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CAPA Medical Device

CAPA Medical Device Introduction
CAPA Medical Device Introduction

What is CAPA in Medical Device Industry?

Quality management is continuous due to constantly changing requirements, regulations, supplies, and development. Therefore, despite best efforts, it is not unusual for a medical device manufacturer to face nonconformance issues. The earlier it is detected and rectified, the better it is. Early detection and correction can minimize damage to product and reputation, prevent escalation of costs and resource utilization, and reduce the risk of NC.

Some deviations may be easy to correct, but some may need a deeper analysis to identify the root cause. Identifying the root cause and implementing measures to correct it for a more enduring solution is called corrective action. It is called preventive action when an error recurs or if a potential error is identified and action is taken to prevent it from becoming a deviation. Together, corrective action preventive action is called CAPA

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It is a requirement for all medical devices companies to have a CAPA System in place to:

  • Identify issues
  • Investigate the root cause
  • Implement corrective actions and preventive actions

Some of the triggers for initiating CAPA include:

  • Nonconformance: When a deviation is noted repeatedly in a product, service, or development.
  • Customer Complaints: Customer feedback about any product issue triggers an investigation of the problem.
  • Audits: Internal and external help identify systemic issues that need further investigation and the implementation of a corrective action, preventive action (CAPA)

Know more about CAPA Management: Managing Quality Using Corrective and Preventive Actions. Watch our demo:

   Importance of CAPA Medical Device

Importance of CAPA in Medical Device

FDA 21 CFR Part 820 and ISO 13485 mandate medical device companies to have a CAPA system to investigate and solve issues and ensure they don’t recur. Manufacturers of Class II and Class III medical devices registered with the US Food and Drug Administration (FDA) will also be inspected periodically to ensure with 21 CFR Part 820.

Any NC will attract FDA 483, known as the ‘Inspectional Observations’ Form, or a warning letter, listing all the gaps observed at the facility. One of the most common reasons for issuing the FDA 483 observations and warning letters is the inadequacy of the medical devices company’s corrective and preventive action procedures.

This letter must be responded to within 15 days, explaining how the inadequacy will be corrected and what procedures will be implemented.

But, apart from the need, a well-implemented CAPA also improves the operational efficiency of the manufacturing company. It will minimize errors and deviations, improve resource utilization, and reduce manufacturing costs by lowering the need for rework, scrapping, and wastage.

This will also directly impact the product’s quality and performance, which will improve customer satisfaction and strengthen brand image.

Learn about Keeping the Heart of QMS Robust: Master How to Ensure Effective Corrective Action in the CAPA Development. Watch our webinar :

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CQ Guide : 5 Things to Consider while Writing CAPAs

Requirements for CAPA Medical Device

According to FDA 21 CFR 820.100, which deals with CAPA, “(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action."

It lists a wide range of requirements, including:

  • Investigating the causes of non-conformances
  • Identifying the corrective and preventive actions to be taken to correct the error and prevent recurrence
  • Verifying and validating the corrective actions taken to ensure it is effective and that it is not hurting the completed product

In ISO 13485:2016 standard, section 8.5.2 deals with corrective action and section 8.5.3 deals with preventive action. ISO 13485:2016 also requires the manufacturer to ensure that implementing corrective actions does not adversely affect the product’s quality, safety, and performance. In a bid to rectify an error or deviation, a new error must not get introduced.
Therefore, manufacturers must standardize the CAPA implementation procedure to ensure its effectiveness and achievement of the desired outcomes. This includes

Establish a Development

Creating a CAPA Development is essential to ensure the effectiveness of the CAPA procedure. It must encompass the following:

  • triggers such as nonconformances, complaints, and audits
  • the team that will be responsible for reviewing the CAPA request (Quality Manager/the Quality Review Board)
  • acceptance of the CAPA
  • tracking and monitoring, and so on

The CAPA form must have all the relevant details filled in.

Conducting Root Cause Analysis

The obvious cause for an issue may not be the real cause. Addressing only the symptoms will leave the real problem hidden and cause the issue to recur. Therefore, root cause analysis must be performed to identify the real reason behind the issue - and there could be more than one. Using 5 Whys or Fishbone Diagrams can help with this and needs a cross-functional team with the required skills to conduct the investigation.

Documenting Nonconformances and Feedback

A nonconformance report (NCR) must document feedback and all non-conformances to prevent making CAPA inefficient due to over- or underestimating issues.

Be Data-Driven

Accessing quality and contextualized data is critical for effectively investigating and implementing CAPAs.

Digitalize CAPA

To have a holistic view of processes and automate the CAPA workflow, invest in a cloud-based solution that provides access to data and enables seamless workflow integration.

Establish Metrics

Once the CAPA is implemented, its effectiveness must be assessed to ensure the outcomes are as desired. Therefore, having clear metrics will help monitor and track for evaluation and course correction where needed.

Find out how to overcome Challenges Related to Escalating Complaints to CAPA. Download the whitepaper:

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Customer Success

CQ Guide: Ultimate Guide to Automation of Corrective and Preventive Actions (CAPA) in the Life Sciences Industry

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Why Choose CQ for CAPA in Medice Devices?

