Risk Management Posts

Risk Management: Key Takeaways from Last Week’s ISO 13485:2016 Webinar

Risk Management: Key Takeaways from Last Week’s ISO 13485:2016 Webinar

Justin L. Smith, Manager of Product Management, Pilgrim Quality Solutions

Last week we hosted a webinar titled “Regulations, Risk, and Responsibilities: Closing the Gap on ISO 13485:2016 Compliance.” The webinar was presented by Dan O’Leary, President of OMBU Enterprises, and Kari Miller, Pilgrim’s Vice President of Regulatory and Product Management. If you were unable to attend the webinar, you can watch the Closing the Gaps in ISO 13485:2016 Compliance On-demand Webinar.

During the webinar, Dan presented several areas where the latest version of ISO 13485 will present significant challenges to medical device manufacturers. These areas include supplier management, complaint handling, integrating regulatory requirements into the quality system, and the way your company approaches risk.
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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…)

Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Top Concerns for Quality Audits: 5 Highlights from Last Week’s SmartSolve Audit Management Webinar

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Recently, we hosted two live demonstrations of SmartSolve Audit Management. The webinar covered a number of topics including how to perform mobile audits, creating audit programs and schedules, working on audits, and managing audit followup.  The webinar also included live Q&A during both sessions.

Some key themes emerged during both sessions that helped us understand the challenges you may encounter when carrying out quality audits, and how SmartSolve Audit Management can help.

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Use Storyboarding to Sell Management on ERM

Use Storyboarding to Sell Management on ERM

Mark Crawford

When we think of solutions, we tend to think about technology and software and implementation—which is fine if the decision to launch an enterprise risk management (ERM) initiative has already been made, the due diligence completed, and the vendor lined up. (more…)

When It Comes to Enterprise Risk Management, 26.6% of All Companies Don’t Do It

When It Comes to Enterprise Risk Management, 26.6% of All Companies Don’t Do It

Mark Crawford

According to a survey by thePoole College of Management at North Carolina State University, over one-fourth (26.6 percent) of all respondents to a recent survey on enterprise risk oversight have no enterprise-wide risk management (ERM) process in place. (more…)

CAPA Risk Management and ROI

CAPA Risk Management and ROI

Konyika Nealy, Director of Quality Assurance, Pilgrim Quality Solutions

CAPA systems provide a wealth of information regarding the quality of a product or process.  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 product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records, of varying degrees of severity, which are often vetted by issuance order rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole. So then, how can a company reclaim efficiency and perhaps even streamline the CAPA process? (more…)

Risk Management Also Pertains to Social Media

Risk Management Also Pertains to Social Media

Mark Crawford

You may be asking… what does enterprise risk management have to do with social media? Most companies have accepted social media into their marketing and advertising strategies—even if they don’t understand it, or invest in it, as a business tool.

This can be dangerous.

According to Michael Krigsman on his blog IT Project Failures, although the benefits of social media are clear, such as direct access to customers, shortened feedback cycles, and personalized marketing—the risks may not be. (more…)

Product Liability: How Exposed Are You?

Mark Crawford

According to regulatory compliance expert James Kolka, management too often ignores the legal and financial threats posed by product liability lawsuits.

“Management often believes that compliance with FDA’s Quality System Regulation (QSR) protects the company from product liability exposure,” says Kolka. “Consequently, the task of product liability management is invisible and not audited. It seems to materialize when there is a lawsuit and a mad scramble to find who is or should have been responsible.” (more…)

Integrating Risk Management into the Design Process

Mark Crawford

Ron Litke, a senior development engineer with Orchid Design, a division of Orchid Orthopedic Solutions, has over 15 years of design and project management for orthopedics and medical devices. In this brief interview he shares some thoughts about implementing risk management during the design and development process. (more…)

Key Reminders for Managing Suppliers

Mark Crawford

Supply chain management is harder than it used to be. Many OEMs are outsourcing more functions instead of keeping them in-house, adding geographical distance and cultural diversity to the supply chain. This, of course, adds complexity as well, which increases the chances of something going wrong and compromising quality. (more…)