Test Management using Telelogic DOORS. Francisco López Telelogic DOORS Specialist

Transcription

1 Test Mngement using Telelogic DOORS Frncisco López Telelogic DOORS Specilist

2 Introduction

3 Telelogic solution for Requirements Mngement DOORS Requirements mngement nd trcebility pltform for complex systems nd softwre development DOORS Web Access Internet Appliction providing globlly distributed stkeholders ccess to review nd discuss requirements in the DOORS dtbse through web browser DOORS/Anlyst Add-in to DOORS for modeling of systems requirements using the Unified Modeling Lnguge DOORS/TrceLine Add-in to DOORS for visulizing, nvigting nd mnging complex requirements nd trcebility structures using grphicl browser

4 Benefits of using DOORS for Requirements Mngement Trcebility from highest level requirements to implementtion 100% trcebility nd verifiction coverge estblished vi links in DOORS Impct ssessments of proposed chnges Anlysis tools let you see which other requirements will be ffected by chnge s report from DOORS. A documented nd controlled development process (SEI, CMM) Mintin bi-directionl trcebility mong the requirements nd the project plns nd work products (CMMI). DOORS provides this trcebility. Controlled ccess to current project informtion A shred dtbse ensures tht ll users re working with current dt A centrl repository llows controlled user ccess to essentil informtion Chnge control The Synergy/Chnge or DOORS Chnge Proposl System implements controlled process for mnging chnge

5 Mrket Leder in Requirements Mngement September 2006

6 Tody s Systems re complex

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18 Systems Development User Requirements Acceptnce Tests System Requirements System Tests Subsystem Reqs. Subsystem Tests Design Integrtion Tests Code

19 Test Mngement using DOORS

20 Telelogic DOORS for Test Mnegement Integrted solution for Requirements-Driven Testing Fcilittes complince with stndrds & regultions Chnge Impct Anlysis Test Coverge Anlysis Metrics on project progress Tested Requirements Tests pssed How? %

21 Test Mngement process 1.Tests definition from requirements: define test nd trce it to requirement 2.Tests execution: test report for ech test run 3.Anlysis: test coverge, chnge impct nlysis, project progress DOORS Doc Tests Definition Test Run 1 DOORS Doc Test Run 2 Req. Specs verify Test Pln, Test Procedures Test Report 1 Test Report 2.

