Webinar Agile Development of Physical Products in a ... · Case Study 1 –Pump Company 22.8.2018...

22.08.2018

Webinar

Agile Development of Physical Products

in a Regulatory Environment

8

Page

CO-Improve Consulting

22.8.2018 Webinar - Agile Development of Physical Products in a Regulatory Environment2

COMPANY PROFILE

SUBJECT MATTER-Expertise INDUSTRIE-Competence

Automotive

Machinery

Electronics

CHANGE-Competence

Strategy

Processes

Organization

Achieve sustainable results

We are your partner for agile transformation and high-performance in product development

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PEDCO – Managed Process Services


We help organizations in the set-up, selection, operation and further development of lean and effective processes;

in compliance with the defined product and process guidelines, efficiently and with transparent costs.

COMPANY PROFILE

Applied SAFe®Managed Process Services Training

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Context


◼ Increasing competitive pressure

◼ High innovation levels and high efficiency

◼ Low time-to-market

◼ Industry 4.0, Lean Start up, Agile

◼ Cyber-physical systems, increased complexity and dependency

◼ Just agile teams are to small to build complex systems

◼ Regulatory and organisational environment is becoming ever moredemanding

◼ Most agile delivery teams face compliance requirements(regulatory and/or organizational).

◼ Strategy and governance steering is needed

WHY AGILITY IS NEEDED IN REGULATED ENVIRONMENTS

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The Historical Roots of Scrum


THE PRINCIPLES OF AGILE DEVELOPMENT WERE NOT INVENTED IN SOFTWARE INDUSTRY

The development of agile methods is based on the publication of

in the Harvard Business Review in 1986“The New New Product Development Game”

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complex

complicated

The Stacy-Matrix


AGILE UNFOLDS IS FULL POTENTIAL IN COMPLEX ENVIRONMENTSW

hat

? (r

equ

irem

ents

)

How ? (technology)

Un

cert

ain

un

kno

wn

clea

rkn

ow

n

established new

chaotic

simple

Stacey-Matrix

transparency

inspectadaption

Empirical process control

Reduction of uncertainty by

empirical process control

start with:advanced development

feasibility studiesconcept phase

Agileproject

Original: Strategic management and organizational dynamics, the challenge of complexity. 3rd ed. Harlow: Prentice Hall, 2002Ralph D. Stacey, Adapted: Dirk Meißner

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Scrum does not require any adaptations for physical products


VALUES, PRINCIPLES AND FRAMEWORK REMAIN UNTOUCHED

Stakeholder Product Owner Development Team Scrum Master

Product Vision

Sprint Backlog

Sprint Planning 2

ArtefactEvent

Sprint1-4 weeks

15 min

Product Backlog

Daily Scrum

Product Backlog Refinement

Sprint Review

Product Increment

Sprint Planning 1

Sprint Retrospective

Product

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The biggest 5 challenges can be solved


ADAPTIONS FOR THE AGILE PRODUCT DEVELOPMENT OF PHYSICAL PRODUCTS

Product IncrementsResults are initially never working potentially deliverable results.

Virtual models, simulations or rapid prototypes also provide valuable feedback and directional decisions.

Matrix organization and specialization

Cross-sectional areas ensure standardization and synergies. Experts can not be assigned to 100% individual Scrum teams.

We organize cross-sectional areas with Kanban and work with Scrum teams in a matrix organisation.

Cross-functional teams

Product development does not only require development engineers.

That's why we also integrate purchasing, industrial engineering and other non-development disciplines into the Scrum team.

Large projectsComplex physical products can not be developed by one Scrum team.

There are different Scaling Frameworks like SAFe, Scrum@Scale, LeSS or Nexus that canhandle complex projects

Regulatory requirements

Regulatory authorities require waterfall processes.

