Travel is restricted, companies have moved to virtual work wherever possible, and the world is attempting to maintain some normalcy in the face of a global pandemic. While the long-term economic impact on supply chains has yet to be seen, there is still an obligation on the part of companies to attempt to maintain supplier quality activities, especially audits.
How Online Food Safety Loopholes Are Impacting Consumer Trust
Investigative journalism conducted by CNBC has shone a light on a plethora of food product quality problems that include but are not limited to expired foods and beverages, mislabeling, counterfeit items and a host of unresolved customer complaints. Many of these identified quality pain points are related to third-party sellers as opposed to the producing brand itself, but there is a consensus that the ecommerce behemoth's apparent failure to clamp down on the number of poor quality consumable products being sold through its marketplace is impacting both consumer trust and the brand reputation of the manufacturer.
Quality Matters: Why The Quality You Deliver Defines Your Brand.
Customer expectations of product quality have evolved and grown in recent years. As a result, there is increased pressure on companies to understand both the nuances of quality itself and why quality matters. In fact, tapping into – and by association, improving - customer experience has become a holy grail for brands, many of whom have seen the benefits that come from both predicting the needs of the customer and personalizing the experience itself. On the flip side, the feedback that companies get from customer experience doesn’t give the full picture, is naturally subjective, and may not provide actionable insights into actual quality pain points.
Medical Device Security: Ongoing Threats And New FDA Guidance
On October 1, 2019, the U.S. Food and Drug Administration (FDA) issued a Safety Communication that was a thinly veiled wake-up call to patients, doctors and manufacturers about potential cybersecurity vulnerabilities in software used in a wide range of connected medical devices.
Why Supply Chain Management Requires A Digital Mindset
Whisper it quietly, but the future of quality is not just here but also making its presence felt. And thanks to a combination of the connected society, evolving customer expectations and the elevation of a digital mindset as a business optimization tool, companies are waking up to the fact that they need to adapt their working practices and quality management to fit the technology requirements of Industry 4.0.
New Product Introduction: Always Expect The Unexpected
Quality Matters: Allergen Awareness, HACCP Violations and Chicken-Fueled Brexit Food Safety Concerns
Fall is here but winter is coming. Three financial quarters in the bag, and just one more to go until the calendar year concludes at the end of December with the holiday season. The good news is that a quality management system will not take time off for family gatherings, parties or other festivities. The same applies to the FDA or other regulatory bodies. And although the possibilities for continuous improvement that quality creates are both endless and rarely time-stamped, companies always need to keep their eye on both the regulatory and compliance landscape.
Report: Quality 4.0 Adoption Will Require More Than Just Emerging Technology
After years of hearing that digital transformation will be the magical ingredient for companies of all shapes and sizes, the consensus is that we are finally on the cusp of integrating emerging technologies into business optimization strategies such as quality management. However, the adoption of next-generation tech is only one part of a quality transformation puzzle that is indelibly linked to the requirements of Industry 4.0.
Report: External Pressures Are Changing How Companies View QMS Solutions
Product quality may be a public reflection of brand values, but companies that don’t optimize quality management, strategy and leadership to fit in with the demands of the modern regulatory and consumer marketplace could become a 21st century anachronism. A recent state-of-the-market report by Gartner said that disparate elements such as regulatory requirements, changing business models and a heightened visibility to product quality issues within the consumer marketplace are accelerating the need for companies to integrate dedicated business optimization software into their internal and external quality management systems (QMS). Traditional QMS processes such as spreadsheets and physical clipboards are reportedly still prevalent, but there is an acknowledgment that automated solutions are the best way to handle document control, corrective and preventative action (CAPA), employee qualification, internal controls and other critical quality functions.
Fighting The Fakes: Why Counterfeits In The Supply Chain Is A Quality Problem
Companies that are not confronting the potential quality issues generated by counterfeits or bogus products in their supply chain ecosystem are leaving themselves open to a world of pain. Logistics Management reported that the prospect of counterfeits in the supply chain is an ever-growing threat, with numerous industry sectors worried about the impact that a fake could have on both consumer confidence and overall product quality. Counterfeiting is already a billion-dollar business, and it is reportedly becoming harder to differentiate the fake from the real thing.
FDA Cleared vs. FDA Approved: Why the 510(k) System Is Broken and How Medical Device Manufacturers Can Reduce Risk
Nearly every day, the public is bombarded with stories of medical device failures. There was the recall of 6 million defective endotracheal tubes used to keep patients breathing during surgery. Or, how about the FDA’s total shutdown of pelvic mesh sales after discovering that the concept didn’t translate well from similar-but-different hernia mesh, instead causing bleeding, infection and even punctured organs in some patients. Maybe you heard about the duodenoscopes used extensively for diagnosing and treating upper digestive tract problems that have sickened hundreds of patients and can even transmit antibiotic-resistant superbugs, that was reported by the New York Times.
HACCP 101: What Food Manufacturers Need to Know
It’s been over 10 years since the multi-state peanut butter salmonella outbreak in 2008 and 2009 that killed nine and sickened over 700 people, leading to one of the largest recalls in U.S. history. Details of the investigation and criminal case tell a disturbing story of food safety gone awry, complete with fraud, lies to federal prosecutors and knowingly selling products that tested positive for contamination.
Why FDA Compliance Needs A Defined CAPA Process.
According to a recent U.S. Food and Drug Administration (FDA) Medical Device Enforcement and Quality Report, the agency has increased annual inspections at manufacturing facilities by 46 percent since 2007. In 2017 alone, the FDA conducted 2,592 inspections, the report said, with foreign facility inspections increasing by 243 percent in the same ten-year period.