CORRECTIVE AND PREVENTIVE ACTION IN CLINICAL RESEARCH

 CORRECTIVE AND PREVENTIVE ACTION IN CLINICAL RESEARCH 

 “A MAN LEARNS FROM HIS MISTAKES”
CAPA HELPS US TO SIMPLIFY THE ABOVE!

CAPA is a fundamental management tool that should be used in any quality method. A basic step-by-step method for completing and recording corrective or preventive steps is given by this software. The outcome would be a comprehensive, well documented investigation and solution that will fulfill the regulatory requirements and form the basis for every company’s successful quality management plan.

CAPA can be applied in many disciplines: Manufacturing, Product Design, Testing Verification and Validation, Distribution, Shipping, Transport and Packaging and Use-Application.

Corrective action: The corrective steps should prevent the recurrence of the problem in order to eliminate the triggers of a non-conformity or other undesirable circumstance. In response to consumer feedback, corrective measures are enforced, unacceptable levels of product noncompliance,  concerns found through an internal audit, as well as adverse or unstable patterns in product and process monitoring, such as statistical process control (SPC) are identified.

Preventive action: Action to eradicate the source of a possible circumstance of non‐conformity or undesirable potential. Preventive action should avoid future problems from arising. In addition to the discovery of possible causes of non-conformity, preventive steps are carried out. 

 OBJECTIVES OF CAPA:

1. Verify that the CAPA system procedures have been identified and reported, addressing the specifications for the regulation of the quality system.

2. Determine if there have been established acceptable causes of product and quality issues. Confirm the review of data from these sources to recognize current product and quality concerns that may need corrective action.

3. Determine if product and quality information sources have been detected that may include unfavourable trends. Confirm that information from these sources is evaluated to identify possible issues with the product and quality that may involve preventive action.

4. Challenge the data information quality system. Verify the completeness, consistency and timeliness of the data obtained by the CAPA system.

5. Verify the use (if necessary) of sufficient statistical methods to identify recurrent quality issues. Determine if research findings are compared through multiple data sources in order to define and develop the magnitude of product and quality issues.

6. Determine if effective steps for substantial product and quality have been taken.

7. Determine whether, prior to implementation, corrective and preventive steps were successful and checked or validated. Confirm that the finished device is not affected negatively by corrective and preventive measures.

8. Verify that corrective and preventive measures have been taken and reported for product and quality concerns.

9. Determine whether information, including dissemination for management review, has been duly disseminated regarding non-conforming product and quality problems and corrective and preventive measures.

PROBLEMS OF CAPA:

• Lack of cross-functionality

• Reactive rather than constructive 

• Overuse versus underuse

• Determination of weak root cause 

• Poor description of a CAPA mechanism

Root Cause Analysis (RCA)

Root cause analysis is an approach for determining the underlying causes of the occurrence of a problem/non‐conformity in order to determine and execute the most appropriate corrective and/or preventive actions. The 5 Whys, the Failure Mode and Effect Analysis (FMEA) and the Fishbone Diagram are three of the RCA approaches widely used.

The 5 Whys: 

The 5-why approach is a root cause analysis method that asks the “why?” Question on several levels to find the root of the problem. The 5why approach might seem easy, but that’s where its power lies: instead of over analyzing a problem, the layers of symptoms that can lead to the root cause of a problem can be stripped away by constantly asking the question “Why”. The ostensible explanation for a problem/non-compliance would always lead to another query. Although this technique is called 5-Why. Before the problem relating to a non-conformity can be identified, one could find that one will have to ask the question less or more times than five times.

Failure Mode and Effect Analysis (FMEA): 

This approach helps to recognize the possible threats of organizational processes and measure them. It is a systematic approach to classify all possible ways in which a method might fail and to rate them. Using a relative rating scale, the step-by-step FMEA technique prioritizes possible risks. The risk depends on three factors:1).the magnitude of the failure/non conformity effect.2) the frequency of failure/non conformity occurrence 3).the ability to detect or avoid failure/ non‐conformity.A Risk Priority Number(RPN) is created by evaluating every failure mode and effect in terms of these three factors. The RPN is used to rate the process-related relative risks; the higher the RPN, the higher the relative risk.

Fishbone Diagram: 

The fishbone diagram (also referred to as Ishikawa diagrams, herringbone diagrams, cause‐and‐effect diagrams, or Fishikawa) is causal diagrams developed by Kaoru Ishikawa (1968) showing the causes of a particular problem/non‐ conformity. The Fishbone diagram is an interesting way to chart the different stages of root cause analysis and takes cause and effect into account. The name of the fishbone diagram derives from its distinct shape, The problem being studied is the head of the fish and the root causes are the bones of fish.

 

CAPA IN CLINICAL RESEARCH

Within clinical research, the implementation of a Quality Management System (QMS) research must begin long before the first patient is enrolled and continue through the completion of the clinical trial report and all other related drug application submission documents. An successful Corrective and Preventive Action (CAPA) program is a key component.

The advantages and risks of a medical product or treatment while maintaining the health of human subjects are addressed by quality in the clinical context thus, clinical CAPAs should concentrate on problems that threaten patient safety and data integrity. A systematic CAPA approach includes recognition of accidents, incident causality review, creation of an action plan based on root cause analysis, verification, confirmation and execution of the action plan, control of effectiveness and closure.

CAPA management system can also involve analyzing, monitoring any concerns with GCP compliance to identify ongoing measures for quality improvement through clinical trials and development projects.

CONCLUSION

Effective resolution of the problem depends on determining the true cause of the problem by doing an investigation of the root cause and discovering appropriate corrective and preventive action. The CAPA is closed when the problem has been successfully fixed by corrective and protective action and prevent it from occurring in the future. It is important to continue process improvement because minor problems will develop and have a negative impact on patient safety.

-By

Jakkula Shirisha 

Pharm.D

Student at Clinosol.