During a production audit at PlastiPharm, a client noted that the number of medical device bags produced during his hour of observation was higher than what was reported for the eight-hour shift (multiplying the hourly output by eight). Which of these explanations best explains why there is a difference?

• The clean room employees were aware a client was observing them and made sure everything ran smoothly for the audit.-- Not Correct
• The goal for the eight-hour shift is always lower than the hourly output to allow employees to take breaks and eat a meal.
• What the client saw during the hour of observation might not have been a typical production hour and should not be used as a measurement of output.
• Differing conditions in the clean room can create variances in the process, which results in lost production and reduces overall shift outputs.