®
IBM Software Group
© 2006 IBM Corporation
Achieve Successful Software Delivery in IT Outsourcing – Outsourcer View
Terence Chow, Rational Brand [email protected]
IBM Software Group | Rational software
2
IBM Software Group | Rational software
3
How’s Information Transform ……
How the customer
explained it
How the project leader
understood it
How the analyst designed it
How the programmer
wrote it
How the business consultant
described it
How the project was documented
What operations installed
How the customer was
billed
How it was supported
What the customer really
needed
IBM Software Group | Rational software
4
IBM Rational Requirement Driven Quality Management Best Practice Process Model
IBM Software Group | Rational software
5
IBM Offers A Unique SolutionThat Ensures Entire Lifecycle Collaboration and Traceability
Systems/Software Developm
ent Test and V
erificatio
n Covera
ge
� Full Coverage
IBM’s full life cycle coverage and traceability add resses� No common set of clear requirements shared by team
� Risk of missing critical requirements� Limited ability to assess requirements change impac t
� Limited ability to identify most critical requireme nts to test� Difficult to prove compliance (auditability)
Customer Requirements
Acceptance Testing
Specifications
DesignIntegration
Testing
System Testing
Implementation
RM QMCustomer
Supplier
Customer
Supplier
Customer
Supplier
IBM Software Group | Rational software
IBM Rational raises the bar for Quality managementPredictability, consistency & efficiency in software delivery
Achieve common goals by optimizing how
people work
Increase controland efficiency by
integrating workflows
CollaborateContinuously improve
by measuring progressin real time
ReportAutomate
Improve knowledge and practice maturity with an environment that develops individual and team talent.
IBM Software Group | Rational software
7
Challenge: Assigning and coordinating test plan ownership and events across distributed teams
Solution: Visualize commitments, reduce rework, track tasks and monitor events
Requirements, Application security
Testing
Individual Task ListTeam event log
Know what others are doing, know what others expect from you
Up-to-date work progress informationTask management for individual and team
Test Objectives, Case assignment and Signoff
Development Iterations
IBM Software Group | Rational software
8
Analyst
Project Manager
QA Manager
Proof of process
Artifact Versioning
Challenge: Centralized QA team works with multiple stakeholders across lines of business
Solution: Keeping version history and managing approval process at different phases
All project stakeholders can review, refine and sign-off on all quality related artifacts
QA team maintains accurate project history with detailed artifact versioning
Requirements Signoff
Quality Certification
Ready for Release
Project A
Project B
Project C
Artifact Reviews and Approvals
IBM Software Group | Rational software
9
Know you are testing the right things
Requirements driven testingKnowing what to test
� Requirements tracking built into the test management tooling
� Customizable attributes enable you to track what is important to your team
� Real-time impact analysis of requirements changes
� Traceability of test results to user needs
IBM Software Group | Rational software
Base project decisions on qualitative risk analysis
10
Collaborative risk based testingRisk management and prioritization
� Risk assessments captured in Test Plan and Test Cases
� Collaboration planning of risk mitigation strategy
� Test Case will contain a risk failure score and a risk priority score
� Documented risk related decisions
IBM Software Group | Rational software
11
Organizational Policies
� Assessing status�Standard
Objectives�Reuse across Test
Plans�All working toward
same objectives�Measures against
objectives
Drive continuous and measured improvement
Challenge: Multiple distributed project teams are competing for test lab assets
Solution: Plan and track quality management objectives against business objectives
IBM Software Group | Rational software
12
Rational DOORS RationalQuality Manager
Business processes
Sketches and storyboards
Use cases
Rich text
Requirements Management� Identify and manage requirements
across their lifecycle� Align team collaboration around
business objectives and outcomes
Accelerate project delivery with history and context that team
members need
Traceable requirements definition and management Challenge: Managing a shared understanding of requirements, business and delivery risks
Solution: Reduce rework, focus meetings, and reuse requirements artifacts on future projects
IBM Software Group | Rational software
13
Test productivity with constant access to quality metricsLifecycle quality perspective to proactively manage risk
Performance risks are always visible and quickly
resolved
Security risks are monitored continuously to ensure business continuity
Tracks software delivery through reports
Testing of requirements can be tracked to assure business needs
are realized
Change management and defect tracking fully integrated to assure
all changes are tested
Quality ManagerDashboard
Tracks real-time execution status
IBM Software Group | Rational software
