![\"\"](\"https:\/\/www.jamasoftware.com\/media\/2020\/06\/2020-06-25_PartV_UsingtheTraceAsWautoWork_1024x512-1.jpg\")
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In the previous Jama Connect\u2122<\/span><\/span> for Medical Device Development solution post<\/a>, we learned how Jama Connect\u00a0could:<\/p>\n Specifically,\u202fwe\u202fsaw how trace helped\u202fensure\u202falignment of these controls through\u202facceptance criteria, increasing confidence in our verification activities and\u202fsupporting\u202fvisibility into the conformance of design outputs.<\/p>\n Capturing and managing\u202fdesign controls\u202fin\u202fJama Connect<\/a> expands the concept of traceability far beyond simply a reporting output required of the Design History File (DHF).\u202fNow, we\u2019ll look at the importance of the trace in Jama Connect.\u202f It’s\u202ffor\u202fmore than connecting\u202finformation for the sake of documentation. It\u2019s\u202fa way of working.\u202fThe matrix provided to the DHF becomes a\u202fbyproduct\u202fof working in Jama Connect.<\/p>\n Organizations\u202fthat\u202fuse\u202fdocuments and spreadsheets to manage requirements, verifications and risk management\u202ffeel\u202fburdened with the overhead of trying to manage the trace of information across documents. I\u2019ve worked with\u202fmany\u202fteams\u202fwho\u2019ve said\u202fmanaging trace\u202fwas\u202fthe\u202fnumber one\u202fconcern\u202fabout\u202ftheir current way of working, and the reason for their transition to Jama Connect. When we talked about their desired state\u202fafter deploying\u202fin Jama Connect, near or at the top of the list was\u202fno longer having to generate and manage the trace matrix.<\/p>\n Prior to Jama Connect, many of these organizations waited\u202funtil\u202fthe end of an effort to create their required matrix.\u202fWhile\u202fworking with these customers, I realized\u202fthe trace matrix should not be\u202fan\u202feffort\u202fin itself\u202f\u2014 it\u202fshould be\u202fa byproduct of\u202fhow teams\u202fwork. When trace becomes just\u202fhow teams work, not only do they remove the burden of having to generate it in the end, they can\u202factually use\u202fthe trace to build efficiencies into\u202fthe design and development process.<\/p>\n The\u202fout-of-the-box configuration provided with the\u202fJama Connect for Medical Device Development\u202fsolution\u202fwas constructed around the value of trace\u202f\u2013 not simply having\u202ftrace but\u202fusing trace.<\/p>\n Using the trace in the Jama Connect for Medical Device Development solution enables you to:<\/p>\n Often, coverage, or gap, analysis\u202fis seen as a way of simply dotting i’s and crossing t\u2019s to make sure a\u202ftrace\u202fmatrix shows\u202ffull due diligence\u202fin product definition, verification and risk\u00a0management.\u202fWhile\u202fvery important,\u202fit\u202fserves only\u202freporting what was done\u202fand as evidence after the fact. However, when this information is\u202flive and accessible, it becomes\u202fmeaningful\u202fduring\u202fdesign and development activities, not just at the end.<\/p>\n In the Jama Connect for Medical Device Development solution,\u202fteams\u202fcan\u202fuse\u202ftrace views and\u202ffilters to\u202fmake assessments about\u202fwork prioritization and managing scope.\u202fFor example, the\u202fsolution\u202fprovides\u202fvisibility\u202finto:<\/p>\n This way,\u202fgap analysis provides meaningful data in the moment for decision making and course correction.<\/p>\n Often, team members\u202fauthoring\u202frequirements, especially system requirements, have a sense of the lower level product definition\u202fand verification activities.\u202fHowever, they\u202fmay not\u202fknow the full\u202fpicture\u202for\u202fthey may\u202fnot\u202fbe tasked with defining lower level\u202fdefinition.<\/p>\n Some examples:<\/p>\n In both examples, a\u202fhigher-level\u202fdesign input, the system requirement, describes\u202fa function fulfilled across disciplines.<\/p>\n In Jama Connect\u202fwe encourage capturing information about lower-level needs in the higher-level items, for allocation and for more detailed gap analysis. To handle the examples above,\u202fsystem requirements are configured to capture impacted disciplines, as shown below\u202fusing a multi-select field:<\/p>\n In addition to capturing the\u202fimpacted\u202fdisciplines\u202fin the system requirement, the configuration requires subsystem requirements capture the single owning discipline, as shown below using a single select field:<\/p>\n With this level of detail captured in system requirements and subsystem requirements, trace again proves useable throughout product definition activities.\u202fFilters provided with the out-of-\u202fthe-box configuration\u202fgive\u202fvisibility into system requirements impacting specific disciplines but\u202flacking\u202fa\u202fsubsystem requirement\u202ffor\u202feach\u202fimpacted discipline.\u202fFor example, we can easily identify system requirements allocated to software that lack a\u202fsoftware requirement, same for any other disciplines identified.<\/p>\n This\u202flooks at\u202fsystem requirements\u202ffrom\u202fa gap analysis\u202fperspective\u202f(\u201cwhere am I missing something?