Non-conformance & CAPA

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Team Business Non-conformance & CAPA is designed to help companies in ISO and FDA regulated environments automate paper-based Non-conformance processes and integrate them with corrective and preventive actions (CAPA) processes within the organisations quality system.

The system provides for a structured investigation of Non-conformance from which corrective and preventative actions can then be generated and tracked.

By implementing the Non-conformance & CAPA application an organisation can readily identify the causes of Non-conformance's and take action to prevent these incidents and their associated costs from reoccurring.

Non-confirmance & CAPA can exist as a standalone application or can be implemented as part of the full Team Business suite.

Example Non-conformance & CAPA

Non-conformance	Root Cause	Corrective/Preventative Action	Person Responsible	Due Date
One employee at the Wastewater Treatment Facility did not know permit requirements or operating limits	New employee induction training did not address permit requirements and operating parameters	Add permit requirements and operating parameters on new employee induction training checklist, train new employee on this information, post this information in the control room	Wastewater Treatment Facility Manager	09/08/2009

Features & Functions

Updates to the Non-conformance record are date and time stamped for audit purposes
Any number of corrective actions may be raised against a nonconformity
User definable corrective action types, e.g. immediate, preventative etc
Overdue notification emails to both the assigned by and the assigned to for Actions

Benefits

The Non-conformance record can only be closed when all actions are closed Tracks related corrective or preventative actions
A full audit trail or history is automatically maintained for each nonconformity
A full audit trail or history is automatically maintained for each corrective action
Identify trends or nonconformity patterns emerging

Here is a selection of screen shots for Non-conformance & CAPA, click for a larger version.

Click on a link below to see a short video of the Non-Conformance & CAPA application:

Creating a Non-Conformance

Creating an Action from a Non-Conformance

Updating a Non-Conformance

“A systematic database to effectively manage the corrective action/preventive action process from identification of the problem to investigation and all the way through closure.Promote consistent and harmonized process throughout the organisation.The system also reduce the risk of lost and incomplete data for the ISO 9001 audit.Technical support and troubleshooting has always been prompt,helpful and easy to follow.”

N Ismail
Manager - QMS/EMS/SMS/LMS Asia