Cost of Poor Quality (COPQ) in Healthcare
The Cost of Poor Quality (COPQ) in the healthcare sector—particularly in medical devices, pharmaceuticals, and biopharmaceuticals—has profound implications for patients, employees, and shareholders. This analysis delves into the impact of the cost of poor quality across these key stakeholder groups. Impact on Patients Poor quality in healthcare can lead to severe consequences for patients, including: […]
Why Change Management Efforts Fail
A Quality Professional’s Perspective on Why Change Management Efforts Fail When you get to the point of your career I now find myself in, you will have seen many change management efforts falter or fail. While some common themes and pitfalls contribute to all such failures, I want to emphasize those that I think are […]
Creating a Sustainable Quality Culture: Balancing Ethics, Efficiency, and Employee Well-Being
“Quality is never an accident; it is always the result of Intelligent effort.” …John Ruskin I have spent the last 20+ years in the biopharmaceutical industry. My journey began modestly, starting with washing lab glassware, researching, and working as a QC environmental monitoring sampler. From there, I advanced to line supervisor and lab manager roles, […]
Why is Achieving a Robust Quality Culture in the Medical Device Industry Challenging?
Aristotle once said, “Quality is not an act; it’s a habit.” This is the first in a series of articles on Quality Culture in the Medical Device Industry. In this first article, we focus on the unique challenges we face in creating a strong quality culture in the medical device industry and considerations for the […]
The Road to Poor Quality
“How did you go bankrupt?” Bill asked. “Two ways,” Mike said. “Gradually and then suddenly.” -Ernest Hemingway, The Sun Also Rises. Gradually, Then Suddenly In Ernest Hemingway’s novel “The Sun Also Rises,” the quote above refers to the character’s financial predicament. However, most of us can see that this sentiment resonates far beyond financial matters and […]
Visualizing Quality Culture Data – Analyzing 2 Scenarios
The following article is taken from June 15th Webinar – “Create a Quality Culture data to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives”. Challenges of Weak or Ambiguous Quality Culture Data Now let’s look at a third quality culture scenario, where you have a weak or ambiguous culture. Notice in this one that […]
When Would A Company Consider Using Quality Pulse?
Using Quality Pulse® has several use cases that add value to an organization. I’ll give 4 as an example, here. Quality Systems Improvement Initiatives The company is undertaking a quality systems improvement initiative in which they are revising their procedures and systems. It may be driven by a regulatory audit, an internal audit, continuous improvement, […]
Reducing Supply Chain Risk with a Scorecard Approach
Global supply chains can be disrupted in many ways, including geopolitical instability, environmental disasters, regulatory non-compliance, and financial instability. To mitigate these risks, companies must proactively assess the vulnerability of their suppliers and manufacturing plants. One of the most effective tools for this is a supply chain risk scorecard that systematically evaluates key risk factors […]
Supply Chain Chaos: Why Resilience Is the New Competitive Advantage
In today’s volatile global economy, “supply chain chaos” has gone from industry jargon to everyday reality. From raw material shortages to geopolitical instability, the once invisible machinery of global commerce is now in chaos. Pandemic shutdowns, natural disasters, and transportation bottlenecks have exposed how fragile global supply chains are. While many companies are scrambling to […]
Quality Assurance’s Role in Due Diligence for the Life Sciences industry
The Quality Assurance (QA) function is pivotal during due diligence in the life sciences industry. QA professionals play a critical role in ensuring compliance, identifying systemic risks, and validating the integrity of operations. This guide outlines the essential QA tasks during due diligence and provides a targeted approach to evaluating and remediating quality-related gaps. Know […]
