isoTracker Corrective and Preventive Action (CAPA) software
The isoTracker Corrective and Preventive Action Software is designed to work with the Complaints, Audits and Competency Testing modules as a standard feature for standardization. The CAPA module is a vital requirement of ISO 9001, enabling the tracking of non-conformances, identification of root causes, investigation routing, corrective actions and/or preventive actions taken as well as the confirmation of all actions.
Non-Conformance
A non-conformance is an action that deviates from the organization’s management structures. This could be a signal of errors or weaknesses in said structures, and needs to be tracked in order to be corrected.
The isoTracker CAPA tool offers a simple way to track non-conformance and assign an importance level to the non-conformance. When the Root Cause is easily determined, it can be recorded simultaneously to the non-conformance. The CAPA software is designed to integrate with Audits and the Competency Testing modules, which means that failed audit checklist items or competency questions can also be attached accordingly. Minor non-conformance can be routed to designated managers according to company policy, along with clearly defined tasks to correct the action at a set deadline.
Root Cause Analysis
Once a non-conformance has been recorded, the focus lies in determining its root cause. Key features such as investigation and/or the non-conformance communication are used to communicate tasks to designated employees, with the capacity to accept or reject communication between those involved. This allows you to identify and record the root cause of non-conformance simply and efficiently.
Corrective and Preventive Actions
Major or critical non-conformances can be escalated to a Corrective Action and/or Preventive Action process. In most instances, a Corrective Action requires a Preventive Action. These may be assigned either simultaneously or in sequence, to designated employees. The non-conformance and its root cause can be attached to the individual CAPA request to further simplify the process. Clear guidelines and accountability must be assigned to senior managers or specific employees within a clearly defined response time.
Multiple follow-up reminders can be set for the due date as well as 24 hour intervals until the response of the relevant CAR or PAR. The CAR or PAR can be escalated to another designated employee if the request is not responded to by deadline. Clear directions may be supported by external documentation, while proof of implementation for corrective and preventive measures taken can be attached to responses. These replies can be Rejected if considered to not effectively correct the identified problem or prevent a potential problem.
A CAPA request can only be closed once its reply has been Accepted. If the reply is not Accepted, warning statements for the complaint, audit or assessment are displayed with the choice to keep the issue open until any outstanding Corrective Action or Preventive Action requests are satisfactorily closed along with satisfactory proof and responses. This ensures full control over the Corrective and Preventive Action Software at all times.