8. 8
Severity
Probability
Frequent Likely Occasional Not often Unlikely
Catastrophic E E H H M
Critical E H H M L
Marginal H M M L L
Negligible M L L L L
E – Extremely high risk H – High risk M – Moderate risk L – Low risk
12. Total S X P X D = RPN
Severity
Probability
Detectability
E (4) H (3) M (2) L (1)
E (4) H (3) M (2) L (1)
E (1) H (2) M (3) L (4)
S
P
D
33 - 48 01 - 1649 - 64 17 - 32
E H M L
25. High LowExtremely High Moderate
E H M L
Unidirectional air flow above and/ or at
critical locations (e.g. turntables,
interventions..) or not (turbulences or
shadowing)
26. Non-viable particulate count
High LowExtremely High Moderate
E H M L
Clean room
parameters
appropriate
Pressure
Air Exchange Rate
Humidity
Temperature
80. Preventing error
is more important than
finding rejects because it
is not always possible to
detect 100% quality
defects
SCIENCE
is always the best answer
81. Quality must be designed
into the process and
cannot be achieved
only by testing
Testing is not the answer