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© 2009 IBM Corporation
®
Requirement Management as a Key Area in e-PLM
PLM Solution RoadShow 2009
IBM Software Group – Product Lifecycle Management
2
목 차
제품개발환경변화에따른대응방안제품개발환경변화에따른대응방안III
e-PLM환경에서의핵심영역e-PLM환경에서의핵심영역IIIIII
요구사항관리솔루션(DOORS) 소개요구사항관리솔루션(DOORS) 소개IIIIIIIII
DOORS - PLM솔루션 IntegrationDOORS - PLM솔루션 IntegrationIVIVIV
DOORS 적용기대효과DOORS 적용기대효과VVV
IBM Software Group – Product Lifecycle Management
3
Product Complexity is Increasing Product Development is Fragmented
Shorter Product Lifecycles Complex Development Organizations
IBM Software Group – Product Lifecycle Management
4
Product Development Improvement Goals
Accelerate Product Time to Market
Improve Product Quality Reduce Product Development Costs
Design Chain Collaboration
Regulatory Compliance New Product Innovation
IBM Software Group – Product Lifecycle Management
5
Complex systems require more types of people working together
Cadence Mentor Catia /UG
Traditional PLM/PDM Domain
Electrical Engineering I.C. Engineering Mechanical EngineeringProduct Management
DOORS
Systems Engineering
DOORS/TAU
Software Engineering
Synergy/TAU Cadence Mentor Catia/UG
Market Planning Concept Design
Complex systems require a ‘holistic’ view of data
Change Requests Impact Analysis Requirements Visibility
Traditional ALM Domain
Future PLM Domain
IBM Software Group – Product Lifecycle Management
6
Key Problem: Vertical Silos
Inconsistent rules and processes, that are not being followed by all stakeholders
Isolated information reduces the productivity of the entire team -> Problems occur at integration stages late in lifecycle
Limited traceability ofartifacts and business objects
Minimal reuse of artifacts and minimal process control
Reliance on document-centric communication
Lack of visibility into total development status
Labor intensiveInsider Know-HowFaulty transfers
IterativeProcess V Process V Process
MCAD E/E
HWAssets
SW Development
Assets
EEAssets
SW Governance
???
IBM Software Group – Product Lifecycle Management
7
Most PLM Environments today do not have the required level ofprocess, data and application integration
Product Architects
ProgramManager
PortfolioPlanning
Manufacturing Execution
Enterprise Resource
Management
Other Enterprise Applications
Enterprise Application Systems
RequirementsManagement
Data Management
Mechanical Authoring
Data Management
Electrical Authoring
Data Management
Software Authoring
Data Management
Analysis & Simulation
StorageSoftwareServers
Product Engineers Quality Operations Sales Service
Enterprise Product Data Mgmt ECR ECOActionActionAction
ECOECO
Critical enterprise applications often isolated
Limited Integration of Authoring Applications – much manual effort
User data access is isolated to application silos
Poor integration of enterprise PDM and other business systems
IBM Software Group – Product Lifecycle Management
8
Extended PLM Solutions to Meet Customer’s Objectives
Portfolio PlanningPortfolio Planning
Concept Development
Concept Development
Product Design
Product Design
Production & Testing
Production & Testing
Sales & ServiceSales & Service
Retirement & Disposal
Retirement & Disposal
1. Design Chain ManagementCustomer Processes: NPI, ECM, CM…Offerings/Tech: Enterprise Engr Chg BPM, New Product Intro BPM, Config Mgt BPM, Integrated Product Chg Mgt
1. Design Chain ManagementCustomer Processes: NPI, ECM, CM…Offerings/Tech: Enterprise Engr Chg BPM, New Product Intro BPM, Config Mgt BPM, Integrated Product Chg Mgt
3. Software DevelopmentCustomer Processes: Software & Embedded Software Dev…Offerings/Tech: Rational Software and Systems Delivery Platform
3. Software DevelopmentCustomer Processes: Software & Embedded Software Dev…Offerings/Tech: Rational Software and Systems Delivery Platform
6. Portfolio & Program ManagementCustomer Processes: Product Mgt, Portfolio Mgt, Part Commonality & Reuse, Part Repair/Replacement, Aftermarket Part SalesOfferings/Tech: Decision Support & Collab (Portal), Asset & Resource Mgt (Maximo), Commonality & Parts Reuse (WPC)
6. Portfolio & Program ManagementCustomer Processes: Product Mgt, Portfolio Mgt, Part Commonality & Reuse, Part Repair/Replacement, Aftermarket Part SalesOfferings/Tech: Decision Support & Collab (Portal), Asset & Resource Mgt (Maximo), Commonality & Parts Reuse (WPC)
4. Electrical & Electronics DevelopmentCustomer Processes: Logic Design, Layout, Routings...Offerings/Tech: Systems Verification
4. Electrical & Electronics DevelopmentCustomer Processes: Logic Design, Layout, Routings...Offerings/Tech: Systems Verification
5. Mechanical DevelopmentCustomer Processes: Prod Auth, PDM, Prod Sim, Dig Mfg, CPD…Offerings/Tech: CATIA, ENOVIA, DELMIA, Simulation & Analysis
