Proactive Quality Systems: FDA Has Made Them A Priority — Has Your Organization?
By Stephanie Christopher, Medical Device Innovation Consortium (MDIC)
FDA’s traditional compliance requirements establish a uniform quality system framework, but do not ensure device quality across the ecosystem. Furthermore, a compliance audit will tell a manufacturer whether the system they have established is compliant with current regulations but offers no insight into how they might improve the device, the system, or the development process.
Taking predictive and proactive measures to improve quality can have far-reaching effects – from more efficient resource allocation to decreased probability of a recall.
Conversely, manufacturers that fail to implement quality objectives as value drivers could put the future of their companies at risk. A 2017 McKinsey analysis revealed that the direct cost of quality is $26 billion to $36 billion dollars annually, representing 6.8 to 9.4 percent of device industry sales.
Of that total, two-thirds was the direct cost of poor quality — for example, “labor costs to remediate failures, as well as the material and financial costs of internal and external quality failures.” The other one-third was the direct cost of ensuring good quality — for example, “organizational costs involved in preventing or appraising quality issues.”
Read more: https://www.meddeviceonline.com/doc/proactive-quality-systems-fda-has-made-them-a-priority-has-your-organization-0001
FDA’s traditional compliance requirements establish a uniform quality system framework, but do not ensure device quality across the ecosystem. Furthermore, a compliance audit will tell a manufacturer whether the system they have established is compliant with current regulations but offers no insight into how they might improve the device, the system, or the development process.
Taking predictive and proactive measures to improve quality can have far-reaching effects – from more efficient resource allocation to decreased probability of a recall.
Conversely, manufacturers that fail to implement quality objectives as value drivers could put the future of their companies at risk. A 2017 McKinsey analysis revealed that the direct cost of quality is $26 billion to $36 billion dollars annually, representing 6.8 to 9.4 percent of device industry sales.
Of that total, two-thirds was the direct cost of poor quality — for example, “labor costs to remediate failures, as well as the material and financial costs of internal and external quality failures.” The other one-third was the direct cost of ensuring good quality — for example, “organizational costs involved in preventing or appraising quality issues.”
Read more: https://www.meddeviceonline.com/doc/proactive-quality-systems-fda-has-made-them-a-priority-has-your-organization-0001