Quality professionals know the value of automation. Minimizing errors that lead to defects, freeing up internal resources and optimizing collaboration can all have a significant impact on your bottom line and brand reputation. These are all key benefits of automated quality management software.
Quality Creates Perspective
A QMS Resource for Quality Champions: news, perspective and commentary on hot issues in quality and quality management.
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.
Workplace Safety: Five EHS Pitfalls That You Need To Be Aware Of.
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.
Lab Safety: How QMS Software Can Prevent Costly Mistakes
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.
Report: 52% Of Children’s Product Recalls Are Not Publicized On Social Media
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.
How To Map ISO 14001:2015 To Your EHS Management System
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.
How To Map Your QMS To EU MDR Requirements
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.
Avoid FDA Warning Letters with These 4 Document Control Best Practices
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.
4 Ways to Leverage Data for Operational Excellence
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.
Documentation Requirements in ISO 13485 – Start with a Quality Management System (QMS)
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.