The nonconformity, Corrective Action and Preventive Action (CAPA) management process is one of the most critical steps of an organization’s management system since it must be viewed as an opportunity to continually improve organizational performance and create a stronger and more profitable relationship with stakeholders. That is because when handled properly, such actions can be converted into increased loyalty and more business.
In this sense, SE Action is a software solution that manages all stages of nonconformity treatment and CAPAs, from the initial record to review of the effectiveness of the action, since it includes tools for organizing, sorting and searching. These are features that improve product simplicity, efficiency, and reliability.
SE Action automates the audit process to perform the following activities:
Registration of item, defect and cause; control group, group to be notified and responsibility route.- Configuration of different types of methods, process flows and classifications.
- Record of occurrence associated with criticality, items, attributes, images, other occurrences, as well as any document (text, spreadsheets, presentations, charts and images) and process.
Registration of nonconformities, CAPAs, etc.- Various query types, audit reports and schedules.
- Pareto, bar, line and pie charts, etc.
- Specific tool that allows users to generate reports and customized charts, available through an interface with SE BI.
The following are some of the main benefits obtained with the use of SE Action:
- Cost reduction with facilities, integration, training and maintenance.
Great reduction of document printouts and paper circulation needs. - Monitoring of no-quality costs.
- Immediate visualization of consultations and management reports through spreadsheets and graphs.
- Fast, easy and safe access to documents and information.
Prevention of new nonconformities. - Secure information access.
- Increased productivity and efficiency for processes, products and services.
- Optimized business performance.
- Information organization and integration.
- Streamlined nonconformity-related activities and CAPA registration, treatment and management.
- Efficiency and improvement of the related business management processes.
- Increased speed, quality and relevance in decision-making processes.
- Promotion of growth opportunities.
- Efficient information circulation for those involved.
- Control of deadlines and nonconformity and CAPA results.
The SE Action offers total flexibility for the organization, including the following actions:
System Parameterization
- Registration of item, defect and cause.
- Registration of control group, group to be notified and responsibility route.
- Configuration of different types of methods, process flows and classification, giving the organization full flexibility when it comes to establishing the steps and flow of each occurrence category.
Record of Occurrence
- Record of occurrence using world-class methods as PDCA, 8 Disciplines and MASP, where it is possible to associate criticality, items, attributes, images, other occurrences, documents and process, and send them for user, function or responsible department approval.
Disposition Action
- Planning (5W2H) and approval of action plan.
- Implementation of the corrections (disposition/ contention/ immediate) actions, implemented to mitigate the impacts of the nonconformity.
- Verification of implemented actions.
Cause Analysis
- Cause analysis performed using tools such as Ishikawa Diagrams, 6M, 5 W’s and 5 Steps Method.
CAPA
- Planning of actions (5W2H) that avoid the reoccurrence or prevent the occurrence of nonconformities, including the association between causes and actions and plan approval.
- Execution of CAPAs, implemented to prevent the recurrence of the nonconformity.
- Verification of the CAPA implementation.
Conclusion
- Reviewing the effectiveness of the actions taken, including verification, standardization and communication, in order to verify if the same are appropriate for treating the real and potential nonconformities encountered and their impacts, avoiding repetition and/or occurrence.
Monitoring
- Monitoring and making changes during all process stages.
- Occurrence cancellation and deletion.
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