#150 – SOCIAL RESPONSIBILITY IS THE NEW BLACK IN RISK – GREG CARROLL

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GregCarrollEven more than reputational risk or cyber risk, social unrest is lining up to be a greater disrupter than any other issue. From Brexit to ISIS to race relations, civil unrest is shaping up to have a profound impact on business.  For the management of uncertainty on business objectives to be truly effective then risk needs to also include all items that disrupt the marketplace.  As such, Social Responsibility is the primary strategy to ensure business resilience. Continue reading

#150 – ERM PLAYBOOK – FOR THE US FEDERAL GOVERNMENT – GREG HUTCHINS

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Greg HutchinsWe’ve been talking about ERM for the US Federal Government for a while.  While, the US federal government has been implementing risk management in many departments, operational ERM to all Federal agencies is a game changer.

The Executive Office issued Circular A 123 last month with the specific requirement that:

“The Administration has emphasized the importance of having appropriate risk management processes and systems to identify challenges early, to bring them to the attention of Agency leadership, and to develop solutions. …  Over the years, government operations have changed dramatically, becoming increasingly complex and driven by changes in technology. Continue reading

#150 – FUTURE PROOFING – THE PROCESS OF ACTIVE ANALYSIS – GEARY SIKICH

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Untitled1-150x150Overview

The ability to effectively respond to and manage the consequences of an event in a timely manner is essential to ensure an organization’s survivability in today’s fast paced business environment. With the emergence of new threats, such as cyber-terrorism and bio-terrorism; and the increasing exposure of companies to traditional threats such as, fraud, systems failure, fire, explosions, spills, natural disasters, etc. an “integrated” approach to Business Continuity Planning is essential. Continue reading

#150 – DO YOUR KPI’S ADVERSELY IMPACT RELIABILITY – FRED SCHENKELBERG

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ABC FredKey performance indicators (KPIs) are measurable values related to essential business objectives. A KPI provides a means to monitor the performance of a specific function.

In larger organizations, with sales & marketing, research & development, operations, supply chain, and other teams working to bring products to market, each department has a specific role. For example, the sales team engages with potential customers to assist with the customer’s purchase decision. The organization and the sales team may want to focus on sales growth or average profit margin as KPIs. Continue reading

#150 – CSR THE NEW WAY … WAS I WRONG? – DR. MICHAEL HOPKINS

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AAA HOPKINS… in Europe and, as we can see, in the US too. Entirely false promises are being made, but this is a fantasy that comforts many. It is a fantasy of withdrawal from a globalised world, stopping the free movement of people and labour.  The real challenge for anyone vaguely liberal/left is to counter this, not with some old-school internationalist vision, but with something that is both local and modern, that accepts there is anxiety instead of telling people they are simply wrong and stupid to feel it, or that it is some kind of false consciousness.
Continue reading

#149 – MINIMIZING CAREER PATH RISK – JOHN AYERS

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AAASome people say take what you love in college. Problem is, not too many high school seniors know what they love. Others say college should be an intellectual journey. Problem is many degrees will not prepare you for the real world in terms of making a good living. I believe college is to prepare you for a career which can support you and a family down the road. If important, intellectual studies can take place outside of work using the internet. Continue reading

#149 – WORKING IT (FREE REVIEW BOOK) – GREG HUTCHINS

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Greg HutchinsThis book is my story and in many ways may become the story of your work, career, and job. So, pay heed.   Understand the conventional rules and challenge/hack the rules described in Working It: The Rules Have Changed.

Freemiums:
1.  At the end of this article, we share how you can get a free review copy of the 200 page book.
2.  Visit WorkingIt.com for additional fun and insights on work. Continue reading

#149 – THE BIG SHORT: COULD IT HAPPEN AGAIN? – ANNETTE DAVISON

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AAA&Risk as a term, is often used or perceived as being synonymous with defence. Being defensive is not a bad thing – but being solely defensive, means your organisation may be missing opportunities. Events of recent times, global financial crisis (GFC) and others, have shown that the historical approaches to governance oversight have not worked. Key points arising from the inquiry into the GFC included:

  • Widespread failure in regulation
  • Breakdowns in corporate governance
  • Policymakers lacked a full understanding of the system they oversaw
  • Systemic breaches of accountability and ethics

Continue reading

#149 – INCORPORATING RELIABILITY INTO DESIGN REVIEWS – FRED SCHENKELBERG

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ABC FredReliability Input into Design Reviews

Consider the following scenario: You are a reliability engineer working for a large corporation that plans to launch a new product. On occasion, you and the team sit down to review the design. The idea is to check the design for any issues with the combined wisdom of all the players involved. Or, perhaps, the review serves as just a status update for the entire team, providing a focus on the most important issues and action items. Continue reading

#149 – SOFTWARE WASTAGE: TIME SPENT, CANCELED PROJECTS, CYBER ATTACKS, AND LITIGATION FOR POOR QUALITY – CAPERS JONES

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Capers Jones pixSoftware demographics and software work patterns show interesting changes over the past few decades. A study in 1990 noted 116 software occupations but only 5 involving quality and none involving risks or cyber-attacks. An updated study in 2016 noted 205 total software occupations of which 32 were involved with risks, cyber-attacks, and quality. This is due to the huge increase in numbers and types of software cyber-attacks. Continue reading

#148 – UNINTENDED CONSEQUENCES OF RISK REPORTING – GEARY SIKICH AND JOOP REMME

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Untitled1-150x150Introduction

In this article we posit three questions. The first question is: “Is it a social responsibility of companies that they undertake a comprehensive risk assessment?” The second question: “Does the notion of conscience and its application to the generation and use of risk information and information in general, create an obligation for the organization to disclose
the results of the comprehensive risk assessment
?” The third question “How do the people Jooplesin the organization communicate the information from the comprehensive risk assessment to stakeholders and yet preserve security and protect the organization?” Continue reading

#148 – US GOVERNMENT ERM REQUIREMENT FINALIZED – GREG HUTCHINS

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Greg HutchinsWe’ve been discussing how ISO 9001:2015 has adopted Risk Based Thinking that will impact 1.2 million companies.  ISO 14001:2015 will impact 400,000 companies.  Now, government agencies are adopting and putting into statute risk management.

We’ve been talking up the fact the US government is requiring Enterprise Risk Management (ERM), specifically Office of Management and Budget Circular OMB A 123, of all US departments.  This is a game changer for federal agencies.  In this article, we’ll look at some of the significant changes in ERM for Federal agencies. Continue reading

#148 – HOW TO MAKE AUDIT MANAGEMENT EFFECTIVE – GREG CARROLL

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GregCarrollEffectiveness is the holy grail of Compliance Management.  Whether regulatory or ERM, ensuring business is conducted as intended is the base requirement to optimising your organization’s performance.

Let’s face it, business spends its money where it will deliver the best return, i.e. to shareholders, so the key to increasing the compliance budget is to measure compliance as a factor of performance not as a safety net. Continue reading

#148 – 3 THINGS YOU HAVE TO KNOW ABOUT ISO 9001:2015 RISK’S DEFINITION BEFORE MOVING ON – MOHAMMAD ELSHAHAT

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AAAWhy do you think most executives and quality practitioners are focusing on the strategies, techniques, and tools when it comes to Risk Based Thinking?

I bet you’ve heard or even read these questions before; What are the best tools to address risks? Is it SWOT or FMEA will be more helpful? How can I implement this risk-based thinking? Continue reading

#148 – USING YOUR ACCREDITATION TO MAINTAIN HIPAA COMPLIANCE – TED SCHMIDT

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00141With the recent changes to the enforcement of HIPAA and HITECH (Health Information Technology for Economic and Clinical Health Act), “covered entities and their business associates” (aka hospitals and their providers) will now be subject to fines/penalties for noncompliance. Since HIPAA was enacted in 2005, the consensus is that there has been little enforcement of these requirements. Continue reading

#147 – THE NINE CIRCLES OF PLANNING HELL – GEARY SIKICH

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Untitled1-150x150The Nine Circles of Planning Hell (Adapted from Dante’s Inferno)

Introduction

Inferno, the first part of Dante’s Divine Comedy that inspired the latest Dan Brown’s bestseller of the same title describes the poet’s vision of Hell. The story begins with the narrator (who is the poet himself) being lost in a dark wood where he is attacked by three beasts which he cannot escape. He is rescued by the Roman poet Virgil who is sent by Beatrice (Dante’s ideal woman). Together, they begin the journey into the underworld or the Nine Circles of Hell. Continue reading

#147 – DONATING TO CAUSES YOU CARE ABOUT IS EASY WITH YOURCAUSE – KELLY EISENHARDT

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Kelly EisenhardtMore and more companies are offering employee engagement programs within their benefits package. It is a winning benefit for the employee, the company, the nonprofits and those the nonprofits serve. While there are multiple platform providers that support employee engagement programs there is only one that has always ensured that no portion of the donation is deducted to cover the platform providers’ operational expense…YourCause. Continue reading

#147 – ICT FASHION VICTIMHOOD – HOWARD WEINER

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AAAWhen I think of the term ‘Fashion Victim’ these two shots from Brazil (one of my favorite movies of all time) come to mind:

There seems to be no length to which some of us will not go to prove that we are on top of the latest and greatest trends. Katherine Helmond’s character in the film, above, is a case in point. Over the course of the film she sports ridiculous clothing and submits herself to intrusive, painful and ultimately destructive medical procedures, all for the sake of fashion. By the end of the film she has virtually destroyed herself. Continue reading

#147 – ACHIEVING PROCESS STABILITY – FRED SCHENKELBERG

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ABC FredWhat Is Process Stability?

Everything varies. Your vendors provide components with a range of values. Your production process varies, too. Creating, monitoring, and maintaining process stability enhances your product reliability performance.

When I started my professional life as a manufacturing engineer, a senior engineer told me that we take a product design and can only make it worse. He said that, if we could make every unit exactly according to the nominal values of the drawing, every unit would work well. Continue reading

#147 – ERM STATUS UPDATE WITH FEDS – GREG HUTCHINS

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Greg Hutchins

US Office of Management and Budget is releasing Enterprise Risk Management update to Circular A – 123 on July 15, 2016.

The new policy document is known as ‘Management’s Responsibility for Enterprise Risk Management and Internal Controls.’  The policy document requires an enterprise risk management program with operational risk controls.  The policy document is a game changer. Continue reading

#146 – THE REAL REASONS WHY WOMEN EARN LESS THAN MEN – ELIZABETH LIONS

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Lions gold podiumStatistically, women earn less than men, but when you look at the same job and the same skill set, the wage disparity is lower than you’d think, according to Pay Scale.

Often the wage difference between men and women has little to do with skill set. Many times it all boils down to how a person perceives themselves and their self-worth. Confidence plays a big factor. Having the guts to ask for more money often equates to earning more.  Continue reading

#146 – SUPPLY CHAIN RISK MANAGEMENT IS THE HOT NEW CAREER – GREG HUTCHINS

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Greg HutchinsThe idea of supply chain risk management has been around for about 10 years. It is only in the last 5 years, that it has become popular. We are still at the early stage of supply chain risk management adoption and deployment.

In terms of total dollar amount, external suppliers provide a significant portion of a manufacturer’s product. For U.S. firms, 50% to 80% or more of the final price of a product can be the cost of purchased goods.  In Japan, it can be even higher.

For these reasons, any supply disruption can kill a supply chain.  As a result, supply chain risk management is now critical to a company’s competitiveness.
Continue reading

#146 – IT IS ALL ABOUT SURVIVABILITY – GEARY SIKICH

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Untitled1-150x150If you want senior management to pay attention give them something that challenges their focus – and understand that their focus is not on how many computers you have or RTO, RPO stats. It is on business survivability – will we be in business tomorrow given the issues that we face today.

What is more important to your organization’s continuity of operations – how many computers you have or where your competition will be coming from in the next five years? Continue reading

#146 – BASELINING SUSTAINABILITY PERFORMANCE WITH ESG, SCIENCE, & TECHNOLOGY – KELLY EISENHARDT

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Kelly EisenhardtBy leveraging their comprehensive ESG database, Thomson Reuters helps companies’ baseline sustainability performance and stay ahead of emerging global sustainability trends. TR recently released their latest Greenhouse Gas Emissions report highlighting “sustainable growth,” in addition to reducing GHG emissions and alignment with the U.N. Guidelines. Continue reading

#146 – HOW SAMPLE SIZE AFFECTS DECISION MAKING – FRED SCHENKELBERG

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ABC FredSample Size Determination

When planning for quality or reliability testing, an often posed question is: How many samples do you need? The trite answer is: Just as many samples as you need and not one more. A better answer is: Enough samples to make the right decision. The realistic expectation is : You will not have enough samples. Continue reading

#146 – RISK AHEAD OR RISK BEHIND – ERIC SCHULZE

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A EricOnly after the ship has sunk does everyone know how it might have been saved. Healthcare is changing at an incredible pace. Identifying what is relevant and prioritizing the changes that will impact a hospital is an enormous challenge for a hospital’s leadership. Unfortunately, many hospitals, especially rural hospitals, are not able to mitigate the problems successfully. Continue reading

#145 – ALTERED STATES: RISK PERCEPTION AFTER THE EVENT – GEARY SIKICH

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Untitled1-150x150Heightened Awareness or Reactive, Backwards Looking?

From financial crises to energy catastrophes to earthquakes and threats of terrorism, we hear a lot about events that challenge our ability to identify and manage risk. Unfortunately some of the things that emerge from many of these events are reactive regulatory rules and requirements. Continue reading

#145 – GATHERING DATA WITH NEVADA CHARTS – FRED SCHENKELBERG

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ABC FredGathering Field Failure Data

A common and rather poor technique to gather field data is to count the number of returns by week or month. This can provide a graph showing the number of returns over time. However, it hides useful information you need to understand your field failures.