That’s a wrong assumption. Scaled Agile frameworks like SAFe have most of the hooks needed for regulatory requirements like ASPICE, FDA, …

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Misunderstanding 1


AGILE IS JUST A NEW PROJECT MANAGEMENT METHOD

practices

rolesevents

artefacts

principles

culturevalues

mind-set

No, agile …

requires a corporate culture based on trust and openness

is based on new principles

requires a new leadership

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Misunderstanding 2


AGILE WORKS WITHOUT PROCESSES

No, …

We continue to apply our individual process elements, methods and tools and also comply with regulatory requirements

ProjektplanungKonzept

ProduktgestaltungSerieneinführung

Konzept-

freigabe

Produkt-

freigabeEntwicklungs-

freigabe

Projekt-

genehmigungProjekt-

start

Projektmanagement

Design-to-Cost

Validierung

Anforderungsmanagement

Konstruktion

Musterbau

Qualitätsmanagement

Einkauf

Fertigungsplanung

Produktion

Serie

Lastenheft-

freigabe

M2

Projekt-

genehmigung

M3

Pflichtenheft-

freigabe

M4

Konzept-

freigabe

M5

Vorabserien-

freigabe

M6

Pilotserien-

freigabe

M8

Produkt-

freigabe

M9

Projektab-

schluss

M10

Entwicklung-

freigabe

M7

Projekt-

start

M1

we do not create complete specifications at the beginning of a project, disintegrate the sequential stage-gate systematic and work cross-functionally and incrementally according to value-oriented priorities

but, …

Product Vision

Sprint Backlog

Sprint Planning 2

Sprint

1-4 weeks

15 min

Product Backlog

Daily Scrum

Product Backlog Refinement

Sprint Review

Product Increment

Sprint Planning 1

Sprint Retrospective

Product

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Misunderstanding 3


WE HAVE TO DELIVER A „POTENTIALLY SHIPPABLE INCREMENT“ AT THE END OF EVERY SPRINT

No, …

we deliver something “complete" to which our customers and stakeholders can give feedback.

this may also be virtual models, simulations or rapid prototypes.

virtual development methods, 3D printing and augmented reality help us demonstrate product increments earlier than ever before.

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Case Study 1 – Pump Company


SCRUM AND KANBAN COMBINED

Agile AwarenessIn executive board

January 2016

Step 1Product family as

Scrum PilotApril 2016

1 PO, 1 SM

hydraulics, mechanics, firmware, electronics

Kanban Team

Plattform und Technologie

Kanban Team

Hardware

Kanban Team

Prüffeld

Scrum Team

Kompaktpumpen

Scrum Team

Antriebe

Scrum Team

Systeme

Scrum

Master Master

Agile CoachSync Team

Step 2Conversion of the whole

Product range of “pump systems” and “drives”

until September 20173 Scrum teams, 3 Kanban teams

in one location

accompanyingteam and

individual coaching

Step 4Rollout outsidedevelopment

from August 2018

Sprint-length4 weeks

Advantages▪ Shorter development times▪ Better fulfillment of market requirementsby▪ High transparency▪ Open dealing with problems▪ Reduction of technical debt

Step 3Rollout on all locations

until march 2018

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Trends in Scaled Agility (12th State of Agile Report by Version One; April 2018)


OVERVIEW IN USAGE OF THE MOST COMMON AGILE FRAMEWORKS

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SAFe - #1 Framework for Scaled AgilitySCALING UP FROM TEAM TOWARDS PROGRAM, LARGE SOLUTION, PORTFOLIO AND ENTERPRISE

More Details on www.scaledagileframework.com

1. Alignment

2. Built-In Quality

3. Transparency

4. Program execution

Core Values


http://www.scaledagileframework.com/

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Case Study 2 – Automotive OEM


SCALED SCRUM TO DEVELOP A NEW E-PASSENGER CAR FAMILY

Announcementto become agile

by the CEOin Sep 16

The e-car projectwas most appropriatedue to it’s complexity

Scrum teams wereestablished inseveral waves

4 → 50Jan 17 - today

Sprint-length2 weeks

Advantages▪ Shorter reaction times▪ Better fulfillment of market requirementsby▪ High transparency▪ Cross-functional co-operation▪ Faster decisions

