22.08.2018
Webinar
Agile Development of Physical Products
in a Regulatory Environment
8
Page
CO-Improve Consulting
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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
22.8.2018 Webinar - Agile Development of Physical Products in a Regulatory Environment3
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
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◼ 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
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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
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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
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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
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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
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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
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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
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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
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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)
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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
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Case Study 2 – Automotive OEM
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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
Modulgruppen Development Teams
…
PO SMSM
SM
Rohbau Scrum Teams
Modulgruppen Development Teams
…
PO SMSM
SM
Rohbau Scrum Teams
Modulgruppen Development Teams
…
PO SMSM
SM
Rohbau Scrum Teams
Modulgruppen Development 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
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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
Spec with text / model _____AAAAABBBBBB
Spec with text / model _____AAAAABBBBBB
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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Learn from case studies
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The conference for novices and experienced practitioners from R&D, HR, organizational
development
Case Studies, Tutorials and Workshops about the concrete application of agile methods in the
manufacturing industry and the development of agile structures and cultures as swarms organization or
Sociocracy 3.0
http://www.co-improve.com/events/agilehardware-konferenz/agilehardware-2018.html
Agile Learning Visits for executives and practitioners
One concrete agile Case Study including the visit of the working areas and direct conversation with managers, product owners, scrum masters and
development teams
http://www.co-improve.com/events.html#agilelearningjourneyscap
24./25.9.
MEET US AT THE AGILE@HARDWARE CONFERENCE ON SEPTEMBER 24TH/25TH
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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
22.8.2018 Webinar - Agile Development of Physical Products in a Regulatory Environment31
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.