5. Mechanical DevelopmentCustomer Processes: Prod Auth, PDM, Prod Sim, Dig Mfg, CPD…Offerings/Tech: CATIA, ENOVIA, DELMIA, Simulation & Analysis
2. Requirements EngineeringCustomer Processes: Market, Customer & Operations Requirements Management…Offerings/Tech: Rational Requirements Engineering
2. Requirements EngineeringCustomer Processes: Market, Customer & Operations Requirements Management…Offerings/Tech: Rational Requirements Engineering
7. Systems EngineeringCustomer Processes: Functional Design, Systems Knowledge-Based Design…Offerings/Tech: Rational Model Driven System Dev & Engineering, PDIF Phase 3 (future)
7. Systems EngineeringCustomer Processes: Functional Design, Systems Knowledge-Based Design…Offerings/Tech: Rational Model Driven System Dev & Engineering, PDIF Phase 3 (future)
Prod
uct
Inno
vatio
n
BU
SIN
ESS
OB
JEC
TIVE
SPr
oduc
t&
Pro
cess
Inno
vatio
n B
usin
ess
Proc
ess
Inno
vatio
n
IBM Software Group – Product Lifecycle Management
9
PLM Goes Integration:
ERP
CRM
PartsMgmt
SCM
StorageServers Software Req.Mgmt
PPM
Enterprise PDM
Product Architects(OEM and/or Suppliers)
Project Management(OEM and/or Suppliers)
Engineering Specialists(OEM and/or Suppliers)
Engineering Specialists(OEM and/or Suppliers)
System View
Information Federation - Management of PLM Enterprise Information Relationships
Business Process Modeling – E.g., Portfolio Planning, Engineering Change, Part Reuse
Product Development Integration FrameworkIBM SOA Foundation
People Collaboration - Role-based PLM Workplace (Portals)
MCAD1
MCADn
ECAD1
EDAn
SW1
SWn
CAPP1
CAPPn
CAE1
CAEn
Maintn
Application SpecificLocal Data Mgmt
AuthoringApplications
IBM Product Development Integration Framework (PDIF) to enable a SOA based PLM process integration
IBM Software Group – Product Lifecycle Management
10
Four key areas are part of IBM Extended PLM (ePLM) and the PDIF framework
Enterprise Integration - Management of PLM and Enterprise Information
Enterprise Process Management – Cross-application processes
Product Development Integration Framework
IBM SOA Foundation
RequirementsManagement
Program and Portfolio
Management
Enterprise PDM
Data Management
Mechanical Authoring
ERP
Data Management
Electrical Authoring
Data Management
Software Authoring
Data Management
Analysis & Simulation
Other Enterprise
ApplicationsEAM
Enterprise Collaboration - Portals and dashboards to Applications
Integrated Product Change Management
RequirementsEngineering
Model Driven SystemDevelopment / Engineering
Software & Systems DevelopmentPlatform
IBM Software Group – Product Lifecycle Management
11
The Rational Core Solution Set for Extended PLM
Integrated Product Change ManagementAutomation of change management across the product development domains by integrating the Software and Systems Delivery Platform (including Rational ClearCase and ClearQuest) with key PLM vendors such as PTC, Siemens PLM, Oracle Agile, Dassault Enovia.
Model Driven Systems Development / EngineeringProducts and services that leverage Rational capabilities for modeling and best practices for systems engineering and model driven development across multiple design domains (software, hardware, and electronics)
Software and Systems Development PlatformAn end-to-end, open, extensible, standards based platform for software lifecycle management including products and services for modeling, testing, building and delivering software, with anemphasis on meeting the unique requirements of A&D and Auto customers such asDoDAF/MoDAF, DO-178B, AUTOSAR, MISRA, etc.
Requirements EngineeringProducts and services to extend requirements engineering beyond the software development domain (e.g. the systems engineering and EDA domains).
IBM Software Group – Product Lifecycle Management
12
Requirements Are Everywhere
RequirementsObj
ectiv
e
Reg
ulat
ion
Criterion NeedRule
IBM Software Group – Product Lifecycle Management
13
What is requirements management?
“The purpose of requirements managementis to establish a common understanding between the customer and the … project ... This agreement with the customer is the basis for planning and managing the … project.”
The Capability Maturity Model for Software (CMM ) from the Software Engineering Institute at Carnegie Mellon University.
- www.sei.cmu.edu/cmm
®
“Analysts report that as many as 71 percent of software projects that fail do so because of poor requirements management, making it the single biggest reason for project failure—bigger than bad technology, missed deadlines or change management fiascoes.”
- CIO Magazine, November 2005
IBM Software Group – Product Lifecycle Management
14
What drives Requirements Management opportunities?
