The following illustration provides a high-level view of the FactoryLogix Administrative Quality Management (AQM) workflow that provides both FRACAS and CAPA capabilities.
A non-conformance can be initiated from a variety of sources, for example:
- A problem at an inspection station whether it is a human, a machine, or a piece of test equipment generating an error or failure
- A problem during manufacturing that generated a non-conformance when a customer opened an incident after a product was shipped
- A problem or failure reported by a field service technician
- An issue with incoming material during the Incoming Quality Control (IQC) process when materials are sampled as they arrive at the loading dock
After a potential non-conformance is identified, evaluated, and documented, the information is sent to the Material Review Board (MRB). MRB members verify the non-conformance, assess the situation, and make a disposition decision to determine what needs to happen to repair, correct, or contain the problem. After a disposition decision is made, the MRB may determine that one or more action plans need to be authored and executed to resolve the non-conformance. A root cause analysis may also be performed.
After executing one or more action plans and validating that all tasks were completed, effectiveness checks may be performed. If the non-conformance passes the effectiveness checks and the problem is resolved, you can close the non-conformance. If you don’t use effectiveness checks, you can close the non-conformance when the action plans are approved and closed.
Some non-conformance workflows require one or more approval levels to ensure that a corrective action or preventive action has been done correctly. Approvals also help ensure that the action plan as authored is suitable to prevent a non-conformance from ever occurring again. There may be multiple people in an organization who need to approve the work done to resolve a non-conformance. The quality manager or an engineer might also need to approve an action plan to prevent or correct a non-conformance from ever occurring again. The goal is to prevent an identified non-conformance from ever occurring again while saving time and money. AQM includes a full range of approval flow options to help you.
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