CQ CAPA Software is a cloud-based solution built on Salesforce is a robust solution for ensuring that the product specs and quality metrics are met before the goods are released into inventory. The CQ solution supports methodologies such as 8D, 5W-2H, and world-class manufacturing (WCM) with smart recommendations for effective CAPA closure.

CQ’s AI capabilities also allow the detection of trends early on and define the appropriate action plan. CQ’s advanced RCA tools ensure success along with effectiveness checks, structured verification, and closure. It helps address systemic issues and drive continuous improvement of business processes using predictive analytics and intelligence to identify the right issues to solve.

Some key advantages include

  • Addressing Systemic Issues

    CQ EQMS is an integrated solution that links the eight key processes essential for a robust quality management system. These include

    • Nonconformance
    • Customer Complaints
    • CAPA
    • Equipment
    • Product and Process Inspections
    • Workforce Digitalization
    • Audit and Risk
    • Supplier Management

    This helps with the collaborative implementation of action plans and verification of the effectiveness of a CAPA.

  • Supports 8D and 5W-2H

    The eight disciplines (8D) problem-solving model is extremely popular among quality professionals in the automotive, manufacturing, and healthcare sectors. CQ leverages this approach to identify, correct, and eliminate recurring problems, along with integrated world-class manufacturing (WCM) and 5W-2H. The CQ CAPA solution is customizable as it provides the building blocks companies need to tailor it to their specific needs.

  • Data-Driven Investigations

    CQ enables businesses to leverage Artificial Intelligence (AI) and data technology for pattern recognition, capturing trends, and data visualization to spot key issues that need immediate corrective action in a fraction of time. CQ’s platform can be used to automatically to identify recurrent nonconformance instances and ascertain similar CAPA records. This proactive feature allows users to identify trends and address them before they become major quality events. The platform also offers quality analytics during investigations and RCA to improve the investigation, which ultimately results in a better CAPA workflow.

  • Integrated Risk Management

    The CQ CAPA Management Solution enables businesses to take a risk-based approach to CAPA. This helps identify and prioritize risks, allowing quality leaders to design appropriate action plans and close CAPAs in sync with the stated risk management goals.

  • Collaboration and Communication

    Collaboration and teamwork are at the core of a CAPA. The CQ CAPA Management Solution facilitates collaboration between different teams and also integrates with ERP and CRM systems to include customer, business, and supplier data to drive decision-making that is inclusive of the various stakeholders.

  • Reduce Cost of Quality (CoQ)

    The cost of poor quality (COPQ) includes all costs that is classified into appraisal costs, internal failure costs, and external failure costs. These costs are associated with poor-quality products or services. By using CQ CAPA Management Solution, organizations can reduce the Cost of Quality (CoQ) by helping businesses implementing strategies to continuously improve the overall quality management system.

CQ Works Great and is a Pleasure to Use

We went live with CQ just a few weeks ago and it works great! We received excellent training and after some playing around and getting used to it we found that it is really easy to use. So far we have implemented Document and Training Management as well as CAPA and both have everything we need right out of the box. After years of cumbersome spreadsheets and databases CQ is a blessing. It makes document management quick and easy… and it’s a pleasure to use.

Helen Cary,
Document Control Specialist

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Example of CAPA in Medical Devices

CAPA Medical Device Instances

Some of the instances when CAPA action maybe required include:

  • Instance 1 : When some components or parts deviate from the specifications consistently. This could be due to many reasons - the required part not being available in sufficient quantity or quality. The part may have been changed without due review and approval. A root cause analysis will need to be performed to understand the causes and sufficient measures put in place to prevent this.
  • Instance 2 : The customers complaining about a device not performing as expected or causing damage or injury. In addition to recalling the product, the company will have to perform a root cause analysis to see how and why this error happened, if it is confined to a batch or across all batches and products, etc.
  • Instance 3 : An audit uncovered a process not being implemented as per the standard operating procedure due to a lack of employee training. This could be an issue of there not being a process of induction and orientation, leading to high-risk situations, and needing CAPA to prevent its recurrence.

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Quality-centric Companies Rely on CQ QMS

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  • lifescan mono
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Frequently Asked Questions

  • CAPA needs expertise and time for effective implementation. Therefore, it must be implemented wisely after assessing critical issues that will have an impact if unattended. Before initiating CAPA, the true cause of product and quality issues must be identified. The data from multiple sources must be analyzed, and the problem investigated thoroughly before initiating CAPA.

  • Preventive action is proactively resolving issues based on trends and risk assessments. Data and information from multiple sources, such as acceptance activities, complaints, services, and returned product records, must be examined and trends captured. Persistent issues are a red flag that needs to be assessed for potential problems, and mitigative measures must be implemented to minimize the risk.

  • CAPA is a dynamic activity that needs much input and thought. At the core is the data, which should be high quality and dependable. It should be complete, without bias, and verified. Data quality must be assessed using sampling tables and reviews of records from select data sources to ensure its reliability, and its completeness and accuracy must be checked promptly.


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