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.
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: Medical Device Manufacturers & Risk
Knowing the difference between FDA Cleared and FDA Approved will help medical device manufacturers reduce risk.
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.
How to Select a Quality Management System: 7 Key Elements for Successful Implementation
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
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.