Failure Mode Effects Analysis (FMEA)
Conducting an FMEA can identify opportunities for labeling-related errors. The FMEA should address each step of the process that is impacted by labeling. Begin by observing compounding personnel in the cleanroom. Identify each point in their workflow where a problem could develop. This observation process should span different shifts and staff members to determine procedural consistency.
In addition, observe the stocking and picking processes in action to determine where a mistake is likely to occur. Watch for every step that requires your staff to make a decision as this provides the opportunity for human error to occur. Pay particular attention to:
1. Lesar TS. IV product labeling. Pharm Purch Prod. 2008;1:2-4.
Optimal Label Components