quality culture Posts

Uncovering the Real Cost of Quality: 1-10-100-1,000-10,000

Uncovering the Real Cost of Quality: 1-10-100-1,000-10,000

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions

Can you capture or even approximate the cost of quality defects? Is it possible to put a price on a true or potential product recall? For manufacturers whose products can mean the difference between life and death, the costs can be staggering. The cost to prevent quality problems? It pales in comparison. No matter the product, the cost impact can not only be in real dollars, but reputation, market momentum, and shareholder value. (more…)

The Do’s and Don’ts of Successful Root Cause Analysis

The Do’s and Don’ts of Successful Root Cause Analysis

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

We often hear that the CAPA process is the “heartbeat” of the quality system. The changes that emerge from the CAPA process are critical to correcting defects, improving business processes, and meeting customer expectations. When you think more about CAPA, you realize that an effective CAPA process hinges on your team’s ability to understand the true cause of each problem you encounter. With that in mind, here are some tips to help refine your root cause analysis process and keep risky problems from reoccurring. (more…)

Leverage Your CAPA Process to Build a Culture of Quality (Free E-Book)

Leverage Your CAPA Process to Build a Culture of Quality (Free E-Book)

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

The Corrective and Preventive Action (CAPA) process is at the heart of your quality and compliance system. When properly implemented, CAPA resolves and prevents critical problems and also keeps you in compliance with FDA regulations. But year after year, lack of CAPA procedures and documentation make the list of top FDA 483 observations. The FDA closely monitors the CAPA process, which is why you need to have a handle on it as well. (more…)

7 Ways Life Sciences Executives Can Help Foster a Quality Culture

7 Ways Life Sciences Executives Can Help Foster a Quality Culture

Matthew Littlefield, President & Principal Analyst, LNS Research

Nearly every executive responsible for quality and compliance in life sciences has the topic of culture on their mind. Why? Because in an industry driven by innovation, deep down it’s the people — the scientists, the engineers, the shop floor workers — that separate one company from another. And having a culture that puts quality and compliance first can be the foremost source of differentiation.

Although many executives understand the importance of a quality and compliance-based culture, few have actually been successful in developing their own. Our recent Quality Management Systems survey verifies this, revealing that 30% of life sciences executives feel their organization considers quality much more of a single department rather than an organizational responsibility. (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.
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