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

3 Benefits of Nonconformance Management Software

[fa icon="calendar'] Wed, Nov 16, 2016 / by Emily Ysaguirre

In compliance management, the role of managing and trackingnonconformances is a critical step to ensuring that product defects are flagged and handled properly. Whenever there is a product that differs from plans and specifications, something must be done. Typically, it will be flagged as a nonconforming material.

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General Quality

3 Ways Risk Management Improves Compliance Across Any Industry

[fa icon="calendar'] Wed, Feb 03, 2016 / by Emily Ysaguirre

Life Sciences, Transportation, Food and Beverage, Environmental Health and Safety (EHS)—regardless of the industry you serve, most businesses have one thing in common: the need to manage risks effectively. Risk management is a growing concept behind compliance that helps you make better decisions to ensure continual improvement. The Quality Management System (QMS) improves this process and reduces chance of error by automating the way you approach risk.

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General Quality

5 Steps Toward a More Efficient Employee Training Software Program

[fa icon="calendar'] Wed, Aug 14, 2013 / by Brenda Percy

Business today is never static. It is constantly revolving and constantly changing. Policies and procedures change, processes change, and employees come and go. With this natural ebb and flow comes the need for an effective training process. This is important because employees can be considered to be the lifeline of the organization—keeping them knowledgeable and up to date on the processes that pertain to them is the key to maintaining a well-informed workforce.

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General Quality

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