{"id":6943,"date":"2023-01-29T01:55:53","date_gmt":"2023-01-29T01:55:53","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=6943"},"modified":"2024-01-11T16:15:59","modified_gmt":"2024-01-11T16:15:59","slug":"medical-device-root-cause-analysis-overview","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/medical-device-root-cause-analysis-overview\/","title":{"rendered":"Dig Deep and Do Medical Device Root Cause Analysis the Right Way\u200b"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6943\" class=\"elementor elementor-6943\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1b0c5cde elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b0c5cde\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6dd05cd3\" data-id=\"6dd05cd3\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7ca59751 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"7ca59751\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-6ea4084d\" data-id=\"6ea4084d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3fab5c3f elementor-widget elementor-widget-post-info\" data-id=\"3fab5c3f\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2023\/01\/29\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tJanuary 29, 2023\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f16c1c2 elementor-widget elementor-widget-heading\" data-id=\"5f16c1c2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">Dig Deep and Do Medical Device Root Cause Analysis the Right Way<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f7ff590 elementor-widget elementor-widget-image\" data-id=\"1f7ff590\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1650\" height=\"928\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Planning-for-root-cause-analysis.jpg\" class=\"attachment-full size-full wp-image-1316\" alt=\"Planning root cause analysis\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Planning-for-root-cause-analysis.jpg 1650w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Planning-for-root-cause-analysis-300x169.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Planning-for-root-cause-analysis-768x432.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Planning-for-root-cause-analysis-1024x576.jpg 1024w\" sizes=\"(max-width: 1650px) 100vw, 1650px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1005398 elementor-widget elementor-widget-text-editor\" data-id=\"1005398\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>\u201cNever try to solve all the problems at once \u2014 make them line up for you one-by-one.\u201d<\/p><p>This quote by author Richard Sloma captures the essence of effective root cause analysis. When presented with a vexing problem, many RA\/QA managers feel overwhelmed, make rash assumptions, or try to \u201cram through\u201d a solution\u2026only to see the problem pop up again like the mythical Hydra.<\/p><p>Let\u2019s start by talking about the consequences of putting off problem resolution and the obstacles you may encounter when tackling nagging little problems (or monster problems).<\/p><p>In this article:<\/p><p><a href=\"#problems\"><u>Problems you\u2019ll encounter<\/u><\/a><br \/><a href=\"#consequences\"><u>The consequences of not dealing with an issue<\/u><\/a><br \/><a href=\"#obstacles\"><u>Obstacles to investigating the true root cause of problems<\/u><\/a><br \/><a href=\"#define-scope\"><u>How to define and scope problems<\/u><\/a><\/p><p><a href=\"#scope-problem\"><u>Properly scoping the problem<\/u><\/a><br \/><a href=\"#case\"><u>Making the case for solving problems<\/u><\/a><br \/><a href=\"#team\"><u>Assembling your team and coming up with a plan<\/u><\/a><br \/><a href=\"#data\"><u>What data will you need?<\/u><\/a><br \/><a href=\"#sampling-analysis\"><u>Creating your sampling and analysis plan<\/u><\/a><br \/><a href=\"#why\"><u>It\u2019s about more than simply asking \u201cwhy?\u201d<\/u><\/a><br \/><a href=\"#test-verify\"><u>Test and verify root cause<\/u><\/a><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-299cde1 elementor-widget elementor-widget-menu-anchor\" data-id=\"299cde1\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\nbody.elementor-page .elementor-widget-menu-anchor{margin-bottom:0}<\/style>\t\t<div id=\"problems\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6006e54b elementor-widget elementor-widget-heading\" data-id=\"6006e54b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Problems you\u2019ll encounter<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ce6da04 elementor-widget elementor-widget-text-editor\" data-id=\"2ce6da04\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>In simple terms, a problem is a gap between\u00a0<strong>what is<\/strong>\u00a0and\u00a0<strong>what should be<\/strong>. There are generally two types of problems: process problems and product problems. Product problems are obvious, but process problems can include things such as lack of effectiveness on the production line, errors on the manufacturing floor, and delays in order processing or shipping.<\/p><p>Here\u2019s an example:<\/p><p>Suppose you are an engineer at a large medical device company. The complaint-handling department tells you that a tubing connector has cracked on your device at a customer site. This is the first failure like this you have seen and you immediately send a service technician to the site. The connector is replaced and the client is back in action. But this action does not address the core problem. Until you know what caused the connector to fail, there is no assurance it won\u2019t happen again. After running some tests on the cracked connector and looking at some records, you discover that a nonconforming connector was used. You rework the affected batch of devices in stock and replace all out-of-spec connectors with approved connectors. Now that the problem has been identified and a temporary fix has been implemented, there is no longer any urgency to follow up, right? This problem seems isolated, but is it really? What about connectors from the same batch that are in devices delivered to other customers?