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Agile PM PIPMG 2017
Copyright © 2017 Trish Melton
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MIME Solutions LimitedAgility Simplicity Innovation Solutions
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Get Agile! Deliver Faster!A case study demonstrating a value-
centred approach to new product launch
Melton Integrated Management & Engineering Solutions
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Get Agile! Deliver Faster!A case study demonstrating a value-centred
approach to new product launch
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
• Lean Six Sigma (LSS) & Theory of Constraints(TOC) challenges Fast Track
• Lean Six Sigma (LSS) & Theory of Constraints(TOC) challenges Fast TrackSome history
• Focus on the Customer• Focus on Benefits• Focus on the Customer• Focus on Benefits
Being Value-Centred
• My definition based on Lean Six Sigma• Other definitions from IT• My definition based on Lean Six Sigma• Other definitions from ITAgile Principles
• Application of agile principles• Application of agile principlesProduct Launch
• What more can we do in Pharma• What more can we do in PharmaNext Steps
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Agile PM PIPMG 2017
Copyright © 2017 Trish Melton
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Some History… a challengeProject Delivery SpeedChallenge• Traditional CPA – fast
tracked• The implication of TOC –
The Theory of Constraintsand Critical Chain
• The importance of leanthinking and riskassessment
Project ManagementDevelopment• Development of agility in
all elements of projectmanagement
• The positive impact onthe team, the measuresof success, customeroutcomes and overallproject culture
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
agile (1) = able to move quickly and with suppleness, skill & control
agile (2) = able to think quickly & intelligently
agile (1) = able to move quickly and with suppleness, skill & control
agile (2) = able to think quickly & intelligently
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Agile PM PIPMG 2017Copyright © 2017 Trish Melton
PM Experience’s – one exampleThe Top 5 reasons why projects are delivered late
(data from a mixed group of PM’s)
Group A Group B Group C1 Scope unclear Scope change/creep Fuzzy objectives (scope
definition)
2 Lack of changemanagement (scopechange)
Lack of clear userrequirements (scopedefinition)
Under estimation ofinput/output fromstakeholders like QA andend users, etc (resourcecapacity and capability)
3 Lack of scheduling (poorplanning)
Resources (appropriatecapacity and capability)
Poor role & responsibilitydefinition
4 Late decision to go(delayed project start butsame project end)
Handover/delivery to enduser
Scope change
5 Poor risk assessment Unexpected equipmentfailure
Improper risk assessment
Agility was neededAgility was needed
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Agile PM PIPMG 2017
Copyright © 2017 Trish Melton
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Some History… PharmaChallenge
Product Launch Challenge• Launch a drug to meet a
business and therapeuticgoal– Specific drug (format, target
patient)– Specific lead time to market
(production)– Specific market– Specific time– Specific cost
Factors to consider?• Regulatory process to be
followed• Regulatory “window” to be
maintained• Teams of part-time subject
matter experts: scientists andengineers
• Technical risks• Design innovation in product
and manufacturing process
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
Agility was neededAgility was needed
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Some History… LSS in ManufacturingReducing Cycletime… Improving Right First Time
• Define• Measure• Analyse• Improve• Control
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Agile PM PIPMG 2017
Copyright © 2017 Trish Melton
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Some History… becoming agile
Changes to how we worked in projects• Value creation• Schedule development• Team working• Risk Management• Customer management
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
A way of being agile was developed within Pharma projects
The main difference to the IT based Agile PM was in scheduledevelopment and management
A way of being agile was developed within Pharma projects
The main difference to the IT based Agile PM was in scheduledevelopment and management
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Being Value-Centredwhat does this mean?
• Waste in projects causes more effort to beneeded– Effort takes time, people, money
• Defining Value “in the eyes of the customer”
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
• Thinking differently– are YOU adding value in all YOU do?– What do YOU do that is waste (waste
costs money……doesn’t add value)
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Agile PM PIPMG 2017
Copyright © 2017 Trish Melton
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Agile PM PIPMG 2017
Being Value Centredsupporting agility
Risk Assessment Theory ofConstraints
Lean Six Sigma
Can we doit any
faster?
