FMEA SEVERITY CRITERIA
VALUE DESCRIPTION
10 HAZARDOUS WITHOUT WARNING
9 HAZARDOUS WITH WARNING
Failure could lead to adverse reaction for customer.
8 VERY HIGH
regulations or product registrations. Failure possible
Failure leads to customer perception of safety issue.
7 HIGH
6 MODERATE
5 LOW
4 VERY LOW
3 MINOR
CRITERIA
Failure could lead to death or permanent injury to
the customer.
Failure could lead to injury to the customer. Failure
would create non-compliance with registered
specifications.
Failure would create noncompliance with GMP
to lead to recall.
Failure renders individual unit(s) unusable. Failure
causes a high degree of customer dissatisfaction.
Recall for business reasons possible but Authority
required recall unlikely.
100% of
product may have to be reworked. Failure causes a
high degree of customer dissatisfaction and
numerous complaints. Failure unlikely to lead to
recall.
Minor disruption to production line. A portion of
the product may have to be scrapped (no sorting).
Customer dissatisfied.
Minor disruption to production line. Failure relates
to non-dosage form issues (like minor packaging
problems) and can be easily overcome by customer.
Minor disruption to production line. A portion of
the product may have to be reworked. Defect
noticed by average customers.

2 VERY MINOR
1 NONE
FMEA PROBABILITY CRITERIA
VALUE DESCRIPTION
10 VERY HIGH: REGULAR FAILURES
8 HIGH: REPEATED FAILURES
6 MODERATE: OCCASIONAL FAILURES
4 LOW: UNLIKELY FAILURES
2 REMOTE: FAILURE IS UNLIKELY
FMEA DETECTABILITY CRITERIA
VALUE DESCRIPTION
10 NORMALLY NOT DETECTED
8 LIKELY NOT DETECTED
6 REGULARY DETECTED
4 ALWAYS DETECTED
2 ALMOST CERTIAN
Minor disruption to production line. A portion of the
product may have to be reworked. Failure not
readily apparent to the customer.
No Effect
CRITERIA
EXPECTED TO HAPPEN REGULARY
EXPECTED TO HAPPEN IN A LOW FREQUENCY
EXPECTED TO HAPPEN INFREQUENTLY
UNLIKELY TO HAPPEN
NOT TO HAPPEN
CRITERIA
FAILURE VERY LIKELY TO BE OVERLOOKED, HENCE
NOT DETECTED
FAILURE MAY BE OVERSEEN
FAILURE WILL NORMALLY NOT BE DETECTED
FAILURE CAN AND WILL BE DETECTED IN ALL CASES
NO FAILURE AND 100% AUTOMATIC INSPECTION