<\/p><p>So, you have some more work to do \u2013 you still need to find out what really caused the connector to split. Was it truly the nonconforming component or something else? In this case, a preconceived notion of the problem stops the team from investigating the true root cause\u2026which may be the reason why the connector cracked.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8b77207 elementor-widget elementor-widget-menu-anchor\" data-id=\"8b77207\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"consequences\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1af7ef elementor-widget elementor-widget-heading\" data-id=\"a1af7ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The consequences of not dealing with an issue can be severe<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb40341 elementor-widget elementor-widget-text-editor\" data-id=\"cb40341\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Medical device manufacturers often get dinged by Notified Bodies and regulators for violating one of three basic tenets:<\/p><p>\u00a0<\/p><ul><li>Their procedures do not follow the regulations.<\/li><li>They do not follow their procedures.<\/li><li>They do not have records to demonstrate that they do follow their procedures.<\/li><\/ul><p>Many people erroneously assume that compliance with nonconforming product regulations only applies to products that have been placed into commercial distribution. However, FDA and ISO mandates apply to problems discovered\u00a0<em>before<\/em>\u00a0distribution occurs, not just after. The intent behind these standards and regulations is to encourage organizations to detect, resolve, and prevent problems effectively. How you accomplish that is up to you.<\/p><p>\u00a0<\/p><table width=\"677\"><tbody><tr><td width=\"211\"><p><strong>Relevant Requirements Governing Medical Device Root Cause Analysis<\/strong><\/p><\/td><td width=\"244\"><p><strong>Nonconforming Product<\/strong><\/p><\/td><td width=\"222\"><p><strong>CAPA<\/strong><\/p><\/td><\/tr><tr><td width=\"211\"><p><strong>US FDA Quality System Regulation<\/strong><\/p><\/td><td width=\"244\"><p><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=820.90\">21 CFR Part 820.90<\/a><\/p><\/td><td width=\"222\"><p><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=820.100\">21 CFR Part 820.100<\/a><\/p><\/td><\/tr><tr><td width=\"211\"><p><strong>ISO 13485:2016<\/strong><\/p><\/td><td width=\"244\"><p>Section 8.3<\/p><\/td><td width=\"222\"><p>Sections 8.5.2 and 8.5.3<\/p><\/td><\/tr><\/tbody><\/table><p>On the far end of spectrum, problems can result in a product recall. The overwhelming majority of problems don\u2019t escalate into full-blown product recalls, but they are also not as rare as you might think. In the 12 months ending 9\/30\/2023, 500 recalls from 119 medical device companies were listed on the\u00a0<u>FDA recalls database<\/u>. Root cause investigations were (or certainly will be) conducted by all 119 companies. Aside from the obvious potential harm to patients and users, recalls are very, very expensive. Tracking down defective products and trying to get them back requires significant resources, and the resulting harm to a company\u2019s reputation can be even more costly. When recalls occur, competitors pounce on the sales opportunity handed to them by a wounded rival. And when investors find out, they immediately start looking for other places to park their money. In any case, when recalls occur, everyone feels the heat from the top down.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-09afa14 elementor-widget elementor-widget-menu-anchor\" data-id=\"09afa14\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"obstacles\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f0f011 elementor-widget elementor-widget-heading\" data-id=\"0f0f011\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Obstacles to Investigating the True Root Cause of Problems<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-08bb4a2 elementor-widget elementor-widget-text-editor\" data-id=\"08bb4a2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li>Having a preconceived notion of the problem<\/li><li>Not recognizing the actual problem<\/li><li>Fixing the product instead of the process that produced the product<\/li><li>Putting a bandage on the problem<\/li><li>Getting mired in \u201canalysis paralysis\u201d<\/li><li>Having a frenetic \u201cfirefighting\u201d culture within the company<\/li><li>Choosing the wrong investigation tool<\/li><li>Suffering a lack of adequate data because products aren\u2019t returned for investigation<\/li><li>Solving the wrong problem (which usually starts with #1 above)<\/li><li>Not having a consistent methodology to find the root cause<\/li><li>Not having enough time to follow all the steps of the methodology<\/li><\/ul><p>We have only scratched the surface of what there is to learn about medical device root cause analysis. Continue reading, and if you want to take the next step in advancing your knowledge, consider Oriel STAT A MATRIX\u2019s training class on\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/root-cause-analysis-for-life-sciences-investigations\">root cause analysis<\/a>.