To develop the concept as appliedto project management:
eliminating wasteful activities &enabling a flow of value to the
customer
To use of risk managementtechniques on scope & schedule
development & the use ofschedule contingency on schedule
management
To use the concept as applied toproject management: managing
dependencies and activityvariation through the use of
schedule buffers
How can projectsFLOW better to
deliver customervalue?
ValueCentred
Copyright © 2017 Trish Melton
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Agile PrinciplesHow can we become agile in Pharma?
Agility in Pharma• Focus on benefits required
by the customer• Develop work packages to
realise benefits• Incremental planning of work
packages within a macroschedule
• Collaboration withstakeholders
• Active teamwork• Requirement for stage gates
driving waterfall planning
Agility in IT• Incremental development
of the final value• Incremental planning• Collaboration with
customers and within theteam
• Built in innovation• Build in responsiveness to
change• Use of Scrum and Sprint
methodology
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
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Agile PM PIPMG 2017
Copyright © 2017 Trish Melton
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Agile Principles
Agile Scope
• Link tobenefits
• Voice of theCustomer(VOC)
AgileSchedule
• Theory ofConstraints(TOC)
• Risk andScheduleBuffer
AgileStakeholders
• Active inputto projectbenefitsoutcome
• Contracts &comms
Agile ProjectTeam
• Accountablesub teams
• Contracts &comms
• VisualFactory
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
Agile Culture
• The combination of the above delivers an agile culture focused on benefitsrealisation
• The project is a way to manage that part of the business being altered by theproject
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Lean Six Sigma is focussed on the delivery of value to acustomer
– The identification of value & the elimination of waste
– The reduction in variation• Less defects and more control (6 sigma)
– The release of value flowing to the customer
ValueValue-added activityAn activity that transforms or
shapes (for the 1st time)material or information to meetcustomer value
WasteNon-value-added activityThose activities that take time or
resources, but do not add to thecustomer value.
Agile ScopeAgile Scope
• Link to benefits• Voice of the
Customer (VOC)
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Agile PM PIPMG 2017
Copyright © 2017 Trish Melton
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Agile PM PIPMG 2017Copyright © 2017 Trish Melton
The Seven Wastes – QUESTIONS TOASK…..
TRANSPORTShould I have to
move thisdeliverable?
MOTIONShould I have to
move this much todeliver this work
package?
INVENTORYShould we have thispile of deliverables?
OVERPROCESSING
Is this activity reallynecessary to deliverthe project or work
package goal?
OVERPRODUCTION
Is there a need forthis deliverable?
DEFECTS
Am I making anymistakes during
delivery?
WAITING
Are deliverableswaiting around to
be processed
Addresses RIGHT scope and RIGHT wayto deliver it
DESIGN MISTAKESWHICH HAVE TO BE
RECTIFIED
DELIVERING SCOPEWHICH IS NOT
NECESSARY
WAITING FORDECISIONS TO BE
MADE ORRESOURCES TO BE
AVAILABLE
REVIEWING ANDAPPROVING FOR NO
PURPOSE
PROJECT TEAMMEMBERS
TRAVELLING TOMEETINGS WITH
EACH OTHER
DOCUMENT HAVINGTO BE MOVED FROMPLACE TO PLACE TO
WORK ON
QUANTITY OF TESTSOR DOCUMENTS
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Agile ScopeKano Analysis
Basic
• Must havefeatures
More ifBetter
• Featureswhichincreasethe benefittocustomer
Delighter
• Featureswhich arenotspecifiedbut wouldenhancethe benefittocustomer
Benefits Focus• Focus on
benefit &deliverable toachieve it
• Look at howthe businesswill use thedeliverable
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
• Identify the spoken andunspoken customer needs
Scope INPLACE
Scope INUSE
BenefitREALISED
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Copyright © 2017 Trish Melton
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Agile Schedule
Current Issues with schedule development methods
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
Agile Schedule
• Theory ofConstraints (TOC)
• Risk andSchedule Buffer
Agile SchedulingCopyright © 2008 Trish Melton
Parkinson’s Law
Student Principle Murphy’s Law
Measures determine behaviours
Work expands to fill thetime available
Leave activities until the lastminute
Anything that can go wrongwill go wrong
People will operate in a way to achieve theperformance targets set
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Traditional Schedule DevelopmentHow do we develop a schedule and estimate the project“deadline”?
