Why Risk-Based Thinking Should Be Part of Your Quality Management System

While the concept of risk is easy enough to understand, figuring out how to apply it to your organization can be somewhat more complicated. Learning how to manage the effect of uncertainty in such a way as to determine the impact on how value is created and sustained requires a deep understanding of your organization’s processes. Many organizations are tempted to avoid these difficulties by ignoring risk management altogether, which can lead to cost overruns, time delays, waste, rework, or even to more serious problems that have an impact on health and safety or the environment.

Fortunately, ISO 9001:2015 for quality management systems (QMS) can provide some much-needed guidance on how to make risk-based thinking the cornerstone of your QMS. ISO 9001:2015 incorporates risk-based thinking throughout to help your organization make better quality decisions that anticipate and prevent process problems. It also incorporates the high-level structure of Annex SL to … Read more...

What Is a Quality Management System (QMS) and Why Do You Need One?

A quality management system allows an organization to link business objectives with customer expectations, provide data that supports evidence-based decision making by leadership, reduce waste and prevent rework, and ensure transparency at each stage of the supply chain.

The cost of poor quality can be high for many organizations. Expensive waste, product rework or recalls, supply chains that lack accountability, and lack of insight into your customer requirements are symptoms of a quality management problem. If you’ve thought about implementing quality practices in your organization, you’ve probably heard the term “quality management system” or its acronym “QMS” and wondered what it means. Is it a software application? Is it a group of people? How can I learn about it? 

This short guide will help you to understand the basics of a quality management system and where to find the best guidance to get started on the path to continual quality improvement in your organization. 

What is a

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Changing Roles in the QMS Cloud Validation Model

Many organizations across countless industries are turning to the Cloud Computing model to validate their Quality Management Systems. With the shift comes a change in who performs what roles in the validation process. Let’s look at this new responsibility landscape.

Who plays what roles

Who does what in the Validation model can change when we move to the Cloud. The customer remains responsible for, on the front end, validation planning and user requirements, and on the back end, user acceptance testing and validation reporting.

The software provider can assume responsibility for system requirements, detailed design, system configuration and development, unit/integration testing and system testing. The cloud provider can now look after the technical architecture and IQ.

Change control – private cloud vs. public cloud

Life sciences companies can tap into a wealth of innovative software that is being developed at a rapid rate – but it comes at a … Read more...

QMS Validation: Changes in the Cloud

Many companies in various industries are turning to the Cloud Computing model to validate their Quality Management Systems. This shift brings with it many changes to the traditional on-premises approach. Let’s look at what has changed in the cloud…and what hasn’t.

A key element in any software validation process is the Installation Qualification (IQ). This is essentially a checklist to ensure all elements needed to effectively run the software are in place. Questions to be answered include whether the software was loaded correctly and whether there is enough memory. The Cloud model’s architecture introduces new elements that companies must be aware of, as these pertain to the validation process.

Regulatory expectations for cloud providers

The traditional and the Cloud architecture share the same basic structure. It consists of:

  • A development environment, where applications are created
  • A test environment, where the recently developed software is tested exhaustively to make sure it
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Success Factors for Moving Into the Cloud

Customers are moving their Quality Management Systems into the cloud for many reasons:

  • It is easier to finance, with expenses spread out over a number of years. Because your company is sharing computing resources with other people, the total cost is cheaper overall. The services component will be higher than if things are kept in-house, but expenses such as hardware purchasing/upgrading and employment of increasingly expensive talent to manage the computing resources will be taken off the corporate ledger.
  • It is faster to deploy. Business benefits are realized much quicker because internal processes, such as reviews, approvals, and the accompanying meetings and endless email chains that typically bog down implementations are no longer part of the equation.
  • It offers faster access to the latest and greatest software features. No longer does the customer need to keep up with newest developments in software and implement those they want. Cloud providers
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Three Approaches to Defining a QMS: Elements

To fully understand how Cloud Computing is changing the world of Quality Management System validation, it’s important to define just what a QMS is. There are three common ways to do so. In this post, we’ll look at the first: QMS Elements.

In this definition, we can think of a QMS as the relationship between roles within an organization and a set of procedures. One set of roles falls under the Executive element. These business decision-makers can hold various titles, including CEO, chief quality officer, a division president or vice-president of quality. Ideally, leaders will be part of a Quality steering committee and participate in audits of their own company’s supply chain and those of their customers,

A second set of roles is encompassed by a company’s Quality and Compliance arm. Different functions have a hand in ensuring product quality, some more directly that others. The typical players are … Read more...

When QMS Validation Goes Wrong: FDA Consequences

Before U.S. manufacturers can begin selling their products, they must ensure, by law, that their wares meet an acceptable level of quality.  A key part of that process is the act of providing objective, documented evidence to the U.S. Food and Drug Administration (FDA) that their processes, equipment and computerized systems are checked and validated.

Failure to meet these requirements can result in consequences of varying degrees of severity, depending on the nature of the offense and an outfit’s history with the FDA. These include:

  • Recommendation – Important feedback provided to companies with a good FDA relationship. An issue is noted in an audit file with the expectation that it be addressed by the next audit.
  • 483 form – A formal notice sent to the head of a company’s Quality department, with a response due within 30 days. This a low-key public record similar to a misdemeanor.
  • Warning letter
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6 Keys to a Great EHSQ Software Implementation

During a panel discussion at the recent 2018 EHSQ Alliance conference in Austin, Tex., Tim Wolf and Greg Oickle from Arcadis – global design and consultancy experts that implement Intelex software for clients – offered their top six keys to successful implementations:

  • It’s important to establish and stay focused on a long-term vision. “It’s about making decisions today that aren’t going to prevent you from doing things tomorrow or two years or five years from now,” said Oickle. “It’s also about considering where you want to be five years from now. Today you might want to do incident management, which will let you enter incidents and figure out what’s happening, but maybe two years from now you might want to assess risks and figure out how you can actually reduce the number of incidents that are reported. So designing with the future in mind is important.”Added Wolf: “There is
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Quality 4.0: It’s time for a QMS Revolution

Why is it time for a Quality Management System revolution?

The world is more complex than it used to be. Businesses around the globe rely heavily on one another through densely intertwined supply chains. Human biases lead to … Read more...

6 Reasons Why Quality Professionals Support Integrated Management Systems

On February 8, 2017, I delivered a presentation to 138 attendees on Integrated Management Systems (IMS) at the monthly ASQ Toronto section meeting. To learn more about IMS, read The Case for EHSQ Integrated Management Systems. The audience consisted of a broad range of experts including CQEs, CQAs, CQIAs, CSSGB, CSSBB, management consultants, auditors, among others.

As part of the introduction, I asked the audience how many people have either heard about or were already familiar with Integrated Management Systems and I’d say about 40% of the audience raised their hands – which is a good sign! I was actually only expecting about 10 to 20 people to raise their hands. This definitely demonstrates that Integrated Management Systems is of interest to quality management professionals.  The concept of an IMS becomes even more important because of the harmonization of standards due to the recent changes in ISO 9001:2015, ISO … Read more...