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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.