The Right Approach: Guerilla Tactics to Pass Any QMS Audit, Part 4

Concluding this four-part series on “Guerilla Tactics to Pass Any QMS Audit,” I will share Tactic 10. Hopefully, through this series, you found a number of solid strategies you could apply immediately to improve your audit success.

Guerrilla Tactic 10 Techniques to Reverse a Finding

Williams’ Law 10: The more wins you can bank with an auditor/customer, the greater the chance they will write off a negative observation as an isolated anomaly.
Williams’ Law 10.5: The more findings an auditor/customer identifies, the deeper they will dig into all subsequent areas.

The key to reversing an auditor’s finding is on-the-spot corrective action. Responsive, ultra-prompt action is required as well as the aforementioned political savvy of the management representative in administering the following techniques.

The Runner Strategy
The concept of “the runner” is somewhat of a super-secret weapon to be used during any formal audit. It’s not so much a formal position as it is a relationship between the management representative and the person filling the role of the runner. The runner needs to be someone who is extremely familiar with all aspects of the quality system. The ideal person for this role is the quality analyst (ISO coordinator, quality systems administrator, etc.), which is the position responsible for the administration of the quality management system. With a seasoned team, the management representative and the runner will develop a set of “silent codes” between themselves; something as simple as eye contact could send the runner to retrieve some supporting documentation to satisfy an auditor’s request.

The purpose of the runner is to maintain a clean record as the audit progresses by supplying real-time supporting information, records, or any other proof of execution that the auditor may request. Most companies typically handle this by having the management representative/escort compile a long laundry list that the auditor asked to see during the tour that would need to be reviewed and/or verified at the end of the audit. This approach invariably results in findings and/or observations due to a variety of reasons, including time constraints, disagreement on the original request, and flat out just forgetting to address all the issues.

The goal of the runner is a rapid response and one-touch of all documents and departments by satisfying all auditor needs, requests, and questions before moving on to another area. The runner is a key strategy to support the guerrilla tactical strategy of getting in and out.

Examples
1. Auditor issue: Observes an operator imaging panels.
Auditor: “How do I know this person has been properly trained to perform this operation?”
Rapid response: As the employee is explaining their training status to the auditor (badge, color code, matrix, etc.), the runner should retrieve the employee’s training record and certified operator test to present to the auditor on the spot—signed, sealed and delivered.

2. Auditor issue: Observes a machinist measuring dimensions.
Auditor: “How do I know that instrument is accurate?”
Rapid response: As the employee is showing the auditor the calibration sticker on the tool and explaining the tool calibration system, the runner should retrieve the calibration certification and NIST traceability records to present to the auditor on the spot.

Instant Gratification
Collateral benefits of the runner strategy include that it demonstrates competence at the operator level, system robustness, management commitment, and quality system compliance. It also supports employee interaction, fosters teamwork, and instills auditor confidence.

The Page Swap Technique
The page swap technique can be employed to correct minor mistakes or omissions in a procedure. This technique is perfectly legal as long as there is a page swap clause in your document control procedure outlining the rationale and rules for its use. If an error and/or omission is identified by an auditor, utilizing the page swap technique to immediately correct the error and present the auditor with a corrected procedure before he/she finishes the audit will generally result in a non-finding. 

Situations that allow a page swap include when:

  • You can swap a single page in a procedure
  • Re-approval of the entire procedure is not required
  • Page content integrity remains intact
  • Page numbering does not change
  • There are typos
  • There are minor wording changes
  • There’s a missing word/phrase
  • Obvious intent was implied

Procedure Revision 
On-the-spot procedure revisions are the reason that key employees and procedure signatories must be present and available for all major audits and customer visits. The ability to rapidly change, approve, and distribute a procedure revision in reaction to an auditor’s finding will be the difference between a formal finding and a clean audit. 

Examples
1. Auditor issue: Identifies an omission or a typo in a procedure. 
Rapid response pages swap: Tell the auditor that the changes are being made and that you will revisit with them promptly. As an audit is continued, the runner should make the necessary changes via a page swap and catch up with the auditor to present the revised page, also presenting the auditor with the approved document control procedure and explaining the page swap clause. One touch!

2. Auditor Issue: Identifies an issue not addressed in the procedure but being performed by the operator. 
Rapid response revision: Tell the auditor the changes are being made and will revisit with him/her promptly. As the audit is continued, the runner should have the necessary changes made to the procedure, changing the revision on the procedure and the master document list (MDL) and hand-carrying the new procedure to secure a signature from each procedure signatory. The runner catches up with the auditor and presents the revised and approved procedure to the auditor, along with the MDL.

