5 Most Useful Resources for Starting Out in Quality

[fa icon="calendar'] Mon, May 21, 2018 / by Alexa Sussman

If you’re just getting started as a quality professional, it can be overwhelming. If you’re unfamiliar with the industry, it’s hard to even know where to find guidance.

To help you get started, we’ve put together some of the best quality and compliance resources we know.

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General Quality

How Machine Learning Can Transform Quality Management

[fa icon="calendar'] Fri, May 11, 2018 / by Rachel Beavins Tracy

Services like Netflix, Google and Facebook are known for using predictive technology to learn our preferences and provide customized suggestions that get smarter over time. Now that technology is coming to the manufacturing floor, helping companies increase production capacity by as much as 20%.

More than just higher rates of production, companies can also expect to see major improvements in quality through the use of machine learning. In this post, we’re looking at how machine learning can transform quality management, from reducing defects to improving efficiency.

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General Quality

Getting Ready for GDPR

[fa icon="calendar'] Mon, Apr 16, 2018 / by Rachel Beavins Tracy

Going into effect May 25, 2018, the General Data Protection Regulation (GDPR) represents the most sweeping changes to EU data privacy laws in 20 years. However, signs are growing that companies are ready for the new requirements, including a new UK report showing fewer than half of organizations have made preparations.

Companies that sell products or services to people in the EU will need to comply with the new regulations or risk a fine of up to 4% of revenue or €20 million, whichever is greater.

In today’s post, we’re examining what companies need to do to get in compliance with the fast-approaching regulatory deadlines.

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Life Sciences General Quality

The Industry 4.0 Approach to Quality

[fa icon="calendar'] Mon, Apr 09, 2018 / by Rachel Beavins Tracy

Experts are calling Industry 4.0 the fourth Industrial Revolution (hence the 4.0). The concept represents a push towards manufacturing digitization that experts say will deliver massive improvements in efficiency, costs and profits in as little as just a few years.

But what will it take to get there, and how can it help improve quality? Today we’re lifting the lid on what Industry 4.0 means in terms of quality, focusing on benefits, challenges and the tools companies will need to make it a success.

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General Quality Industry 4.0

4 Hidden Costs of Poor Document Control [Infographic]

[fa icon="calendar'] Mon, Apr 02, 2018 / by Rachel Beavins Tracy

Poorly controlled documents are a huge source of risk in organizations today,costing millions in profits and productivity every year. This infographic highlights four hidden costs of poor document control and how automation can help. 

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General Quality

3 Things You Need to Know About the MDSAP

[fa icon="calendar'] Mon, Mar 26, 2018 / by Alexa Sussman

Audits are an essential part of the Life Sciences as they ensure manufacturers are producing safe products and operating within compliance.

Previously, audits meant surprise business interruptions for manufacturers and a lot of travel and administrative work for auditors. With many Life Science manufacturers operating internationally, they were being audited separately to satisfy the requirements of each country in which they operated. At the end of the day, there was a lot of repeat work on both ends.

So regulatory agencies and legislators have come together to develop single audit programs that create comprehensive audits that satisfy the requirements of multiple countries. This creates a globally harmonized and efficient international audit management system.

One of the major programs is the Medical Device Single Audit Program (MDSAP). As the deadlines for these changes approaches quickly, here are 3 things that medical device manufacturers should know about the MDSAP.

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Life Sciences General Quality

Risk-Based Regulatory Compliance for Manufacturing: A Practical 4-Step Approach

[fa icon="calendar'] Fri, Mar 23, 2018 / by Rachel Beavins Tracy

In 2015, the Code of Federal Regulations totaled nearly 180,000 pages of requirements. While not all of these will apply to any single manufacturer, regulatory compliance is still a major challenge for companies. In fact, many of them aren’t even aware of certain regulatory risks until it’s too late.

This fact is especially true when companies use manual or paper-based methods for quality or environmental management, which make it difficult to effectively track compliance activities.

With that in mind, today’s post looks at a practical, risk-based approach manufacturers can use to identify and assess compliance gaps.

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General Quality EHS Risk Management

Comparing ISO 9001 and ISO 13485

[fa icon="calendar'] Mon, Mar 19, 2018 / by Rachel Beavins Tracy

ISO 13485 for medical device quality management shares many similarities with ISO 9001, the leading global quality management standard with more than 1.1 million certificates worldwide.

While most standard revisions now follow ISO 9001’s new high-level structure, ISO 13485 does not, even though it was released after ISO 9001. Clearly there are structural differences, but you may be wondering—how different are they?

Today we’re looking at the similarities and differences between the two standards, and whether life sciences companies and related services need both certifications.

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General Quality

The Charles Dickens Guide to Quality and Safety

[fa icon="calendar'] Tue, Dec 12, 2017 / by Rachel Beavins Tracy

Author Charles Dickens was famous for his depictions of 19th Century life and the effects of the Industrial Revolution on the working class. Dickens himself had a difficult life, forced into a workhouse pasting labels on shoe polish at age 12 after his father went to debtors’ prison.

Dickens understood factory life well in his era, and he’d probably have a lot to say about workplace safety and quality.

In this post, we take a look at several iconic Dickens stories, mining them for some truly Victorian quality and safety insights.

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General Quality

7 Golden Rules of Effective Corrective Action

[fa icon="calendar'] Wed, Jun 28, 2017 / by Rachel Beavins Tracy

One of the last things you want to hear after a safety or quality incident is “I knew this would happen.”

Why is this statement so common when a problem occurs? Often, it’s a history of similar incidents, previous near-misses, or simply because the warning signs were always there. No matter the reason, it’s a sign that your corrective action process is not working.

With that in mind, let’s look at 7 golden rules of corrective action that will help boost your effectiveness and prevent problems before they happen.

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General Quality