– We base our activity duration estimates on “norms” rather than reality– We ask our team for “certainty” so they add “safety” in their estimates– We build a critical path based on our previous understanding of activity
dependencies without estimating the resources we intend to use– We don’t assess specific schedule risks during estimation– We plan to start “as early as possible” to keep activities off the critical
path– We develop a list of milestone dates – and build in rigidity
Lack oftrust
Resourceproductivity
goal
Murphy’sLaw
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
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Agile PM PIPMG 2017
Copyright © 2017 Trish Melton
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Traditional Schedule ManagementHow do we manage the schedule to attempt to meet theproject “deadline”?
– The team focus on meeting milestone dates (critical & non-critical) notthe “deadline”
– Unexpected things happen for which we have no contingent response– Expected things happen for which we have no contingent response– When we do things quicker than estimated we can’t “use” the time – the
‘safety’ is lost within each activity– We rarely do things quicker than estimated (task delivery time expands
to fill the time allowed)– We allow resource to start “as late as possible” & expect them to
multitask across projects – resources become distracted
StudentPrinciple
Murphy’sLaw
Parkinson’sLaw
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
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The result!
• A schedule development and managementculture which slows projects down
We get caughtup in the tasksand not in theproject goal
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
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Agile PM PIPMG 2017
Copyright © 2017 Trish Melton
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Fast Tracking…..• What happens when we try to speed projects
up by taking more risks……Traditional
Fast Track
AB
CD
X
AB
CD
Y3015 18
3018 24
Copyright © 2008 Trish MeltonAgile PM PIPMG 2017Copyright © 2017 Trish Melton
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Agile….• What we want to do is
– increase the predictability of outcomes…..– Decrease the time it takes to deliver scope….– Stop doing things which don’t add value to the required project
outcome– Allow schedules to flow through bottleneck management
AgileA
BD2
Z
D1
14 1615
Copyright © 2008 Trish Melton
Various concepts can be combined to deliver an agileapproach which has the potential to increase project
speed….. reliably
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
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Agile PM PIPMG 2017
Copyright © 2017 Trish Melton
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Agile PM PIPMG 2017Copyright © 2017 Trish Melton
Schedule BottlenecksThe Theory of Constraints (TOC) is based on themanagement of dependent events & statisticalfluctuations
– Dependent Events – steps in a process are linked together• Understanding why things are dependent: duration or resource and
identifying bottlenecks
– Statistical fluctuations – the time to do things varies aroundan ‘average time’ – sometimes slower and sometimesfaster
• Understanding the impact of variation: what’s the likelihood that a chain ofactivities of average duration “x” each will actually deliver “x”
– Dependent Events with Statistical Fluctuations• If an activity is faster than normal the deliverable still can’t progress because
it’s connected to the activity in front which may have been slower thannormal
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Theory of Constraints (TOC)How do we use?