Let’s take a look at a way to gather the same field failure data and retain the critical information necessary for time-to-failure analysis. Continue reading

#145 – DEMYSTIFYING RISK – LIFE VS. DEATH – GREG CARROLL

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GregCarrollRisk management is suffering from too much consultant-speak – mystifying what is a standard business practice. When inducting new staff in the concepts of risk management, I use the most obvious analogy which clarifies the issues simply: that of our own mortality. Continue reading

#145 – SASB: PROMOTING SUSTAINABILITY – KELLY EISENHARDT

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Kelly EisenhardtIn today’s world, many investors are looking closely at a company’s sustainability performance and risks. The Sustainability Standards Accounting Board (SASB) continues to advance the use of sustainability accounting standards that are backed by evidence-based research and stakeholder participation. Continue reading

#145 – MEETING REQUIREMENTS, EXCEEDING EXPECTATIONS AND HAPPINESS – MALCOLM PEART

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Malcom Peart pixHow often do we hear or read that some organization or other purports to aim to exceed their Clients’ expectations? Are such statements mere puffery and sales pitch by some top-line grabbing salesman or are they genuine goals in line with the mantra of continuous improvement? And if we exceed somebody’s expectations are they happy about it? Continue reading

#144 – EFFECTIVE CONCURRENT ENGINEERING REDUCES PRODUCIBILITY RISK – JOHN AYERS

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AAAMost companies have policies and procedures for concurrent engineering but many are ineffective for various reasons resulting in poor implementation of improved producibilty in their products. I have made this observation based on working for a variety of companies in different industries. Three examples of different approaches I encountered are presented below for your consideration. Two of the examples were used by defense companies, one of which I consider excellent and the other poor. One method was used by a commercial company is one I consider to be very good. Continue reading

#144 – CHAMPIONING WOMEN IN THE SOCIAL IMPACT SECTOR – KELLY EISENHARDT

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Kelly EisenhardtSince launching The Wakeman Agency in 2003, Vanessa Wakeman has been recognized as a champion for nonprofits and progressive organizations at the forefront of innovation and social change. At the helm of an award-winning agency that produces high impact special events and public relations campaigns, Vanessa and her team help tell the stories of a diverse group of clients who want to make the world a better place. Ms. Wakeman has been featured and highlighted in media sources such as PR Week, The New York Daily News, ABC Eyewitness News, SmartMoney, Westchester, and Philanthropy Journal magazine. Continue reading

#144 – GATHERING FIELD DATA FOR IMPROVING RELIABILITY – FRED SCHENKELBERG

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ABC FredImportance of Field Data

Customers experience product failures. Understanding these failures that occur in the hands of customers is an essential undertaking. We need this information to identify increasing failure rates, component batch or assembly errors, or design mistakes. Continue reading

#144 – BEHIND COMPLIANCE MANAGEMENT FAILURES AT MITSUBISHI, VW, AND TARGET – GREG CARROLL

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GregCarroll2016 has seen a virtual tsunami of compliance failures involving some of our largest companies. From Mitsubishi to VW, from ANZ to Target, almost weekly there have been media reports about some company employees having run amok – unbeknownst to their executives and boards. People are asking: “What happened to the compliance management systems that are supposed to monitor and prevent such abuses?” Executives and boards are naturally starting to question the entire compliance management function. Continue reading

#144 – ARE YOU PLAYING ASSET ROULETTE? – KEITH RIDGEWAY

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Keith ImageDid you know on average around 30% of all organisations do not know what they own, where their assets are located or who is using them; and over 65% of information recorded on asset registers is incomplete, inaccurate or even missing.   What’s more concerning is a number of these assets may not be statutory compliant e.g passenger/good/DDA lifts, fire, gas, pressure asset etc.

How effective is your asset management system and how accurate is your asset register; To find out please answers below the following questions  Continue reading

#144 – ENTERPRISE RISK MANAGEMENT AND STRESS – JIM KLINE PH.D.

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aIMG_4231Introduction

Enterprise Risk Management is the process of determining what an organization’s operational risks are and the appetite that upper level management has for those risks. The idea is that by identifying the risks ahead of time, the risks can be avoided or mitigated.

Like all such procedures, the goal is worthy. However, there are weaknesses. One of the little recognized problems is how people react under stress. Continue reading

#143 – CORPORATE SOCIAL RESPONSIBILITY BALANCING THE RISKS AND REWARDS – GEARY SIKICH AND JOOP REMME

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Untitled1-150x150Summary

In this article, we intend to offer a realistic perspective on corporate social responsibility. First we offer our perspective on the related concepts of corporate social responsibility and sustainability, clarifying why anyone in the business community should spend some energy on them. Then we relate corporate social responsibility to corporate risk.

UntitledFocusing corporate risk on the risk in future developments, we then see the background for the challenges within corporate social responsibility. From the complexities around those challenges, we then go to developing business, which then brings us to our conclusion. The conclusion has to make sense in managerial terms and that is why we give the reader a twelve step program to effectuate improvements in terms of corporate social responsibility. Continue reading

#143 – TRACKING AND REPORTING FIELD FAILURES – FRED SCHENKELBERG

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ABC FredComplications When Tracking Field Data

Fielded products fail day by day. Customers report these failures, generally seeking a way to remedy this issue. Gathering the reported or returned products or confirmed failures is common practice.

Depending on the product, a simple replacement or exchange may suffice. For other products, repair or a refund may be appropriate. In general, and not always, when a product fails in the hands of a customer, the organization designing, manufacturing, and distributing the product learns of the failure. Continue reading

#143 – ARE YOU BEING MISLEAD OR CONNED? – KEITH RIDGEWAY

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Keith ImageSome weeks ago I wrote an article on all AB (accreditation  bodies) and CB ( certification Bodies) should join up with institutes  to  ensure hard working companies do not get conned by using  ISO management standard consultants  claiming to be experts  and non- UKAS approved certifying companies.

I recently was asked by two companies to carry out independent 2nd party  audits. Continue reading

#143 – SUSTAINABILITY KNOWLEDGE – KELLY EISENHARDT

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Kelly EisenhardtAlyson Slater heads GRI’s Knowledge Unit, which is tasked with collecting and mobilizing the vast knowledge and experience found within GRI’s staff and multi-stakeholder network. The Knowledge Unit also leads the development of new products and services to help reporting organizations, data users, and thought leaders optimize their use of GRI Sustainability Reporting Standards and the resulting reported data. GRI’s Emerging Market Regional Hubs in Hispanic America, Africa and South East Asia also fall under Alyson’s remit. Continue reading

#143 – TECHNOLOGY THOUGHT LEADER: SHERI DOVER – MARGAUX HUTCHINS

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AAASheri Dover is an entrepreneur and founder of the PDX Code Guild. She is a thought leader in the Portland tech startup community. Here, she talks with us about how the PDX Code Guild helps people get high-paying jobs in the technology sector.

Can you tell me a few things about yourself?

My name is Sheri Dover. I am the founder and the CEO of PDX Code Guild. Continue reading

#143 – DO YOU KNOW THE RISKS IN YOUR MEASUREMENT SYSTEM? – AFAQ AHMED

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aaaOrganizations have processes and every process has a certain amount of risk associated with it due to variations. By managing process variations we can minimize risks to achieve desirable results. Every process has input variables (X) that delivers outputs (Y). Changes in (Y) is dependent on changes in (X) and can be expressed as:

Y=f(X) Continue reading

#142 – AMAZON’S SECRET WEAPON: BEING ANTICIPATORY – DANIEL BURRUS

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BurrusDan_040In many ways it seems impossible that Amazon has been in business for more than 20 years. Time does fly! During that time, Amazon has been – and continues to be – the largest and most innovative leader in the e-commerce market. You may be surprised to discover the other markets Amazon has not only entered, but is also in the process of redefining and reinventing. Continue reading

#142 – WHAT CAN VALUE ADDED AUDITING™ DO FOR YOU? – GREG HUTCHINS

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Greg Hutchins

Value Added Auditing(VAA) is risk based auditing.  Or another way to think about it is VAA is analytical auditing where the sponsor and auditee get valuable information to improve their operations and become more competitive.

So, what can VAA do for you?

Value added auditing facilitates the company’s and its supplier’s improvement. For example, the auditor may determine if controls or systems are in place ensuring that: Continue reading

#142 – RAISING THE VOICES OF SUSTAINABILITY THOUGHT LEADERSHIP – KELLY EISENHARDT

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Kelly EisenhardtSustainability thought leaders are seeking experienced communications organizations to help get their vision and mission communicated both internally and externally, along with promoting new trends.

Tim Gnatek is President and Co-founder of Blue Practice where he manages media relations, corporate and employee communications, thought leadership programs, content generation, and creative campaigns. Continue reading

#142 – BLACK SWANS, GREY SWANS, WHITE SWANS …. – GEARY SIKICH

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Untitled1-150x150We hear a lot about things that are being called “Black Swans” today thanks to Nassim Taleb and his extremely successful book, “The Black Swan: The Impact of the Highly Improbable,” now in its second edition. I have written several articles centering on the “Black Swan” phenomenon; defending, clarifying and analyzing the nature of “Black Swan” events. And, I am finding that wildly improbable events are becoming perfectly routine events. Continue reading

#142 – THE STRESS – STRENGTH CONCEPT IN PRACTICE – FRED SCHENKELBERG

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Stress–Strength Concept

ABC FredIdeally, in every design of every component the stress–strength relationship looks like this figure:AAA 1You will notice that the stress is well below the strength. This implies there is very little chance of failure as a result of the element being overstressed. Also, ideally, we fully characterize all stresses and all strengths for each element of a product. This is generally difficult to accomplish and it is rarely done to that extent. Continue reading

#142 – ARE YOU A SYSTEMS CONTROLLED AND/OR PEOPLE CONTROLLED ORGANIZATION? – KEITH RIDGEWAY

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Keith ImageAre you a (Systems Controlled & People Driven) or a (People Controlled and People Driven) organisation?

Every day we hear of organisations failure to prevent accidents, environmental incidents, non-conformities, product recalls and at worst a child, adult or an animal was killed. Continue reading

#141 – WHAT WILL QUALITY LOOK LIKE IN 20 YEARS? – PETER J. HOLTMANN

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179fed3To look to the future, the quality profession is revisiting its roots. The question is, “Where is the next generation to help the profession look ahead?” Or, as I like to think of it, “What’s the emoticon for quality?”

I recently attended ASQ’s World Conference on Quality and Improvement where we discussed powerful questions such as, “What will quality look like in 20 years? What will it be called? Will it still be relevant?”

Continue reading

#141 – WASHINGTON STATE ADOPTS ERM – GREG HUTCHINS

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Greg HutchinsIn the US, there are a number of Enterprise Risk Management (ERM) developments:

  • US Feds are requiring ERM in all federal departments.
  • Feds are pushing ERM to states that have federal funding.
  • Fed are thinking of putting ERM into enforcement and contracts.

Continue reading

#141 – RELIABILITY MODELING USING THE MONTE CARLO APPROACH: WORTH GAMBLING ON – FRED SCHENKELBERG

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ABC FredModeling Complex Systems and Their Variability

The Monte Carlo approach relies on data that describe the variation of elements within the system. It also connects the elements such that the result is an estimate of performance. For reliability modeling this is easiest to imagine for a series system. Continue reading

#141 – REAL WORLD VOLATILITY: IMPLICATIONS FOR SCENARIO GENERATION – GEARY SICKICH

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Untitled1-150x150Introduction

In the risk-neutral world, all business and government continuity planning would be risk-balanced. However, in reality, risks, threats, hazards and their consequences change depending on an organizations exposure, sensitivities to impact and other factors. For instance, a natural disaster, can occur without much warning and can have direct and indirect impact on an organization. Complicating the Business Continuity Planners life is a simple fact, events have unforeseen consequences that can rarely be planned for. Continue reading

#141 – CARBON EMISSIONS AND FOOD WASTE REDUCED WITH BALDOR’S SPARCS PROGRAM – KELLY EISENHARDT

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Kelly EisenhardtThe White House Climate Change Plan to Reduce Methane Emissions identified landfills as being responsible for 18% of all methane emissions and approximately 100 million metric tons of carbon dioxide pollution. [1] Baldor Specialty Foods, a leading produce distributor in the Northeast and Mid-Atlantic states based in the Bronx, NY, is on a mission to reduce these numbers by tackling the overwhelming problem of food waste in the United States. Continue reading

#141 – RISK LEADERSHIP PROFILE: ED PERKINS BY MARGAUX HUTCHINS

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OLYMPUS DIGITAL CAMERAEd Perkins is an electrical engineer and cyber security guru who is a candidate for 2017 President-elect of IEEE USA, the U.S. group of the biggest technical society in the world. Ed talks with us about what makes engineering cool, the importance of STEM, and the future of technology. 

Ed Perkins CIA CERM is also the developer of the Certified Enterprise Risk Manager® – Cyber Security™ certificate and is an expert on the NIST Risk Management Framework. Continue reading

#140 – US FEDS ADOPT ERM – GREG HUTCHINS

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Greg HutchinsThe President of the US has emphasized:

“the importance of having appropriate risk management processes and systems to identify challenges early, to bring them to the attention of Agency leadership, and to develop solutions.”

The President’s Executive Office (Office of Management and Budget) is updating Circular A – 123 to ensure Federal executives and managers are effectively, efficiently, and economically managing risks that inhibit the agency from achieving its strategic and operational objectives.

Continue reading

#140 – COVER YOUR ASSETS AND PLAUSIBLE DENIABILITY – ED PERKINS

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OLYMPUS DIGITAL CAMERAIn an earlier post [1] we looked whether ‘plausible deniability’ was now a dead strategy in the face of enterprise risk management (ERM) and the likely impact of the US SEC (Securities and Exchange Commission) guidance [2] regarding disclosure obligations relating to operational and cybersecurity risks and cyber incidents. The SEC noted that “a number of disclosure requirements may impose an obligation on registrants to disclose such risks and incidents. Continue reading

#140 – DRIVERS OF CHANGE: BUSINESS CONTINUITY PLANNING IMPLICATIONS – GEARY SIKICH

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Untitled1-150x150Introduction

Unpredictability is the new normal. As the world approaches 7 billion in population this year, there is an ever increasing demand for food, energy and a voice in how things are run. How do these changes affect business continuity planners, you may be asking? Then simple answer is, they will have far reaching effects on how business continuity planning is conducted. No longer can we be satisfied with the assurance that our “hot site” is available, or that we can maintain business operations in the face of a pandemic; or that we can deal with the aftermath of a natural disaster. Continue reading

#140 – FAULT TREE ANALYSIS BASICS – FRED SCHENKELBERG

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Fault tree analysis (FTA) is a technique used to explore the many potential or actual causes ABC Fredof product or system failure. It is best applied when there are many possible ways for something may fail. For example, when my car doesn’t start, it could be a dead battery, a faulty starter, a loose wire, an absence of fuel, and on and on. Continue reading

#140 – THE RISK CHALLENGE TO THE QUALITY PROFESSION – JAMES KLINE PH.D

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aIMG_4231With the adoption of ISO 9001.2015 and the Office of Management and Budget’s (OMB) revision of Circular A-123, management of both the private sector and federal government must now pay formal attention to risk across their enterprise. In addition, the Government Accountability Office (GAO) has updated the “Standards for Internal Control in the Federal Government”, the Green Book, to better accommodate risk assessment. Continue reading

#140 – RISK AHEAD OR RISK BEHIND? – ERIC SCHULZE

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A Eric“Only after the ship has sunk does everyone know how it might have been saved.”

