{"id":114,"date":"2024-12-06T19:40:18","date_gmt":"2024-12-06T19:40:18","guid":{"rendered":"https:\/\/engprojects.tcnj.edu\/bamdi\/?page_id=114"},"modified":"2024-12-06T20:44:28","modified_gmt":"2024-12-06T20:44:28","slug":"hazard-analysis","status":"publish","type":"page","link":"https:\/\/engprojects.tcnj.edu\/bamdi\/hazard-analysis\/","title":{"rendered":"Hazard Analysis"},"content":{"rendered":"\n<figure class=\"wp-block-table\"><table><tbody><tr><td>Hazard<\/td><td>Hazardous Situation&nbsp;<\/td><td>Potential Harms<\/td><td>Severity&nbsp;<\/td><td>Occurrence<\/td><td>Risk<\/td><\/tr><tr><td>Battery Depletion&nbsp;<\/td><td>No power or data&nbsp;<\/td><td>Ineffective treatment&nbsp;<\/td><td>2<\/td><td>2<\/td><td>R1<\/td><\/tr><tr><td>Material Degradation&nbsp;<\/td><td>Medication not delivered properly&nbsp;<\/td><td>Reduced treatment effectiveness&nbsp;<\/td><td>4 <\/td><td>4<\/td><td>R3<\/td><\/tr><tr><td>Biofilm Build up&nbsp;<\/td><td>Feedback malfunction&nbsp;<\/td><td>Incorrect data&nbsp;<\/td><td>3 <\/td><td>3<\/td><td>R2<\/td><\/tr><tr><td>Overheating of Electronics&nbsp;<\/td><td>Discomfort due to heat&nbsp;<\/td><td>Discomfort or potential burns&nbsp;<\/td><td>2 <\/td><td>2<\/td><td>R1<\/td><\/tr><tr><td>Improper Device Assembly&nbsp;<\/td><td>Device malfunction&nbsp;<\/td><td>Reduced treatment efficiency&nbsp;<\/td><td>4 <\/td><td>4<\/td><td>R3<\/td><\/tr><tr><td>Sensor malfunction<\/td><td>Inaccurate feedback&nbsp;<\/td><td>User to be mislead&nbsp;<\/td><td>3 <\/td><td>4<\/td><td>R2<\/td><\/tr><tr><td>Delayed Timing Activation<\/td><td>Delay of treatment<\/td><td>Reduced treatment effectiveness<\/td><td>5 <\/td><td>3<\/td><td>R3<\/td><\/tr><tr><td>Microcontroller Malfunction&nbsp;<\/td><td>No data or improper feedback&nbsp;<\/td><td>User decision inaccuracy&nbsp;<\/td><td>3<\/td><td>3<\/td><td>R2<\/td><\/tr><\/tbody><\/table><figcaption class=\"wp-element-caption\">Hazard Spreadsheet<\/figcaption><\/figure>\n\n\n\n<p>Note: <\/p>\n\n\n\n<p><strong>R1<\/strong>: Low level of risk<\/p>\n\n\n\n<p><strong>R2<\/strong>: Moderate level of risk<\/p>\n\n\n\n<p><strong>R3<\/strong>: High level of risk<\/p>\n\n\n\n<p>&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>Rating&nbsp;<\/td><td>Probability of Occurrence&nbsp;<\/td><td>Description<\/td><\/tr><tr><td>5<\/td><td>Frequent&nbsp;<\/td><td>Events are likely to occur during use.&nbsp;<\/td><\/tr><tr><td>4<\/td><td>Occasional&nbsp;<\/td><td>Events may occur during typical use.&nbsp;<\/td><\/tr><tr><td>3<\/td><td>Remote&nbsp;<\/td><td>Event is unlikely but still possible to occur during typical use.&nbsp;<\/td><\/tr><tr><td>2<\/td><td>Rare<\/td><td>Event is very unlikely to occur however it is still possible.&nbsp;<\/td><\/tr><tr><td>1<\/td><td>Very Unlikely&nbsp;<\/td><td>Events are extremely unlikely to occur during typical use, almost impossible.<\/td><\/tr><\/tbody><\/table><figcaption class=\"wp-element-caption\">Occurrence Table<\/figcaption><\/figure>\n\n\n\n<p>&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>Ratings&nbsp;<\/td><td>Severity of Effect<\/td><td>Consequence&nbsp;<\/td><td>Treatment&nbsp;<\/td><\/tr><tr><td>5<\/td><td>Death&nbsp;<\/td><td>&#8211;<\/td><td>&#8211;<\/td><\/tr><tr><td>4<\/td><td>Severe Discomfort&nbsp;<\/td><td>Struggles to breathe, speaks in single words; severe wheezing<\/td><td>Hospital Visit<\/td><\/tr><tr><td>3<\/td><td>Moderate Discomfort<\/td><td>Noticeable shortness of breath, audible wheezing, and visible retractions<\/td><td>Hospital Visit for abundant treatment<\/td><\/tr><tr><td>2<\/td><td>Mild Discomfort<\/td><td>Mild Shortness of breath while walking<\/td><td>Self-Treatment<\/td><\/tr><tr><td>1<\/td><td>No Harm<\/td><td>&#8211;<\/td><td>&#8211;<\/td><\/tr><\/tbody><\/table><figcaption class=\"wp-element-caption\">Severity Table<\/figcaption><\/figure>\n\n\n\n<p>&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Mitigations (for R3)<\/h2>\n\n\n\n<p><strong>Material Degradation due to