Archive for the ‘Newsletters’ Category

Deliver More Customer Value

Tuesday, December 4th, 2018

 

This Month

 Events
 
SES Lunch and Learn on January
23, 2018.
 
Sponsored by the AZ Technology Council. More Information and Registration Below.

 

      

 

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence

Improved Profits and More!

Welcome to this month’s edition!
 
As always we have provided you with a range of topics this year. Our goal is to support you in your continual development and improvement of your management systems and overall business performance. 
 
As we plan ahead for 2019, we would love to know what topics you would like to see in next year… is there a particular subject you’re interested in learning more about? Do you have a query around a specific element of a  standard, or method of improvement? Please let us know.
 
The best to you this holiday season and throughout the New Year! Thank You for being a valued subscriber of our performance improvement newsletter.    

 

Deliver More Customer Value
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With the New Year approaching, many of us are thinking of what is the best way to shape our company’s economic future and growth into the most profitable form possible.

The answer is to deliver more than your share of customer value!

Keep in mind your competition won’t be standing idle while you innovate and grow. To stay ahead of your competition, you should keep a strategic focus on what sets your company apart within your industry.

You could have a number of marketable differences from your competition. Spending more on R&D, or sales efforts? Acquiring capital equipment beyond your current capacities? Is what you’re doing focused on internal needs, or are you implementing your customer’s ideas?

 

All you quality professionals, yes you!  Yours is a unique role in driving successful change in organizations. Not only should you be leveraging your support with specific solution development and expertise use, including project management support, you are often a key player and change agent in the change management activities that support project implementation and overall quality improvement.

The American Society for Quality and the Association of Internal Management Consultants conducted a study with more than 800 respondents.  The study indicated an expanding role for Quality Management Professionals and the need for new skills.

Top Areas Rated Very Important
  • Client Relationship Management 78%
  • Integrating Project and Change Management 77%
  • Rapid Implementation and Continuous Improvement 69%
  • Strategic Performance Measurement 66%
Key Personal Competencies in Addressing Future Responsibilities
  • Process Improvement 85%
  • Change Management 70%
  • Critical Thinking and Risk Management 65%
  • Leading Through Influence 61%
1. Conduct face-to-face customer interviews.
Of all the ways to learn about customer needs-telephone, e-mail survey, Internet, nothing comes close in effectiveness to face-to-face customer interviews.

Many of us use customer surveys to determine satisfaction levels. We use a Likert Scale method (1-5) based on questions we have determined are important. The reality, though, is that most questions asked are actually customer-reactive, not market-customer proactive interviews. Should we be asking our customers “Please rate the quality of our products?”, or “How can we provide a better quality product to you?”

 
Get out and visit your customers and find out what’s important to them!
 
2. Develop a Voice of the Customer mentality.
 
Voice of the Customer studies typically consist of both qualitative and quantitative steps. They are generally conducted at the start or finish of a new product, process, or service design in order to better understand the customer’s wants and needs. That e-mail survey with the 3-5% average return, is it handing you a report of “what the customer wants?” This is a flawed model. Train your people to be VOC experts!

Best of all, you’ll develop a reputation among customers as “that supplier who really does listen to us!”

 

3. Become a Quantitative Organization.
After you conduct good qualitative customer interviews, you can target specific customer ideas you could work on. Which ideas do you target in your product design? Which ideas do you target in your product realization processes? At this point get quantitative. Being quantitative helps you to understand which customer outcomes are most important and least satisfied.

The key to taking advantage of the future is in changing the way your company approaches your current and future customers. Start now, with a new approach and you’ll shape a sustainable organization for Year 2019 and beyond!

 
HEY! Interested in learning more and what best practices are used by world class organizations to produce above the NORM RESULTS!

 

Register NOW for OUR Lunch and Learn “Achieve Breakthrough Performance” on January 23, 2019.  Detailed Information and Registration Below… 

Achieve Breakthrough Performance!
project management flow chart or mindmap - a sketch on a napkin with cup of coffee
 
Sustaining Edge Solutions, Inc. Lunch and Learn.
 
Sponsored by the Arizona Technology Council. The AZTC is the premier choice for business networking events in all of Arizona. 

