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In 2010, the Food and Drug Administration noted that insufficient corrective and preventive action procedures topped the list of most common FDA inspectional observations for the medical device industry. Year after year, this problem continues to exist, making a faulty or incomplete CAPA program one of the biggest challenges faced by the industry.

An effective CAPA is essential to resolve any problem that occurs related to the quality and safety of the product and the manufacturing process. It should facilitate identifying the problem, determining the true cause, correcting it, and preventing its future recurrence.

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FDA 21 CFR 820.100 establishes CAPA as an important subsystem to minimize device errors and delineates the requirements of the CAPA as:

  • A corrective and preventive action subsystem that helps to collect and analyze data to identify and investigate product and quality problems
  • Take appropriate and effective CAPA to prevent a recurrence
  • Verifying or validating corrective and preventive actions
  • Communicating CAPA to the people concerned
  • Enabling management review by providing relevant information
  • Documenting CAPA initiatives with clarity

While we’re bringing in the importance of CAPA from the perspective of the medical device industry, it is a critical part of the quality & safety workflows across industries including manufacturing, hi-tech, CPG, automotive, aerospace, oil & gas, and construction.

To effectively achieve this purpose of taking corrective/preventive action, the CAPA system should have 6 key elements.

An Effective CAPA System – 5 Key Capabilities

A good CAPA requires the following elements to be effective:

#1 – Process, Process, Process

Like the Plan-Do-Check-Act (PDCA) cycle, the CAPA systems should also have the following steps:

  • Description of the Problem: The first step is identifying and describing the potential or actual problem that could be a nonconformity or incident. The description should include data about the trigger, an explanation of the problem, and evidence to prove the problem exists. This helps in understanding the problem and identifying potential solutions to take corrective action.
  • Evaluating the Problem: The problem should be evaluated to determine the severity level and decide when and how action needs to be taken. The impact of the problem and the solution should also be analyzed to do a cost-benefit analysis, impact assessment, etc.
  • Investigation: The root cause of the problem should be identified. Often, a trigger maybe a superficial cause that sets off the event, but there will be underlying reasons that need to be understood and addressed. For example, a component may be faulty because of the incorrect maintenance process of one of the machines on the assembly line. That may have been the root cause of the problem, but to get to it, quality and engineering teams must work together to get to the root of the issue. CQ’s 5 WHY RCA tool may be an ideal solution to use in this case.
  • Create an Action Plan: Knowing the root cause will help with identifying the course of action to be taken. This needs to be detailed to minimize disruption of operations and enhance the existing processes and workforce productivity. Robust documentation is critical in this step.
  • Implement and Assess Impact: The solution should be implemented as per the plan and the impact assessed to ensure it has the desired effect.

#2 – A Proven Framework for Conducting an RCA

A CAPA can be effective only when the root cause is addressed by the corrective and preventive actions. To arrive at the root cause, some of the popular methods include:

  • 5 Why Analysis
  • Fishbone Diagram
  • Pareto Chart
  • Scatter Plot Diagram
  • Failure Mode and Effects Analysis (FMEA).

The 5 Why Whiteboard from ComplianceQuest can help increase the effectiveness of a CAPA. It also promotes the use of best practices across teams and minimizes variations in how RCA is performed.

Some of the key capabilities of ComplianceQuest’s ‘5 Why Root Cause Analysis’ tool include:

  • Designed for robust documentation of the 5 Why process
  • Ideal for both in-office and hybrid teams to collaborate
  • Easy to tag a person on the team to work together on the RCA process
  • Addition and deletion of Why nodes are easy
  • It is easy to mark whether a particular cause is a root cause or an expected problem
  • Add action plans
  • Add evidence as needed
  • All activities are timestamped for audit trails

#3 – Well-Planned Documentation

Documentation is an important aspect of CAPA and a regulatory requirement. It should detail the problem, the CAPA process, the root cause analysis findings, the implementation and impact, and the resources used.

This demonstrates the completeness of the process and ensures the effectiveness and compliance of CAPA.

#4 – Integrated Risk Management

It is imperative to identify the risks associated with the root causes and their potential impact on the quality and safety of the product.

Identifying the risks, the severity and frequency, prioritizing them, and putting in control measures are important aspects of CAPA that improve quality and safety performance.

In some organizations, risk management operates in a silo, which is inefficient because continuous monitoring of risk and quick resolution is critical. It is therefore essential to implement an EQMS solution with an integrated risk management module.

#5 – Data and Metrics-Driven to Enable Continuous Improvement

It is important to have an objective measure of the effectiveness of the CAPA. Establish CAPA-related metrics for your enterprise and compare the results to ensure the CAPA system is indeed performing as expected. For instance, the no. of open CAPAs as a ratio of total CAPAs is a critical measure of operational efficiency.

A business is constantly evolving as is the ecosystem to which it belongs. Therefore, there is a constant change in risks, opportunities, and threats.

The CAPA system should also keep pace and therefore needs to be reviewed periodically and updated as the company evolves. This requires data and insights into internal processes as well as industry benchmarks and regulatory requirements. A good CAPA system should reflect these changes so that the quality and safety are not compromised.

Automating the CAPA Workflow with ComplianceQuest

CAPA is a very evolved process, often involving multiple workflows. As a result, any action taken in one “process” can have an impact on another, leading to unforeseen consequences. An effective CAPA allows quality and safety leaders to have a holistic view of the process flows and a data-driven approach to CAPAs.

The 5 key elements of CAPA are also intricately linked, requiring continuity and transparency.

Manual systems cannot ensure this visibility and transparency, especially for complex problems and issues. This is one of the reasons why CAPA can be ineffective. With a manual or legacy system, identifying the root cause can also be a challenge, especially in terms of collaborating with diverse stakeholders.

A cloud-based solution like ComplianceQuest can overcome many of the challenges by providing a unified view of enterprise-wide data. This ensures that the CAPA workflow is robust, enabling businesses to effectively correct and prevent issues.

From a long-term standpoint, data residing in the CAPA system will also throw out much-needed insights to meet overall business performance, and spot opportunities and threats ahead of time.

To know more about how the ComplianceQuest CAPA management software can help your business, visit: https://www.compliancequest.com/capa-management-software/

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