CONFIDENTIAL
October 26th 2012 Slide 2
RISKS AND REQUIREMENTS IN NPD
CONFIDENTIAL
Luc Van Goethem
Consultant applied physi...
CONFIDENTIAL
October 26th 2012 Slide 3
CONFIDENTIAL
October 26th 2012 Slide 4
Main causes for new product failures
CONFIDENTIAL
October 26th 2012 Slide 5
CONFIDENTIAL
October 26th 2012 Slide 6
Scope
This sessions focus is on the NPD process and the risk not having
an adequate...
CONFIDENTIAL
October 26th 2012 Slide 7
CONFIDENTIAL
Early risk assessment
CONFIDENTIAL
October 26th 2012 Slide 8
Early stage risk assessment: why?
Wait for the risk to come true ?
More freedom to ...
CONFIDENTIAL
October 26th 2012 Slide 9
Uncontrolled learning curve
“The further we get in the process,
the more we get to ...
CONFIDENTIAL
October 26th 2012 Slide 10
Reverse the learning curve
CONFIDENTIAL
October 26th 2012 Slide 11
An Approach to reverse the learning curve
Avoid unnecessary risk:
 Define / Limit...
CONFIDENTIAL
October 26th 2012 Slide 12
An Approach to reverse the learning curve
Move it to the front end:
 Plan to miti...
CONFIDENTIAL
October 26th 2012 Slide 13
CONFIDENTIAL
Risk assessment
CONFIDENTIAL
October 26th 2012 Slide 14
Types of risk
Product risk
• Legal and regulatory requirements such as ISO 9001, V...
CONFIDENTIAL
October 26th 2012 Slide 15
Risk sources
Project Management
• Top management eg resources overcommitted, confl...
CONFIDENTIAL
October 26th 2012 Slide 16
Risk assessment: role in overall risk management
CONFIDENTIAL
October 26th 2012 Slide 17
Overview risk assessment tools
31010 IEC 2009
CONFIDENTIAL
October 26th 2012 Slide 18
FMECA intro
Failure Mode and Effects Analysis (FMEA)
Failure Modes, Effects and Cr...
CONFIDENTIAL
October 26th 2012 Slide 19
FMECA items
Component
Function (product break down / BOM should be available)
Fail...
CONFIDENTIAL
October 26th 2012 Slide 20
FMECA: functional level or piece-part level?
Functional FMECA
• Considers the fail...
CONFIDENTIAL
October 26th 2012 Slide 21
FMECA: Strengths & weaknesses
Strengths:
• Avoid costly modifications by the early...
CONFIDENTIAL
October 26th 2012 Slide 22
Main reasons for an ineffective FMECA !!
Organisation / management level:
• Lack o...
CONFIDENTIAL
October 26th 2012 Slide 23
Is a typical top down risk assessment tool
Fault tree analysis FTA
CONFIDENTIAL
October 26th 2012 Slide 24
Strengths of FTA
• A disciplined approach which is highly systematic
• Flexible en...
CONFIDENTIAL
October 26th 2012 Slide 25
How can risk assessment help you in
meeting requirements ?
Use risk assessment too...
CONFIDENTIAL
October 26th 2012 Slide 26
Gathering Requirements
Requirements elicitation tools
FIDENTIAL
27.09.2012
Slide 1...
CONFIDENTIAL
October 26th 2012 Slide 27
It’ s not a Santa Claus list
Aim high to land in the middle does
not work in produ...
CONFIDENTIAL
October 26th 2012 Slide 28
23.10.2009
Market requirements vary.
Custom needs shift.
New regulations are passe...
CONFIDENTIAL
October 26th 2012 Slide 29
23.10.2009
To specify in excessive detail.
The customer overspecified the requirem...
CONFIDENTIAL
October 26th 2012 Slide 30
Option management & requirements
Be aware of extra risk due to design changes (sch...
CONFIDENTIAL
October 26th 2012 Slide 31
Determine user group
willingness & motivation
ability to learn
medical condition
p...
CONFIDENTIAL
October 26th 2012 Slide 32
User Centred Design strategies
Less dependent of abilities of the user
more accomo...
CONFIDENTIAL
October 26th 2012 Slide 33
Life cycle requirement
Safety
Security
Reliability
Maintainability
Resilience
Avai...
CONFIDENTIAL
October 26th 2012 Slide 34
Dependability requirements
i.e. define a safe system (dependability)
• generate re...
CONFIDENTIAL
October 26th 2012 Slide 35
Requirements pitfalls
Difficulties in implementing these requirements due to
misun...
CONFIDENTIAL
October 26th 2012 Slide 36
Requirements recommendations
Need for requirement tracebility
Prioritisation of re...
CONFIDENTIAL
October 26th 2012 Slide 37
Requirement management as a process
• Business requirements
• User requirements
• ...
CONFIDENTIAL
October 26th 2012 Slide 38
It takes more than a ‘moment’
Risk
management
Active
Requirements
management
Succe...
CONFIDENTIAL
October 26th 2012 Slide 39
VERHAERT MASTERS IN INNOVATION®
Headquarters
Hogenakkerhoekstraat 21
9150 Kruibeke...
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Innovation day 2012 11. luc van goethem & frederik wouters - verhaert - 'risk & requirements cooperating or counteracting forces in the process'

