Quality Management Posts

The Pursuit of Zero Waste: Continuous Improvement to Drive Quality

The Pursuit of Zero Waste: Continuous Improvement to Drive Quality

Kevin Lee, Industry Solutions Consultant, Pilgrim Quality Solutions

Quality Challenges Create Waste

In a perfect world, all products are designed and manufactured to 100% of their design specifications; all people are trained and certified; and, all equipment is properly maintained and calibrated. All incoming supplies are used in the manufacturing processes, and there are zero deviations or defects. This nirvana product paradise does not exist in our world. (more…)

Get Your Documents Under Control

Get Your Documents Under Control

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

Do people ever tell you that you’re a control freak? That’s not typically a compliment, unless you work in the Quality or Compliance departments at your company. Then it’s an aspiration.

A robust Document Control process lies at the heart of a Quality Management system. Nearly every element of auditing and compliance is verified by examining documented evidence. That’s the FDA inspectors’ bread and butter, so to stay compliant, you need to keep your organization’s documents fresh and handy. (more…)

How to Prepare for Your Next FDA Inspection (Free E-Book)

How to Prepare for Your Next FDA Inspection (Free E-Book)

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Think about your next FDA inspection. How will you feel when the inspection arrives at your facility? Will you be rushed or calm? Flustered or confident? Perhaps more importantly, who will control the direction of the inspection? You… or the inspector?
(more…)

Building a Long Term Quality Management Analytics Strategy

Building a Long Term Quality Management Analytics Strategy

Dan Jacob, Research Analyst, LNS Research

Manufacturers have historically struggled to generate meaningful Quality Management Analytics. With the advent of the Industrial Internet of Things (IIoT) and Big Data Analytics, it’s now more important than ever to have a long term Quality Management Analytics strategy. (more…)

8 Sites Life Sciences Quality Managers Should Follow

8 Sites Life Sciences Quality Managers Should Follow

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

When it comes to keeping your ears tuned to the latest industry news, there are so many resources and voices vying for your attention. It can be tough for Quality Managers to know which sources to really keep an eye on, which to bookmark when you need to research or gather information on a particular topic, or where to go for commentary on industry hot buttons. Here we’ve gathered a list of resources you should browse, bookmark, or tune in to help keep you informed. In no particular order, here are 8 resources and one bonus site to peruse. (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…)

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…)

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…)

Document Management in the Quality Fold: What You Should Know

Document Management in the Quality Fold: What You Should Know

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

If you work in the Quality arena, you probably know that the effectiveness of a Quality Management System (QMS) relies extensively upon enterprise-wide collaboration and begins with a solid process for managing important documents, like standard operating procedures. But as rapidly as business and its processes evolve these days, many organizations struggle to stay current in a sea of change. So it’s not surprising that document management remains at the very top of quality management processes being automated within the highly regulated Life Sciences space. (more…)

Life Sciences Quality Challenges: EQMS Webinar Follow-up and Infographic

Life Sciences Quality Challenges: EQMS Webinar Follow-up and Infographic

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

LNS Research recently hosted a webinar highlighting steps to help Life Sciences firms address quality challenges. The webinar presented three quality-related initiatives that have delivered measurable business results. Each concept is outlined below, followed by the infographic that summarizes the findings from LNS’ research. (more…)