QMS Posts

When Does it Make Sense to Automate EQMS?

When Does it Make Sense to Automate EQMS?

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

You need to manage your quality system, and you might think you have everything under control with a manual process. But manual processes including disparate tracking systems for controlling documents, deviations, customer complaints, change controls, and other quality processes are often cumbersome and difficult to control, with limited to no visibility across processes.

So when is it necessary to bite the bullet and adopt an automated enterprise quality management system (EQMS)? The timing may not be the same for every organization, but you should examine your quality management processes and see where quality management software can help fill in the gaps, creating a more cohesive closed-loop process and better preparing you for any internal audits, regulatory inspections, or regulatory reporting. (more…)

Key Reminders for Managing Suppliers

Mark Crawford

Supply chain management is harder than it used to be. Many OEMs are outsourcing more functions instead of keeping them in-house, adding geographical distance and cultural diversity to the supply chain. This, of course, adds complexity as well, which increases the chances of something going wrong and compromising quality. (more…)

Are They Just Pulling Our (Supply) Chain?

The FDA, Congress, the US Consumer Products Safety Commission, US Immigrations and Customs Enforcement, the Department of Justice. These and countless other regulatory bodies are more proactively evaluating the potential risk and liability to our country’s goods and products; and as we’ve seen, the sharing of information among these regulatory bodies is leading to more cohesive enforcement activities with the continuous goal of protecting the consumer. (more…)

Wake Up and Watch Out: Getting Serious About QMS

“If it’s not broken, don’t fix it.” Really? If you only want to maintain the status quo, you might get away with letting sleeping dogs lie. But no one really wants to get hauled off by the dog catcher during a pleasant nap. Unfortunately, it’s happening every day to manufacturers who don’t take quality management seriously.

Quality management is about continuous improvement and product safety. And each time we optimize, we strengthen our preventive measures for avoiding unwanted surprises and disruptions in our operations. (more…)