Human Error in Corrective and Preventative Actions

by | Jan 24, 2022 | CAPA, Compliance, Consulting Group, Guidance, QMS, Quality, Quality Systems, Regulatory, Standardization, Standards


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When an error occurs, corrective and preventative actions are developed to help strengthen the quality management system (QMS). The corrective and preventive actions (CAPA) are a part of a continuous improvement system. CAPA procedures should describe the data sources, how it is collected, by whom and how it’s connected to the CAPA. The CAPA process includes five main steps: assessment, initiation, investigation and planning, implementation, and effectiveness. Arguably, the most extensive phase is the investigation and planning phase, as it’s the phase where the root cause of the CAPA is determined.

Human error as the root cause of CAPA’s is often cited more frequently than it should be. More often than not, the actual cause of human error is a process or system that will continue producing problems unless adequately addressed. When human error is frequently identified, especially similar issues, it can signal investigators that internal issues are not investigated thoroughly.

Human error as the root cause should be taken seriously, and only be the conclusion after a thorough investigation instead of a convenient way to avoid the investigative step. In the few instances where well-trained personnel make one-time errors following well-defined processes, the brief moment of distraction can have profound effects. Typically, there are two categories user error falls into:

  • Knowledge-based errors occur when the employee is multi-tasking beyond their limit or cannot devote the proper attention and focus required to accomplish the task.
  • Rule-based errors are typically more technical and result from personnel being inadequately prepared to perform the task.

Upon closer examination, human errors may present as systemic errors. Reviewing the documentation and asking appropriate questions can lead to more systemic problems and show that perhaps the issue is not a human error but rather an issue within the process for creating, maintaining, or distributing that procedure.

Enhancing a QMS through continuous improvement relies on CAPA processes. However, if CAPA investigations into the root cause of the issue are inadequate, the QMS itself will suffer greatly. Human error should be used as an opportunity to improve processes and increase efficiency rather than a convenient way to close a CAPA quickly. Experts at EMMA International can help create and implement any stage of a QMS, including root cause analysis and closure of CAPA’s. For more information, contact EMMA International by phone at 248-987-4497 or by email at info@emmainternational.com.

Alexis Ferrier

Alexis Ferrier

Alexis is a Technical Writer at EMMA International. She has research and development experience in both device and drug products. Additionally, Alexis has experience in quality assurance, quality control, regulatory requirements, and international compliance. She holds a Bachelor of Science in Chemistry from Michigan Technological University.

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