2. DEFINITION
NONCONFORMANCE: Not meeting specifications or requirements.
DEVIATION: Not following specified instructions.
CONTAINMENT: Action taken to arrest the effects of nonconformance.
VARIANCE: A one time waver to perform a task through a planned deviation.
3. INTRODUCTION
CAPA is the efforts taken by the organization to eliminate causes of NON-CONFORMITIES or other
undesirable situations.
Nonconformance may be a market complaint, failure of a machinery , failure of quality
management system, misinterpretation of written instructions.
CAPA is designed by a team including QA personnel and personnel involved in the actual
observation of nonconformance.
Failure to adhere to proper CAPA handling is considered as violation of USFDA regulations on
Good Manufacturing Practices ( GMP). As a consequence, a medicine or medical device can be
termed as adulterated or substandard.
4. CAPA has 2 distinct functions.
1) CORRECTIVE ACTION (CA):
The first goal is to find the root cause , errors , base events that preceded the problem.
The second goal is to take direct action directed at root cause.
2) PREVENTIVE ACTION (PA):
Primary goal is to inform an organization and prevent the problem from returning.
5. OBJECTIVES OF CAPA
Verification of CAPA system procedures that addresses the requirements of quality system
regulation.
Evidence that appropriate sources of product and quality problems have been identified.
Data sources for CAPA are of appropriate quality and content.
Verify that appropriate Statistical Process Control (SPC) methods are used to detect recurring
quality problems.
All the corrective and preventive actions are implemented and documented.
6. HOW TO IMPLEMENT CAPA
There are many approaches to apply two functions of CAPA.
A. Corrective action: There are nine steps to implement corrective action.
Identification of the possible causes.
Problem statement is created by using 5Q approach.
Symptom of the problem is observed and communicated.
7. Implementation and validation of corrective action.
Permanent corrective actions are determined.
Root causes are verified.
Theories are developed according to causes.
Problem description is prepared.
8. B) PREVENTIVE ACTION: following are the steps for preventive action.
Define the problem.
Search for databases.
Link problems to
causes.
Design a preventive
measure.
Assure system
documents are
updated.
9. Common failures of CAPA implementation.
1) Lack of examination.
2) Lack of agreement information.
3) Lack of communication.
4) Lack of execution.
10. THINGS TO CONSIDER ABOUT CAPA
Successful execution of CAPA is highly dependent upon the effectiveness of planning that
goes into it.
CAPA is a major focus of FDA during inspections.
There are certain steps to remember which are follows:
1) Establishment of plan:
Proper training.
Regular validation programme.
Logistical concerns.
Regulatory concerns.
Documentation list.
11. 2) Effective preparation:
Find the experienced personnel with right skills.
Define role and responsibility of each member and team role.
Provide training.
Outline the priorities.
3) CAPA Interaction plan:
Written communication plan – SOP or CAPA specific.
Outline types of communication.
12. 4) CAPA writing:
Defining specific title.
Avoid unnecessary descriptors.
Appropriate dates, times, document names and numbers , deviation numbers.
Facts used to tackle the problems
Actions taken to resolve the problems.
5) Continuous evaluation:
Study the problem
Determine extent
Establishment of root cause.
Use of process flow diagram.
13. 6) Updates of procedures:
Secure approvals for new/updated procedures.
7) Proof of execution:
Assemble documentation like:
SOPs
Records
Audits
Training
15. 10) Perform internal review and approvals:
Prepare CAPA project teams.
Approval should be performed by QA Department Head.
16. ROLE OF CAPA IN QUALITY SYSTEM
The role of a CAPA system is to continuously improve product and processes in the quality
system.
CAPA is a continuous quality improvement subsystem.
CAPA decision making is based on risk assessment and impact assessment.
Risk assessment is performed on three levels: End user, compliance, and business.
The CAPA system receives information from two Quality management loops:
I. The internal feedback-loop : Quality data from within the organization.
II. The external feedback-loop: Quality data from outside the organization.
