Incident management / CAPA for industrial sites: When Excel is no longer enough!

iRevolution
17/10/2024

Incident management / CAPA for industrial sites:
When Excel is no longer enough!

QHSE (Quality, Health, Safety, Environment) at industrial sites is a crucial element in ensuring risk prevention and compliance with quality, health, safety and environmental standards. Regulations require you to track undesirable events (incidents, complaints, non-conformities, etc.) and manage Corrective Actions and Preventive Actions (CAPA).

These are crucial elements in risk management, and in ensuring the organization compliance with various standards and certifications in an industrial context.

A robust system must be implemented to:

Capture and track all QHSE-related events

Define the steps in the investigation and resolution process

Create event-related CAPA(s) if necessary

Assign appropriate responsibilities to each CAPA. Very often, this tracking is carried out in Excel files (or equivalent), but this no longer meets regulatory requirements.

The use of digital tools can optimize the QHSE process:

Centralized data entry for greater accuracy and efficiency

Synchronization of information between different systems

Easy access to data for the personnel concerned

And above all, traceability of updates (Audit Trail), which is not possible in Excel.

But what if I don't want to invest in a complete QMS solution that will force me to review my Quality processes?

Management software and CAPA

This is a real issue today: quality management software and CAPA are integrating more and more “professions” into their approach. Too often, it's not the solution that adapts to your processes, but you who have to adapt to the solution.

However, there are alternatives: at iRevolution, we have used our “Low-Code” software development platforms to propose an approach to event and CAPA monitoring for industrial sites.

This low-code approach enables us to adapt completely to your internal procedures, with the ability to easily customize the solution to your needs. As a result, you have a pragmatic solution that meets your quality challenges while bringing flexibility to your organization.

Easy data entry

Easy access to data for the personnel concerned

Reduction of manual data entry errors through data entry aids

Integration with production systems (ERP and MES)

Analysis and reporting

Integrated analysis tools to assess trends

Real-time dashboards on QHSE KPIs

Predictive functions to anticipate potential adverse events

Audit trail

Unique event number and CAPA

Trace all modifications (history)

Search and filter tools for auditors

Workflow management

Automatic task allocation

Corrective action progress tracking

Alerts and reminders to ensure deadlines are met

Accessibility and mobility

User-friendly interface accessible on different devices

Secure data access for relevant personnel

Root cause analysis

Integrated root cause analysis tools (5 Whys, Ishikawa, etc.)

Ability to link actions to identified root causes

At iRevolution, we've been developing software solutions for over 10 years in the most demanding regulated sectors (such as healthcare, sensitive industrial sites, etc.).

Our regulatory, functional and technical experts are here to help you integrate our software solutions to meet your needs.