Quality Posts

Supplier Quality Management in the Medical Device Industry

Supplier Quality Management in the Medical Device Industry

Daryl Oldham, Product Marketing Manager, Pilgrim Quality Solutions, an IQVIA company

When I recapped the first webinar in Pilgrim Quality Solutions’ Quality In, Quality Out: Supplier Quality Management four-part series, I started my blog with two questions:

  • Do you have the proper process in place to evaluate, monitor, track, and rate your suppliers?
  • How confident are you that you can rely on your suppliers or even that you are protected from issues your suppliers encounter at any of their locations?

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Know Your Suppliers: Protect Your Customers

Know Your Suppliers: Protect Your Customers

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Knowing your suppliers is as important as knowing the material they provide. Life Sciences regulators around the globe could not agree more! If you have a product defect, it doesn’t matter who is at “fault”, your supplier or your own organization.

Ultimately regulators are going to hold your organization (the license holder for the finished product) responsible for the quality of the materials and services your suppliers provide you. This is evidenced in recently updated standards and regulations such as ISO 13485:2016 and EU MDR, or long-standing standards such as 21 CFR Part 820 and Part 211, or ICH Q9 and Q10. However, and more importantly, the only thing the public will see and react to is your product and your brand. It pays to maintain tight oversight of your suppliers, and not just for compliance reasons. (more…)

Quality In, Quality Out: Exploring Supplier Quality Management – Key Takeaways

Quality In, Quality Out: Exploring Supplier Quality Management – Key Takeaways

Daryl Oldham, Product Marketing Manager, Pilgrim Quality Solutions, an IQVIA company

Do you have the proper processes in place to evaluate, monitor, track, and rate your suppliers? How confident are you that you can rely on your suppliers, or even that you are protected from issues your suppliers encounter at any of their locations?

As global outsourcing activities increase, manufacturers should be placing additional emphasis on the control/oversight of their suppliers, and paying attention to potential risks. Poor cost of quality results in rework, waste, delays in product approval, resource inefficiencies, corrections and removals, enforcement actions, etc., which impact the bottom line. (more…)

Extended Supply Chains Require Enterprise QMS that Extends Outside your Four Walls

Extended Supply Chains Require Enterprise QMS that Extends Outside your Four Walls

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

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. Regulators will continue to focus in this area as data shows that scrutiny is warranted. For example, from the FDA for Medical Devices (just a portion of the life science market), 24% of all observations made in the period ending September 30th, 2017, were due to supplier issues. (more…)

The Need for QMS Transformation & Structured QMS Data

The Need for QMS Transformation & Structured QMS Data

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

As product recalls, product bans, drug shortages, plant shutdowns, and enforcement actions continue to rise, industry and regulators alike are looking for answers on how to change the perspective of the Life Sciences industry from one of Compliance to one of Quality.

Is the solution to increase the amount of data we capture and report within our documents? After all, we so carefully record a great deal of data in a Quality Management System (QMS). No, data in and of itself, is not the answer. While data/metrics go a long way toward accomplishing the shift from compliance to quality, that data needs to be transformed into intelligence that is informed, actionable, proactive, and predictive.
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Quality Nirvana Revisited

Quality Nirvana Revisited

Kari Miller, Regulatory & Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

With the pace at which business moves today, we’re not often provided the opportunity to revisit previous blog posts, reflect back on position statements, or re-examine our thoughts from a fresh perspective. However, recently an e-book that I authored two years ago, Finding Your Path to Quality Nirvana, was re-published, giving me the opportunity to reassess some of the questions that were posed within its pages.

In the e-book, I answered the following questions, and I wondered, now that time has passed, what came to be, and how some of the questions would be answered today. (more…)

Heralding the Era of Human Data Science

Heralding the Era of Human Data Science

Marla Kessler, Senior Vice President, Strategy, Marketing, and Communications, IQVIA

It’s an exciting time in healthcare. We now live in a world of bionic eyes and pills made from 3D printing. We are seeing technology advance health every day providing a glimpse of the potential ahead of us. Sharing this vision, we at IQVIA are exploring a new discipline – Human Data Science – to bring together the advances in data science with the possibilities of human science to improve health. (more…)

Sample, Skip and Switch – The Basics of Risk-based Incoming Inspection

Sample, Skip and Switch – The Basics of Risk-based Incoming Inspection

Bernard Jee, Product Manager, Pilgrim Quality Solutions, an IQVIA company

You’re probably conducting incoming inspections today but if you aren’t taking a risk-based approach, chances are you’re performing inspections you don’t need to do and possibly overlooking the items which need to be inspected most.  Implementing a risk-based sampling system helps you spend less time and less money inspecting high-quality raw materials when you are already confident that they are good. You’re also able to pinpoint poorly performing raw materials and suppliers based on their inspection state. (more…)

Make the Move: Solutions for Next-Generation QMS

Make the Move: Solutions for Next-Generation QMS

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

More than ever before, Life Science quality professionals are feeling the pressure of increasing regulations and the rapid pace of business and industry-driven change. In previous posts, we’ve discussed these challenges, as well as the imperatives for the next generation of quality solutions that will help meet them. Next-generation enterprise quality management systems (QMS) must drive real product quality, link closely with business objectives, enable global harmonization, support enterprise quality, and enable an organization’s culture of quality. That’s a tall order for most quality systems that are deployed within Life Sciences organizations today.
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The Keys to Implementing an Inclusive Quality Management System

The Keys to Implementing an Inclusive Quality Management System

David Thomas, Sr. Director of Global Services, Pilgrim Quality Solutions, an IQVIA company

Frequently, I’m on the road speaking with customers and addressing quality professionals, and frequently I’m asked, “If you had to give one piece of advice to someone looking to implement an Enterprise Quality Management System (QMS), what would it be? When implementing an Enterprise QMS, the best advice is inclusion.

It’s one simple word – inclusion – but one loaded with such wide-ranging positive impact. (more…)