When a potential non-conformance is identified, the first step is to document the incident. Documentation requirements vary depending on the source and type of the non-conformance. For example, a failure at test might require certain critical information such as re-creating steps and production unit information. A customer incident might require documentation including customer name and address, account manager, or other customer-related details.
Properly documenting the nature of a non-conformance is an important part of the initiation process. You use a non-conformance profile to specify documentation requirements for non-conformances, including:
Observation (a statement characterizing the nature of the non-conformance).
Who discovered the failure or reported the non-conformance? This information is supplied automatically if the failure was initiated from a FactoryLogix production or receiving process.
What failed? This information may be supplied automatically if the failure was initiated from a FactoryLogix production or receiving process.
Where did it fail? This information may be supplied automatically by FactoryLogix under some circumstances but may also indicate a location outside the factory walls (perhaps the failure was discovered in the field or reported by a customer).
When did it fail? This information may be supplied automatically in some circumstances, but also can be supplied manually.
Under what conditions did the failure occur? Is the failure repeatable?
Evidence of the non-conformance. Evidence can be test results, analytical data, or other documents that serve as evidence for the non-conformance.
