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  CAPA FDA

CAPA FDA - An Effective Plan

capa fda

An Effective Quality Plan For Easy Implementation, Reducing Defects and Lowering Penalty Costs

An ultimate guide for developing an efficient, formalized CAPA FDA plan to know where to begin when a systemic issue or defect is found

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CAPA FDA Video

What are the Objectives of CAPA FDA?

A CAPA plan is a quality management strategy used in the manufacturing and production industries to identify and rectify defects to ensure they won’t repeat again in the future. Once a CAPA plan is implemented, it must illustrate ten objectives to meet the intent of the FDA 21 CFR 820.100 requirement. The ten objectives of CAPA FDA are:

  • Validate that the CAPA system procedures that deal with the quality system requirements regulation have been specified and documented.
  • Define if appropriate sources of product and quality problems have been identified and make sure the data sources are analyzed to identify existing product and quality problems that may require corrective action.
  • Identify the unfavorable trends of product and quality sources and make sure that data from these sources are analyzed to find out potential product and quality problems that may need preventive action.
  • Verify that the quality data information received by the CAPA system is complete, precise and appropriate.
  • Verify that accurate statistical methods are operating to detect recurring quality problems.
  • Determine if failure investigations are implemented to detect the root cause
  • Determine if suitable actions have been taken for product and quality problems identified from data sources.
  • Determine if corrective and preventive actions were potent and confirmed or validated prior to implementation and ensure that corrective and preventive actions do not adversely impact the finished device.
  • Validate that corrective and preventive actions for product and quality problems were executed and documented.
  • Determine if information related to nonconforming product and quality problems and corrective and preventive actions has been properly distributed, including dissemination for management review.

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CAPA FDA Requirements

The FDA (U.S. Food and Drug Administration) places stringent requirements on Corrective and Preventive Action (CAPA) processes within regulated industries such as pharmaceuticals, medical devices, and food manufacturing. Compliance with these requirements is essential to ensure product safety and quality.

The FDA provides detailed guidance documents outlining the CAPA processes' expectations. Companies must consult these documents for comprehensive guidance. While the FDA doesn't prescribe a specific CAPA template, it does expect organizations to maintain thorough documentation of CAPA activities. A well-structured CAPA template based on FDA regulations can help organizations ensure compliance and consistency in documenting CAPA activities.

As part of the CAPA process, organizations must develop a CAPA plan that outlines the approach for addressing identified issues. The corrective action and preventive action plan should include details on root cause analysis, corrective actions, preventive actions, timelines, and responsible personnel. The FDA mandates that organizations implement corrective actions to address existing problems and preventive actions to avoid future issues as part of their CAPA process. These actions should be evidence-based and tailored to the specific problem.

Organizations can refer to FDA-issued warning letters and inspection observations as examples of CAPA-related issues and how they were addressed. These examples offer insights into the FDA's expectations. Compliance with FDA CAPA requirements involves thorough investigation and documentation of issues, root cause analysis, verification of corrective actions' effectiveness, and ongoing monitoring to prevent recurrence.

CAPA FDA Requirements
Investigate CAPA Processes

How Does FDA Train its Inspectors to Investigate Your CAPA Processes?

How to Implement CAPA FDA?

Implementing the two functions of CAPA FDA, the Corrective Action Preventive Action, approach are as follows:

CAPA FDA corrective action implementation

Corrective Action

When an issue is identified or communicated, a structured set of activities are initiated to describe the problem in detail so that the team can identify a root cause path. After selecting a root cause path, a permanent corrective action is identified, implemented and validated.

The steps for Corrective Action are detailed below:

  • Problem Statement is formed by using the 5 Why approach and the Fishbone diagram to identify the possible causes of the Problem Statement.
  • Problem Description is written based upon further analysis of the What, When, Where, and How Big data was collected.
  • Possible causes on the fishbone diagram can then be reduced by using data from the Problem Description.
  • The root cause is verified and permanent Corrective Actions are determined for the root cause and the inspection process.
  • Validation and Implementation of the Corrective Action.