Top 10 Auditor Hot Buttons
These auditor hot buttons should be included in the internal audit program and be part of the scavenger hunt activity during the ISO rallies.

Conclusion
It is my hope, should you survive all four installments of this series, that you will have found a few helpful takeaways in the development or improvement of your own quality system and internal audit program. The strategies, techniques, and tactics presented throughout this series are tried-and-true, practical applications with lessons learned over the course of my career that I hope you will find some value in. As you go through your quality journey, I will remind you to always remember Williams’ Master Law. 

Williams’ Master Law: It’s always about the dollars!

I would argue that any pursuit can, and will, be quantified by cost. In other words, it must make financial sense. I believe you will find that everything we have discussed in this series makes perfect sense from both a practical and financial perspective.

Editor’s note: Read Part 1, Part 2, and Part 3

This column originally appeared in the July 2020 issue of PCB007 Magazine.

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2020

The Right Approach: Guerilla Tactics to Pass Any QMS Audit, Part 4

07-27-2020

Concluding Steve Williams' four-part series on “Guerilla Tactics to Pass Any QMS Audit,” he shares Tactic 10 on techniques to reverse a finding.

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The Right Approach: Guerilla Tactics to Pass Any QMS Audit, Part 3

06-29-2020

Continuing the series, “Guerilla Tactics to Pass Any QMS Audit,” Steve Williams shares Tactic 9, which includes documentation tips to avoid audit "dings."

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The Right Approach: 5 Reasons I Am Already Over Our ‘New Normal’

06-09-2020

Steve Williams captures his perspective on COVID-19 changes and shares his top five reasons why he is over the "new normal" based on his experiences over the last few weeks, indicating what the near future is going to look like.

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The Right Approach: Guerilla Tactics to Pass Any QMS Audit, Part 2

05-26-2020

Continuing March’s Part 1 column on “Guerilla Tactics to Pass Any QMS Audit,” Steve Williams covers tactics 5–8 and hopes you find a number of solid strategies you can apply immediately to improve your audit success.

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The Right Approach: Guerilla Tactics to Pass Any QMS Audit, Part 1

03-25-2020

"Guerrilla tactics" was chosen as the name for this series to reflect a number of nontraditional, take-no-prisoner concepts, techniques, and tactics that were born in the quality trenches and will guide any company to a successful audit result. In Part 1, Steve Williams covers four tactics to pass any QMS audit.

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The Right Approach: The Founding Fathers of Quality—Ishikawa and Shewhart

02-15-2020

This column continues the series of installments, each highlighting one of the seven founding fathers of quality (as selected by the author). It is important to understand and acknowledge their revolutionary contributions that still form the foundation of modern quality practices.

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The Right Approach: The Founding Fathers of Quality–Juran and Crosby

01-18-2020

This column continues the series of installments, each highlighting one of the seven founding fathers of quality (as selected by the author). It is important to understand and acknowledge their revolutionary contributions that still form the foundation of modern quality practices.

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2019

The Right Approach: The Founding Fathers of Quality—W. Edwards Deming

12-26-2019

This column begins a series of seven installments, each highlighting one of the seven founding fathers of quality (as selected by the author). Steve Williams explains why it is important to understand and acknowledge their revolutionary contributions that still form the foundation of modern quality practices.

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The Right Approach: Making Quality Initiatives Fun

12-13-2019

How do you overcome resistance and gain employee buy-in when implementing a new initiative, especially one that is generally seen as dry and boring, such as a quality management system? Follow Law 2 from Quality 101 Handbook: The Biggest Little Book on Quality You’ll Ever Need. For the sake of continuity, Law 1 states, “Never fear an unexpected customer visit.” If every employee lives and breathes the quality system every day, there will never be a need for an audit-prep panic. In this column, I will focus on Law 2.

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The Right Approach: A Conversation With Prototron’s Van Chiem

09-16-2019

I recently spoke with Van Chiem, a process engineer with Prototron Circuits, about developing in-house flex and rigid-flex processes and capabilities at their facility in Tucson, Arizona.

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A Conversation With Prototron's Van Chiem

07-30-2019

Van Chiem, a process engineer with Prototron Circuits, recently spoke with Steve Williams about developing in-house flex and rigid-flex processes and capabilities at their facility in Tucson, Arizona.

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Help Wanted! How to Train New Employees in Today’s Digital World

06-07-2019

In six short years, millennials will make up around 50% of the global working population. With our ever-increasing culture of information overload since the mobile revolution began, attention spans have been shrinking. While millennials seem to be the subject of much of the reporting on Digital-Age attention spans, the effect can be seen across all age ranges. How can you train anyone in this environment? Read on.