• Build a critical chain: a critical chain is a critical path withfinite resources
• The schedule is built initially without any “safety” –recognising that there may be only a 50% confidence ofachieving these
• Resources are “ring fenced” and categorised as those doingcritical or non-critical tasks
• The schedule is NOT managed by “task due dates” but by“time to complete”
• Schedule “buffers” are built based on task variation andplaced within the schedule to protect critical activities fromnon-critical ones
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Agile PM PIPMG 2017
Copyright © 2017 Trish Melton
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Schedule Risk Management is a structuredmethodology to assess “time” uncertainty
– Assess ‘time uncertainty’ against each item in the WorkBreakdown Structure (WBS) - the potential for NOTachieving estimated durations or not enabling the benefit
• More than just assessing estimation accuracy– Remove any schedule ‘safety’ from each activity and build
buffers– This concept works with other agile concepts
• It challenges the WBS - does each activity add value?• It asks the team to trust the project manager - it is about achievement of
the project critical chain NOT individual task delivery
Schedule Risk Assessment
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Agile PM PIPMG 2017Copyright © 2017 Trish Melton
Critical activity withno contingency
Critical activity withno contingency
Buffer
Non-Critical activitywith no contingency
Critical activity withno contingency
Non-Critical activitywith no contingency
Critical activity withno contingency Buffer
Agile ScheduleMaking your schedule flow
• Build schedule “buffers” based on task variation– Buffer sizes are determined as half the difference between a safe and an
aggressive estimate– Place within the schedule to protect critical activities from non-critical ones
(FEEDING BUFFER) and to protect the overall project due date(PROJECT BUFFER)
– Buffers are used or ‘run down’ as the project proceeds – recognising whenrisks have not occurred and time has been saved or vice versa`
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Agile PM PIPMG 2017
Copyright © 2017 Trish Melton
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Agile Stakeholders
Vision• Shared vision of success• Benefits focused• Focus on the goal – the
likelihood of success
Contracting• Working out how best to
work together• Communication• Decision making
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
Agile Stakeholders
• Active input toproject benefitsoutcome
• Contracts &comms
TECHNOLOGYTRANSFER
CLINICALTRIALS
PRIMARYFACILITY
PROCESSVALIDATION
50% CHANCEOF SUCCESS
>50%CHANCE
OF CTSUCCESS
50% CHANCEFACILITY
COMPLETEWITHIN
TIMELINE
50% CHANCELINE ACCESS
ISSUES(PEOPLE OREQUIPMENT)
REGULATORYAPPROVAL
LAUNCHSTOCK BUILD
FAIL/PASS PASS FAIL/PASS FAIL/PASS
LAUNCH
<50% CHANCEOF APPROVAL
WITHINTIMELINE
FAIL
> 50% CHANCETHAT ENOUGH
STOCK FORLAUNCH
PASS
> 50% CHANCEDELAY TOLAUNCH
FAIL
GREEN = PASS AMBER = FAIL/PASS RED = FAIL
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Agile Stakeholderskey principles
‘Real’ partnership formation
Understand stakeholder business drivers todetermine waste & value added activities
Agile decision making – identify those best madeearly & those best made late
Flexible development – change is inevitable hencemanage it
Build in robust technical solutions from concept
Use innovative strategies rather than traditionalAgile PM PIPMG 2017Copyright © 2017 Trish Melton
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Agile PM PIPMG 2017
Copyright © 2017 Trish Melton
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Agile StakeholdersCommercial & Regulatory Role
• Commercial• Early Planning
– Market requirements &product indications
– Forecast Volumes
• Later Planning– Link to supply chain -
product inventory - where& when
– Forecast volumes -managing the changes
• Regulatory• Early Planning
– Link to clinical & stabilitystudies
– FDA issues includingNDA submissions
– Technology transfer, e.g.equivalence
• Later Planning– Managing the “clinical
window”– Continuous review of the
facility operation
Agile PM PIPMG 2017
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Agile Project Team
REAL Teamwork• Team goals• Team behaviours• Eliminating errors
& variation
REAL-TIME communication• Project Kanban• Visual Boards
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
Agile Project Team
• Accountable subteams
• Contracts &comms
• Visual Factory
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Agile PM PIPMG 2017Copyright © 2017 Trish Melton
Agile Project TeamResource & Performance Management Issues
• Resource Management– No overall ownership of
resources by any oneproject
– Shared critical expertise– Challenge to get work
package ownership andunderstanding of its placeon the critical path
– Functional priorities maydrive resourcebehaviours
• Performance Management– Focus on portfolio
optimisation needed asmuch as good projectmanagement
– Project prioritisation key aslinked to original projectgoals
– Project Manager’s ‘soft’skills are fundamental togood outcomes
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Agile TeamEliminating Functional Behaviours
• By having Work Package teams with a team target,members focus on a shared goal
• The team work together to complete the package• Increased working across traditional functional boundaries
Agile PM PIPMG 2017Copyright © 2017 Trish Melton
• How can wesolve theproblem?
