Danish physicist Niels Bohr once said, “Every great and deep difficulty bears in itself its own solution. It forces us to change our thinking in order to find it.” Bohr’s work was instrumental in the discovery of the electron, an elusive subatomic particle whose location, even now, we can only describe in terms of a field of probability.
A proactive approach to employee training is the foundation to Good Manufacturing Practice (GMP) compliance. By creating a comprehensive, standardized program and keeping an eye out for common mistakes, companies can foster a proactive quality culture that prevents problems at their source.
ISO 13485 for Medical Device Quality Management Systems is growing in popularity, with the number of certified facilities jumping 13% from 2015 to 2016.
When it comes to solving problems that arise in manufacturing, identifying the cause of what went wrong is top priority. But what about once you’ve pinpointed the root cause of the issue? That’s when the real work starts, and you have to make a corrective action plan capable of fully resolving the problem.
You hear it all the time on Car Talk, the classic radio show where mechanics Tom and Ray (aka “Click and Clack”) dispense hilarious advice to clueless car owners. The caller’s car was smoking for months before breaking down. Or the driver taped over a flashing temperature light, continuing to drive her dad’s car until it died altogether.
Musculoskeletal disorders (MSDs) such as carpal tunnel syndrome and herniated discs are some of the most common workplace injuries. According to the U.S. Occupational Safety and Health Administration (OSHA), MSDs account for 34% of lost-time injuries and every $1 in $3 spent on workers’ compensation costs.
Many of us grew up with the old-fashioned food pyramid: 6 servings of grains, 5 servings of fruits and veggies, 3 servings of dairy and so on. Today, we have MyPlate, where the basic concepts behind the old food pyramid still appear to hold sway.
Research shows a full 70 percent of organizational change projects fail, a statistic which has remained at the same level since the 1970s. It’s one reason why so many companies are hesitant to implement changes, even when the potential upside is big.
The U.S. Food and Drug Administration (FDA) requires companies to validate any software used in design, manufacture, packaging, labeling, storage, installation and servicing of finished devices. Companies must also use change control to ensure changes to IT systems don’t create unintended risks.
Drug companies are constantly grappling with complicated changes in their industry. Those that are quick to identify new pharmaceutical risks and develop policies and procedures to mitigate them can reduce their exposure in an ever-changing landscape. Several important industry trends are reshaping the sector’s future, and we characterize these as the 7 deadly risks of pharma.
Risk has always had an implicit role in ISO standards, but newer versions are giving risk a more prominent place in quality and environmental management standards. Updated standards like ISO 9001:2015 and 14001:2015 require companies to apply risk-based thinking to a variety of processes across planning, operations and performance evaluation.
