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General Quality, EHS, Risk Management

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

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.

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Mar 23, 2018
   
Risk-Based Regulatory Compliance for Manufacturing: A Practical 4-Step Approach

In 2015, the Code of Federal Regulations totaled nearly 180,000 pages of requirements. While not all of these will apply to...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Mar 23, 2018
4 Risk Management Gaps and Opportunities [Infographic]

To achieve operational excellence, you need a comprehensive, forward-thinking approach to managing safety and quality risks.

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Thu, Dec 07, 2017
Tips for Managing the Top 5 Life Sciences Risks [Infographic]
Life sciences companies face risks that threaten product quality, patient safety and profitability--this infographic reviews...
Rachel Beavins Tracy
By Rachel Beavins Tracy
on Tue, Nov 07, 2017
How Risk Management Helps When Disaster Strikes

Hurricane Harvey has been wreaking havoc on Texas and the surrounding area for days now. By now I’m sure your social media...

Alexa Sussman
By Alexa Sussman
on Tue, Aug 29, 2017
Weathering the Storm: The Importance of a Weather-Related Risk Management Plan for Your Supply Chain

We wear boots to walk on icy sidewalks and bring umbrellas when it rains—we plan ahead and prepare for bad weather events in...

Alexa Sussman
By Alexa Sussman
on Tue, Aug 01, 2017
5 Tools for Getting Started with Risk in ISO 9001:2015

The ISO 9001:2015 standard places a great deal of emphasis on using risk to drive processes and make decisions. The old...

Emily Ysaguirre
By Emily Ysaguirre
on Tue, Jun 06, 2017
What Does “Risk-Based Thinking” Mean in the Context of New ISO Standards?

Risk has always had an implicit role in ISO standards, but newer versions are giving risk a more prominent place in quality...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Tue, Jan 10, 2017
How to Build a Risk-Based Aviation Safety Management System

You can do all the audits you want and assign corrective actions until the cows come home, but unless your aviation Safety...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Tue, Nov 29, 2016
6 Common Risk Management Gaps in the Life Sciences Industry

More than 4 in 5 companies believe risk management is a key capability for managing complexity and adapting to changes in...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Thu, Nov 17, 2016

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