Tag Archives: QMS

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

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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

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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

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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
… Read more...

The ISO 9001:2015 Transition Deadline Is Approaching. Are You Ready?

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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

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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 –
… Read more...

Documentation and Traceability: Ensuring Your Software is Doing What it Should

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Software validation is at the heart of the Quality process. It’s the method by which manufacturers provide objective, documented evidence that their processes, equipment and computerized systems are checked and validated to ensure the quality of their final products.

Traditional on-premise validation of a Quality Management System (QMS) typically utilizes a “V Model” workflow. The process begins on the top left, with the left side defining a series of required deliverables. Once these are mapped out, you can configure and develop the system. Finally, as illustrated on the right arm of the model, the system is tested, with these actions being traced back to the previous planning stages.

The model helps organizations answer key questions about the project, such as:

  • What are you trying to accomplish?
  • What are the roles?
  • What documents are you going to generate?
  • Who approves them?
  • What process will you follow to develop this
… Read more...

Managing QMS Validation the Modern, Efficient Way

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With every trip to our local pharmacy, grocery store or corner variety shop, we pass hundreds of products that have reached the shelves only after a lengthy process designed to ensure their quality.

It’s not something the everyday consumer thinks much about. But without this crucial element of the manufacturing process, we would never be able to trust the quality of the many products whose high standards we take for granted. It’s quite easy to envision the catastrophes that would result.

Core to the process of ensuring quality is the concept of validation. This is the process whereby pharmaceutical manufacturers provide objective, documented evidence that their processes, equipment and computerized systems are checked and validated to ensure the quality of their medicines and medical devices.

Central to the validation journey is the required documentation produced with each step. To satisfy regulators, companies must record evidence to prove what work was … Read more...

What Can Go Wrong, Will Go Wrong: Quality Case Studies

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How do Quality failures happen? What causes a self-driving car to kill a pedestrian? Or a well-known food brand to be contaminated with bacteria that cause a massive listeria outbreak? The sheer scale of some of these types of disasters might lead us to believe that the causes are equally large, that they ought to have been obvious to anyone or that only willful ignorance could be to blame. In reality, disaster is often the result of a cascading series of tiny, almost imperceptible Quality failures. They build slowly over time in organizational cultures not in the habit of looking for them or of being mindful of their presence and meaning when they do appear as smaller symptoms.

Quality Management isn’t simply a series of abstract ideas we follow to get a certification that allows us to bid on certain contracts from our customers. Quality Management serves a higher purpose; … Read more...

Building the Business Case for Quality Management

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Quality Management is, unfortunately, not a switch that an organization can simply turn on to produce a steady flow of process efficiency and customer satisfaction. It is a rigorous and prescriptive approach to meeting the stated and implied needs of your customers, suppliers, partners and employees. This means that it requires patience, dedication and, of course, financial investment.

Implementing Quality Management and investing in a Quality Management System requires the initiative of executive sponsorship in any organization. Leadership typically doesn’t spend money without a strong business case that highlights either the costs of not investing (COPQ) or the market advantage that investment could provide. Given the reality that the benefits of Quality Management are difficult to quantify in direct terms and have longer payback periods, executives with no experience in Quality Management often don’t see the value of investing in it compared to investments in sales and engineering, where the … Read more...

Cermaq Serves Up Great Quality with Intelex

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Barbeque salmon for dinner, anyone?

If you are a salmon lover, chances are you have eaten a Cermaq salmon. The company supplies to 70 countries around the world, providing more than 2.5 million salmon meals daily. Their vision is to provide the world with clean, healthy and sustainable food today and into the future.

Cermaq is one of the largest fish farming companies in the world, employing 4,200 workers worldwide and producing nearly 158,000 tons of salmon and trout each year through its locations in Norway, Canada and Chile with an operating revenue of US$1.16 billion.

To produce the highest-quality fish, Cermaq set out to improve its processes to achieve its strategic goals for quality and sustainability across a global footprint.

Cermaq was looking for a Quality Management Software system to help ensure the superiority of their products and in turn fulfil customer preferences. They set three initiatives for the … Read more...