The result of this impact evaluation should be used to assess the seriousness of the problem. Part of the evaluation is an explanation of exactly why the problem is of concern, such as its possible impact on costs, product quality, safety or reliability. This involves impact and risk evaluations to gauge the potential impact of the problem and the actual risks to the company and customers.

Once described and documented, the problem should be evaluated to determine the need for action and the level of action required. Evaluate the potential impact and risk level It's also important to specify any available information that indicates the problem exists - for example, steadily increasing downtime may be evidence for a potential equipment problem.Īn automated CAPA process, from start to finish. The description of the problem should be concise but contain sufficient information to ensure that the problem is easily understood when read. The source of information may be external or internal, such as a customer complaint, service request, risk assessment or internal quality audit. This requires an accurate and complete description of the specific source of the information that initiated the action, as well as a detailed description of the problem and available evidence that the problem exists. In any effort to implement a CAPA programme, the first step is to clearly define the potential or actual problem, whether it's a non-conformance or system failure. To effectively investigate and correct quality issues to prevent recurrence, a comprehensive CAPA process should conduct and track the following seven procedures meticulously:ġ. Quality event issues will continue to plague companies working in GMP environments until they take the necessary steps to strengthen their CAPA programmes. The MHRA also found insufficient investigation or documentation of potential serious incidents, with the objective of determining the root cause and implementing appropriate CAPAs. Often there was no review of repeated deviations, indicating a failure of CAPAs to resolve the issue. In some cases, CAPAs were inadequate or formal CAPAs were not raised at all. In 324 GMP inspections of pharmaceutical manufacturing plants, including 82 inspections overseas, the agency uncovered numerous deficiencies related to incident investigations and CAPA implementation in 2016.Įxamples of CAPA-related deficiencies reported include deviation reports containing insufficient information to describe the investigations conducted or demonstrate the evidence supporting the proposed root cause.

In the UK's Medicines & Healthcare products Regulatory Agency's (MHRA) inspectorate deficiency trend data for 2016¹, for instance, the most cited deficiency that year was related to companies' quality systems, as it was in 2015. Yet many pharmaceutical companies' CAPA systems today are falling short. A sound Corrective and Preventive Action (CAPA) programme can be a powerful tool for improving product quality, streamlining production and ensuring regulatory compliance.

Capa processes