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A Case Study of Integrating IBM Rational DOORS and IBM Rational
Quality Manager for Use in an FDA Environment – SSD-1716
Brian LaHaieRationalTechnical Professional,
[email protected]
Paul SpalittaMgr. DQA Tools and Automation, Accuray
[email protected]
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© 2012 IBM Corporation2
The Premier Event for Software and Systems Innovation
Please note
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subject to change or withdrawal without notice at IBM’s sole
discretion.
Information regarding potential future products is intended to
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The information mentioned regarding potential future products is
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development, release, and timing of any future features or
functionality described for our products remains at our sole
discretion.
Performance is based on measurements and projections using
standard IBM benchmarksin a controlled environment. The actual
throughput or performance that any user will experience will vary
depending upon many factors, including considerations such as the
amount of multiprogramming in the user’s job stream, the I/O
configuration, the storage configuration, and the workload
processed. Therefore, no assurance can be given that an individual
user will achieve results similar to those stated here.
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© 2012 IBM Corporation3
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Abstract
The US Food and Drug Administration (FDA) requires manufacturers
of class II and class III medical devices to establish and maintain
procedures to control product design and ensure that specified
requirements are met.
A critical aspect of Design Control is the establishment and
maintenance of traceability from specifications to verification and
validation (test) cases and steps.
Accuray Incorporated, a leading supplier of Robotic Radio
surgery and Radiation Therapy Systems, uses Rational DOORS and
Rational Quality Manager (RQM) to manage specifications and tests
for their products in a highly-regulated and extremely competitive
environment.
This session will introduce the audience to some of the issues
encountered and overcome by the Accuray team in integrating DOORS
and RQM for their use.
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© 2012 IBM Corporation4
The Premier Event for Software and Systems Innovation
Agenda
Customer Need
Environment Overview
Solution Overview
Conclusion
Q&A
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© 2012 IBM Corporation5
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Customer NeedMigrate a new organization’s legacy artifacts into
the corporate standard tooling consisting of the following:
–Rational DOORS 9.3.0.4
–Rational Quality Manager 3.0.1
Maintain all trace relationships between the legacy requirements
and test script steps
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© 2012 IBM Corporation6
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Environment Overview
- Requirements in MS Word Documents
- Test Scripts in MS Word Documents
- Manually traced by unique requirement ID
Requirements
Test Scripts
Before the Migration
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© 2012 IBM Corporation7
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- Requirements in Rational DOORS
- Test Scripts in Rational Quality Manager
- Manually traced by unique requirement ID with live link to
DOORS Web Access (DWA)
Environment OverviewAfter the Migration
Link to DWA
Quality Manager
DOORS
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© 2012 IBM Corporation8
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Test Case
REQ5 REQ7 REQ8
Test Case
REQ1 REQ2 REQ4 REQ9
Test Case
REQ3 REQ6 REQ10
Test Plan REQ1 REQ2 REQ3 REQ4 REQ5 REQ6 REQ7 REQ8 REQ9 REQ10
Step 1 - - REQ1
Step 2 - - REQ2
Step 3 - - REQ4
Step 4 - - REQ9
Environment OverviewAfter the Migration
Tests Script
Step 1 - - REQ3
Step 2 - - REQ6
Step 3 - - REQ10
Tests Script
Tests Script
Step 1 - - REQ5
Step 2 - - REQ7
Step 3 - - REQ8
DOORS
Quality Manager
(RQMI)
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© 2012 IBM Corporation9
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Import Word Documents into DOORS and RQM– Converted requirements
documents to spreadsheets and imported into DOORS
– Converted test scripts into XML and imported into RQM
Scripts to migrate the requirements to test artifact linkage–
Script #1 - Exports DOORS requirements into a .csv file
– Script #2 - Links DWA URLs to RQM Test Script Steps
– Script #3 - Creates DOORS Views for RQM Test Plans
– Script #4 – Links DOORS requirements to RQM Test Cases
Data passed between the scripts via export and import files
Integration, Sharing, and Collaboration Technology– Integrate
using DXL (DOORS eXtension Language)
– Integrate using OSLC (Open Services for Lifecycle
Collaboration)
Integration maintained via DOORS RQM Interface (RQMI)
Solution Overview
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© 2012 IBM Corporation10
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Solution OverviewImport Word Documents into DOORS
DOORS
.doc .csv
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© 2012 IBM Corporation11
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Solution OverviewImport Word Documents into RQM
.doc .xml
Quality Manager
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© 2012 IBM Corporation12
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Solution OverviewScript #1 – Exports Requirements to CSV
File
DOORS_export.csv
(DXL)
DOORS
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© 2012 IBM Corporation13
