Human Error in Corrective and Preventative Actions

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


‌ 

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.

More Resources

Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
Importance of Pharmaceutical GMP

Importance of Pharmaceutical GMP

Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...

Ready to learn more about working with us?

Pin It on Pinterest

Share This