Explain CAPA in Quality with an Example?

CAPA in quality management is a structured approach to identify, resolve, and prevent product defects or non-conformities. For example, in a pharmaceutical company, a batch of medication fails potency requirements during routine testing. Corrective Action: The company investigates and finds a mixing machine malfunction caused uneven distribution of the active ingredient. They repair the machine, retest the batch, and release it if compliant. Preventive Action: They revise procedures to include frequent equipment checks, schedule regular maintenance, and train operators to detect potential machine issues. Monitoring: Future batches are tracked, audits are performed, and maintenance and training records are verified to ensure CAPA effectiveness.

What is an Example of Corrective and Preventive Action (CAPA)?

In a manufacturing context, a company producing automobile engine parts finds that some components fail quality checks due to incorrect dimensions. Corrective Action: Investigation reveals a machine was miscalibrated. The company recalibrates the machine, inspects the defective parts, and ensures future outputs meet specifications. Preventive Action: They enhance their calibration process to include a verification step, train staff on proper calibration, and schedule regular audits of machine calibration procedures. This ensures both immediate problem resolution and prevention of recurrence, leading to improved product quality and customer satisfaction.

What is a CAPA Example?

A CAPA (Corrective and Preventive Action) example spans industries like construction, automotive, aerospace, food, healthcare, and manufacturing, focusing on identifying root causes, implementing corrective actions, and preventive measures to ensure continuous improvement and prevent recurrence.

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Understanding CAPA And Nonconformity Examples in Various Industries

Corrective and Preventive Action (CAPA) and nonconformities are crucial in ensuring quality, safety, and regulatory compliance across various industries. Let's explore these concepts with industry-specific perspectives:

Construction Industry

In the construction industry, CAPA helps address quality issues, adverse events, or deviations in drug distribution or administration. Corrective actions focus on addressing the immediate issue, such as product recalls due to contamination. On the other hand, preventive actions help identify and rectify the root causes of issues to prevent their recurrence, like updating manufacturing processes to prevent future contamination instances. Nonconformities refer to instances where products, processes, or procedures do not meet the required quality standards, leading to deviations from established norms.

Automotive Industry

In the automotive industry, CAPA helps to identify and resolve issues that impact vehicle safety, performance, or regulatory compliance. Corrective actions may include recalling vehicles with faulty components, while preventive actions could involve redesigning those components to prevent similar issues in future models. Nonconformity refers to deviations from design specifications, manufacturing standards, or safety regulations that affect automotive products’ intended function or performance.

Aerospace Industry

For the aerospace sector, CAPA entails meticulous investigation and resolution of quality deviations in aircraft manufacturing, maintenance, or operation. Corrective actions might involve repairing aircraft components found to be defective during routine inspections. Preventive actions could encompass revising maintenance procedures or enhancing training to prevent future occurrences of similar defects. Nonconformities in aerospace denote instances where aircraft, components, or processes deviate from established standards, potentially jeopardizing flight safety or operational integrity.

Food Industry

In the food industry, CAPA addresses issues related to food safety, quality, and compliance. Corrective actions could involve recalling contaminated food products from the market, while preventive actions might include adjusting sanitation practices to prevent further contamination outbreaks. Nonconformities refer to cases where food products, packaging, or processing procedures do not meet regulatory requirements, potentially posing health risks to consumers.

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Examples of CAPA in Different Industries

Corrective and Preventive Actions (CAPA) are an integral part of quality management systems across various industries. Here are some CAPA examples in different industries and potential warning letter scenarios:
- CAPA example: Batch Failure Investigation and Resolution
  
  Issue: A pharmaceutical company discovers a batch of products that failed quality testing due to a packaging defect.
  
  CAPA Steps:
  
  Corrective Action: Quarantine and recall the affected batch, investigate the root cause of the packaging defect, and address the issue.
  
  Preventive Action: Review and update packaging procedures, conduct additional training for packaging personnel, and implement enhanced quality checks.
  
  Example of Warning Letter Scenario: Inadequate Investigation
  
  Issue: The FDA finds that a pharmaceutical company's investigation into a batch failure was inadequate and lacked proper documentation.
  
  Warning Letter: The FDA issued a warning letter to the company, citing concerns about their inadequate investigation practices and requesting a detailed corrective action plan to address the deficiencies. The company must provide evidence of improved investigation procedures, documentation, and staff training.
- CAPA example: Product Defects and Process Improvement
  
  Issue: A manufacturing company observes a recurring defect in a product due to a flaw in the production process.
  