A cross-functional teamderived the

suitable scaled approachNov 16 – Jan 17

PO SM

POPO PO PO PO

PLAS Scrum Team

PO

PO SM

POPO PO PO PO

PLQ Scrum Team

PO

PO SM

POPO PO PO PO

PLED Scrum Team

PO

PO SM

POPO PO PO PO

PLD Scrum Team

PO

PO SM

POPO PO PO PO

PLC Scrum Team

PO

PO SM

POPO PO PO PO

PLM Scrum Team

PO

PO SM

POPO PO PO PO

PLPP Scrum Team

PO

PO SM

POPO PO PO PO

PLPF Scrum Team

PO

APO SM

LPOLPO LPO LPO LPO

Scrum Team Production

LPO

PO SMSM

SM

Rohbau Scrum Teams

Modulgruppen Development Teams

…

PO SMSM

SM

Rohbau Scrum Teams


…

PO SMSM

SM

Rohbau Scrum Teams


…

PO SMSM

SM

Rohbau Scrum Teams


…

PO SMSM

SM

Rohbau Scrum Teams


…

PO SM

APO

APOAPO

APO APO APO APOAPO

APO

APO

Scrum Team Vehicle

Stakeholder

Line Organization

GPO SMSM

SM

Scrum Teams Structure

Development Teams

…

IPO SMSM

SM

Scrum Teams

Integration

Development Teams

…

QPO SMSM

SM

Scrum Teams

Cross-functional services

Development Teams

…

APO SM

GPO

GPOGPO

GPO GPO

Scrum Team Engineering

GPO IPOQPO

LPO

LPO

Completely new“fancy” project area

decision-makersCTO+1

are on the project areabi-weekly

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VARYING LEVELS OF CRITICALITY, FROM SAFETY-CRITICAL TO SECURITY-CRITICAL

Scaled Agility in Complex or Regulated Environments

▪ Quality: Have a managed process & established QMS

▪ Safety and Security: Transparency in Execution & Continuous Compliance

▪ Effectiveness: Manage Process & Solution variations, reduce waste and do exactly what is needed

▪ Traceability: Ensure process & product compliance

▪ Verification and Validation: Engineering based on Principles & Practices


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Applied SAFeA CUSTOMIZABLE IMPLEMENTATION OF SAFE AS A PROCESS MODEL

Customize and Extend

Develop Compliant

Implement SAFeFast & Precise

Learn, Innovateand Improve


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Quality: Have a managed process▪ Systematic and responsive quality management to enable a controlled

process; in fact establish an agile quality management system▪ Establish Organizational Process Focus: Learn, innovate and improve▪ Reliability and correctness of product; e.g. with emergent design


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Quality processes needed for agile organizationsPROCESSES FOR COMPLIANCE WITHIN REGULATED ENVIRONMENTS

▪ Pilot, train and verify processes improvements & process changes.

▪ Learn as a system, not as individuals.▪ Share available knowledge.▪ Use defined metrics.▪ Work with proven best practices.▪ Ensure that knowledge doesn’t get lost▪ Inspire people to question the status

quo. ▪ Ensure feedback cycles and structured

improvement of PAL.


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Activities as part of each processAPPLIED SAFE IMPLEMENTATION DETAIL

Activities are the main element for process users; these descriptions have to be understandable and must contain: ▪ Role according the RASCI ▪ Phase performed ▪ Predecessor and successor activities ▪ Input and output work products.

Activities do not contain any secondary information like ‘How to ...’.; this belongs to a practice.


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Practices APPLIED SAFE IMPLEMENTATION DETAILS: STRUCTURED PRIORIZATION WITH WSJF

While activities tell you what to do, practices describe how something can be done.▪ A practice is a profound description of

how to do something. ▪ A practice is a method or technique that

has consistently shown superior results▪ Practice can evolve to become better as

improvements are discovered. ▪ Practices indicates training


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Work Product Models DEFINE RELATIONS BETWEEN DEFINED WORK PRODUCTS

Work Products are grouped in packages. Provides for each package on each level an overview of the work products and their direct relations. ▪ They are a great help in order to

understand dependencies on a larger scale.

▪ Navigable work product models ease the navigation and enable another view to processes and its results.

▪ Work products are shown in their relationships and with their direct relations out side of the package.


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Traceability: Ensure process & product compliance• Systematic and responsive quality management to enable a controlled

process; in fact establish an agile quality management system.