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The New Frontier of Manufacturing

04-18-2019

While M2M and H2M connectivity are the primary focus of Industry 4.0, the true underlying benefit of Industry 4.0 comes in the form of machine-to-business (M2B) connectivity or the "machine-as-a-service" concept. This is changing the way we purchase equipment.

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The Right Approach: Industry 5.0—Can We Learn From Other Industries?

03-01-2019

The last few IPC APEX EXPO events have focused heavily on Industry 4.0, which is all about the Internet of Things (IoT), automation, and data exchange between machines.

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The Right Approach: Star Trek Inspires Medical Technology—An Update

02-06-2019

Today, most of us have used some kind of wearable device to monitor our steps, exercise, heart rate, etc. However, as an eight-year-old watching Star Trek with my dad and younger brother in the late 1960s, this wearable technology would have been thought to be crazy.

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2018

Global Sourcing: The 5 Cs of Choosing the Right PCB Supplier

10-30-2018

Global sourcing is a complex process and choosing a supplier is always an important decision. The higher the technology, the more important the process for choosing the right one. Considering the highly complicated process of manufacturing printed circuit boards, these guidelines will assist in your decision.

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The Right Approach: The Value of Coopetition

07-17-2018

As our industry continues to evolve and shape-shift, printed circuit board manufacturing continues to shrink through consolidations and attrition. Unfortunately, this trend will most likely continue, albeit at a slower pace than over the last decade. In what has truly become a global economy, partnering with worldclass suppliers is mandatory, and excluding a sub-set of this dwindling supply base because they also happen to be in a crossover business will severely hinder this effort.

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The Right Approach: International Automotive Task Force (IATF) 16949 Standard, Explained

05-22-2018

While this list is not all-inclusive, it will give organizations an idea of what they are signing up for by pursuing IATF 16949 QMS certification. The standard is very demanding and requires a high level of discipline, but as they say, “What doesn’t kill us makes us stronger!”

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The Right Approach: The Rebirth of Made in America

05-04-2018

I have been on the record for the past 10 years saying that jobs we lost overseas may move out of China to a new low-cost country, but they were never coming back. I have never been happier to be wrong! I talk to a lot of CEOs, and the first question I ask is, “How’s business?” The answers are overwhelmingly positive, and it is clear that their optimism is at a level not seen for over a decade. America as a low-cost country. Think about that.

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Willy Wonka: The Lean Case Study

02-16-2018

No matter where my travels take me, I hear a wide and limitless supply of excuses for why Lean will not work in “my” organization. One of my favorite ways of illustrating that Lean will indeed work anywhere is to take a Lean look at a very unlikely organization, Willy Wonka’s Chocolate Factory.

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The Right Approach: Culture Shift is Key to Quality Improvement

01-03-2018

Any major initiative, whether implementing ISO, lean manufacturing or introducing a new product, requires culture change. How this change is managed will be the difference between success or failure of the project. This column will offer some fundamental elements that will help navigate your next major implementation by shifting the culture.

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2017

The Right Approach: Steve’s Particular Set of Skills (to become a World-Class Quality Manager)

11-14-2017

Being a quality professional today is nothing like it was 20 or 25 years ago; on a personal level, I can attest to this fact. It is no longer adequate to appoint a quality manager simply based on a person’s command of acceptance criteria and industry specifications; in the 21st century, a truly hybrid executive is needed.

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The Right Approach: Navigating Process Change? TPC is the Key

10-02-2017

Change is a given. While this adage may be quite true and normally a good thing, it can wreak process engineering havoc in a printed circuit operation. Change is good, but the operative word is controlled change relative to the complex processes involved in manufacturing a printed circuit board.

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The Right Approach: Is Exceptional Service Worth a 40% Cost Increase?

06-23-2017

“When did this happen?” I asked myself during a recent visit to my men’s only barber shop as I noticed that my $10 haircut was now $14. While I vaguely remember the price going up a little every couple of years, I really hadn’t been paying attention. This caused me to revisit an article I wrote 10 years ago and research whether this 40% cost increase was reasonable.

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The Right Approach: Finding the Next Generation of 'Board Rats'

05-10-2017

Owners of printed circuit board shops across the country are united in their top concern for their businesses: finding new talent. While this problem crosses all industries, what is unique is the complexity and learning curve of our business.

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The Right Approach: Why Trump Will Be Good for Our Industry

02-22-2017

Regardless of which side of the political fence you fall on, what matters most around any election are the policy implications. Taking the partisanship out of politics and looking strictly at the Trump policy promises, there is cause for optimism in business.

