Editor's note: This blog was originally published in December 2020 and was updated with new information in October 2023.
With corrective and preventative action (CAPA), enterprises can plan and execute rigorous investigations into failures, find root causes, and implement improvements to their parts and manufacturing processes. Let’s dive into what this is, why it’s essential, how it works, and how to implement it.
Sometimes called corrective action, CAPA is about continually improving processes intended to eliminate causes of product non-conformities and other undesirable scenarios. Standardized CAPA workflows provide a robust structure to initiate, evaluate, assign, monitor, review, and approve steps to improve quality and compliance by correcting existing issues.
Corrective actions are only half of the story; preventative actions ensure the problem does not recur. With the CAPA as a history of action, stakeholders can take preventative measures and automatically generate change notices. By focusing on quality and continuously implementing improvements to address the original issue, enterprises can proactively reduce the risk of their product failing again.
The simplest distinction between corrective and preventative actions is that they are reactive and proactive, respectively. Corrective actions address existing problems (typically identified by audits or complaints) and focus on solving the immediate issue and preventing a recurrence. Preventative actions aim to prevent problems before they occur (typically identified through risk assessment or trend analysis) and focus on mitigating risks. Both are essential components of quality and risk management systems, and help organizations maintain high standards while minimizing disruptions.
When products and machinery fail in the field, it’s important to diagnose and fix the problem as fast as possible. Doing so helps mitigate adverse effects, which could include:
By implementing corrective and preventative actions, enterprises can benefit from:
Organizations across industries harness this process to improve their product quality as part of a quality management program. In fact, CAPA in the pharmaceutical industry is seen as critical to success.
This process helps collect and analyze relevant product-related information; identify and investigate product and quality problems; and trigger appropriate and effective corrective and/or preventive actions to prevent problem recurrence.
Before the digitally connected enterprise, the process of creating a CAPA was often fraught with major issues that could exacerbate the original problem. Because of siloed data, organizations were missing necessary information. Combine this with a poorly defined process, and organizations found themselves dealing with:
Now, stakeholders can use predefined – but configurable – workflows that are integrated with bills of materials (BOMs), parts, and documents to link all quality inputs. With this connected visibility into multiple independent action threads from complex CAPAs through integrated reporting and effectiveness monitoring, organizations gain direct and accurate insight into potential issues.
Addressing non-conformances, customer complaints, and deviations is the backbone for correcting failures. But organizations can now bolster this process throughout the digitally connected enterprise by managing CAPAs in real time and ensuring stakeholders take impactful, accurate actions.
With PTC’s Windchill, the industry-leading PLM software, enterprises can digitally connect siloed information and feed that data into a corrective and preventative action. This provides transparency and quality throughout the process in a streamlined way.
CAPA principles can be applied wherever there is a need to identify, investigate, and address problems, whether they are related to quality, safety, compliance, or process improvement. The versatility of CAPA principles make them a particularly valuable tool for organizations across a wide range of industries, such as healthcare and pharmaceuticals, food and beverage, manufacturing, IT and high tech, and utilities.
While there may be initial investments associated with training employees in CAPA principles, these costs are typically outweighed by the long-term benefits, such as cost savings, risk reduction, regulatory compliance, and overall business improvement. CAPA principles can also increase engagement, improve efficiency, and offer a competitive advantage by consistently delivering high-quality products and services.
Although CAPA is essential for addressing quality issues and driving relevant improvements, it should be integrated into a broader quality management framework. A holistic approach to quality management – that starts with a solid PLM foundation – ensures that an organization consistently meets quality standards and strives for ongoing excellence in addition to correcting and preventing problems.
There certainly are upfront efforts to implementing CAPA principles: training, process development, documentation, resource allocation, change management, etc. But once again, the benefits far outweigh the perceived workload. CAPA is an essential component of effective quality management and continuous improvement. By addressing issues at their root causes, organizations can reduce the overall workload associated with recurring problems and crises.
CAPA is a critical framework that empowers organizations to both address existing problems and proactively prevent their recurrence through a comprehensive approach to quality management and continuous improvement. It's a versatile tool that can be applied in various industries and provides organizations with the means to identify, investigate, and address issues effectively.
To better understand how to implement quality control into manufacturing practices, read Aberdeen’s Report, “Weaving Quality into the Digital Thread.” If you want learn about PTC’s solutions for quality management, please visit the PLM Quality Management page.
Jeff is the VP for Windchill Digital Thread. His team leads Navigate, Visualization, Windchill UI and Digital Product Traceability. Prior to joining PTC, Jeff spent 16 years implementing and using PLM, CAD and CAE at Industrial, High Tech & Consumer Products companies including leading the first Windchill PDMLink implementation in 2002. He was active in the PTC/USER community serving as Chair for the Windchill Solutions committee and on the Board of Directors for PTC/USER helping to bring voice of customer input together and create a community where people could network for tools and processes. Jeff attended Rensselaer Polytechnic Institute and Lehigh University.