Cleaning<\/strong>&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Use a corrosion resistant materials\n<ul class=\"wp-block-list\">\n<li>Select materials made to withstand repeated cleaning cycle\u00a0<\/li>\n\n\n\n<li>Degradation resistant materials\u00a0<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>User guidelines for cleaning\n<ul class=\"wp-block-list\">\n<li>Design a safe and sustainable cleaning solution\u00a0<\/li>\n\n\n\n<li>List acceptable cleaning materials that can be used to avoid degradation\u00a0<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>Resisdual Risk Evaluation&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Simulating typical cleaning cycles on device materials\n<ul class=\"wp-block-list\">\n<li>Observe degradation of material\u00a0<\/li>\n\n\n\n<li>Ensure risk remains below acceptable level\u00a0<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p><strong>Improper Device Assembly \/ Disassembly<\/strong>&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Clear assembly instructions\n<ul class=\"wp-block-list\">\n<li>Provide step-by-step instructions associated with illustrations to guide users through the assembly\/disassembly process\u00a0<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Design with intuitive assembly\n<ul class=\"wp-block-list\">\n<li>Implement design principles that ensure the device is assembled correctly<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>Residual Risk Evaluation&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Conduct a usability test\n<ul class=\"wp-block-list\">\n<li>Confirm risk of misassembly is at an acceptable level<\/li>\n\n\n\n<li>Acquire feedback to ensure assembly process is straightforward and intuitive\u00a0<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p><strong>Delayed Timing of Activation<\/strong>&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Reliable timing mechanism\n<ul class=\"wp-block-list\">\n<li>Ensure microcontroller is calibrated and rigorously tested to reduce delay\u00a0<\/li>\n\n\n\n<li>Program device to reset before the device is activated\u00a0<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p>Residual Risk Evaluation&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Test timing accuracy\n<ul class=\"wp-block-list\">\n<li>Confirm delay is minimized\u00a0<\/li>\n\n\n\n<li>Risk remains below acceptable\u00a0<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Hazard Hazardous Situation&nbsp; Potential Harms Severity&nbsp; Occurrence Risk Battery Depletion&nbsp; No power or data&nbsp; Ineffective treatment&nbsp; 2 2 R1 Material Degradation&nbsp; Medication not delivered properly&nbsp; Reduced treatment effectiveness&nbsp; 4 4 R3 Biofilm Build up&nbsp; Feedback malfunction&nbsp; Incorrect data&nbsp; 3 3 R2 Overheating of Electronics&nbsp; Discomfort due to heat&nbsp; Discomfort or potential burns&nbsp; 2 2 R1 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/engprojects.tcnj.edu\/bamdi\/hazard-analysis\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Hazard Analysis&#8221;<\/span><\/a><\/p>\n","protected":false},"author":625,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ngg_post_thumbnail":0,"footnotes":""},"class_list":["post-114","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/engprojects.tcnj.edu\/bamdi\/wp-json\/wp\/v2\/pages\/114","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/engprojects.tcnj.edu\/bamdi\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/engprojects.tcnj.edu\/bamdi\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/bamdi\/wp-json\/wp\/v2\/users\/625"}],"replies":[{"embeddable":true,"href":"https:\/\/engprojects.tcnj.edu\/bamdi\/wp-json\/wp\/v2\/comments?post=114"}],"version-history":[{"count":0,"href":"https:\/\/engprojects.tcnj.edu\/bamdi\/wp-json\/wp\/v2\/pages\/114\/revisions"}],"wp:attachment":[{"href":"https:\/\/engprojects.tcnj.edu\/bamdi\/wp-json\/wp\/v2\/media?parent=114"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}