Upload
jaime-britt
View
36
Download
3
Embed Size (px)
DESCRIPTION
Establishing a Winning Approach for Outsourcing Projects. Terence Chow, Rational Technical Specialist [email protected]. The fantasy of outsourcing. Focus on the core business Save cost Better control on budget Better ROI Time to market / Time to profit Access to expertise Etc…. - PowerPoint PPT Presentation
Citation preview
®
IBM Software Group
© 2007 IBM Corporation
Establishing a Winning Approach for Outsourcing Projects
Terence Chow, Rational Technical [email protected]
IBM Software Group | Rational software
2
The fantasy of outsourcing
Focus on the core business
Save cost
Better control on budget
Better ROI
Time to market / Time to profit
Access to expertise
Etc…..
IBM Software Group | Rational software
3
Why do Outsourcing Project Fail?
42%
37%
27%
26%
24%
24%
0% 10% 20% 30% 40% 50%
Unclear or continually changing productdefinitions
Product does not meet customer or marketrequirements
Unrealistic schedule expectations
Projects not adequately staffed
Unclear or continually changing priorities
Unrealistic financial expectations
Source: AberdeenGroup, August 2006
IBM Software Group | Rational software
4
Why is requirements management so critical?
“Analysts report that as many as 71 percent of software projects that fail do so because of poor requirements management, making it the single biggest reason for project failure - bigger than bad technology, missed deadlines or change management fiascoes”
- CIO Magazine, November 2005
IBM Software Group | Rational software
5
The CIO must drive down costs while increasing project success at the same time
Reduce rework in all stages
of development
30% of all project costs are associated with rework. Requirements mistakes account for up to 70% of this cost, at an average of $1,300 in labor to fix each requirement
“Only 41% of projects are considered successful.”– IBM CIO Study
A six-month delay can cost companies up to 33% of ROI on a five year business case
Requirements activities impact up to 35% of a project effort, and can cause waiting time, and redundant activities that eat up to 10% of your budget
Improve requirements definition productivity with current resources
Faster results – minimize delays that impact time to value
CIO Magazine recently reported, “as many as 71%of software projects that fail, do so because of poor
requirements management, making it the single biggest reason for project failure."
IBM Software Group | Rational software
6
Analyst
Challenge: Poor collaboration between Parties
Current Concerns
Stakeholder interaction is inconsistent and disparate (email / docs)
Stakeholders overlooked or rely too heavily on delegates
Stakeholders see needs as unique, unable to understand and negotiate
CIO: “Our new strategic roadmap identified several areas we need to consolidate capabilities and costs, lets get the team to evaluate approaches that we can all get behind.”
No synergy, 41% of projects fail to achieve investment return
No Meaningful dialogue or alignment to strategy
Analyst: “People don’t seem to be on the same page”
Stakeholders not engaged Stakeholder:" I do not have time, and no resources, so we
will have to catch up later”
User: “Let me ask my manager if I can get more involved
Low user involvement
No cross-functional collaboration or understanding
Stakeholder:" Here are my needs, in my models, and my documents. Call me today.”
Sidebar conversations
Stakeholder: “My process drives 90% of revenue, tell me when to test my solution
Unrealistic Unyielding
Expectations
IBM Software Group | Rational software
7
How’s Requirement flows……
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
© 2007 IBM Corporation
How to Manage Requirement
IBM Software Group | Rational software
9
Requirements Are Everywhere
Requirements
Obj
ectiv
eG
oalAim
Reg
ulat
ion
Criterion NeedFeat
ureFunction R
ule
Ris
k
IBM Software Group | Rational software
10
Acceptance
test
validating the product
Stakeholder Requirements
V-Shape Requirement Development
Statement of need Operational use
satisfies
Component Requirements
Component test
evaluating components
Subsystem Requirements
Subsystem
test
evaluating the subsystems satisfies
System Requirements
System
test
verifying the system
satisfies
ITIL, ISO9001
Company Standard
confront
Implementation Outsourcing
Design Outsourcing
IT Outsourcing
IBM Software Group | Rational software
11
Requirement Database Unlimited hierarchy of Projects/Folders supports scalability
Organize Your Projects
Deleted Folder
DOORS Documents
Folders
Projects
IBM Software Group | Rational software
12
Everything you need in one window!