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Innovation day 2012 11. luc van goethem & frederik wouters - verhaert - 'risk & requirements cooperating or counteracting forces in the process'

  1. 1. CONFIDENTIAL October 26th 2012 Slide 2 RISKS AND REQUIREMENTS IN NPD CONFIDENTIAL Luc Van Goethem Consultant applied physics and systems Luc.vangoethem@verhaert.com
  2. 2. CONFIDENTIAL October 26th 2012 Slide 3
  3. 3. CONFIDENTIAL October 26th 2012 Slide 4 Main causes for new product failures
  4. 4. CONFIDENTIAL October 26th 2012 Slide 5
  5. 5. CONFIDENTIAL October 26th 2012 Slide 6 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
  6. 6. CONFIDENTIAL October 26th 2012 Slide 7 CONFIDENTIAL Early risk assessment
  7. 7. CONFIDENTIAL October 26th 2012 Slide 8 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 !
  8. 8. CONFIDENTIAL October 26th 2012 Slide 9 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.
  9. 9. CONFIDENTIAL October 26th 2012 Slide 10 Reverse the learning curve
  10. 10. CONFIDENTIAL October 26th 2012 Slide 11 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!)
  11. 11. CONFIDENTIAL October 26th 2012 Slide 12 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
  12. 12. CONFIDENTIAL October 26th 2012 Slide 13 CONFIDENTIAL Risk assessment
  13. 13. CONFIDENTIAL October 26th 2012 Slide 14 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
  14. 14. CONFIDENTIAL October 26th 2012 Slide 15 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
  15. 15. CONFIDENTIAL October 26th 2012 Slide 16 Risk assessment: role in overall risk management
  16. 16. CONFIDENTIAL October 26th 2012 Slide 17 Overview risk assessment tools 31010 IEC 2009
  17. 17. CONFIDENTIAL October 26th 2012 Slide 18 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
  18. 18. CONFIDENTIAL October 26th 2012 Slide 19 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 …….
  19. 19. CONFIDENTIAL October 26th 2012 Slide 20 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”
  20. 20. CONFIDENTIAL October 26th 2012 Slide 21 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
  21. 21. CONFIDENTIAL October 26th 2012 Slide 22 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
  22. 22. CONFIDENTIAL October 26th 2012 Slide 23 Is a typical top down risk assessment tool Fault tree analysis FTA
  23. 23. CONFIDENTIAL October 26th 2012 Slide 24 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
  24. 24. CONFIDENTIAL October 26th 2012 Slide 25 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.
  25. 25. CONFIDENTIAL October 26th 2012 Slide 26 Gathering Requirements Requirements elicitation tools FIDENTIAL 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 Description Proba- bility Impact Score Mitigation Contin- gency Respon sible Due date sw no sw tester plan staff test by test eng pm project multi-site teams pm sales no sales buy-in taste no taste testing with proto
  26. 26. CONFIDENTIAL October 26th 2012 Slide 27 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
  27. 27. CONFIDENTIAL October 26th 2012 Slide 28 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
  28. 28. CONFIDENTIAL October 26th 2012 Slide 29 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
  29. 29. CONFIDENTIAL October 26th 2012 Slide 30 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
  30. 30. CONFIDENTIAL October 26th 2012 Slide 31 Determine user group willingness & motivation ability to learn medical condition physical abilities & fatigue, mental & emotional state level of education …
  31. 31. CONFIDENTIAL October 26th 2012 Slide 32 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
  32. 32. CONFIDENTIAL October 26th 2012 Slide 33 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
  33. 33. CONFIDENTIAL October 26th 2012 Slide 34 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
  34. 34. CONFIDENTIAL October 26th 2012 Slide 35 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
  35. 35. CONFIDENTIAL October 26th 2012 Slide 36 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
  36. 36. CONFIDENTIAL October 26th 2012 Slide 37 Requirement management as a process • Business requirements • User requirements • Functional requirements • Product requirements • Architectural or system requirements • Design requirements • Risk & Safety requirements • ….. Performance Risk Strategy Cost Timing
  37. 37. CONFIDENTIAL October 26th 2012 Slide 38 It takes more than a ‘moment’ Risk management Active Requirements management Succesfull projects
  38. 38. CONFIDENTIAL October 26th 2012 Slide 39 VERHAERT MASTERS IN INNOVATION® Headquarters Hogenakkerhoekstraat 21 9150 Kruibeke (B) tel +32 (0)3 250 19 00 fax +32 (0)3 254 10 08 ezine@verhaert.com 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 willard.vanderheijden@verhaert.com 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 for their customers. We are a leading integrated product innovation center; creating technology platforms, developing new products and business in parallel, hence facilitating new-growth strategies for our clients.

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