Simple mistakes can cost life sciences companies millions of dollars in revenue and time spent resolving the problem. When you consider the crucial role of lab work in bringing a product to market, it becomes clear just how vital quality management is to the product lifecycle.
A study by consumer advocacy organization Kids In Danger (KID) said that digital information about child-related product recalls is often hard to find, with brands making a conscious decision to limit consumer awareness of potential safety or compliance issues with children’s products. As a result, and according to KID’s “Recalls Online: Missed Opportunities for Engagement” report, transparency around a product recall process is very much a hit-and-miss affair, especially in terms of what the customer needs to do next.
Companies that have not upgraded their EHS management system to ISO 14001:2015 could find that they not only no longer have a valid certification but also that they’re overlooking key environmental compliance issues.
The EU's revision of medical device legislation was long overdue ... but what is the impact? Medical device manufacturers who are not up to speed with the latest European Union compliance requirements could find themselves struggling to catch up.
Incomplete records stuffed in the trash, with the signatures still showing. Blank forms issued complete with signatures. Employees shredding documents without bothering to record why and what they were destroying, even as inspectors were onsite.
Data can be a gift and a curse when it comes to operational excellence. For some companies, ineffective practices make data a barrier to improvement, with too many data points and metrics obscuring the most strategic course of action.
When it comes to ISO certifications, one thing companies can count on is a mountain of documentation. It’s especially true for certifying to ISO 13485 for medical device quality management, as medical device manufacturers must provide extensive documentation as evidence of the safety of their products—and the effectiveness of their quality processes.
Total Quality Management (TQM) emerged in the 1980s in response to economic losses experienced due to Japanese manufacturers producing higher quality goods at lower cost. TQM was a natural outgrowth of the Toyota Production System, eventually giving rise to approaches like Lean Manufacturing and Six Sigma.
Experts are calling Industry 4.0 the fourth Industrial Revolution (hence the 4.0). The concept represents a push towards manufacturing digitization that experts say will deliver massive improvements in efficiency, costs and profits in as little as just a few years.
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.
