Sec. 820.40b Document controls.

(b) Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.

Interpretation:

Why would the FDA want the “same” individuals to review and approve changes?  The reason is insight.  These individuals are usually at a better advantage for evaluating the changes.  However, individuals don’t always hang around for the life of a product (or process).  On a positive note the FDA gives us a little leeway by adding “…unless specifically designated otherwise.”  This effectively allows an organization to delegate to another individual who is competent for the task.

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Reference: www.FDA.gov

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