Preventive Action

Preventive Action occurs after the root cause has been found out and permanent corrective action has been validated. Preventive Action recognizes the value of the information and the actions taken during the Corrective Action function.

The steps for Preventive Action are detailed below:

  • Capture the Problem Statement as an Object-Defect for available databases.
  • Connect the root causes to the Problem Statement with the Permanent Corrective Action
  • Update documents
  • Failure Mode and Effects Analysis (FMEA)
  • Control Plan Methodology
  • Work Instructions
  • Document information for future retrieval including supporting information.
CAPA FDA preventive action implementation
mustangbio case study

Guidance on Corrective Action and Preventive Action and Related QMS Processes

mustangbio case study
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Step-by-Step Instructions for CAPA FDA Plan

To develop an efficient CAPA FDA plan, the below phases must be followed:

  • Identify possible problems related to quality, product or non-conformity

    In this initial phase, once you receive a complaint through internal or external systems such as a customer complaint line, the management review process, a staff suggestion box or an audit, collect more information about the issue.

  • Evaluate the severity of the problem and its impact on the business

    In the second phase, the primary objective is to decide if the issue requires a CAPA plan to resolve by evaluating the severity, damage and complexity of the issue. The evaluation will discover if a simple change could keep the issue under control or if the CAPA guidelines are needed.

  • Assess the procedures for investigation

    In this third phase, the goal is to investigate the issue and determine its root cause. The root cause is crucial information to prevent its occurrence or reoccurrence.

  • Investigate the problem with accurate data

    In the fourth phase, the intent is to use the information gathered from steps one, two and three to develop a plan to resolve the issue and the root cause.

  • Develop the plan

    Preventive actions are the dynamic measures to monitor or prevent potential risks before they amplify into huge, potentially hazardous issues. Common preventive actions involve:

    • Reviewing or auditing suppliers
    • Monitoring and analyzing negative trends
    • Implementing alarms and establishing training programs
    • Conducting risk analysis and regular performance reviews
    • Developing disaster recovery plans and calibration control programs

  • Perform systematic follow-ups to ensure the effectiveness of the solutions

    The next step of your implementation is documenting and monitoring the effectiveness of the corrective or preventive actions. This step is important as it ensures that the action is not only accurate but it will also resolve the issue and prevent it from recurring.

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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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manage CAPA quality with ComplianceQuest

Managing the CAPA quality with ComplianceQuest

With CQ CAPA Management Software, you can detect trends, identify and initiate a corrective and/or preventive action process, conduct or link to an existing investigation and root cause analysis (RCA), ensure effectiveness checks with a structured verification and closure and define action plans to change or improve. This is designed to offer integrated risk management along with a built-in workflow indicator that companies can use or may configure to suit their needs.

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Looking for CAPA FDA and CAPA quality implementation? Here is the ultimate guide for developing an efficient, formalized CAPA plan

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Related Checklists

Quality-centric Companies Rely on CQ QMS

  • Flex
  • Skyworks
  • 3m logo
  • YKK
  • Qorvo
  • Canon
  • Vyaire
  • Stryker
  • Staar Surgical
  • CDC
  • Tilray
  • Dr Reddy's
  • Freenome

Frequently Asked Questions

  • A CAPA Quality System (CAPA is an abbreviation for ‘Corrective and Preventive Action’) is absolutely vital for a complete QMS program. Good Manufacturing Practices (GMP), a requirement and a fundamental tenet of the program, is the quality management system that must be used by pharmaceutical and medical equipment manufacturers to comply with FDA guidelines.

  • CAPA FDA helps to collect and analyze information, identify and investigate product and quality problems, and take appropriate corrective and/or preventive action to prevent their recurrence. Reviewing and validating corrective and preventive actions, reporting corrective and preventive action activities to the people concerned, enabling relevant information for management review, and documenting these activities are necessary for addressing effectively product and quality problems, preventing their recurrence and preventing or reducing device failures.

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Blog | April 4th, 2025

The Merger of ISO 13485 and FDA QSR 21 CFR 820 for Medical Devices – Proposed Changes and Implications

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