Healthcare is changing at an incredible pace. Identifying what’s relevant and prioritizing the changes that will impact a hospital is an enormous challenge for a hospital’s leadership. Unfortunately, many hospitals, especially rural hospitals, are not able to mitigate the problems successfully.   Continue reading

#139 – OPERATIONAL EXCELLENCE IS NOT SOMETHING NEW! – JOSEPH PARIS

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Paris_Aug2012There is a lot of content created around Operational Excellence and its companion disciplines – including; Leadership, Lean, Six-Sigma, Theory of Constraints, Project Management, and so on – which together comprise Operational Excellence (including the content produced by myself).  But are all of these concepts as “new” as some would have you believe?  Have they never been embraced or implemented in the past?  Continue reading

#139 – RISK TREATMENT STRATEGIES – GREG HUTCHINS

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Greg HutchinsWhen evaluating risk response strategies, executive management along with process owners must align risk responses with the organization’s risk appetite, business objectives, costs/benefits, and overall risk strategy/tactics. Risk response strategies and tactics may involve: Continue reading

#139 – WHY WE NEED INTELLIGENT DISOBEDIENCE IN CORPORATE AMERICA – KELLY EISENHARDT

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Kelly EisenhardtEmpowering employees to speak up when they see something that is wrong or when they are asked to do something that might cause harm is critical to the survival of all organizations. Each employee needs to internalize their own personal accountability for the actions they take under executive leadership. Continue reading

#139 – STAR ACADEMICS: DO THEY GARNER INCREASING RETURNS? – JAMES KLINE PH.D.

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aIMG_4231I recently completed my dissertation of the same title. The evaluative purpose of the dissertation was twofold. The first was to determine if, as the title indicates, star academics garner increasing returns for the university they work at. The second was to determine what criteria helps academics in obtaining National Institute of Health (NIH) funds.  NIH provides the largest amount of federal funding for scientific research. As a result, receipt of NIH funds makes a significant contribution to university revenue. Conventional wisdom and some supporting research indicate that star academics bring in substantial amounts of grant money. They also attract a higher quality of supporting academics and graduate students. Continue reading

#139 – EXPLOITING NEW CHALLENGES IN ERM – GEARY SIKICH

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UntitledHeightened Awareness or Reactive, Backwards Looking?

From financial crises to energy catastrophes to earthquakes and threats of terrorism, we hear a lot about events that challenge our ability to identify and manage risk. Unfortunately some of the things that emerge from many of these events are reactive regulatory rules and requirements. Continue reading

#138 – IN A WORLD OF ‘BLACK SWANS’, HOW DO YOU KNOW WHICH ONE TO WORRY ABOUT? – GEARY SIKICH

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UntitledIntroduction

There’s always a story that explains why an event is a “Black Swan” – after the fact. Where are the “Black Swan” prognosticators before events occur? I see “after the fact” articles and statements, such as, “we knew that was coming” or “we predicted this” – all after the fact. Generally projections and predictions seem never to hold sway until after the fact. Predictions and projections never seem to occur when the prognosticator specifies — is it just that the timing never seems to work out – until after the fact. From Nostradamus to the “Bible Code” we are enamored with predictions – after the fact. Does there seem to be a theme developing here? Continue reading

#138 – US FEDS REQUIRE ERM – GREG HUTCHINS

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Greg HutchinsThe President of the US has emphasized:

“the importance of having appropriate risk management processes and systems to identify challenges early, to bring them to the attention of Agency leadership, and to develop solutions.”

The President’s Executive Office (Office of Management and Budget) is updating Circular A – 123 to ensure Federal executives and managers are effectively, efficiently, and economically managing risks that inhibit the agency from achieving its strategic and operational objectives.  Continue reading

#138 – 6 TRAITS YOU SHOULD DEVELOP TO BECOME AN EXCEPTIONAL QUALITY PRO – CINDY FAZZI

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2014-bl-author-cindy-fazziIn a regulated company, quality professionals may be revered or dreaded or downright misunderstood. But there’s no denying their important role. As quality guru Joseph Juran said, all improvement happens project by project and in no other way. To paraphrase Juran, I would say a high-quality product or service happens step by step and process by process. Guess who’s responsible for making sure every step and every process is working effectively? You got that right—quality pros. Continue reading

#138 – LIFE TESTING: WHERE TO START? – FRED SCHENKELBERG

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ABC FredReliability or life testing involves estimating the expected durability over time of an item. This may be an entire system, a product, or an individual component. We may also focus on an element of a component, such as a material property. At the end of the testing we want to say something meaningful about the expected performance over time. Continue reading

#138 – MITIGATE RISK BY DETERMINING CRITICAL DATUM – KEITH RIDGEWAY

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Keith ImageEvery day we are exposed to all types of hazards, but what really makes these hazards become risks.

For the past 30 years, I’ve been involved in one way or another, investigating the root causes of failure modes be it a system, process, person, plant or product.   During this time I’ve applied different problem-solving tools like “FMEA, 8D, 5Whys, FEA’s, DMAIC etc” in order to find the true root cause of this failure mode.   Only to get frustrated, thinking I had found the root cause, only 3 months later a new failure mode would come to the surface. Continue reading

#138 – HEALTHCARE@RISK – ALIGNING YOUR STRATEGIC VISION WITH YOUR BUSINESS OBJECTIVES – TED SCHMIDT

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00141With all of the changes in healthcare reimbursements, how do you ensure that your hospital is properly funded to meet your financial/operational needs while achieving your hospital’s vision? These changes are especially concerning for Hill-Burton hospitals, Safety Net hospitals, and faith-based hospitals that serve a disproportionate share of indigent patients. Continue reading

#137 – RESOLVING TEAM CONFLICT MINIMIZES LOW MORALE RISK – JOHN AYERS

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John Ayers pixAs we know, team conflict is not good and needs to be resolved quickly to maintain a high level of team moral and performance. This notion is true in sports as well in the work place. There are a number of approaches to resolve conflicts. For example: ignore them and hope they work themselves out; fire the main instigator as president Truman did with General MacArthur; confront them and resolve them. I offer an example herein of two approaches to resolve conflict, one of which I feel is a bad approach and one a good approach that I favor. Continue reading

#137 – WHY IS ISO 31000 A MUST KNOW ISO STANDARD? – GREG HUTCHINS

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Greg Hutchins pixMore ISO management systems are incorporating RBT and risk, so the standard is becoming a ‘must know’ standard. ISO 31000 risk management principles, risk management framework, and risk management process are the preferred tools to use with ISO management systems because ISO 31000: Continue reading

#137 – STILL USING PAPER FOR AUDITS? – HERE’S WHY YOU NEED TO AUTOMATE – STEVE HARRISON

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Steve Harrison author photoA recent quality management system benchmark survey showed manual processes are still predominant over automated systems.[1] The results of the survey were compiled from over 100,000 professionals worldwide and the majority of the participants work in quality or regulatory positions across pharmaceutical, medical device and biotech industries. Continue reading

#137 – WHEN IT COMES TO CYBERSECURITY, DISCONNECTS ‘R US’ – ED PERKINS

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OLYMPUS DIGITAL CAMERAA recent report from the cybersecurity firm Barkly, on results from a survey they conducted of IT professionals and IT executives, found that while the IT professionals who have direct responsible for cybersecurity feel their organizations are vulnerable, the executives from those organizations are significantly more confident that things in general are fine. For their Cybersecurity Confidence Report[1], Barkly surveyed of 350 IT professionals and found that 50 percent are not confident in their current security products or solutions. Continue reading

#137 – AN EMPLOYEE RETENTION PROGRAM THAT COSTS NOTHING – ELIZABETH LIONS

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Lions gold podiumRetention is like life insurance. No one thinks about it until they need it.

With the job market heating up and passive candidates starting to get antsy and look for different jobs, managers need to consider retaining their top talent. The irony is retention costs nothing.  Continue reading

#136 – DOES YOUR COMPANY NEED A QUALITY DEPARTMENT? – TIM RODGERS

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#136 – HOW PERFORMANCE EXCELLENCE HELPS BROADEN THE HORIZON OF QUALITY – MICKEY GARCIA

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2015-bl-author-mickey-garciaSince W. Edwards Deming’s pioneering work in the 1950s, we have witnessed remarkable progress in the disciplines of both quality and management. Through the years, the best practices of the day have been given fancy names such as total quality management (TQM), Six Sigma and, most recently, Lean everything—just to name a few. Continue reading

#136 – HOW MANY RELIABILITY ENGINEERS DOES IT TAKE TO REPLACE A LIGHT BULB? – FRED SCHENKELBERG

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ABC FredHow many reliability engineers does it take to replace a light bulb? Well, none, but that’s because reliability engineers would use a reliable bulb to avoid the need for replacement.

Of more importance is answering the question ‘How many reliability engineers does an organization need?’ Is it

(a) none,

(b) one really good reliability engineering professional, or

(c) an entire staff of highly talented reliability engineers? Continue reading

#136 – HOW TO ESTIMATE AND PRIORITIZE RISKS – STEPHEN FLICK

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AAA FILICKEstimating and prioritizing risks is a time-consuming process and the results of risk estimation and prioritization don’t often inspire a great deal of confidence in the process. It’s not a perfect process and it will probably never be. We’re not perfect and nothing we ever make[1] will ever be. Continue reading

#136 – ON THE PAYOFF OF ATTENDING AN ELITE COLLEGE – NATIONAL BUREAU OF ECONOMIC RESEARCH

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thIn today’s high-tech economy, just about everybody has gotten the message that it pays to get a college degree. What is less clear to many parents and their college-bound youngsters is whether it makes economic sense to attend an elite school with a total four-year price tag big enough to buy a nice suburban house in many parts of the country.

Does the earnings return from a diploma with the name of an elite institution stamped on it justify the higher expense, or is the reputation of the college aristocracy vastly overblown, at least when it comes to subsequent income? It’s a question that more and more economists are researching, while many parents and policymakers would like to know the answer.

Yet researchers have long found it difficult to tease out the labor market effects of college quality versus other characteristics that employers reward. The problem is that students who attend selective schools are likely to have higher earnings potential regardless of where they attend college for the very same reasons that they were admitted to the more selective schools in the first place. In a recent NBER Working Paper, Stacy Berg Dale and Alan Krueger try two novel approaches to solving this problem. In Estimating The Payoff To Attending A More Selective College: An Application of Selection On Observable and Unobservables (NBER Working Paper No. 7322) they use data from the College and Beyond Survey to match 6,335 students who were accepted and rejected by a comparable set of colleges in 1976. They then compare labor market outcomes in 1995 among students who had the same menu of choices, but among whom some attended more selective schools than others. They also use this data set and the National Longitudinal Survey of the High School Class of 1972 to estimate the impact on students’ subsequent earnings of the average SAT scores of all the schools they applied to as well as the average SAT score of the school they attended.

They find that school selectivity, measured by the average SAT score of the students at a school, doesn’t pay off in a higher income over time. “Students who attended more selective colleges do not earn more than other students who were accepted and rejected by comparable schools but attended less selective colleges,” the researchers write. They also find that the average SAT score of the schools students applied to but did not attend is a much stronger predictor of students’ subsequent income than the average SAT score of the school students actually attended. They call this finding the “Spielberg Model” because the famed movie producer applied to USC and UCLA film schools only to be rejected, and attended Cal State Long Beach. Evidently, students’ motivation, ambition, and desire to learn have a much stronger effect on their subsequent success than the average academic ability of their classmates.

Still, they do find that some aspects of colleges are related to students’ subsequent economic success, even after adjusting for the abilities of the students upon applying to college. For example, students who attend colleges with higher average tuition costs or spending per student tend to earn higher incomes later on. The internal real rate of return on college tuition for students who went to college in the late 1970s was a startlingly high 16 to 18 percent. But with college costs up sharply since then, returns have probably come down to a more normal range. The authors speculate that tuition may affect future earnings because schools with higher tuitions offer more resources or higher quality products to their students.

Finally, the results of this study suggest that no matter what measurement of college quality is used, the income gains from attending an elite college are highest for students from a disadvantaged background. “School admission and financial aid policies that have as a goal attracting students from more disadvantaged family backgrounds may raise national income, as these students appear to benefit most from attending a more elite college,” they say. Their results are bound to play a role in the national debate over financial aid and affirmative action policies at the nation’s premier schools.

Christopher Farrell – (C) National Bureau of Economic Research

#135 – OPERATIONAL EXCELLENCE MATURITY MODEL – JOSEPH PARIS

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Paris_Aug2012I have met countless Continuous Improvement and Operational Excellence professionals over the course of my career.  And, in turn, I have become acquainted with their roles and efforts in regards to driving value to their organizations.  Oftentimes, these professionals, although possessing great passion for, and pride in, the value they drive to their companies, express their frustrations at the lack of proper support from their company in their efforts. Continue reading

#135 – RISK ASSESSMENT BENEFITS – GREG HUTCHINS

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Greg Hutchins pixRisk assessment is a critical element of ISO 31000 risk management framework. Risk assessment provides the requisite evidence based data and information for Risk Based Thinking, specifically risk based problem solving and risk based decision making. Using the appropriate risk assessment for the organization can determine how to treat and manage specific risks. Continue reading

#135 – STRUCTURING ICT MANAGEMENT TO ALIGN IT WITH THE ENTERPRISE – PART IV PRINCIPLES OF ENTERPRISE ICT ALIGNMENT – HOWARD WIENER

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Howard Wiener PixIn the previous posts in this series, we covered:

  • Part I: models of the enterprise and ICT and the need to rationalize the two in order to manage both properly.
  • Part II: a four-level enterprise model consisting of strategy, business model, operating model and operational architecture; the need for and value of creating and maintaining the as-is model.
  • Part III: the as-is model and its role in the existing EA, planning for transformation and ensuring that the enterprise is equally capable of evaluating changes emanating outside-in and inside-out.