At this Lunch and Learn, attendees will learn how to develop a framework for evaluating and establishing breakthrough improvement at their organizations.

In today’s highly competitive marketplace, organizations that succeed use a systematic approach in the design, integration, and alignment of strategic business efforts and leadership decision making. These organizations use an evidence-based business model to understand and act on the needs of stakeholders to achieve breakthrough improvement and scalable profit growth.

Speakers for this lunch and learn event are Walter Tighe, President and Owner of Sustaining Edge Solutions, and Dennis Stambaugh, Senior Management Consultant of Sustaining Edge Solutions.

Location: Brother John’s Beer, Bourbon & BBQ

1801 N. Stone Ave.Tucson, AZ
Date: Wednesday January 23, 2019
Time 11:30AM-1:00PM

There is no charge to attend, and lunch is included. Wow – There is such a thing as a free lunch.

 
REGISTER NOW!  LOOKING FORWARD TO SEEING YOU.

 

Integrated Management Systems
Close up on a file tab with the word ISO 9001 focus on the main text and blur effect. Concept image for illustration of Quality Standards

Does your company operate under more than one management system standard?  We have a number of clients that are certified to multiple global standards, which begs the question –  If so, Do you operate under a single Integrated Management System?      

 
The number of management systems has risen dramatically in recent years, reflecting the needs and demands of more and more organizations looking to improve their performance across a wide range of areas and sectors.  

 

ISO 9001 (quality), ISO 13485 (medical devices) ISO 50001 (energy) and ISO 14001 (environment) and others are some of ISO’s most well-known and used management system standards. Unlike other types of standards, MSSs have an impact on many different aspects and functions of an organization and, increasingly, companies have more than one.

 
The quest for continual improvement and sustained performance has prompted the need for a handbook to help guide organizations through effective management system design that is agile and integrated, to respond and grow. 
 
The Integrated use of Management System Standards Handbook brings together international expertise, diverse industry case extracts and implementations, and best-practice guidance on integrating management system standards. It has just been updated to reflect the vast number of changes to both ISO and non-ISO standards. 

 

Michael McLean, Leader of the ISO working group that developed the handbook, says “Many organizations benefit from multiple management systems to help them ensure their systems and processes are in line with their objectives and help them maintain their business model through ever-changing environments.

 

This handbook provides a practical guide for organizations to effectively align their management systems with their strategies, plans and operations. It features illustrations as applied in real-world organizational contexts and relevant case studies, all of which can be applied to all kinds of sectors and industries. It is applicable to any kind of MSS, not just those published by ISO.”

You can purchase the Integrated use of Management System Standards Handbook released November 2018 at the ANSI Webstore.

 

Skills Versus Perception Gap
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As manufacturing faces a shortage of up to 2 million skilled workers over the next decade, it’s important to understand how a typical person – one who doesn’t work within the industry – views the sector as a viable career path for the workforce of tomorrow.

The Thomas Publishing Company recently conducted a survey of over 1,000 American adults from all walks of life, to gauge their perceptions of the manufacturing industry. Their study showed that 3 in 4 respondents claimed to be “very” or “somewhat familiar” with manufacturing, other findings showed what appears to be a gap between perception and reality when it comes to many aspects of the industry.

For example, over 55 percent of respondents described the state of the U.S. manufacturing industry as “stable but weak” or “declining.” This contradicts data from the Bureau of Labor Statistics clearly showing a booming U.S. manufacturing sector.

 
In an indication that the industry has a ways to go in fighting the perception that manufacturing is a “dirty hands” vocation, only half of the respondents said they would describe the manufacturing industry as “high tech.” That still leaves half of America either thinking of the industry as “low tech” (17%) or “not sure whether the industry is high tech or low tech” (32%).

On a positive note, about 66% of respondents said that they would be “likely” or “very likely” to encourage someone entering the workforce to pursue a career in manufacturing. This is evidence that attitudes about the industry are changing for the better. However, the 34% of respondents who indicated that they were “not at all likely ” to encourage someone to pursue a career in manufacturing cited reasons such as “poor job security/stability” (38%), “safety concerns” (28%), and “low pay” (38%).