\u201d). Another use of this same view\u202fidentifies\u202fwork to be done.\u202fLike the\u202fexample above, if I am a Software\u202fEngineer,\u202fI can use that same filter to identify all accepted system requirements that I need to work on \u2013 those\u202fexpecting but\u202flacking a\u202fsoftware response.<\/p>\n The concept described above for disciplines\u202falso applies\u202fto verification methods. The out-of-the box configuration of\u202fsystem and subsystem requirements provides a multi-select field for defining the verification method for the requirement:<\/p>\n In the verification items, we capture the method in a single select field:<\/p>\n Just like we saw for requirement allocation to disciplines, we can\u202fuse trace for more detailed gap analysis to begin defining verifications early, as requirements are accepted.\u202fFor\u202fexample, trace\u202fcan tell us which requirements\u202fverified by \u201cTesting\u201d or \u201cInspection\u201d\u202flack\u202fa verification of that type. Testing teams can easily identify verification coverage gaps and address those gaps as requirements are\u202faccepted, instead of having to wait for large, fully formed requirement documents to be approved.<\/p>\n The benefits of trace and the ability to use trace as described above are only\u202fpossible\u202fif trace becomes a way of working. There are three\u202fkeys to making this a reality:<\/p>\n Including\u202fdesign controls in a single system\u202fmarks\u202fthe fundamental requirement of\u202fa useful\u202ftrace. It\u2019s\u202ftoo much work to manage connections across multiple documents and\u202fthere\u2019s\u202ftoo little confidence in the manual maintenance of the trace to be useful. A single system, like Jama Connect,\u202faffords teams the opportunity to make trace useful and actionable.<\/p>\n To encourage trace as a way of working, you\u202fhave to\u202fmake it\u202feasy to\u202fconnect\u202fto\u202fnew or existing information.\u202fYou can create\u202fnew information, both upstream and downstream, directly from related items\u202fIn Jama Connect. This allows for authoring of new information and the automatic tracing of items.<\/p>\n The image below shows\u202fjust one way to establish the trace.\u202fThis\u202fapproach\u202fcreated new items\u202fdirectly from their related items.<\/p>\n We\u2019re looking at a system requirement. I can create any of the listed related items directly from here, automatically establishing a trace. Note that what\u2019s presented as options is\u202fdetermined\u202fby rules dictating what information can be traced. This ensures only valid traces are established. The Jama Connect for Medical Device Development\u00a0solution\u00a0enforces relationships through a\u202frelationship\u202frule aligned to 21 CFR 820.30 and ISO 13485:2016.<\/p>\n Jama Connect provides many ways to navigate\u202fitem relationships, assess coverage and identify gaps. Trace View and Filters\u202fare\u202fimportant\u202ffeatures supporting these activities.\u202fThe key here\u202fis\u202fto\u202fact on the information\u202fthese views provide.\u202fYou can fill gaps\u202fand\u202festablish\u202frelationships established\u202fdirectly from these views.\u202fThis is\u202f\u201cactionable traceability.\u201d<\/p>\n We\u202fdesigned\u202fthe Jama Connect for Medical Device Development solution to\u202fhelp device manufacturers\u202frealize the goal of designing and developing safe, effective and innovative Medical Device products. A goal we can all get behind!<\/p>\n Hopefully this series\u202fhelps you as you work toward that goal. Each post had a purpose: \u202fto\u202fintroduce the Jama Connect for Medical Device Development solution<\/a>\u202fand\u202fdescribe components of the solution<\/a>,\u202fto learn\u202fhow to incorporate\u202fsystems thinking into design inputs activities<\/a>,\u202fthen to understand\u202fdesign\u202finputs,\u202fdesign\u202foutputs,\u202fverifications<\/a>, and the relevant regulations and standards informing the solution, and finally,\u202fhow to use\u202fthe trace.<\/p>\n I hope it\u2019s been informative and helpful. Through these concepts, the solution brings value and introduces visibility and efficiency into design control activities.<\/p>\n <\/p>\n <\/p>\n\n
Use the trace to build efficiencies into the design and<\/h4>\n
development process.<\/h4>\n
1. Manage\u202fscope\u202fthrough trace<\/h6>\n
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2. Plan and identify connected activities<\/h6>\n
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For Requirements<\/h6>\n
![\"\"](\"https:\/\/www.jamasoftware.com\/media\/2020\/06\/image-2.png\")
<\/p>\n![\"\"](\"https:\/\/www.jamasoftware.com\/media\/2020\/06\/image-3.png\")
<\/p>\nFor\u202fVerification<\/h6>\n
![\"\"](\"https:\/\/www.jamasoftware.com\/media\/2020\/06\/image-4.png\")
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<\/p>\nThe benefits of trace.<\/strong><\/h4>\n
1.Capture design controls in a single system.<\/h6>\n
2. Create through trace.<\/h6>\n
![\"\"](\"https:\/\/www.jamasoftware.com\/media\/2020\/06\/image-6.png\")
<\/p>\n3. Actively monitor trace<\/h6>\n
Catch up on all posts in the series.<\/h4>\n
\u00a0Stay up to date on the Jama Connect for Medical Device Development solution here.<\/h5>\n