Systems and software delivered must support business objectives and meet customer needs
• In-house development• Outsourced development• Packaged applications• Systems
Control costs & improve global operational efficiencies
Ensure regulatory compliance in a changing global environment
Deliver systems and software faster but with higher quality
Need to align IT or systems development with business goals / customer needs
Ensure regulatory compliance
IBM Software Group – Product Lifecycle Management
15
RM is a lifecycle activity
Configuration/Change Management Tools
Metrics Tools
Project Management Tools
Documentation Tools
Requirements Management & Traceability Tools
RequirementsCapture &
Engineering
Analysis & Design
Tools
ModelingTools
SimulationTools
CodingTools
TestingTools
Portfolio PlanningPortfolio Planning
Concept Development
Concept Development
Product Design
Product Design
Production & Testing
Production & Testing
Sales & ServiceSales & Service
Retirement & Disposal
Retirement & Disposal
IBM Software Group – Product Lifecycle Management
17
DOORS: Dynamic Object Oriented Requirements SystemDOORS: 요구사항 관리 도구
Gathering/Expressing/Organizing/Tracing/ReviewingAgreeing/Changing/Validating
Telelogic DOORS
like Excel like Word
+
IBM Software Group – Product Lifecycle Management
18
Import All Your Data & Create Documents
DOORSDOORS ASCII
Spreadsheet
MS-Project
Tool Integrations*
FrameMaker
HTML
PowerPointWord
OutlookExcel
Microsoft
MS-WordRTF
OLE
ASCII
Spreadsheet
MS-Project
Tool Integrations*
FrameMaker
MS-Word
RTFMS-Word
Direct Entry
IBM Software Group – Product Lifecycle Management
19
Start in Word
Simply import into a DOORS document
Microsoft Word import
IBM Software Group – Product Lifecycle Management
20
Use your corporate template to export a document
Document
Microsoft Word export
TableBook
IBM Software Group – Product Lifecycle Management
21
DOORS Database & Document View
Unlimited hierarchy of Projects/Folderssupports scalability
Deleted Folder
DOORS Documents
Folder
Project
Organize your projects
Improves productivity, reduces errors, increases quality
Everything you need in one window!
IBM Software Group – Product Lifecycle Management
22
1. 820.30(b) Design and Development Planning
Each manufacturer shall establish and maintain plans that describe or reference the design and developmentactivities and define responsibility for implementation.
The plans shall identify and describe the interfaces with different groups or activities that provide, or resultin, input to the design and development process.
The plans shall be reviewed as design and development evolves.The plans shall be updated as design and development evolves.The plans shall be approved as design and development evolves.
2. 820.30(c) Design Input2.1. Each manufacturer shall establish procedures to ensure that the design requirements relating to a
device are appropriate and address the intended use of the device, including the needs of the userand patient.
2.2. Each manufacturer shall maintain procedures to ensure that the design requirements relating to adevice are appropriate and address the intended use of the device, including the needs of the userand patient.
2.3. The procedures shall include a mechanism for addressing incomplete requirements.2.4. The procedures shall include a mechanism for addressing ambiguous requirements.2.5. The procedures shall include a mechanism for addressing conflicting requirements.2.6. The design input requirements shall be documented by a designated individual(s).2.7. The design input requirements shall be reviewed by a designated individual(s).2.8. The design input requirements shall be approved by a designated individual(s).2.9. The approval, including the date and signature of the individual(s) approving the requirements,
shall be documented.2.10. Questions.
2.10.1. Summarize the manufacturer's written procedure(s) for identification and control ofdesign input.
2.10.2. From what sources are design inputs sought?2.10.3. Do design input procedures cover the relevant aspects, such as: (Mark all that apply and
list additional aspects.)2.10.3.1. intended use2.10.3.2. user/patient/clinical2.10.3.3. performance characteristics2.10.3.4. safety2.10.3.5. limits and tolerances2.10.3.6. risk analysis2.10.3.7. toxicity and biocompatibility2.10.3.8. electromagnetic compatibility (EMC)2.10.3.9. compatibility with accessories/auxiliary devices2.10.3.10. compatibility with the environment of intended use2.10.3.11. human factors2.10.3.12. physical/chemical characteristics2.10.3.13. labeling/packaging2.10.3.14. reliability2.10.3.15. statutory and regulatory requirements2.10.3.16. voluntary standards2.10.3.17. manufacturing processes2.10.3.18. sterility2.10.3.19. MDRs/complaints/failures and other historical data2.10.3.20. design history files (DHFs)
2.10.4. For the specific design covered, how were the design input requirements identified?2.10.5. For the specific design covered, how were the design input requirements reviewed for
adequacy?
