What Is Corrective and Preventative Action (CAPA)?

Written By: Derek Koziol
  • 6/26/2020
  • Read Time : 2 min
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When products and machinery fail in the field, we all know the importance of diagnosing and fixing the problem as fast as possible. We’re worried about the adverse effects; whether it’s harming an individual, costly downtime, dealing with a faulty product, or even failing to follow governmental regulations and laws. 

With a corrective and preventative action (CAPA), enterprises can plan and execute rigorous investigations into failures, find root causes, and implement improvements to the product’s parts and manufacturing processes. Standardized ISO workflows provide a robust structure to initiate, evaluate, assign, monitor, review, and approve steps to improve quality and compliance by correcting existing issues and preventing recurrence.  

Let's take a closer look:

What Issues Does CAPA Address?

By implementing a CAPA, enterprises can benefit from:

  • Structured measurable improvement process
  • Preventative actions from the design history “lessons learned”
  • Compliance in regulated industries

Before the digitally connected enterprise, the information needed for CAPAs and the process of putting one together was often fraught with major issues that could exacerbate the original problem. Missing quality records because of siloed data would lead to; reactive measures rather than proactive measures, poor root cause determination, poor definition of a CAPA process, and lack of cross-functionality.

Now, however, stakeholders can use predefined, but configurable, workflows that are integrated with BOMs, parts, and documents, linking all quality inputs. With this connected visibility into multiple independent action threads from complex CAPAs, integrated reporting and effectiveness monitoring provides direct and accurate insight.

How Does CAPA Help Drive a Digitally Connected Enterprise?

But corrective actions are only half of what a CAPA is; preventative actions ensure that the problem does not happen again. Having the CAPA as a history of action, stakeholders can use that information for 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.

Addressing non-conformances, customer complaints, and deviations through CAPAs is the backbone to correcting failures. But we can now bolster this process throughout the digitally connected enterprise with the ability to manage CAPAs in real-time and ensure actions taken are impactful and accurate. 

With PTC’s industry-leading PLM software, enterprises can digitally connect siloed information and feed that data into a CAPA, providing transparency and quality through the corrective and preventative process in an intelligent way. 

To better understand how to implement quality control into manufacturing practices in order to transform and bring value to an enterprise, check out Aberdeen’s Report, “Weaving Quality into the Digital Thread”. For more information about PTC’s solutions for quality management, visit the PLM Quality Management page

 
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About the Author

Derek Koziol

Derek Koziol has over 20 years as an experienced Continuous Improvement leader with deep expertise in Six Sigma, lean, change management and program management.

With an MBA and LSSMBB, he has led global enterprise Product Lifecycle Management (PLM) initiatives in several industries ranging from technology and automotive, to complex pharma and medical devices.

What Is Corrective and Preventative Action (CAPA)?
What is CAPA? Find out more about the importance of corrective and preventative action in manufacturing.