Continue reading

#135 – HEALTHCARE AT RISK: LEADERSHIP, RISK, AND YOUR MANAGEMENT SYSTEM – ERIC SCHULZE

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A EricDuring the DNV GL symposium, I overheard someone say that after four years of “doing” ISO, they can “kind of see” how leadership and management review can contribute to improvement. It is unfortunate that it has taken years for the benefits of ISO to be appreciated, but sadly it is a common observation and truth for many hospitals using the 9001 framework as part of their accreditation. Implementing, maintaining, and improving a management system is a journey, not a destination. Continue reading

#135 – HOW SAFE IS SAFE ENOUGH FOR YOUR SYSTEM – FRED SCHENKELBERG

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ABC FredSETTING THE MARGIN FOR SAFETY

Estimating the set of stress and stress curves is an interesting exercise that may have a greater purpose: safety. The connection is clear when considering the potential consequences of failure. For example, the loss of braking power when landing an aircraft may result in the aircraft rolling off the end of the runway. Continue reading

#135 – SIX LESSONS QUALITY MANAGERS CAN LEARN FROM STAR WARS – DAVID BUTCHER

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2014-blog-author-photo-david-butcherBeginning with A New Hope nearly 40 years ago, characters in the epic Star Wars saga have offered many lessons that may prove valuable for even the most seasoned quality managers. There are numerous examples of positive behaviors that managers might consider emulating in their daily work and behaviors that should always be avoided. Continue reading

#134 – HEALTHCARE @ RISK – UNDERSTANDING CONTEXT – TED SCHMIDT

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00141In an effort to better understand the “context” of the environment in our hospitals, we conducted some basic research. Our results, though mostly unscientific, do bring us to our current state in healthcare. We considered the different influences on how we practice medicine, how we run our hospitals (including most importantly, how our hospitals get paid) and the influences of technology and innovation. Here is a brief synopsis of what we found. Continue reading

#134 – KKR PORTFOLIO COMPANIES GET NEW GREEN SOLUTIONS PLATFORM – KELLY EISENHARDT

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Kelly EisenhardtAs Environmental, Social and Governance (ESG) issues continue to grow in importance for mainstream investors, KKR’s pioneering environmental initiative provides the resources and tools necessary for its participating private equity portfolio companies to determine materiality and the means to measure it. Continue reading

#134 – IT’S LONELY AT THE TOP! – KIRBY URNER

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AAA IRBYGiven ISO 9001:2015, we see new emphasis on executive involvement, who may even be the Chief Risk Officer (CRO) someone with lots of experience, most probably in IT, operations, legal or accounting.

Now let’s look at IT side of the risk business, where the CRO will need allies who grew up in computer science or something similar (philosophy?).  Since IT is integral to all processes and project, we think that this is where we think most risks will reside.  The CRO’s best friend may be the CEH, the Certified Ethical Hacker. Continue reading

#134 – HOW SIX SIGMA CAN HELP YOU? – JOHN AYERS

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AAASix Sigma is a powerful tool used to solve a problem or improve a process. The company (one of the 4 big defense companies) I worked for over 20 years lived, breathed and ate it every day. I became a six sigma specialist. For those readers not familiar with six sigma, I offer the following example to hopefully provide some insight into how it works and the benefits it offers.   Continue reading

#134 – WHY YOU WEREN’T HIRED – ELIZABETH LIONS

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Lions gold podiumAh, the job search.

Rejection isn’t meant for the faint of heart and in a job search one must have a bullet proof ego to withstand hours of searching for the right job, applying, networking, re-writing the resume – and other mind numbing tasks in order to do one simple thing – replace an income. Continue reading

#133 – ISO 31000 AS AN ERM STANDARD – GREG HUTCHINS

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IGreg Hutchins pixSO 31000 is 23 pages long, but these pages provide an entry level Enterprise Risk Management (ERM) guideline.

Why is this important?

An organization develops ISO 31000 ERM capabilities to provide a structured, consistent, disciplined, and achievable approach to risk management that facilitates Risk Based Thinking throughout the organization. Risk Based Thinking is composed of 1. Risk based, problem solving (RB – PS) and 2. Risk based, decision making (RB –DM). Both RB – PS and RB – DM are the basis for all management and supervision. We discuss this in our new book: ISO 31000: Enterprise Risk Management. Continue reading

#133 – PREPARING FOR ISO 13485:2016 CHANGES – JAMES JARDINE

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AAA = james jardineAs 2015 comes to a close, medical device manufacturers throughout the world share one collective concern: how will the ISO 13485:2016 revision compare with other versions of the standard? In a new three-part video series, Walt Murray, MasterControl’s director of Quality and Compliance Consulting (QCC) services, walks through what, why, when and how changes are coming to the standard. Continue reading

#133 – THOUGHTS ON SMART PHONES AND PRIVACY – KIRBY URNER

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AAA IRBYAdvanced high school students are getting exposed to RSA (the first public key cyrypto system) along with their math track.  In such schools as the exclusive Phillips Academy, I’m sure they are having informed debates in their classrooms, regarding the Apple vs. FBI standoff.

I think this is important because everyone who wants privacy and to make sure that their financial, medical information, and all information is kept private should be interested in the Apple vs. FBI standoff that ended in a whimper.  All of us will be eventually become cyber experts.

They’re certainly better equipped, concept-wise, than less privileged kids who might not even get any SQL, even in all four years of high school (!). Continue reading

#133 – MONSANTO’S PLAN: FEED 9.6 MILLION PEOPLE AND BE CARBON NEUTRAL BY 2021 – KELLY EISENHARDT

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Kelly EisenhardtThe world’s population is expected to reach 9.6 billion people by 2050. Feeding everyone on a scale that big without increasing the world’s existing farming footprint by means of deforestation is a true challenge. With new technologies like precision agriculture, big data analytics, and the Internet of Things, Monsanto is creating the path to lower carbon emissions while increasing farming productivity. Continue reading

#133 – RISK IS NOT EVEN HALF OF IT! – IAN DALLING

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AAA DallingLast month’s Insight explained that MSS 1000 is a universal management system standard that facilitates the creation of fully integrated management systems without boundaries addressing the totality of the management of an organisation irrespective of size and type. We now look at how it promotes a holistic management of uncertainty. Continue reading

#133 – PROJECT DASHBOARDS: ARE WE MISSING THE PICTURE? – MALCOLM PEART

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Malcom Peart pixI was once asked by a non-English speaker; “What is a dashboard?” Our Client wanted a ‘dashboard’ summary of the monthly status as part of Project Controls for a ‘health check’.

I explained that cars have dashboards. Analogously, I told her that my first car (a Spitfire) had a ‘dashboard’ with a speedometer (marginally functional) to measure speed, temperature gauge (working) to warn of impending overheating, fuel gauge (temperamental) to let me know when I needed to top-up the tank, an odometer (erratic) to let me know how far I had travelled, plus a rev-counter that didn’t work. Continue reading

#132 – WHAT TO DO IF THERE IS NO AUDIT DOCUMENTATION? – GREG HUTCHINS

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Greg Hutchins pixMost organizations have established operational standards, objectives, metrics and expectations, which are operationalized through procedures and work instructions. If these exist, then the value added auditor can use these as a metric to conduct an audit.

The internal auditor determines whether the business objectives, standards, metrics, processes and work instructions are acceptable to meet audit objectives and then determine if they are being met.

But, what does the internal auditor do if there are no technical, procedures, policies, specifications, standards, or other types of documents? Continue reading

#132 – STRUCTURING ICT MANAGEMENT TO ALIGN IT WITH THE ENTERPRISE: PART 3 CHARTING TO BE – HOWARD M. WIENER

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Howard Wiener PixIn previous posts (Part 2) , I defined a simple hierarchy for portraying the Enterprise and made a case for the importance of understanding and documenting the as-is Enterprise Architecture to a reasonable level of detail.

Continue reading

#132 – MERITS OF RISK MANAGEMENT: COMPLIANCE AS AN INVESTMENT – ANNETTE DAVISON, BOB BURFORD

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AAA&Burford

ABSTRACT

Understanding and implementing sound compliance programs is a fundamental component of corporate governance and risk management. Effective risk management is not limited to understanding an organisation’s regulator-driven compliance requirements. It also includes managing an organisation’s overall operating context risks, within a business outcomes’ framework in order to mitigate these risks and in some cases, turn them into opportunities. With the increasing costs of implementing compliance systems and risk management measures, questions are often asked about their ‘worth’ to an organisation. In this paper, the costs of non-compliance as well as the benefits of good compliance and risk management programs are considered. Continue reading

#132 – 5 LESSONS I LEARNED FROM A SUCCESSFUL ISO 9001:2015 CERTIFICATON AUDIT – LILLIAN ERICKSON

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2016-nl-bl-author-lily-ericksonThe publication of ISO 9001:2015 in September generated much anxiety among companies fearing a bumpy transition to the new and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.

Despite having quality experts involved with the ISO changes since they were proposed some years ago, even we did not know how our ISO assessors would apply the new requirements, what evidence they would expect to see, and how to pre-emptively satisfy their expectations. Continue reading

#132 – A, B, AND C’S OF CAREER ADVANCEMENT – JOHN AYERS

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AAAYou may have heard about the Peter Principle (every employee tends to rise to his/her level of incompetency) and Putt’s law (the most competent person tends to sink to the bottom while the least talented person rises to the top). You have not heard of the A, B, C Theory because it is mine. I will explain what it is and you decide if there is any merit in it. Continue reading

#132 – UNPREDICTABILITY OF CASCADE EFFECTS IN DISASTER PLANNING – GEARY SIKICH

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AAA GThe definition below was presented in a recent questionnaire conducted by Project Snowball in the European Union (EU). As used in the questionnaire the term “cascading effects” is defined as:

“Cascading effects are the dynamics present in disasters, in which the impact of a physical event or the development of an initial technological or human failure generates a sequence of events, linked or dependent from each other, that result in physical, social or economic disruption.  Continue reading

#131 – DO YOU PYTHON? – KIRBY URNER

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AAA - imagesIf you have visited a bookstore recently you may have noticed an explosion in Python-related titles, especially for kids.

The Python I mean is not the invasive species of the snake now eating Florida alligators, nor Monty Python the comedy troupe, but the computer language, made in Holland originally but nowadays world-owned.  Python, the language, appears to be taking over the world!   Continue reading

#131 – ISO 31000: MUST KNOW STANDARD – GREG HUTCHINS

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Greg Hutchins pixMore ISO management systems are incorporating RBT and risk, so the ISO 31000 standard is becoming a ‘must know’ standard.  ISO 31000 risk management principles, risk management framework, and risk management process are the preferred tools to use with ISO management systems because ISO 31000: Continue reading

#131 – DISASTER PREPAREDNESS AND ISO 9001 – STEPHEN FLICK

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AAA FILICKThis week is “Severe Weather Awareness Week” in Missouri[1]. Seems odd, in a way, that we’re limiting our awareness of severe weather and what it can do to one week when weather disasters happen throughout the year.

Damage caused by tornado, Joplin, MO – May, 2011 (Eric Thayer, Reuters) Continue reading

#131 – THOMSON REUTERS UNDERSTANDS CR&I IS KEY TO PERFORMANCE – KELLY EISENHARDT

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Kelly EisenhardtThomson Reuters wants investors to know that corporate responsibility, sustainability, diversity, and inclusion are drivers that support strong financial performance. Combining these function areas into one global department has allowed the team to strengthen its purpose and work closer with business units to achieve measurable objectives and drive financial growth. Continue reading

#131 – RETIREMENT RISK CONSIDERATIONS – JOHN AYERS

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AAAIn my view, the major retirement consideration is sufficient income to maintain a similar lifestyle you enjoyed when working. If you recently retired or plan to do so within the next few years, it is probably too late to assess considerations to improve your retirement position because your retirement income is already cast in stone. On the other hand, if you have a number of years before retirement and wondering how you should prepare for it, keep reading because I offer some valid recommendations for you to ponder based on my own experience since retiring in 2012 at the age of 71. Continue reading

#131 – RELIABILITY MATURITY MATRIX – FRED SCHENKELBERG

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ABC FredThe concept of a maturity model is not new. A maturity model provides a means to identify the current state and illuminate the possible improvements to a reliability program. The matrix serves a guide to assist an organization in improving its program.

The matrix has five stages. In general, the higher stages are most cost effective and efficient at achieving higher rates of product reliability performance. These stages—uncertainty, awaking, enlightenment, wisdom, and certainty—are described in the following. The complete matrix is posted at http://accendoreliability.com/reliability-maturity. Continue reading

#130 – WORST CASE TOLERANCE ANALYSIS – FRED SCHENKELBERG

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ABC FredWorst-case tolerance analysis is the starting point when creating a tolerance specification. It is a conservative approach as it only considers the maximum or minimum values of part variation—whichever leads to the worst situation. Setting tolerances such that the system will function given the expected variation of manufactured components improves that ability of the system to perform reliably. Continue reading

#130 – ISO 31000 ERM CERTIFICATES – GREG HUTCHINS

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Greg Hutchins pixBritish Standards Institution (BSI) continues to issue Enterprise Risk Management Certificates (ISO 31000) according to the Bahrain News Agency.   BSI issued a certificate to Gulf Petrochemical Industries Company (GPIC).

What’s interesting is that IS 31000 is for implementing a risk management framework NOT for certification.  But, the marketplace  is saying something else: there is demand for ISO risk certificates and certification.   Continue reading

#130 – WHO IS REALLY MANAGING YOUR PROJECT? – MALCOLM PEART

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Malcom Peart pixAs a client have you chosen to manage the project yourself or leave it to your Contractor or have you decided to utilise a consultant? If it’s too much to do it by yourself and Contractors are, well they’re contractors aren’t they… you have little choice but to engage a Consultant. Continue reading

#130 – ISO 9001:2015 – IMPLEMENTING RISK BASED THINKING: PART II – DENIS DEVOS

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AAA Denis DevosThis is a continuation from Part 1: ISO 9001:2015 – IMPLEMENTING RISK BASED THINKING

  1. Conducting a Qualitative Process-Level Risk Assessment – Without a Flowchart

In many cases, the risk assessment team may choose not to list risks on the flowchart itself, but brainstorm a list of process risks instead. In order to do that, a simple table can be used to guide the thought process. The sheet could look like the example in Figure 2 below. Enter the name of the process, the internal and external customers for the process, the stakeholders or “interested parties” in the header.

Continue reading

#130 – RBT IN HEALTHCARE: PROCESS METABOLISM – TED SCHMIDT

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00141Process metabolism is a concocted term to describe and hopefully understand how our processes work in their environment. It’s a concept that we need to begin to embrace if we want to improve our patient safety. Embracing and understanding process metabolism in our high-risk processes will allow for better process design and therefore yield more reliable results. Continue reading

#130 – CERM BOOTCAMP RELECTIONS – JAMES KLINE PH.D.

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aIMG_4231Introduction

This article discusses my impressions of the CERM Boot Camp I attended from February 29 to March 4, 2016. The presenters were Greg Hutchins and Ed Perkins. At the outset I need to note that I have known Greg for more than 30 years. We also bid on a couple of jobs together. I met Ed a couple of times prior to the Boot Camp. Continue reading

#129 – TIGER MOM’S CRY: SILICON VALLEY SUICIDE CRISIS AND MYSTERY – DR. TRUDY

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Dr. Trudy

When the suicides happened in the most elite high school, Henry M. Gunn High School, an affluent community, also in the heart of Silicon Valley, the home of the most brilliant and successful inventors, invention and companies, it raises a red flag and Centers for Disease Control and Prevention (CDC) is conducting an investigation and trying to find out the root cause of the invisible, mysterious and contagious disease, suicide cluster. I was informed more than 10 years ago in Oregon that parents in Palo Alto have organized patrol teams around the Caltrain tracks but obviously the suicide symptom is not alleviated after a decade later. Continue reading

#129 – RISK ASSESSMENT: WHAT FUTURE ARE YOU PLANNING FOR? – GEARY SIKICH

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UntitledIntroduction

There exists an overabundance of guidance for conducting risk assessments. Yet, it seems that we still have difficulty in getting risk assessments to reflect the appropriate level of concern for the identified risks that we are assessing. We also tend to view risk in relation to the place where we are employed and the industry that we work in. When we look at risk assessment from this perspective it should be clear that we are missing the point precisely, or at best, are being too narrowly focused, when it comes to assessing risk for our organizations. Continue reading

#129 – WHAT MAKES THE BEST RELIABILITY ENGINEER? – FRED SCHENKELBERG

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ABC FredFormal education (masters or Ph.D) or design/manufacturing engineering experience?