Comply with FDA Design Control Guidance GMP Regulation
1. Capture design and related information1.1. Input electronically formatted data1.2. Reference external information sources1.3. Reference external documentation
2. Store design and related information2.1. Identify and tag design information as unique “design elements”2.2. Organize design elements
2.2.1. Organize by Design Control Guidance Element2.2.2. Organize by inter-relationships
2.3. Ensure all design elements are available2.3.1. Store design elements by Design Control Guidance Element2.3.2. Store design elements and their historical values
3. Manage all user needs3.1. Identify the source of the user need3.2. Identify all user types (groups)3.3. Identify the customer (s)3.4. Profile the expected patients3.5. State the intended use of the product (family)3.6. Capture the acceptance criteria for each user need
4. Manage design input requirements4.1. Identify the source of the requirement4.2. Identify the associated user need4.3. Capture requirement description and attributes4.4. Capture acceptance criteria4.5. Assign responsibility for each requirement4.6. Manage incomplete requirements4.7. Manage ambiguous requirements4.8. Manage conflicting requirements4.9. Approve all requirements
5. Manage acceptance5.1. Ensure the acceptance of every user need5.2. Ensure the acceptance of every design input requirement5.3. Document the results of every user need acceptance test5.4. Document the results of every design input requirements test5.5. Make acceptance results available
6. Manage change6.1. Maintain history of design element changes
6.1.1. Make complete change history available6.1.2. Maintain history within and across any organizational procedure6.1.3. Maintain history within and across any project milestone6.1.4. Maintain history within and across any Design Control Guidance Elements
6.2. Capture frequency and nature of element changes6.2.1. Provide rationale for change6.2.2. Describe decisions made6.2.3. Identify approval authority for the change6.2.4. Capture date, time, and signature of approving authority
6.3. Identify impacted elements due to a change in another element6.3.1. Create backward traces to design elements within and across any organizational procedure6.3.2. Create backward traces to design elements within and across any project milestone
1.1. Identify impacted elements due to a change in another element• Traceability Reports: consistency with driving design elements• Impact Reports: other design elements affected• Links to impacted design elements1.1.1. Create backward traces to design elements within and across any organizational
procedure• Traceability Reports: Procedure Attribute
1.1.2. Create backward traces to design elements within and across any project milestone• Traceability Reports: Milestone Attribute
1.1.3. Create backward traces to design elements within and across Design ControlGuidance Elements• Traceability Reports: Linked design elements
1.1.4. Create forward impacts to design elements within and across any organizationalprocedure• Impact Reports: Procedure Attribute
1.1.5. Create forward impacts to design elements within and across any project milestone• Impact Reports: Milestone Attribute
1.1.6. Create forward impacts to design elements within and across Design ControlGuidance Elements• Impact Reports: Linked design elements
1.2. Associate changed design elements with related elements• Link Change Design Object with affected design element(s)• Traceability Links and Reports from affected design element(s)• Impact Links and Reports from affected design element(s)1.2.1. Associate design element changes with decisions, rationale, and approval authority
information• Change Decision Objects with following Attributes:• Disposition Attribute• Decision Attribute• Rationale Attribute• Owner Attribute• Management Approval Attribute
1.2.2. Provide associations within and across any organizational procedure• Change Design Object Traceability Link on Procedure Attribute• Change Design Object Impacts Link on Procedure Attribute
1.2.3. Provide associations within and across any project milestone• Change Design Object Traceability Link on Milestone Attribute• Change Design Object Impacts Link on Milestone Attribute
1.2.4. Provide associations within and across Design Control Guidance Elements• Change Design Object Traceability Link to traced design elements• Change Design Object Impacts Link to linked design elements
1.3. Mange the change process• Design Change Module• Design Change Reports• Object History• Object History Reports• Versions• Baselines
1. 820.30(b) Design and Development Planning
Each manufacturer shall establish and maintain plans that describe or reference the design and developmentactivities and define responsibility for implementation.
The plans shall identify and describe the interfaces with different groups or activities that provide, or resultin, input to the design and development process.
The plans shall be reviewed as design and development evolves.The plans shall be updated as design and development evolves.The plans shall be approved as design and development evolves.
2. 820.30(c) Design Input2.1. Each manufacturer shall establish procedures to ensure that the design requirements relating to a
device are appropriate and address the intended use of the device, including the needs of the userand patient.
2.2. Each manufacturer shall maintain procedures to ensure that the design requirements relating to adevice are appropriate and address the intended use of the device, including the needs of the userand patient.
2.3. The procedures shall include a mechanism for addressing incomplete requirements.2.4. The procedures shall include a mechanism for addressing ambiguous requirements.2.5. The procedures shall include a mechanism for addressing conflicting requirements.2.6. The design input requirements shall be documented by a designated individual(s).2.7. The design input requirements shall be reviewed by a designated individual(s).2.8. The design input requirements shall be approved by a designated individual(s).2.9. The approval, including the date and signature of the individual(s) approving the requirements,
shall be documented.2.10. Questions.
2.10.1. Summarize the manufacturer's written procedure(s) for identification and control ofdesign input.
2.10.2. From what sources are design inputs sought?2.10.3. Do design input procedures cover the relevant aspects, such as: (Mark all that apply and
list additional aspects.)2.10.3.1. intended use2.10.3.2. user/patient/clinical2.10.3.3. performance characteristics2.10.3.4. safety2.10.3.5. limits and tolerances2.10.3.6. risk analysis2.10.3.7. toxicity and biocompatibility2.10.3.8. electromagnetic compatibility (EMC)2.10.3.9. compatibility with accessories/auxiliary devices2.10.3.10. compatibility with the environment of intended use2.10.3.11. human factors2.10.3.12. physical/chemical characteristics2.10.3.13. labeling/packaging2.10.3.14. reliability2.10.3.15. statutory and regulatory requirements2.10.3.16. voluntary standards2.10.3.17. manufacturing processes2.10.3.18. sterility2.10.3.19. MDRs/complaints/failures and other historical data2.10.3.20. design history files (DHFs)
2.10.4. For the specific design covered, how were the design input requirements identified?2.10.5. For the specific design covered, how were the design input requirements reviewed for
adequacy?
