5 Questions for Your Corrective Action Plan

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

Danish physicist Niels Bohr once said, “Every great and deep difficulty bears in itself its own solution. It forces us to change our thinking in order to find it.”

Bohr’s work was instrumental in the discovery of the electron, an elusive subatomic particle whose location, even now, we can only describe in terms of a field of probability.

Within this context, today’s post looks at how we can change our thinking to pin down similarly elusive solutions to problems requiring corrective action. The trick is to ask detailed questions about the problem and the corrective action process, ensuring you’re not just going through the motions. 

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Quality Management

Avoid FDA Warning Letters with These 4 Document Control Best Practices

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

Incomplete records stuffed in the trash, with the signatures still showing. Blank forms issued complete with signatures. Employees shredding documents without bothering to record why and what they were destroying, even as inspectors were onsite.

These practices may sound outrageous, but the document control horror stories are all right there in the U.S. Food and Drug Administration (FDA) warning letters. Even organizations that wouldn’t dream of engaging in such obvious violations could be subject to 483 notices and warning letters if they don’t get document control right.

With that in mind, let’s take a look at 4 document control best practices to help companies avoid FDA warning letters.

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Life Sciences

EU GDPR Data Protection Regulations ‒ Four Ways to Manage the Risks

[fa icon="calendar'] Wed, Feb 14, 2018 / by Sean Salvas

Are you ready for the GDPR? This new EU data protection regulation poses new risks for organization of all shapes and sizes.

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3 Ways EHS Software Helps You Maintain Chemical Compliance

[fa icon="calendar'] Mon, Feb 12, 2018 / by Alexa Sussman

3 Ways EHS Software Helps You Maintain Chemical ComplianceUnder the Toxic Substances Control Act, the EPA is given the authority to issue regulations regarding the exposure to, testing of and controlling of chemical substances. To keep the workforce and environment safe, regulators have created globally recognized standards for classification and labeling of hazardous chemicals as well as REACH for the European Union.

These standards require an ongoing effort to manage chemical inventory and workplace safety.  Automated EHS software has tools to help you maintain chemical compliance efficiently and safely.

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How Different Industries Use Bowtie Risk Assessment

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

When it comes to making decisions informed by risk, each industry has its preferred risk assessment tools. A risk matrix is a common one, as is Failure Modes and Effects Analysis (FMEA).

One tool that doesn’t get as much attention is the bowtie risk assessment. The bowtie model is useful for visualizing complex risk scenarios where you don’t have historical data to create a risk matrix.

Let’s look at how different industries like aviation, energy, life sciences and manufacturing are using this risk model.

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Quality Management EHS

Quality Innovation Trend – The Risk Register

[fa icon="calendar'] Wed, Feb 07, 2018 / by Sean Salvas

Businesses are becoming more risk-conscious, bringing risk management tools such as the Risk Register to the fore.

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Employee Training Tips for a GMP Compliant Workforce

[fa icon="calendar'] Tue, Feb 06, 2018 / by Rachel Beavins Tracy

Is your employee training program proactive, looking forward and evolving to incorporate lessons learned? Or is it reactive, only changing after problems occur?

A proactive approach to employee training is the foundation to Good Manufacturing Practice (GMP) compliance. By creating a comprehensive, standardized program and keeping an eye out for common mistakes, companies can foster a proactive quality culture that prevents problems at their source.

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4 Benefits of Using a Centralized Solution for Water Management

[fa icon="calendar'] Mon, Feb 05, 2018 / by Alexa Sussman

Water and wastewater management are closely tied with energy use, environmental impact and employee safety, as each of these impacts—and is impacted by—water management processes in your organization.

Just like with all of your other EHS processes, how you manage and organize water and wastewater management can make a big difference in its success.

Here are some benefits of managing all water and wastewater permits, analytical results and reports in one central platform.

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5 Quality Management Trends to Watch for in 2018

[fa icon="calendar'] Fri, Feb 02, 2018 / by Alexa Sussman

Technology, business best practices and quality management all saw substantial growth and change in 2017. We don’t anticipate that these areas will stop innovating any time soon.

We talked to five of our industry leaders to find out what quality management trends we’re likely to see in 2018—with focuses on the market outlook, the evolution of technology, regulated industries, Environmental Health and Safety (EHS) and software.

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Quality Management

Europe's Aging Population ‒ Are Your Valued Older Workers Really a Health & Safety Risk?

[fa icon="calendar'] Wed, Jan 31, 2018 / by Sean Salvas

There’s a short answer to this question. No, older people shouldn’t be a considered a health and safety risk even though the aging population in Europe is inevitably leading to changes in the workplace.

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