Ducks in a Row

It’s time to get your ‘ducks in a row’ to be well prepared to meet the challenge of changing regulation and standards that are harmonizing requirements around a patient centric quality outcome.  Accountable leaders have more responsibility placed upon them now than ever before, requiring a high-performance Quality Management System (QMS) to enable the delivery of the operational results that their stakeholders expect.  Additionally, beyond a clear patient centric safety focus, there exists ever increasing market pressures due to dynamics associated with the healthcare payer system that will demand economic value on a fast approaching horizon.  A patient centric focus that delivers both safety and value will require absolute management control to ensure the satisfaction of regulatory stakeholders and business stakeholders alike.

The European Union Medical Device Regulation (EU MDR) is a great example of significant change.  The purpose of the EU MDR is to ensure safety, control, and transparency of the quality of medical device products. EU MDR clearly requires manufacturers to be more accountable for quality across a product’s lifecycle, and they expect this to be accomplished through the QMS… 

Chapter 2 - Article 10, General Obligations of Manufacturers:  The quality management system shall cover all parts and elements of a manufacturer's organization dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.

Management control requires a sound strategy to measure, monitor, report, review and improve the QMS.  This cannot be accomplished using KPIs as a primary process and/or product measurement mechanism.  Management control is derived through the strategic use of a structured measurement system and sound data analytics program, capable of providing the visibility necessary to manage dynamic organizations within a complex environment.  Such a system will enable responsible management to make informed decisions, correcting the biases inherent in subjective human observation.  The information provided by properly measuring the performance of the system will yield value to an organization through improved leadership and organizational focus.

Ensuring a high-performance Quality Management System can best be accomplished through the utilization of improved management control mechanisms that both measure and improve the systemic constraints associated with providing high quality products through processes that are well executed by qualified people.  To do this it is essential to have a QMS performance measurement strategy that quantifies management control in terms of people, process and product by focusing on:

·       The quality of the design and interaction of the system of QMS processes

·       The skillset, training, competency and organizational management of the people who execute the QMS processes

·       The quality of the marketed product, resultant from QMS management control

The measurement of QMS performance must ensure the provision of an understanding of the operational ‘quality’ of the Quality System, built upon the foundation of three tenants.

·       First, the stakeholders, whether they are regulatory stakeholders or business stakeholders, require that the Quality System is compliant to the regulation or standards that the company must adhere to.

·       Second, the processes within the Quality System must be effective at obtaining the results that are expected of them.

·       Third, the business stakeholders have an expectation that those processes are efficient in operational execution.

A thorough understanding of the quality of the Quality Management System, through measurement of the of Quality System and the quality of the results it provides, is required to enable the management team to minimize risk to the patient, reduce the regulatory risk to the organization, and provide value to the market.

Larry Mager