Comply with FDA Design Control Guidance GMP Regulation
1. Capture design and related information1.1. Input electronically formatted data1.2. Reference external information sources1.3. Reference external documentation
2. Store design and related information2.1. Identify and tag design information as unique “design elements”2.2. Organize design elements
2.2.1. Organize by Design Control Guidance Element2.2.2. Organize by inter-relationships
2.3. Ensure all design elements are available2.3.1. Store design elements by Design Control Guidance Element2.3.2. Store design elements and their historical values
3. Manage all user needs3.1. Identify the source of the user need3.2. Identify all user types (groups)3.3. Identify the customer (s)3.4. Profile the expected patients3.5. State the intended use of the product (family)3.6. Capture the acceptance criteria for each user need
4. Manage design input requirements4.1. Identify the source of the requirement4.2. Identify the associated user need4.3. Capture requirement description and attributes4.4. Capture acceptance criteria4.5. Assign responsibility for each requirement4.6. Manage incomplete requirements4.7. Manage ambiguous requirements4.8. Manage conflicting requirements4.9. Approve all requirements
5. Manage acceptance5.1. Ensure the acceptance of every user need5.2. Ensure the acceptance of every design input requirement5.3. Document the results of every user need acceptance test5.4. Document the results of every design input requirements test5.5. Make acceptance results available
6. Manage change6.1. Maintain history of design element changes
6.1.1. Make complete change history available6.1.2. Maintain history within and across any organizational procedure6.1.3. Maintain history within and across any project milestone6.1.4. Maintain history within and across any Design Control Guidance Elements
6.2. Capture frequency and nature of element changes6.2.1. Provide rationale for change6.2.2. Describe decisions made6.2.3. Identify approval authority for the change6.2.4. Capture date, time, and signature of approving authority
6.3. Identify impacted elements due to a change in another element6.3.1. Create backward traces to design elements within and across any organizational procedure6.3.2. Create backward traces to design elements within and across any project milestone
1.1. Identify impacted elements due to a change in another element• Traceability Reports: consistency with driving design elements• Impact Reports: other design elements affected• Links to impacted design elements1.1.1. Create backward traces to design elements within and across any organizational
procedure• Traceability Reports: Procedure Attribute
1.1.2. Create backward traces to design elements within and across any project milestone• Traceability Reports: Milestone Attribute
1.1.3. Create backward traces to design elements within and across Design ControlGuidance Elements• Traceability Reports: Linked design elements
1.1.4. Create forward impacts to design elements within and across any organizationalprocedure• Impact Reports: Procedure Attribute
1.1.5. Create forward impacts to design elements within and across any project milestone• Impact Reports: Milestone Attribute
1.1.6. Create forward impacts to design elements within and across Design ControlGuidance Elements• Impact Reports: Linked design elements
1.2. Associate changed design elements with related elements• Link Change Design Object with affected design element(s)• Traceability Links and Reports from affected design element(s)• Impact Links and Reports from affected design element(s)1.2.1. Associate design element changes with decisions, rationale, and approval authority
information• Change Decision Objects with following Attributes:• Disposition Attribute• Decision Attribute• Rationale Attribute• Owner Attribute• Management Approval Attribute
1.2.2. Provide associations within and across any organizational procedure• Change Design Object Traceability Link on Procedure Attribute• Change Design Object Impacts Link on Procedure Attribute
1.2.3. Provide associations within and across any project milestone• Change Design Object Traceability Link on Milestone Attribute• Change Design Object Impacts Link on Milestone Attribute
1.2.4. Provide associations within and across Design Control Guidance Elements• Change Design Object Traceability Link to traced design elements• Change Design Object Impacts Link to linked design elements
1.3. Mange the change process• Design Change Module• Design Change Reports• Object History• Object History Reports• Versions• Baselines
The usual way of traceability without DOORS?
User Reqts Technical Reqts Test CasesDesign HW/SW
Cross R
ef er en ceW
o rks pa ce
IBM Software Group – Product Lifecycle Management
23
Drag-and-drop to link within a document . . . . . . or from
document to document
Traceability; drag-and-drop linking
IBM Software Group – Product Lifecycle Management
24
Traceability view
1. 820.30(b) Design and Development Planning
Each manufacturer shall establish and maintain plans that describe or reference the design and developmentactivities and define responsibility for implementation.
The plans shall identify and describe the interfaces with different groups or activities that provide, or resultin, input to the design and development process.
The plans shall be reviewed as design and development evolves.The plans shall be updated as design and development evolves.The plans shall be approved as design and development evolves.
