A look into CAPA Investigations

Corrective and Preventive Actions (CAPA) is a method by which organizations take steps to bring about improvements and corrections into their processes. The basic aim of CAPA is to identify the causes of nonconformities or deviances from the processes, practices or products and rectify them to bring them in line with the stated objectives to produce desired outcomes.

Many GxPs have adapted the principles inherent in CAPA. Many ISO standards are created to this effect. The fundamental aim of CAPA can be related in the following:

• Investigation of the root causes of problems or risks
• Identification of the causes of the root causes of the stated problems in the system
• Means and methods of correcting these problems by identifying the risk and taking steps to prevent their recurrence

Now, what are CAPA investigations?

CAPA investigations are systematic investigations an organization carries out into its Quality Systems to detect the root causes of the identified problems and risks.

CAPA investigations lie at the heart of the act of identifying the root causes of a practice. CAPA investigations are carried out to investigate the causes for which a product, process or a Quality System could be nonconforming.

All the core elements of the chain -product, process and Quality System nonconformities -apply to CAPA investigations. The FDA requires such organizations to carry out a systematic root cause investigation under the series of Secs 820 and its many sections, whose primary aim is to identify the nature and nonconformities and their extent and take corrective actions before or after they have started to get distributed into the market.

Operative part on CAPA investigations

The operative part of FDA expectation on CAPA investigations is that the CAPA investigation should be carried out in a manner that is proportionate to the degree to the extent of risk in the nonconformity.

The Preamble to FDA's CAPA guideline states that there should be proportionality between the gravity of the problem and the inherent or attendant risk and the CAPA.

Levels of CAPA investigations

CAPA investigations consist of these levels:

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