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c5db3c8 elementor-widget elementor-widget-menu-anchor\" data-id=\"c5db3c8\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"define-scope\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17b2a83c elementor-widget elementor-widget-heading\" data-id=\"17b2a83c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">How to Define and Scope Problems<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3fded163 elementor-widget elementor-widget-text-editor\" data-id=\"3fded163\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>\u201c<em>If I had an hour to solve a problem I\u2019d spend 55 minutes thinking about the problem and 5 minutes thinking about the solution<\/em>.\u201d<\/strong><\/p><p>\u00a0<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-1324 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Define_Scope_RootCauseAnalysis.jpg\" alt=\"Define_Scope_RootCauseAnalysis\" width=\"1651\" height=\"1100\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Define_Scope_RootCauseAnalysis.jpg 1651w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Define_Scope_RootCauseAnalysis-300x200.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Define_Scope_RootCauseAnalysis-768x512.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Define_Scope_RootCauseAnalysis-1024x682.jpg 1024w\" sizes=\"(max-width: 1651px) 100vw, 1651px\" \/><\/p><p>\u00a0<\/p><p>Pretty smart advice from Albert Einstein. Too often we jump immediately into problem-solving mode without fully understanding the problem itself. Frequently a problem seems unsolvable because it is really multiple problems and each requires its own solution. A well-defined problem statement is objective and based in data. It presents the problem but not a cause or solution. It clearly defines a performance gap and focuses the team, and it can be understood by people who are not directly involved.<\/p><p>Well-written problem statements must be able to answer two questions.<\/p><ul><li>What is the thing that is wrong? (e.g., the connector\u2026)<\/li><li>What is wrong with the thing? (e.g., it contains cracks\u2026)<\/li><\/ul><p>Problem statements should:<\/p><ul><li>Be measurable (where possible)<\/li><li>Be concise<\/li><li>Be specific<\/li><\/ul><p>Consider the following problem statements:<\/p><ul><li><strong><em>Poorly written: <\/em><\/strong>Hypodermic needles are defective.<\/li><li><strong><em>Better: <\/em><\/strong>Hypodermic needles, Gage 25, show too much variation in their inner diameter, beyond specification limits.<\/li><\/ul><p>It is important that you do not confuse symptoms, problems, and causes. If you are feeling achy, weak, or tired, those are\u00a0<em>symptoms<\/em>. But the\u00a0problem\u00a0may be that you have a fever, and the\u00a0cause\u00a0may be an infection.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-006af20 elementor-widget elementor-widget-menu-anchor\" data-id=\"006af20\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"scope-problem\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-79d9fe0 elementor-widget elementor-widget-heading\" data-id=\"79d9fe0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Properly scoping the problem<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b92b90c elementor-widget elementor-widget-text-editor\" data-id=\"b92b90c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Some problems quite obviously need to be solved, but others are not clear-cut. For instance, do you need to solve the \u201cproblem\u201d that your company is losing 4% of a specific component to damage during warehouse handling and transit? That depends on several factors. Do not expect a problem statement to make its own case \u2013 it must be backed up with the reasons why the problem should be solved.<\/p><p>A frequent pitfall in problem solving is that the wrong problem \u2013 one that doesn\u2019t matter or does not advance the organization\u2019s strategic business plan \u2013 is solved. To make good decisions, you should think \u201cbusiness case\u201d and examine problems with three things in mind:<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-1392 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/rootcause_problemstatement.png\" alt=\"\" width=\"1167\" height=\"435\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/rootcause_problemstatement.png 1167w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/rootcause_problemstatement-300x112.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/rootcause_problemstatement-768x286.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/rootcause_problemstatement-1024x382.png 1024w\" sizes=\"(max-width: 1167px) 100vw, 1167px\" \/><\/p><p>In the problem statement example given above (hypodermic needles), the impact could be serious. If the inner diameter of the needles is too small, it could cause undesirable constriction. If it is too large, it might cause a patient\u2019s blood pressure to drop.<\/p><p>In many situations the original problem statement might be quite broad, but \u201cgeneral\u201d problems are very hard to solve and it\u2019s even harder to measure your success in solving them. The better you define and focus the problem, the easier it will be to verify the solution. There are no rules that tell you when a problem is focused enough. Narrowing a problem allows you to localize the problem definition and use time and resources most efficiently. Developing a focused problem statement is a balancing act \u2013 you have to focus so that you have a clear path forward, but you don\u2019t want to get bogged down.