  CAPA Steps:
  
  Corrective Action: Identify and fix the specific flaw causing the defect, rework or dispose of defective products, and ensure the immediate issue is resolved.
  
  Preventive Action: Conduct a thorough process review, update standard operating procedures, enhance quality control measures, and provide additional training to operators.
  
  Example of Warning Letter Scenario: Lack of Process Control
  
  Issue: A manufacturing facility is found to have inconsistent product quality due to inadequate process control measures.
  
  Warning Letter: Regulatory authorities issue a warning letter to the manufacturing company, highlighting concerns about their lack of process control. The company must submit a comprehensive plan detailing how it will enhance its process control mechanisms, including monitoring, documentation, and continuous improvement efforts.
- Corrective action preventive action example: Post-Market Surveillance and Design Improvement
  
  Issue: A medical device company receives reports of a specific model of their product malfunctioning after a certain period of use.
  
  CAPA Steps:
  
  Corrective Action: Investigate the reported malfunctions, recall the affected devices, and address the root cause of the issue.
  
  Preventive Action: Revise the device's design based on the investigation findings, conduct rigorous testing, update risk assessments, and improve monitoring for post-market surveillance.
  
  Example of Warning Letter Scenario: Inadequate Adverse Event Reporting
  
  Issue: A medical device company is found to have failed to report adverse events associated with its devices to regulatory agencies within the required timeframe.
  
  Warning Letter: Regulatory authorities issue a warning letter to the company, citing its inadequate adverse event reporting practices. The company must implement a comprehensive plan for the timely and accurate reporting of adverse events, including process improvements, training, and enhanced documentation practices.
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Challenges Related to Escalating Complaints to CAPA

Examples of Nonconformity in Different Industries

Minor Nonconformance Example

Minor nonconformances are deviations from established standards or procedures that have a low impact on product quality, safety, or compliance. These nonconformances are less severe than major nonconformances and can be corrected without causing significant disruptions in production or operations. Here are some examples of minor nonconformances in different industries:

Manufacturing Industry

Cosmetic defects on a product that do not affect its functionality or safety
Minor variations in dimensions or tolerances that fall within an acceptable range
A temporary equipment malfunction that does not lead to a production stoppage
Minor discrepancies in labeling or packaging that do not impact product identification or safety

Food Industry

Slight variations in the color or texture of a food product that do not affect taste or safety
A small deviation in ingredient quantities within an acceptable tolerance
Minor packaging errors include a misprinted date code that does not impact product freshness
A temporary temperature fluctuation in a refrigeration unit that is quickly corrected

Healthcare Industry

Minor documentation errors in patient records, such as typos or missing signatures
Slight discrepancies in inventory counts that can be reconciled without affecting patient care
Temporary issues with medical equipment calibration are promptly addressed

Construction Industry:

Minor deviations from architectural plans that do not compromise structural integrity
Small aesthetic flaws in finished surfaces that do not impact functionality
Slight delays in the delivery of non-critical construction materials
Minor deviations from safety procedures that are promptly corrected

Aerospace Industry

Minor discrepancies in documentation related to aircraft maintenance procedures
Slight variations in the weight of components within an acceptable range
Small cosmetic imperfections on non-essential aircraft surfaces
Temporary disruptions in supply chain logistics that do not impact production schedules

Manufacturing Industry
- Cosmetic defects on a product that do not affect its functionality or safety
- Minor variations in dimensions or tolerances that fall within an acceptable range
- A temporary equipment malfunction that does not lead to a production stoppage
- Minor discrepancies in labeling or packaging that do not impact product identification or safety
Food Industry
- Slight variations in the color or texture of a food product that do not affect taste or safety
- A small deviation in ingredient quantities within an acceptable tolerance
- Minor packaging errors include a misprinted date code that does not impact product freshness
- A temporary temperature fluctuation in a refrigeration unit that is quickly corrected
Healthcare Industry
- Minor documentation errors in patient records, such as typos or missing signatures
- Slight discrepancies in inventory counts that can be reconciled without affecting patient care
- Temporary issues with medical equipment calibration that are promptly addressed
Construction Industry:
- Minor deviations from architectural plans that do not compromise structural integrity
- Small aesthetic flaws in finished surfaces that do not impact functionality
- Slight delays in the delivery of non-critical construction materials
- Minor deviations from safety procedures that are promptly corrected
Aerospace Industry
- Minor discrepancies in documentation related to aircraft maintenance procedures
- Slight variations in the weight of components within an acceptable range
- Small cosmetic imperfections on non-essential aircraft surfaces
- Temporary disruptions in supply chain logistics that do not impact production schedules