 
These perceptions (or misperceptions) are among 4 myths about American manufacturing that the industry needs to work toward addressing. There are a wealth of great reasons why it’s great to work in manufacturing – building broad awareness among those entering the workforce is critical.

To download the complete Thomas Manufacturing Perception Report, and read the 4 Myths of Manufacturing visit the Thomas Website.

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In the News
AIAG Announces Global Core Tools APP

The AIAG development team is creating a Software as a Service (SaaS) cloud application based on the Microsoft development tools and hosting will be provided worldwide via the Microsoft Azure Cloud Computing Platform.  The software will support DFMEA, Process Flow, PFMEA, Control Plans, and Gage R&R studies, along with several other support forms that are referenced in the Core Tools manuals.

 

The objective is to assist the supply base with better, faster, and lower cost solutions to support their quality improvement and product development initiatives. This product, designed with smaller supplier needs in mind, will make authoring and management of the essential core tools more effective and efficient, so smaller suppliers can focus on developing quality products for their customers

 

Update from the IATF -New Interpretations

On November 19th, 2018, the International Automotive Task Force (IATF) released new sanctioned interpretations for the IATF 16949:2019 standard. These new SIs are effective as of January, 2019.
To review IATF 16949:2016 Sanctioned Interpretations 1-15, and rationale for each change click here.

 

Pricing it Right 
 
Price transparency is one way of gaining consumer trust by making purchasing choices easier. A new standard for unit pricing will help consumers compare products quickly and effectively, a win-win solution for all.

ISO 21041, Guidance on unit pricing, aims to clear up the confusion by defining unit pricing systems and enhancing transparency of pricing information. The standard provides guidance on how unit pricing should be displayed in-store (both on-shelf and on packaging), online and in advertisements. It also highlights the importance of clarity and consumer education. For more information visit the ISO Website.

Training Courses
 
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
 
Don’t see a course or schedule that fits your needs?  Contact us.
 
Every business today needs to get their message out.
Original Content Creation and Social Selling continues to grow through websites such as LinkedIn, Facebook and other channels.

Here are some survey findings one social selling company recently assembled on activity in the sector:

  • 79% of salespeople who use social media outsell those who don’t.
  • 53% of buyers said they listen to peer recommendations before they make a purchase.
  • 65% of buyers feel the vendor’s content had an impact on their final purchase decision.
These trends will continue to grow. Thought content-from blog posts to videos-that create a sense of excitement among consumers will only become more crucial.
Businesses with the most compelling, original voices will rise above the noise.

 

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642
 

 

Health and Safety-A New Approach

Friday, November 2nd, 2018

 

This Month

 Events
 
SES Lunch and Learn on January
23, 2018.
 
Sponsored by the AZ Technology Council. More Information and Registration Below.

 

      

 

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence

Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems, our services include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard. Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do You have a Subject of Interest for our Newsletter?  Please let us know. 

 

Health & Safety- New Approach
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The release of the new ISO 45001 Standard is a significant event for global Occupational Health and Safety. This  international standard specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018-“Occupational health and safety management systems-requirements” which replaces OHSAS 18001 as the primary OH&S standard used internationally.

Released in March 2018, ISO 45001 marks a significant step in the overall effort to improve OH&S standards worldwide. The standard sets out the requirements for an OH&S management system and includes an implementation guide, enabling organizations to proactively improve OH&S performance, as well as provide a safe and healthy working environment that prevents work-related injury and ill health.

 

This new standard, which will replace OHSAS 18001, follows the approach of other management systems such as ISO 14001 and ISO 9001 and has an increased emphasis on management commitment, worker involvement, and risk control. Organizations already certified to OHSAS 18001 will have three years to comply with the new ISO 45001 standard, although certification of conformity to ISO 45001 is not a requirement of the standard.

What are the major differences between OHSAS 18001 and ISO 45001?

