[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-657478-105":59,"doc-detail-657478-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","quality-control-factsheet-optimization-of-an-analytical-method","Quality Control factsheet - Optimization of an Analytical method","","The Quality Control factsheet describes how an analytical method for assessing purity in in-process samples and drug products was executed across multiple QC laboratories worldwide. Although long-term performances were comparable, the assay produced short-term higher and lower yield periods that triggered recurring OOT/OOS investigations and raised concern about cross-lab performance. A DMAIC Lean Six Sigma project standardized materials, revised SOPs, and implemented training and mistake-proofing to reduce variability, improve trend detection, and cut investigation time and costs.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/quality-control-factsheet-optimization-of-an-analytical-method/657478/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/quality-control-factsheet-optimization-of-an-analytical-method/657478.png","ImageObject",300,407,{"name":92,"@type":93},"Dusta123","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-10-26",true,{"@type":102,"interactionType":103,"userInteractionCount":8},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What problem did the project address in the analytical method’s performance?","Question",{"text":112,"@type":113},"Short-term periods of higher and lower yields caused recurring out-of-trend and out-of-specification investigations, leading to concerns about assay performance consistency across laboratories.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What critical-to-quality points were defined to prevent continued OOT/OOS results?",{"text":117,"@type":113},"The project focused on reducing assay variability across all sites, identifying and eliminating root causes of short-term fluctuations, and ensuring reliable alert and reaction to trends, alongside improved communication and performance review frequency among sites.",{"name":119,"@type":110,"acceptedAnswer":120},"How did the project improve results after standardization and training?",{"text":121,"@type":113},"The standard deviation across the three labs decreased significantly (21%), site-to-site method differences were eliminated, within-site variability was reduced, and the likelihood of method-related OOS/OOT results dropped, also reducing investigation time and delivering a €600,000 per-year cost avoidance.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},657478,1792980655,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":8,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":81,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":129,"read_time":39},962093541925,"https://ap-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45","Quality Control  \nfactsheet  \nQuality Control factsheet  \nOptimization of an Analytical method  \nAn analytical method used to analyze purity in in-process samples and drug products is executed at several individual test laboratories at production sites worldwide. The long-term trend results show that the test laboratories' long-term performances are comparable (similar mean and standard deviation) . However, the trend results also display outputs that are not randomly distributed around the mean. The assay control data show short term periods of higher and lower yields, causing recurring out of trend and out of specification investigations. The performance of the assay across the labs has become a big concern.  \nVoice of the Customer  \nTo prevent that the assay would continue to lead to OOT/OOS results it was decided to reduce the variability of method and find the root cause of the shorter term periods of higher and lower results. The following Critical To Quality points are defined:  \n Variability of the assay. Reduce the variability of the assay for all sites  \n Find and eliminate root causes that create shorter-term periods of higher and lower results  \n Reliable and alert reaction on trend of the results from the method.  \n Improve communication and frequency on the performance of the method between all sites  \nDMAIC Approach  \nThe complex nature of performing assays at different sites over the world required a structured approach, starting with developing a robust implementation strategy. A Project Team was formed, with QC, Analytical Development, QA, Procurement, Regulatory Affairs and at least one representative of all sites. A green belt project is started using the DMAIC approach (Define, Measure, Analyze, Improve and Control) and based on standard Lean Six Sigma tools.  \nDefine phase  \nTo get a clear picture of the problem the following actions were performed during the define phase to define and scope the project:  \n Project Charter  \n Voice of the customer  \n Stakeholder Analysis  \n Communication Plan  \nProgress  \n[www.progress-lifesciences.nl](www.progress-lifesciences.nl) Bijlmermeerstraat 20  \n2131 HG Hoofddorp  \n+31 (0) 23-563 5016 [info@progress-lifesciences.nl](info@progress-lifesciences.nl)  \nQuality Control factsheet  \nMeasure phase  \nTo detect differences between sites the following actions were performed:  \n Fish Bone Analysis (Ishikawa diagram) to define all influences of men, machine, method, materials and environment on the performance of the assay  \n SIPOC process mapping (Supplier(s), Inputs, Process, Outputs and Customers) to identify which chemicals and materials are used on the various sites  \n Detailed Process mapping to identify all detailed process steps.  \n Spaghetti diagrams to identify waste in motion in the laboratory  \n Detect differences in technique performed, technicians were filmed at all sites  \n Determine differences in equipment, technicians, materials and site the assay was performed at all 3 sites with technicians of each site.  \nAnalyze phase  \nAll data collected in the measure phase is analyzed. All factors that could have an impact on the performance of the assay are identified. E. g. chemicals, pipetting performance, differences in cooling capacity of equipment, incubation times etc.  \nImprove phase  \nTo improve the assay the following measures are taken:  \n All materials and chemicals used at all sites were standardized. The standard operating procedures (SOP’s) from the all sites were revised and a standardized method was introduced  \n A training document describing the method in detail was written.  \n A new training method was developed to eliminate operator variation  \n Where possible standard tool kits were introduced and Poka-yoke solutions introduced  \nOverall result and Control phase  \nAfter the introduction of the standardized method and training of the technicians, the results were  \nanalyzed. The standard deviation in the assay results of the three labs decreased s","cbCaiqaBAH6gci6l","https://ap.wps.com/l/cbCaiqaBAH6gci6l","pdf",2406666,"English","# Voice of the Customer\n# DMAIC Approach\n## Define phase\n## Measure phase\n## Analyze phase\n## Improve phase\n## Overall result and Control phase\n# Progress","[{\"question\":\"What problem did the project address in the analytical method’s performance?\",\"answer\":\"Short-term periods of higher and lower yields caused recurring out-of-trend and out-of-specification investigations, leading to concerns about assay performance consistency across laboratories.\"},{\"question\":\"What critical-to-quality points were defined to prevent continued OOT/OOS results?\",\"answer\":\"The project focused on reducing assay variability across all sites, identifying and eliminating root causes of short-term fluctuations, and ensuring reliable alert and reaction to trends, alongside improved communication and performance review frequency among sites.\"},{\"question\":\"How did the project improve results after standardization and training?\",\"answer\":\"The standard deviation across the three labs decreased significantly (21%), site-to-site method differences were eliminated, within-site variability was reduced, and the likelihood of method-related OOS/OOT results dropped, also reducing investigation time and delivering a €600,000 per-year cost avoidance.\"}]","Quality Control factsheet - Optimization of an Analytical method | PDF"]