Accelerate Sustainable Capability: Pilot Study Report

Executive Summary

The Accelerate Sustainable Capability (ASC) pilot study provided participating manufacturers with another avenue to improve their performance and compliance in a sustainable and efficient manner as well as provide the FDA with measurable performance metrics to assess product safety and quality. Ultimately, the ASC pilot study aimed at the successful development of quality tools and engagement strategy that could guide out of compliance medical device manufacturers to achieve improved and sustained compliance, greater maturity of their quality systems and enabling business processes, while supporting faster closure of their open advisory actions.

The ASC pilot study enrolled seven manufacturers, some with open Form 483 observations or warning letters from the FDA. It included an initial CMMI appraisal, action planning, quarterly check points, submission of quarterly metric reports, and a quarterly residual risk assessment. Success criteria for the study included progress towards compliance, improvement in quality management system and business process maturity, and the ability to address compliance observations/violations.

With guidance from a knowledgeable Capability Maturity Model Integration (CMMI) appraisal team, the ASC pilot process was uniquely tailored for each specific manufacturers’ compliance and quality needs. The program was designed to strengthen the culture of quality within an organization by assessing the capability and maturity of the existing quality system and business processes against the CMMI maturity model. Insight was then provided to the site on how to address compliance concerns more sustainably and in alignment with industry best practice.