Importance of Corrective Action Preventive Action in Quality Management System

Introduction:

When the analytical results found out of specification or out of trend in that case systematic and detail investigation need to be done to find out the exact root cause. Hence there is requirement of competent corrective action and preventive action (CAPA). Management of CAPA is the most important part of a competent quality management system (QMS).

The main aim of CAPA is to ensure to reduce or to avoid the errors repeatedly observed during product development, analysis, validation, transfer, manufacturing, stability study. Regulatory agencies like US FDA, MHRA, TGA, ISO stresses more robust CAPA control using scientific approach.

What is CAPA:

CAPA is a systematic quality management system approach to identify, investigate, recognise and rectify the errors although preventing the unwanted and repetitive errors.

Corrective action is the initial step to find out problem or root cause of the error and taking a necessary action as a corrective action to prevent the similar errors in the future by, changing the document, checking of process, repairing of equipment’s or instruments.

Preventive action is the procedure to control the errors or incidence observed repeatedly by upgradation of equipment’s or instruments, revise the procedure, providing training and modify the manufacturing process.

Root Cause Analysis:

To find out the root cause proficient reviewer should review and understand the hypothesis and manager verify and should know the background and verify the same. Root cause analysis is vital to find out the nonconformity and recommend the corrective actions for recognized problem. The Ishikawa fishbone diagram is useful in combination with 5 Why’ technique to find out the root cause. Following are the main types of root causes which are represented by fish bones these also specified to as 6Ms.

1. Manpower: Association of skilled, accountable and quality conscious persons in the analysis and manufacturing.  Skilled persons with
2. Methods: Standard procedures, techniques, guidelines, job guidance and strictly following all parameters and execution of work precisely.
3. Machines: All Instruments and equipment’s must be clean, calibrated, maintained with specific standard operating procedures.
4. Materials: Raw materials, packaging materials and finished products chemical properties and physical condition is fine. Material must be supplied by audited or qualified vendors.
5. Measurements: Assessed data received from instruments, equipment’s and computers are authentic, verified, calibrated and skilled, attentive personnel doing his job consistently.
6. Milieu (Environment): The conditions such as location, temperature, vibration, humidity, lights, cleanliness will impact on manufactured product.

Importance of CAPA:

The importance of CAPA management is to understand its following requirement.

1. To maintain the GMP compliance,
2. It is 21 CFR regulatory requirement,
3. Reduce fundamental issues from occurring,
4. Improve the practice and system,
5. Enhance consciousness of a quality system,
6. It increases the productivity by reducing the operation cost and time,
7. Implementing the CAPA helps to improves of quality system.

Implementation of CAPA System:

To achieve the effective and quality documents implementation of following 7 steps of corrective or preventive action is very much significant.

1. Identification: Identify the problem transparently,
2. Evaluation: Evaluate the extent which lead to failure with its probable impact and necessary action to mark the risk,
3. Investigation: The strategy to find out root cause of problem,
4. Analysis: Conduct the systematic evaluation with evidence,
5. Action Plan: Create a checklist of required action plan to rectify the failure,
6. Implementation: Implement the plan of action
7. Follow Up: Confirm and check execution and the effectiveness of the plan of action.

Conclusion:

Corrective action and preventive action help company to improve competitive situation by reducing the operational cost save time and ensure the compliance. This improves the system to avoid the repetitive issues through manufacturing and analysis.

References:

1. Code of Federal Regulations, Title 21, Food and Drugs, Part 820,
2. Code of Federal Regulations, Title 21, Food and Drugs, Part 211,
3. Sivakumar BV, Ph.D. Significance of Root cause analysis and challenges in implementing Appropriate CAPA” Pharma Bio World. 2017
4. FDA, Current Good Manufacturing Practice Requirements for Combination Products,
5. FDA, Guide to Inspections of Quality Systems (Rockville, MD, Aug. 1999).

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