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CORRECTIVE/PREVENTIVE ACTION

Corrective Action, Preventive Action module of Quality Management Software (Quality Institute Software Solutions) QISS is designed to keep track of all the activities related to corrective action and preventive action being taken on an actual/potential Nonconformity.

The Corrective Action, Preventive Action (CAPA) module, along with the nonconformity (NCR) module can be used by organizations to build an automated mechanism for finding problems and opportunities for improvement. This mechanism then helps the organization to act on the problems/opportunities in a disciplined manner without the usual drudgery. The process then assures improving the effectiveness and efficiency of the organization.

The Corrective Action, Preventive Action (CAPA) module will help execute actions automatically to stay in compliance with ISO based standards, and/or achieve higher levels of performance. It will help use models like the 8-D problem solving techniques model pioneered by the automotive industry, or the DMAIC model used in Six Sigma. This module, including the Nonconformity (NCR) module, can be also used for supplier performance improvement management.

The Corrective Action, Preventive Action CAPA module provides a flexible tool with enough power to go beyond the minimum and achieve the best performance possible from a particular organization. Tools to help investigate the causes of problems 5-Whys, Cause and Effect, Fishbone Diagram are provided as a part of the software. Like the document control module in Quality Management Software (Quality Institute Software Solutions) QISS, it makes it impossible for an organization to be in noncompliance with the standard.

This module meets requirements of ANSI/ASQ/ISO Q9001: 2008 clause 8.5.2 ‘Corrective Action’ and clause 8.5.3 ‘Preventive Action’.

Corrective/Preventive Action (CAPA/CPAR) Introduction Video

“The organization shall take action to eliminate the causes of NCR in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered.”
“The organization shall take action to eliminate the causes of NCR in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problem.”

ISO 9001:2008 Quality management systems – Requirements, Clause 8.5.2, 8.5.3

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