verhaert innovation day 2012 - luc van goethem & frederik wouters (verhaert) - risk &...

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October 26th 2012 Slide 1

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Risks and requirements in NPD

Frederik Wouters

Director Business Development

[email protected]

Luc Van Goethem

Consultant Applied Physics and Systems

[email protected]

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Main causes for new product failures

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Scope

This sessions focus is on the NPD process and the risk not having

an adequate deliverable (product) as an output.

Product risk is handled for those aspects influenced by the NPD

process

Innovation Process

FEI NPD NPI

Front End of Innovation New Products Development New Products Introduction

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Early risk assessment

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Early stage risk assessment: why?

Wait for the risk to come true ?

More freedom to adjust in early project phases

=> Early detection of risk allows for measures at

lower cost and with less impact on schedule

=> Learn to fail fast !

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Uncontrolled learning curve

“The further we get in the process,

the more we get to know”.

This induces important

risk/cost/schedule impacts

Normal

Time

Learning curve

System specification

Conceptual design

Detailed design

Tooling / purchase

Integration

Test

Cost curve

Time

System specification

Conceptual design

Detailed design

Tooling / purchase

Integration

Test

Late changes can invoke a lot of

rework > impact on planning & cost.

Illustrated by the project cost profile

is exponential from start and end.

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Reverse the learning curve

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An Approach to reverse the learning curve

Avoid unnecessary risk:

Define / Limit the level of innovation according objectives

Identify remaining risk:

Review if you have a clear set of requirements: identify TBD’s/TBC’s.

Ensure that you properly understand the requirements and that

there is a consensus, identify YOUR risks (level of knowledge).

Are all disciplines /aspects covered before starting the next phase (also

human aspects!)

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An Approach to reverse the learning curve

Move it to the front end:

Plan to mitigate risk and allocate priorities in a solid development plan

Ensure that requirements/functions/performance, … can be met. This

might involve early verification (e.g. by breadboarding)

Get control on the process:

Plan project buffers instead of task buffers to protect your project

Set-up a control system and a transparent documentation (configuration

control)

Strategic / tactical and operational levels

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Risk assessment

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Types of risk

Product risk • Legal and regulatory requirements such as ISO 9001, VDE, UL, FCC, FDA, CE, machinery directive,

ROHS,…

• Functional risks

• Reliability

• Lifetime

• Quality

• Performance

• Product cost

• Human factors

• Service cost / warranty cost

Project risk • Project timing

• Project cost

• Performance

• Resources (human, investments,…)

• Quality

• IP

• Tools

• Market and competitors

Business risk

Enterprise risk

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Risk sources

Project Management

• Top management eg resources overcommitted, conflicting inter-project priorities

• Planning eg impossible schedule commitments, no integrated planning and control

• Project management eg Poor control of design changes, Poor control of customer changes

• No project cost accounting ability

• Conflicting project priorities

• Poorly organized project office

Financial eg Currency rate fluctuations

Natural disasters

Vandalism, sabotage or unpredicted side effects

Market risk

Operational risk

Media

Technical

• Technology changes

• Project failures

Legal & regulatory

• Violating trade marks and licenses

• Unforeseen regulatory requirements

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Risk assessment: role in overall risk management

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Overview risk assessment tools

31010 IEC 2009

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FMECA intro

Failure Mode and Effects Analysis (FMEA)

Failure Modes, Effects and Criticality Analysis (FMECA)

FMECA is a bottom up risk assessment tool, typically used to assess technical risks.

Goals

• to identify potential failure modes for a product or process,

• to assess the risk associated with those failure modes,

• to rank the issues in terms of importance

• to address the most serious concerns

• to identify and carry out corrective actions

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FMECA items

Component

Function (product break down / BOM should be available)

Failure modes

Failure effect

Current controls & detections

Ratings

• Severity

• Probability

• Detectability

• RPN risk priority number

Recommended actions

New RPN (to evaluate effectiveness)

Actions chosen

Item owner

Follow up to completion

…….

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FMECA: functional level or piece-part level?

Functional FMECA

• Considers the failures at the functional block level (e.g. a power supply)

• This method can be used early in the design process.

• Provides more overview / insight in system interactions and dependencies.

Piece part FMECA

• Considers the individual components (e.g. a transistor)

• Used when a detailed design is available

• A piece part FMECA provides more in depth evaluation.

• A piece part FMECA requires far more effort.

Tailoring of FMECA

• Determine the level of detail according to the needs and type of product

• Start at functional level and dig deeper where needed

• Maximise your “return on investment”

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FMECA: Strengths & weaknesses

Strengths:

• Avoid costly modifications by the early identification of design deficiencies……if used early

• Provide an understanding of the factors which influence the reliability of the system

• To provide proof that care has been taken to ensure that the design will meet its specification in

service.

Weaknesses:

• FMEA can be a time/resource consuming & inefficient process … see tailoring

• Inability to deal with multiple-failure scenarios or unplanned cross-system effects.

• Software/hardware interactions

• Human interactions with hardware

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Main reasons for an ineffective FMECA !!

Organisation / management level:

• Lack of follow-up to insure implementation

• Not enough support of management

Typically 50% of field problems can occur at interfaces or integration with the

system.

Disconnect between FMEA and company information

• Eg Field failure data

• Eg previous products design

The FMEA is not completed during the "window of opportunity”.

