Your Data is Your Most Valuable Asset: Getting Started with Quality 4.0

Data science and machine learning have surged in prominence over the past few years, and digital transformation seems to be on everyone’s agenda. Have you ever wondered why? Even though quality engineering has long been a data-driven pursuit, we now have the potential to get even deeper insights from our data because of several recent innovations:

  1. Computing power per dollar has increased steadily (e.g. through adoption of GPUs).
  2. Open-source software packages with powerful machine learning algorithms are freely available, reliable, robust, and well-maintained.
  3. Infrastructure for data storage and management is readily available and cost-effective.
  4. Cloud-based software, platforms, and infrastructure helps companies focus on their core competencies and scale rapidly when needed.
  5. Algorithms are often more revealing when Big Data is available.

It’s easy and cheap to collect data but using it to generate actionable insights can be more challenging. Think, for example, about the digital displays available to a production … Read more...

The New Partnership-Based Landscape of QMS Validation

Many organizations across countless industries are turning to the Cloud Computing model to validate their Quality Management Systems. With this shift comes many changes, including a new emphasis on partnerships. Let’s look at this new partnership-based landscape.

Three’s company

With more than two parties (traditionally the customer and the software provider) now involved in the validation process (the cloud provider has now added to the mix), the concept of the typical Service Level Agreement (SLA) changes in the cloud. It’s important, says Ray Glemser, CEO of IT solutions and services provider Glemser Technologies Corp., for a customer to recognize they are now in partnership with the other two players, who are performing more specialized functions for them.

“These are tied together in what we used to call an SLA,” Glemser says. “We are now organizing them into quality agreements where the quality system validation state needs to be maintained … Read more...

Quality Management Tools for Enabling Customer Relationships

In February 2002, the United States Secretary of Defense, Donald Rumsfeld, uttered the following infamous phrase:

“There are known-knowns; there are things we know we know. We also know there are known-unknows, that is to say we know there are some things we do not know. But there are also unknown-unknowns, the ones we don’t know we don’t know.”

Slovenian philosopher Slavoj Žižek’s clever rejoinder fills in the obvious missing element and demonstrates the secret wisdom of Rumsfeld’s analysis:

“…What he forgot to add was the crucial fourth term: the ‘unknown knowns,’ the things that we don’t know that we know.”

When it comes to knowing what customers want, we could learn a lot from Rumsfeld and Žižek. Sometimes customers know what they want and how to articulate it; sometimes they know what they want but not how to articulate it. Even more difficult to understand is when customers don’t … Read more...

How Software Provider Innovation Is Driving Change in QMS Validation

Important changes are taking place in the way many software providers develop their products, ones that have direct impacts on the validation process.

Waterfall development vs. Agile development

For many years, developers have used the “waterfall” model to create their software. This involves creating a fully developed version of the software before presenting it to customers or internal customer representatives for testing and feedback. Each step – plan, analyze, design, construct, test, deploy and maintain – is done one after the other, forming a waterfall visual.

Here, all user requirements are defined before anything is developed. A major drawback to the Waterfall model is that it is often impossible to know all user requirements at the outset of a software development project. Those that are identified often change during the months-long development cycle. Others do not become evident to users until the completed version is put before them. Developers … Read more...

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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Why ISO 9001:2015 Is So Important for Your Organization

Perhaps you’ve heard of ISO 9001:2015. Perhaps you know that it’s an important certification to have for your business. Perhaps you also believe that it’s a complicated and time-consuming process that is difficult to understand, and that it’s challenging to convince management that you need to do it.

In fact, ISO 9001:2015 is the simplest and most achievable version of the ISO 9001 standard for organizations of all sizes. More than 1 million organizations have certified to ISO 9001:2008 and realized the benefits of improved Quality Management, reduced operational waste and increased customer satisfaction. Certifying to ISO 9001:2015 will give you all that and more. It can also help your organization meet regulatory requirements and create new opportunities as many clients in the public sector and automotive industries begin to require it from their suppliers and partners.

The new Intelex Insight Report, Starting Your Certification to ISO 9001:2015 – Read more...

The Space Shuttle Disasters and Quality Management

On January 28, 1986, the Space Shuttle Challenger was destroyed 73 seconds after lifting off from Cape Canaveral, Florida. Seven crew members died, a $3 billion-dollar orbital vehicle was lost, and NASA’s Space Shuttle program was suspended for 32 months.

The official cause of the disaster was the failure of an O-ring to prevent hot gases from leaking through the joint in the solid rocket motor during launch.[i] The Rogers Commission – the body tasked with investigating the disaster – found that the O-ring design had been a point of concern for several years prior to the disaster, but that any concerns had been either poorly communicated or ignored in favor of maintaining project delivery on-time and on-budget.[ii]

In addition to the faulty initial design of the O-rings, the Commission determined that the unusually cold temperatures at the time of the launch (conditions in which none of the … Read more...

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
Read more...

The Cloud – What is it?

As we’ve seen in previous posts, many organizations across countless industries are turning to the Cloud Computing model to validate their Quality Management Systems. To gain a full appreciation of this movement and to see how it can potentially benefit your organization, it’s important to know just what characterizes the Cloud model and what makes it unique.

Traditionally, companies have owned and operated their Quality Management System using their own resources – an in-house IT department and fully owned, on-premises computing resources. However, given the increasingly sophisticated nature of QMS software and the high cost of specialized talent capable of managing, maintaining and upgrading it, firms are adopting the Cloud model is becoming an appealing alternative.

The three players

The Cloud model features three main players: the customer, the software provider, and a middle level participant, the cloud provider. The provider’s function is to manage the infrastructure and all … Read more...