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 continues to be a major focus in most businesses today, regardless of industry. In the past few years, Life Sciences organizations 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. Subsequently, the standards organizations and regulators around the globe have taken note and responded accordingly. 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 by impacting the availability of products and services within that supply chain. Supplier impact, at a minimum, effects two legs of the three-legged Governance, Risk, and Compliance (GRC) stool: those two legs are Risk and Compliance. The impact of suppliers on an enterprise can be significant. (more…)

Quality within the BioPharma Industry Landscape

Quality within the BioPharma Industry Landscape

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

The American Society for Quality, touted as the “Global Voice of Quality,” states that manufacturers in the pharmaceutical industry are always working to balance the demands of meeting global regulations and production costs, in an effort to produce the most innovative research and development while also producing safe, reliable prescription drugs. As a biopharmaceutical industry veteran, I know the challenge is real. In fact, when illustrating a graphic representation of the Biopharma industry’s information management landscape, as I see it, the depiction is quite dense and complex. (more…)

A Deviation by Any Other Name

A Deviation by Any Other Name

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

What’s in a name? Depending on industry, a word can have very precise meaning. Look up the word “deviation” on the internet and the first definition to appear reads: noun, The action of departing from an established course or accepted standard. Statisticians use the term to define “The act of deviating” or “Deviation from a norm”.

If you search for the definition of “deviation” as applied in the Pharmaceutical industry, you’ll find some variation of “Unexpected departure from an approved instruction, procedure, established standard or specification.” In other words, “deviation” is not a desirable term in the Quality lexicon. (more…)

Continuing Education in the Quality Space

Continuing Education in the Quality Space

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

An important facet of any organization’s quality efforts is the knowledge of its personnel. The depth of each employee’s knowledge and skills contributes to the company’s ability to achieve its mission and goals. Conversely, employees who do not have the knowledge to perform their day-to-day functions pose a quality risk. This equation applies as much to long-time employees as to new hires. (more…)

Limit the Stakes with Risk-Based Employee Training

Limit the Stakes with Risk-Based Employee Training

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

Employees often know little about product liability and the role they have in the company’s overall risk profile. The acts or omissions of even one employee can have severe financial and operational consequences for companies. Employee risk management training is essential to bridging the awareness gap.

With the adoption of ISO 13485:2016, Life Sciences manufacturers have stepped up their risk-based training requirements. What about your organization? How do you currently define training requirements? If you’re not considering risk as you define them, you will need to add this consideration into your process. (more…)

EU MDR: T-Minus 500 Days…Are You Equipped?

EU MDR: T-Minus 500 Days…Are You Equipped?

Mark Rhys Burke, Senior Account Executive, Pilgrim Quality Solutions, an IQVIA company

In May 2017, the European Union (EU) embarked upon a three-year transition period designed to give medical device manufacturers time to comply with new regulatory requirements. The enforcement deadline for compliance with the Medical Device Regulation (EU MDR) is May 26, 2020. That deadline is looming large for everyone in the industry.

That said, I regularly speak to individuals who express trepidation about this rapidly approaching date. They simply don’t have the necessary documents and data prepared to meet the stringent new requirements – and they’re not alone. A recent survey of more than 200 regulatory and quality leaders at major medical device companies showed that 78% of those polled did not have sufficient understanding of the new regulations. (more…)

Quantify Risk to Boost CAPA Efficiency

Quantify Risk to Boost CAPA Efficiency

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

Corrective and Preventive Action (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 not uncommon 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 for aging reasons, 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. (more…)

Distinguish Yourself with Risk-based Supplier Inspections

Distinguish Yourself with Risk-based Supplier Inspections

Tommy Tully, Product Manager, Pilgrim Quality Solutions, an IQVIA company

Optimization of your supplier quality management processes gives you room to differentiate yourself from your competitors and gain advantages in your industry. Optimization alone, however, does not happen without regard for potential risks inherent within complex supply chains or ever-evolving regulatory requirements.

Your organization can distinguish itself from your competitors by circumventing potentially adverse situations before they become realities. Minimizing supplier-related risk will maximize your compliance and quality improvement activities, thereby growing customer trust and brand loyalty which will ultimately increase your organization’s bottom line. (more…)

Ready your Internal Audits for ISO 13485:2016

Ready your Internal Audits for ISO 13485:2016

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

Time is running out – one month and counting. Manufacturers must meet the requirements of ISO 13485:2016 by February 28, 2019 to maintain their certification.

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. (more…)

19 Quality Compliance Resolutions for 2019

19 Quality Compliance Resolutions for 2019

Be the change you want to see in 2019. We asked members of the Pilgrim blogging community to tap into their subject matter expertise to compile a list of some behaviors or routines that have been proven to fuel success. Consider these 19 suggested resolutions for Quality and Compliance practices, and think about how you can turn them into daily habits to drive your organization’s continuous improvement this year and beyond. (more…)