-> functional FMEA early in design process

-> Piece part FMEA should be available at design reviews

Failure to get to root cause.

-> Expert input is necessary.

-> Should be team action

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Is a typical top down risk assessment tool

Fault tree analysis FTA

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Strengths of FTA

• A disciplined approach which is highly systematic

• Flexible enough to allow analysis of a variety of factors, including human

interactions and physical phenomena.

• The application of the "top-down" approach focuses attention on those effects of failure

which are directly related to the top event.

• The pictorial representation leads to an understanding of the system behaviour and

the factors

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How can risk assessment help you in

meeting requirements ?

Use risk assessment tools to select the most promising concepts / exclude the

most risky concepts

• Use major requirements as top event in a FTA

• Use functional FMECA in the concept faze of NPD

FMECA: use the requirements as basic input for the ratings

• Eg the severity of an image defect in an office printer is much lower than

for a medical diagnostic printer

• Eg the severity rating for a low budget hand tool will be much lower than

for a professional craftsmen tool.

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Gathering Requirements

Requirements elicitation tools

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27.09.2012

Slide 14

Reporting & communication

Risk register / Risk Breakdown Structure

•Set priorities to keep focus on added value: risk score ranking

•Communicate with stakeholders

•Track and control

•Assign responsibilities

•Reporting is incidental to good RM, not the sole focus of it!

•If you only focus on reporting, you will not motivate the required culture change

•Weakness: combinatorial risks, illusion of control

N°Category

DescriptionProba-

bility

ImpactScore

MitigationContin-

gency

Respon

sible

Due

date

sw

no sw tester

plan stafftest by test

eng

pm

projectmulti-site

teams

pm

sales

no sales buy-in

taste

no taste testing

with proto

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It’ s not a Santa Claus list

Aim high to land in the middle does

not work in product development!

Remember we search for added value,

being a balanced concept

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October 26th 2012 Slide 27 23.10.2009

Market requirements vary.

Custom needs shift.

New regulations are passed.

Technology evolves.

Engineers find better ways

Don’t fix all of you specifications

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October 26th 2012 Slide 28 23.10.2009

To specify in excessive detail.

The customer overspecified the requirements and now we're contractually required

to build it this way. Does he think he's an engineer?

To specify excessive capability.

As usual the customer overspecified the requirements, it's like asking for a car that

sits 20 and fits in compact car's parking space

Don’t Overspecify

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Option management & requirements

Be aware of extra risk due to design changes (schedule,

cost, impact on other design items, …)

Examples:

Hot cold treatment:

• Temperature target 2 °C very demanding

and not usefull for treatment

Borehole measurement:

• 5 µm target very demanding , set by quality department

and not usefull for end user (production)

Overspecified Underspecified

Risk reduction Buffer Options

Risk increase Cost / Timing Late changes

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Determine user group

willingness & motivation

ability to learn

medical condition

physical abilities & fatigue,

mental & emotional state

level of education

…

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User Centred Design strategies

Less dependent of abilities of the user

more accomodating of disabilities

from unpacking until disposal

Matching environmental conditions

For different conditions of us :

Intended use

Intended misuse

Unintended use

Unintended misuse

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Life cycle requirement

Safety

Security

Reliability

Maintainability

Resilience

Availability

Confidence

Fault prevention

Fault tolerance

The ability to deliver

a service that can be

trusted.

Ability to perform as

and when required

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Dependability requirements

i.e. define a safe system (dependability)

• generate requirements to ensure the root causes of risks are avoided

• ensure risk doesn’t arise

• ensure if it arises it doesn’t develop into an incident

• ensure damage is minimised

• ensure if damage occurs cost of recovery is minimised

-> generate requirements that ensure there is a high probability that these safety

functions will be available

Requirements that specify the detection, isolation, diagnosis, and recovery of the system

from failures and its restoration to an acceptable state and therefore a level of fault

tolerance, fault handling and fault recovery, diagnostic & error messages

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Requirements pitfalls

Difficulties in implementing these requirements due to

misunderstanding

unclarity

ambiguity

inconsistent

conflicting

unverifiable

imprecise

incorrect

incomplete

Be careful not to specify on the lower level

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Requirements recommendations

Need for requirement tracebility

Prioritisation of requirements

Incremental commitment

Rich definitions & Visual thinking

Human, technical and economic aspects should be balanced

Just good enough

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Requirement management as a process

• Business requirements

• User requirements

• Functional requirements

• Product requirements

• Architectural or system requirements

• Design requirements

• Risk & Safety requirements

• …..

Pe

rfo

rma

nce

Ris

k

Str

ate

gy

Co

st

Tim

ing

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It takes more than a ‘moment’

Risk management

Active Requirements management

Succesfull

projects

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Hogenakkerhoekstraat 21

9150 Kruibeke (B)

tel +32 (0)3 250 19 00

fax +32 (0)3 254 10 08

[email protected]

More at www.verhaert.com

VERHAERT MASTERS IN INNOVATION® Netherlands

European Space Innovation Centre

Kapteynstraat 1

2201 BB Noordwijk (NL)

Tel: +31 (0)633 666 828

[email protected]

More at www.verhaert.com

VERHAERT MASTERS IN INNOVATION® helps companies and governments to innovate.

We design products and systems for organizations looking for new ways to provide value

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verhaert innovation day 2012 - luc van goethem & frederik wouters (verhaert) - risk &...

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