{"id":68,"date":"2017-05-17T18:12:31","date_gmt":"2017-05-17T17:12:31","guid":{"rendered":"https:\/\/leansigma.ie\/?page_id=68"},"modified":"2019-04-14T00:11:50","modified_gmt":"2019-04-13T23:11:50","slug":"corrective-action-preventative-action-capa","status":"publish","type":"page","link":"https:\/\/leansigma.ie\/?page_id=68","title":{"rendered":"Corrective Action Preventative Action (CAPA)"},"content":{"rendered":"<h2>\n<h3>Course Outline <\/h3>\n<\/h2>\n<p>On this five-day Lean Sigma course participants will learn about Six Sigma, Lean principles and the practical application of these tools and techniques, as well as how they can actively direct, manage and participate in these programs.<\/p>\n<p>This course is suitable for anyone who wish to develop their skills in the areas of process improvement, including\u00a0senior managers, department managers, line managers, internal consultants, change agents, project managers and team leaders.<\/p>\n<p>\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"534\" height=\"534\" src=\"https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/leanthinking.jpg\" alt=\"Finbarr Sheehy - Lean Sigma Training - Business Excellence - Lean Thinking\" srcset=\"https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/leanthinking.jpg 534w, https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/leanthinking-300x300.jpg 300w, https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/leanthinking-350x350.jpg 350w, https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/leanthinking-100x100.jpg 100w, https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/leanthinking-150x150.jpg 150w, https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/leanthinking-460x460.jpg 460w, https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/leanthinking-120x120.jpg 120w, https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/leanthinking-310x310.jpg 310w\" sizes=\"auto, (max-width: 534px) 100vw, 534px\" \/>\t\t\t\t\t\t\t\t\t\t\t<\/p>\n<h3 style=\"font-size: 2.14286rem; font-style: normal;\">Learning Objectives<\/h3>\n<blockquote style=\"font-weight: 500;\">\n<p style=\"font-size: 15.4px;\"><em style=\"font-size: 15.4px;\"><br \/>Within the Pharmaceutical Industry, the concept of Corrective Actions and Preventive Actions (CAPA) is a key element of any Quality Management System, focusing on Continual Improvement and Customer Satisfaction.<\/em><\/p>\n<\/blockquote>\n<p style=\"font-size: 14px; font-style: normal; font-weight: 500;\">A Corrective Action is based on a non conformance event that has happened in the past. Preventive Action is based on preventing a non conformance event in the future.<\/p>\n<p style=\"font-size: 14px; font-style: normal; font-weight: 500;\">This programme provides an understanding of the basic concepts involved in Root Cause Analysis and the tools used to conduct\u00a0 detailed investigation and reporting.<\/p>\n<p>\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"624\" src=\"https:\/\/leansigma.ie\/wp-content\/uploads\/2018\/04\/x13-1024x624.jpg\" alt=\"\" srcset=\"https:\/\/leansigma.ie\/wp-content\/uploads\/2018\/04\/x13-1024x624.jpg 1024w, https:\/\/leansigma.ie\/wp-content\/uploads\/2018\/04\/x13-600x366.jpg 600w, https:\/\/leansigma.ie\/wp-content\/uploads\/2018\/04\/x13-460x280.jpg 460w, https:\/\/leansigma.ie\/wp-content\/uploads\/2018\/04\/x13-768x468.jpg 768w, https:\/\/leansigma.ie\/wp-content\/uploads\/2018\/04\/x13-120x73.jpg 120w, https:\/\/leansigma.ie\/wp-content\/uploads\/2018\/04\/x13-310x189.jpg 310w, https:\/\/leansigma.ie\/wp-content\/uploads\/2018\/04\/x13.jpg 1037w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t<\/p>\n<p style=\"font-size: 14px; font-style: normal; font-weight: 500;\">The primary objective of this course is to develop an understanding of the principles and techniques involved in the practice of Root Cause Analysis.\u00a0 Emphasis is placed on the practical aspects of how to perform an analysis.\u00a0 In addition, this course will provide effective methods which can be used with a Corrective Action system to helps you and your team to ensure costly issues are resolved quickly.<\/p>\n<p style=\"font-size: 14px; font-style: normal; font-weight: 500;\">Attendees will also learn advanced skills in root cause analysis, problem prevention, and continuous improvement.\u00a0 Included will be the identification of the characteristics and changes that have contributed to simple and complex problems and how to fix them, as well as, working with the tools and templates to capture all needed data to comply with CAPA reports.