2. 820.30(c) Design Input2.1. Each manufacturer shall establish procedures to ensure that the design requirements relating to a
device are appropriate and address the intended use of the device, including the needs of the userand patient.
2.2. Each manufacturer shall maintain procedures to ensure that the design requirements relating to adevice are appropriate and address the intended use of the device, including the needs of the userand patient.
2.3. The procedures shall include a mechanism for addressing incomplete requirements.2.4. The procedures shall include a mechanism for addressing ambiguous requirements.2.5. The procedures shall include a mechanism for addressing conflicting requirements.2.6. The design input requirements shall be documented by a designated individual(s).2.7. The design input requirements shall be reviewed by a designated individual(s).2.8. The design input requirements shall be approved by a designated individual(s).2.9. The approval, including the date and signature of the individual(s) approving the requirements,
shall be documented.2.10. Questions.
2.10.1. Summarize the manufacturer's written procedure(s) for identification and control ofdesign input.
2.10.2. From what sources are design inputs sought?2.10.3. Do design input procedures cover the relevant aspects, such as: (Mark all that apply and
list additional aspects.)2.10.3.1. intended use2.10.3.2. user/patient/clinical2.10.3.3. performance characteristics2.10.3.4. safety2.10.3.5. limits and tolerances2.10.3.6. risk analysis2.10.3.7. toxicity and biocompatibility2.10.3.8. electromagnetic compatibility (EMC)2.10.3.9. compatibility with accessories/auxiliary devices2.10.3.10. compatibility with the environment of intended use2.10.3.11. human factors2.10.3.12. physical/chemical characteristics2.10.3.13. labeling/packaging2.10.3.14. reliability2.10.3.15. statutory and regulatory requirements2.10.3.16. voluntary standards2.10.3.17. manufacturing processes2.10.3.18. sterility2.10.3.19. MDRs/complaints/failures and other historical data2.10.3.20. design history files (DHFs)
2.10.4. For the specific design covered, how were the design input requirements identified?2.10.5. For the specific design covered, how were the design input requirements reviewed for
adequacy?
Comply with FDA Design Control Guidance GMP Regulation
1. Capture design and related information1.1. Input electronically formatted data1.2. Reference external information sources1.3. Reference external documentation
2. Store design and related information2.1. Identify and tag design information as unique “design elements”2.2. Organize design elements
2.2.1. Organize by Design Control Guidance Element2.2.2. Organize by inter-relationships
2.3. Ensure all design elements are available2.3.1. Store design elements by Design Control Guidance Element2.3.2. Store design elements and their historical values
3. Manage all user needs3.1. Identify the source of the user need3.2. Identify all user types (groups)3.3. Identify the customer (s)3.4. Profile the expected patients3.5. State the intended use of the product (family)3.6. Capture the acceptance criteria for each user need
4. Manage design input requirements4.1. Identify the source of the requirement4.2. Identify the associated user need4.3. Capture requirement description and attributes4.4. Capture acceptance criteria4.5. Assign responsibility for each requirement4.6. Manage incomplete requirements4.7. Manage ambiguous requirements4.8. Manage conflicting requirements4.9. Approve all requirements
5. Manage acceptance5.1. Ensure the acceptance of every user need5.2. Ensure the acceptance of every design input requirement5.3. Document the results of every user need acceptance test5.4. Document the results of every design input requirements test5.5. Make acceptance results available
6. Manage change6.1. Maintain history of design element changes
6.1.1. Make complete change history available6.1.2. Maintain history within and across any organizational procedure6.1.3. Maintain history within and across any project milestone6.1.4. Maintain history within and across any Design Control Guidance Elements
6.2. Capture frequency and nature of element changes6.2.1. Provide rationale for change6.2.2. Describe decisions made6.2.3. Identify approval authority for the change6.2.4. Capture date, time, and signature of approving authority
6.3. Identify impacted elements due to a change in another element6.3.1. Create backward traces to design elements within and across any organizational procedure6.3.2. Create backward traces to design elements within and across any project milestone
1.1. Identify impacted elements due to a change in another element• Traceability Reports: consistency with driving design elements• Impact Reports: other design elements affected• Links to impacted design elements1.1.1. Create backward traces to design elements within and across any organizational
procedure• Traceability Reports: Procedure Attribute
1.1.2. Create backward traces to design elements within and across any project milestone• Traceability Reports: Milestone Attribute
1.1.3. Create backward traces to design elements within and across Design ControlGuidance Elements• Traceability Reports: Linked design elements
1.1.4. Create forward impacts to design elements within and across any organizationalprocedure• Impact Reports: Procedure Attribute
1.1.5. Create forward impacts to design elements within and across any project milestone• Impact Reports: Milestone Attribute
1.1.6. Create forward impacts to design elements within and across Design ControlGuidance Elements• Impact Reports: Linked design elements
1.2. Associate changed design elements with related elements• Link Change Design Object with affected design element(s)• Traceability Links and Reports from affected design element(s)• Impact Links and Reports from affected design element(s)1.2.1. Associate design element changes with decisions, rationale, and approval authority
information• Change Decision Objects with following Attributes:• Disposition Attribute• Decision Attribute• Rationale Attribute• Owner Attribute• Management Approval Attribute
1.2.2. Provide associations within and across any organizational procedure• Change Design Object Traceability Link on Procedure Attribute• Change Design Object Impacts Link on Procedure Attribute
1.2.3. Provide associations within and across any project milestone• Change Design Object Traceability Link on Milestone Attribute• Change Design Object Impacts Link on Milestone Attribute
1.2.4. Provide associations within and across Design Control Guidance Elements• Change Design Object Traceability Link to traced design elements• Change Design Object Impacts Link to linked design elements
1.3. Mange the change process• Design Change Module• Design Change Reports• Object History• Object History Reports• Versions• Baselines
1. 820.30(b) Design and Development Planning
Each manufacturer shall establish and maintain plans that describe or reference the design and developmentactivities and define responsibility for implementation.
