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.
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.
Companies that don’t factor a potential delay into a new product introduction are leaving themselves open to preventable quality pain points and, potentially, a hit to more than just the balance sheet.
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.
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.
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.
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.
Knowing the difference between FDA Cleared and FDA Approved will help medical device manufacturers reduce risk.
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.
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.
Most people are acutely aware that their personal work/life balance is skewed disproportionately towards the workplace. We spend a lot of time in the work environment, interacting with individuals who are colleagues rather than friends.
To help you avoid QMS implementation failure, this paper outlines seven key considerations in selecting a QMS software solution, exploring elements such as: • Features to look for as you gather your requirements • Common mistakes and pitfalls to avoid during the evaluation process • Tips for choosing a vendor and QMS that will unlock quality opportunities and deliver exceptional results
