STATISTICAL TOPICS AND ANALYSIS IN RISK ASSESSMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 77

Area within the process or product
“space” where the failure to patient
occurs, F.

Area within the process or
product “space” where both
the hazard and the failure
occur, F & H.

Area within the process or
product “space” where a
hazard occurs, H.

Process, product
“space,” or population

Figure 4.1 Venn diagram visualization of ISO 14971 section E. ( See insert for color representation of the figure .)

80