There are fundamental differences, but the main change is that ISO 45001 concentrates on the interaction between an organization and its business environment while OHSAS 18001 was focused on managing OH&S hazards and other internal issues. But the standards also diverge in many other ways:

  • ISO 45001 is process-based – OHSAS 18001 is procedure-based
  • ISO 45001 is dynamic in all clauses – OHSAS 18001 is not in structure content.
  • ISO 45001 considers both risk and opportunities – OHSAS 18001 deals exclusively with risk
  • ISO 45001 includes the views of interested parties – OHSAS 18001 does not require.

 

Companies that have already implemented an effective OH&S management system in accordance with OHSAS 18001 should expect a smoother transition to ISO 45001.   ISO 45001 uses ISO’s “high level structure” (HLS), so that it has a common framework with other management systems, such as ISO 9001 and ISO 14001. Integration of ISO 45001 requirements into these management systems should make it easier for certification.

By emphasizing a proactive approach to risk-control, certification to ISO 45001 demonstrates a strategic commitment to continuous improvement of OH&S, which in turn improves staff morale, minimizes costs, and strengthens market reputation. Third-party certification against the standard’s requirements sends a strong signal to both internal and external stakeholders that your organization is committed to safe and secure business operations.

 

For more information on the ISO 45001 OH&S Standard, including development assistance needs –  Contact Us.

 

 

Achieve Breakthrough Performance!
project management flow chart or mindmap - a sketch on a napkin with cup of coffee
 
Sustaining Edge Solutions, Inc. Lunch and Learn.
 
Sponsored by the Arizona Technology Council. The AZTC is the premier choice for business networking events in all of Arizona. 

At this Lunch and Learn, attendees will learn how to develop a framework for evaluating and establishing breakthrough improvement at their organizations.

In today’s highly competitive marketplace, organizations that succeed use a systematic approach in the design, integration, and alignment of strategic business efforts and leadership decision making. These organizations use an evidence-based business model to understand and act on the needs of stakeholders to achieve breakthrough improvement and scalable profit growth.

 

Speakers for this lunch and learn event are Walter Tighe, President and Owner of Sustaining Edge Solutions, and Dennis Stambaugh, Senior Management Consultant of Sustaining Edge Solutions.

 

Location: Brother John’s Beer, Bourbon & BBQ
1801 N. Stone Ave.Tucson, AZ
Date: Wednesday January 23, 2019
Time 11:30AM-1:00PM

 

There is no charge to attend, and lunch is included. There is such a thing as a free lunch.
 
REGISTER NOW!  LOOKING FORWARD TO SEEING YOU.

 

Management Systems Conference
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In October we attended the National Quality Assurance (NQA) Certification Body (CB) Third Party Auditor and Management Systems Consultants Conference. NQA is one of the leading global ANAB accredited CB for many certification standards.

 
We always look forward to this conference which delivers valuable information. An example is the results of the various standards transition process. So listen up our successful transitioned clients, including our newsletter readers who have more than likely been involved in this process.
 
ISO 9001:2015 Transition CB Nonconformance’s  
 
#1: 6.1 Actions to address risks and opportunities
#2: 9.2 Internal audit
#3: 9.3 Management review
#4: 4.1 Understanding the organization and its context
#5: 4.2 Understanding the needs of interested parties
#6: 5.1 Leadership and commitment  
#7: 7.1.6 Organizational Knowledge  

An important learning lesson here is that many of these nonconformance’s found were a result of the new standard requirements, which are the responsibility of the company senior management team.   

An interesting breakout session topic we attended was titled “What to look for when no documented information is presented.” Example questions that were presented that could be asked during an audit scope of 4.1 Understanding the organization and its context included:

  • What are your markets or market sectors?
  • Are there any regulations or standards you have to plan for/work with? 
  • Do you have any indispensable partners? What kind of customers are you after? Who does your perfect customer look like? 
  • Who makes up your core team? 
We did found these questions to be quite relevant to drive the gathering of information and determining the organization and its context. 
 
Stay tuned to our next month newsletter issue!  We will share much more information on the AS9100D:2016 Standard transition results and Aerospace Update.  

 

ISO 19011:2018 Auditing Systems

ISO 19011 is defined as the standard that sets forth guidelines for auditing management systems. The standard contains guidance on managing an audit program, the principles of auditing, and the evaluation of individuals responsible for managing the audit programs. This 2018 version replaces the previous version of ISO 19011 from the Year 2011.

