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…)

Medical Device Complaint Handling: If you can’t stop the complaining, start the efficiency gaining.

Medical Device Complaint Handling: If you can’t stop the complaining, start the efficiency gaining.

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Complaints can come from anywhere; it’s what you do with them that matters.

And when it comes to reportable events, time is what matters most. The clock begins ticking the moment your organization becomes aware of a complaint. Having an easy-to-use, intuitive medical device complaint handling system can make all the difference when you need to quickly get information to the FDA CDRH or any other regulatory body. Your organization may never be able to fully eliminate complaints, but it can improve their handling.

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How to Get Started with Quality Analytics

How to Get Started with Quality Analytics

Matthew Littlefield, President & Principal Analyst, LNS Research

There is a lot of hype when it comes to Industrial Internet of Things (IIoT) and Big Data Analytics. Many executives today see the mainstream media marketing campaigns being run by companies like IBM with Watson winning Jeopardy and are instantly interested in seeing how such a tool might be able to solve their business problems.

Although there is undisputed business value in using Big Data Analytics to enable predictive and prescriptive analytics, LNS Research sees most industrial companies are just at the earliest stages of adopting these technologies as part of IIoT pilot projects. For most companies, there is still much work to be done in gaining insights from the data already locked up in their enterprise systems.

In this post we will examine how quality executives can start getting value from the data they already have with an eye to the future, making sure the investments made today will pay dividends in a fully mature IIoT world. (more…)

Sample, Skip and Switch – The Basics of Risk-based Incoming Inspection

Sample, Skip and Switch – The Basics of Risk-based Incoming Inspection

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

You’re probably conducting incoming inspections today but if you aren’t taking a risk-based approach, chances are you’re performing inspections you don’t need to do and possibly overlooking the items which need to be inspected most.  Implementing a risk-based sampling system helps you spend less time and less money inspecting high-quality raw materials when you are already confident that they are good. You’re also able to pinpoint poorly performing raw materials and suppliers based on their inspection state. (more…)

Supplier Quality Tools – How the Right Technology Improves Supplier Quality Management

Supplier Quality Tools – How the Right Technology Improves Supplier Quality Management

Matthew Littlefield, President & Principal Analyst, LNS Research

This article is part 2 of a 2-part supplier quality management series. The first article can be found here.

As was stated in the last blog post of this series, challenges to life sciences organizations are substantial, and poised to grow as time moves on. From one direction, life sciences companies are facing stiff competition within industry, which is putting pressures on speed of delivery and quality expectations. From another direction, the industry is battling with the tightening grip of government regulations, which is demanding higher proof of documentation and specification, with increased (and potentially devastating) penalties for noncompliance. Moreover, the industry itself, in large part as a response to these pressures, is rapidly transitioning to a distributed model of production to improve efficiencies across the product development lifecycle. (more…)

The Winds of Change Keep Blowing; Don’t Let Them Throw You Off Course: Best Practices in Change Control

The Winds of Change Keep Blowing; Don’t Let Them Throw You Off Course: Best Practices in Change Control

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

Take a trip down the grocery store aisle and you’ll quickly see packages and cans boasting “New and Improved Formula” for everything from soup to soap. It seems that manufacturers are constantly improving their products. But are they really better…or just different? The reality is, companies are changing their products. It doesn’t necessarily mean it’s a change for the better.

It could be that a vital ingredient is no longer readily available or is suddenly more expensive. It could be that the competition launched a smear campaign to discredit a product by claiming it’s unsafe or unhealthy. It could even be the manufacturer’s own attempt simply to make news.

Regardless, change is inevitable and impacts every business unit and process across an organization, including the Quality Management department. In fact, Change Control is a vital part of the quality manager’s job. The FDA has certain expectations of companies and, like it or not, documenting change is one of them that falls squarely on the shoulder of QA. (more…)

Leadership’s Role in Improving Supplier Quality Management in Life Sciences

Leadership’s Role in Improving Supplier Quality Management in Life Sciences

Matthew Littlefield, President and Principal Analyst, LNS Research

The demands on quality organizations are rising across the board, but perhaps none as quickly or urgently as in the life sciences industries. While increased competition and the need to innovate certainly aren’t unique circumstances for life sciences, the level of scrutiny from regulatory agencies and the rapidly evolving nature of the supplier network are, placing an incredible burden on elevating supplier quality management capabilities. (more…)