5 Speed Bumps You Must Negotiate on the Road to Rapid EQMS Deployment

5 Speed Bumps You Must Negotiate on the Road to Rapid EQMS Deployment

Rob Harrison, Research Analyst, LNS Research

When an organization has determined a quality process improvement imperative and resolved to take a time-sensitive course of action by harnessing technology in the form of EQMS, there are critical elements that must be considered to ensure success. These elements relate specifically to meeting the timeline demands while guaranteeing the solution delivers the correct functionality in a secure and responsive manner without compromising user adoption and potential for improvement and expansion. (more…)

QMS: Pain Management for Supply Chain Management

QMS: Pain Management for Supply Chain Management

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

Supply chain management is tougher than it used to be. In just about every industry, it seems OEMs (Original Equipment Manufacturers) are increasingly outsourcing once-traditional in-house functions, adding geographical distance and other external variables to the supply chain. This, of course, adds complexity to the process stream and requires manufacturers to have a pretty high “chain” tolerance as the likelihood that something will go wrong and quality will be compromised grows greater. (more…)

5 Quality Management Software Lessons You Can Learn from Superheroes

5 Quality Management Software Lessons You Can Learn from Superheroes

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Superheroes give us an escape from everyday life and embody qualities to which we’re supposed to aspire. Though fictional, superheroes transport us to another world and can motivate us mere mortals to be more considerate of one another. They also have the power to convince us to open up our wallets for various movies, memorabilia, or miscellaneous merchandise. But at their core, they can also teach us some great life lessons, and even some that correlate directly to quality management. Don’t believe me? Let’s take a look at 5 quality management software lessons sourced from a variety of superheroes. (more…)

The Do’s and Don’ts of Successful Root Cause Analysis

The Do’s and Don’ts of Successful Root Cause Analysis

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

We often hear that the CAPA process is the “heartbeat” of the quality system. The changes that emerge from the CAPA process are critical to correcting defects, improving business processes, and meeting customer expectations. When you think more about CAPA, you realize that an effective CAPA process hinges on your team’s ability to understand the true cause of each problem you encounter. With that in mind, here are some tips to help refine your root cause analysis process and keep risky problems from reoccurring. (more…)

Pick Up a New Habit: Making Quality a Priority

Pick Up a New Habit: Making Quality a Priority

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

“Quality isn’t an act, it’s a habit.”

Aristotle said it first. But it doesn’t take a philosopher or a scientist to recognize that excellence doesn’t happen overnight. Just ask the drum major in the local high school band or the prima ballerina in the regional ballet company. It takes ongoing commitment to reach the pinnacle and continuous improvement to remain there.

The QA director at a leading pharma or medical device company know this, too. Very well. The practice of continual improvement starts with a unified, enterprise-wide commitment to ongoing best efforts and to process improvement. (more…)

EQMS Implementations: A Matter of Need and Speed

EQMS Implementations: A Matter of Need and Speed

Rob Harrison, Research Analyst, LNS Research

It’s fairly obvious to anyone with their eye on industrial operations that manufacturing has increased in speed tremendously over the past few decades due to several factors like automation, increased collaboration across departments, analytics that allow greater agility and responsiveness, and others. This is true in virtually all industry verticals.

What may be less obvious to the onlooker but is no less true, is the parallel pressure that’s been placed on quality organizations to elevate their systems and processes to deliver ever-higher quality and consistency in products. Spurred on by factors like increasingly global and disparate suppliers, tightening regulations and compliance initiatives, and immediate potential for brand and reputation damage via social media, the writing is on the wall that the processes and systems of yesteryear are no longer cutting it. Today, with increasing frequency, these issues are shaping Enterprise Quality Management Software (EQMS) implementations. But aren’t these a major undertaking? Yes, mostly—but not out of pure necessity. (more…)

The Anatomy of Great Risk-Based GMP Audits

The Anatomy of Great Risk-Based GMP Audits

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

If you’re responsible for planning and carrying out your company’s internal audits, you know how much planning and effort it takes to monitor your quality system for GMP and ISO compliance. As your quality system has matured, you’ve probably noticed that certain sites, departments, or processes require more of your attention, while others are consistently in compliance and don’t need as much assistance. If this is the case in your organization, it’s time for you to consider a risk-based approach to your internal quality system audits. (more…)

Strategies for Electronic Medical Device Reporting (eMDR) Success [free e-book]

Strategies for Electronic Medical Device Reporting (eMDR) Success [free e-book]

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

We’ve all been anticipating the final electronic reporting deadline since last Valentine’s Day when the deadline of August 14, 2015 was first announced. Are you ready? For all medical device manufacturers and importers out there, don’t get stuck with a less than ideal process just to meet this deadline. Get your complimentary e-book to arm your company with knowledge you need to build a successful electronic medical device reporting process that works best for you.

Whether or not you are already submitting your medical device reports electronically, this e-book can help you understand how the process works, and design a great eMDR process to meet your mandatory reporting requirements. Learn tips from companies who were the first to implement, and get a handle on all the steps you will need to follow. (more…)

ISO 9001:2015 and the 8 Quality Management Principles to Take You to the Head of the Class

ISO 9001:2015 and the 8 Quality Management Principles to Take You to the Head of the Class

Sandy Carson Hessen, Marketing Communication Manager, Pilgrim Quality Solutions

For more than half a century, the International Standard for Organizations (ISO) has been developing standards to protect society from potential errors. It’s been 26 years since the introduction of the Quality Management System standards model, ISO 9001, specifically.

The most current version, ISO 9001:2008 was adopted to address fulfilling regulatory requirements and customer satisfaction through continuous improvement of the quality system. The standards apply worldwide and provide consumers with a base-level confidence in an organization’s ability to provide conforming products. Theoretically, it’s been working, but for those concerned with quality, it certainly makes sense to evaluate whether there’s room for improvement. (more…)

Do You Want to Improve Your Supplier Quality Management Process Today? Here are the Places to Start

Do You Want to Improve Your Supplier Quality Management Process Today? Here are the Places to Start

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Cost of quality, defect rates, and customer complaints can often be tied back to a common cause – poor supplier quality. Supplier-related defects are the most costly and difficult to correct, which is why managing supplier quality properly is incredibly important.

Your organization depends on you to ensure that suppliers are providing high quality materials in a timely manner. This means that you need to filter through a complex and potentially global web of suppliers, and understand where potential problems are occurring (or where they may occur in the future). So let’s take a look at some process improvements that will help you hone in on your most important suppliers and manage their quality activities for maximum impact. (more…)