By addressing its Quality Culture, our customer, a global medical device manufacturer, was able to address FDA and Notified Body concerns as well as improve overall employee satisfaction and business results.
The Problem
Our customer was receiving frequent, similar FDA and Notified Body nonconformances related to quality system failures across the organization. These findings were leading to an adverse relationship with FDA and the European Union Competent Authorities.
The regulators were concerned that the company’s leadership was creating a quality culture where quality was viewed as a necessary evil and not a fundamental part of the business model. This culture presented itself in several ways:
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Communication. The company’s quality vision was neither visible nor understood by the organization.
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Direction. A lack of quality direction from company executives resulted in the growth of independent quality cultures and decision-making within the business.
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Disconnection. Business operations were not connected, resulting in highly variable business processes across the organization.
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Inconsistencies. Regulatory requirements were interpreted inconsistently across the business.
FDA identified deficiencies related to these issues within the following Quality System Regulation subparts at each of the company’s sub-businesses:
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Management responsibility
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CAPA
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Complaint handling
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Medical device reporting
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Risk management/field corrective actions
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Internal audit
The Solution
Escalation of enforcement in the form of FDA Warning Letters pushed the organization to take action. The company’s leadership decided that a significantly different approach would be required to effectively address the quality concerns across the organization. Past quality initiatives launched within the organization had encountered many challenges, including:
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Lack of buy-in at all levels
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Lack of engagement within the company to systemically address concerns
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Lack of consistent priorities as leadership personnel changed
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Lack of communication channels to educate and communicate about quality initiatives
Our Approach
The manufacturer reached out to Oriel STAT A MATRIX. We assisted the manufacturer in overhauling its quality culture, using a custom approach focusing on people, processes, and systems.
People
Oriel STAT A MATRIX worked with the organization’s executives to help them understand the need to develop a formalized control mechanism at the center of the organization. This entailed creating a new organizational structure with a corporate quality entity, the Corporate Quality Governing Body. This entity included the Quality Vice Presidents from all of the company’s sub-businesses and geographic locations. It became the governing body for all activities related to quality, improving alignment in both quality culture and quality initiatives. Each of the company’s sub-businesses was given a “dotted line” reporting relationship to the Governing Body. The Governing Body then developed and deployed a highly visible, frequently recited quality policy across the organization.
Processes
We then assisted the company in the development of expert groups – the Councils – made up of subject matter experts from each of the sub-businesses. The Councils were tasked with addressing specific areas of concern identified by FDA. The Councils reviewed the FDA findings, conducted root cause analyses, and identified solutions that would systemically address the concerns while accommodating individual sub-business needs. They delivered their strategic approaches for resolving issues to the newly formed Corporate Quality Governing Body for consideration and implementation.
Systems
Oriel STAT A MATRIX then guided the development of a corporate quality management system (QMS). The QMS disseminated the strategic solutions that had been developed by the cross-functional Councils and accepted by the Corporate Quality Governing Body. The Governing Body would approve either a corporate policy or a corporate procedure, and the expert Councils then incorporated the policy or procedure into their “local” procedures and practices. A new corporate audit function was established to monitor and evaluate the effectiveness of the new QMS implementation.
Results
The results of this customized solution led to an improved relationship with FDA, as the organization was able to demonstrate a systematic mechanism for resolving quality and compliance concerns. The implementation of the new Corporate Quality Governing Body and QMS reduced variation within local processes, which translated into a uniform quality system across the organization. The new, consistent focus on quality communicated by the company’s senior leadership created a quality culture focused on manufacturing safe and effective products for patients