ISO 19011:2018 provides valuable information on how to improve an audit program systematically, just as other departments in an organization are expected to improve. One aspect of such improvement is continuously ensuring the audit program objectives are in line with the management system policies and objectives. For auditing improvements, organizations should consider the needs of customers and other interested parties.
What are the Main Differences between ISO 19011:2011 and ISO 19011:2018?
  • Addition of the risk-based approach to the principles of auditing
  • Expansion of the guidance on managing an audit program, including audit program risk
  • Expansion of the guidance on conducting an audit, particularly the section on audit planning
  • Expansion of the generic competence requirements for auditors 
  • Removal of the annex containing competence requirements for auditing specific management system disciplines 
  • Expansion of Annex A to provide guidance on auditing New Concepts such as organization context, leadership and commitment, virtual audits, compliance and supply chain.  
We highly recommend that you obtain a copy of ASQ/ANSI/ISO 19011:2018.  You can purchase ISO 19011:2018 on the ASQ WebsiteASQ members do receive a 20% discount.     
 

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In the News
Congratulations to Our Newly Certified Clients!

 
Apriva, ISS LLC. received ISO 9001:2015 Certification through NQA.  Apriva designs, develops, installs and supports mobile voice and data systems.

Falcon Engineering Corporation received AS9100D certification.  The company delivers comprehensive multi-disciplined services in mechanical engineering, textile engineering, and manufacturing.

 
 
World Quality Day 2018 – November 8th 
       

A special day has been created to draw attention to the importance of quality issues, and it’s known as “World Quality Day.”

Quality is an important aspect of everything we do, including how businesses and organizations function. As such, a special day has been created to draw attention to the importance of quality issues, and it’s known as “World Quality Day.”

The day’s purpose is to promote the awareness of quality around the world, as well as encourage growth and prosperity for individuals and organisations through the implementation of strong quality standards.

For more information on World Quality Day visit the World Quality Day Website.

Hey America, You’re Wrong – Manufacturing Is Not Failing, It’s Flourishing.
 
Survey Calls Out Public Misconceptions About Modern American Manufacturing.

A recently released survey by Leading2Lean shows that a majority of Americans believe that the American manufacturing sector is failing. That couldn’t be farther from the truth. In reality, manufacturing is growing at such a fast rate that over the next decade, nearly 3.5 million manufacturing jobs will need to be filled and an estimated 2 million of those jobs will go unfilled.

To view the subject survey click here.

 

Cyber Security for Supply Chain

 
Analysts estimate that up to 80% of cyber breaches may originate in supply chains-attacks where hackers sabotage software or hardware before it’s sent to the customer. Protecting supply chains is therefore an absolute priority for all organizations.

Cyber attacks on businesses and industry may have disastrous consequences for the companies affected. Ultimately, they may even force some businesses or industries to close.

For more information, visit the IEC Website Article.

 

Training Courses
 
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
 
Don’t see a course or schedule that fits your needs?  Contact us.
 
The quality management profession is about helping organizations put in place competent systems to ensure that the activity of an organization consistently delivers on its promises to customers and stakeholders. This includes an improvement framework to continuously improve.
 

A system of governance, assurance and improvement combined with your culture of quality are your investment in trust and reputation. The quality profession is your business partner in enhancing trust in your organization. 

 
Chartered Quality Professionals are the people who support and develop quality competence and culture using their unique view across the organization and its stakeholders, and their unique skills in establishing systems of operational governance, assurance and improvement.

How will you celebrate November 8th World Quality Day 2018?

 

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642
 

 

Standards and Risk Management

Monday, September 3rd, 2018

 

This Month

 Events
 
AZTC Technology and Business Expo October 24, 2018 Tucson, Arizona
Convention Center We are Exhibiting. More information below.

 

Breakthrough Performance.  Save the Date – January 16, 2019. SES Workshop with  lunch. Information to follow.


 

      

 

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence

Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems, our services include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard. Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do You have a Subject of Interest for our Newsletter?  Please let us know.  