• Team members stop focusing in on the projectgoals and aim to increase functional efficiency
• UDE of ourproject process
• What’s the realproblem..
• Change measure of success to match thedelivery of value to the Customer and assignclear accountabilities
• We measure functional performance & hold noone accountable for completed packages of“value”
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Copyright © 2017 Trish Melton
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Team Value ManagementControlling leading indicators
• How well we manage our processes determines our ability to deliver on timeand within cost
• We define a specification limit which is outside of the control limits – if theprocess is in control we will always meet specification
This is variationwhich is “natural”
to the process
SpecialCause
identified
TIME
Con
trol
Mea
sure
s
Mean
Upper Control Limit (mean + 3δ)
Lower Control Limit (mean – 3δ)
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Team Visual ManagementPlans and measures come together……
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Team Visual ManagementExample Critical Path of Risks
Red risks
Amber risks
Green risks
DESIGN andPROCUREMENT
High probability ofon-time completion,
meeting budgetand quality goals
0 2 6
QUALIFICATION
Medium probabilityof on-time
completion,meeting budget
and quality goals
0 4 3
CONSTRUCTION
Low probability ofon-time completion,
meeting budgetand quality goals
3 5 1
PROJECTSTART-UP
Lowprobability ofsuccessfulstart-up on
time
COMMISSIONING
Medium probabilityof on-time
completion,meeting budget
and quality goals
0 5 3
Mitigation plans areall trending green
Mitigation plansappear to be
working
Amber risks aretrending to red asmitigation planshave not been
resourced
Mitigation planshave failed and
need contingencyactions ASAP
Build & Monitor the Risk Profile
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Agile PM PIPMG 2017Copyright © 2017 Trish Melton
Agile PrinciplesAn Agile Process
1. WBS
2. WasteAnalysis
3. RiskAnalysis
4. FlowAnalysis
5. ControlAnalysis
Generate the work package structure and contents and then assignresources. Challenge the deliverables list at this point. Team goals agreed
Review the activities and the way the packages interact for any waste andthen eliminate or reduce, Be innovative. Be challenging.
Assess risks likely to have a schedule or benefits impact and developmitigating activities within the schedule and scope
Assess work package variation which is likely to have a schedule orbenefits impact and develop buffers to manage
Develop measures which will confirm the likelihood that the schedule willbe delivered and to what level of predictability. Be visual. Communicate
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Case Study – Product Launch• Typically these product launch projects are:
– Late, over budget and have technical issues whenmanufacturing launch stock causing regulatoryissues
• Development & launch of a new product– Technical, technology and regulatory challenges– Competitive market with a need to launch quickly
• Looking at a simplified WBS based on 5 workpackages (or work streams)
Raw Materials development
Process development
Facility Renovation
Facility Validation Launch Stock Manufacture
Copyright © 2008 Trish MeltonAgile PM PIPMG 2017Copyright © 2017 Trish Melton
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Case Study – Product LaunchAgile Scope Agile Schedule Agile
StakeholdersAgile ProjectTeam
A very high levelWBS with macrodependenciesbetween them
Work Packagesare customised todeliver value (Kanoapproach)
Use of schedulebuffers to managemacrodependenciesbetween workpackages
Development ofmicro scheduleswith buffer
Users integratedinto work packageteams
Work Packagelevelcommunication(Visual Boards)
Team are pulledtogether based onsubject matterexpertise
Daily meetingsaround the visualboard
Team iterate withina WP and own themicro schedule
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Case Study – Product LaunchTraditional Schedule
• All development activities require similar skills– Typically there are delays to the start of the facility renovation– Typically validation is delayed and takes longer– Manufacture typically has a lot of contingency and makes up for
