Table 2

Worksheet with risk priority numbers (RPNs): first five ranks

Failure modeEffectSeverityPossible causesOccurrenceDetectionRPNRank
Degraded specimenFalse negative4Time between sampling and processing too long (>6 days) because of late delivery to the pharmacy44641
Degraded specimenFalse negative4Time between sampling and processing too long (>6 days) because of late delivery from pharmacy to laboratory44641
Degraded specimenFalse negative4Time between sampling and processing too long (>6 days) because of delay in the laboratory44641
Mixed-up kitsNegative test result never communicated to the user3Wrong code because of manual entry by the pharmacist54602
Degraded specimenFalse negative4Inadequate environmental temperature at user’s home34483
Degraded specimenFalse negative4Inadequate environmental temperature during transport34483
Degraded specimenFalse negative4Inadequate environmental temperature in the pharmacy34483
Degraded specimenFalse negative4Inadequate environmental temperature in the wholesaler’s vehicle34483
Anonymous specimenPositive test result never communicated to the user4The pharmacist provides the kit without using the programme’s management software43483
Anonymous specimenNegative test result never communicated to the user3Wrong code because of manual entry by the pharmacist53454
Mixed-up kitsA person who has not done the test receives communication of a negative result by letter3Wrong code because of manual entry by the pharmacist43365
Mixed-up kitsA person who has not done the test receives communication of a positive result by phone call3Wrong code because of manual entry by the pharmacist43365
Anonymous specimenNegative test result never communicated to the user3The pharmacist provides the kit without using the programme’s management software43365
Degraded specimenFalse negative4Inadequate environmental temperature in the laboratory33365