CAPA Management - Quality Management System (QMS)

CAPA Management

The Nonconformity and Corrective/Preventive Action (CAPA) Management module quickly detects errors in production processes and provides long-term solutions with root cause analysis. In this way, problems such as quality deviations and customer complaints are quickly addressed and corrective steps are taken.

The module systematically records, analyzes and resolves all nonconformities. It also monitors the effectiveness of actions taken, helps prevent similar problems in the future and ensures continuous compliance with quality standards.

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CAPA Management Module

The Nonconformity and Corrective/Preventive Action (CAPA) Module detects nonconformities, performs root cause analysis and plans corrective/preventive actions. This process increases efficiency, reduces risks and ensures continuous improvement.

Non-Conformance Management

Root Cause Analysis

Corrective Actions

Evaluation

CAPA Reporting

Non-Conformance Detection and Recording

It allows recording of nonconformities detected during production or as a result of quality controls. The aim is to ensure product quality and improve production processes.

Features

Defining Nonconformity
Determining the Type of Nonconformity
Priority and Risk Assessment
Instant Notification and Alert

Nonconformity Identification
Nonconformities detected in the production line or quality control processes are recorded on the system. These records form the basis for tracking faulty products and process deviations.

Determining the Type of Nonconformity
Classification is made according to categories such as raw material error, production process deviation, equipment failure or environmental factor. In this way, the source of nonconformities is analyzed more clearly.

Priority and Risk Assessment
Detected nonconformities are evaluated and prioritized according to their effects on production and quality. High-risk situations are highlighted in the system for priority intervention.

Instant Notification and Warning
Critical nonconformities are immediately reported to the responsible personnel. This warning mechanism prevents production losses through rapid intervention.

Root Cause Analysis

It enables the source of detected nonconformities to be determined and analysis to prevent similar errors from occurring in the future. The aim is to support continuous improvement of processes.

Features

Data Collection and Analysis
Root Cause Determination Methods
Risk Assessment and Impact Analysis
Reporting and Approval

Data Collection and Review
Process data, equipment reports and production records that cause the nonconformity are analyzed in detail. These data form the basis for correctly understanding the problem and creating solutions.

Root Cause Determination Methods
The root cause of the problem is determined using methods such as "5 Why" analysis, "Fishbone Diagram" and "Pareto Analysis". These tools offer a systematic analysis approach.

Risk Assessment and Impact Analysis
The potential impacts of the identified root cause on production, quality, customer satisfaction and cost are assessed. This assessment helps prioritize actions.

Reporting and Approval
Analysis results and suggested corrective actions are reported and submitted to management for approval. The improvement process is initiated in line with the approved activities.

Corrective and Preventive Action (CAPA) Planning

It ensures that preventive activities are planned to eliminate detected nonconformities and to prevent similar errors from occurring in the future. The aim is to continuously improve quality and increase operational safety.

Features

Creating an Action Plan
Assignment of Deadlines and Responsibilities
Activity Progress and Control
Preventive Action Planning

Creating an Action Plan
Step-by-step action plans are prepared to resolve nonconformities. Targets, required resources and implementation methods are defined for each action.

Deadline and Responsibility Assignment
The completion time and responsible person for each activity are determined. A tracking system is put into operation to ensure timely and accurate implementation.

Activity Progress and Control
The progress of defined actions is monitored through the system. Delays and completion rates are reported and the process is managed transparently.

Preventive Action Planning
In order to prevent the same errors from recurring, process-based preventive actions are determined. This step provides a proactive approach to quality management.

Implementation and Results Evaluation

Manages the implementation process of corrective and preventive actions taken and analyzes the level of success. The aim is to ensure continuous improvement by evaluating the effectiveness of the implemented solutions.

Features

Activity Application
Impact Assessment
Verification and Approval
Results Reporting

Activity Implementation
Corrective and preventive activities are implemented in line with the determined deadlines. Each activity is recorded in the system and integrated into the processes.

Impact Assessment
The impact of the activities on the nonconformity is analyzed. The success rate is measured by checking whether the problem recurs and additional actions are planned if necessary.

Verification and Approval
It is verified whether the activities have achieved the specified goals. When success is achieved, the result is approved and the process is completed.

Results Reporting
The findings obtained are reported and shared with management. These reports form the basis for directing process improvement efforts.

CAPA Reporting and Traceability

It ensures that all CAPA (Corrective and Preventive Action) processes are recorded and that past nonconformities are traceable. The aim is to ensure continuous improvement by monitoring the effectiveness of implemented corrective and preventive actions.

Features

Creating CAPA Reports
Trend and Repetition Analysis
Data Visualization
Preparation for Audit

CAPA Report Creation
All completed CAPA processes are analyzed and detailed reports are prepared. These reports include the results of the corrective and preventive activities implemented and reveal improvement opportunities.

Trend and Recurrence Analysis
Critical problem areas are identified by analyzing recurring nonconformities over time. This analysis helps develop permanent solutions to specific problems.

Data Visualization
The type, frequency and impact of nonconformances are presented in graphical and tabular formats to facilitate analysis. Visualization allows decision makers to understand the data set quickly and effectively.

Preparation for Audit
All CAPA records are archived in the system and complete reporting is provided during audits. This ensures that documents are properly presented and traceability is ensured during audit processes.