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2016

The Right Approach: My Leadership Journey

10-20-2016

I have been in leadership positions for the majority of my 40-year career, but it has not always been a smooth and natural relationship. With the following three stories, I will attempt to share the lessons learned on my journey as a lifelong student in pursuit of the art of leadership.

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The Right Approach: FOD and the Aerospace Industry

10-06-2016

Unless you are currently building aerospace product to AS9100[1] you are probably saying, “What the heck is FOD?” What started out as a requirement to prevent damage to aircraft parts such as engines has been flowed down to any component or assembly including PCBs.

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The Right Approach: Our IoT Lives

06-08-2016

In March, at the 2016 IPC APEX EXPO show in Las Vegas, the next big thing everyone was talking about was the Internet of Things (IoT). Equipment manufacturers were standing in line to tout their machines as IoT-capable and just waiting for the industry to catch up. But the IoT has been at play in our personal lives for quite a while…

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The Right Approach: Quick & Easy 6S to Reduce Handling Issues

05-19-2016

Handling is often the source of many pain points for PCB fabricators, resulting in rework, scrap and customer returns. Quick & Easy 6S is a fantastic tool to minimize handling risk by reducing product travel and improving shop cleanliness.

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The Right Approach: Best Practices: It’s Only Common Sense

04-29-2016

One of the fascinating things about Best Practices is that it is occurring everywhere—and many times without the knowledge of the person or organization doing it! How can this be? Most best practice principles fall under a very old-fashioned ideal that some of us still remember: common sense.

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The Right Approach: Increase Profits by Minimizing Inspection

04-19-2016

Identifying and fixing problems instead of foolishly trying to “inspect in quality” by sorting will have a greater impact on profit than raising prices your product, hammering your suppliers for lower costs or most any other traditional profit enhancement initiatives an organization can implement.

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2015

Data Analytics through Statistical Techniques

11-30-2015

Many companies get caught in data traps. They focus so heavily on cost and survival that they end up using data as merely a marketing and sales tool. In doing so, they fail to realize the true power of data: It can transform every aspect of a business.

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Cycle Time Reduction with WORK, Part I

10-27-2015

Lean, theory of constraints, quick response manufacturing, cross training, and SPC are powerful, tried and true methodologies for process improvement--but they are rooted in high-volume manufacturing environments and don't always play nice in a high-mix, low-volume operation. This article talks about the new WORK manufacturing strategy specifically developed to overcome these shortcomings while capitalizing on their strengths.

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Computer on Wheels

10-05-2015

You could say that today's automobile is a "computer on wheels," but from a point of accuracy it would be more like 35 computers on wheels. With printed circuit boards being the backbone of our electronic products, this is major market segment for our industry. In this article, Steve Williams writes about the evolution of automotive electronics, and the future of the industry.

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Supply Chain in the 21st Century

07-28-2015

The shift away from vertical integration has pushed the topic of supply chain management to the forefront of strategic planning for many manufacturers. This wide-ranging article talks about supply chain management, a brief history of supply chain innovation, managing supply chain risk, as well as presents the "7 Rights" of supply chain management.

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Best Practices 101: Part 6

05-26-2015

One roadblock to achieving the true benefits of best practices is that traditional improvement efforts have always focused on reducing the time of value-added steps; in other words, reducing the amount of time it takes to do something to a product, or touch time.

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Best Practices 101, Part 5: Process Capability

04-06-2015

Not every process is a good candidate for statistical control, and that in these instances, alternate process control methods may be required. Steven Williams talks about continuous improvement when it comes to process capability.

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2014

Star Trek Inspires Medical Tech for 2015

11-30-2014

Close to 50 years after Dr. Leonard H. "Bones" McCoy of the Starship Enterprise first used a fictional tricorder to scan patients for ailments and anomalies, real-world medical science is turning that science fiction into a reality.

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Best Practices 101, Part 4

11-23-2014

"Looking back through the annals of the U.S. PCB industry, when it comes to quality, we have evolved from a reactive, to a proactive mindset. This evolution has led to what is loosely called the zero-defects methodology. The old gold standard of three sigma is no longer acceptable and has gone the way of the dinosaur," writes Columnist Steve Williams.

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Best Practices 101, Part 3

10-16-2014

Columnist Steve Williams writes, "Fresh out of training, the value stream mapping (VSM) team often runs out and starts mapping the first process they see. While VSM, if anything, is better than nothing, efforts should be focused on the critical processes having the greatest impact on the product."

