What Is Corrective and Preventative Action (CAPA)?

Written By: Derek Koziol
  • 12/10/2020
  • Read Time : 2 min
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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.

What is CAPA?

Sometimes referred to as simply corrective action, this is about continually improving processes intended to eliminate causes of product non-conformities and other undesirable scenarios. Standardized workflows provide a robust structure to initiate, evaluate, assign, monitor, review, and approve steps to improve quality and compliance by correcting existing issues.  

But 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. 

Why Implement Corrective and Preventative Action?

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: 

  • Harming an individual
  • Incurring costly downtime
  • Dealing with a faulty product
  • Being penalized for failing to follow governmental regulations and laws

By implementing corrective and preventative actions, enterprises can benefit from:

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

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.

What is CAPA Process?

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:

  • Reactive measures rather than proactive measures
  • Poor root cause determination
  • Lack of cross functionality

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.

How to Implement CAPA?

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. 

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.

 
Tags:
  • Quality
  • Digital Thread
  • PLM
  • Windchill

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.