Failure could lead to death or permanent injury to the customer. Failure likely to lead to recall.
Failure could lead to adverse reaction or cause a high degree of customer dissatisfaction.
Failure would create noncompliance with GMP regulations or product registrations.
Failure possible to lead to recall.
Stop production process.
Failure causes a high degree of customer dissatisfaction and numerous complaints.
Failure unlikely to lead to recall.
Reject product
Failure relates to non-dosage form issues (like minor packaging problems) and can be easily overcome by the customer.
Failure would not be noticeable to the customer.
Not readily apparent to the customer