Improves productivity, reduces errors, increases quality
Document Views
OLE
Context
Requirements
Spell check
IBM Software Group | Rational software
13
Show only what I am interest!
®
IBM Software Group
© 2007 IBM Corporation
How to Manage Requirement Relationship?
IBM Software Group | Rational software
15
1. 820.30(b) Design and Development Planning
Each manufacturer shall establish and maintain plans that describe or reference the design and developmentactivities and define responsibility for implementation.
The plans shall identify and describe the interfaces with different groups or activities that provide, or resultin, input to the design and development process.
The plans shall be reviewed as design and development evolves.The plans shall be updated as design and development evolves.The plans shall be approved as design and development evolves.
2. 820.30(c) Design Input2.1. Each manufacturer shall establish procedures to ensure that the design requirements relating to a
device are appropriate and address the intended use of the device, including the needs of the userand patient.
2.2. Each manufacturer shall maintain procedures to ensure that the design requirements relating to adevice are appropriate and address the intended use of the device, including the needs of the userand patient.
2.3. The procedures shall include a mechanism for addressing incomplete requirements.2.4. The procedures shall include a mechanism for addressing ambiguous requirements.2.5. The procedures shall include a mechanism for addressing conflicting requirements.2.6. The design input requirements shall be documented by a designated individual(s).2.7. The design input requirements shall be reviewed by a designated individual(s).2.8. The design input requirements shall be approved by a designated individual(s).2.9. The approval, including the date and signature of the individual(s) approving the requirements,
shall be documented.2.10. Questions.
2.10.1. Summarize the manufacturer's written procedure(s) for identification and control ofdesign input.
2.10.2. From what sources are design inputs sought?2.10.3. Do design input procedures cover the relevant aspects, such as: (Mark all that apply and
list additional aspects.)2.10.3.1. intended use2.10.3.2. user/patient/clinical2.10.3.3. performance characteristics2.10.3.4. safety2.10.3.5. limits and tolerances2.10.3.6. risk analysis2.10.3.7. toxicity and biocompatibility2.10.3.8. electromagnetic compatibility (EMC)2.10.3.9. compatibility with accessories/auxiliary devices2.10.3.10. compatibility with the environment of intended use2.10.3.11. human factors2.10.3.12. physical/chemical characteristics2.10.3.13. labeling/packaging2.10.3.14. reliability2.10.3.15. statutory and regulatory requirements2.10.3.16. voluntary standards2.10.3.17. manufacturing processes2.10.3.18. sterility2.10.3.19. MDRs/complaints/failures and other historical data2.10.3.20. design history files (DHFs)
2.10.4. For the specific design covered, how were the design input requirements identified?2.10.5. For the specific design covered, how were the design input requirements reviewed for
adequacy?
