Deviation Management Quiz

What is a deviation in the context of the given text?

• An excursion of environmental conditions specified for controlled areas

• A breakdown of equipment or utility systems affecting product quality

• A deficiency in a characteristic, product specifications, process parameter, or procedure

• A departure from an established and approved procedure resulting in non-conformances

Why do we need to record deviations?

• To ensure process information is retained

• To eliminate future issues

• To protect the patient

• To support continuous improvement

A deficiency in a characteristic, product specifications, process parameter, record, or procedure that renders the quality of a material or product unacceptable, indeterminate or not according to specified requirements

• Non-conformance

• Root Cause

• Deviation

• All of the above

Do we need to raise deviation reports for breakdown of equipment / utility systems which may affect quality attributes of a product / bulk?

• True

• False

Deviations that are found to be CRITICAL should be reported within...

• 1 hour

• 8 hours

• 24 hours

• 48 hours

How many times can a CAPA commitment date be extended?

• Twice

• Once

• Never

• Thrice

What is the severity definition for a moderate/major deviation according to the text?

• A deficiency which cannot be classified as either critical or major

• No adverse effects on patient

• May pose risk on patient safety and product quality

• Possess significant risk on patient and product quality

Reporting of a deviation is required regardless of the final batch disposition. If a batch is rejected, deviation reporting is still required.

• True

• False

Nature of Deviation - Deviations from Good Documentation Practices

• Document

• Process

• Utilities / Facilities

• Product

NOT all problems, incidents, deviations or findings can be addressed or corrected.

• True

• False