CAPA(Corrective And Preventive Action) Management for Medical Device HTTPS://WWW.OPERONSTRATEGIST.COM/CAPA MANAGEMENT/
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, welldocumented and actionable way.
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.
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. 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
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.
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
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.
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.
Thank You. For More Information Contact Us www.operonstrategist.com info@operonstrategist.com +91-9325283428