Transfer□Estimate
Reason for Change:□Safety □GMP □Function □Cost □Schedule □Authority
Brief description of solution/Alternatives:
Quality Impact Schedule Impact Cost Impact
Approval : Date: Signature:
Approval: Date: Signature:
Pharma Eng. Project - PH Phase-Case Study : State-of-art CIP tablet compression system
-Project Handover
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No. Item Requirements Referencedocument
CompliesYes/no
Signature,Date Remarks
1 General documents
- Design and construction documents- As built Drawings- Change Management Summary- Completion Punch list-Training documents
2 Building -Final facilities walkdown Conducted-Authority permissions-Final Certificate of Occupancy -Building/Facility Turnover Checklist
3 Process -List of equipment, system-O&M Manual ,Certification, Assemble drawing and so on (including mechanical installation, electrical principle and wiring).--All test record, FAT,SAT, Qualification , validation Document-Detailed list of spare parts for 2 years operation-Maintenance plan-Tools list
4 Control System
-Data Migration Complete-Passwords for operation and setting-Configuration Management Procedures-Defect Management Procedures-Disaster Recovery -Source Code & coding standard
Project Handover list
Pharma Eng. Project - PH Phase-Case Study : State-of-art CIP tablet compression system
-Lessons LearnedFeasibility CD CAPEX BD Planning DD Procur. CC Quali Validation &
Start up
1st LL workshop 2nd LL workshop 3rd LL workshop Final LL workshop
Project Success-What went well
General Learning & Findings
Unintended Consequences, Impacts to the Project and Recommendations – What did not go well?
RCA Analysis for High Impact Incidents
LL Action Items
Description Factors that Promoted this Success
Description Identified By
What point? What was the impact? recommendations
Define Factors Corrective Action
EffectiveSolutions
Items Action Items Responsibility Deadline
Engineering Project Lessons Learned Report
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Useful links:PM:
www.pmi.org
www.ispe.org
Global Authorities:
www.ich.org
www.fda.gov
www.ema.europa.eu
www.pda.org
www.pics.org
More information....
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Q & A
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Thanks for your attention!
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