CAPA (Corrective and Preventive Action) is a quality management system used in the pharmaceutical and medical device industries to continuously improve processes, procedures, and the organization. CAPA involves corrective actions to address existing issues and preventive actions to prevent potential problems. The CAPA process follows the PDCA (Plan-Do-Check-Act) cycle. PDCA involves planning improvements, implementing them, checking results, and acting to correct or improve further. The goal of CAPA and PDCA is continual improvement through systematically addressing problems, identifying root causes, and verifying that issues have been resolved.

1. CAPA(Corrective And
Preventive Action)
Management for Medical
Device
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MANAGEMENT/

2. What is CAPA ?
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.

3. CAPA divided into two different but
related functions:
1. Corrective Action (CA) is a step that is taken to remove the
causes of an existing nonconformity or undesirable situation.
2. Preventive Action (PA) is a step that is taken to remove the
causes of potential nonconformities or potential situations
that are undesirable.

4. 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.

5. 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.

7. 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.
Plan:
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

8. Do:
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.

9. Check:
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

10. Act:
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.

11. Purpose of CAPA
1. One of the most important quality system elements is the corrective and
preventive action subsystem.
2. And its purpose of this corrective and preventive action subsystem is to collect
information, analyse information, identify and investigate product and quality
problems, and take appropriate and effective corrective and/or preventive action
to prevent their recurrence.
3. Verifying or validating corrective and preventive actions, communicating
corrective and preventive action activities to responsible people, providing
relevant information for management review and documenting these activities
are essential in dealing effectively with product and quality problems, preventing
their recurrence, and preventing or minimizing device failures.

12. Thank You.
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