Comply with FDA Design Control Guidance GMP Regulation
1. Capture design and related information1.1. Input electronically formatted data1.2. Reference external information sources1.3. Reference external documentation
2. Store design and related information2.1. Identify and tag design information as unique “design elements”2.2. Organize design elements
2.2.1. Organize by Design Control Guidance Element2.2.2. Organize by inter-relationships
2.3. Ensure all design elements are available2.3.1. Store design elements by Design Control Guidance Element2.3.2. Store design elements and their historical values
3. Manage all user needs3.1. Identify the source of the user need3.2. Identify all user types (groups)3.3. Identify the customer (s)3.4. Profile the expected patients3.5. State the intended use of the product (family)3.6. Capture the acceptance criteria for each user need
4. Manage design input requirements4.1. Identify the source of the requirement4.2. Identify the associated user need4.3. Capture requirement description and attributes4.4. Capture acceptance criteria4.5. Assign responsibility for each requirement4.6. Manage incomplete requirements4.7. Manage ambiguous requirements4.8. Manage conflicting requirements4.9. Approve all requirements
5. Manage acceptance5.1. Ensure the acceptance of every user need5.2. Ensure the acceptance of every design input requirement5.3. Document the results of every user need acceptance test5.4. Document the results of every design input requirements test5.5. Make acceptance results available
6. Manage change6.1. Maintain history of design element changes
6.1.1. Make complete change history available6.1.2. Maintain history within and across any organizational procedure6.1.3. Maintain history within and across any project milestone6.1.4. Maintain history within and across any Design Control Guidance Elements
6.2. Capture frequency and nature of element changes6.2.1. Provide rationale for change6.2.2. Describe decisions made6.2.3. Identify approval authority for the change6.2.4. Capture date, time, and signature of approving authority
6.3. Identify impacted elements due to a change in another element6.3.1. Create backward traces to design elements within and across any organizational procedure6.3.2. Create backward traces to design elements within and across any project milestone
1.1. Identify impacted elements due to a change in another element Traceability Reports: consistency with driving design elements Impact Reports: other design elements affected Links to impacted design elements1.1.1. Create backward traces to design elements within and across any organizational
procedure Traceability Reports: Procedure Attribute
1.1.2. Create backward traces to design elements within and across any project milestone Traceability Reports: Milestone Attribute
1.1.3. Create backward traces to design elements within and across Design ControlGuidance Elements Traceability Reports: Linked design elements
1.1.4. Create forward impacts to design elements within and across any organizationalprocedure Impact Reports: Procedure Attribute
1.1.5. Create forward impacts to design elements within and across any project milestone Impact Reports: Milestone Attribute
1.1.6. Create forward impacts to design elements within and across Design ControlGuidance Elements Impact Reports: Linked design elements
1.2. Associate changed design elements with related elements Link Change Design Object with affected design element(s) Traceability Links and Reports from affected design element(s) Impact Links and Reports from affected design element(s)1.2.1. Associate design element changes with decisions, rationale, and approval authority
information Change Decision Objects with following Attributes: Disposition Attribute Decision Attribute Rationale Attribute Owner Attribute Management Approval Attribute
1.2.2. Provide associations within and across any organizational procedure Change Design Object Traceability Link on Procedure Attribute Change Design Object Impacts Link on Procedure Attribute
1.2.3. Provide associations within and across any project milestone Change Design Object Traceability Link on Milestone Attribute Change Design Object Impacts Link on Milestone Attribute
1.2.4. Provide associations within and across Design Control Guidance Elements Change Design Object Traceability Link to traced design elements Change Design Object Impacts Link to linked design elements
1.3. Mange the change process Design Change Module Design Change Reports Object History Object History Reports Versions Baselines
1. 820.30(b) Design and Development Planning
Each manufacturer shall establish and maintain plans that describe or reference the design and developmentactivities and define responsibility for implementation.
The plans shall identify and describe the interfaces with different groups or activities that provide, or resultin, input to the design and development process.
The plans shall be reviewed as design and development evolves.The plans shall be updated as design and development evolves.The plans shall be approved as design and development evolves.
2. 820.30(c) Design Input2.1. Each manufacturer shall establish procedures to ensure that the design requirements relating to a
device are appropriate and address the intended use of the device, including the needs of the userand patient.
2.2. Each manufacturer shall maintain procedures to ensure that the design requirements relating to adevice are appropriate and address the intended use of the device, including the needs of the userand patient.
2.3. The procedures shall include a mechanism for addressing incomplete requirements.2.4. The procedures shall include a mechanism for addressing ambiguous requirements.2.5. The procedures shall include a mechanism for addressing conflicting requirements.2.6. The design input requirements shall be documented by a designated individual(s).2.7. The design input requirements shall be reviewed by a designated individual(s).2.8. The design input requirements shall be approved by a designated individual(s).2.9. The approval, including the date and signature of the individual(s) approving the requirements,
shall be documented.2.10. Questions.
