<p class="MsoNormal"><span lang="EN-US">The risk
will be assessed by determining an overall risk for each requirement and
specification based on a combination of risk Severity and risk Probability and
risk Detectability as follows:</span></p><p class="MsoNormal"><img src="http://127.0.0.1/csv-software/www/index.php?action=back.file.get&amp;file=images/risque_800x-.png" style="width: 800px;"></p><p class="MsoNormal" align="left"><b><span lang="EN-US">Severity</span></b><span lang="EN-US">: Impact on Patient Safety, Product
Quality, and Data Integrity (or other harm)<o:p></o:p></span></p><p class="MsoNormal" align="left"><b><span lang="EN-US">Probability</span></b><span lang="EN-US">: Likelihood of the fault occurring<o:p></o:p></span></p><p class="MsoNormal" align="left" style="text-indent: 35.4pt;"><b><span lang="EN-US">Risk Class</span></b><span lang="EN-US"> =
Severity x Probability<o:p></o:p></span></p><p class="MsoNormal" align="left"><b><span lang="EN-US">Detectability</span></b><span lang="EN-US">: Likelihood that the fault will be
noted before harm occurs<o:p></o:p></span></p><p class="MsoNormal">







</p><p class="MsoNormal" align="left"><b><span lang="EN-US">Risk</span></b><span lang="EN-US"> = Risk Class x Detectability<o:p></o:p></span></p>