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Customized CAPA Guidance Addresses 483 Findings for a Medical Device Manufacturer

Our customer, a major medical device manufacturer, received an FDA Form 483 that documented deficiencies related to the company’s corrective and preventive action (CAPA) program.

Under the guidance of Oriel STAT A MATRIX’s regulatory experts, our customer developed a company-wide CAPA program that addressed FDA concerns and resulted in a stronger, more effective global CAPA program. 

Customer Challenge

Address FDA Form 483 findings related to the company’s corrective and preventive action (CAPA) processes.

The FDA Form 483 serves as a wake-up call: There’s something wrong that must be fixed. For our customer, the FDA identified their CAPA system as a significant weakness. CAPA is a major area of focus for the FDA, and has been one of the quality system deficiencies most frequently cited by the FDA since 1997.

The FDA expressed concern with the effectiveness of our client’s CAPA training program and an inconsistent approach to performing CAPA root cause investigations. The company needed to develop a comprehensive CAPA training initiative and redesign its CAPA and root cause analysis processes to remediate these issues. It sought a partner who could provide the necessary subject matter expertise and industry experience to help them meet these goals.

Oriel STAT A MATRIX Approach

The company chose Oriel STAT A MATRIX because of our proven track record of assisting FDA-regulated companies with similar deficiencies, and our long, successful history designing regulatory assurance training programs and implementing effective quality systems.

  • After conferring with the client, Oriel STAT A MATRIX proposed the following activities:
  • Define the required CAPA competencies
  • Design and deliver customized training
  • Coach employees as they applied their new knowledge and skills
  • Evaluate and certify in-house CAPA expertise
  • License training materials to the company for ongoing use
  • Create a workforce prepared to support CAPA activities, and design more effective processes for CAPA and root cause investigation

We developed and implemented a comprehensive CAPA and root cause analysis training program that supported nine client sites located around the world.

Our Activities Included:

Define competencies

Oriel STAT A MATRIX worked with the client to define the necessary skills and knowledge (competencies) for the different levels of personnel involved in the CAPA program. Using these competencies as the base, Oriel STAT A MATRIX’s training professionals designed multiple versions of CAPA training courses.

Design and deliver customized training

Our consultants used Oriel STAT A MATRIX’s existing CAPA and root cause analysis training materials as the foundation for the training courses. We then added exclusive client-specific examples and workshops to ensure that the courses would satisfy the company’s training objectives. Oriel STAT A MATRIX trainers delivered the most rigorous version of the CAPA courses, with a final exam, to a group of more than 200 employees.

Coach employees

After the training ended, Oriel STAT A MATRIX switched to a coaching role. Our consultants coached 200 employees as they began applying what they had learned in order to resolve actual CAPAs at the company. This hands-on support reinforced what was taught in the classroom and allowed employees to get answers when they mattered most.

Evaluate and certify in-house CAPA experts

Employees seeking to become certified as CAPA Practitioners developed reports on existing CAPAs, which were presented to the company’s senior management. Oriel STAT A MATRIX trainers also evaluated the reports to assess each employee’s ability to apply CAPA tools to real-world projects. Oriel STAT A MATRIX certified the employees who successfully passed both the exam and review, thus providing the company with a group of externally certified CAPA Practitioners. Ongoing recertification is planned for the future.

License training materials

The CAPA Practitioners used coursework, licensed from Oriel STAT A MATRIX, to roll out CAPA training to more than 1,000 additional employees. This training provided employees with the basic competencies needed to support the CAPA Practitioners in their CAPA projects.


A comprehensive CAPA training initiative and optimized CAPA process that met the requirements of 21 CFR 820.100 and prevented further FDA enforcement action.

  • Trained more than 1,000 employees
  • Certified 120+ employees as CAPA Practitioners
  • Produced a library of CAPA and root cause analysis training materials for the company’s ongoing use

Our customer achieved the initial objectives for the program: Address the FDA 483, complete a successful follow-up inspection, and prevent further enforcement action by the FDA.

In addition, the customer discovered other, long-lasting benefits. The company now has a workforce prepared to support effective CAPA activities. To date, more than 1,000 employees have been trained in CAPA through the program, with 120+ employees certified as CAPA Practitioners. The company also has a library of CAPA and root cause analysis training materials for ongoing use.

With Oriel STAT A MATRIX’s expert assistance, the company also designed more efficient and effective CAPA and root cause investigation processes. In the first six months after our engagement ended, the company saw the average time to complete a CAPA decrease by 27%.


Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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