2018 Posts

The Benefits of Supplier Management

The Benefits of Supplier Management

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

Supply chain risks grow as an organization’s suppliers expand geographically and companies increase offshoring and outsourcing activities. The increasing sophistication in technology, and ever-increasing regulatory oversight, are additional factors in the increased supply chain risk. Resulting supply chain issues are impacting medical device and pharmaceutical manufacturers around the globe, costing billions of dollars in market devaluations, recalls, regulatory fines, and settlements. But supplier management is a viable tool in the arsenal to minimize the risk of those outcomes. (more…)

The Medical Device Regulatory Landscape is Impacting Supplier Control

The Medical Device Regulatory Landscape is Impacting Supplier Control

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

Ask any corporate executive to list the top objectives of their organization’s Quality department and they’ll include the need for predictive and proactive risk management strategies. The Medical Device industry is no exception to this reality; if the industry wants to improve patient outcomes, then it has to manage risk.

One of the largest sources of organizational risk is dependence on third-party suppliers. Today’s global economy has added complexity to supply chains, and longer supply chains are making it increasingly difficult to manage our suppliers, and in many cases our suppliers’ suppliers, thereby increasing overall risk. The plethora of regulatory requirements placed in Medical Device organizations, including FDA mandates and the updates to ISO 13485:2016, reflect this new reality. (more…)

Supplier Risk and its Impact on Corporate Risk

Supplier Risk and its Impact on Corporate Risk

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

Risk is a major focus in most businesses today, regardless of industry. In the past few years, the Life Sciences have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. So it’s no surprise that minimizing business and operational risks, as well as legal and regulatory compliance, is on every executive’s mind, and for good reason.

Supplier risk, put simply, is the probability associated with a supplier causing an interruption in an organization’s supply chain and to the availability of products and services within that supply chain. Supplier impact, at a minimum, two legs of the three-legged Governance, Risk, and Compliance (GRC) stool: Risk and Compliance. It is safe to say then that the impact of suppliers on an enterprise is significant. (more…)

Planning for the medical device market: Getting the edge from post-market surveillance

Planning for the medical device market: Getting the edge from post-market surveillance

Pam Weagraff, Director MedTech Regulatory, IQVIA
Phil Johnson, Senior Principal, Quality and Compliance Services, IQVIA

Robust, predictive post-market surveillance systems that monitor medical device safety after launch, reduce both costs and demands on resources and increase product safety and performance. However, as competition intensifies, could it be time to revisit the approach?

The historical role of post-market surveillance (PMS) of medical devices has been reactive. It has focused on collating and reporting adverse events, such as device malfunctions or patient injuries, in order to trigger product returns, modifications, exchanges and recalls as necessary. However, as medical device complexity increases, PMS approaches will need to be more rigorous, leading to earlier detection of potential product failures in the field. (more…)

Supplier Management Validation: What’s Your Plan?

Supplier Management Validation: What’s Your Plan?

Ninoshka Ortiz, Senior Validation Specialist, Pilgrim Quality Solutions, an IQVIA company

To fulfill the needs of trending technologies and Life Science needs, a global supplier management program helps to integrate an appropriate level of assurance that suppliers and vendors are able to consistently supply quality of materials and services that are in compliance with regulatory requirements.

Have you considered whether your integrated supplier management program:

  • Is validated to effectively help your company to asses, manage and monitor supplier qualifications, and risk and compliance across your global supply chain process?
  • Is consistently producing the expected results for the intended use that your company is continuously seeking?

(more…)

Exploring Supplier Quality Management for MedTech

Exploring Supplier Quality Management for MedTech

Phil Johnson, Senior Principal, Quality and Compliance Services, IQVIA

As MedTech manufacturers, do you have the right business and regulatory processes in place to manage your respective supplier management responsibilities? Last week, I presented Part 2 of Pilgrim Quality Solutions’ 4-part webinar series, Quality In, Quality Out, taking an in-depth look at supplier quality management (SQM) processes for both medical device and in-vitro diagnostic medical device manufacturers. The key takeaway from the presentation? These manufacturers need to secure and maintain effective supplier agreements to manage both the regulatory and business needs of the product/material or service being provided.

During this webinar, I laid out the regulatory drivers for medical device supplier quality management and the importance of Quality in the evaluation, monitoring, and approval of suppliers. I also provided guidance for suppliers regarding how they manage their relationships with the legal manufacturers of the product. At the conclusion, I brought it all together by highlighting the prominence of SQM-related FDA 483s. (more…)

Why Supplier Management Belongs in your Enterprise QMS

Why Supplier Management Belongs in your Enterprise QMS

Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company

In over a dozen years as a sales engineer, and now as manager of that team, I have heard numerous recurring questions raised about specific topics when speaking to clients about their software needs and what processes belong in which systems.

One topic that has arisen over the past few years is best practices for supplier management. Should supplier management, and specifically supplier onboarding and maintenance, be a function of the Enterprise Resource Planning (ERP) system or the Quality System? This is by far the most common and most debated element. (more…)

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?

(more…)

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…)