Make timely and better informed decisions to achieve business objectives
Measure effectiveness of processes and practices to improve organizational outcomes
Gain insight into projects that span geographical and organizational boundaries
Executive Dashboards
Quality & Performance Dashboards
Project Level Dashboards
Continuously Improve Your Process
You cannot Improve what you cannot Measure
Process Lead
IBM Software Group | Rational software
15
✔ Stakeholder and team coordination reduces mistakes✔ Risk identification and management leads to educated
prioritization decisions✔ Test traceability linked to business requirements improves
customer satisfaction
✔ Running tests earlier leads to reduced repair costs✔ Running more tests in less time improves coverage✔ Reducing manual labor leads to fewer testing errors✔ Lab configuration automation improves efficiency and asset
utilization
✔ Real-time dashboards enable proactive risk management✔ Customizable reports facilitate ongoing process improvement
IBM Rational Quality ManagerA central hub for business-driven software quality
Mitigate business risk with collaboration
Improve operational efficiency with automation
Make confident decisions with effortless reporting
IBM Rational Quality Manager
CONTINUOUS test plan participate
AUTOMATED context GOVERNANCEuse case distributed access dashboardssynchronize EASY HANDOFF trace LABUTILIZATION functional PERFORMANCEsecurity compliance
IBM Software Group | Rational software
16
Quality Assurance is nothing but DO THE THING RIGHT!
But, how about …..DO THE RIGHT THING?
IBM Software Group | Rational software
17
IBM Offers A Unique SolutionThat Ensures Entire Lifecycle Collaboration and Traceability
Systems/Software Developm
ent Test and V
erificatio
n Covera
ge
� Full Coverage
IBM’s full life cycle coverage and traceability add resses� No common set of clear requirements shared by team
� Risk of missing critical requirements� Limited ability to assess requirements change impac t
� Limited ability to identify most critical requireme nts to test� Difficult to prove compliance (auditability)
Customer Requirements
Acceptance Testing
Specifications
DesignIntegration
Testing
System Testing
Implementation
RM QMCustomer
Supplier
Customer
Supplier
Customer
Supplier
IBM Software Group | Rational software
18
The Case for Requirements Management: Quality Improvement and Cost Savings
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.
Boehm ‘76, 88
56% of all bugs can be traced to errors made during the
requirements stagesave money effective requirement practicessave money effective requirement practices
IBM Software Group | Rational software
19
Traceability in DOORS - drag-and-drop linking
IBM Software Group | Rational software
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
Traceability view
“End-to-end visual validation in a single view”
User Reqts Technical Reqts Test CasesDesign
IBM Software Group | Rational software
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
Stakeholder Reqts System Reqts Test CasesSubsystem
Traceability view
“End-to-end visual validation in a single 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
Stakeholder Reqts System Reqts Test CasesSubsystem1. 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
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?
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
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
1.1. 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
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?
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
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
1.1. 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
Stakeholder Reqts System Reqts Test CasesSubsystem
Acceptance test
validating the product
StakeholderRequirements
Statement of need(Capability)
Operational use
satisfies
ComponentRequirements
Component test
evaluating components
SubsystemRequirements
Subsystem test
evaluating the subsystemssatisfies
SystemRequirements
System test
verifying the systemsatisfies
Acceptance test
validating the product
StakeholderRequirements
Acceptance test
validating the product
StakeholderRequirements
Acceptance test
validating the product
StakeholderRequirements
Statement of need(Capability)
Operational use
satisfies
ComponentRequirements
Component test
evaluating componentssatisfies
ComponentRequirements
Component test
evaluating components
ComponentRequirements
Component test
evaluating components
SubsystemRequirements
Subsystem test
evaluating the subsystemssatisfies
SubsystemRequirements
Subsystem test
evaluating the subsystemssatisfies
SystemRequirements
System test
verifying the systemsatisfies
SystemRequirements
System test
verifying the systemsatisfies
IBM Software Group | Rational software
Simple document view of a database; or more complex for different role
See multiple requirements logically
Multiple Document Views
IBM Software Group | Rational software
23
Increases customer confidence, validates alignment
Orphan reports & traceability reports show “missing” links
Traceability verification or “completeness”
IBM Software Group | Rational software
What are Suspect Links?
