To introduce risk-based thinking across your organization ‒ as mandated in ISO 9001 and other important standards ‒ follow our Plan-Do-Check-Act checklist.Read More
While most standard revisions now follow ISO 9001’s new high-level structure, ISO 13485 does not, even though it was released after ISO 9001. Clearly there are structural differences, but you may be wondering—how different are they?
Today we’re looking at the similarities and differences between the two standards, and whether life sciences companies and related services need both certifications.Read More
Six people were killed in the collapse of a pedestrian bridge at Florida International University on March 15.
The bridge, designed to keep students safe, did just the opposite in its final stages of construction. A National Transportation Safety Board team is launching an investigation to determine exactly what went wrong.Read More
BBS is a best practices strategy for improving safety performance, but without the right tools in place, companies face a high risk of failure. That’s because BBS is all about changing human habits, which are often ingrained over years of habit. You can’t manage what you don’t measure, which is why soft programs that live outside the EHS Management System often fail.
In this post, we’ll look at what BBS is and how technology can help support your BBS program, including tips on how to construct powerful BBS checklists.Read More
Pharmaceuticals companies who want to reduce the risks of clinical trials need to realize that their document and data controls are just as important as all the ground-breaking research that goes into drug development.Read More
Imagine a situation where your plant has a huge backlog of corrective actions 30, 60, even 90 days overdue. Defects and complaints are high, quality costs are rising and nobody seems motivated to fix the problem.
You got a nonconformance from your ISO registrar because of it, and you’ve got another audit next week where you’ll surely get hammered again. One of your most valued team members is so frustrated with the inaction and lack of accountability, he’s looking for a new job. Sound extreme?
It’s more common than you think.
Today we’re tackling the issue of overdue corrective actions, providing a practical guide for turning the ship around so you can stop this destructive cycle.Read More
You have a solid quality system in place for product design, production and testing. Your medical devices pass all tests with flying colors. You’re off the hook once they leave for distribution, right?
Quality management extends beyond your four walls. If a product has your name associated with it, it’s your responsibility even once it’s in the hands of patients.
Here are four ways to effectively manage postmarket events with automated Quality Management System (QMS) software.Read More
EtQ has helped Maple Leaf Farms address challenges, such as allowing Quality Assurance to directly initiate Corrective Actions (CAPAs) on the Enterprise Quality Management System.Read More
Emergency Preparedness Plans (EPPs) let you record personnel, equipment and external parties associated with emergency procedures.
This document is equally as important to members of the EHS and emergency response teams that must create it, as it is to other employees of the organization that must follow it.
Here are three steps to utilize your EHS software to build an effective EPP.Read More
Imagine the following situation: The U.S. Food and Drug Administration (FDA) is inspecting your facility, and regulators ask to see documentation for your Hazard Analysis and Critical Control Points (HACCP) plan.
You spend 20 minutes trying to pick out the most recent documents, only to get hammered by regulators because only a few are actually dated. What’s more, most references to related documents are broken. After this impressive start, how well do you think the rest of the inspection will go?
Food manufacturers must keep track of numerous documents in order to ensure compliance and mitigate risks. This post looks at 7 of the most common document control gaps that companies should address to avoid regulatory citations and food safety issues.Read More