{"id":55308,"date":"2021-03-18T17:25:16","date_gmt":"2021-03-18T21:25:16","guid":{"rendered":"https:\/\/caireadydev1.wpenginepowered.com\/life-sciences\/?p=55308"},"modified":"2025-06-21T17:53:19","modified_gmt":"2025-06-21T21:53:19","slug":"human-error-and-how-history-repeats-itself","status":"publish","type":"post","link":"https:\/\/caiready.com\/life-sciences\/blog\/human-error-and-how-history-repeats-itself\/","title":{"rendered":"Human Error and How History Repeats Itself"},"content":{"rendered":"

In an industry where the need for accuracy and compliance is essential, there is a category of error which still occurs at an astounding rate, affecting both cost and product availability.\u00a0 In the case where the human is part of the process, there will always be a \u201chuman error\u201d factor.\u00a0 This is the largest variable in the manufacturing process.\u00a0 The interesting part is that most of the errors are preventable, especially given that the most common area where the FDA finds observations is related to procedures.<\/span><\/p>\n

Why is it that writing and following procedures is one of the most cited issues by the FDA?\u00a0 Procedures have been required since the beginning of time, or as part of every pharmaceutical and biotech facility in my career. \u00a0 Companies struggle to write good procedures.\u00a0 The evidence is clear\u2026 this is an easy win to eliminate many regulatory findings.\u00a0 As shown below, history continues to repeat itself with regards to procedures.<\/span><\/p>\n\n\n\n\n\n\n\n
Year<\/b><\/td>\nDrug Observations<\/b><\/td>\nDevice Observations<\/b><\/td>\n<\/tr>\n
2020<\/b><\/td>\n382 of 1513<\/span><\/td>\n987 of 1602<\/span><\/td>\n<\/tr>\n
2015<\/b><\/td>\n897 of 3626<\/span><\/td>\n2215 of 4083<\/span><\/td>\n<\/tr>\n
2010<\/b><\/td>\n1043 or 3796<\/span><\/td>\n1457 or 4132<\/span><\/td>\n<\/tr>\n
2006<\/b><\/td>\n938 of 3503<\/span><\/td>\n1376 of 4444<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Inspection Observations (24 November, 2020)<\/span><\/a><\/p>\n

In the development and implementation of procedures, there are common issues, listed below,\u00a0 which have repeated themselves throughout the history of this industry.\u00a0 Consistently for over 20 years, these are the top findings \u2013 not just top procedure findings, but top overall findings for both drugs and devices.\u00a0 They include:<\/span><\/p>\n