Engineering Change Notice (ECN) System for ISO & IATF Compliance
Challenges:
Inefficient and difficult to maintain:
Paper-based and hybrid systems for Engineering Change Notice and Preventive Action are inexpensive initially. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing ECN tasks and other documentation, obtaining approval and signatures, and manual search and retrieval of documents during inspections and audits.
No Integration and information Sharing :
ECN maybe triggered by customer or internally due to process change, cost down, market requirements, customer requirements, regulatory requirements, etc. With manual and hybrid systems, these sources are not connected, making data collection slow and incomplete. Without connectivity, critical information may fall through the cracks, and the ECN assessment is likely to be unreliable.
Solutions:
Blue Ocean ECN Systems are designed by industry practitioners and experienced quality consultant for automating the ENC process in any organization.
An automated ECN system reduces audit time and findings, and decreases risk of product recalls. It improves product quality and increase productivity, increases customer satisfaction, and ensures FDA and ISO compliance.
Blue Ocean ECN software is a robust, easy-to-use system designed to effectively manage change process integrate it with other quality processes critical to regulatory compliance, such as risk management and document management system.
Key benefits and features:
- Assign critical ECN assignments to responsible parties utilizing email alerts
- Electronic signature of approvals at all levels, completely automates the ECN process
- Set up organization defined ECN categories and priorities to make the ECN module work for you
- Link to controlled documents and even escalate document requests from the ECN
- Track full history of ECN by product, product category, and customer
- Create and assign multiple tiers of approvals
- Work flow control for effective control
- Real time ECN dashboard for better management
