Investigations have historically been among the most commonly cited observations in FDA 483s so a robust investigation strategy is an important element of any firm’s quality program. A strong investigation is supported by a thorough and complete evaluation of the major elements: root cause analysis, impact assessment and scope, historical analysis, establishment of CAPAs, and a CAPA effectiveness check. All of these elements are interdependent.
In seeking a true root cause analysis, often the causes of the event, including ancillary probable causes, are evaluated and eliminated. Also, the initial impacted product lots are considered and other processes that may lead to expanding the scope of an investigation often occurs. An area often overlooked is a thorough review of the history of that event through conducting a historical analysis.
A robust historical analysis requires using broad key search terms through previous observed deviations to ensure a comprehensive evaluation to determine whether an event is a repeat occurrence. It also requires evaluating the search outputs of those similar previous events of the effectiveness of CAPAs that may have been previously issued for similar events. Comprehensive historical analysis is a critical element of an investigation when determining root cause and scope of impact as well as developing additional CAPAs.
If you need help in working through investigations or understanding the interdependencies of all of the elements of an investigation, please contact Lachman at LCS@lachmanconsultants.com for a free consultation.
