The time has come for a step-change in the responsible management of product and process quality within the Medical Device industry. This begins with a new approach to the measurement of product and process quality, moving beyond the ineffective use of key process indicators (KPI), and finally focusing on what truly matters:
1) Product quality measurement focused on patient harm and the critical to quality (CtQ) controls associated with those failure modes causing harm to the patient.
2) Process quality measurement focused on compliance to regulation, effectiveness in obtaining results and efficiency in operational execution.
3) Cost of poor quality (COPQ) measurement focused on the business costs associated with internal CtQ production process control failures, external product failures, and Quality System process failures.
Such a focused and responsible approach, providing for the quantitative and objective management of product and process quality, can better facilitate regulatory oversight and could potentially enable a reduction in the frequency of on-site surveillance inspections as a result, due to an increase in regulator confidence. Most importantly, however, this approach better enables your organization to more effectively address those emerging issues that could impact patient safety and organizational profitability.
The Mgmt-Ctrl measurement solution provides the necessary step-change for the responsible management of product and process quality that your business and regulatory stakeholders expect within the Medical Device industry. We are a performance management company, focused on the measurement, management, and improvement of product and process quality.