<\/p><p>Going back to the problem statement example concerning hypodermic needles, a more focused problem statement would read: Hypodermic needles, Gage 25, supplied by vendor A, lot #123, in October 2018, show too much variation in their inner diameter, beyond specification limits.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f5fcf5a elementor-widget elementor-widget-menu-anchor\" data-id=\"f5fcf5a\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"case\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2e3d996 elementor-widget elementor-widget-heading\" data-id=\"2e3d996\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Making the case for solving problems<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9728bd5 elementor-widget elementor-widget-text-editor\" data-id=\"9728bd5\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Once you have recognized a problem and determined it is worth addressing, you need to make a case for doing so. As we said before, many problems make their own case and it will be obvious to almost everyone that they should be solved. Sometimes, though, what may seem obvious to you could be viewed differently by others. Recognize the differing priorities of your internal audience in making your case. Engineers speak the language of measurement, while management speaks the language of money. For instance, you could say that a reduction in product defects by 50% will \u201creduce scrap, improve customer satisfaction, and reduce the labor needed for rework.\u201d However, it will be much better if you make the case that doing so will \u201ccut material costs by $275,000 per year, increase sales by 1-2%, and reduce labor costs by $150,000 per year.\u201d That\u2019s specific, measurable, and\u00a0<em>impactful<\/em>. By crafting a clear problem statement and making a compelling business case, you can articulate how you will measure success.<\/p><p>After that, the next step is to prioritize the problems. Projects should be meaningful and manageable. To help evaluate them, create a matrix and weight the projects, as shown below.<\/p><p>\u00a0<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-1393 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/RootCause_SolvingProblems.png\" alt=\"Root Cause Analysis Problem Solving\" width=\"1446\" height=\"847\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/RootCause_SolvingProblems.png 1446w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/RootCause_SolvingProblems-300x176.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/RootCause_SolvingProblems-768x450.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/RootCause_SolvingProblems-1024x600.png 1024w\" sizes=\"(max-width: 1446px) 100vw, 1446px\" \/><\/p><p>\u00a0<\/p><p>Remember, as amazing as you are, you are not a superhero.\u00a0<strong>Success is measured by victories, not by the size and number of battles<\/strong>. It\u2019s better to achieve success one small problem at a time than fight ongoing battles on multiple fronts. Doing so will also reduce your stress level and make your work more meaningful.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0bf40c9 elementor-widget elementor-widget-menu-anchor\" data-id=\"0bf40c9\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"team\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ecbe6c5 elementor-widget elementor-widget-heading\" data-id=\"ecbe6c5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Assembling Your Team and Coming Up with a Plan<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-188c4dc elementor-widget elementor-widget-text-editor\" data-id=\"188c4dc\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-1333 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Assembling-your-team.jpg\" alt=\"\" width=\"1650\" height=\"1100\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Assembling-your-team.jpg 1650w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Assembling-your-team-300x200.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Assembling-your-team-768x512.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Assembling-your-team-1024x683.jpg 1024w\" sizes=\"(max-width: 1650px) 100vw, 1650px\" \/><\/p><p>\u00a0<\/p><p>Now that you have convinced management that they should dedicate resources to solving a specific problem, it\u2019s time to get started on solving it.<\/p><p><strong><em>Woohoo, let\u2019s go!<\/em><\/strong><\/p><p><strong>Not so fast\u2026you\u2019ll probably need some help.<\/strong><\/p><p>First, it is important to recognize that problem solving is a project \u2013 that is, a temporary endeavor to accomplish a given goal. Second, finding the root cause of a problem typically requires a team. For example, a quality engineer assigned to lead the team may need assistance from Manufacturing and Engineering staff members, who usually are permanent team members. That said, permanent team members may need the assistance of others as the project evolves. An example would be support from statisticians related to applying statistical tools. This is where your sales skills come in. You need to convince management that there is a need for a team and supporting personnel. This will ensure the availability of resources to move the project along with a sense of urgency.<\/p><p>Very few problems are cast in stone from the beginning. Most projects evolve. During each phase of the problem-solving process you\u2019ll learn more about what is really going on. With this in mind, you need to be open to revisiting the scope, definition, and purpose of the project. It is very tempting to want to jump directly into action. After all, you are paid to get results, not hold endless meetings to discuss taking action!