2.10.1. Summarize the manufacturer's written procedure(s) for identification and control ofdesign input.
2.10.2. From what sources are design inputs sought?2.10.3. Do design input procedures cover the relevant aspects, such as: (Mark all that apply and
list additional aspects.)2.10.3.1. intended use2.10.3.2. user/patient/clinical2.10.3.3. performance characteristics2.10.3.4. safety2.10.3.5. limits and tolerances2.10.3.6. risk analysis2.10.3.7. toxicity and biocompatibility2.10.3.8. electromagnetic compatibility (EMC)2.10.3.9. compatibility with accessories/auxiliary devices2.10.3.10. compatibility with the environment of intended use2.10.3.11. human factors2.10.3.12. physical/chemical characteristics2.10.3.13. labeling/packaging2.10.3.14. reliability2.10.3.15. statutory and regulatory requirements2.10.3.16. voluntary standards2.10.3.17. manufacturing processes2.10.3.18. sterility2.10.3.19. MDRs/complaints/failures and other historical data2.10.3.20. design history files (DHFs)
2.10.4. For the specific design covered, how were the design input requirements identified?2.10.5. For the specific design covered, how were the design input requirements reviewed for
adequacy?
Comply with FDA Design Control Guidance GMP Regulation
1. Capture design and related information1.1. Input electronically formatted data1.2. Reference external information sources1.3. Reference external documentation
2. Store design and related information2.1. Identify and tag design information as unique “design elements”2.2. Organize design elements
2.2.1. Organize by Design Control Guidance Element2.2.2. Organize by inter-relationships
2.3. Ensure all design elements are available2.3.1. Store design elements by Design Control Guidance Element2.3.2. Store design elements and their historical values
3. Manage all user needs3.1. Identify the source of the user need3.2. Identify all user types (groups)3.3. Identify the customer (s)3.4. Profile the expected patients3.5. State the intended use of the product (family)3.6. Capture the acceptance criteria for each user need
4. Manage design input requirements4.1. Identify the source of the requirement4.2. Identify the associated user need4.3. Capture requirement description and attributes4.4. Capture acceptance criteria4.5. Assign responsibility for each requirement4.6. Manage incomplete requirements4.7. Manage ambiguous requirements4.8. Manage conflicting requirements4.9. Approve all requirements
5. Manage acceptance5.1. Ensure the acceptance of every user need5.2. Ensure the acceptance of every design input requirement5.3. Document the results of every user need acceptance test5.4. Document the results of every design input requirements test5.5. Make acceptance results available
6. Manage change6.1. Maintain history of design element changes
6.1.1. Make complete change history available6.1.2. Maintain history within and across any organizational procedure6.1.3. Maintain history within and across any project milestone6.1.4. Maintain history within and across any Design Control Guidance Elements
6.2. Capture frequency and nature of element changes6.2.1. Provide rationale for change6.2.2. Describe decisions made6.2.3. Identify approval authority for the change6.2.4. Capture date, time, and signature of approving authority
6.3. Identify impacted elements due to a change in another element6.3.1. Create backward traces to design elements within and across any organizational procedure6.3.2. Create backward traces to design elements within and across any project milestone
1.1. Identify impacted elements due to a change in another element Traceability Reports: consistency with driving design elements Impact Reports: other design elements affected Links to impacted design elements1.1.1. Create backward traces to design elements within and across any organizational
procedure Traceability Reports: Procedure Attribute
1.1.2. Create backward traces to design elements within and across any project milestone Traceability Reports: Milestone Attribute
1.1.3. Create backward traces to design elements within and across Design ControlGuidance Elements Traceability Reports: Linked design elements
1.1.4. Create forward impacts to design elements within and across any organizationalprocedure Impact Reports: Procedure Attribute
1.1.5. Create forward impacts to design elements within and across any project milestone Impact Reports: Milestone Attribute
1.1.6. Create forward impacts to design elements within and across Design ControlGuidance Elements Impact Reports: Linked design elements
1.2. Associate changed design elements with related elements Link Change Design Object with affected design element(s) Traceability Links and Reports from affected design element(s) Impact Links and Reports from affected design element(s)1.2.1. Associate design element changes with decisions, rationale, and approval authority
information Change Decision Objects with following Attributes: Disposition Attribute Decision Attribute Rationale Attribute Owner Attribute Management Approval Attribute
1.2.2. Provide associations within and across any organizational procedure Change Design Object Traceability Link on Procedure Attribute Change Design Object Impacts Link on Procedure Attribute
1.2.3. Provide associations within and across any project milestone Change Design Object Traceability Link on Milestone Attribute Change Design Object Impacts Link on Milestone Attribute
1.2.4. Provide associations within and across Design Control Guidance Elements Change Design Object Traceability Link to traced design elements Change Design Object Impacts Link to linked design elements
1.3. Mange the change process Design Change Module Design Change Reports Object History Object History Reports Versions Baselines
User Reqts Technical Reqts Test CasesDesign
Traceability is the key to Requirement Managmenet
Initial user requirements should be decomposed to detailed requirements, then to design, tests, etc.