Where do you look when hiring a new reliability engineer? Do you head to U of Maryland or other university reliability program to recruit the top talent? Or, do you promote/assign from within? Where do yo find the best reliability people?

What make a good reliability engineer? Continue reading

#129 – ELIMINATING BIASES THAT CONTRIBUTE TO SAFETY ISSUES – DAVID PATRISHKOFF

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David PAs stated in our CERM article 127, highly effective safety initiatives are not a short list of “Do’s” and “Don’ts” but include a complex mix of integrated and interacting best safety practices as shown in Figure 1. In this article, we will focus on one of the 7 critical ingredients of an effective Cascading Safety Management System: The Elimination of Biased Thinking and Mental Blocks highlighted with the arrow in Figure 1. Continue reading

#129 – ISO 2015 – IMPLEMENTING RISK BASED THINKING PART 1 – DENIS DEVOS

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  1. AAA Denis DevosRequirements for Risk Based Thinking in ISO 9001:2015

The most important new concept to emerge in Quality Management Systems in the past 15 years is the Risk Based Thinking requirements of ISO 9001:2015.   There are two definitions of risk in the ISO family of standards, and since they are very similar to each other, you can choose either one, or use them both together. Continue reading

#129 – VIACOM AND SECOND CHANCE TOYS PARTNER FOR KIDS AND ENVIRONMENT – KELLY EISENHARDT

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Kelly EisenhardtViacom, one of the world’s largest media corporations and Second Chance Toys, an east coast nonprofit have partnered to reduce the amount of plastic toys that enter landfills and to put smiles on the faces of kids living below the poverty level by collecting and distributing toys to those in need.

Ali Tuck, Vice President of Corporate Social Responsibility at Viacom, manages Viacom’s CSR strategies across multiple networks and develops cross-company partnerships with corporations and non-profit organizations. Continue reading

#128 – COMMON SENSE ESSENTIALS TO GREAT DESIGN – JOHN AYERS

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AAAThere are many design rules of thumb I have heard over the years. For example: KISS (keep it simple stupid); make it idiot proof; be realistic with tolerances; do not make assumptions that are not realizable (zero gap for instance); and many more. The most important rule of thumb I have experienced is “common sense”.   To illustrate my point, I have a few examples that are below. Continue reading

#128 – WHEN TO STOP TESTING – FRED SCHENKELBERG

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ABC FredWhen should you stop testing? The quick answer is to stop testing when the testing provides no value. If no one is going to review the results or use the information to make decisions, those are good signs that the testing provides no value. Of course, this may be difficult to recognize. Continue reading

#128 – MAKING IT RAIN IN AFRICA SAVES LIVES – KELLY EISENHARDT

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Kelly EisenhardtThe Coca Cola Foundation and its partners are working with local African governments to build infrastructure that supplies clean drinking water and sanitation facilities. These efforts are meant to minimize the spread of disease and empower local communities with educational opportunity and economic prosperity. Continue reading

#128 – BEWARE THE WALLS MAY BE LISTENING AND THE APPLIANCES ARE LOOSE – ED PERKINS

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OLYMPUS DIGITAL CAMERAUnsuspecting consumers, thinking they have found a bargain, or that they have joined the latest gadget trend, or both, can be unpleasantly surprised, according to recent revelations on how mobile and IoT (Internet of Things) devices can have built-in security issues.

Here is a recap of some if the issues found in consumer gadgets:

Smart TVs: A recent news report that Samsung “smart” TVs can listen to conversations in the room[1]. This became hot news during that week. Samsung published a “clarification” on its website[2]. Continue reading

#128 – ALARM FATIGUE – JEFF HARRIS

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AAA-Jeff-150x150In the mid 1960’s, a man witnessed an awful multi-car pileup in San Francisco. That man also happened to have a PhD in psychology and was an inventor as well and he decided to do something about rear end collisions. The result was a third brake light installed at the top of the rear window in automobiles. Testing showed that the addition of the third light reduced rear end collisions by 50 to 60%. Continue reading

#128 – PROVING QUALITY: TOOLS THAT SHAPE INFORMATION – QP SYSTEMS

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Screen Shot 2016-02-28 at 9.46.47 PM

To quality professionals, the challenge “So prove it!” is far more than a school yard taunt, since their organizations must continually demonstrate to customers, board members, suppliers, associations, regulatory bodies, and others that their products or services indeed meet the quality standards that they espouse.

Continue reading

#127 – CASCADING THREATS TO HOSPITAL PATIENT SAFETY – DAVID PATRISHKOFF

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David PGoing to a hospital to get healthier should not be a life-threatening activity. Yet, various research accounts (The Institute of Medicine) state that around 100,000 Americans die annually from preventable hospital errors. Patient Safety America estimates the number of deaths to be between 210,000 and 440,000 a year. Whatever the real number may be, the fact is the cascading threats that create preventable hospital deaths are invisible, underestimated and can build up slowly and silently over time. Continue reading

#127 – CAREER DISRUPTION! – GREG HUTCHINS

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Greg Hutchins pixToday’s New York Times had an article: Is There Any Stopping Donald Trump?.  “They (voters) want to try something utterly different—utterly disruptive, to use the locution du jour—and that leaves them, on the Republican side, with the options of Trump and Ben Carson. Trump has the fire.”

We live in the age of disruption.  I’ve seem my career and work be disrupted.  So, this is my story and in many ways may become the story of your work, career, and job. So, pay heed.   Understand the conventional rules are now being changed.  For more tips, visit: Working It.com

I started out of high school doing manual work.   My first job was as an ordinary seaman in the merchant marine. I worked on rust buckets on and off for 5 years.   This manual work was very hard and frankly not suited to my style, abilities, temperament, and life direction. Continue reading

#127 – DESIGN FOR RELIABILITY IS MORE THAN A SET OF TASKS – FRED SCHENKELBERG

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ABC FredWhat is “design for reliability” (DFR) and how would you recognize it if it was occurring? Is it possible for an individual to ”do” DFR? Is design for reliability a specific technique? Like meditation, nearly anyone can strike a pose that appears similar to someone in deep meditation, yet can you tell by observation if that person is really mediating? Probably not. The same is true for organizations or people declaring that they are doing DFR. Maybe they are—or maybe not. Continue reading

#127 – SASB ANNOUNCES NEW SUSTAINABILITY ACCOUNTING CREDENTIALS – KELLY EISENHARDT

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Kelly EisenhardtSASB has announced a new educational program focused on teaching professionals how to identify, manage, and evaluate sustainability topics relevant to the company’s bottom line. This new program is called the Fundamentals of Sustainability Accounting (FSA) Credential.

Nicolai Lundy is the Director of Education for the Sustainability Accounting Standards Board (SASB) where he oversees SASB’s educational products. His responsibilities include designing value-add educational programs, leading program development, and identifying opportunities to improve existing programs. Continue reading

#127 – CONWAY’S LAW – KIRBY URNER

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AAA IRBYNot every day does one learn of a new law, such as Moore’s, so call me a latecomer in not learning of Conway’s Law until recently.

What does it say?

I’ll try from memory before checking a veridical source:  that how organizations code themselves in software has a tremendous influence on their more overt intra-human communications patterns.  Or, in other words.

“We are what dog food we eat.” Continue reading

#127 – IT’S JUST MONEY! – ELIZABETH LIONS

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new oneMy client looked at for me a long time across the table in Starbucks and said, “I can negotiate for others, but not for myself, she said. For whatever reason, talking about money really stresses me out.”

This surprised me a great deal. Competent woman, educated and an admirable career path. Certainly well accomplished and in a sales role to boot! Continue reading

#126 – PROCESS DESIGN FOR PATIENT SAFETY – TED SCHMIDT

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00141Recently, I wrote about the benefits of using the SIPOC diagram for process identification and process control.   As a profession, we still struggle with this concept of process approach or process management. We too often revert back to our old practices of addressing issues by revising our procedures and conducting training on the newly revised procedure. We should be smart enough not to keep doing the same things and expect different results. Continue reading

#126 – HUMAN FACTORS AND RISK – PAUL KOSTEK

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Paul Kostek PixThere is an aviation old joke that in the future the airplane will have a crew of two, a pilot and a dog. The pilot to feed the dog and the dog to bite the pilot if he tries to touch anything.

I started this article after reading about United Airlines plan to bring in all 12,000 of its pilots for additional training outside of their normal training schedule. This was being done as a result of several incidents that raised concerns about pilot response to failures. Continue reading

#126 – AT&T – “ADAPT OR ELSE” – GREG HUTCHINS

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Greg Hutchins pixThe New York Times this weekend had a front page article on the future of work.

“Gearing Up for the Cloud: AT&T Tells It’s Workers: Adapt, or Else”

I guess this says it all:  For large companies who have to compete in the world of disruption: employees are being told that they must adapt. But how? Continue reading

#126 – NATIONAL CSR AWARDS SPOTLIGHT UK SUSTAINABLE BUSINESSES – KELLY EISENHARDT

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Kelly EisenhardtWith previous sponsors and supporters like Mercedes-Benz, Natwest and Carillion, the 2016 National CSR Awards celebrates business excellence and innovation in Corporate Social Responsibility and will be held on May 12, 2016 at The Crystal in London, England. The Awards focus on the disciplines of leadership, sustainability, community development, worker rights, education, circular economy and clean energy. Continue reading

#126 – PROCESS CAPABILITY AND REQUIREMENTS – FRED SCHENKELBERG

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ABC FredCommunication between suppliers or vendors and their customers often entails a mix of specifications and requirements. Customers set requirements and suppliers offer specifications. When they match, or when a supplier component specifications meet the customer’s requirements, we have the potential for a transaction. Continue reading

#126 – ELECTRONIC HEALTH RECORDS: PANACEA OR PANDORA’S BOX? – JEFF HARRIS

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AAA-Jeff-150x150On September 25th, 2014, a 42 year old Liberian man in the U.S. visiting family fell ill and went to a Dallas, Texas hospital for treatment. He told the nurse that he had fever and abdominal pain and was from a West African country that was in the midst of an Ebola outbreak. The nurse duly noted this in their state of the art electronic health record (EHR) system and passed him along to the ER physician. He was sent home with antibiotics.  Eleven days later he became the first person in the U.S. to die of the Ebola virus and set up an epidemiological nightmare. Continue reading

#125 – WALKERTON, NORTH BATTLEFORD, FLINT – IS OUR WATER SUPPLY GOVERNANCE BROKEN? – ANNETTE DAVISON

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AAA&Drinking waterborne outbreaks still occur in the developing world. However, it is not always the utility at fault. As the events of Flint continue to unfold, it is worth looking back at our waterborne outbreak history and whether we are doomed to keep repeating the governance errors of the past.

The issue

The World Health Organization calls for a catchment to consumer approach to drinking water management. Part of this approach includes understanding the governance framework in which the water supplier operates. Continue reading

#125 – PRACTICING RADICAL TRANSPARENCY AND SHARED PROSPERITY AT BEN & JERRY’S – KELLY EISENHARDT

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Kelly EisenhardtCompanies that commit to radical transparency and shared prosperity gain loyalty and increased profits, as consumers begin to buy from companies that share their values.

Jostein Solheim is Chief Executive Officer, Ben & Jerry’s Homemade Inc. and Chair, CEO Connection® Social Impact Committee. CEO Connection leverages the combined resources of the mid-market community to provide mid-market companies ($100 million to $3 billion in revenue) programs they cannot get on their own, which makes the collaboration a natural fit. Continue reading

#125 – TO RETIRE OR NOT TO RETIRE? – VICTORIA LAI

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IMG_0864To retire or not to retire? 

Can I afford to retire?

I can’t retire until my kid has finished college and has a job. My daughter is still living at home and needs support.

So a little background:  

Margaux is sixteen years old. She has been a homeschooler for five years. She is doing college math, physics, software, and working on a startup. I’m worried because college costs a lot of money and that means as parents, we have to help our kids get an education, find a job, and settle down – all of which take longer.

And by the way, don’t forget the huge debt that we co-signed.  Bottom line: we may have to work longer to pay it off.  So, good bye retirement.

Continue reading

#125 – PROCESS CONTROL AND CAPABILITY – FRED SCHENKELBERG

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ABC FredIf you buy more than one of an item used in your product, you will have to deal with variability. In general, the variability from part to part is minimal and expected. Occasionally, the variability is large and causes reliability problems.

According to O’Connor and Kleyner (2012, Practical Reliability Engineering, Wiley), “The main cause of production-induced unreliability, as well as rework and scrap, is the variability inherent in production processes.” Continue reading

#125 – HOW TO CORRECT A FAILING LEAN SIX SIGMA PROGRAM – DAVID PATRISHKOFF

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David PWe are living in a time of great disruption and uncertainty. Every organization is facing great risks. Some of these risks are visible and many others are hidden. So, it’s crucial that every company develops and implements tools to identify, mitigate and transform risks into dramatic improvements and even disruptive innovations. Continue reading

#125 – QUALITY MANAGEMENT HAS MOVED ON! – ANDREW FOY

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AAA FoyQuality assurance was originally conceived to document a set of procedures aimed at ensuring that quality standards and processes were adhered to by a business; but has now moved beyond the tick box concept and can play an integral part in improving business performance.

Specialist contractors are increasingly expected to demonstrate independent certification to the ISO standards of Quality Management (ISO 9001), Environmental Management (ISO 14001) and Health & Safety Management (OHSAS 18001), especially if they want to work for the better customers at the higher levels of the industry. Continue reading

#124 – US FEDERAL ERM REQUIREMENTS – GREG HUTCHINS

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Greg Hutchins pixLast year, we reported that White House Office of Management and Budget (OMB – executive office) is requiring US departments to design and implement Enterprise Risk Management (ERM).  The requirements are part of the OMB Circular A 11 Section 270 – Performance and Strategic Reviews.

Continue reading

#124 – COULD YOU BE LIABLE FOR THE HEALTH OF YOUR EMPLOYEE’S CHILDREN? – ANNETTE DAVISON

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AAA&Could you be liable for the health of your employees’ children and grandchildren?