The plans shall identify and describe the interfaces with different groups or activities that provide, or resultin, input to the design and development process.
The plans shall be reviewed as design and development evolves.The plans shall be updated as design and development evolves.The plans shall be approved as design and development evolves.
2. 820.30(c) Design Input2.1. Each manufacturer shall establish procedures to ensure that the design requirements relating to a
device are appropriate and address the intended use of the device, including the needs of the userand patient.
2.2. Each manufacturer shall maintain procedures to ensure that the design requirements relating to adevice are appropriate and address the intended use of the device, including the needs of the userand patient.
2.3. The procedures shall include a mechanism for addressing incomplete requirements.2.4. The procedures shall include a mechanism for addressing ambiguous requirements.2.5. The procedures shall include a mechanism for addressing conflicting requirements.2.6. The design input requirements shall be documented by a designated individual(s).2.7. The design input requirements shall be reviewed by a designated individual(s).2.8. The design input requirements shall be approved by a designated individual(s).2.9. The approval, including the date and signature of the individual(s) approving the requirements,
shall be documented.2.10. Questions.
2.10.1. Summarize the manufacturer's written procedure(s) for identification and control ofdesign input.
2.10.2. From what sources are design inputs sought?2.10.3. Do design input procedures cover the relevant aspects, such as: (Mark all that apply and
list additional aspects.)2.10.3.1. intended use2.10.3.2. user/patient/clinical2.10.3.3. performance characteristics2.10.3.4. safety2.10.3.5. limits and tolerances2.10.3.6. risk analysis2.10.3.7. toxicity and biocompatibility2.10.3.8. electromagnetic compatibility (EMC)2.10.3.9. compatibility with accessories/auxiliary devices2.10.3.10. compatibility with the environment of intended use2.10.3.11. human factors2.10.3.12. physical/chemical characteristics2.10.3.13. labeling/packaging2.10.3.14. reliability2.10.3.15. statutory and regulatory requirements2.10.3.16. voluntary standards2.10.3.17. manufacturing processes2.10.3.18. sterility2.10.3.19. MDRs/complaints/failures and other historical data2.10.3.20. design history files (DHFs)
2.10.4. For the specific design covered, how were the design input requirements identified?2.10.5. For the specific design covered, how were the design input requirements reviewed for
adequacy?
Comply with FDA Design Control Guidance GMP Regulation
1. Capture design and related information1.1. Input electronically formatted data1.2. Reference external information sources1.3. Reference external documentation
2. Store design and related information2.1. Identify and tag design information as unique “design elements”2.2. Organize design elements
2.2.1. Organize by Design Control Guidance Element2.2.2. Organize by inter-relationships
2.3. Ensure all design elements are available2.3.1. Store design elements by Design Control Guidance Element2.3.2. Store design elements and their historical values
3. Manage all user needs3.1. Identify the source of the user need3.2. Identify all user types (groups)3.3. Identify the customer (s)3.4. Profile the expected patients3.5. State the intended use of the product (family)3.6. Capture the acceptance criteria for each user need
4. Manage design input requirements4.1. Identify the source of the requirement4.2. Identify the associated user need4.3. Capture requirement description and attributes4.4. Capture acceptance criteria4.5. Assign responsibility for each requirement4.6. Manage incomplete requirements4.7. Manage ambiguous requirements4.8. Manage conflicting requirements4.9. Approve all requirements
5. Manage acceptance5.1. Ensure the acceptance of every user need5.2. Ensure the acceptance of every design input requirement5.3. Document the results of every user need acceptance test5.4. Document the results of every design input requirements test5.5. Make acceptance results available
6. Manage change6.1. Maintain history of design element changes
6.1.1. Make complete change history available6.1.2. Maintain history within and across any organizational procedure6.1.3. Maintain history within and across any project milestone6.1.4. Maintain history within and across any Design Control Guidance Elements
6.2. Capture frequency and nature of element changes6.2.1. Provide rationale for change6.2.2. Describe decisions made6.2.3. Identify approval authority for the change6.2.4. Capture date, time, and signature of approving authority
6.3. Identify impacted elements due to a change in another element6.3.1. Create backward traces to design elements within and across any organizational procedure6.3.2. Create backward traces to design elements within and across any project milestone
1.1. Identify impacted elements due to a change in another element• Traceability Reports: consistency with driving design elements• Impact Reports: other design elements affected• Links to impacted design elements1.1.1. Create backward traces to design elements within and across any organizational
procedure• Traceability Reports: Procedure Attribute
1.1.2. Create backward traces to design elements within and across any project milestone• Traceability Reports: Milestone Attribute
1.1.3. Create backward traces to design elements within and across Design ControlGuidance Elements• Traceability Reports: Linked design elements
1.1.4. Create forward impacts to design elements within and across any organizationalprocedure• Impact Reports: Procedure Attribute
