This SOP establishes procedures for documenting and investigating production failures. Production failure investigations are not required by 21 CFR 111. However, it is a good business practice to conduct production failure investigations. The goal of the investigation is not simply to determine the proximate cause of the failure (e.g. a lot of raw material was subpotent or contaminated), but also to identify whether other production batches are affected; to identify contributory factors and areas where the overall quality system needs to be strengthened; and to identify appropriate corrective and preventive actions to prevent recurrence of the problem.

Examples of issues to be examined during a production failure investigation might include (depending on the circumstances of the failure):

• Are other batches affected that were made during the same time period (or using the same equipment, or using the same raw materials or components)?
• Is an adequate system in place for approving vendors and qualifying their certificates of analysis?
• Do certain ingredients or components merit additional testing of each lot prior to release?
• Should additional specifications be implemented for the raw material (or component, or manufacturing process, or finished product)?
• Are the in-process controls used during production appropriate and adequate?
• Is the equipment calibration and maintenance program adequate?
• Has employee training been effective?
• Are standard operating procedures, master manufacturing records, and other documents written clearly and comprehensively?

The report template may be used to report production failures.

The log can be used to track manufacturing failure investigations. Whenever a significant failure occurs in production, such as an unplanned occurrence adulterates the product or a manufactured batch fails to meet specifications, the company may want to conduct a failure investigation to determine the root cause of the problem and how it can be prevented in the future. Such failure investigations are not required by dietary supplement GMPs, but may be helpful to the company’s operations. Details about each investigation should be recorded on a Failure Investigation Report.