Kari Miller Posts

Extending Quality Management Beyond the Four Walls of Your Quality Organization

Extending Quality Management Beyond the Four Walls of Your Quality Organization

Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions

Let’s face it, the arms of regulators are getting longer and so is their vision. The extended supply chain is experiencing additional oversight by regulatory bodies around the world, and in fact, your suppliers’ suppliers are not immune to that scrutiny. The list of organizational quality stakeholders continues to grow as the value chain expands to include suppliers and even regulators themselves.

This means that a Quality Management System (QMS) needs to be enterprise strong and it needs to be global if an organization is to respond to harmonization of standards, guidelines, and regulations around the world regarding the organization’s value chain.
(more…)

Quality Management Systems: More than the Company Historian

Quality Management Systems: More than the Company Historian

Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions

Product Quality is a given in Life Sciences organizations; after all, the purpose of producing a medical device or pharmaceutical is to improve the life of the patient using the product. The backbone to producing quality goods is a Quality Management System (QMS) that, by definition, supports the processes focused on consistently meeting customer requirements and enhancing customer satisfaction.

In a global industry environment that is constantly evolving, it has become apparent that a new approach will be required if organizations are to achieve the goal implicit in that definition. The Quality Management System will need to simultaneously evolve beyond the role of company historian and expand its primary focus of achieving compliance. Quality data needs to be turned into information that is informed, actionable, proactive, and predictive. In other words, information that truly fosters a culture of quality.
(more…)

CGMP and ISO 13485: Aligning Device Quality Worldwide

CGMP and ISO 13485: Aligning Device Quality Worldwide

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

Regulators around the world commonly assess product design to ensure safety and efficacy in medical devices. The product approval process is key to ensuring the safety and efficacy of life-improving and life-saving products introduced into their market. However, oversight does not stop there. Worldwide, regulatory bodies are looking to ensure sustainability; they need to “see” that an organization can continuously produce and provide safe, quality product to their market. How do they do that? By auditing an organization’s quality system.
(more…)

The Case for Quality System Transformation

The Case for Quality System Transformation

Kari Miller, VP of Regulatory and Product Management, Pilgrim Quality Solutions

Recently, Pilgrim was a sponsor and a presenter at the American Medical Device Summit. The conference examined the challenges and opportunities currently facing the medical device industry. It also focused on the journey to best practices in the area of design, quality, compliance, technology, and strategy.

The quality track examined the value of creating an environment conducive to building a quality culture, with change management, harmonization, and collaboration as central themes. In fact, collaboration was a key theme throughout the conference as an element of innovation, risk management, sustainability, and compliance.
(more…)

3D Printing Medical Devices: The New Frontier in Personalized Medicine and its Impact on Quality Compliance

3D Printing Medical Devices: The New Frontier in Personalized Medicine and its Impact on Quality Compliance

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

3D printing or Additive Manufacturing is the new frontier in the Life Sciences industry and personalized medicine, where medical devices and even pharmaceuticals can be produced on demand, with specifications suited to a specific patient. For the Life Sciences industry, it means the potential to transform the way patients are treated, improving the efficacy of their treatment and their quality of life.
(more…)

Reaching Nirvana: Making the Case for a Global Enterprise Quality Management System

Reaching Nirvana: Making the Case for a Global Enterprise Quality Management System

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions

The definition of Quality is widely accepted as the achievement of customer expectations through conformance to their requirements. It makes sense then, that a Quality Management System (QMS) supports the processes focused on consistently meeting customer requirements and enhancing customer satisfaction. But establishing a QMS is a tall order in our global economy where value chains are getting longer and longer.

For organizations in Life Sciences, where the ultimate end user (customer) is a patient, and regulatory compliance is mandatory in all countries the organization serves, the task can seem quite daunting. So why would anyone want to complicate it even further by implementing a global Enterprise Quality Management System? (more…)

Living a Quality Corporate Culture

Living a Quality Corporate Culture

Kari Miller, Sr. Director of Industry Solutions & Product Management, Pilgrim Quality Solutions

A culture of quality requires teamwork.  Teamwork is the natural result of working in an environment where people feel they are part of something bigger than themselves. When personal success on the job is defined by the success of that something bigger, an organization has achieved a critical ingredient for a quality culture. The company’s welfare, and therefore the employee’s welfare, is also directly tied to that of its suppliers and customers. (more…)

Quality is Everyone’s Job

Quality is Everyone’s Job

Kari Miller, Senior Director of Industry Solutions and Product Management, Pilgrim Quality Solutions

Vision, values, goals and strategy are the guiding principles of a corporation and culture culminates from them. Quality culture refers to the complete awareness, commitment, attitude, and behavior of the organization with respect to quality.  Corporate leadership must effectively communicate and more importantly demonstrate quality as an inherent value of the organization. (more…)

Crafting a Quality Culture

Crafting a Quality Culture

Kari Miller, Senior Director of Industry Solutions and Product Management, Pilgrim Quality Solutions

Most people in industry are familiar with W. Edwards Deming, Joseph Juran, Jim Harrington, and others whose ideas are usually grouped under the term Total Quality Management. However, the practices they embrace aren’t just about Total Quality Management; they are about management best practices which embrace a culture of quality.
(more…)