By John E Lincoln
Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.
It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to “close-the-loop” on corrective and/or preventive actions (CAPA), and do proper impact analysis / actions. Such failure investigation and root cause analysis is a major element of cGMP compliance. If inadequately performed it is also a key source of regulatory problems. How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? How can line operators brains be engaged by the use of such simple yet powerful tools? Use the templates, tools and methodology presented in this webinar to facilitate a closed-loop problem resolution system to reduce “fire fighting” and minimize compliance problems.