CAPA Requirements in ISO 9001:2015

CAPA Requirements in ISO 9001:2015
October 7, 2020 seouser
capa requirements

For your business to comply with the ISO 9001:2015 standard it needs to establish a quality management system (QMS) that includes adequate corrective and preventative action (CAPA) processes.

These processes need to be properly defined according to the CAPA requirements in ISO 9001:2015 before your business will be considered compliant.

What is CAPA?

CAPA processes provide a structure for businesses to deal with and rectify current and potential quality management issues.

Corrective action tackles existing problems by identifying and eliminating the cause.

Preventative action seeks to avoid problems before they happen by identifying potential nonconformities ahead of time.

In other words, corrective is reactive and preventative is proactive.

The two are connected but, for the sake of a thorough and effective CAPA structure, they should be defined as individual processes, so they can be implemented separately when needed.

A new focus in ISO 9001:2015

ISO 9001:2015 changed the focus from a sometimes passive, box-ticking preventative action plan to a more proactive, risk-based thinking approach.

To comply with the latest release of ISO 9001, your business must take a greater strategic view of risk within the business.

Management and team leaders need to be actively involved in identifying, recording, removing and mitigating risk.

Employees down the chain of command must be able to give their feedback on risk to management for consideration.

Other changes in ISO 9001:2015

Unlike the previous releases of ISO 9001, this version doesn’t require separately documented, predefined procedures for preventative actions.

This doesn’t mean preventative action is any less important.

It’s still a vital component of the new risk-based approach.

With ISO 9001:2015, it’s necessary to compile separate reports for corrective action and preventative action in response to nonconformities and quality issues.

These reports are an integral part of your internal audits.

What to include in a CAPA report

When a quality management nonconformity is identified, it’s important to report on the responding CAPA process.

Multiple people might contribute to the report, including whoever initiated the CAPA process, the person responsible for implementing it and whoever needs to sign it off.

The report would typically include:

  • the nature of the nonconformity
  • its severity
  • immediate actions that were taken
  • suspected causes
  • the plan for corrective and/or preventative actions
  • verification that action was taken and was effective
  • sign-off from a quality manager once the process is complete.

Key steps in a compliant CAPA process

There’s no single template for a CAPA process that can be applied to every business or industry.

These key steps should be implemented for an effective and compliant CAPA process.

1. Identification

When a nonconformance, quality issue or defect is noticed by a staff member or customer, the nature of the issue must be recorded.

Include as much context and information as possible.

2. Evaluation

Evaluate the severity of the issue to decide if it warrants a CAPA plan.

Not all issues need a CAPA response.

This will depend on the complexity and potential harm of the issue.

3. Investigation

Investigate the root cause of the issue.

This can be a time-consuming step because there might be more than one cause.

Don’t point fingers until the causes are clearly identified.

4. Implementation

Implement either corrective or preventative action (or both).

Corrective action needs to be immediate to resolve the issue.

Preventative actions must ensure the issue doesn’t reoccur.

5. Monitoring

Monitor the CAPA that was implemented to document its effectiveness.

The actions taken must have resolved the issue and stopped it from reoccurring.

An internal audit can also be useful.

6. Modification

If any weaknesses are identified in the CAPA process, modifications must be made so that the initial corrective response is effective and the preventative action is more proactive in the future.

How isoTracker’s CAPA software can help

isoTracker offers modular, cloud-based quality management software that includes CAPA capabilities to facilitate ISO 9001:2015 compliance.

The benefits of using QMS software for CAPA compliance include:

  • centralized on a cloud-based system
  • automated workflows and reminders
  • subscription-based and priced flexibly
  • facilitates better teamwork for CAPA processes
  • real-time data for analytics and reporting
  • free after-sales support from isoTracker.

The QMS modules that include CAPA software are Complaints Management, Audit Management, Training and Non-Conformance Management software.

Contact us to find out more or to discuss your company’s CAPA requirements in ISO 9001:2015.

Alternatively, go ahead and sign up for a free 60-day trial of isoTracker’s quality management software.

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