The Eight Disciplines (8D) model is a problem-solving methodology used primarily within the automotive industry to identify root causes, correct them in the short term and prevent them in the long term.
Given its reputation for reliability in the automotive space, it's no surprise the method has been embraced by engineers in other industries tasked with solving similar types of problems. Drug and device manufacturing is one such space where 8D seems like a fit, particularly within corrective and preventive action (CAPA) programs.
But despite its success, the 8D model presents a serious compliance problem under both FDA and global ISO regulations––one that regulators are seizing on as evident by the top-cited inspectional observation within the device space since 2010: "Procedures for corrective and preventive action have not been [adequately] established."Continue Reading