capa management process flow chart | Operon Strategist

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.

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 a 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.

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If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device