Is Your CAPA Creating Bottlenecks? – Not Everything Needs to be a CAPA
Blog | November 9th, 2022

Is Your CAPA Creating Bottlenecks? – Not Everything Needs to be a CAPA

Nikki Willett, CSO/VP of Industry Solutions at ComplianceQuest, pointed out a few years ago in her article ‘It’s Raining CAPAs’ that organizations must evaluate problems for their risk level and then implement a CAPA only for highly critical problems. Willett has more than three decades of industry experience, with two decades in quality and regulatory compliance. In her journey, she had seen companies struggle with CAPA due to overuse of the process for minor as well as major problems, leading to bottlenecks.

Though some companies do implement risk mitigation plans and assess FMEA/FTAs in the product development cycle, it is often done at the beginning or the end of the process. Instead, these techniques should be integrated with nonconformance and CAPA processes. This will enable identifying critical problems and make companies proactive, making product and process improvement more effective.

Need for Effective CAPA Management

CAPA or Corrective Action, Preventive Action is a regulatory requirement as per FDA 21 CFR 820, ISO 9001:2015, and ISO 13485:2016. By triggering a CAPA, at the right time, companies can solve problems with agility and nimbleness. An effective process for CAPA management is critical to ensure quality excellence.

The underlying need for an effective CAPA is identifying the root cause, which is made possible through internal processes such as:

  • Identification of the problem
  • Input from employees
  • Document reviews
  • Management reviews
  • Internal audits

External sources that trigger a CAPA include:

  • Customer feedback and complaints
  • Returns and recalls
  • Non-conformities identified during external audits

CAPA continues to be one of the top reasons for FDA warning letters since it is not used as intended. The two main factors responsible for it becoming a bottleneck can be broadly categorized as:

  • The overuse of CAPA for every problem leaves the quality team struggling to investigate each issue and implement appropriate corrective actions.
  • Businesses use manual or semi-automated systems that deny them access to valuable insights needed to evaluate the risks and assess the criticality of the event. It also adds complexity to an already complex problem, introducing human errors.

Overuse of CAPA

Initiating CAPA for every complaint can lead to hundreds of issues open and awaiting a solution. On the face of it, it may seem important to address all issues. But in the effort to create a perfect system, the major problems may not be addressed in a timely manner, while minor problems take away all the attention of the quality team.

FDA recommends that CAPA be opened only for the following reasons:

Reason #1 – In Case of an Injury or Death : If it is a result of a product failure, CAPA must be opened.

Reason #2 – If the Event is Recurring : Pay attention when an event is recurring. It will still need a risk assessment to evaluate the severity of the event and whether CAPA needs to be initiated.

Reason #3 – Possible Alternative Ways to Manage the Issue : Using change management and design control, alternative solutions can be found for issues that do not need CAPA.

Reason # 4 – Critical Issues Identified During Risk Assessment : All risks should be evaluated for severity and frequency, and CAPA should be initiated for the highly critical ones.

Of course, this FDA recommendation is only a guideline and quality teams must open CAPAs when needed, but the key is to not overuse them.

How does CAPA Risk Assessment and Management Improve Quality & Compliance?

Corrective and Preventive Action (CAPA) risk assessment and management is used in various areas of quality and compliance. Here are some key areas. 

  • CAPA helps identify potential issues and risks before they escalate into compliance violations.
  • CAPA risk assessment helps streamline risks based on priority, thus reducing the chances of severe quality and compliance issues.
  • By addressing the most critical risks, organizations can efficiently allocate resources to enhance overall quality and compliance.
  • CAPA risk management helps make decisions using data and evidence to improve output.
  • With CAPA risk management, organizations can align with regulatory requirements, reducing the risk of non-compliance and associated penalties.
  • Effective risk management ensures that actions taken are well-documented and traceable, crucial for demonstrating compliance during audits and inspections.
  • Integrating Risk Assessment with CAPA for Greater Effectiveness

    Considering the pressure to be compliant, it is hardly surprising that businesses err on the side of caution. But, it renders the process ineffective in the absence of data and without proper risk assessment. Moreover, how effective CAPA implementation is also a measure of the quality management system’s effectiveness. When it fails, it sends a clear message that the QMS also needs to be evaluated and needs improvement.

    Some of the key areas of improvement include:

    • Planning: The first step to a successful CAPA is establishing the code rules and ownership that clearly define the parameters and the resources affecting its performance. It should be simple, scalable, risk-based, and integrated with other enterprise systems.
    • Source Error Tracking: When data sources are siloed, quality leaders have a fragmented view of data, making it difficult to cross-reference source errors and deviations. It is essential to have a holistic view of data across the product or process value chain. This will provide an accurate understanding of the root cause and improve the outcome of corrective and preventive actions.
    • Trending, Analysis, and Risk Management: This helps with identifying recurring and critical events and focusing the CAPA effort only on those. By implementing metrics and analytics, managers can quickly identify and act on the product, process, or quality-related issues
    • Employee Accountability and Management Visibility: Assigning roles and responsibilities, empowering employees with data, and providing them with the necessary training on sound investigation methods, proper documentation, and creating awareness about CAPA can help create a culture of quality and continuous improvement.

    ComplianceQuest EQMS to Prioritize CAPA Efforts

    ComplianceQuest EQMS is an integrated and scalable, cloud-based system with CAPA as one of its modules. It seamlessly integrates with enterprise systems and other quality systems such as change management, risk assessment, and root cause analysis to enable businesses to determine critical events and focus the CAPA efforts on important areas where fixes are needed.

    By providing access to enterprise-wide data (in a secure manner), ComplianceQuest empowers business, quality, and functional leaders to make informed decisions to increase the effectiveness of CAPA and QMS.

    To know more about how CQ EQMS and CAPA solutions can make your CAPA efficient and effective, visit:

    You can also request a demo here:

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