some of the delays
• Typically within this organization:– 50% projects will be late by up to 4 weeks– 35% projects are within a week of target– 15% projects will be early by up to 2
weeks
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Agile PM PIPMG 2017Copyright © 2017 Trish Melton slide 38
Case Study – Product LaunchTraditional Schedule
Duration M1 M2 M4 M5 M6 M7 M8 M9 M10 M11 M12 M13 M14 M15 M16 M17 M18 M19Process Development 24Raw Material (1) development 14Raw Material (2) development 16Facility Rennovation 24Facility Validation 16Manufacture 12
M3
• Typical problems occur on the critical path– Place schedule buffers to FEED CP– Place a schedule buffer to protect the due date
• Conduct a waste analysis on each work package• Determine buffer size through review of estimation
risk
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Agile PM PIPMG 2017Copyright © 2017 Trish Melton
Case Study – Product LaunchResource Loading
• Resource allocation– Challenges the CP– Allows scheduling on non-CP or near CP
day
0.5
1
1.5
Cannot allocate a resourceabove this level
Pers
on 1
Pers
on 2
Pers
on 3
Pers
on 4
Pers
on 5
Work Content for 1 Package Typical response to a resourceload analysis
•Person 1– Working on CP activities– Need an additional resource
•Person 2 & 5– Working on near CP– Leave as is
•Person 3– Working on non CP & CP– Delay non CP to late finish
•Person 4– Working on CP– Give him more work
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Case Study –Product LaunchResource Levelling & Cell working
• We are always trying to maximise use of resourceversus management of the CP
min
s
1
2
3Schedule duration
Work Distribution for 1 Package
Pers
on 1
Pers
on 2
Day
s
1
2
3Schedule duration
Pers
on 1
Pers
on 2
Pers
on 3
Pers
on 4
Pers
on 5
Work Content for 1 Package
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Case Study – Product LaunchBuffer Development
• Identify the schedule duration for an activity onthe CP– Ask the activity owner for a best case (50% probability)
and a worst case (95% probability)– Use the best case duration in the schedule– Take half of the difference between the best and worst
case and place in a buffer (feed or project)– The buffer is available for a number of parallel paths
converging on the CP mid-project or the end date.• During project delivery allow activity owners to
take from the buffer as needed• Track buffer usage
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• The project team build the work breakdown structure from anunderstanding of value specific to the customer
• A schedule risk assessment is completed & contingency allocated toproject buffers
• Activity durations are linked to specific resource profiles• Buffers are placed in parts of the schedule to best protect the delivery of
value to the customer• Schedule risks are evaluated and mitigated
no safetyestimate
safeestimate
BufferSize
+/-50% +/-95% weeks1 Process Development 12 24 62 Raw Material (1) development 10 14 23 Raw Material (2) development 8 16 44 Facility Rennovation 16 24 45 Facility Validation 8 16 46 Manufacture 8 12 2 at end
pre (4)
pre (6)
BufferPlacementTask
Case Study – Product LaunchA New Schedule Management Culture
Copyright © 2008 Trish MeltonAgile PM PIPMG 2017Copyright © 2017 Trish Melton
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Agile PM PIPMG 2017Copyright © 2017 Trish Melton slide 43
Case Study – Product LaunchAgile Schedule
Duration M1 M2 M7 M8 M16 M17 M19Process Development 24Raw Material (1) development 14Raw Material (2) development 16Facility Rennovation 24Facility Validation 16Manufacture 12
Duration M1 M2 M7 M8 M16 M17 M19Process Development 12Raw Material (1) development 10Raw Material (2) development 8FEED BUFFER 1 6Facility Rennovation 16Facility Validation 8FEED BUFFER 2 8Manufacture 8PROJECT BUFFER 2
M12
M12M5
M5 M9
M9
M14
M14
M15
M15
M18
M18
M6
M6
M10
M10
M11
M11
M13
M13
M3
M3
M4
M4
• 20% reduction in planned schedule duration– Agreed resources for all on critical path– Some activities deleted from process development scope– Some dependencies challenged within the validation work package
taking them off the critical path
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Agile PM PIPMG 2017
