Quality Management Posts

Pick Up a New Habit: Making Quality a Priority

Pick Up a New Habit: Making Quality a Priority

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

“Quality isn’t an act, it’s a habit.”

Aristotle said it first. But it doesn’t take a philosopher or a scientist to recognize that excellence doesn’t happen overnight. Just ask the drum major in the local high school band or the prima ballerina in the regional ballet company. It takes ongoing commitment to reach the pinnacle and continuous improvement to remain there.

The QA director at a leading pharma or medical device company know this, too. Very well. The practice of continual improvement starts with a unified, enterprise-wide commitment to ongoing best efforts and to process improvement. (more…)

Quality Risks: Use Quality System Data to See the Big Picture

Quality Risks: Use Quality System Data to See the Big Picture

Kevin Lee, Industry Solutions Manager, Pilgrim Quality Solutions

On a day-to-day basis, most of us are busy taking care of the details. We’re fixing problems as they happen, checking things off to-do lists, and responding to emails. But as we move through our busy days, most of us are aware of the periodic need to take a step back, look at the big picture, and assess our progress against our goals. That high-level look often reveals trends that need to be reinforced or changed as we move forward. Nowhere is this truer than within a quality system. The seemingly small or micro details that we work through each day add up with other processes and details to form the bigger (macro) picture of our organization’s risk.
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You Reap What You Sow: Tips to Growing Your Customers’ Success

You Reap What You Sow: Tips to Growing Your Customers’ Success

Regina Brimmer, Customer Success Manager, Pilgrim Quality Solutions

Most Fridays, this is a B2B blog focused on strategies for Quality and Compliance management. But just this once, you’ll find you’ve clicked on an advice column. We’re going to give you some relationship advice that will go a long way toward nurturing your organization’s reputation for Quality. Today, you will pick up some essential tips for cultivating your customers’ success and satisfaction.
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Supplier Quality Maturity: Ideas that Will Motivate You to Move to the Next Level

Supplier Quality Maturity: Ideas that Will Motivate You to Move to the Next Level

Roxane Napoli, Senior Marketing Manager, Pilgrim Quality Solutions

Recently, Pilgrim co-sponsored a webinar with LNS Research titled “Supercharge Supplier Quality Management for Competitive Advantage.” During the webinar, Dan Jacobs, LNS Research Analyst, provided many insightful data points from his recent research and made the case for focusing on and advancing supplier quality maturity.

The data is clear…and compelling. Almost every organization can achieve significant gains by improving supplier quality management processes and maturity. If you haven’t watched the webinar, you can access it here and see the data for yourself.
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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.
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Evaluating the Cost of Quality: It’s Simple Math

Evaluating the Cost of Quality: It’s Simple Math

Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions

Every regulated organization understands the need to implement a quality system. In fact, it’s a “shall” clause for all Life Science companies to ensure they are in compliance with industry regulations.

The focus of any effective quality system is, and rightly so, all about ensuring Patient Safety. From there, as the organization matures, its people, processes and technology evolve from a compliance, to a correction, to a prevention mindset, eventually resulting in increased quality brand recognition and shareholder value.
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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.
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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…)

Fusion 2016: Reflections of a First-Timer

Fusion 2016: Reflections of a First-Timer

Rick Lowrey, CEO, Pilgrim Quality Solutions

“The most successful customer conferences are contingent on active customer participation and Pilgrim team collaboration.”

#PilgrimFusion 2016 was my first customer event since joining Pilgrim Quality Solutions as CEO in May 2015.  I had the opportunity to meet many customers at once and learn and understand their experience with Pilgrim as their compliance and quality partner. Having spent years in software, I’ve attended my share of user conferences both as a user and as an employee of an enterprise software business, but this year was an entirely new experience. (more…)

3 Considerations for QMS Rapid Implementation: Like Sands through the Hourglass

3 Considerations for QMS Rapid Implementation: Like Sands through the Hourglass

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

Time waits for no one. No one is more aware of this than companies that cater to the world’s growing health care industry. These organizations walk a fine line every day between producing life-altering solutions as quickly as they can conceive of them, and doing so in full regulatory compliance and to 100-percent quality.

Life Sciences companies today are performing this balancing act between productivity and quality amid myriad growing pressures from customers, suppliers, and regulators, as their operations are having increasingly global impact. When you sprinkle risk management concerns and reputation management into the operations mix, the pressure grows even stronger. (more…)