a case study of integrating ibm rational doors and ibm...

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]

© 2012 IBM Corporation2

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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.



Agenda

Customer Need

Environment Overview

Solution Overview

Conclusion

Q&A



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



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



- 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



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


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)



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



Solution OverviewImport Word Documents into DOORS

DOORS

.doc .csv



Solution OverviewImport Word Documents into RQM

.doc .xml

Quality Manager



Solution OverviewScript #1 – Exports Requirements to CSV File

DOORS_export.csv

(DXL)

DOORS



- {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)



- 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)



Solution OverviewScript #3 – Creates DOORS Views for RQM Test Plans

DOORS_import.csv

(DXL)

DOORS



Solution OverviewExport the DOORS Requirements to RQM

DOORS



Solution OverviewDOORS Requirements Linked to RQM Test Plan

Quality Manager



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)



Test Case

Test CaseTest Plan

Test Case



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)



Test Case

Test CaseTest Plan

Test Case


REQ1REQ2REQ4REQ9

REQ5REQ7REQ8


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)



Solution OverviewDOORS Requirements Linked to RQM Test Cases

Quality Manager



Solution OverviewDOORS Requirements Linked to RQM Test Cases

DOORS



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


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)



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



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



www.ibm.com/software/rational



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Acknowledgements and disclaimers

© Copyright IBM Corporation 2012. All rights reserved.– U.S. Government Users Restricted Rights - Use, duplication or disclosure restricted by GSA ADP Schedule Contract with IBM Corp.

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