OOT investigations

 Root cause investigations refer to the process of identifying and addressing the underlying cause or causes of a problem or nonconformance. Root cause investigations are typically conducted when a problem or nonconformance has been identified, and corrective action is required to prevent recurrence.

The root cause investigation process involves a systematic and thorough examination of the problem or nonconformance, using a variety of tools and techniques to identify the underlying cause or causes. The investigation may involve data collection, analysis, and review of relevant documentation and records, as well as interviews with personnel involved in the process.

The objective of the root cause investigation is to identify the underlying cause or causes of the problem or nonconformance, rather than just addressing the symptoms or immediate causes. This enables the development of effective and sustainable corrective and preventive actions (CAPAs) that address the root cause and prevent recurrence of the problem.

Root cause investigations are typically governed by standard operating procedures (SOPs) and regulatory requirements, such as good manufacturing practices (GMPs), good laboratory practices (GLPs), and other applicable regulations. It is essential to document the investigation process and to maintain accurate and complete records to demonstrate compliance with these requirements.

Root cause investigations can be applied in a range of industries, such as pharmaceuticals, biotechnology, medical devices, and food and beverage manufacturing, to address quality issues, safety concerns, and process improvements.

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