Chemical Policy Development: A Recipe for Managing Restricted Substances Throughout the Full Product Lifecycle 

Restricted Substances Full Product Lifecycle

How does your organization manage restricted substances? Do you currently have a governance, risk management and compliance (GRC) network or chemical policy in place? Do you know which elements are considered essential as part of a plan to ensure consistent compliance?

A GRC Network is an interconnected set of processes, rules, tools and systems to adopt, implement, manage and monitor integrated, organizational programs. This achieves safety and compliance throughout the product lifecycle and up and down the supply chain. Many senior risk and compliance managers rely on this type of managed approach.

At the recent virtual Engage’20 Regulatory Compliance Forum and User Conference, Kami Blake, Sr. Customer Success Expert at Verisk 3E, discussed the importance of developing a GRC Network and chemical policy and how to take an approach which focuses on processes and policy. She outlined which considerations should be made to ensure intelligent compliance across the product lifecycle, … Read more...

Do You Know How Cold-Chain Requirements for the COVID-19 Vaccine Can Impact its Time to Launch?

COVID-19 Vaccine cold supply chain
The Good News: The Vaccines Work


News of promising results in COVID-19 vaccine research has brought a glimmer of hope to people around the world. Within the space of two weeks, both Pfizer and Moderna have announced that early results of their front-runner vaccines show an effectiveness rate of about 95%. The news catalyzed an upsurge in the stock market and spurred governments around the world to begin planning for delivering the vaccines to the most vulnerable populations.


The Bad News: Delivering the Vaccine Will Be Challenging


While the world’s attention has been on the vaccine as a way out of the COVID-19 crisis, distributing the vaccine globally will require one of the largest logistical operations in modern history. The most significant barrier to large-scale distribution is the requirement of a seamless cold-chain. Pfizer’s vaccine needs to be stored at an ultra-cold -75C, while Moderna’s vaccine requires storage at … Read more...

World Quality Day: COVID-19 Accelerates Push for Quality Maturity in Life Sciences

COVID-19 Quality Supply Chains FDA

COVID-19 has brought unprecedented challenges to quality and supply chain management within the life sciences industry. Drug shortages caused by unprecedented supply and demand pressures continue to be significant challenges for many life sciences companies today and for the general public at large as the pandemic continues to escalate.


The Fragile State of the Pharmaceutical Supply Chains in the US


According to a recent report by the Center for Infectious Disease Research and Policy (CIDRAP), the US domestic pharmaceutical supply chain remains in a state of heightened vulnerability, with almost three quarters of the critical drugs required to treat COVID-19 patients facing significant shortages. The current shortages have brought quality management into the spotlight for many life science organizations and have tightened the focus on issues of quality maturity across the larger pharmaceutical manufacturing value chain.

Beyond supply chain disruption, additional factors including implementation of new public health safety protocols, … Read more...

How to Build Supply Chain Resiliency in a Pandemic World

Supply Chain Resiliency

When we go shopping at our local grocery store, pharmacy, hardware outlet, or just about any other kind of retailer, we expect the goods we’re seeking to be there, sitting on the shelf, ready for us to purchase and take home to use whenever we so desire. We take for granted this instantaneous availability of practically anything we want or need.


The Robust Design and Interconnected Systems of Global Supply Chains


What we so infrequently consider is why we are able to do so. The answer lies in the advanced efficiencies built into the modern supply chain that underpins these products’ raw material sourcing, manufacture, and ultimate delivery to the retail outlets we frequent. It’s easy to forget all the necessary steps that must take place for us to enjoy this convenient consumption.

Because supply chains have become so invisibly ingrained in our lives, it’s also easy to forget just … Read more...

How Home Renovation Projects Have Exposed Supply Chain Fragility

Supply Chain Fragility

Like many people around the world, you’ve probably been working from home for the past six months. Perhaps you’ve also been monitoring your children as they navigate the improvised labyrinth of online learning. All day, every day, you’ve been immersed in your home environment far more than you ever thought you would be. It seems like you’re constantly preparing food, loading the dishwasher, doing laundry, getting snacks, and engaging in a seemingly infinite number of other mundane activities that have turned your quiet home into a concerto for frazzled knowledge-worker soloist and obsolete-appliance orchestra.

If this is you, then perhaps your familiarity with your home has bred contempt for its flaws. Perhaps, you reason, if you’re to be imprisoned in your home during the dreaded second wave of the pandemic, it’s time to switch things up a bit, time to retire your veteran appliances and draft in a new generation … Read more...

