Converge Consulting was already partnering with this company on a variety of critical supply chain initiatives (sales & operations planning, long range manufacturing & capacity planning), so we were familiar with their manufacturing supply lines and suppliers in general. This allowed for a speedy and smooth project onboarding and ramp up.
We conducted a formal Clinical and Commercial Manufacturing Supplier Risk Assessment. We evaluated each supplier using a methodology based on weighted scoring dimensions within defined supplier and quality risk categories.
Then, a Clinical and Commercial Manufacturing Supplier Risk Management Plan was developed based on the assessment findings. It included a phased approach to mitigating each supplier’s identified risk. Also, the plan aligned with both the company’s Quality Risk Management Policy and CARES Act Sec. 3112: Additional manufacturer reporting requirements in response to drug shortages.
The completed plan now identifies and evaluates supply risks for each supplier location. It also includes options for mitigating a potential shortage or other interruption, as well as an individual redundancy plan for each supplier.