Get Agile! Deliver Faster! - PIPMG Agile - Deliver Faster Trish Melton.pdf · Get Agile! Deliver...

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www.mimesolutions.com Agile PM PIPMG 2017 Copyright © 2017 Trish Melton Page 1 Melton Integrated Management & Engineering Solutions MIME Solutions Limited MIME Solutions Limited MIME Solutions Limited Agility Simplicity Innovation Solutions Tel: +44(0)1829 759272 Fax: +44(0)1829 759330 Mob: +44(0)7812 072891 [email protected] www.mimesolutions.com Get Agile! Deliver Faster! A case study demonstrating a value- centred approach to new product launch Melton Integrated Management & Engineering Solutions MIME Solutions Limited MIME Solutions Limited Get Agile! Deliver Faster! A case study demonstrating a value-centred approach to new product launch Agile PM PIPMG 2017 Copyright © 2017 Trish Melton Lean Six Sigma (LSS) & Theory of Constraints (TOC) challenges Fast Track Lean Six Sigma (LSS) & Theory of Constraints (TOC) challenges Fast Track Some 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 IT Agile Principles Application of agile principles Application of agile principles Product Launch What more can we do in Pharma What more can we do in Pharma Next Steps

Transcript of Get Agile! Deliver Faster! - PIPMG Agile - Deliver Faster Trish Melton.pdf · Get Agile! Deliver...

Page 1: Get Agile! Deliver Faster! - PIPMG Agile - Deliver Faster Trish Melton.pdf · Get Agile! Deliver Faster! A case study demonstrating a value-centred approach to new product launch

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Agile PM PIPMG 2017

Copyright © 2017 Trish Melton

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MIME Solutions LimitedAgility Simplicity Innovation Solutions

Tel: +44(0)1829 759272Fax: +44(0)1829 759330Mob: +44(0)7812 072891

[email protected]

Get Agile! Deliver Faster!A case study demonstrating a value-

centred approach to new product launch

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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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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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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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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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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

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 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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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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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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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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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 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

Agile PM PIPMG 2017Copyright © 2017 Trish Melton

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Agile PM PIPMG 2017Copyright © 2017 Trish Melton

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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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 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 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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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 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

Agile PM PIPMG 2017Copyright © 2017 Trish Melton

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Copyright © 2017 Trish Melton

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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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Copyright © 2017 Trish Melton

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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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Copyright © 2017 Trish Melton

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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”

Copyright © 2017 Trish Melton

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Copyright © 2017 Trish Melton

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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

Page 24: Get Agile! Deliver Faster! - PIPMG Agile - Deliver Faster Trish Melton.pdf · Get Agile! Deliver Faster! A case study demonstrating a value-centred approach to new product launch

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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

Agile PM PIPMG 2017Copyright © 2017 Trish Melton

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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: [email protected]– 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