2015 Posts

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…)

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: Practices in Change Control

The Winds of Change Keep Blowing; Don’t Let Them Throw You Off Course: 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…)

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…)

Prepare To Succeed: Stay Ready For Your Next FDA Audit

Prepare To Succeed: Stay Ready For Your Next FDA Audit

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Congratulations! You’re being audited by the FDA! If you’re doing business within the United States, you may find your organization faced with an unannounced FDA audit. But unannounced doesn’t mean that you need to be unprepared or out of control. Let’s take a closer look at ways you can prepare yourself, your team, your site, your quality system, and even the FDA inspector for a successful audit.

“An audit is a unique opportunity for you to tell your story. In
essence, you are communicating and demonstrating how
you run your business within the framework of your Quality
Management System.”

Konyika Nealy, VP of QA & Validation, Pilgrim Quality Solutions

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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…)