What is CAPA management?

The CAPA management system is the cornerstone of a Quality Management System, especially in the Pharmaceutical/Medical Device Industry, and the backbone and driver for quality improvements. The (Corrective And Preventive Action) CAPA management system feeds the Quality System to improve processes, procedures, organization and business in a structured, well-documented and actionable way.

Operon Strategist audits the existing (Corrective And Preventive Action) CAPA management system of clients determines how effective it is in identifying & correcting quality problems. An effective Corrective And Preventive Action system enables easy collection & analysis of information. This information is used to identify & investigate existing; potential product & quality problems.

CAPA Management Process Flow Chart

PDCA cycle is one of the manageable and easiest processes to deal with any situation or problem-related to process control and continuous improvement. The PDCA cycle is used for a new product or for conceptualization, problem-solving, project performance and many other fields. PDCA cycle is mostly used in the software field for Software development lifecycle. The PDCA cycle is normally used in manufacturing and Service industries for new product development and also finds its place in Project Management of any field. Specifically, areas like change management also use the PDCA cycle for their implementation.

What does a PDCA cycle do?

PDCA cycle promoted by Deming finds an important role in continual improvement. It assists a process to improve its performance on a staged and steady manner.

  1. Initiate the objectives and goals of the task to be improved or developed.
  2. Report the task in detail with clear identification
  3. Develop a group that will be a part of the PDCA and set the deadlines
  4. Observe the data to be used, resources that will be needed cost expected risks and making less severe steps, manpower required, assistance needed from management.
  5. Produce an execution plan with the breakdown of each task, owner, expected outcome, operating procedure or guidelines etc.


  1. Perform all the tasks, as per the implementation plan.
  2. Keep the associates informed about the progress.
  3. Follow the schedule and highlight any remarkable concerns and variations noted.


  1. Validate whether the outcome as planned, once the activity is performed.
  2. Make a note of all differences, faults, best practices, pain areas and challenges faced
  3. Identify the root causes of the problems


  1. Correct the defects and make it follow to the specifications
  2. Spot the preventive actions for all the root causes found.
  3. Execute the preventive actions and check whether the outcome is as expected.
  4. Repeat the steps Do-Check-Act until all of the targets are meant to be satisfied with the stakeholders.

Consequently, the PDCA cycle will help in improving the performance of a process stage by stage in a steady and regular manner.

There is a strong link between QUALITY and OPERATIONAL EXCELLENCE, as a well-established CAPA management system will have its benefits for the business, for instance:

        • Improved safety and security
        • Improved customer satisfaction
        • Increased productivity
        • Infrastructure efficiency gains
        • Better product quality
        • Avoiding the cost of regulatory non-compliance

The risk-based CAPA requirements demand a well-documented system that determines the root cause of non-conformances, system failures or process problems, corrects the problems, and prevents them from recurring. The documentation must identify why something went wrong—or why it may go wrong—and what has been done to make sure it does not happen again. One of the most important quality system elements is the corrective and preventive action subsystem. And its purpose of this corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.

In an industry where patients’ health and wellness depends on products functioning properly, an organization cannot afford any weak areas that could lead to nonconformities or lower quality products

We help manufacturers to audit their current quality system reviews as per the standards to determine how effective it is in identifying quality problems. We carry out systematic and independent process audits to determine the conformity or nonconformity of your QMS Requirements. We also help you with an effective (Corrective And Preventive Action) CAPA management system which enables easy collection & analysis of information, this information can be used further to identify & investigate existing, potential product and quality problems. Also, provide guidance for US FDA 510(k) premarket notification for your medical device.