(46c) LOPA as Practiced at Pfizer's Global Manufacturing API Facility in Kalamazoo, Michigan

The standard risk assessment practices used in industry since the OSHA 1910.119 regulation was issued, are to conduct Process Hazard Analyses (PHAs) for hazardous and exothermic (or otherwise high risk) processes. During PHAs, the potential consequences of an undesired event are evaluated along with the safeguards that exist to mitigate the consequences or reduce the frequency of the event. If the PHA team determines that the risk is still not tolerable, additional safeguards are recommended to reach a tolerable level of risk. Typically, a Quantitative Risk Assessment (QRA) can be completed to evaluate the effectiveness of these existing or newly proposed safeguards. Unfortunately, this is a complex and time consuming task. The relatively new methodology of Layer of Protection Analysis (LOPA) allows a PHA team to evaluate the effectiveness of safeguards in reducing risk in an efficient yet semi-quantitative fashion using some basic assumptions and standard lookup tables. At Pfizer Kalamazoo, the LOPA methodology has been utilized to evaluate the effectiveness of Safety Instrumented Functions (SIF) (e.g. automated critical interlocks and alarms) in achieving a tolerable risk. Several scenarios will be shared that will provide an overview of how the LOPA methodology has been used in a multi-batch pharmaceutical facility.