• Reliability and correctness of product;

e.g. with emergent design


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Process Design for regulated EnvironmentsPROCESSES NEED TO COMPLY, NOT TO REPLICATE A REFERENCE MODEL


Map

ped

, har

der

fo

r A

sses

smen

t &

QA

, o

pti

miz

ed fo

r u

sage

in c

om

pan

y

Reference Model• Process Area 1

• GP 1.1• GP 1.2• …

• Work Products• WP 1• WP 2• …

Company Process Model• Process Area 1

• GP 1.1• GP 1.2• …

• Work Products• WP 1• WP 2• …

Easy for Assessment

CMMI• Process Area X

• GP x.1• GP x.2• …

• Work Products• WP x1• WP x2

• …

AS9100• Process Area Y

• GP y.1• GP y.2• …

• Work Products• WP y1• WP y2

• …

A-SPICE 3.0• Process Area Z

• GP z.1• GP z.2• …

• Work Products• WP z1• WP z2

• …

Custom• Process Area W

• GP w.1• GP w.2• …

• Work Products• WP w1• WP w2

• …

My Company Process Model• Epic Kanban

• What I do• The way we like it• Is better for us

• Work Products• SAD• CM Plan• …

• Roles• Business Owner• Developer• Tester

Spec with text / model _____AAAAABBBBBB




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...and identify gaps.

Assure Compliance to Reference ModelsENSURE COMPLIANCE WITH A SUSTAINABLE MECHANISM; AVOID INTERPRETATION GAMES

Map standard requirements...

...to defined process assets

© PEDCO AG 2016, Applied SAFe® all rights reserved


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Lessons Learned


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Lessons Learned (1/2)OF SCALED AGILE APPLICATIONS/MAPPINGS TO VARIOUS REFERENCE MODELS

Regulated requirements have common background▪ Mapping of scaled agility to reference model is surprisingly straight

forward, once the lean-agile mindset is understood▪ Avoid the bear trap: Map compliance elements always to value adding

deliverables▪ Automate mechanisms to prove mapping to reference models

-> reduce discussion time and interpretation games▪ Some reference models ask for process- and product-specific

requirements -> Scope those requirements for purpose

Compliance is often a ‘negotiation game’▪ Don’t forget the human element of stakeholders & appraisers▪ Solution Intent and agile Design control needs to be established

Demonstrate compliance in small iterations based on flow▪ Avoid ‘quality depth’; do not ‘build in’ compliance at the end of

development▪ Treat audits like a normal system demo▪ Focus on outcomes

Read/use available sources; e.g:▪ Software Engineering Institute: ‘Scaling Agile

Methods for Departments of Defense Program

▪ CMMI Institute: ‘A Guide to Scrum and CMMI’

▪ TIR45 from AAMI: ‘Agile practices in the development of medical device software’


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Lessons Learned (2/2)OF SCALED AGILE APPLICATIONS/MAPPINGS TO VARIOUS REFERENCE MODELS

Some experience:▪ A mapping of Scaled Agile Frameworks to reference

models is achievable within a lower number of weeks.

▪ Depending on the attributes of a solution or on existing documentation the form of ‘DoD’s can vary very much.

▪ Commercial frameworks such as SAFe or others are an excellent starting point to be applied in the development of high assurance systems.

Separate ‘What shall be done’ from ‘How something is done’▪ Model only necessary steps in the process

▪ Build and rely on heuristics to model the process for usage

▪ Ensure that practices can be changed/selected easily by performers

Quality Management System▪ Let the QMS be easily accessible and easy to use.

▪ Promote transparency for each endeavor, process instantiations need to be specialized to reduce waste.

▪ Allow fast process changes and pilot in appropriate levels.

▪ Allow process users to perform tailoring themselves in a controlled and easy way. Trust that they will do it good!


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Thanks for your interest and attention

CO-Improve ConsultingDirk Meißner

CEO & Founder

• Certified Scrum@Scale Practitioner, SAFe 4.5 Program Consultant (SPC), Professional Scrum Master (PSM I), Certified Scrum Master (CSM), Certified Product Owner (CSPO), Certified Agile Leader (CAL I)

• Studied Aeronautical Engineering (Dipl.-Ing.) and Business Administration (Dipl. Kfm)

• 9 years industry experience in aerospace and defense program management

• 22 years consulting experience in the manufacturing industry


PEDCOPeter Pedross

CEO & Founder

• Certified in SAFe, DAD, EFQA, CMMI, PMI.• Studied Software Engineering, Finance and Management Psychology• World-wide responsible for lifecycles, processes, methods and tools at a

leading Swiss financial institute• Several publications and lectures since 1995 in USA, Japan and Europe.• Encountered first experience with Agile in 1999 (XP)• President of the board for computer science at the Swiss Association of

Quality and member of the board of directors.

Webinar Agile Development of Physical Products in a ... · Case Study 1 –Pump Company 22.8.2018...

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