Software Non-Conformity Management

This module represents the core of the Quality system due to its high level of integration with all the other aspects of Quality Control and Assurance.

Subscription

• Guided surfing through the catalogue;
• Guided liability identification;
• Simplified data entry functionality with configurable features;
• Searching previous ‘similar’ Non Conformities;
• Printing the subscription that will be sent to the person in charge;
• Integration with Corrective actions and Costing;
• Possibility of recording several comments at different levels;
• Integration with fax or e-mail managing system for transmission

Analysis

• Zoom down search engine;
• Full surfability according to different aggregation methods (date, factory, division, family, article, supplier, fault, etc.);
• Data export in Excel^® to be examined and re-processed by the user;
• Graphics.

Planning

From any point of the Quarta EVO system, it is possible to feed the Non Conformity container that becomes the privileged place from where to obtain, through statistic analysis, indicators on the trend and on the costs of non-quality and of derived actions.

• Various types of Non Conformity: System, Acceptance, Production, Final Inspection, Return, Complaint, etc.;
• Completely configurable non conformity classification of by means of a hierarchical catalogue with several levels (faults, causes, etc.);
• Alarm management;
• Completely configurable Workflow of Non conformity document.

• automatic registration of non-conformities in any phase of check/process along with the association of documents in any format;
• punctual supervision of the state and of the activities;
• instant check and revision of non-conformities;
• statistical analysis of highlighted non-conformities;
• survey of direct and indirect costs;
• trackability of data and informations even through the visualisation of the father-child bond tree;
• Sign history of document visualisations, of comments and of feed-backs in order to keep under control processes’ phases;assimilation with other processes and/or other structured documents from Quarta EVO or other systems;

Quarta EVO Complaint and claim

Quarta EVO Returned

Quarta EVO Corrective and Preventive Actions

Quarta EVO Document Management

Quarta EVO Lot Inspection

Indicators and KPIs

UNI EN ISO 9001

UNI EN ISO 9100

UNI EN ISO 22000

UNI EN ISO 13485

IRIS

21 CFR PART 11