Procedures for corrective actions are also mandatory in the QMS for the majority of ISO management systems. Regulatory authoritiesĬAPA is most commonly used in highly regulated industries and is a mandatory part of a QMS for any pharmaceutical or medical device manufacturer reporting to the U.S Food and Drug Administration (FDA) or who is compliant with ISO:13485 Medical Devices as well as European Pharmaceutical GMP and IATF. CAPA can be an alternative to processes such as the plan-do-check-act (PDCA) by Shewhart (modified by Deming), or other quality improvement initiatives such as Total Quality Management (TQM), Six Sigma, and Lean. CAPA is categorized under the section Measurement, Analysis and Improvement in ISO:13485 and is closely related to continuous improvement processes. Project Quality Management also supports continuous process improvement activities. The CAPA process can be used as a quality management approach when working with project management and is categorized under Plan Quality Management in PMBOK. In the guide to the Project Management Body of Knowledge (PMBOK), project quality management is divided into three categories. Project quality management includes the processes for incorporating the organization’s quality policy regarding planning, managing, and controlling project and product quality requirements in order to meet stakeholders’ objectives. Project quality managementĬAPA projects are related to quality management of a product/system. ![]() It is the QMS that dictates how the project quality management is handled. A QMS consists of procedures, instructions, forms, and documentation for the organization’s activities in order to ensure quality goals and conformity. Quality is usually controlled through a QMS. A frequently used definition of quality is defined by ISO 9000 as the degree to which a set of inherent characteristics of an object fulfils requirements. Quality management is the coordination of activities to control an organization with regard to quality. action plan for corrective and/or preventive actions.preparation of a procedure for the investigation.In this article a 7-step framework is presented. The purpose of this article is to give the reader an overview of the context in which CAPA is used, how to perform a CAPA, and which risks to be aware of. There are not a regulatory defined framework for the CAPA process only different requirements. The FDA defines the purpose of a CAPA procedure as: collecting and analyzing information, identifying and investigating product and quality problems, and taking appropriate and effective corrective and/or preventive action to prevent their recurrence. ![]() CAPA is also an integrated part of ISO:13485 and Good Manufacturing Practice (GMP) for medical products. CAPA is a mandatory part of the Quality Management System (QMS) for any pharmaceutical or medical device manufacturer reporting to the U.S. ![]() When working with CAPA, corrective actions are defined as actions set in motion to eliminate a nonconformity or other unwanted situations which have already occurred, and preventive actions as actions set in motion to eliminate potential nonconformities or unwanted situations. The CAPA processes should be well defined to support an effective and efficient project management process. ![]() 3 The purpose of an efficient CAPA processĬorrective and Preventive Actions (CAPA) are processes designed to improve quality and handle nonconformity as well as other undesirable situations.
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