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In addition to a disposition decision, further action(s) may be required. The disposition team can initiate several different action plans for a non-conformance. Each of these action plans will be subject to a process of plan creation, plan approval, plan execution, and verification. 

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Action planDescription
Repair/Correction Action Plan (CAPA “Correction”)

In this case, it is decided that the related production unit or defective material should be repaired. A plan to perform this repair is created and executed, and the repairs are verified. 

A repair action plan may take several forms: 

  • A simple reroute to a pre-defined out-of-route operation or out-of-route process flow. The non-conformance cannot be marked as complete until the unit completes its out-of-route processing.
  • A reroute to a Just-In-Time (JIT) process flow. The unit is held until the JIT repair process is approved. The non-conformance repair/correction cannot be marked complete until the unit completes the JIT process flow.
  • A general action plan conforming to the structure outlined in the topic Action plan structure and life cycle.
Containment Action PlanIt may be necessary to rapidly contain the problem as an emergency first response. A plan to contain the issue will be created and executed. The plan might include locating other products/materials in the factory that may have similar non-conformances or recalling products from the field that are believed to have the same problem using a field service notice or product recall.
Root cause analysis

An investigation will be performed to determine the root cause of the non-conformance.

Establishing a root-cause is a critical part of the process for any non-conformance that requires corrective or preventive actions to be taken. At the time of disposition, you can trigger a root cause analysis or make it mandatory as part of the non-conformance template definition.


Note
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titleNote:

There may be circumstances where root cause analysis determines that no corrective or preventive actions need be undertaken. In such cases, if corrective action plans are configured as mandatory, only a user assigned as a supervisor in the non-conformance template will be able to close out the non-conformance using a special supervisory override function. 


Corrective or preventive action plans cannot be approved until the root cause investigation and analysis are completed for a non-conformance. 

You can record more than one root cause for a non-conformance. In this case, if corrective actions are configured as mandatory, you need to generate more than one corrective action plan (that is, at least one corrective action plan for each root cause).   

When the root cause investigation and analysis are complete, you can configure notifications to be sent to team responsible for the non-conformance. 

Corrective Action Plan

In many cases, it may be necessary to identify the root cause(s) of the non-conformance and put corrective actions in place to prevent recurrence of the problem. For incidents subject to CAPA rules, this is a hard requirement. For example, maybe the production unit failure was caused by a design flaw. A plan is put in place to generate a new revision of the product to correct the flaw (a new FactoryLogix assembly revision). Another possibility is the failure may have been caused by a flaw in the production process. It may be necessary to modify the production process to prevent recurrence of the failure (a new FactoryLogix process revision). 

 You can also make creating and executing a corrective action plan mandatory in a template (mandatory corrective action plan infers mandatory root cause analysis). 

Specialized tasks for corrective action plans 

Repair/correction action plans may incorporate specialized tasks: 

  • Create New Assembly Revision - The design of the product must be updated as part of the corrective action plan.   
  • Create New Process Revision - The manufacturing process of the product must be updated as part of the corrective action plan.  

To complete either of these task types, process engineers must create the appropriate new revision in FactoryLogix, complete all required approval processes, and release the new revision to production. Once this is done, the new revision can be linked to the task via the non-conformance management environment, and only then may the task be marked as completed. 

When one of these specialized tasks is created by the corrective action team, team members can specify notes and instructions for the process engineer to follow when creating the new revision. Notifications are sent to the assigned process engineer to inform the engineer of the need for a new revision, including the notes and instructions that were constructed by the corrective action team. 

Preventive Action Plan

After performing a root cause analysis, you may want to put addition measures in place to prevent similar—yet different—incidents from occurring in the future. For example, the company may decide to create additional training programs to raise awareness or address particular operator skill sets. 

You can create one or more preventive action plans at any point after the root cause is established.

Corrective and preventive action plans are functionally identical from a software point of view, though they serve different business purposes and may be executed by different groups of people.