Case Study – Product LaunchA New Schedule Management Culture
Buffer Run-down• The Schedule buffers are used
to protect the critical activitiesand the agreed projectdeadline
• The team communicate aboutthe work they have left to finishand alert team membersappropriately
• As risks do not occur the teamcan “run-down” the buffers andre-evaluate the end-date
Time
Sche
dule
Buf
fer Plan
Actual
Delivery “early”
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Case Study – Product LaunchAgile Project Schedule Metrics
Weeks to Launch (at end M12) Buffer Usage
Critical Chain Milestones Risk Profile
14 weeks
Buffer Total UsedPre-Facility 6 wks 6 wks
Pre-Manufacture 8 wks 6 wks
Pre-launch 2 wks 0
Process ‘frozen’ by mid M5
Regulatory approval by mid M13
Product Launch by mid M16
Product Performance AmberRegulatory Approval AmberResource Availability GreenEngineering Performance GreenFacility Logistics Amber
Copyright © 2008 Trish Melton
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Case Study – Product LaunchOutcomes
• Product launched when market expected it• Business had an increased level of predictability in
project outcome• Achieved actual delivery of 15 months
– Approx 20% time saving– Approx 5% resource saving
Project delivery style Average Duration(months)
Predictability
Traditional 20 +/- 1 month
Fast Track 16 + 3 months
Agile (case study) 15 +/- 2 weeks
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Copyright © 2017 Trish Melton
Case Study – Product LaunchKey Changes
Changes to Project TeamComposition and WoW (cell)
Strong links to all parts of theproduct supply chain
The Clinical “window” Define& Manage
Uncertainty of success inClinical Trials managed
Working with RegulatoryBodies
Agile techniques to driveinnovation and ownership
R&D working outside“traditional” boundaries
Engineering/manufacturinginvolved earlier
“Engineering” a robustmanufacturing process
“Building in Value” in the eyesof the customer
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Summary
• Lean Six Sigma• Theory of Constraints• Schedule Risk Management
Agility
• Ensures a proactive approach to the management of projectuncertainty
• Enables a way to manage innovation without introducing risk tocompliance – Builds in Compliance
Risk-Based
• Have a shared goal, communicate and partner• Stop “integrating safety” into estimates & being task focussed• Stop multitasking which reduces effectiveness of critical resources• Stop doing things which don’t add value• Recognise that no “one size fits all”
CultureChange
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And finally…• Increased project
speed is onlyuseful if it:– Builds in
compliance– Supports risk
mitigation– Delivers value
Application of AGILE concepts
Change theculture
Take a ‘riskbased approach’
• For more information please contact the author:– Dr Trish Melton: Email: Trish.Melton@mimesolutions.com– Note that the author has given permission for use of specific content
from previous publications– www.mimesolutions.com
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References• Goldratt, E M; “Critical Chain”; The North River Press: ISBN: 0566080389
• Melton, P M, Baker J P & Day C: (Jan, 2001), IChemE PMSG Seminar, ProjectManagement in Pharmaceuticals: From Discovery to Delivery, “Fast Track toLaunch – An Example of How Good Project Management can Support ProductLaunch Strategy”.
• Melton P M (Oct 2002), The Chemical Engineer, “Get Agile – Deliver Faster” – adescription of a faster track project management strategy within the biotechbusiness.
• Melton P M (Sept 2004) The Chemical Engineer, “To Lean or Not to Lean” –examines the benefits of using “lean thinking” on business processes and projectmanagement
• Melton, T; (2009) “Real Project Planning: Developing a Project Delivery Strategy” ;Elsevier: ISBN: : 978-0-7506-8472-9
• Melton, T and Iles-Smith, P; (2009) “Managing Project Delivery: MaintainingControl and Achieving Success”; Elsevier: ISBN: 978-0-7506-8515-3
• Melton P M (April 2007), Project Management – Facing Today’s Challenges, “HotTopic - Can We Do it Any Faster?” considering schedule development andmanagement culture. ISPE Paris Conference
Agile PM PIPMG 2017Copyright © 2017 Trish Melton