isoTracker Corrective and Preventive Action (CAPA) software

The Corrective and Preventive Action features integrate with the Complaints, Audits and Competency Testing modules in isoTracker as a standard feature of all of them. As a critical requirement of ISO 9001, the isoTracker CAPA module 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 all actions.

Non-Conformance

A non-conformance means that something went wrong that needs to be addresses and fixed. A non-conformance can be found in a service, a product, a process, from a supplier or in an organization’s management systems.

A non-conformance can be identified through a complaint, an internal audit, a supplier audit or through regular testing or assessment. This occurs when something does not meet the requirements of a customer, industry regulations or an organization’s internal procedures.

Non-conformances can be recorded in the isoTracker CAPA module where an importance of Critical, Major or Minor can be ascribed to them. The relevant Root Cause can be entered at the same time or in the future once it has been identified. As the CAPA module integrates with the Audits and the Competency Assessment modules, failed or unsatisfactory audit questions or incorrectly answered competency questions can also be associated with the non-conformance. If the non-conformance is minor in importance or has only occurred once, then action requests to correct the non-conformance can be assigned to staff members with a specific deadline to respond by within the non-conformance object communication features. For more critical non-conformancdocument version controles the Corrective Action Request features are more appropriate.

Root Cause Analysis

After recording a non-conformance the emphasis has to be on pinpointing and recording its root cause. This can be done by assigning tasks to selected users in isoTracker using the investigation and/or the non-conformance communication features. Once a satisfactory reply has been received it can be accepted and recorded in the Root Cause section or it can be rejected if additional work is required to come up with a viable Root Cause.

Corrective Actions

Corrective Actions are to correct something that has gone wrong and will describe the actions that are required to fix the problem.

There will probably be an initial step that is taken to keep the complainant happy, such as immediately replacing the offending product.

With that done, the issue now has to be resolved. This is done by eliminating the problem and making sure that it does not happen again. The steps that should be taken are:

  • Assigning to relevant staff action points with the objective of preventing the issue from reoccurring.
  • Staff must then report back on what they actually did with proof of what they did.
  • There then must be a confirmation, again with proof, that the measures taken were effective in preventing recurrence. In most instances this will take a bit of time.
  • Once it is clear that the problem will not reoccur then the issue can be closed.

The CAR task notification features in isoTracker facilitate this process and will help ensure that these tasks are top of mind through reminders and escalation.

Preventive Actions

Preventive Actions are proactive measures to prevent something from happening or something that has already happened from getting worse.

Processes and controls need to be regularly monitored so that potential problems can be identified and removed before they occur. If a complaint or an audit indicate that there may be a potential problem then a preventive action must be implemented to eliminate it and therefore prevent it from occurring. The steps that should be taken are:

  • Assigning actions to relevant staff with the objective of preventing a potential issue from occurring.
  • Proof that the assigned actions were implemented.
  • Proof of the effectiveness of the implemented tasks.
  • Closure of the issue when it is clear that the potential problem will not occur.

The many notification features in isoTracker can help with the investigation and the identification of the potential issue, the tasks assigned to prevent it from occurring and the closure of the issue. In addition, as Corrective Actions and Preventive Actions are often required on the same issue these can easily be assigned to different staff members and again kept top of mind for all involved in the corrective and preventive measures.