Decomposition creates traceability relationships
Relationships define your traceability model
Your traceability model is the basis for your process
Enforce your traceability model; improve your process
IBM Software Group | Rational software
1616
Drag-and-drop to link within a document . . .
. . . or from document to
document
Traceability; drag-and-drop linking
IBM Software Group | Rational software
17
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
18
•Increases customer confidence
•Detect missing links
•Creation and deletion of links is recorded in history
Traceability through an Orphan report shows “missing” links
Traceability Verification or “Completeness”
IBM Software Group | Rational software
19
StakeholderRequirements
SystemRequirements
SubsystemRequirements
ComponentRequirements
System test plan
Integration test plan
Componenttest plan
Acceptance test Plan
Imp
act
An
alys
is Derivatio
n A
nalysis
Derivation Analysis
Impact Analysis
Impact / Derivation Analysis
IBM Software Group | Rational software
20
StakeholderRequirements
SystemRequirements
SubsystemRequirements
ComponentRequirements
System test plan
Integration test plan
Componenttest plan
Acceptance test Plan
All requirements are allocated to subrequirements?
All requirements are tested without an exception?
Requirement Coverage Analysis
®
IBM Software Group
© 2007 IBM Corporation
How to Manage Requirement Change?
IBM Software Group | Rational software
23
Suspect links are visible directly in the document -
as indicators or as a full description
Never miss a change again
Suspect Links
Clear on a right click
IBM Software Group | Rational software
24
structured,
linked and
traced,
Non-
integrated
project data
is imported,
to produce
reports of
managed
information
The Requirement lifecycle
®
IBM Software Group
© 2008 IBM Corporation
Requirement is Good now. What about Delivery?
Wu, Ying-Ki YK Rational Technical [email protected]
IBM Software Group | Rational software
26
Acceptance
test
validating the product
Stakeholder Requirements
V-Shape Development & Delivery- Now focusing on Delivery
Statement of need Operational use
satisfies
Component Requirements
Component test
evaluating components
Subsystem Requirements
Subsystem
test
evaluating the subsystems satisfies
System Requirements
System
test
verifying the system
satisfies
ITIL, ISO9001
Company Standard
confront
IBM Software Group | Rational software
27
Although cancellation rates are downand fewer projects are troubled,
improving software development governance provides increased value to projects, producing about 30% more projects
that deliver expected value.
Source: Standish Chaos Report, Allinean ROI of Software Development
The unsuccessful failure rate for software projects (including outsourcing) is still alarmingly high- Decision making, Accountability, Performance, Risk Management
Software project results
Project success rates average less than 55%
Cancelled projects cost $81 Billion worldwide each year
Of the 50% of projects which are successfully delivered, 28% of these projects are not yielding the expected planned value
Software project waste
$55 Billion
$38 Billion in lost dollar value
$17 Billion in cost over runs
IBM Software Group | Rational software
28
Problems of Outsourcing – Risks are not fully shifted to subcontractors as stakeholders bear the risk of project failure.
