What happens if a Registrar finds nonconformance’s at my facility during the registration audit?
It is important to note that there are several degrees of nonconformances. Typically, these are minor and major nonconformances, and possibly also observations. An observation is just that: an observation. It is not considered to be a violation of the criteria. It is typically an identifier that there may be a better way to monitor a process or document a procedure. It’s not a problem; just a potential for improvement – a way to avoid future problems. A minor nonconformance by itself doesn’t indicate a systemic problem with the quality management system. It is typically an isolated or random incident. An example is if the most current version of a document is not available at an operator’s station; the updated version exists but a copy of it is not available for the operator’s use and the operator is using an outdated procedure. Other examples are a form without a document control number on it or an internal audit with an overdue corrective action request pending.
It is important to note that there are several degrees of nonconformances. Typically, these are minor and major nonconformances, and possibly also observations. An observation is just that: an observation. It is not considered to be a violation of the criteria. It is typically an identifier that there may be a better way to monitor a process or document a procedure. It’s not a problem; just a potential for improvement – a way to avoid future problems. A minor nonconformance by itself doesn’t indicate a systemic problem with the quality management system. It is typically an isolated or random incident. An example is if the most current version of a document is not available at an operator’s station; the updated version exists but a copy of it is not available for the operator’s use and the operator is using an outdated procedure. Other examples are a form without a document control number on it or an internal audit with an overdue corrective action request pending. A major nonconformanc
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- What happens if a Registrar finds nonconformance’s at my facility during the registration audit?