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Best Practices 101, Part 2

09-09-2014

Process flow diagrams are a great first step, but they don't tell the entire story. Value stream maps add one critical ingredient that standard process flowcharts don't have: Time. Process flowcharts do not capture this important element. They simply present a snapshot of the sequence of steps in the process. Time is essential to understanding how one operation affects another and where your resources are being spent.

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Best Practices 101, Part 1

07-17-2014

In the global economy that is today's business environment, there are no guarantees. The need for best practices is present in every industry, but mandatory in technology industries such as PCB manufacturing. In this new series, Columnist Steve Williams conveys personal lessons gained through his involvement with more than 1,000 manufacturing companies.

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Customer Feedback: Perception is Reality

05-29-2014

What does it mean to be world-class? It means being on par with the top performers globally in your chosen craft. There are, of course, numerous quantitative metrics used to measure this, such as turnover, quality certifications, productivity, and the requisite financial ratios. But perhaps the most important metric is qualitative: How do your customers think you're doing?

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Capturing Tribal Knowledge

04-03-2014

Elizabeth II, Queen of Great Britain and Northern Ireland, made the following salient proclamation more than 50 years ago: "It's all to do with the training: You can do a lot if you're properly trained." What has held true through the ages is not a secret; people perform better when properly trained.

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Time for a 'Lean Diet'

02-20-2014

In the drive to continuous improvement, while Lean is one of the most powerful tools available to organizations, it is also one of the most underutilized. Columnist Steve Williams offers a primer for companies considering the Lean journey.

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2013: A Look Back

01-10-2014

After a very challenging year for the domestic PCB industry, global business conditions are slowly improving. Columnist Steve Williams takes a look back at 2013 and also looks forward to what we can expect for the rest of 2014.

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2013

Point of View: The Value of a Strategic Consultant

12-12-2013

New blood, a fresh set of eyes, or an outside perspective: No matter what you call it, the right consultant can add exponential value to any organization. How can you make sure you choose the right consultant and avoid the wrong one?

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Point of View: 3D Printing - Tales from the Road

11-14-2013

In September of last year, columnist Steve Williams wrote about the potential of 3D printing to "save" American manufacturing, as it was quickly becoming the new industry buzzword. Fast forward a year and it is clear that 3D printing may be here to stay and not just another passing fad.

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Temporary Process Change

10-13-2013

Change is a given. While this adage may be quite true and normally a good thing, it can cause havoc in the documentation system of a printed circuit operation. To be successful, there must be a formal methodology to handle process change.

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Lessons from Lombardi - Not Just for Football Anymore

08-23-2013

Columnist Steve Williams writes, "It occurred to me after reading an article in a local paper recently that solid management fundamentals are timeless and cross all industries. It is critical that an organization have a foundation based on a practical management game plan to be in the chase for excellence."

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POV: Operational Excellence Through Continuous Improvement

08-07-2013

Continuous improvement is a journey, and as with most things worthwhile, needs to be an integral part of an organization's everyday life. It can only come from people, motivated and committed, learning what they can learn, solving problems that they can solve, and implementing solutions that they develop.

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Point of View: What Do Customers Want?

07-03-2013

Mel Gibson was able to read women's minds in the movie "What Women Want." Columnist Steve Williams, on the other hand, believes that he can offer guidance on what customers want.

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Point of View: Unleashing the Power of Teams

06-14-2013

One of the most powerful tools in the operational improvement toolbox is not something you can put your hands around, but, if mastered, it can take organizational performance to a new level. Highly-effective teams can make the difference between step function improvement and abject failure.

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2012

Manufacturing Advantage: Japan! Where is the Love for Kanban and Lot Size of One in the U.S.?

12-01-2012

More than 50 years ago, American industry rejected the manufacturing tools and techniques of Dr. W. Edwards Deming, while most of Asia welcomed and ran with this guidance. While this has slowly changed, a couple of important concepts still have not been embraced here in the U.S.

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Point of View: RoHS: Six Years After

11-08-2012

It is worth taking a look back at the span of six years, and the regulatory implications to our industry stemming from one regulation that has impacted the electronics industry in a mighty big way: RoHS.

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Will 'Old' PCB Technology Save American Manufacturing?

10-11-2012

3D printing is a hot topic right now, especially with equipment prices dropping and reports of this incredible technology entering the consumer marketplace. With its origin in the additive process of PCB manufacturing, will this technology save American manufacturing?

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Point of View: A Cautionary Tale

03-08-2012

As we all look to improve our manufacturing organizations in 2012 and become leaner and meaner, the fictitious canoe story is a reminder to focus on the right things and concentrate on activities that will improve the bottom line.

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