In today’s business world, owners are constantly grappling with concerns and surmounting obstacles, the least of which is actually staying afloat financially in what can be an unforgiving economy.

However, the struggle to turn a profit pales in comparison to some of the harsher consequences of failing to comply with certain regulatory requirements.

Take HRIS broker Zenefits for example. Failure to comply with several licencing regulations issued by the California Department of Insurance landed them a $7million fine.

That’s just the tip of the iceberg; more severe penalties extend to include government bodies compelling you to dissolve your company, and ultimately the endangerment of the lives and well-being of individuals your organization is servicing.

“On a global scale, we are all being asked to do more with less—and for less. At some point soon, the current internal systems will not be able to hold back the deluge, and companies will be faced with a stark decision—consistently improve or perish” – Erik Myhrberg and Joseph Raciti, Practical Field Guide for ISO 13485

Often, these kinds of requirements take the form of the ISO 13485 standard for medical device manufacturers.

In this article, I’ll break down the ISO 13485 standard, from a basic introduction to suggestions and resources for implementing it in your business or organization.

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Organizations, including businesses, do not exist in a vacuum. Every organization is embedded in a wider web of societal, political, and environmental systems, that spans from smaller local networks to expansive and complex global systems.

As IAG puts it:

“Sustainability is neither a program nor an initiative, it’s considered simply good management.”

This statement recognizes the link between an organization and the social, environmental and economic wellbeing of the communities in which they operate.

An organization’s relationship to the society and wider environment in which they exist and operate is a key factor in their ability to succeed and thrive. It can also be an insight into their general performance.

ISO 26000 is a set of guiding principles for businesses and organizations to use to steer them in a more socially responsible direction.

In order to better contribute to the health and welfare of their supporting societies and environments, businesses must enforce principles of ethical and transparent behaviour.

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Deepwater Horizon – arguably one of the most catastrophic industrial disasters of human history, and the estimated largest marine oil spill in the history of the petroleum industry.

It also happens to be one of the most abysmal failures of quality management by any company, period.

On an otherwise unsuspecting evening of April, 2010, approximately 50 miles off the coast of Louisiana in the Gulf of Mexico, the first in a chain of quality management related failures became glaringly apparent as the emergency response protocols were enforced after an oil leak in the drilling well was discovered.

The oversights were as follows:

• Lack of proper quality assessment resulted in weak, potentially contaminated cement or “drilling mud” used in the initial failsafe failing to properly block the leak.
• Fluid pressure tests were not properly carried out and clear warnings were ignored.
• Rising oil and gas levels were not properly monitored.
• The final failsafe on the ocean floor, designed to close the leaking pipe shut, failed to close due to the conditions of the drill pipe.

The aftermath of this chain of negligence left 11 people dead, caused over 130 million gallons of oil to leak into the Atlantic Ocean, and cost over $62 billion in damages.

Not one point of failure, but four. Clearly not an anomaly, this disaster was the result of a series of systematic failures that uncover a dark truth about the reality of cost-cutting and disregard for quality control.

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It’s no secret that documenting and analyzing your business processes is vital to creating a healthy business.

Yet, despite the benefits of bpm software and business process mapping being readily talked about, value stream mapping doesn’t get the same share of attention.

This is a mistake.

Value stream mapping is just as, if not more, important to reducing waste and increasing your business’ efficiency than standard process mapping.

That’s why I’ll be showing you how to make a value stream map from start to finish, with no wasted time and no needlessly confusing terms.

Let’s go.

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We always seem to be caught up in a never-ending mission to make our businesses better.

You have to ride out crises, fight through external problems, and still improve your performance week on week, quarter on quarter, year on year.

So how do we approach this improvement to get the most from it?

The key is about making improvement part of the daily process.

This approach falls under the umbrella of continuous improvement; what Toyota call Kaizen.

This is the art of taking a million steps forward. Compounding every success and safeguarding against every failure.

In this Process Street article, we’ll look at:

• Why Kaizen is important
• What are the other Toyota Production System concepts?
• Things to consider when implementing Kaizen.
• How Samsung use Kaizen selectively to optimize production

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Finding ways to improve processes within your organization can be tough.

There always seems to be so many things to measure and so many variables to consider.

Where do you start? How do you determine what’s good? Who takes responsibility for improvement?

Fortunately, you don’t have to go in blind.

There are loads of approaches you can take to process improvement, but one of the key techniques used by some of the world’s top companies is Six Sigma.

The Six Sigma school of thought is all about finding the right focus and tightening up processes around that goal. The end result should be the reduction of defects from a process. This saves resources, time, effort, and most of all money!

In this Process Street article, we’re going to give you an intro into Six Sigma while linking off to resources for you to explore deeper.

We’ll investigate the key Six Sigma principles which can shape and direct process improvement in your business.

The core Six Sigma principles

The 7 key Six Sigma principles we’ll cover are:

• Always focus on the customer
• Understand how work really happens
• Make your processes flow smoothly
• Reduce waste and concentrate on value
• Stop defects through removing variation
• Get buy-in from the team through collaboration
• Make your efforts systematic and scientific

You could categorize these as lean Six Sigma if you want to as well.

Given the evolving nature of the different schools of business process improvement, there will always likely be some disagreement over what the specific principles are.

For this reason, I feel it’s important to include the various competing principles even if some other lists might look at only 5 or 6 principles.

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The Ford Production System paved the way for most modern lean manufacturing, and the best physical embodiment of it was the Willow Run B-24 bomber production facility in WWII.

After intervention from Ford, Willow Run was able to go from producing one bomber per day to one per hour. That’s 24x their original output.

At the heart of the facility stood the “pacing clock”. This monitored what we now call takt time.

Takt time is the pulse of your operations – the rhythm and rate by which tasks and products are completed. By monitoring and setting guidelines for this single figure, Ford (and company) was able to build a facility which could produce the same as half of the entire German aircraft industry.

That’s why today we’ll be breaking down what takt time is, how to calculate it, and how it can be used in almost any system to reliably track your progress and provide an early warning system for any problems you encounter.

Let’s get started!

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