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Use this Root Cause Analysis Form (based on the 5-Why Method) to assist your team in investigating the root cause of a nonconformance and documenting the follow up actions to ensure effectiveness.

A Fishbone Diagram is a great tool for determining or identifying the root cause of a deviation by looking at various angles of potential causes.

A Hold Tag is used to identify products, equipment, or materials that are placed on hold while pending a CAPA investigation. The use of Hold Classification Codes eliminates confusion around why the item is quarantined

Use this Hold & Release Log to document the status of products, equipment, or materials placed on hold, as well as the justification for releasing or rejecting quarantined items.