CAPA Requirements in ISO 9001

Despite the best of efforts, nonconformities can slip in due to several factors. CAPA ISO 9001 requires organizations to take action not only to eliminate the causes of the nonconformities but also to prevent their recurrence. 

For this, it is essential for businesses to understand the true cause of the nonconformity and not just the visible cause, correct it to contain the damage, and implement controls to minimize the risk of its recurrence.

CAPA, or Corrective Action/Preventive Action, is a structure that helps businesses deal with quality management issues and rectify them to prevent potential issues.

Corrective action is a reactive measure where an existing problem is resolved by identifying and eliminating the cause. To ensure such nonconformities do not occur in the future, businesses must take preventative action. The two are connected but must be addressed separately for greater effectiveness.

What is CAPA ISO 9001:2008?

In ISO 9001:2008, CAPA is covered in Clause 8.5.2, 8.5.2 Identification and Traceability. It addresses the need for the manufacturer to identify the product appropriately and monitor its lifecycle to ensure it conforms to the specifications at every stage.

This helps with the traceability of products, ensuring that only those that have passed the required inspections and tests can be despatched to the customers.

The identification and traceability can be achieved through:

  • Physical part marking
  • Labeling
  • Tags
  • Bar codes
  • Signage
  • Visual indicators
  • Part segregation
  • Lay down areas
  • Storage racks.

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What is CAPA ISO 9001:2015?

In the revised ISO 9001:2015, Clause 10.2 focuses on preventing nonconformity recurrence. Some of the ways to identify nonconformities include:

  • Customer complaints
  • Adverse results and trends identified through monitoring
  • Reviews
  • Assessments or inspections
  • Noncompliance

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To prevent nonconformity and ensure the effectiveness of the corrective action, identification of the root is critical. Determining key metrics that need to be tracked to measure the effectiveness of the corrective action is also important.

It is also essential to know when to initiate a CAPA plan in ISO 9001. Not all problems need to be addressed the same way, and the decision must be based on:

  • The impact of the deviation on the safety of the product
  • The product and/or reliability of the product
  • Its impact on the manufacturing and maintenance operations
  • The frequency of its occurrence
  • How difficulty or easy it is to detect
  • Customer complaints
  • Impact on quality or management system issues
  • The complexity of the problem

Whenever a nonconformance is detected, a report should be raised and logged appropriately and accepted by the relevant Line Manager before closure.

A root-cause analysis must be initiated to identify the root cause of the nonconformity, which forms the basis for the corrective and preventive actions. These should be documented and stored for easy retrieval.

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What are the Changes in CAPA ISO 9001:2015?

ISO 9001:2015 introduced a risk-based approach to CAPA. Earlier, it was a reactive process where actions were taken to correct and prevent after an event occurred. With a risk based approach, manufacturing companies have to take a strategic view of potential issues and implement controls to mitigate or reduce the impact of the risks. 

This approach requires the involvement of the leadership team to lead the way and establish a culture of quality. Employees must be empowered with knowledge and tools to give recommendations and feedback that the management can use as inputs to devise its risk-management strategies.

Another difference from the earlier versions is that ISO 9001:2015 does not require the separate documentation of predefined procedures for preventative actions, though it is critical to the risk-based approach. Instead, it requires separate reports to be filed for the corrective and preventative actions taken to address nonconformities and quality issues. These reports are also required as part of internal audits.

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ISO 9001 Corrective and Preventive Action Procedures

ISO 9001 does not prescribe any one procedure for the CAPA process, and each business must create its own based on its risks and quality goals. But, we recommend the following steps to make the process effective and compliant.

Step 1 Recording the Issue: The nonconformance or deviation must be recorded the moment it is reported with context and all relevant information to help with the root cause analysis and CAPA.

Step 2 Assess Severity: Not every deviation needs CAPA. The decision to initiate a CAPA should depend on the severity of the issue. Therefore, assessing the impact is critical.

Step 3 Perform Root Cause Analysis: The next step is to identify the root cause. Every issue can have one or more root causes and therefore needs a structured approach such as 5 Why or Fishbone to identify the causes. This is essential to implement the right corrective action and controls to prevent future recurrence. 

Step 4 Implement Solution and Controls: Based on the findings, implement the corrective and preventative actions as needed for immediate resolution of the issue and prevent its recurrence.

Step 5 Track and Monitor Impact: The effectiveness of the CAPA is important to ensure the root cause is addressed and that the risk is mitigated. This can be established by conducting an internal audit.

Step 6 Course Correction: In case the CAPA process is found to be inefficient and not meeting its goal, it must be modified to ensure the desired outcome.

Automating the workflow can help businesses improve the effectiveness of the CAPA program. A cloud-based solution such as ComplianceQuest can help with the following:

  • Provide Data-Driven Insights: Data is critical to enable businesses to have visibility and arrive at insights that can drive strategies. It helps identify trends in nonconformity and assess impacts to prioritize risks that need to be addressed first.
  • Document: Businesses can centralize documents and automate the document workflow to manage the process effectively and improve compliance.
  • Communication and Collaboration: It can facilitate the sharing of information easily and allow different teams to collaborate for root cause analysis and implement CAPA.
  • Monitor and Track Progress: Transparency and visibility also make it easier to monitor the impact of CAPA better and ensure its effectiveness by assessing the KPIs.
  • Compliance: As the CQ EQMS is aligned with ISO standards, it helps businesses meet the requirements to improve compliance.

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ISO 9001 Corrective Action Request Form (Explain ISO 9001 corrective action request template/form document and how it helps to track corrective action, status, and it's results)

The CAPA processes may be initiated based on inputs from varied sources, including nonconformances, complaints or audits. Once a deviation has been identified, a request to initiate CAPA must be filled and submitted. This is used to evaluate the error/deviation, its gravity and impact, and decide whether a CAPA is needed and what the procedure should be. Once the request is validated, formal CAPA will be initiated.

The form also helps with tracking all corrective and preventive actions taken for a particular nonconformance.

ISO 9001 requires this form to be maintained thoroughly to demonstrate compliance and the organization’s commitment to continuous improvement of the quality management system.

Once the CAPA form is authorized, it becomes a CAPA report.

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