All non-conformances must be resolved by identifying the root cause and defining the action(s) taken to prevent recurrence. In addition, the immediate.

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Presentation transcript:

All non-conformances must be resolved by identifying the root cause and defining the action(s) taken to prevent recurrence. In addition, the immediate containment actions, impact of all identified causes and the root cause must be explored. Objective evidence of resolution is required for all NCRs (major and minor) and an effectivity date of compliance (in some cases, this may be almost immediately – such as a procedure missing an approval signature but in other instances – like when training or equipment recalibration is needed, it may take longer)

The Task Groups monitor which questions in the checklists result in the greatest number of non-conformances. This can indicate a need for supplier training or perhaps a revision to the checklist to clarify the requirement, for example. Some of the Task Groups post their data on eAuditNet in the Resources section.