In general, to apply a risk-based approach to establish the quality of anything, one would require a defined and measurable outcome/parameter. Once such an outcome/parameter is known or established, then it is used to reflect the chances of achieving success or failure in manufacturing or producing quality products. If the defined outcome/parameter is not available, then it would not be possible to use a risk-based approach. The manufacturing of quality pharmaceutical products falls in this category, i.e., there is no define parameter/outcome available for a “quality product,” thus risk-based assessment approach in pharmaceutical manufacturing is not possible at present.
To apply a risk-based approach, one would require to define the quality pharmaceutical products with a measurable parameter. So, please seek a definition of a “quality pharmaceutical product” along with its measurable parameters using qualified and validated scientific methods. As an example, please see here (Link).