1.1.5. Create forward impacts to design elements within and across any project milestone• Impact Reports: Milestone Attribute
1.1.6. Create forward impacts to design elements within and across Design ControlGuidance Elements• Impact Reports: Linked design elements
1.2. Associate changed design elements with related elements• Link Change Design Object with affected design element(s)• Traceability Links and Reports from affected design element(s)• Impact Links and Reports from affected design element(s)1.2.1. Associate design element changes with decisions, rationale, and approval authority
information• Change Decision Objects with following Attributes:• Disposition Attribute• Decision Attribute• Rationale Attribute• Owner Attribute• Management Approval Attribute
1.2.2. Provide associations within and across any organizational procedure• Change Design Object Traceability Link on Procedure Attribute• Change Design Object Impacts Link on Procedure Attribute
1.2.3. Provide associations within and across any project milestone• Change Design Object Traceability Link on Milestone Attribute• Change Design Object Impacts Link on Milestone Attribute
1.2.4. Provide associations within and across Design Control Guidance Elements• Change Design Object Traceability Link to traced design elements• Change Design Object Impacts Link to linked design elements
1.3. Mange the change process• Design Change Module• Design Change Reports• Object History• Object History Reports• Versions• Baselines
User Reqts Technical Reqts Test CasesDesign
End-to-end visual validation in a single view !
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Increases customer confidence
Orphan reports & traceability reports show “missing” links
Creation and deletion of links is recorded in history
Traceability verification or “completeness”
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Traceability taking you outside of DOORS
Everybody should understand the importance of requirements and be able to demonstrate that they meet requirements
By extending traceability to go beyond the boundaries of DOORS, more people are encouraged to work against requirements.
Create links fromDOORS to elements storedwithin applicationsoutside of DOORS
Right click the link indicator
Tool Tip on link indicator
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URLs bringing you back in to DOORS
Insert links into other applications that connect back to requirements stored in DOORS
Security controls still apply
Authentication still required
URLs can also take you to a DOORS database, Project, Folder, Module or Object
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DOORS Discussions
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Differentiating Change Management
Lifecycle Change Management– Telelogic Change for multiple, configurable
processes– Flexible process, user definable states– Integrated into full lifecycle change process– Multiple approvers
DOORS Change Proposal System - CPS– Providing a built in change process for– requirements– Predefined process– Grouped changes ensure requirements
consistency
Configurable Requirement Change Lifecycle
Propose Change
Review TestAssignAssigned
ResolvedConclude
Closed
Defer
Rework
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How Can I Find Changes Easily?
… a change by this user here…
… shows up as a warning flag to this user here.
If documents are linked …
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Current Version
PreviousBaseline Change
History
History and Baselines
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Printing with standard layouts
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What is DOORS/TraceLine?
DOORS/TraceLine is a DOORS extension for managing and visualizing information and its traceability in DOORS
• Browser based environment
• Requirements visualisation
• View, navigate and edit content
• Arrange information in task or viewpoint-specific views
• Create graphical and textualcontent or traceability reports
• Plug-in your own DXL functions
• For non-technical users, increase productivity, and reduces training
All specifications subject to change without notice
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What Does DOORS Web Access Look Like?
Navigation Area
Details Area
Document Area
Document Area
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Teamcenter
BaselinedProject
DOORS
HTML
DOCS
Temporary Location (DOORS Formal, Descriptive & Link Modules)
EX
PO
RT
(HTM
L Format)
IMPORT
EXPORT
HTML
DOCS
Temporary Location (DOORS/TeamcenterModules)
PDM Structure
Updated Data
HTMLFiles
DOORS Items, Attributes & Links
IMPORT
VAULTCurrent Data
HTML
Files
DOORS Items, Attributes & Links
Synchronize
DOORS - Teamcenter Integration View
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DOORS - MatrixOne Integration View
To the MatrixOne
Object
To the MatrixOne Document
DOORS URL
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Key DOORS Customers
AutomotiveAerospace/DefenseCommunications Finance, IT and more
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structured, linked and
traced,
Non-integrated
project data
is imported,
to produce reports of managed
information
Telelogic DOORS:
DOORS
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As much as a 200:1 cost savings results from finding errors in the requirements stage versus finding errors in the maintenance stage of the software lifecycle.
56% of all bugs can be traced to errors made during the requirements stage
Boehm ‘76, 88
Relative Cost To Repair:
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감사합니다.