1.0 Definition
Corrective action: It is the action taken to eliminate an undesirable situation or any other non-conformity or this step can be initiated to prevent recurrence.
Preventive action: It is the action taken to eliminate the cause of non-conformity or prevent occurrence of an undesirable situation.
1.1 Objectives:
1. The procedures of CAPA system should be verified to understand the requirements of defined quality system.
2. The sources of the problems in a product or quality system should be identified. These sources are analyzed further to develop appropriate corrective action.
3. Identification of unfavorable trends in the sources of product or quality aspects. These sources are analyzed further to develop preventive action.
4. The quality data information system received by the CAPA should be checked for accuracy and completeness.
5. To detect the problems in the aspects of quality various statistical methods are employed. They are analyzed by comparing with other data sources where the discrepancies are identified and solved.
6. The investigation procedures are to be monitored so they are properly implemented and followed.
7. The actions taken should be determined to see that they align with the problems detected in product or quality.
8. The corrective and preventive action should be checked so they are effective, verified, validated before implementation and they should not show any impact to the finished device.
9. The corrective and preventive action should be verified and documented.
10. Information regarding implementation of corrective and preventive actions in reducing the non-conformities in the product or quality should be documented for management review.
2.0 CAPA Process:
1. Inputs Internal/External sources
2. Elements Analyze data, 820.100 (a) (1)
Investigate cause, 820.100 (a) (2)
Identify Action, 820.100 (a) (3)
Verify/ Validate Effectiveness, 820.100 (a) (4)
3. Outputs Implement changes, 820.100 (a) (5)
Disseminating Information, 820.100 (a) (6)
Submit for management, 820.100 (a) (7)
Document, 820.100 (b)
2.1 Sources
1. Internal sources
Inspection data, Rework data, internal audits, Equipment data, Nonconforming material reports, process control data, scrap data, acceptance activities.
2. External sources
medical device reports, legal claims, complaints, legal claims, field service reports, external audits.
2.2 Statistical Tools
Pareto charts, control charts, Mean and standard deviation, experimental design, run charts, t tests, graphical methods like spreadsheets, scatter plots, fish bone diagrams and histograms.
2.3 Analysis techniques
Material and Quality review boards, Management and other internal reviews.
3.0 Outline of investigation procedure
1. Identifying and characterizing problem
2. Determining the scope of the problem and its impact
3. Investigation of the data, process, operations and other sources.
4. Root cause determination.
3.1 Root causes
Manufacturing, Purchasing and supply, design, training, management, maintenance, documentation, testing, change control.
3.2 Analysis tools to determine root cause
Fault tree analysis, 5 whys, and Fishbone diagrams.
4.0 Application of CAPA in Product life cycle:
1. Pharmaceutical development: It is used in design and development process.
2. Technology transfer: It is used in feedback, feedforward and continual improvement.
3. Commercial Manufacturing: It is used to evaluate the effectiveness of actions
4. Product Discontinuation: even if the product is discontinued CAPA is used to study the impact of the product and the remaining products in the market.
Capa, corrective action, preventive action, root cause , product life cycle