Features are missing Requirements are not fully tested
Requirement changes are not being notified
Too many bugs in UAT & ProdLack of defect management process
Lack of validation or verification
Last minute delayLack of project transparency
Lack of communication
IBM Software Group | Rational software
29
Software Subcontract Management- Repeatable process to manage subcontractors
Outsourcing can be a win-win situation
Activities to perform
Ensure regulatory compliance in a changing global environment
Commitment & Ability to perform
Goals
Verification & Measurement
IBM Software Group | Rational software
30
Goals towards SSM- Involves establishing specific, measurable and time-targeted objectives
Committing on goals is the 1st step to success
3) Customer tracks subcontractor’s result & performance against commitments
2) Customer and subcontractor maintain ongoing communications
1) Customer and subcontractor agree to their commitments to each other
IBM Software Group | Rational software
31
Goal: Define a clear ‘Acceptance criteria’ - Work towards defined goals
IBM Software Group | Rational software
32
Commitment & Ability to perform towards SSM
Assign clear responsibility and allocate adequate resources to reduce project risk
3) Subcontractors are trained and receive orientation in the technical aspects
2) Adequate resources and funding are provided for managing the subcontract
1) Customer manager is designated to be responsible for establishing and managing subcontractor
IBM Software Group | Rational software
33
Assign clear responsibility and allocate adequate resources to reduce project risk- Know your team and role
Defines resources & responsibilities
Defines project administrators
Defines Project
IBM Software Group | Rational software
34
Activities to perform towards SSM
Communication and tracking to monitor status
3) Customer conducts acceptance testing as part of the delivery of the subcontractor’s software products
2) Documented and approved subcontractor’s software development plan to track the activities and status
1) Contractual agreement between the customer and subcontractor is used as the basis for managing the subcontract
IBM Software Group | Rational software
35
Activity: The work to be subcontracted is defined and planned according to a documented procedure- project transparency and communication
Structured plan to fulfill Software Subcontract Management, e.g. Business Objectives, Requirements, Acceptance Criteria, Schedule, Attachments, & etc
Create snapshot to record of your progress.
IBM Software Group | Rational software
36
Activity: The work to be subcontracted is defined and planned according to a documented procedure- Schedule check points to review subcontractor progress
IBM Software Group | Rational software
38
Activity: A documented subcontractor’s software development plan is reviewed and approved by the prime contractor - project transparency and communication
Clearly define the responsibility of reviewal and approval
IBM Software Group | Rational software
39
Activity: Subcontractor’s performance is evaluated on a periodic basis - Requirements are covered by test cases
IBM Software Group | Rational software
40
Activity: The software subcontractor’s performance is evaluated on a periodic basis - project transparency and communication
Real-Time tracking of covered
requirements
IBM Software Group | Rational software
41
Activity: Plan is used for tracking the software activities and communicating status- Requirement changes are being notified
IBM Software Group | Rational software
42
Activity: Plan is used for tracking the software activities and status- Understand which test cases can be impacted due to requirement change (Impact Analysis)
IBM Software Group | Rational software
43
Activity: Tracking the software activities and status- Transparent and centralised overview of defect and its status (defect tracking)
Manage, evaluate, prioritise defects in real-time. Understand project health and help to make right decisions.
IBM Software Group | Rational software
44
Activity: Tracking the corresponding communication - Transparent and centralised overview of defect and its status
Defect status
In-Context Communication
are kept !
