ABSTRACT

Product quality planning and assessment are critical to assure that a product meets the requirements of the customer and that it satisfies all safety and regulatory requirements. One of the key elements to success is to manage and reduce risk effectively throughout the product’s life cycle. This requires a delicate balance between risk, cost and performance. Risk management provides the required decision framework centered on understanding risks and evaluating their acceptability by weighting technical and economic practicability against risk/benefits. It manages the residue risk, as risk cannot be completely eliminated.