42 ....................................................................................................................................................................................................................................................................................................................................................................................................................................................................... Process Risk Assessment We have set up processes to pursue comprehensive process safety evaluation. The benefits of this approach are numerous — not only is the identification of any potential risks/hazards achieved prior to scale-up; any necessary changes to the process can be completed prior to process scale-up. This direction is further supported through rigorous Pre-start-up safety review (PSSR). A pre-start-up safety review is a crucial part of any process safety management program (PSM), and it is the final step to ensure safety and efficacy before bringing an improved or new process online. For us, a proper PSSR actually starts with an effective change process to help increase the visibility of the scope and ensure a smooth PSSR. The PE, TAT and PMT teams along with safety carry out approximately 40-50 PSSRs per month with over 90% adherence of points discussed in the review. Walkthrough Final P&ID (Review & Sign-off) Tech transfer/ War room Change management & campaign initiation Plant modification Process risk assessment PSSR compliance review & sign off Process hazard training Pipeline verification & batch starting Process Risk Assessment is conducted for the process executed for scale-up for the below scenarios: a. New synthesis route/Project for Scale-up b. Change in the existing process chemistry or Change in equipment Prior to conducting a risk assessment, following information are reviewed: • Tech Pack • Process Flow Chart & P & ID • Reaction Calorimetry, Basis of Safety (BoS) and Classification of critical scenarios, from the Chemical Process Hazard Evaluation (CPHE) report • Batch Production Record (BPR) • Material Safety Data Sheet of chemicals used and any Toxicological information • Hazards to the environment • Previous campaign process concerns .
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