Major Nonconformance Example

Major nonconformances are significant deviations from established standards, procedures, or requirements that substantially impact product quality, safety, or compliance. They require immediate attention and corrective action. Here are examples of major nonconformances in different industries:

Manufacturing Industry

Critical defects in a product that render it unsafe for use or unusable
Substantial deviations in dimensions or tolerances that affect product functionality
Equipment failure led to a prolonged production shutdown
Major discrepancies in labeling or packaging can lead to product misidentification or safety hazards

Food Industry

Contamination of food products with harmful bacteria or foreign objects
Significant variations in ingredient quantities outside acceptable tolerances
Incorrect allergen labeling poses a serious health risk to consumers
Failure to meet food safety regulations, resulting in a product recall

Healthcare Industry

Incorrect administration of medication or treatment poses a severe risk to patients
Significant errors in patient records that compromise patient care or safety
Failure to follow established surgical procedures leads to adverse outcomes
Major deviations from hospital protocols that jeopardize patient well-being

Construction Industry:

Structural defects that compromise the safety and integrity of a building
Critical deviations from architectural plans that affect building stability
Major safety violations resulting in injuries or fatalities on a construction site
Failure to meet building code requirements leads to legal and safety issues

Aerospace Industry

Critical deviations from aircraft maintenance procedures that jeopardize flight safety
Structural defects in aircraft components could lead to catastrophic failure
Severe disruptions in the supply chain for critical aerospace materials or parts
Failure to meet aviation regulations leads to the grounding of aircraft

Manufacturing Industry
- Critical defects in a product that render it unsafe for use or unusable
- Substantial deviations in dimensions or tolerances that affect product functionality
- Equipment failure led to a prolonged production shutdown
- Major discrepancies in labeling or packaging can lead to product misidentification or safety hazards
Food Industry
- Contamination of food products with harmful bacteria or foreign objects
- Significant variations in ingredient quantities outside acceptable tolerances
- Incorrect allergen labeling poses a serious health risk to consumers
- Failure to meet food safety regulations, resulting in a product recall
Healthcare Industry
- Incorrect administration of medication or treatment poses a severe risk to patients
- Significant errors in patient records that compromise patient care or safety
- Failure to follow established surgical procedures leads to adverse outcomes
- Major deviations from hospital protocols that jeopardize patient well-being
Construction Industry:
- Structural defects that compromise the safety and integrity of a building
- Critical deviations from architectural plans that affect building stability
- Major safety violations resulting in injuries or fatalities on a construction site
- Failure to meet building code requirements leads to legal and safety issues
Aerospace Industry
- Critical deviations from aircraft maintenance procedures that jeopardize flight safety
- Structural defects in aircraft components could lead to catastrophic failure
- Severe disruptions in the supply chain for critical aerospace materials or parts
- Failure to meet aviation regulations leads to the grounding of aircraft

CAPA Implementation Stories and Regulatory Insights

Real-Life Scenario in Aerospace: In the aerospace industry, a CAPA was initiated after routine inspections found cracks in turbine blades. The corrective action involved replacing the defective blades and conducting a detailed analysis to identify the manufacturing defect. Preventive actions included modifying the production process and enhancing quality checks. This CAPA story not only highlights the critical nature of aerospace industry regulations but also showcases the thoroughness required in the CAPA process to ensure safety and compliance.

Regulatory Compliance Focus: CAPA systems are heavily scrutinized during regulatory audits. Detailed documentation of each CAPA, including actions taken and their effectiveness, is crucial. For instance, in the food industry, regulatory bodies like the FDA require stringent tracking of CAPA related to food safety issues, such as contamination or mislabeling. Ensuring compliance through CAPA helps in maintaining the necessary licenses and avoiding potential fines or shutdowns.

Utilizing CAPA KPIs for Continuous Improvement:

CAPA Aging: This metric measures how long CAPAs remain open. Ensuring CAPAs close within predefined timelines is vital for compliance and operational efficiency.
First Time Right: Measures the percentage of CAPAs resolved correctly on the first attempt, indicating the precision of the initial corrective action and the adequacy of the root cause analysis.