 

Standards and Risk Management
risk management flow chart drawn by hand isolated on blackboard

A key aspect of risk is that it is integral to all activities within an organization that impact its sustainability, resilience and business excellence. Without an effective analysis of risk, it is impossible for an organization to develop a realistic strategy or achievable objectives. How can an organization implement effective information management systems, or quality systems, or plan for organizational change without analyzing risk?

 

While there is considerable evidence that organizations perform better when they adopt voluntary quality standards, insurers continue to ignore these standards when setting terms and conditions for policyholders, according to a new white paper from the Association of Insurance and Risk Managers in Industry and Commerce.

Entitled “Standards: Supporting Risk Management and Adding Business Value,” the white paper focuses on the value that standards and accredited conformity assessment can play in the management of risk.  Building on this theme, the paper goes on to discuss how risk management benefits from the rigor of the terminology of international risk management standard ISO 31000 and the associated ISO Guide 73, adding that standards are intended to work together.

Some standards that relate closely to risk management-quality, health and safety, environment, business continuity and information management-are measurable and auditable and can therefore form the basis of certifiable schemes.While it isn’t compulsory for organizations to achieve third-party certification, becoming certified communicates best practice to stakeholders and supply chains. And since becoming certified reflects the organization’s attitude and exposure to risks, it may also reduce insurance premiums.

 

The paper describes accreditation as robust international recognition that is an independent declaration of an organization’s competence. The term covers the validity and suitability of its methods, the appropriateness of its equipment and facilities, and ongoing assurance.

 

The paper details how standards help organizations

  • Remove technical barriers to trade
  • Improve supply chains and create fair and equal competition
  • Provide business credentials
  • Increase consumer protection
  • Give regulatory support
  • Stimulate innovation
  • Manage organization risk

To view the complete white paper Click Here.

 

Malcolm Baldrige Board of Examiners
ANNOUNCEMENT: August 13, 2018 News Release NIST Public Affairs Office:

We are proud to announce that the Commerce Department’s National Institute of Standards and Technology (NIST) has named Dennis G. Stambaugh, Senior Management Consultant of Sustaining Edge Solutions, Inc. in Tucson, Arizona, to the Board of Examiners for the 2018 Malcolm Baldrige National Quality Award.

Appointed by the NIST Director, examiners are responsible for reviewing and evaluating applications submitted for the Baldrige Award, as well as other assessment-related tasks. The examiner board is composed of more than 300 leading experts competitively selected from industry, professional, trade, education, health care, and nonprofit (including government) organizations from across the United States.

 

Those selected meet the highest standards of qualification and peer recognition, demonstrating competencies related to customer focus, communication, ethics, action orientation, team building, and analytical skills. All members of the board must take part in a nationally ranked leadership development course based on the Baldrige Framework for Performance Excellence and the scoring/evaluation processes for the Baldrige Award. They must also complete an independent review of a Baldrige Award application or other comparable examiner task.

Since joining SES, Dennis has helped develop and is currently engaged with our clients with a Breakthrough Improvement Model that provides a Baldrige-based Quality Leadership Framework for continuous organizational improvement, alignment, and integration of key business systems.

A Breakthrough Improvement Gap Analysis is offered by SES for improved organizational effectiveness and performance, with a feedback report to help prioritize key leadership and work processes for strategic improvement.  We also provide services to assist with written applications for the SWAE Regional Baldrige Awards, leading to application for the National Baldrige Award for Performance Excellence.

For further information on our gap analysis and achieving breakthrough improvement for your organization, please contact Dennis at dstambaugh@sustainingedge.com, or call us directly at 888-572-9642.

 

Reducing Energy Consumption and Improving the Food Chain
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Reducing energy consumption and improving energy efficiency are at the forefront of the global climate change agenda. ISO 50001, the flagship International Standard for improving energy performance, has just been updated.

ISO 50001:2018, Energy management systems – Requirements with guidance for use, transformed the energy performance of organizations worldwide when it was first published in 2011, giving them a strategic tool to use their energy more efficiently and effectively. It provides a framework for managing energy performance and addressing energy costs, while helping companies reduce their environmental impact to meet emissions reduction targets.

