This week’s roundup considers the changes to the management commitment clause within ISO 9001:2015, and looks into why empathy plays an important part in the quality journey. We conclude with tips on how you can start managing your compliance obligations more effectively, today.
Risk has always been essential to ensuring quality in pharmaceutical and medical device manufacturing. But with the latest version of ISO 9001, risk is now officially part of the management system standard.
One of the biggest changes in ISO 9001:2015 is the replacement of preventive action with risk-based thinking requirements in context, leadership and planning sections.
Experts will say risk-based thinking is a watered-down version of more robust risk management processes, but the guiding principles are the same. Identify your hazards, consider the potential consequences and take action as necessary.
With that in mind, let’s look at 3 critical areas life sciences companies can integrate risk to improve quality and safety.
This week’s roundup brings you updates and insights from the Life Sciences industry.
First, MPO magazine shows us how the laws for regulatory audits are changing, and how that can impact medical device manufacturers and suppliers in a positive way. Then, ODT Magazine “tests your patience” as it reviews the FDA’s most recent guidance updates to medical device testing.
Finally, the Traqpath blog gives insight into how automating corrective actions benefits your organization.
Pharmaceutical and medical device manufacturing is all about managing risk. How do you take a product from concept or molecule to finished product in a way that minimizes risks to patients and the company?
Organizations tend to focus on a standard set of risk tools, relying on things like Failure Modes and Effects Analysis (FMEA), risk matrices and the Risk Register to ensure risks are caught before they become problems.
And while these tools are incredibly valuable to risk management in general, sometimes it’s the process or system itself that creates hidden risks.
In today’s post, we’ll look at 4 of these risks, and how companies can address them.
This week’s roundup is focused on Environmental Health and Safety (EHS). We have compiled articles on protecting your most important tool (your hands!), how to weld a stronger workforce and the role of risk management in EHS processes.
After the mega-merger era of 2015-2016, the passage of the 21st Century Cures Act and a new administration in the White House, many in the medical device industry are wondering what changes are on the horizon for 2017.
It’s unclear whether the U.S. Food and Drug Administration (FDA) or the market will be the biggest driver of change, or exactly how these elements will affect the industry.
In this post, we’ll look at some of the most important medical device trends to watch this year.
5 Essential Tips for Effective Sanitation + Finding Solutions for Regulatory Compliance and Cost-Efficiency
First, Food Quality & Safety Magazine shares 5 tips for reducing foodborne illness under FSMA standards. Then, we take a look at how investing in a food safety system is a smarter long-term investment than risking recall. Finally, EtQ’s Tim Lozier looks at the future of predictive analytics for compliance management in the food and beverage industry.
Quality management experts throughout history have used the Pareto Principle (also called the 80/20 rule) in various ways. Vilfredo Pareto, an Italian economist, first came up with the idea based on his observation that 80 percent of Italy’s land belonged to just 20 percent of the country’s population.
Joseph Juran, one of the fathers of quality management, later adapted it into “The Rule of the Vital Few.” The ratio doesn’t have to be 80/20, and the numbers don’t have to add up to 100, but the idea is simple: a small number of inputs have an outsized impact on the outputs. For example, 20 percent of causes create 80 percent of your quality problems. In a more familiar example, most of us probably wear just 10 percent of what’s in our closets for 80 percent of the time.
With that in mind, this post looks at 7 ways you can apply the Pareto Principle to improve your quality management efforts.
This week’s roundup brings you the latest from the Life Science industry. In the news, we see the potential implications of Trump’s FDA pick on the medtech and biotech industries. Then, an article from MPO magazine sheds light on the benefits and best practices for corrective actions in the Life Sciences. Finally, EtQ’s blog guides us through everything you need to know when considering cloud software for your Life Science solution.
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.
But meeting FDA requirements around software validation and change control isn’t always straightforward, particularly if you don’t have in-house experts to guide the process.
With that in mind, let’s take a closer look at what’s required for initial validation, and how to use change control to maintain a validated Quality Management System (QMS).