Risk Posts

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…)

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…)

Gain Competitive Advantage through Risk-based Employee Training

Gain Competitive Advantage through Risk-based Employee Training

Lynn Willis, Partner Enablement and Training Manager, Pilgrim Quality Solutions, an IQVIA company

Being competitive takes skill. Remaining competitive takes continuous effort. It’s what every enterprise strives for, so organizations would do well to heed wise words from the father of business management, Peter Drucker: “The only sustainable competitive advantage is an organization’s ability to learn faster than the competition. Your organization may be getting a run for your money, quite literally, by not investing in a solid learning strategy.”

And when it comes to managing a life sciences organization’s product quality and corporate regulatory risk, wiser words have not been spoken. (more…)

Risk-based CAPA and the Drive for Continuous Improvement

Risk-based CAPA and the Drive for Continuous Improvement

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

No matter the industry, if you are a member of a Quality Affairs team, you know that a Corrective and Preventive Action (CAPA) system provides a wealth of information regarding the quality of your organization’s products and processes. However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line.

For instance, it is commonplace for a CAPA to be initiated for each nonconformance or deviation, or product quality-related complaint or audit finding, regardless of scope or severity. Despite intense regulatory pressures, though, not every one of these circumstances should necessarily trigger a CAPA. The “everything is a CAPA” syndrome is both costly and time consuming. (more…)

Risk-based Audits: 5 Steps to Taking the “Risky” out and Putting the “Quality” in Your Business

Risk-based Audits: 5 Steps to Taking the “Risky” out and Putting the “Quality” in Your Business

Phil Johnson, Senior Director, Quality & Compliance Services, IQVIA

If you’re responsible for planning and carrying out your company’s internal audits, you know how much planning and effort it takes to monitor your quality system for GMP and ISO compliance. As your quality system has matured, you’ve probably noticed that certain sites, departments, or processes require more of your attention, while others are consistently in compliance and don’t need as much assistance. If this is the case in your organization, it’s time for you to consider a risk-based approach to your internal quality system audits.

The Value of a Risk-based Approach

A quality risk-based approach to internal audits allows you to assess the importance and performance of each area to be audited, and to use your results to devote your auditing time and resources to these critical business areas. Based on this risk assessment, you may also decide that certain areas of your business don’t need as much oversight. (more…)

ISO 13485 Compliance: Embed Risk Management within your Supplier Inspection Process

ISO 13485 Compliance: Embed Risk Management within your Supplier Inspection Process

Kavitha Rajaram, Senior Software Development Analyst, Pilgrim Quality Solutions, an IQVIA company

With deadlines approaching, ISO 13485 compliance is becoming more critical than ever before. Additionally, since ISO 13485 will be used as an auditing standard for the Medical Device Single Audit Program (MDSAP), your company may need to adhere to these standards during a regulatory audit. If you haven’t signed up for MDSAP audits yet, to prepare, you should conduct a gap analysis that closely examines organizational processes, especially quality management.

One of the prime high-risk areas in any manufacturing enterprise is its supply chain. A solid Supplier Quality Management system will support the processes that enhance supplier quality and keep supplier risk under control, improving the enterprise’s overall quality and compliance. (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, an IQVIA company

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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Practical Tips for Managing Supplier Risks in the Life Sciences Industry – Part 2

Practical Tips for Managing Supplier Risks in the Life Sciences Industry – Part 2

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company

Earlier this week we shared the first in a two-part series on practical tips for managing supplier risks in the Life Sciences industry. In the previous post we discussed how resource planning, understanding the rules, preparation, and planning lay the foundation for a successful supplier-risk management program. In today’s post we’ll provide practical tips for setting goals, coaching recommendations, and best practices for supplier performance and risk monitoring.
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Practical Tips for Managing Supplier Risks in the Life Sciences Industry

Practical Tips for Managing Supplier Risks in the Life Sciences Industry

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company

It is critical today that risk-based thinking be embedded across respective quality and compliance activities throughout the Life Sciences. ISO13485:2016 regulations are driving the industry to this paradigm. I recently explored practical tips for managing life sciences supplier risks together with a team of consultants, including Dr. Carmine Jabri of E.M.M.A. International Consulting Group, Aida Markham of QACV Consulting, and Kenneth Christie of VTS Consultants, Inc. This post is the first in a two-part series that examines our findings, which you also can uncover on-demand here.
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