<\/p>\n<h3>\u00a0<\/h3>\n<p style=\"font-size: 14px; font-style: normal; font-weight: 500; color: #7a7a7a;\">Topics to be covered include:<\/p>\n<ul style=\"font-size: 14px; font-style: normal; font-weight: 500; color: #7a7a7a;\" type=\"square\">\n<li style=\"font-size: 14px;\">Efficient root cause analysis programs<\/li>\n<li style=\"font-size: 14px;\">Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions<\/li>\n<li style=\"font-size: 14px;\">Developing and implementing programs to prevent re occurrence<\/li>\n<li style=\"font-size: 14px;\">Increasing accuracy through efficient documentation practices<\/li>\n<li style=\"font-size: 14px;\">Areas of Regulatory Agency concerns<\/li>\n<li style=\"font-size: 14px;\">Identifying and tracking deviations and non-conformances<\/li>\n<li style=\"font-size: 14px;\">Responding to complaints and deviations with corrective and preventative actions<\/li>\n<li style=\"font-size: 14px;\">Learning to analyze and trend data to identify existing and potential causes of non-conformance<\/li>\n<li style=\"font-size: 14px;\">Integrating RCA with other systems: internal auditing, CAPA and complaint handling<\/li>\n<li style=\"font-size: 14px;\">Determining whether or not a complaint should go through a CAPA program<\/li>\n<li style=\"font-size: 14px;\">Determining internal and external reporting requirements<\/li>\n<li style=\"font-size: 14px;\">Writing effective SOPs<\/li>\n<li style=\"font-size: 14px;\">Performing trend analysis and using effective RCA tools (Flow Charting, Fault Tree Analysis, Fishbone Diagrams, etc.)<\/li>\n<li style=\"font-size: 14px;\">Analyzing HPRA and FDA Warning Letters and common citations to avoid non-compliance<\/li>\n<\/ul>\n<p>\u00a0\u00a0This course is intended for all personnel concerned with quality and analysis correction of problems.\u00a0 The material presented\u00a0will be of value to varying levels of expertise among the participants.\u00a0 It will be particularly valuable to those new to this field or those who wish to refresh their knowledge of these technologies.<\/p>\n<h3><img loading=\"lazy\" decoding=\"async\" style=\"font-size: 2.14286rem;\" src=\"https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/waste.jpg\" alt=\"Finbarr Sheehy - Lean Sigma Training - Business Excellence - No Waste\" width=\"238\" height=\"238\" \/><\/h3>\n<h3>\u00a0<\/h3>\n<h3>Training Materials<\/h3>\n<p>This Lean Six Sigma Green Belt Training course is supported with a very comprehensive training manual and selected text books to be used as a reference source after the course.<\/p>\n<h3>Certification<\/h3>\n<p>Lean Sigma certification is provided by LeanSigma.ie. Certification is based on the successful implementation of a simple process improvement\u00a0in the workplace.<\/p>\n<h3>Course Trainer<\/h3>\n<p>Finbarr Sheehy has over 25 years experience in the areas of Root Cause Analysis and Problem Solving. Finbarr has over 12 years CAPA experience within the Pharma industry. He has assisted in the design and redesign of Deviation Systems, Investigation Reviews and Training Systems.<\/p>\n<h3>Course Cost<\/h3>\n<p><a title=\"Contact Us\" href=\"https:\/\/leansigma.ie\/contact-us\/\">Contact us<\/a> today to determine the best value for you and your organisation.<\/p>\n<p>\u00a0<\/p>\n<p>\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"295\" height=\"171\" src=\"https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/sixsigma.jpeg\" alt=\"Finbarr Sheehy - Lean Sigma Training - Business Excellence - Lean Six Sigma\" srcset=\"https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/sixsigma.jpeg 295w, https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/sixsigma-120x70.jpeg 120w\" sizes=\"auto, (max-width: 295px) 100vw, 295px\" \/>\t\t\t\t\t\t\t\t\t\t\t<\/p>\n<h1>Contact Finbarr to discuss and design the programme that is right for you<\/h1>\n<p>\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"294\" height=\"128\" src=\"https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/talk.jpg\" alt=\"Finbarr Sheehy - Lean Sigma Training - Business Excellence - Talk to Finbarr\" srcset=\"https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/talk.jpg 294w, https:\/\/leansigma.ie\/wp-content\/uploads\/2017\/05\/talk-120x52.jpg 120w\" sizes=\"auto, (max-width: 294px) 100vw, 294px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Course Outline On this five-day Lean Sigma course participants will learn about Six Sigma, Lean principles and the practical application of these tools and techniques, as well as how they can actively direct, manage and participate in these programs. This course is suitable for anyone who wish to develop their skills in the areas of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-68","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/leansigma.ie\/index.php?rest_route=\/wp\/v2\/pages\/68","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/leansigma.ie\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/leansigma.ie\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/leansigma.ie\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/leansigma.ie\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=68"}],"version-history":[{"count":5,"href":"https:\/\/leansigma.ie\/index.php?rest_route=\/wp\/v2\/pages\/68\/revisions"}],"predecessor-version":[{"id":1512,"href":"https:\/\/leansigma.ie\/index.php?rest_route=\/wp\/v2\/pages\/68\/revisions\/1512"}],"wp:attachment":[{"href":"https:\/\/leansigma.ie\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=68"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}