<\/p><p>You should recognize that our innate bias toward action has pitfalls. Foremost among them is the fact that every specialist on your team will see a problem through his\/her own lens. Regardless of whether your team will be around for 3 months or 3+ years, make sure it is cross-functional. You will need and want different points of view. Your team will likely have some strong personalities who will pontificate about probable causes with confidence, sometimes before you even have any data. As the leader, it is important that you listen and frame these theories as possible causes, not probable causes. Your ultimate goal is to refine and focus the problem, collect facts, develop probable causes, verify causes against the facts, and then divide and conquer.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6f0c5e9 elementor-widget elementor-widget-menu-anchor\" data-id=\"6f0c5e9\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"data\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d0e0fdb elementor-widget elementor-widget-heading\" data-id=\"d0e0fdb\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What data will you need?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1edf037 elementor-widget elementor-widget-text-editor\" data-id=\"1edf037\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>With your team assembled, one of the first things you must define is what data you need to gather, and how you are going to capture and evaluate it. There may be some instances in which you will use historical data, and other instances in which you will need to collect data. Do not collect data under the false assumption that \u201cmore is better.\u201d In problem solving, we sometimes grab all the data we can find in the hope that it will somehow lead to enlightenment. But if data is not collected specifically to resolve a problem, it simply wastes time and money. Ask your team which questions need answers and what data will provide those answers. The primary purpose of the data is to localize the problem. At some point you will need to decide whether the cost of obtaining more data and refining the focus is worth the investment.<\/p><p>It is important that before you look for data needed to address the problem, you write a specific, concrete, and measurable operational definition. You want to:<\/p><ul><li>Determine the purpose of the measure<\/li><li>Identify the work object (item, event, behavior) to be measured<\/li><li>Identify the characteristic to be measured and define it in operational language<\/li><li>Locate the process point at which the data is available<\/li><li>Plan the sampling and analysis<\/li><li>Implement the measuring system and refine it<\/li><\/ul><p>Probable causes are only as valid as the data that supports them. The data you use provides an agreed-on basis for decisions. The data should be understood by all who use it and cannot be \u201cgamed\u201d to support a specific agenda. It is important to objectively verify your sources of data. Here\u2019s an example illustrating why.<\/p><p>Management wanted to improve the testing cycle times at its five test labs. The goal was to turn around 80% of all test results within 48 hours. After a few months, the results came in.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-1399 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/RootCause_LabResults.png\" alt=\"Root Cause Analysis Lab Results\" width=\"1258\" height=\"156\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/RootCause_LabResults.png 1258w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/RootCause_LabResults-300x37.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/RootCause_LabResults-768x95.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/RootCause_LabResults-1024x127.png 1024w\" sizes=\"(max-width: 1258px) 100vw, 1258px\" \/><\/p><p>Wow, at first glance the data would seem to indicate that Lab B is not meeting expectations, right? Not so fast. It turns out that Lab B calculates their turnaround time based on the actual time samples arrive at their facility, even though samples always arrive late in the afternoon. The other four labs start the clock the next morning, when they actually start processing the samples \u2013 on average, nearly 16 hours later than Lab B. After Lab B applied the same rules being used by other labs, their performance jumped to 77%.<\/p><p>\u00a0<\/p><p style=\"text-align: center;\"><strong><em>When evaluating data, embrace the proverb:<br \/>\u201cTrust but verify.\u201d<\/em><\/strong><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1e0a9d0 elementor-widget elementor-widget-menu-anchor\" data-id=\"1e0a9d0\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"sampling-analysis\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-58365e4 elementor-widget elementor-widget-heading\" data-id=\"58365e4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Creating your sampling and analysis plan<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0b77e36 elementor-widget elementor-widget-text-editor\" data-id=\"0b77e36\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Now that you have defined what data you require, you need to determine how much to collect, as well as how often and by what means it will be collected. If you are using historical data, what period should you consider? The last 3 months? What data collection sheets will be needed? What other data will be required to enable analysis or diagnosis? You have to determine both your method of analysis and what statistical tests will be performed. For example, how will you plot the data for analysis? Quite often, looking at a checking sheet or spreadsheet will make the analysis difficult. Graphs such as histograms or time plots illuminate the data, thus making the analysis more effective and efficient.