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- {Legacy ID}
- {Legacy ID}
- {Legacy ID}
- {Legacy ID}
Solution OverviewScript #2 – Links DOORS Web Access URLs to RQM
Test Script Steps
Step 1 -
Step 2 -
Step 3 -
Step 4 -
Tests Script
Step 1 -
Step 2 -
Step 3 -
Tests Script
Tests Script
Step 1 -
Step 2 -
Step 3 -
- {Legacy ID}
- {Legacy ID}
- {Legacy ID}
- {Legacy ID}
- {Legacy ID}
- {Legacy ID}
DOORS_export.csv
DOORS_import.csv RQM_import.txt
Quality Manager
(Java)
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© 2012 IBM Corporation14
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- REQ3
- REQ6
- REQ10
Solution OverviewScript #2 – Links DOORS Web Access URLs to RQM
Test Script Steps
Step 1 -
Step 2 -
Step 3 -
Step 4 -
Tests Script
Step 1 -
Step 2 -
Step 3 -
Tests Script
Tests Script
Step 1 -
Step 2 -
Step 3 -
- REQ1
- REQ2
- REQ4
- REQ9
- REQ5
- REQ7
- REQ8
DOORS_export.csv
DOORS_import.csv RQM_import.txt
Quality Manager
(Java)
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© 2012 IBM Corporation15
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Solution OverviewScript #3 – Creates DOORS Views for RQM Test
Plans
DOORS_import.csv
(DXL)
DOORS
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© 2012 IBM Corporation16
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Solution OverviewExport the DOORS Requirements to RQM
DOORS
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© 2012 IBM Corporation17
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Solution OverviewDOORS Requirements Linked to RQM Test Plan
Quality Manager
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© 2012 IBM Corporation18
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Test Case
Test CaseTest Plan
Test Case
REQ1 REQ2 REQ3 REQ4 REQ5 REQ6 REQ7 REQ8 REQ9 REQ10
Solution OverviewScript #4 – Links DOORS requirements to RQM
Test Cases
RQM_import.txt
Step 1 - - REQ1
Step 2 - - REQ2
Step 3 - - REQ4
Step 4 - - REQ9
Tests Script
Step 1 - - REQ3
Step 2 - - REQ6
Step 3 - - REQ10
Tests Script
Tests Script
Step 1 - - REQ5
Step 2 - - REQ7
Step 3 - - REQ8
Quality Manager
(Java via IIE API)
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© 2012 IBM Corporation19
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Test Case
Test CaseTest Plan
Test Case
REQ1 REQ2 REQ3 REQ4 REQ5 REQ6 REQ7 REQ8 REQ9 REQ10
Solution OverviewScript #4 – Links DOORS requirements to RQM
Test Cases
RQM_import.txt
Step 1 - - REQ1
Step 2 - - REQ2
Step 3 - - REQ4
Step 4 - - REQ9
Tests Script
Step 1 - - REQ3
Step 2 - - REQ6
Step 3 - - REQ10
Tests Script
Tests Script
Step 1 - - REQ5
Step 2 - - REQ7
Step 3 - - REQ8
Quality Manager
(Java via IIE API)
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© 2012 IBM Corporation20
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Test Case
Test CaseTest Plan
Test Case
REQ1 REQ2 REQ3 REQ4 REQ5 REQ6 REQ7 REQ8 REQ9 REQ10
REQ1REQ2REQ4REQ9
REQ5REQ7REQ8
Solution OverviewScript #4 – Links DOORS requirements to RQM
Test Cases
RQM_import.txt
Step 1 - - REQ1
Step 2 - - REQ2
Step 3 - - REQ4
Step 4 - - REQ9
Tests Script
REQ3 REQ6 REQ10
Step 1 - - REQ3
Step 2 - - REQ6
Step 3 - - REQ10
Tests Script
Tests Script
Step 1 - - REQ5
Step 2 - - REQ7
Step 3 - - REQ8
Quality Manager
(Java via IIE API)
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© 2012 IBM Corporation21
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Solution OverviewDOORS Requirements Linked to RQM Test Cases
Quality Manager
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© 2012 IBM Corporation22
The Premier Event for Software and Systems Innovation
Solution OverviewDOORS Requirements Linked to RQM Test Cases
DOORS
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© 2012 IBM Corporation23
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Test Case
REQ5 REQ7 REQ8
Test Case
REQ1 REQ2 REQ4 REQ9
Test Case
REQ3 REQ6 REQ10
Test Plan REQ1 REQ2 REQ3 REQ4 REQ5 REQ6 REQ7 REQ8 REQ9 REQ10
Step 1 - - REQ1
Step 2 - - REQ2
Step 3 - - REQ4
Step 4 - - REQ9
Environment OverviewAfter the Migration
Tests Script
Step 1 - - REQ3
Step 2 - - REQ6
Step 3 - - REQ10
Tests Script
Tests Script
Step 1 - - REQ5
Step 2 - - REQ7
Step 3 - - REQ8
DOORS
Quality Manager
(RQMI)
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© 2012 IBM Corporation24
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Conclusion Migrated requirements and test artifacts while
maintaining test script step
level tracing– Over 14,000 requirements
– Over 150 test plans
– Over 1,200 test cases
– Over 1,200 test scripts
Step level tracing was enhanced because of DOORS Web Access live
links
Roughly 240 hours to fully implement
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© 2012 IBM Corporation25
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Conclusion Key contributing factors to success
– Collaboration between the client and IBM team
– Common understanding of the problem
– Flexible and powerful sharing and integration capabilities of
DXL and OSLC
Efficient and effective migration results enabled by the
solution– Removal of error prone steps
– Automation of time-consuming repetitive steps
– Reuse of existing DOORS and RQM capabilities
Managed solution development process– A distributed and
multidisciplinary solution team
– A cloud (shared) development environment
– Multiple iterations emphasizing integration, verification and
validation
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© 2012 IBM Corporation26
The Premier Event for Software and Systems Innovation
www.ibm.com/software/rational
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© 2012 IBM Corporation27
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Acknowledgements and disclaimers
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