The Double Diamond©: A Blueprint for Enhanced RBDM

In Quality Risk Management (QRM), a decision is rarely a single moment. It’s usually a decision stack: a higher-level Pharmaceutical Quality System (PQS) decision that depends on many smaller decisions made inside the QRM process. That’s why I use the Double Diamond© as a blueprint for enhanced Risk-Based Decision Making (RBDM). It’s not just a graphic. It’s decision architecture - a simple way to make the invisible decision layers visible, and to apply the ‘right’ level of formality where it actually matters. 

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