22 Test Definition Tests defined from requirements Requirements Document Tests Document

23 Trcebility I Requirements verified by ech test Tests Associted Reqs

24 Trcebility II Test Coverge: show if requirements re verified nd how Requirements Associted Tests

25 Tests Execution I Crete new Test Report

26 Tests Execution II Enter test results

27 Anlysis Requirement sttus: pproved/tested

28 Trcebility is the key to conformnce User Reqts Technicl Reqts Design Test Cses (b) Design nd Development Plnning Ech mnufcturer shll estblish nd mintin plns tht describe or reference the design nd development ctivities nd define responsibility for implementtion. The plns shll identify nd describe the interfces with different groups or ctivities tht provide, or result in, input to the design nd development process. The plns shll be reviewed s design nd development evolves. The plns shll be updted s design nd development evolves. The plns shll be pproved s design nd development evolves (c) Design Input 2.1. Ech mnufcturer shll estblish procedures to ensure tht the design requirements relting to device re pproprite nd ddress the intended use of the device, including the needs of the user nd ptient Ech mnufcturer shll mintin procedures to ensure tht the design requirements relting to device re pproprite nd ddress the intended use of the device, including the needs of the user nd ptient The procedures shll include mechnism for ddressing incomplete requirements The procedures shll include mechnism for ddressing mbiguous requirements The procedures shll include mechnism for ddressing conflicting requirements The design input requirements shll be documented by designted individul(s) The design input requirements shll be reviewed by designted individul(s) The design input requirements shll be pproved by designted individul(s) The pprovl, including the dte nd signture of the individul(s) pproving the requirements, shll be documented Questions Summrize the mnufcturer's written procedure(s) for identifiction nd control of design input From wht sources re design inputs sought? Do design input procedures cover the relevnt spects, such s: (Mrk ll tht pply nd list dditionl spects.) intended use user/ptient/clinicl performnce chrcteristics sfety limits nd tolernces risk nlysis toxicity nd biocomptibility electromgnetic comptibility (EMC) comptibility with ccessories/uxiliry devices comptibility with the environment of intended use humn fctors physicl/chemicl chrcteristics lbeling/pckging relibility sttutory nd regultory requirements voluntry stndrds mnufcturing processes sterility MDRs/complints/filures nd other historicl dt design history files (DHFs) For the specific design covered, how were the design input requirements identified? For the specific design covered, how were the design input requirements reviewed for dequcy? (b) Design nd Development Plnning Comply with FDA Design Control Guidnce GMP Regultion Comply with FDA Design Control Guidnce GMP Regultion Ech mnufcturer shll estblish nd mintin plns tht describe or reference the design 1.1. Identify nd development impcted elements due to chnge in nother element 1. Cpture design nd relted informtion ctivities nd define responsibility for implementtion. Trcebility Reports: consistency 1. Cpture with design driving nd relted design informtion elements 1.1. Input electroniclly formtted dt 1.1. Input electroniclly formtted dt The plns shll identify nd describe the interfces with different groups or ctivities tht provide, Impct or result Reports: other design elements ffected 1.2. Reference externl informtion sources 1.2. Reference externl informtion sources 1.3. Reference externl documenttion in, input to the design nd development process. Links to impcted design elements 1.3. Reference externl documenttion Crete bckwrd trces to design elements within nd cross ny orgniztionl 2. Store design nd relted informtion The plns shll be reviewed s design nd development evolves. procedure 2. Store design nd relted informtion 2.1. Identify nd tg design informtion The plns shll s unique be updted design s design elements nd development evolves Identify nd tg design informtion s unique design elements The plns shll be pproved s design nd development evolves. Trcebility Reports: Procedure Attribute 2.2. Orgnize design elements 2.2. Orgnize design elements Orgnize by Design Control Guidnce Element Crete bckwrd trces to design elements Orgnize within by Design nd Control cross Guidnce ny project Element milestone Orgnize by inter-reltionships (c) Design Input Trcebility Reports: Milestone Orgnize Attribute by inter-reltionships 2.3. Ensure ll design elements re 2.1. vilble Ech mnufcturer shll estblish procedures to ensure tht the design requirements relting Crete to bckwrd trces to design 2.3. Ensure elements ll design within elements nd re cross vilble Design Control Store design elements by Design device Control re pproprite Guidnce nd Element ddress the intended use of the device, including the needs of the user Guidnce Elements Store design elements by Design Control Guidnce Element Store design elements nd their nd historicl ptient. vlues Store design elements nd their historicl vlues 2.2. Ech mnufcturer shll mintin procedures to ensure tht the design requirements relting Trcebility to Reports: Linked design elements 3. Mnge ll user needs device re pproprite nd ddress the intended use of the device, including the needs of Crete the user forwrd impcts 3. to design Mnge elements ll user needs within nd cross ny orgniztionl 3.1. Identify the source of the user need nd ptient. procedure 3.1. Identify the source of the user need 3.2. Identify ll user types (groups) 2.3. The procedures shll include mechnism for ddressing incomplete requirements. Impct Reports: Procedure 3.2. Identify Attribute ll user types (groups) 3.3. Identify the customer (s) 2.4. The procedures shll include mechnism for ddressing mbiguous requirements Identify the customer (s) 2.5. The procedures shll include mechnism for ddressing conflicting requirements Crete forwrd impcts to design elements within nd cross ny project milestone 3.4. Profile the expected ptients 3.4. Profile the expected ptients 3.5. Stte the intended use of the 2.6. product The (fmily) design input requirements shll be documented by designted individul(s). Impct Reports: Milestone 3.5. Stte Attribute the intended use of the product (fmily) 3.6. Cpture the cceptnce criteri 2.7. for The ech design user need input requirements shll be reviewed by designted individul(s) Crete forwrd impcts to design 3.6. Cpture elements the cceptnce within nd criteri cross for ech Design user need Control 2.8. The design input requirements shll be pproved by designted individul(s). Guidnce Elements 4. Mnge design input requirements 2.9. The pprovl, including the dte nd signture of the individul(s) pproving the requirements, 4. Mnge design input requirements shll be documented. Impct Reports: Linked design elements 4.1. Identify the source of the requirement 4.1. Identify the source of the requirement Questions Associte chnged design elements with relted elements 4.2. Identify the ssocited user need 4.2. Identify the ssocited user need 4.3. Cpture requirement description nd ttributes Summrize the mnufcturer's written procedure(s) for identifiction nd control Link ofchnge Design Object 4.3. with Cpture ffected requirement design element(s) description nd ttributes 4.4. Cpture cceptnce criteri design input. Trcebility Links nd Reports 4.4. from Cpture ffected cceptnce design criteri element(s) 4.5. Assign responsibility for ech requirement From wht sources re design inputs sought? 