Corrective and Preventive Action (CAPA) software
The isoTracker CAPA system integrates with the Complaints, Audits and Competency Testing modules as a standard feature of all of them. As a critical requirement of ISO 9001, isoTracker CAPA software permits the recording of non-conformances, the identification of root causes, the routing of investigations, the recording of corrective actions and/or preventive actions taken and the verification of the implementation of all actions.
A non-conformance is a deviation from an organisation’s management systems. It can be indicative of a mistake or weakness in the management systems and will need to be recorded and then corrected.
The isoTracker CAPA software permits you to record one or more non-conformances and assign an importance to each. If the Root Cause can be identified then it can be recorded at the same time as the non-conformance or added at a later time. In the Audits module failed audit checklist items can also be included in a non-conformance while in the Competency Testing module failed competency questions can be attached to a non-conformance.
Then for a Minor non-conformance, but more importantly depending on an organisation’s policies, the non-conformance can be routed to selected staff members using the communication features in the non-conformance object to assign a clearly defined task to be corrected within a specific time deadline.
Root Cause Analysis
After recording a non-conformance the focus has to be on identifying its root cause. The investigation and/or the non-conformance communication features in isoTracker can be used to communicate tasks to selected members and with the ability to have a recorded dialogue between team members the root cause for the non-conformance can be identified and recorded.
Corrective and Preventive Actions
For Major or Critical non-conformances then the process can be escalated to that of a Corrective Action and/or Preventive Action. Normally, a Corrective Action requires a Preventive Action and these can be assigned either simultaneously or in sequence to the same or to different staff members. The non-conformance and its root cause can be specifically attached to the individual CAPA requests. Clear instructions and responsibility must be assigned to one or more of the staff members with a clearly defined response period. Multiple follow-up reminders can be set to go off on the due date and then at 24 hour intervals until the relevant CAR or PAR is responded to. In addition the CAR or PAR can be escalated to another party if the required request is not responded to within the allotted time. Clear instructions can be supported by external documentation and proof of the implementation of the Corrective and Preventive measures taken can be attached to the reply.
The reply to the CAR and PAR can be Rejected if it is deemed not to effectively correct the identified problem or prevent the potential problem from occurring. A CAPA request is only closed when its reply is Accepted. If not Accepted then when the issue is being closed, be it a complaint, an audit or an assessment, warning statements are displayed giving the option not to close the issue until any outstanding Corrective Action requests or Preventive Action requests are satisfactorily closed with required proof of implementation and effectiveness.
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