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Non Conformance and CAPA Workflow Solution

Real-time control of lead times and non-conformance costs

capa procedure ennov

Business Problem

Non Conformance and CAPA: Quality at the Heart of Your Organization

Quality management software combining document and process management effectively improves the management of non-conformances and associated action plans. It also provides management tools adapted to your business problems. Non-conformance management is a requirement of ISO 9001 standards.

The benefits are significant. For a production process, for example, anomalies resolved at the design stage are significantly less costly than those resolved in manufacturing, or worse, once the products are distributed or sold. Addressing non-conformances involves the implementation and monitoring of action plans, the effectiveness of which will need to be assessed.

Providing Organizational Structure Without Constraint

The implementation of quality management software helps avoid the loss of information by having a global vision of the process and assigning responsibilities based on standard rules. Each incident is recorded and its associated actions items are tracked. Ennov offers significant value thanks to its powerful workflow engine, which covers different scenarios:

  • Automatic assignment to the proper site or location
  • Intelligent routing according to the type of incident
  • Calculation of the estimated cycle times based on level of urgency
  • Quick system adaptations

Data analytics are also essential. Ennov produces reports and automates the publication of indicators to monitor lead times and costs. These reports facilitate the QSE management process.

Proposed Solution

Coordinating People and Activities to Address Non Conformances

Ennov Quality management software has a complete and configurable workflow engine that automates the procedures for managing non-conformances.  Ennov allows the coordination and management of scheduled, pending and completed tasks to ensure each issue is thoroughly addressed.

  • Fast, flexible and iterative as needed
  • Configurable based on your non-conformance management rules
  • Easily define process steps
  • Define workflow participants and the information to be processed by stage
  • Time limit calculations for each task
  • Non-conformance information form accompanies the process

View of Current Non Conformances

Each user has a task list that presents the master records to be processed in either a list or calendar form. The department manager or entity manager has global views that present non-conformances classified by priority level, criticality, domain or site. The display methods and confidentiality rules are configurable.

Integrated Statistics: Control the Process and Analyze the Data

Exported non-conformance data automatically feeds business or business intelligence tools. You have real-time control of lead times and costs associated with non-conformances which is very useful when measuring the continuous improvement of operational performance. Business indicators such as the number of incidents reported per product line, the average time required to process corrective actions or the cost of non-conformances can be monitored month by month.

Some Non Conformance Management Features

  • User friendly interface for incident reporting
  • Automatic routing to the right people based on the information entered
  • Email alerts on tasks to perform
  • History of exchanges throughout the process
  • Management of action plans in connection with non-conformances and the evaluation of the effectiveness for each corrective or preventive action
  • Global visibility into all non-conformances categorized according to business aspects (type of incident, severity, product line, etc.)
  • Automatically generated dashboards and monitoring panels
  • Automatically calculated indicators and statistics

Why Choose Ennov

Hundreds of corporate customers trust Ennov

Over 15 years of experience providing BPMS solutions

150+ life science customers, many more in other industries

Modern architecture and interface

100% web-based. Highly scalable. User-centric design

Our commitment to your success

Very high customer satisfaction. 98.5% of projects delivered on time and within budgets.

Hundreds of corporate customers trust Ennov

Available as cloud-based or on premises deployment

You can switch between deployment options at any time.

We make you autonomous

System configuration and management require no IT skills.

Improved security and optimized performance

Data is hosted locally for total flexibility. Single-tenancy minimizes business interruptions.

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