… a change by this user here…
… shows up as a warning flag to this
user here.
If documents are linked …
�
IBM Software Group | Rational software
“How are changes communicated?”Suspect links are visible directly in the document -
as indicators or as a full description
Never miss a change again
IBM Software Group | Rational software
DOORS - Test Integration
� Test against requirements rather than what is built
� Integration withRational QualityManager
IBM Software Group | Rational software
27
Centralized test management hub allowing full lifecycle support across all types of testing and platforms
StorageCollaboration
Search & QueryDiscovery
Administration: Users, projects, process
Presentation:Mashups
Best Practice Processes
Manage
Test Lab
Create
Plan
Build
Tests
Report
Results
Execute
Tests
IBM Collaborative Application Lifecycle Management
Test Management
Rational Quality ManagerQuality Dashboard
RequirementsManagement
DefectManagement
Open Lifecycle Service Integrations
FunctionalTesting Performance
TestingWeb Service
Quality
CodeQuality
Security andCompliance
Test Data Quality
Java System z, iSAP .NET
homegrown
Open Platform
IBM Software Group | Rational software
28
© Copyright IBM Corporation 2009. All rights reserv ed. The information contained in these materials is provided for informational purposes only, and is provided AS IS without warranty of any kind, express or implied. IBM shall not be responsible for any damages arising out of the use of, or otherwise related to, these materials. Nothing contained in these materials is intended to, nor shall have
the effect of, creating any warranties or representations from IBM or its suppliers or licensors, or altering the terms and conditions of the applicable license agreement governing the use of IBM software. References in these materials to IBM products, programs, or services do not imply that they will be available in all countries in which IBM operates. Product release dates and/or capabilities
referenced in these materials may change at any time at IBM’s sole discretion based on market opportunities or other factors, and are not intended to be a commitment to future product or feature availability in any way. IBM, the IBM logo, Rational, the Rational logo, Telelogic, the Telelogic logo, and other IBM products and services are trademarks of the International Business Machines
Corporation, in the United States, other countries or both. Other company, product, or service names may be trademarks or service marks of others.
Learn more at:�IBM Rational software
�Rational launch announcements�Rational Software Delivery Platform
�Accelerate change & delivery�Deliver enduring quality
�Enable enterprise modernization
�Rational trial downloads�developerWorks Rational
�Leading Innovation�IBM Rational TV
�IBM Business Partners�IBM Rational Case Studies
�Ensure Web security & compliance�Improve project success�Manage architecture
�Manage evolving requirements�Small & midsized business
�Targeted solutions
IBM Software Group | Rational software
29
Quality Management offers a centralized test management hub and full lifecycle support across all types of testing and platforms
Collaboration
Presentation:Mashups Discovery Query
Storage
Administration: Users, projects, process
Best Practice Processes
IBM Collaborative Application Lifecycle Management
Quality Dashboard
Test Management
Create Plan
Build Tests
Manage Test Lab
Execute Tests
Report Results
Requirements Management
DefectManagement
FunctionalTesting Performance
TestingWeb Service
Quality
CodeQuality
Security andCompliance
Open Platform
homegrown
Open Lifecycle Service IntegrationsJava System z, i
SAP .NETTest DataQuality
IBM Software Group | Rational software
30
Unify the team through real-time, in-context collaborationA single, dynamic quality contract provides clear a nd accountable direction
� Unify the entire team with a shared view of quality assets�Central location for assets (e.g.,
business objectives requirements, resources, platform, exit criteria)
� Comprehensive dynamic planning and updates� Integrated process workflow, not
artifacts drives team activities, hand-offs, reviews/approvals and sign-offs
� Know what others are doing and what others expect of you�Task management for individuals and
team