HelloFresh Is Using Technology To Take a Huge Bite Out of a Multitrillion Dollar Industry

When families are counting on you for dinner, an unreliable supply chain is not an option. HelloFresh focuses on every step of the farm-to-door journey, shipping meal kits to millions of Americans, each filled with all of the ingredients necessary to prepare three to five different meals.

I recently found out how HelloFresh is using technology to reduce waste, improve quality processes and streamline supplier relations, all while doubling orders and revenue year-over-year.

It’s estimated that 40 percent of the food supply in the United States goes to waste because of over-portioning and wasteful distribution. Because of the attention to correct portioning, HelloFresh reduces the dinner food waste of its customers by at least 21 percent, resulting in a staggering reduction of food waste each week.

The company has over 2,500 employees in the United States who provide millions of meals that are carefully planned, carefully sourced and delivered … Read more...

Pivoting Towards Progress: Driving Agility in Quality and Supplier Management by Foolproofing Supply Chains

As the saying goes: “Progress doesn’t always follow a straight line.” No matter how severe short-term challenges can be, what is critical is that you’re always moving forward.

While predicting future changes or disruptions is next to impossible (particularly in the business world), planning for every major scenario is crucial and is essentially what sets forward-thinking leaders apart from the rest.


Navigating through Disruption: Current Challenges in Quality and Supplier Management


While no industry or sector is immune to the effects and aftereffects of the COVID-19 pandemic, there are some that have been harder hit than others. The quality and supplier management space just happen to fall into that category. Within these practice areas, supply chains have gone through a severe disruption.

While there is a breadth of challenges that supply chain leaders have been facing, the most common ones include the following:

Type of DisruptionHow They are Brought
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How the Elliott Review Can Help You Protect Your Food Supply Chain

Most people have heard about the EU horsemeat scandal in 2013, in which supermarkets in the UK were found to be selling beef products adulterated with horse meat. While this is perhaps the most high-profile example of food crime in recent years, its visibility also serves to overshadow many other disturbing, and more common, examples of food crime. For example, in July 2013, North Yorkshire Trading Standards sampled lamb curries from 10 takeaways and discovered that seven contained lamb and chicken, one contained lamb and beef, and only one contained just lamb as advertised. In December 2013, West Yorkshire Joint Services conducted tests on 873 food samples from restaurants and takeaways. 38% of these samples failed the test for food authenticity and showed that they were adulterated by unlisted ingredients and substitutes, including the use of cheese analogue instead of real cheese and chicken substituted for beef. In an earlier sample, they tested 16 lamb … Read more...

Canadian Honey Producers Stung by Sophisticated Food Fraud

Food fraud is big business. Criminal organizations around the world earn millions of dollars annually by cutting high-quality food products with cheaper substitutes to increase profits. The practice is so ubiquitous throughout the food industry that food protection agencies refer to it as economically motivated adulteration (EMA) The consequences of this practice can include reputational damage to respected food brands, public health crises resulting from adulteration using hazardous elements designed to avoid standard integrity testing, and financial damage to legitimate producers who can’t compete with cheaper adulterated products.  

According to a recent news story, the Canadian Food Inspection Agency (CFIA) has been conducting targeted surveillance on international producers of adulterated honey entering the Canadian market since 2018. By analyzing 240 samples of imported honey, CFIA determined that one-fifth of the samples advertised as pure honey are adulterated with corn syrup, rice syrup, and cane sugar syrup. As a result of the inspection, … Read more...

Protecting the food supply chain from fraud and malicious attack

Every few years, an intentional adulteration of the food supply grabs headlines around the world. In 2008, Chinese dairy manufacturers added the chemical melamine, a plasticizing agent, to milk and infant formula to boost the detectable protein levels, resulting in the hospitalization of 54,000 children and six deaths. The 2013 EU horse meat scandal, in which horse meat was substituted for beef in products sold across the EU, severely damaged consumer confidence in traceability and testing standards for meat products. Perhaps even more disturbing is the possibility of intentional contamination of the food supply to cause harm, a possibility that has gained more attention in the age of global terrorism. 

With the complexity of today’s international food supply chain, it is vital that the food industry move beyond food safety and quality approaches to incorporate food fraud—to protect against intentional contamination for economic gain—and food defence—to protect against intentional contamination to cause harm. … Read more...