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The workshop outlines CAPA tools and the CAPA process, distinguishes corrective vs preventive action types, and connects root cause analysis methods (e.g., fishbone and fault tree) to quality system improvement and patient safety.",{"@graph":14,"@context":72},[15,34,55],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/control-of-laboratory-error-through-corrective-and-preventive-actions-capa-process/657480/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/control-of-laboratory-error-through-corrective-and-preventive-actions-capa-process/657480.png","ImageObject",300,407,{"name":42,"@type":43},"Syukur Setiap Hari","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-29","2026-10-26",true,{"@type":52,"interactionType":53,"userInteractionCount":30},"InteractionCounter",{"@type":54},"ViewAction",{"@type":56,"mainEntity":57},"FAQPage",[58,64,68],{"name":59,"@type":60,"acceptedAnswer":61},"What are the main sources of diagnostic errors in the laboratory workflow?","Question",{"text":62,"@type":63},"Diagnostic errors can originate in pre-analytical steps (e.g., patient misidentification, specimen collection, order entry, handling/transport/storage), analytical steps (e.g., equipment malfunction, sample issues, undetected QC failure), and post-analytical steps (e.g., data entry/validation, excessive TAT, delayed critical results).","Answer",{"name":65,"@type":60,"acceptedAnswer":66},"How does ISO 15189:2012 define nonconformities and what must laboratories do?",{"text":67,"@type":63},"ISO 15189:2012 defines nonconformities as “Nonfulfillment of a requirement.” It requires clinical labs to have a documented procedure to identify and manage nonconformities across the quality management system, including pre-examination, examination, and post-examination processes.",{"name":69,"@type":60,"acceptedAnswer":70},"What is the difference between corrective action and preventive action in CAPA?",{"text":71,"@type":63},"Corrective action addresses nonconformities when they are determined to recur, requiring identification, documentation, and elimination of the cause(s). Preventive action uses proactive processes to prevent problems from occurring or reduce potential severity, focusing on risks from trends or patterns.","https://schema.org",{"og:url":32,"og:type":74,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":76,"canonical":32},"index,follow",{"doc_id":78,"site_id":7},657480,1792980661,{"code":4,"msg":81,"data":82},"success",[83,87,91,95,100,105,109,114,119,122,126],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":84,"show_sort_weight":85,"slug":86},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":88,"show_sort_weight":89,"slug":90},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":92,"show_sort_weight":93,"slug":94},"Exam",70,"exam",{"id":96,"doc_module":4,"doc_module_name":25,"category_name":97,"show_sort_weight":98,"slug":99},5,"Comic",60,"comic",{"id":101,"doc_module":4,"doc_module_name":25,"category_name":102,"show_sort_weight":103,"slug":104},6,"Technology",50,"technology",{"id":106,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":107,"slug":108},7,40,"healthcare",{"id":110,"doc_module":4,"doc_module_name":25,"category_name":111,"show_sort_weight":112,"slug":113},8,"Research & Report",30,"research-report",{"id":115,"doc_module":4,"doc_module_name":25,"category_name":116,"show_sort_weight":117,"slug":118},9,"Religion & Spirituality",20,"religion-spirituality",{"id":117,"doc_module":4,"doc_module_name":25,"category_name":120,"show_sort_weight":117,"slug":121},"World Cup","world-cup",{"id":123,"doc_module":4,"doc_module_name":25,"category_name":124,"show_sort_weight":123,"slug":125},10,"Lifestyle","lifestyle",{"id":127,"doc_module":4,"doc_module_name":25,"category_name":128,"show_sort_weight":96,"slug":129},19,"General","general",{"code":4,"msg":81,"data":131},{"doc_id":78,"user_id":132,"nickname":42,"user_avatar":133,"doc_module":4,"category_id":106,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":30,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":139,"language":140,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":12,"update_tm":79,"read_time":144},962093541965,"https://ap-avatar.wpscdn.com/davatar_276721f389ce27ea32af1340a28f341c","11/7/2017  \nControl of laboratory error through“Corrective and Preventive Actions”  \nEdward Randell  \nIFCC Committee on Clinical Laboratory Management [http://www.ifcc.org/ifcc-education-division/emd-committees/c-clm/](http://www.ifcc.org/ifcc-education-division/emd-committees/c-clm/)  \nSatellite Educational Workshop on Intelligent Clinical Laboratory Management: Impacts on Quality System Improvement  \nHilton Durban -October 22, 2017  \n1  \nDiagnostic Errors   \nDiagnostic errors result in death or disability almost 2x more often than other medical errors (Including medication errors, surgical errors, and others associated with treatment.)  \n2  \nEdward Randell/ Control of laboratory error through “Corrective and Preventive Actions”  \n11/7/2017  \nDiagnostic Errors   \nInside the Laboratory  \nPre-Analytical  \n• Patient misidentification  \n• Specimen collection  \n• Order entry  \n• Handling/Transport/Storage  \nAnalytical  \n• Equipment Malfunction  \n• Sample issues  \n• Undetected QC failure  \nPost-Analytical  \n• Data entry/validation  \n• Excessive TAT  \n• Delayed Critical Results  \n3  \nEdward Randell/ Control of laboratory error through “Corrective and Preventive Actions”  \nNonconformities  \nNonconformities are accidents, errors, events, incidents, occurrences, and accidents  \nCLSI and ISO 15189:2012 define nonconformities as “ Nonfulfillment of a requirement”  \nISO 15189:2012 (section 4. 9) holds clinical labs accountable to have:  \n“a documented procedure to identify and manage nonconformities in any aspect of the quality management system, including preexamination, examination or post-examination processes.”  \nEdward Randell/ Control of laboratory error through “Corrective and Preventive Actions” 4  \n11/7/2017  \nWhy is addressing nonconformities important?  \n55 year old male with type II DM with chest discomfort of 1 hr duration.  \nSeveral previous visits , all with normal ECG and mild troponin elevations.  \nEdward Randell/ Control of laboratory error through “Corrective and Preventive Actions” 5  \nWhy is addressing nonconformities important?  \nNonconformities are weaknesses in procedures that may lead to significant patient harm in certain circumstances.  \nEdward Randell/ Control of laboratory error through “Corrective and Preventive Actions” 6  \n11/7/2017  \nPresentation Outline   \n• Defining corrective and preventive actions.  \n• CAPA Tools  \n• CAPA Process.  \n• Summarize Role in Quality Improvement and Patient Safety.  \nEdward Randell/ Control of laboratory error through “Corrective and Preventive Actions” 7  \nPassive and Active Nonconformities  \nComplaints Incidents Adverse Events  \nPassive  \nActive  \nSafety audits  \nReview of internal QC  \nReview of external QA Review of QC failures Quality Indicator Monitoring  \nStaff comments Incident reporting Near misses Investigating instrument problems  \n8  \nEdward Randell/ Control of laboratory error through “Corrective and Preventive Actions”  \n11/7/2017  \nCorrective Action  \nISO 15189:2012 (section 4. 9):  \n“When it is determined that nonconformities in pre-examination, examination and post-examination processes could recur… the laboratory shall take action to identify, document and eliminate the cause(s) . ”  \nEdward Randell/ Control of laboratory error through “Corrective and Preventive Actions” 9  \n Corrective Action: Two types   \n10  \nEdward Randell/ Control of laboratory error through “Corrective and Preventive Actions”  \n11/7/2017  \nCorrective Actions  \nComplaint  \nEdward Randell/ Control of laboratory error through “Corrective and Preventive Actions”  \nQC or  \nPT Failure  \nReport  \n11  \nPreventive Actions  \nPolicy & Procedure Review  \nProactive processes to prevent a problem from occurring or reduce potential severity.  \nFocus: Risks associated with trends or patterns.  \nEdward Randell/ Control of laboratory error through “Corrective and Preventive Actions”  \n11/7/2017  \nCAPA  \nCorrective Action  \nRemedial Action  \nRoot cause analysis  \nPreventive Action  \nFMEA  \nProspective Ri","cbCaioav8j1rwQPw","https://ap.wps.com/l/cbCaioav8j1rwQPw","pdf",1757609,15,"English","# Diagnostic Errors\n## Inside the Laboratory\n## Nonconformities\n## Presentation Outline\n## Corrective Action\n## Preventive Actions\n## CAPA Process\n## Root Cause Analysis\n## Fishbone and Fault Tree Analysis","[{\"question\":\"What are the main sources of diagnostic errors in the laboratory workflow?\",\"answer\":\"Diagnostic errors can originate in pre-analytical steps (e.g., patient misidentification, specimen collection, order entry, handling/transport/storage), analytical steps (e.g., equipment malfunction, sample issues, undetected QC failure), and post-analytical steps (e.g., data entry/validation, excessive TAT, delayed critical results).\"},{\"question\":\"How does ISO 15189:2012 define nonconformities and what must laboratories do?\",\"answer\":\"ISO 15189:2012 defines nonconformities as “Nonfulfillment of a requirement.” It requires clinical labs to have a documented procedure to identify and manage nonconformities across the quality management system, including pre-examination, examination, and post-examination processes.\"},{\"question\":\"What is the difference between corrective action and preventive action in CAPA?\",\"answer\":\"Corrective action addresses nonconformities when they are determined to recur, requiring identification, documentation, and elimination of the cause(s). Preventive action uses proactive processes to prevent problems from occurring or reduce potential severity, focusing on risks from trends or patterns.\"}]","Control of laboratory error through - Corrective and Preventive Actions - CAPA Process | PDF",38]