SWIESH – Corrective action and preventive action are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice (GMP). It focuses on the systematic investigation of the root causes of non-conformities in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence   (for preventive action).

Corrective and preventative action refers to actions taken by an organization in order to correct non-compliance with regulations, non-conformity with best codes of practice or any other workplace situation that is less than desirable. A corrective action refers to action taken to correct a situation that has already occurred, whereas a preventative action foresees that non-conformity is likely to occur and takes pre-emptive action in order to stop it from eventuating.

Standards surrounding corrective and preventative action require firstly locating and documenting the cause of the nonconformity. An analysis then needs to be carried out to quantify the effect that the nonconformity has had on the product or service provided. If necessary the product should be recalled, customers notified, or the product removed from circulation. Stringent follow-up is required to ensure that the corrective action has been effective. Corrective and preventative action can include anything that addresses a possible issue from occurring, as well as any actions taken to remedy a situation after it has happened.

Key Features :

  • Creating corrective and preventative action plans
  • Dividing these action plans into operational tasks, and tracking their progress
  • Automatic email notifications to the various people involved at the company based on their role and scope of activity
  • Action plan monitoring dashboards

One important aspect of EHS programs is the Corrective Action and Preventive Action (CAPA) process.  CAPA is a methodology that strives to identify errors or nonconformity in a process along with the resulting problems, and then to understand the impacts, implement corrective action, and implement preventive measures. This concept is commonly built into many systems, processes and programs. One example is incident reporting standards for health and safety requirements as mandated by OSHA.

Other examples of CAPA programs include the “Plan Do Check Act” philosophy common to Crisis Management, as well as Quality Management Systems (QMS) focused on continual improvement and customer satisfaction. CAPA also forms the core of quality management disciplines such as Lean Manufacturing and Six Sigma, or ISO 9000. Permanent embedding of CAPA as part of a continuous improvement process in highly structured and regulated environments is critical.

A common criticism of CAPA programs is they often do not deliver the Return on Investment (ROI) expected by management. In order for CAPA programs to drive enterprise-wide benefits, they need to connect and fully integrate with strategies and solutions, and other supporting corporate-wide information systems. Further, CAPA programs need to have clear definitions of risk, severity and impact. These need to be clear and should be utilized to manage prioritization.  Effective CAPA programs should also be developed to enable organizations to integrate related disciplines, such as risk, incident, business continuity and audit management into a broader enterprise governance program.