Nov 18, 2020

Ensuring adequate processes for corrective and preventative action (CAPA) management is a critical step for medical device manufacturers implementing ISO 13485:2016 or other quality management systems. However, effective CAPA management can prove a perennial challenge even to larger, more mature manufacturers.

Emergo by UL consultants with expertise in medical device quality management system implementation and training have identified several processes and steps to help manufacturers establish and maintain compliant CAPA practices that are also scaled appropriately for their operations. In general, companies must first ensure that employees designated to oversee CAPA processes are properly enabled and empowered to do so.

“The people working on CAPA processes are the most familiar with those processes, and are most likely to be able to create solutions that will work for their firms,” says Luana Zerafa, Senior RA/QA consultant at Emergo by UL. “Therefore, it is recommended to have your CAPA experts work with your product or process experts to successfully remediate an issue and develop an optimal solution.”

CAPA and “appropriate actions”

Regulators typically cite “appropriate actions” as necessary for manufacturers to take in order to address nonconformities under CAPA processes. However, appropriate actions often vary from company to company, as well as depend on the nature and severity of a nonconformity. In order to accommodate these variances, regulators allow risk-based, least-burdensome approaches to CAPA management.

A five-tier risk assessment—minimal, low, moderate, significant or critical—feeds into three major CAPA categories (opportunity for improvement, minor or major). Below, we’ll discuss a roadmap applicable to manufacturers of various sizes to support effective and compliant CAPA efforts.

“It’s advisable to take a risk-based approach to CAPA management and allocate time according to criticality of nonconformities, while handling lower-risk items outside of a full CAPA mitigation,” says Ken Pilgrim, Senior RA/QA Consultant at Emergo by UL.

A general roadmap for CAPA management

  1. Documenting nonconformities and feedback

Manufacturers should use a non-conformity workflow and associated forms to document a nonconformity event as well as any related feedback from customers or internal sources. QMS and CAPA personnel should ensure that appropriate tie-ins exist between nonconformity and feedback forms.

  1. Initial investigations conducted in a timely manner

The initial investigation of a non-conformity should aim to understand issues including pervasiveness of the problem, the risk it poses and the likelihood if its recurrence. Leveraging the ISO 14971 risk management standard is recommended to help assess the non-conformity as well as appropriate corrective actions necessary. These investigations usually lead to one of four courses of action:

  • No action required: Applicable in cases of non-conformities that are cosmetic rather than functional problems and where the event is relatively rare, the risk relatively low, and potential solutions would be cost-prohibitive.
  • Opportunity: A non-conformity provides an opportunity for improving a product or process via a non-CAPA pathway.
  • Critical: A non-conformity requires a CAPA and resolution, but in a less timely manner.
  • Most critical: A non-conformity requires a CAPA and resolution in a timely manner. However, corrective procedures should include enough flexibility to allow quick resolution of particular non-conformities without having to make exceptions on a frequent basis.

One key goal of an initial investigation is that CAPA staff should be able to determine the root cause of a non-conformity to ensure that a problem does not reoccur. Rather than blaming individual employees as part of a root cause analysis, companies should target issues such as inadequate training, prioritization or other more systemic factors.

During the course of an initial CAPA investigation, employees should understand acceptability thresholds in terms of risk, and be able to distinguish between less-critical cosmetic and more critical safety and performance issues associated with non-conformities under investigation.

  1. Implement chosen solution
  2. Check that chosen solution is effective

Correctly identifying the root cause of a non-conformance can ensure selection of an appropriate and effective solution.

  1. Monitoring for trends

CAPA staff should periodically check a company’s record of past non-conformities to identify any possible trends; what was initially considered a rare or one-off non-conformance may in fact be occurring more frequently, and require additional or revised corrective or preventative actions.

Minimizing band-aid solutions to non-conformities

Given the crucial role root cause analysis plays in effective CAPA processes, manufacturers are well served by supporting proper training and development of these skills for designated staff. Emergo by UL consultants note that root cause analysis and related skills are not frequently prioritized or taught, which may lead to “band-aid” approaches to non-conformity issues rather than more long-lasting corrections.

Sarah Fitzgerald is Senior Consultant, Quality and Regulatory Affairs and Stewart Eisenhart is Manager, Copy/Editorial at Emergo by UL.

Related medical device quality management resources from Emergo by UL:

  • Medical device and IVD RA/QA consulting support
  • ISO 13485:2016 consulting and gap analysis
  • US FDA QSR (21 CFR Part 820) consulting for medical device companies
  • Medical Device Single Audit Program (MDSAP) training for manufacturers


  • Sarah Fitzgerald and Stewart Eisenhart