<\/p><p>Also, recognize that there will be inconsistencies in how people describe the same defect. For instance, \u201cclear bag\u201d and \u201cunprinted bag\u201d might be terms used by different inspectors to mean the same defect. This can create confusion in tabulations. In general, you want to collect data at the earliest point in the process at which it becomes available. Break down the data into useful categories using data stratification techniques (e.g., what, who, where, when). Never use data simply because it is available.<\/p><p>Beware of unconscious bias, which includes \u201cjudgment samples\u201d (you selectively pick the units to be included) or \u201cconvenience samples\u201d (typically the most accessible and convenient units for you to gather). An example of this would be the most recent batch of components received from a supplier, which may or may not be representative of the larger pool of components. With regard to quantity, oversampling can waste a lot of time with very little additional accuracy. Undersampling can lead to incorrect conclusions. In deciding how many to select, one quick option is to use an online statistical sampling calculator. This will tell you how many samples you should select to achieve an acceptable degree of accuracy.<\/p><p>There is still plenty to learn about medical device root cause analysis. If you want to take the next step in advancing your knowledge, consider Oriel STAT A MATRIX\u2019s training class on\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/root-cause-analysis-for-life-sciences-investigations\">root cause analysis<\/a>.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c1c5613 elementor-widget elementor-widget-menu-anchor\" data-id=\"c1c5613\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"why\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57160fd elementor-widget elementor-widget-heading\" data-id=\"57160fd\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">It\u2019s About More Than Simply Asking \u201cWhy?\u201d<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8a909d2 elementor-widget elementor-widget-text-editor\" data-id=\"8a909d2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-1338 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Getting-Root-Cause-Answers.jpg\" alt=\"Getting Root Cause Answers\" width=\"1649\" height=\"1100\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Getting-Root-Cause-Answers.jpg 1649w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Getting-Root-Cause-Answers-300x200.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Getting-Root-Cause-Answers-768x512.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Getting-Root-Cause-Answers-1024x683.jpg 1024w\" sizes=\"(max-width: 1649px) 100vw, 1649px\" \/><\/p><p>\u00a0<\/p><p>One of the adorable annoyances of 4-year-olds is their persistent inquisitive nature.\u00a0<strong><em>Why can\u2019t I have another piece of cake? Why do I need to go to bed? Why can\u2019t I have Froot Loops for dinner?<\/em><\/strong>\u00a0 Following the seemingly innocent and inquisitive strategies of a 4-year-old can help you dig\u00a0deeply\u00a0into problems and overcome preconceived notions of what is going on.<\/p><p><br \/><strong>Here\u2019s an example:<\/strong><\/p><p>\u201c10% of blood glucose meters are being rejected for rework at the Texas assembly facility.\u201d<\/p><ul><li><strong>Why is the rework rate higher at the Texas facility than other facilities?<\/strong>The Texas facility assembly line workers are simply not as adept at assembly.<\/li><li><strong>Why are the Texas workers not as good?<\/strong>They have not been trained on updated assembly methods.<\/li><li><strong>Why hasn\u2019t the Texas facility team received training?<\/strong>The Training and Development Manager works in the Florida headquarters and has not updated the Texas team on new manufacturing methods.<\/li><li><strong>Why hasn\u2019t the Training and Development Manager trained the Texas team?\u00a0<\/strong>Senior management mandated a 20% reduction in travel costs last year, so the T&amp;D Manager had to postpone the visit for several months in order to \u201cbatch\u201d the assembly methods training with other training at that facility.<\/li><\/ul><p>Ah ha! See how digging deeper revealed one possible cause? This technique can work quite well on many problems, but you also need to know when to stop. If you go too deep, you may actually lose focus! Also, take care not to jump to conclusions. In this case, it would seem that the higher defect rate at the Texas facility was caused by a cut in the travel budget and lack of training, but those factors may only partially account for the higher defect rate \u2013 there may be other forces at work.