Work health and safety legislation in Australia places a strict duty on the ‘person conducting the business or undertaking’ to understand, monitor and mitigate workplace risks. This is not new, we know that employers are responsible for their employees. Continue reading

#124 – AN ANGEL IN DISTRESS – DAVID PATRISHKOFF

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David PThis is the second CERM Insights article in a series about the application of Cascade Effect Thinking and tools to mitigate risks and transform them into dramatic improvements and even disruptive innovations for small, mid-sized and very large organizations.

More than a million ISO certified companies will have to integrate risk management with a risk assessment.  We detail a case study how this can be done using quality risk tools.  Four of 40 possible cascading risk assessment and management tools are demonstrated in this case study: Gamified Process Risk Mapping, New Process Wish List, Cascading Risk Map & the Future State Process Map. Continue reading

#124 – ANATOMY OF A MEDICAL DEVICE ATTACK – JEFF HARRIS

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AAA-Jeff-150x150TrapX, a security company that specializes in medical device attacks, outlined how these attacks occur in a report titled “Anatomy of an Attack: MedJack” in May of 2015. In this report several case studies are examined in detail. In the first case study, malware was inserted on a blood gas analyzer. Continue reading

#124 – PERSONAL RISK IN THE INTERNET OF THINGS – KIRBY URNER

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AAA IRBYLast month in this blog, I chronicled a “device failure”:  my car key broke off in the ignition.  I modeled this “exception” (to my reasonable expectations) using Python code, suggesting pseudo-coding one’s risk model as a first step in a risk assessment process. Continue reading

#124 – PROJECT QUALITY REVIEWS AND AUDITS – MICHAEL STANLEIGH

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AAA StanleighWe have audited projects from a variety of industry sectors including: Manufacturing, Information Technology, Software Development, Insurance, Banking, Mining, Government and Universities. Despite the differences in their services and products, our approach to completing a project quality review & audit is similar. It requires about three (3) very intensive weeks to complete the in-depth quality review & audit and deliver the final report. Continue reading

#123 – INCREASE ORGANIZATIONAL EFFECTIVENESS THROUGH PROJECT QUALITY REVIEWS & AUDITS – MICHAEL STANLEIGH

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AAA StanleighCorporations throughout the world are losing billions in wasted project spending owing to their mis-management, poor quality processes, lack of knowledge in how to manage projects, etc.  These projects are often not included in the normal auditing practices. Understanding the process of auditing projects, in addition to their other best practices; will positively impact the organization’s profits, shareholders and customers by ensuring well-informed decisions are made about their key projects. Continue reading

#123 – MEDICAL DEVICE ATTACKS – JEFF HARRIS

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AAA-Jeff-150x150What cybersecurity threats are happening right now involving medical devices? In a word – malware. TrapX, a security company thoroughly examined three hospitals for the presence of malware.  The results were astounding. They found malware in X-ray equipment, blood gas analyzers, CT scanners, and ventilators, as well as infusion pumps. Continue reading

#123 – WHAT IS RISK? – GREG HUTCHINS

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Greg Hutchins pixRisk is an interesting concept because there are a number of definitions and interpretations.  And this bears on quality because the lack of consistency can make deployment difficult.

Two elements to risk can be seen in the below definitions. There is upside risk and there is downside risk.  Some risk definitions have this and others don’t.

Upside risk is opportunity risk, the reward that can be achieved in undertaking a new endeavor. Downside risk is the risk of loss. For example, project risk is the inability to achieve project objectives within cost, schedule, and quality constraints. Process risks are the risks of producing nonconforming products or services due to unstable and incapable processes. Continue reading

#123 – CASCADE EFFECT THINKING – DISRUPTIVE PARADIGM SHIFTING – DAVID PARISHKOFF

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David PIf Knowledge is Power, then understanding the cascading factors that shape our destiny can potentially offer Disruptive Knowledge and Decisive Power. Cascade Effect Thinking (CET) is a new paradigm that dynamically discovers the truth about interacting threats and opportunities in unique, analytical and gamified ways. Continue reading

#123 – Why Quality Professionals Fail to Get Boardroom Buy In – Syed Ali

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AAA SyedMy observation in the last 40 years working and negotiating in various parts of the world is that we do not know how to effectively communicate the concept of quality in business and financial terms to  the board. We are very poor at talking “Business”

Quality professionals fail to get the attention of the top management and it’s often because they do little more than regurgitate the requirements of standard. Continue reading

#122 – IS FAA AGREEMENT WITH BOEING A TEMPLATE FOR RISK? – JAMES KLINE PH.D.

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aIMG_4231In the past two years, a number of global companies have been fined for committing major violations of law or safety regulations. General Motors (GM) was fined $35 million. A US Congressional investigation determined that GM engineers looking at ignition switch complaints, made a design change, but failed to issue a recall notice. Continue reading

#122 – Value Added Auditing™ = Analytical Auditing – Greg Hutchins

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Greg Hutchins pixQuality, system, and internal auditing are focusing on risk management, process control, process capability, and organizational effectiveness. These value added audits require more information to be collected and analyzed to evaluate value, risk, waste, effectiveness, and efficiency. As an organization moves toward value added auditing, the auditor or audit team will collect more information, conduct in-depth analysis, and obtain sufficient evidence in order to reach conclusions. Continue reading

#122 – METHODS TO ESTIMATE ALT VALUE – FRED SCHENKELBERG

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ABC FredHere is an example of how to determine the future value of a specific reliability task. Many of us face the challenge of how to justify spending product development resources to provide insights and information to the rest of the team. Accelerated life testing (ALT) is particularly difficult: It is time consuming, expensive, and at times statistically complex. Having a clear method to estimate the value serves your career and the organization well, as both benefit from the right investments. Continue reading

#122 – REVIEW OF TOP POTENTIAL THREATS AND EMERGING CRISES FOR 2016 – GEARY SIKICH

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UntitledThreat Analysis 2016 – A Review of Top Potential Threats and Emerging Crises for 2016

We are well beyond the dreaded Mayan Calendar apocalypse of 2013. In November 2016, the United States will have a Presidential election and a new president. How well will we do, or, how poorly will we perform when, and if, unplanned for crises emerge from threats that we continue to overlook? My top picks for threats, emerging crisis issues and high impact risks in 2016 and their current status: Continue reading

#122 – YOUR MEDICAL DEVICE IS HACKABLE – JEFF HARRIS

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AAA-Jeff-150x150In 2011, at a hacking convention known as Black Hat, a security researcher and insulin pump user demonstrated how he could remotely disable and modify his insulin pump over a wireless connection using inexpensive and readily available equipment.

In 2012, another security researcher demonstrated how he could capture and reverse engineer wireless communication from an Implantable Cardioverter Defibrillator (ICD) and cause the device to deliver a lethal shock to the heart. Continue reading

#121 – RISK, CODING, AND LIFE – KIRBY URNER

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AAA - images

As I was leaving the training facility (<guild />) this afternoon, turning the key in my car’s ignition, it broke off.   Having a backup key somewhere hidden under the car would have been nice.  No such luck.  At least I had one at home, and access to public transportation. Continue reading

#121 – THREE REASONS WHY YOUR QMS IS LIKELY FRUSTRATING – ERIC SCHULZE

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A EricMany hospitals have started the ISO 9001 journey. This journey probably started because the hospital wanted a fresh and new approach with their accreditation.  For the first time a hospital could begin to decide how they would meet requirements and not have to abide by a prescriptive way of doing things. Continue reading

#121 – WorkingIt.com Website, Prospering In Disruption – Greg Hutchins

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Greg Hutchins pixWork is structure.
Anonymous

We developed WorkingIt.com to explain how work, careers, and jobs are evolving.  The site’s tagline is ‘Brand U Work in the Disruption Economy.”

A full treatment of work, careers, and jobs is beyond the scope of this site and frankly beyond my abilities.  Hopefully, this site offers a unique structure, my thoughts about how you’ll work due to the current epidemic of disruption and how you’ll progress in your Brand U career. Continue reading

#121 – RISK AND POKA YOKE – JAMES KLINE PH.D.

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aIMG_4231On March 28, 1979 there was a cascading failure in reactor number 2 at Three Mile Island. This failure allowed large amounts of nuclear reactor coolant to escape. The accident coalesced the anti-nuclear movement and ultimately caused the decline in nuclear plant construction in the United States. Continue reading

#121 – MECHANICAL RELIABILITY TESTING – FRED SCHENKELBERG

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ABC FredMechanical systems wear out and fail eventually. The ability of a structure to support a load, move though the specified range of motion, or spin degrades with use and time. Even our joints eventually wear out.

Accelerated life testing (ALT) has value as it provides information about a system’s reliability performance in the future. There is plenty of ALT literature concerning the failure mechanisms unique to electronic components and materials but less has been written about mechanical reliability testing. Continue reading

#120 – RISK BASED, DECISION MAKING – ED PERKINS

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OLYMPUS DIGITAL CAMERARisk based decision making is employed to implement risk management. But how is this implemented? In this article we will look at the process of making “risk based” decisions.

Risk management is a process that involves several activities.

  • Risk Assessment, to identify and assess risks and Risk Events;

Continue reading

#120 – RISK BASED THINKING: PATIENT SAFETY THROUGH ACCREDITATION – TED SCHMIDT

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00141This past week, Centers for Medicare and Medicaid Services  (CMS) identified 758 hospitals that have high rates of patient safety issues. As a result, their 2016 Medicare reimbursements are being reduced by 1%. This is the second year for this federal mandate and there are over 400 (over 50%) repeat hospitals. The CMS program is entitled “Hospital-Acquired Condition Reduction Program”. The name alone is very telling. Continue reading

#120 – IS VUCA DISRUPTING ISO? – GREG HUTCHINS

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Greg Hutchins pixYes. Standards making organizations are being disrupted by Volatility, Uncertainty, Complexity, Ambiguity (VUCA).

In much the same way, ISO is innovating with RBT and risk requirements.

It seems ISO is innovating and developing a new business model based on RBT due to its changing marketplace and its uncertainty, specifically: Continue reading

#120 – ALPHA AND BETA TESTING – FRED SCHENKELBERG

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ABC FredDuring the development process you and team may work to understand what customers may want or expect for the new product. You may even conduct focus groups or review past product field failures and call center records. Alpha and beta testing are crucial components to the development process.

Your customers are your best testers for your next product. They will explore the features, expose the product to use conditions in unconscious ways, and let you what they consider failures without needing the specification document. Continue reading

#120 – DESIGN FOR MANUFACTURABILITY, REVISITED – TIM RODGERS

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AAAI was going through some old papers the other day and discovered an article I wrote in September 1990 about design for manufacturability (DFM). I had just completed my first assignment at Hewlett-Packard’s now-defunct Printed Circuit Division, co-authoring a DFM manual for circuit designers to guide their decision-making when evaluating options. Continue reading

#119 – WHY DOESN’T PRODUCT TESTING CATCH EVERYTHING? – FRED SCHENKELBERG

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ABC FredIn an ideal world the design of a product or system will make use of perfect knowledge of all the risks and failure mechanisms. The designed product then is built perfectly without any errors or unexpected variation and will simply function as expected for the customer. Wouldn’t that be nice!

Along with perfect manufacturing and perfect materials, the assumption that we have perfect knowledge is the kicker though.

Continue reading

#119 – ARE WE SOWING THE SEEDS OF OUR OWN DESTRUCTION? – HOWARD M. WIENER

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Howard Wiener PixI’m becoming increasingly concerned that we’re on our way to creating an environment that will breed domestic terrorists and enable foreign ones.

First and most importantly, we’re creating an environment in which people are marginalized. This is exactly the mechanism that has spawned numerous splinter groups and terrorist organizations in the Middle East and Northern Africa. These groups have certainly exaggerated and publicized their marginalization to bolster their own agendas, but there’s a germ (or more) of truth in many cases. Continue reading

#119 – TEN WAYS OF COPING WITH A BAD BOSS – CHRIS ANDERSON

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AAA Chris AndersonFirst, understand that your boss may not know they are a bad boss. A hands-off manager may not realize that failure to provide any direction or feedback is a symptom of a bad boss. What are the main management mistakes that they’re making and how do you go about coping with a bad boss? Continue reading

#119 – IMPLEMENTING VALUE ADDED AUDITING IN HEALTHCARE – TED SCHMIDT

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0014 “We need help with our audit program”. “Our internal auditing is expensive and leadership wants it to show value”. And finally, “Our auditors will audit where they know they’ll find the known problems”.

These are quotes that we hear routinely with DNVGL hospitals. These statements are coming from the individuals who are in charge of the audit program, the internal auditors, and of course, leadership. Continue reading

#119 – WHAT IS ISO CONTEXT? – GREG HUTCHINS

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Greg Hutchins pixContext is a critical concept introduced and used extensively in ISO 9001:2015. ISO 31000 defines context as the environment in which the organization operates and achieves its business objectives.

In ISO 9001:2015, context may also include the following:

  • Culture, tone at the top, Corporate Social Responsibility (CSR) and other critical competitive attributes.

Continue reading

#118 – THE JERK AT WORK! – ELIZABETH LIONS

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Lions gold podiumThere is a game being played at work.

After witnessing thousands of promotions and job searches, this is the best analogy I have to describe what goes on: the office is nothing but a game.

As in any game, there are rules.

Make no mistake, the people at the top know the game and the rules, which is how they got there.

Continue reading

#118 – ISO 31000 PRINCIPLES – GREG HUTCHINS

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Greg Hutchins pixISO 31000 is organized around 11 risk management principles.   A management principle refers to a fundamental idea, rule, or truth about a subject. ISO 31000 risk principles serve as the guideline, method, logic, design, and implementation for the risk management framework and its process. Continue reading

#118 – HOW TO ESTIMATE RELIABILITY WITHOUT PROTOTYPES – FRED SCHENKELBERG

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ABC FredHOW TO ESTIMATE RELIABILTY EARLY IN A PROGRAM

In a few discussions about the perils of the mean time between failures (MTBF), individuals have asked about estimating MTBF (reliability) early in a program. They quickly referred to various parts count prediction methods as the only viable means to estimate MTBF. Continue reading

#118 – HOW DISRUPTORS CAN LEARN FROM THEIR FOREBEARS – DANIEL BURRUS

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BurrusDan_040In today’s vastly complex economic landscape, many companies would like to be the “disruptor” instead of being the “disrupted” — that is, they want to find a new niche in a certain industry, a problem no one’s yet been able to solve or one nobody’s aware of, and they want to exploit this niche and solve this problem, thereby upending their industry with next-gen technology and unprecedented business methods. Continue reading

#118 – UAV’S COMING TO YOUR NEIGHBORHOOD – PAUL KOSTEK

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Paul Kostek PixHere in Seattle we’ve had several interesting incidents/accidents with personal UAVs (unmanned aerial vehicles) or drones.

