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
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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...

Three Approaches to Defining a QMS: Processes and Plan, Do, Check, Act

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. Yesterday, we looked at the first, QMS Elements.

A second way to define a Quality Management System is the QMS Processes model. It starts by defining your customers’ requirements and what goods and services you will provide to satisfy them. Once the product is created and distributed, a process of continuous improvement then takes place to ensure ongoing quality. It involves measurement and analysis of customer feedback, reallocation of resources to improve the product (if required) and distribution of the updated offering.

A third QMS definition, known as the Plan, Do, Check, Act model, is based on activities. It follows a popular model used in various business applications beyond Quality. Plan activities focus on such things as … Read more...

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...

Quality in the Automotive Industry

Each industry will have different interpretations of the concept of Quality and how to prioritize its tenets within their own field of practice, expertise and work experience. Perhaps the best fundamental principle is the definition of Quality given by the International Organization for Standardization (ISO) as “the degree to which a set of inherent characteristics fulfills requirements where a requirement is a need or expectation.” This look at the Automotive sector is one in a series of blogs that provides a quick look at how the concept of Quality applies in different industries.

Automotive quality dates to Henry Ford’s vision of mass-produced vehicles that a trained workforce could rapidly assemble with consistency and precision. Today, automotive quality reflects three principles:

  • Quality in Product means the ability of the vehicle to fulfill its expected functions and behavior, such as engine efficiency, product features and environmental exhaust standards.
  • Quality in Production means
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The ISO 9001:2015 Transition Deadline Is Approaching. Are You Ready?

The deadline for making the transition from ISO 9001:2008 to ISO 9001:2015 is September 14, 2018. After that date, organizations that have not certified to the new standard will lose their ISO 9001 certification until they have successfully moved to the new standard. Have you made the transition yet?

ISO 9001:2015 demonstrates to your customers and suppliers that you know how to meet customer needs with efficiency and insight, and that your organization understands Quality at every level from the leadership down. Further, ISO 9001:2015 certification is considered a prerequisite to doing business in many industries. Organizations that miss the deadline and lose their certification are therefore at considerable risk of brand damage and lost business opportunities.

The new Intelex Insight Report on ISO 9001:2015 can help you navigate your way around the new standard. If you’re rushing to meet the transition deadline and need a quick summary of what … 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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