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-26af762 elementor-widget elementor-widget-menu-anchor\" data-id=\"26af762\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"test-verify\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a2ed4f8 elementor-widget elementor-widget-heading\" data-id=\"a2ed4f8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Test and verify root cause<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-823e665 elementor-widget elementor-widget-text-editor\" data-id=\"823e665\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Now that you have a list of probable causes, you need to narrow them down to the actual cause. This process of elimination must be verified with logic and fit the \u201cfootprint\u201d of the symptoms. A theory about a cause will always have some hidden assumptions. Using the Texas facility example above, the assumption is that the problem is associated with lack of training. The theory is plausible, but you need more data to verify it. For instance, what is the expected \u201cper piece\u201d throughput of assembly line workers in Texas versus other facilities? How experienced and respected are the line supervisors in Texas versus other facilities? What set of parameters is the Texas facility using to approve products for release? You need to determine what data is needed to examine this in more detail.<\/p><p>Sometimes the best way to verify a probable cause is to implement a remedy and observe the results. In this case, sending the T&amp;D Manager to the Texas facility to train the employees might be a good first step, followed by careful measurements of the subsequent rejection rates in that facility.<\/p><p>But use caution when using a trial-and-error approach to problem solving. Throwing money at a problem can be counterproductive and obviously expensive. You might be wrong.<\/p><p>Keep in mind that there are factors that can distort the results, including:<\/p><ul><li><strong>Coincidences:<\/strong>Just because it worked once does not mean it will work every time.<\/li><li><strong>The Hawthorne effect<\/strong>: People will often react positively to the mere fact that someone is finally taking action.<\/li><li><strong>The guinea pig fallacy<\/strong>: Do not assume that something that works on a small scale or in carefully controlled trials will still work when it is implemented across the board.<\/li><li><strong>Time to identify probable causes and prioritize them for verification<\/strong>: Recognize that finding the root cause may take some time, and time is usually a major resource that may not necessarily be available to the team.<\/li><\/ul><p>There are myriad ways you can plot your cause-and-effect data: scatter plot diagrams, Pareto charts, stratified frequency plots, \u201cdiscrete C and continuous Y,\u201d tree diagrams, and more.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-1401 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Tree-Diagram.png\" alt=\"Tree Diagram\" width=\"1039\" height=\"472\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Tree-Diagram.png 1039w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Tree-Diagram-300x136.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Tree-Diagram-768x349.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Tree-Diagram-1024x465.png 1024w\" sizes=\"(max-width: 1039px) 100vw, 1039px\" \/><\/p><p>These tools can help you visualize the data so you can spot patterns that otherwise would be difficult to see just by looking at numbers. The human brain is wired for pictures, not data, so use this basic fact to your advantage!<\/p><p>\u00a0<\/p><p><strong>Consider the example below:<\/strong><\/p><p>A manager in a call center of an insurance company wants to know why customers are complaining about the long time on they spend on hold. Using a histogram, the manager plots the data related to the last 150 calls placed to the call center. The result is presented below.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-1402 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Historgram.png\" alt=\"Historgram\" width=\"1071\" height=\"607\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Historgram.png 1071w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Historgram-300x170.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Historgram-768x435.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/01\/Historgram-1024x580.png 1024w\" sizes=\"(max-width: 1071px) 100vw, 1071px\" \/><\/p><p>Interpreting the histogram, it is quite apparent that Monday is the worst day. But why? This will cause the manager to look at things such as volume of calls and staffing levels as the root cause journey continues.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e5a28ab elementor-widget elementor-widget-heading\" data-id=\"e5a28ab\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Want to learn more?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c20c267 elementor-widget elementor-widget-text-editor\" data-id=\"c20c267\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>We have covered only part of what there is to learn about medical device root cause analysis. 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Analysis the Right Way \u201cNever try to solve all the problems at once \u2014 make them line up for you one-by-one.\u201d This quote by author Richard Sloma captures the essence of effective root cause analysis. When presented with a vexing problem, many RA\/QA managers feel overwhelmed, make [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1316,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[20],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/medical-device-root-cause-analysis-overview\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Dig Deep and Do Medical Device Root Cause Analysis the Right Way \u201cNever try to solve all the problems at once \u2014 make them line up for you one-by-one.\u201d This quote by author Richard Sloma captures the essence of effective root cause analysis. 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