Improving the Food Chain
ISO 22000:2018 the international Food Safety Standard that specifies the requirements to ensure safe production within the entire food chain, from farm to fork, has now been revised and has been released. The standard has now a strong connection with the food hygiene principles of Codex Alimentarius and a new approach to risk in two different levels, the organizational (strategic direction of the business) and the operational level.

You can purchase these standards at the TechStreet Store.

 

Effective Performance Metrics
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Performance metrics are a vital part of managing an organization. Many organizations have a tendency to select metrics by copying what competitors measure, what is in  business articles and what benchmarked firms are using.

The best organizational metrics keep the focus on its strategic direction, not the direction in which others are going.

Some metrics should be able to evaluate results (outcome or lagging metrics), while others should allow proactive management of the vital factors (process or leading metrics) that create those outcomes. For example, on-time delivery (an outcome) might be significantly impacted by equipment reliability (a leading indicator for delivery performance). However, equipment reliability is an outcome measure for the maintenance facilities management process. As much as possible, metrics should be focused toward business drivers, such as process or leading indicators, instead of outcomes.

Once the desired metrics have been identified, the real work begins. Decisions must be made regarding:
  • Who owns the metric.
  • Where will the data be acquired and how often.
  • How might the raw data be manipulated (normalized) to allow more equivalent comparisons over time.
  • How often should the metrics be reported and analyzed for decision making.
Although it might sound simple, creating operational definitions is an important component of metric details. In other words, what is meant by the terms as expressed in mathematical terms (for example, numerator, denominator and time boundaries)? A company might ask, “What is meant by on-time delivery? When it is picked up by the carrier, or when it arrives at the target location.

 

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In the News
Manufacturing Day Coming Soon – October 5th 

       

Inspire the Next Generation of Manufacturers!  Every year, thousands of manufacturers around the country open their doors to inspire the next generation of manufacturers.

Manufacturing Day addresses common misperceptions about manufacturing by giving manufacturers an opportunity to open their doors and show, in a coordinated effort, what manufacturing is – and what it isn’t. By working together during and after MFG DAY, manufacturers will begin to address the skilled labor shortage they face, connect with future generations, take charge of the public image of manufacturing, and ensure the ongoing prosperity of the whole industry

 

For more information and to Host, Find or Attend an Event in your state visit the MFG DAY Website.

Southern Arizona Technology and Business Expo October 24, 2018 Tucson Convention Center, Arizona

Join over 400 local business leaders in discovering new technologies, great products, innovative and emerging Arizona-based tech companies and much more at the largest Tech + Business Expo in Tucson, showcasing over 60 booths! Sustaining Edge Solutions is Exhibiting, See You There! 

The Arizona Technology Council (AZTC) and the Arizona Commerce Authority (ACA) present the Sixth Annual Southern Arizona Tech + Business Expo on Wednesday, October 24, 2018 at the Tucson Convention Center.

AZTC Member: Early Bird $35 (expires Sept. 19), $45 after Sept. 19 Non-AZTC Members: Early Bird $45 (expires Sept. 19), $55 after Sept. 19.  REGISTER NOW!

 
 
IATF 16949 Automotive Standard SIs and FAQs
The International Automotive Task Force (IATF) has approved the release of updated IATF 16949 Sanctioned Interpretations (SIs) and Frequently Asked Questions (FAQs).

Sanctioned Interpretations alter the existing published requirements of the IATF 16949:2016 standard. Frequently Asked Questions clarify an existing requirement. The approved Sanctioned Interpretations include, for example

 

SI 12 –  Clause 5.1.1.2, Process effectiveness and efficiency

SI 13 – Clause 9.3.2.1, Management review inputs – supplemental
FAQ 21 – clause 8.6.2, Layout inspection and functional testing
FAQ 22 – clause 9.2.2.4, Product audit

SI and FAQ Downloads

The IATF 16949:2016 SIs and FAQs are located on the IATF Global Oversight Website.

Training Courses
 
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
 

Don’t see a course or schedule that fits your needs?  Contact us.

 

Now is the time to begin planning your next business moves with the approaching new year ahead. What kind of results do you want to create for yourself and your business?

Do you have customers coming back for more of your product or service? Do you have a set of ideal customers you want to cultivate? Are your business processes in control and capable of producing what you, your employees, and your customers require on a continuous basis?

