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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the updated version exists but a copy of it is not available for the operator's use and the operator is using an outdated procedure.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 ...
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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the updated version exists but a copy of it is not available for the operator's use and the operator is using an outdated procedure.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.
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What happens if a Registrar finds nonconformance’s at my facility during the registration audit?
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