In one case a person flew their UAV into the Space Needle, no damage and no one was hurt; at a parade an operator lost control and hit and knocked out a parade attendee and the operator was cited by police; UAV stuck on power lines over a lake, result – power turned off and UAV recovered at a cost of $35K and the operator was not found; and just recently a UAV was flown into the Ferris wheel on the waterfront, no damage to the wheel though a table on a nearby deck was destroyed. Continue reading

#117 – A RISK WORTH TAKING – PAUL PALMES

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AAA PalmesThe 2015 revision of ISO 9001 adds the concept of “Risk-based Thinking” to quality management systems (QMS) requiring registered organizations to “determine the risks and opportunities” needed to ensure that the QMS achieves expected results and improvement. Clause 6.1, (Actions to address Risks and Opportunities), is one of several clauses created by ISO’s new “high level structure” designed to produce a common format and base level text within its catalog of management systems standards. The addition of risk-based thinking is a welcome addition to ISO 9001, currently the largest selling standard in the world and applicable to any organization seeking third party registration of their products and/or services in the marketplace. Continue reading

#117 – ISO 31000: MUST KNOW STANDARD – GREG HUTCHINS

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Greg Hutchins pixMore ISO management systems are incorporating RBT and risk, so the standard is becoming a ‘must know’ standard. ISO 31000 risk management principles, risk management framework, and risk management process are the preferred tools to use with ISO management systems because ISO 31000: Continue reading

#117 – EMERGENCY EYEWASH RESPONSE BEST PRACTICES – DR. BILL POMFRET

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AAA PomfretnUntitled1During the past year or so while conducting 5 Star Health & Safety Management System™ Audits, I have been astounded at the number of chemical plants and laborites where employees had not practiced, and could not use the provided eyewash stations. Continue reading

#117 – FACING THE FEAR OF STATISTICS – FRED SCHENKELBERG

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ABC FredWhen reading a report and there is a large complex formula, maybe a derivation, do you just skip over it? Does a phrase such as 95% confidence of 98% reliability over 2 years not help your understanding of the result? When you read about hypothesis testing, confidence intervals, point estimates, parameters, independent identically distributed variables, random samples, orthogonal arrays, do you just shiver a bit? Do you know of folks around you who not only do not understand these terms but do not want to understand them? Continue reading

#117 – GET PRODUCTS TO MARKET SOONER BY SYSTEMATIZING QUALITY CYCLES – JAMES JARDINE

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Creating a product and getting it to market is not a one-time achievement. It entails a series of ongoing cyclical processes.

It all starts with an initial idea developed with a collaborative team. Input is gathered from all the necessary sources and then tweaks to the original concept are made as needed. Many different types of reviews, approvals, and regulatory checks are also required during this development stage. Then it’s time to provide suppliers or vendors with specific orders to ensure all the puzzle pieces will fit together as planned. Once your organization’s employees receive all the training they need to make the product according to the specifications that have been devised it feels like you’ve almost reached the finish line. Now you just flip a switch and watch as the magic is made while you celebrate your magnificent accomplishment, right? Continue reading

#117 – PREVENTIVE ACTION IS DEAD: LONG LIVE RISK BASED THINKING – STEPHEN FLICK

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AAA FILICKThe latest revision of ISO 9001 has done away with the preventive actionclause[1], which reads as follows:

“The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. Continue reading

#116 – RBT IN HEALTHCARE – WHY COMMUNICATION IS KEY – JEFF HARRIS

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AAA JeffThe single biggest problem in communication is the illusion that it has taken place.” 
George Bernard Shaw

On January 13th, 1982, an Air Florida passenger jet crashed into the 14th Street Bridge after takeoff from Washington National Airport, killing 74 passengers on the plane and 4 people in their vehicles on the bridge. After reviewing the flight data recorder, it was discovered that the first officer had repeatedly told the captain that something wasn’t right at takeoff and was rebuffed. Instead of assertively repeating his concerns, the first officer finally agreed with the captain that everything was normal. Continue reading

#116 – ISO 31000 RISK MANAGMENT PRINCIPLES – GREG HUTCHINS

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Greg Hutchins pix

I’ve been working on an ISO 31000 book and am struggling to finish it.  Why?

Well.  ISO 31000 standard is 26 pages.  And, my book has ballooned out to more than 26o pages.  Do I have to say more?

One reason why my book is ten times longer than the standard is because ISO 31000 is a guideline that is open to interpretation and based on guidelines. Continue reading

#116 – WHAT QUALITY REALLY MEANS? – LANE HIRNING

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AAA HIRNINGA friend of mine recently asked me to review his PowerPoint presentation for an upcoming investor conference, which I was happy to do. The first thing that struck me was his choice of fonts—different types and different colors. Second was the slide templates creating an inconsistent layout. It seemed like a trivial thing to point out, but I had to ask him: What kind of a first impression are you going to make with this presentation? Continue reading

#116 – MAKING SUPPLY CHAINS SAFER WITH GENDER EQUALITY PRINCIPLES – KELLY EISENHARDT

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Kelly EisenhardtWomen working in global supply chains are most at risk for being victims of unfair practices, violence, and slavery. The United Nations recognizes this and has created the Women’s Empowerment Principles to help companies view these issues through the gender lens. Continue reading

#116 – THE CONSTANT FAILURE RATE MYTH – FRED SCHENKELBERG

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ABC FredHave you said yourself or have you heard someone say any of the following:

  • “Let’s assume it’s in the flat part of the curve”
  • “Assuming constant failure rate…”
  • “We can use the exponential distribution because we are in the useful life period.”

Continue reading

#116 – WHY SHOULD A SUPPLIER WORK HARDER FOR YOU? – TIM RODGERS

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AAAA recent LinkedIn discussion addressed the question of the best strategy for dealing with poor supplier performance. A lot of the respondents seemed to advocate a punitive approach, either threatening the loss of future business if performance doesn’t improve, or combing through the terms & conditions in the contract for enforcement language. I’ve always thought that there’s a lot of similarity between managing suppliers and managing subordinates, and I wonder if some of these same people threaten their teams with punitive actions when individual performance doesn’t meet expectations. Continue reading

#115 – PONTIUS PILATE MANAGEMENT (AVOIDING ACCOUNTABILITY) – MALCOLM PEART

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Malcom Peart pixHow many times do we experience the situation when something bad happens and the manager who feels they may be responsible has his, or her, moral-fortitude challenged? The challenged manager inevitably goes into self-preservation mode. “Can I duck for cover?” and avoid the flak is their first question. But, and as with most bad situations, there is no time so how can blame be diverted? Continue reading

#115 – DOES A CERTIFICATION MAKE YOU A PROFESSIONAL RELIABILITY ENGINEER? – FRED SCHENKELBERG

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ABC FredDoes a Certification Make You a Professional Reliability Engineer?

The short answer to this question is “No, it doesn’t.”

A certification is just a piece of paper that conveys that you have mastered some body of knowledge. You most likely also committed to abide by a code of ethics. You may also have committed to continuing education to maintain the certification. Continue reading

#115 – ISO 31000 – LET THE FUN BEGIN! – GREG HUTCHINS

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Greg Hutchins pixFirst a confession.  We say that we’ve been using ISO 31000 for a ten or so years.

Say what?  ISO 31000 was developed in 2009.  How can you been using the standard since 2006.  OK, technically you’re right.  But, we’ve been using AS/NZS 4360 since 2006.  The Australian and New Zealand risk management standard was developed in 2004.  Most importantly, ISO 31000 has a strong ‘look and feel’ to AS/NZS 4360. Continue reading

#115 – USE OF UNTREATED SEWAGE AS FERTILIZER IN CANANA – DR. BILL POMFRET

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AAA PomfretnUntitled1The headlines this week regarding Montreal’s eight-billion-litre untreated sewage dump came and went with a few large plumes of dark-brown water or white effluent witnessed in the St. Lawrence River and strong early morning odours in some quarters, but little visible sewage detected overall. Continue reading

#115 – STRUCTURING ICT MANAGEMENT TO ALIGN IT WITH THE ENTERPRISE PART II: UNDERSTANDING AS IS – HOWARD M. WIENER

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Howard Wiener PixIn the previous post, I defined a simple hierarchy for portraying the Enterprise:

  • Strategy—What markets will we serve and how will we position ourselves in them?
  • Business Model—What products and services will we sell? What characteristics will they have? How will they be priced? How will we publicize and advertise them?
  • Operating Model—How will we produce what we will sell? What capabilities are required?
  • Operational Architecture—How will we design and enable our organization to provide the capabilities needed?

Continue reading

#115 – WHAT MAKES A GOOD OPERATIONS MANAGER? – TIM RODGERS

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AAAA few months ago someone posed an interesting question on a LinkedIn group discussion: What are the three most-important characteristics of a good operations manager? A lot of the discussions I’ve been following lately seem to be preoccupied with issues like this. What makes a good manager? Continue reading

#114 – THE CONVENIENT USE OF MTBF – FRED SCHENKELBERG

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ABC FredSometimes making an assumption is a good thing. You can achieve more with less. A well-placed assumption saves you time, work, and worry. The right assumption may even be left unstated: It’s so good that no one questions it.

Have you ever assumed that the failures for a system follow an exponential distribution? Did you assume that tallying up the total hours and dividing by the number of failures was appropriate? Did you even check? Continue reading

#114 – THREE THINGS I’VE LEARNED ABOUT QUALITY PROFESSIONALS – JOHN BECKSTRAND

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AAA 2014-bl-author-photo-jon-beckstrandOver the past 15 years, as the leader of an organization dedicated to improving the success of the quality profession, I have met hundreds of people throughout the world who have a unique mission:  build greater quality into the things we use every day. Continue reading

#114 – 5 STAR FIRE SAFETY AUDITING – Dr. BILL POMFRET

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AAA PomfretnUntitled1Fire is probably the only single factor, which could completely paralyse a thriving enterprise in a short span of time, many managements have to their cost appreciated this too late when the stark realism of the situation presents itself in the form of twisted steel- work projecting a ghostly silhouette above a mass of blackened rubble. Continue reading

#114 – RBT IN HEALTHCARE: SIPOC DIAGRAM FOR PROCESS MANAGEMENT – TED SCHMIDT

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00141This week I read in Forbes that a new study (published in October 2015 issue of Anesthesiology) finds that medication errors occur in one-half (50%) of all surgeries. This incorporates the perioperative, surgery and postoperative periods. The data continues to support the cold reality that as healthcare providers, we must change to protect our patients. Continue reading

#113 – IMPORTANCE OF PROFESSIONAL CLEANING – DR. BILL POMFRET

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3b829cdThe founder and president of Safety Projects International Inc, has a mission – to help clean up Canada and several other countries.  However, rather than doing it himself, Dr Bill Pomfret aka Dr Clean is getting the workers themselves to do it – which is simple in its logic but offers a huge challenge in execution. Continue reading

#113 – CAN ISO 31K AND COSO ERM WORK TOGETHER? – GREG HUTCHINS

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Greg Hutchins pixISO 31K and COSO ERM are the two competing risk management frameworks?  ISO 31K is the national standard for many countries.  However, COSO ERM is the de facto risk standard for many global and publicly listed companies.

We have used both.  There are differences.  However, the similarities outweigh the differences.  And, the critical question is:

So, can ISO 31000 and COSO ERM work together?

Yes. The COSO definition of control supports and reinforces ISO 9001:2015 control requirements, specifically both frameworks are: Continue reading

#113 – DEFENDING WOMEN IN ASIA, AFRICA AND LATIN AMERICA – KELLY EISENHARDT

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Kelly EisenhardtWomankind Worldwide has helped more than 18 million women and their families across the globe over the last 26 years with issues of discrimination, poverty, and violence. The organization sees the newly passed U.N. Sustainable Development Goals as a path toward the future and as a way to engage all levels of government and civil society in the safety and empowerment of women and their families. Continue reading

#113 – WHY DO YOU NEED A CYBER SECURITY SYSTEM? – ED PERKINS

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OLYMPUS DIGITAL CAMERACybersecurity (or lack thereof) is nearly a daily news story. Many stories revolve around lack of ‘compliance’ with expected practices and regulations. Others detail how the cyber attackers apparently waltzed in and ran roughshod over a company’s or organization’s computer systems. Continue reading

#112 – HEALTHCARE@RISK: DEFINING RISK-BASED THINKING – TED SCHMIDT

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00141Hospitals that conform or certify to ISO 9001 (specifically those in the DNV-GL Healthcare accreditation scheme) are aware of the recent revision to ISO 9001.  This 2015 version introduces a new term, “risk-based thinking”, that is raising eyebrows and causing ire in some circles.   The main source of this ire is the fact that risk-based thinking is not defined in ISO 9001:2015 or in the associated standard ISO 9000:2015, “Fundamentals and Vocabulary”. Continue reading

#112 – WHY I’M NOT IN HIGH SCHOOL – MARGAUX HUTCHINS

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IMG_4268In the United States, every child is supposed to go to high school. This is the law in most countries.

I decided to break the law. I don’t go to high school. 

 If you’re a parent, check in with your kids and ask them what they think of school. It may be a good conversation starter on their future. It may save you money for not being on the hook for paying for college. Continue reading

#112 – CONTEXT FOR STRUCTURING ICT MANAGEMENT TO ALIGN IT WITH THE ENTERPRISE – HOWARD M. WIENER

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Howard Wiener PixA model of an average enterprise is multidimensional.  There are more than the three dimensions with which we are intrinsically comfortable or the seven that is the upper limit we are supposedly able to conceptualize.  Optimizing our ability to manage in such a complex context requires that we integrate increasingly numerous specialized disciplines yet keep things simple enough to synthesize a ‘big picture’ view.  Continue reading

#112 – LET’S TALK ABOUT PAY! – LEIZA DOLGHIH

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AAAAANegotiating employment agreements or the real reason why Jennifer Lawrence got paid less than Bradley Cooper.  Somebody recently went through Sony’s hacked e-mails and found some that show Jennifer Lawrence and Amy Adams were paid less than the male leads in American Hustle. This prompted Jennifer Lawrence to write an essay titled“Why Do I make Less Than My Male Co-Stars?” Continue reading

#112 – MENTAL HEALTH IS THE WEAK LINK IN HEALTH AND SAFETY PROGRAMS – DR. BILL POMFRET

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3b829cdMental Health is the weak link in most company’s health & safety programs, it is really a Silent Epidemic surrounded by stigma.