4.5. Assign responsibility for ech requirement Do design input procedures cover the relevnt spects, such s: (Mrk ll tht Impct pply nd Links nd Reports from ffected design element(s) 4.6. Mnge incomplete requirements 4.6. Mnge incomplete requirements list dditionl spects.) Associte design element chnges with decisions, rtionle, nd pprovl uthority 4.7. Mnge mbiguous requirements 4.7. Mnge mbiguous requirements 4.8. Mnge conflicting requirements intended use informtion 4.8. Mnge conflicting requirements 4.9. Approve ll requirements user/ptient/clinicl Chnge Decision Objects 4.9. with Approve following ll requirements Attributes: performnce chrcteristics sfety Disposition Attribute 5. Mnge cceptnce 5. Mnge cceptnce 5.1. Ensure the cceptnce of every user need limits nd tolernces Decision Attribute 5.1. Ensure the cceptnce of every user need 5.2. Ensure the cceptnce of every design input requirement risk nlysis Rtionle Attribute 5.2. Ensure the cceptnce of every design input requirement 5.3. Document the results of every user need cceptnce toxicity test nd biocomptibility Owner Attribute 5.3. Document the results of every user need cceptnce test 5.4. Document the results of every design input requirements electromgnetic test comptibility (EMC) 5.4. Document the results of every design input requirements test 5.5. Mke cceptnce results vilble comptibility with ccessories/uxiliry devices Mngement Approvl Attribute 5.5. Mke cceptnce results vilble comptibility with the environment of intended use Provide ssocitions within nd cross ny orgniztionl procedure 6. Mnge chnge humn fctors Chnge Design Object 6. Trcebility Mnge chnge Link on Procedure Attribute 6.1. Mintin history of design element chnges physicl/chemicl chrcteristics Chnge Design Object Impcts 6.1. Mintin Link history on Procedure of design Attribute element chnges Mke complete chnge history vilble lbeling/pckging Mke complete chnge history vilble Mintin history within nd cross ny orgniztionl relibility Provide ssocitions within nd cross ny project milestone procedure Mintin history within nd cross ny orgniztionl procedure Mintin history within nd cross ny project sttutory milestone nd regultory requirements Chnge Design Object Trcebility Mintin Link history on Milestone within nd Attribute cross ny project milestone Mintin history within nd cross ny Design voluntry Control stndrds Guidnce Elements Chnge Design Object Impcts Link Mintin on Milestone history within Attribute nd cross ny Design Control Guidnce Elements 6.2. Cpture frequency nd nture of element chnges mnufcturing processes Provide ssocitions within 6.2. nd Cpture cross frequency Design nd Control nture Guidnce of element chnges Elements Provide rtionle for chnge sterility Provide rtionle for chnge Describe decisions mde MDRs/complints/filures nd other historicl dt Chnge Design Object Trcebility Link to trced design elements Describe decisions mde Identify pprovl uthority for the chnge design history files (DHFs) Chnge Design Object Impcts Link Identify to linked pprovl design uthority elements for the chnge Cpture dte, time, nd signture of pproving For the specific uthority design covered, how were the design input requirements 1.3. Mnge identified? the chnge process Cpture dte, time, nd signture of pproving uthority 6.3. Identify impcted elements due to chnge For in the nother specific element design covered, how were the design input requirements reviewed for Design Chnge Module 6.3. Identify impcted elements due to chnge in nother element Crete bckwrd trces to design elements dequcy? within nd cross ny orgniztionl procedure Crete bckwrd trces to design elements within nd cross ny orgniztionl procedure Design Chnge Reports Crete bckwrd trces to design elements within nd cross ny project milestone Crete bckwrd trces to design elements within nd cross ny project milestone Object History Object History Reports Versions Bselines 1.1. Identify impcted elements due to chnge in nother element Trcebility Reports: consistency with driving design elements Impct Reports: other design elements ffected Links to impcted design elements Crete bckwrd trces to design elements within nd cross ny orgniztionl procedure Trcebility Reports: Procedure Attribute Crete bckwrd trces to design elements within nd cross ny project milestone Trcebility Reports: Milestone Attribute Crete bckwrd trces to design elements within nd cross Design Control Guidnce Elements Trcebility Reports: Linked design elements Crete forwrd impcts to design elements within nd cross ny orgniztionl procedure Impct Reports: Procedure Attribute Crete forwrd impcts to design elements within nd cross ny project milestone Impct Reports: Milestone Attribute Crete forwrd impcts to design elements within nd cross Design Control Guidnce Elements Impct Reports: Linked design elements 1.2. Associte chnged design elements with relted elements Link Chnge Design Object with ffected design element(s) Trcebility Links nd Reports from ffected design element(s) Impct Links nd Reports from ffected design element(s) Associte design element chnges with decisions, rtionle, nd pprovl uthority informtion Chnge Decision Objects with following Attributes: Disposition Attribute Decision Attribute Rtionle Attribute Owner Attribute Mngement Approvl Attribute Provide ssocitions within nd cross ny orgniztionl procedure Chnge Design Object Trcebility Link on Procedure Attribute Chnge Design Object Impcts Link on Procedure Attribute Provide ssocitions within nd cross ny project milestone Chnge Design Object Trcebility Link on Milestone Attribute Chnge Design Object Impcts Link on Milestone Attribute Provide ssocitions within nd cross Design Control Guidnce Elements Chnge Design Object Trcebility Link to trced design elements Chnge Design Object Impcts Link to linked design elements 1.3. Mnge the chnge process Design Chnge Module Design Chnge Reports Object History Object History Reports Versions Bselines End-to-end visul vlidtion in single view

29 Chnge Impct Anlysis Esy to ssess the impct of chnges A chnge here Impcts here nd here

30 Metrics on Project Progress

31 Thnk you!