Abstract: A method for building risk-management workflows (‘Step A’), comprising several risk analysis tools seamless integrated (‘Step B’), to be applied to process design, process and equipment qualification, manufacturing stages and supply management (‘Step C’) of multi-step processing of chemical, pharmaceutical or biologic products (‘Step D’), for risk identification, assessment, mitigation and management over lifecycle (‘Step E’), thus supporting ongoing process verifications, product quality reviews, and knowledge-based process and product continuous improvement (‘Step F’). Workflows (‘Step A’) can be specific of certain stages (‘Step C’), products (‘Step D’), production equipment or facilities used to produce products, but can and should be combined to support the lifecycle management aspects of steps ‘E’ and ‘F’.