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Corrective and Preventive Action Plan Examples

Some of the common examples of issues that require corrective and preventive action procedures include:

Receiving raw materials or components that do not pass inspection. The root cause analysis will help identify whether the problem is at the customer end, or the suppliers to them, and even whether this error is being triggered by mismatched communication from the customer end
Finished products/components that do not conform to the specifications and fail during the inspection or testing stage. The CAPA will help identify the root cause, which could be in a manufacturing process, the machine used for manufacturing, or the employee not having sufficient training. CAPA would include addressing these core issues
Product being received from the customer due to defects. A root cause analysis will help trace back the source of the problem and implement appropriate solutions to minimize recurrence.
Conducting audits/inspections periodically will help identify any systemic issues and proactively eliminate them to prevent noncompliance issues.

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Corrective and preventive action plan examples

Do not miss the chance to gain insights from real corrective action preventive action examples and discuss how it can help your business improve quality and compliance.

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Frequently Asked Questions

CAPA is a robust approach used in quality management to identify, address, and prevent issues that can lead to product defects, non-conformities, or other quality-related problems. The ComplianceQuest CAPA Management solution is designed to seamlessly integrate with audit findings, instances of nonconformance, and other readily available solutions. This facilitates the streamlined identification and effective management of various quality issues.

Here's a CAPA example in quality:

Scenario: Imagine a pharmaceutical company that produces a medication. During routine quality control testing, it is discovered that a batch of medication has failed to meet the specified potency requirements.
- Corrective Action: The company's first step is to take corrective action to address the immediate problem. They investigate the root cause of the potency failure. It was determined that a malfunctioning mixing machine resulted in uneven distribution of the active ingredient in the medication. The corrective action involves repairing the mixing machine, retesting the affected batch, and releasing it for distribution if it passes.
- Preventive Action: The company implements preventive actions to prevent similar issues in the future. They revised their quality control procedures to include more frequent and thorough checks on the mixing equipment. They also schedule regular maintenance for all production equipment to prevent unexpected malfunctions. Additionally, they decide to train their operators on recognizing potential equipment issues that could impact product quality.
- Monitoring and Verification: The company continues to monitor the quality of future batches and conducts ongoing audits to ensure that the implemented corrective and preventive actions are effective. They also review their records to ensure the mixing equipment has been maintained and operators have received proper training.
Here's a corrective and preventive action example in a manufacturing context:

Scenario: Imagine a company that manufactures automobile components, such as engine parts. They've been experiencing a recurring issue where some engine parts fail quality checks due to incorrect dimensions, leading to engine performance problems in the vehicles they're installed in.

Corrective Action (CA):
- Identify the Problem: The company identifies that a specific batch of engine parts is consistently failing quality checks due to incorrect dimensions.
- Root Cause Analysis: After investigating, they find that a particular machine used in manufacturing has been calibrated incorrectly, leading to out-of-spec dimensions.
- Corrective Measures: The company immediately recalibrates the machine to the correct specifications and performs quality checks on the affected parts batch to ensure they meet the required dimensions.
- Verification: They thoroughly test the recalibrated machine to confirm it produces parts with the correct dimensions. They also conduct additional checks on previously produced parts to ensure the issue has been resolved.
Preventive Action (PA):
- Identify Potential for Recurrence: The company recognizes that improper machine calibration can potentially affect other batches of parts in the future.
- Root Cause Analysis and Preventive Measures: They investigate the calibration process for all machines involved in production. They find that the calibration process lacks a systematic verification step after adjustments.
- Process Enhancement: The company revises the calibration process to include a verification step after every calibration. This ensures that machines produce parts within specified tolerances before they resume production.
- Employee Training: They conduct training sessions for the production team, emphasizing the importance of proper machine calibration and the newly added verification step.
- Regular Audits: The company implements a schedule for regular audits of machine calibration processes to catch any deviations early.
In this example, the corrective action addresses the immediate issue of out-of-spec engine parts caused by incorrect machine calibration. The preventive action focuses on enhancing the calibration process and ensuring the same issue doesn’t recur. This proactive approach resolves the current problem and minimizes the likelihood of similar issues arising, leading to improved product quality and customer satisfaction.

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What is a CAPA Example?