IBM Software Group | Rational software
45
Activity: Tracking the software activities and status- Transparent and centralised overview of defect and its status
Audit Trail - Accountability
IBM Software Group | Rational software
46
Activity: Tracking the corresponding communication - Transparent and centralised overview of defect and its status (Subcontractor’s view)
Sub-Contractor’s profile: know which projects are involved
Notifications, and defects will be displayed in dashboard
Customisable charts for project analysis
Know what is happening in this
project
IBM Software Group | Rational software
47
Activity: Tracking the software activities status - Understand which requirement has associated defect
IBM Software Group | Rational software
48
Measurement & Verification towards SSM
Ensure deliver quality products that satisfy customer’s expectation
3) Evaluation acts as input for future subcontractor selection criteria
2) The activities for managing the software subcontractor are measured & reviewed
1) Measurements are made to determine the status of activities for managing subcontractor
IBM Software Group | Rational software
50
Subcontractor provides step-by-step screenshots evidence as attachments.
Result Details
Test Execution overview
Verifications are measured & reviewed- Testings are recorded as evidence for validation and verification
IBM Software Group | Rational software
51
The activities for managing the software subcontractor are measured & reviewed- Tracking possible over due items, and take actions to minimize risks before project deadline
Tracking over due items
IBM Software Group | Rational software
52
The activities for managing the software subcontractor are measured & reviewed- Defects can be traced, and can be filtered
Tracking all the defects
IBM Software Group | Rational software
53
Measurements are made to determine the status of activities for managing subcontractor - Views of project status from multiple perspectives- Charting to show healthiness & completeness of project- Performance evaluation- Reference for future project
IBM Software Group | Rational software
54
Overview of SSM on quality aspect
JAZZ TEAM SERVER
ManageTest Lab
CreatePlan
BuildTests
ReportResults
ExecuteTests
IBM Collaborative Application Lifecycle ManagementIBM Collaborative Application Lifecycle Management
FunctionalTesting Performance
TestingWeb Service
QualityManualTesting
Security andCompliance
Quality Management
Rational Quality ManagerQuality Dashboard
Open Lifecycle Service Integrations
DefectManagement
RequirementsManagement
- DOORS
Best Practice Processes
JavaSystem z, iSAP
.NET
IBM Software Group | Rational software
56
Centralized Outsourcing Management Solution
ManageDefects
ReportResults
ExecuteTests
CreatePlan
BuildTests
IBM Collaborative Application Lifecycle ManagementIBM Collaborative Application Lifecycle Management
Quality Management
Rational Quality Manager
Quality Dashboard
IBM Collaborative Application Lifecycle ManagementIBM Collaborative Application Lifecycle Management
Requirement Traceability
Telelogic DOORSCollaborative Requirement Repository
Impact Analysis Test Requirement
Test Result
Bi-directional synchronization
IBM Software Group | Rational software
57
Flexible Deployment
IBM Collaborative Application Lifecycle Management
Requirement Traceability
Telelogic DOORSCollaborative Requirement Repository
Impact Analysis
IBM Collaborative Application Lifecycle ManagementIBM Collaborative Application Lifecycle Management
Requirement Traceability
Telelogic DOORSCollaborative Requirement Repository
Impact Analysis
ManageTest Lab
CreatePlan
BuildTests
ReportResults
ExecuteTests
IBM Collaborative Application Lifecycle Management
Quality Management
Rational Quality ManagerQuality Dashboard
ManageTest Lab
CreatePlan
BuildTests
ReportResults
ExecuteTests
ManageTest Lab
CreatePlan
BuildTests
ReportResults
ExecuteTests
IBM Collaborative Application Lifecycle ManagementIBM Collaborative Application Lifecycle Management
Quality Management
Rational Quality ManagerQuality Dashboard
Customer Outsourcing
IBM Software Group | Rational software
58
Benefits
Reduce outsourcing projects still have high failure rate [DOORS] Requirement Repository to maintain the “Source of Trust”
[DOORS] Requirement Integrity through Traceability
Mitigate risks of using Subcontractors [RQM] Real Time Quality Dashboard to increase Transparency
[RQM] Test Coverage visibility
[RQM] Defect Management
Improve your winning chance when outsourcing projects Real Time Monitoring & Tracking during lifecycle
Full Lifecycle Traceability ensure No Missing Issue
Highly Quality project delivery
IBM Software Group | Rational software
59