Mental health issues are often buried in the workplace says Dr. Bill Pomfret, Managing consultant of Safety Projects International Inc. who is trying to uncover them, at a recent conference he asked over 400 delegates, how many had a system in place for managing mental health, it was pitiful, with only a few hands being raised. Continue reading

#112 – LEAN SIX SIGMA AND THE SIPOC TOOL FOR HIGHER ED – NORMA SIMONS

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20bb2dbThe Lean Six Sigma (LSS) methodology that was originally developed in manufacturing is slowly making its way to the education space. As the concepts of Lean Six Sigma spread and provide the template for improving efficiency and enhancing institutional performance, the SIPOC tool is invaluable for changing the thinking and approach to project management, process improvement and LSS implementation. Continue reading

#111 – WHAT IS ISO 9001: 2015 AUDITABILITY? – GREG HUTCHINS

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Greg Hutchins pixThis is the #1 question for CB’s with the new revision of ISO 9001:2015 standard.  Most management experts acknowledge that ISO 9001:2015 is a significant change.

Auditability implies consistent outcomes from auditing management systems.  If outcomes are different among CB’s, then the quality of the assessment and the reliance on the outcomes may be called into question.   Continue reading

#111 – FDA REQUESTS PUBLIC INPUT ON QUALITY METRICS GUIDANCE – OLIVER WOLF

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a cust-nl-writer-photo-oliver-wolf-largeIn line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule.  At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) released the draft guidance “Request for Quality Metrics” and is now seeking public input by September 28, 2015 on a number of key points. Continue reading

#111 – WHAT IS QUALITY MANAGEMENT? – IAN WALKER

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aaaQuality Management’ is a generic term, and the word ‘Quality’ means nothing on its own.

Quality’ is an individual’s perception. Take a wrist watch for example. What is its purpose?

My first initial thoughts are to tell the time, however for others a wrist watch is much more than that it may often be viewed a piece of jewellery and the more expensive the exclusive the brand name the better. Continue reading

#111 – ISO 9001:2015 IS OUT: WHAT NOW? – JAMES KLINE

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aIMG_4231

The ISO 9001.2015 standard is  out.  Two important questions are: How did we get here?  What happens now?  Greg Hutchins, a Risk and Quality Expert, in his book “ISO: Risk Based Thinking 2015 Edition”, says we have gotten here through an evolutionary process, which, because of VUCA (Volatility, Uncertainty, Complexity and Ambiguity), requires a greater assessment of the external environment than is the case with just a quality focus. Continue reading

#111 – PREDICT FUTURE BENEFITS THROUGH EFFECTIVE RISK MANAGEMENT – KIRON BONDALE

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Benefits management needs to be practiced over the full lifecycle of the project and kiron-bondalebeyond.

An integral component of benefits management is the regular re-validation of expected benefits. If this is not done, there is risk of continued investment without hope of a valid return based on changes to the assumptions and analysis supporting the original business case. Continue reading

#110 – T. ROWE PRICE INVESTS IN BALTIMORE WITH FINANCIAL EDUCATION – KELLY EISENHARDT

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Kelly EisenhardtTo have the biggest impact companies need to invest in the communities in which they operate. T. Rowe Price believes Baltimore is worth the investment.

Renee Christoff heads T. Rowe Price’s Corporate Social Responsibility department, focusing on strategic, effective, and impactful ways for the firm and its associates to engage in the community. Continue reading

#110 – THE 4 BIGGEST MISTAKES IN COMPLIANCE MANAGEMENT – GREG CARROLL

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GregCarrollMere compliance with a Framework is an insufficient audit approach; it is critical to assess whether it is current, timely, communicated broadly, and meets the needs of the business. The 4 biggest mistakes are:

  1.      Not being Outcome focused
  2.      Not using Risk base targeting
  3.      Not Value Adding
  4.      Not being timely Continue reading

#110 – SAFETY OF MIDDLE EASTERN MIGRANT WORKERS – DR. BILL POMFRET

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3b829cdThe culture in the Arab States is difficult to understand, especially the Kingdom of Saudi Arabia, e.g. the recent collapse of a crane at the Grand Mosque in Mecca was not a disaster but “a blessing in disguise”, the 107 people killed, say Muslim leaders “that dying while on the hajj is a ‘great honour from God” what about the other 238 who were injured?, they are not in heaven, but are innocent victims of the tragedy. Continue reading

#110 – FIVE WAYS TO KEEP YOUR JOB SEARCH CONFIDENTIAL – ELIZABETH LIONS

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Lions gold podiumMany people decide the New Year is the time to find another job but with this fast moving market people are looking even in forth quarter. The exception to the rule would be individuals at the Manager, Director or Vice President level. They will hang onto their jobs until spring and ditch the job search until after they receive their sizable bonuses. Continue reading

#110 – RBT IN HEALTHCARE: USING CHECKLISTS – TED SCHMIDT

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0014Failure Modes and Effects Analysis (FMEA) are utilized extensively in our hospitals in an effort to mitigate risk and help create a safer environment for our patients.  As discussed in my last article, the completion of the FMEA is often times a pencil-whipping exercise. Continue reading

#109 – SEPTEMBER 24TH HAJJ STAMPEDE DEATH TOLL REACHES 800 – DR. BILL POMFRET

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3b829cdYet another disaster has struck pilgrims on the annual Muslim pilgrimage, this time 800 worshippers were trampled to death and hundreds more were hurt beneath a crush of people making their way to a ritualistic stoning of the devil, a re-enactment of a story from the Quran involving the Prophet Abraham — that takes place during the hajj.

Continue reading

#109 – FAILING TO GET FEEDBACK ON FIELD FAILURES – FRED SCHENKELBERG

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ABC FredImagine you are requested to assist a design team in determining how to best improve the reliability of a product. You learn that the organization produces a range of point of sale (POS) devices and they have invited you to a meeting to discuss the product and ways to improve the field reliability. Continue reading

#109 – MOORE’S LAW CONTINUES TO DRIVE CHANGE – DANIEL BURRUS

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BurrusDan_040When I talk about digitization and digital advancement, I often mention what I refer to as the Three Digital Accelerators: bandwidth, storage, and processing power. These three technological tenets drive digital disruption and are increasing exponentially every year, and thanks to rapidly advancing technology, will continue to do so. Continue reading

#109 – REQUIREMENTS DEVELOPMENT AND RISK MANAGEMENT – PAUL KOSTEK

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Paul Kostek PixOne of the keys to a successful project is having a set of requirements that are well defined and stable. We’ve all worked on projects where a lack of defined and controlled requirements has led to scope creep which result in schedule delays.   Continue reading

#108 – RELIABILITY GOALS: 4 KEY ELEMENTS – FRED SCHENKELBERG

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ABC FredThe reliability target, objective, mission, or goal is the statement that provides a design team with focus and direction. A well-stated goal will establish the business connection to the technical decisions related to product durability expectations, while providing clarity across the organization and enabling a common language for discussing design, supply chain, and manufacturing decisions. Continue reading

#108 – INTEGRATING SUSTAINABILITY INTO TRADITIONAL EDUCATION: REVAMPING THE MBA – KELLY EISENHARDT

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Kelly EisenhardtBusiness school graduates who understand the concepts of sustainability and demonstrate practical knowledge, stand a better chance at landing positions with today’s leading companies. Continue reading

#107 – GOALS WITHOUT APPORTIONMENT OR MEASURES: YOU GET WHAT YOU ASK FOR? – FRED SCHENKELBERG

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ABC FredIn my job as a reliability professional, I often encounter circumstances in which a company sets reliability goals that appear to have been met and yet the fielded product fails to perform as reliably as expected. Such a disconnect can have a number of causes, so let’s look at an example. Continue reading

#107 – ERM IN ISO IS ENHANCED RISK MANAGEMENT – GREG HUTCHINS

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Greg Hutchins pixISO maintains risk has implicitly been a part of the standard since the ISO 9001:2015 revision.  How?  In the new standard, ‘preventive action’ has evolved to ‘actions to address risk and opportunities.’  This changes the Corrective Action – Preventive Action (CAPA) model.  In the past, Preventive Action was implemented as a result of Corrective Action specifically to prevent the recurrence of the nonconformity. Continue reading

#107 – MEN AND WOMEN AT WORK: WHO GETS HEARD IN MEETINGS? – ELIZABETH LIONS

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Lions gold podiumEvery women may know the feeling over being overlooked or run over in a meeting.

No one likes it.

Especially executive women.

Harvard Business Review surveyed more than 7,000 people, including female executives at or above the Vice President level. The consistent feedback was the women feel less acknowledged during meetings. While men agreed with this opinion, the disagreed with why women didn’t feel powerful. Continue reading

#107 – RBT IN HEALTHCARE: IS MY FMEA ENOUGH? – TED SCHMIDT

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0014Failure Modes and Effects Analysis (FMEA) was developed in the late 1940’s by the U.S. military as a means of determining the effect of system and equipment failures.  In the 1960’s, NASA refined the FMEA as a means to improve reliability of space hardware.  FMEA was introduced into healthcare in the 1990’s.  When properly completed, a FMEA identifies and mitigates potential risks.  Continue reading

#106 – CRESCENT WRENCH VS. BOX WRENCH – MARK MOORE

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Odd title I know, but do you expect anything different from me?  I had this thought a while OLYMPUS DIGITAL CAMERAback – a memory of past busted up knuckles to be clear – that my family didn’t have many tools while I was growing up.  If we had any specific size box or open-end wrenches, they were few and far between and probably in pretty bad shape.  No, when I was a boy and I needed to do something on my bicycle, I had to rely on that good old standard, the adjustable crescent wrench.   Continue reading

#106 – ‘FUTURE OF QUALITY: RISK®’ IS NOT NEW CONCEPT – GREG HUTCHINS

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Greg Hutchins pixIn 2000, I wrote Risk Management: Is It the Future of Quality Management? for ASQ’s Quality Progress.  We’ve been evangelizing this concept a long time.

Why do I bring this up?

We’ve been evangelizing the mantra for 15 years.  We felt so strongly that we have a  have a registered trademark on the Future of Quality: Risk® Continue reading

#106 – WORLD HAS LIMITED RESOURCES … IS INTELLIGENCE ONE OF THEM – MALCOLM PEART

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Malcom Peart pixIt has been suggested that Stone Age man had a higher IQ than today’s modern homo sapiens. “That cannot be” says the modern man but, if one thinks about such an assault on our modern-day ego and self-confessed superiority, the alleged ‘primitive’ man was able to survive in extreme conditions, travelled the planet and set the foundations for today’s societies. Continue reading

#106 – DECISION FOCUS AND VALUE IN A RELIABILITY PROGRAM – FRED SCHENKELBERG

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ABC FredAn essential element of any successful reliability program is the notion that all reliability activity relates to decisions. If you are performing a highly accelerated life test (HALT) only because it is listed on the product development guidelines or because it was carried over from the last program’s plan, and the HALT results are not part of the design improvement decision-making process, then you probably should not be doing so. Continue reading

#106 – 5 POINTS TO REMEMBER FOR A SMOOTHER MANAGEMENT SYSTEM AUDIT – WILL HUGGETT

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AAA1My client, a leader in innovative rail friction management, was recently preparing for an integrated ISO 14001/OHSAS 18001 audit and I was asked to provide onsite training to prepare their employees. The company and its staff are well versed in audits, having been registered under ISO 9001 for several years. In addition to the required EHS awareness training, I was also asked to provide my thoughts on what to expect during the upcoming audit. Continue reading

#105 – RISK BASED THINKING IN HEALTHCARE – TED SCHMIDT

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0014In our last article, I revealed some very unfortunate statistics- hospitals are not as safe for patients as we might have thought.  As a pharmacist on the inside looking out, it is often hard to accept the facts as they are presented.  These facts, unfortunately, are true. We have to change the way we think and the way we perform our work to begin changing those statistics.  We also have to bring our colleagues along with us on this journey. Continue reading

#105 – WHAT IS RISK BASED THINKING? – GREG HUTCHINS

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Greg Hutchins pixWhat is Risk Based Thinking (RBT)?

We get this question weekly and sometimes daily it seems.

Why?  ISO has not defined Risk Based Thinking?  And, this is a hugely important question because ISO has elevated RBT to the same level as PDCA and Process in the Final Draft International Standard (FDIS) of ISO 9001:2015. Continue reading

#105 – MANAGING RISK THROUGH CONSTRAINTS – ANGELA MONTGOMERY

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1dba0a5Risk and Constraints

Every single process, relationship and communication in our organization, whether we are aware of it or not, is affected by variation. If we ignore variation then we are not managing, and if we are not managing then “risk management”loses its meaning.  Continue reading

#105 – INFLUENCE AND RELIABILITY – FRED SCHENKELBERG

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ABC FredReliability professionals today face a challenge. Engineering and operations staff members are taught to think for themselves, to make decisions, to get things done. The entire staff is highly educated, motivated, and willing to lead a team or organization to results. Continue reading

#105 – ‘FAST PASS’ TO SERVICE WITH VERIFIED VOLUNTEERS – KELLY EISENHARDT

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Kelly EisenhardtProviding safe and vetted volunteer resources is important for today’s nonprofits and the people they serve. Verified Volunteers was founded three years ago with the goal of transforming the screening process for America’s nonprofits. Continue reading

#104 – OPPORTUNITIES AND UPSIDE RISKS – GREG HUTCHINS

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Greg Hutchins pix 

In today’s global and highly competitive marketplace, every organization faces uncertainty and risk.  This is the fundamental premise of the ISO 9001:2015 standard.  It could be upside risk as to where a company is going to invest, how it will invest, and what type of business outcomes it expects to achieve based upon its investment risk profile.  These are fundamental business model and market issues.  Continue reading

#104 – IPC FAST TRACKS DATA COLLECTION FOR ROHS AND REACH – KELLY EISENHARDT

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Kelly EisenhardtManaging RoHS and REACH compliance declarations continues to be burdensome for most companies. Although both regulations have been around for many years now, the process for collecting and managing declarations is still complex. Continue reading

#104 – QUALITY RISK MANAGEMENT – PRETESH BISWAS

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AAA1Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmaceutical, pharmacovigilance, and by agencies regulating these industries. Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. Continue reading

#104 – CAREER RISK: HOW TO CONNECT WITH SOMEONE ON LINKEDIN – ELIZABETH LIONS

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new oneWith the bull employment market in full swing, many are looking for new jobs. Introverts are pressured into growing their network. Many of us turn to online avenues because it feels safer and less time consuming than in person networking. Introverts in particular, prefer this type of connection. For them online networking feels less intrusive. Continue reading

#104 – UNCERTAINTY AND UNDERSTANDING RISK – ANGELA MONTGOMERY

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1dba0a5A Deming-Goldratt Take on Risk Management
If we could predict the outcome of everything we do with mathematical certainty, then our lives would be much simpler. In reality, we exist within a complex web of interdependencies and such certainty is not possible. Hence, we live with uncertainty and its inevitable companion: risk. Continue reading