The demands of today’s business environment have caused many of us to shift our approach from thinking as a professional to acting as an entrepreneur. Avoiding past mistakes and taking the time to plan your next moves can make the difference between failure, or sustainable growth for your organization.

 

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642
 

 

Certification Transition Deadline

Monday, August 6th, 2018

 

This Month

 Events
 

AZTC Technology and Business Expo October 24, 2018 Tucson, Arizona
Convention Center We are Exhibiting!

      

 

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence

Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems, our services include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard. Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

 

Do You have a Subject of Interest for our Newsletter?  Please let us know.

 

Certification Transition Deadline
Close up on a file tab with the word ISO 9001 focus on the main text and blur effect. Concept image for illustration of Quality Standards

September 2018- the deadline for transition to ISO 9001:2015 and other QMS Standards – is here now!

Most of us are willing to claim we experienced some angst with the transition and time period over the last three years. This also included the transition certification body process of wondering do we have it right, and am I going to lose our certification?  Relax, we are not aware of any company that has not been successful with transitioning to various standards. However, common nonconformance threads do exist and have been communicated throughout our industry.

 

Let’s dive into what are the common nonconformity issues written by certification body auditors based on our investigation, and other feedback we have received.

 

Section 4 – Not addressing the new requirement to identify and define internal and external interested parties. Also, not looking comprehensively and beyond the common repeatable parties of interest such as customers, management, suppliers and employees.

 

Section 6 – One of the sub-sections is defining change management. Auditors found that this is not effectively implemented. Another problem is the evaluation of risk. ISO 9001:2015 requires an organizational risk and opportunities evaluation. Internal and external issues missing from the evaluation. This included lack of specific actions to address, and lack of evidence on how the actions were evaluated.

 

Section 7 – Infrastructure and work environment needs, and the method of determining those needs has been a recurring issue for many years. Not taking the proper time to conduct a comprehensive analysis based on your company product and service needs can result in missed requirements. New to ISO 9001 is the organization’s need to improve their organizational knowledge. This can be through the capture of best practices and lessons learned. Auditors have cited organizations with quality systems that did not effectively capture knowledge.
On-going findings include document control and records retention not effective. An example is training records not effectively addressed and retained.

Section 8 – Receiving inspection was cited as not always effective and the process for approving vendors and disqualifying vendors not defined. Additional common findings included non-conforming material areas not clearly defined or material not identified. Also, formal production change control, and the authorization of change, including necessary actions. Nonconforming outputs – much more than just nonconforming product issues now.

Section 9 – Auditors found lack of training records for ISO 9001:2015 internal auditor training. Management review records that did not address the mitigation of risk or actions taken. Findings also included management reviews that used the prior standard agenda, missing new input requirements. Under AS9100D – risks identified as a new management review meeting output was found missing.

 

Section 10 – This new section pulls together two subjects – non-conforming material and corrective action. Nothing different – organizations have had to address non-conforming material and corrective action for years. A new issue in the new standard is the addition here of customer complaint language. Auditors found customer complaint logs maintained, but decisions regarding disposition or corrective action not defined or documented. Additionally, corrective action follow-ups were not documented all the time.

Hopefully this information has given you insight into processes you may want to investigate for further improvement. Remember, your CB Auditor will be back.

Have examples beyond these you would like to share with us for communicating to our readers? As always, all responses will remain anonymous.  Let us know!

 

Quality Plans Guidance Updated
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In order to effectively transform business ideas into actions, you need a plan. A quality plan. Guidance on how to create one has just been updated, providing a powerful tool to complement any operational and quality management system, including ISO 9001 and others.

 

Producing something – whether it be a product, service, process or project – always involves a series of interconnected or complementary processes and tasks that have to be performed, and planning them effectively in advance often leads to better results. A quality plan helps organizations do just that, as it includes a specification of the actions, responsibilities and associated resources that are needed to achieve the desired outcomes.

 

It is useful as it describes how an organization will actually go about producing the product or service and how these actions can have an impact on other processes or parts of the business.  It is a particularly useful tool for validating new products, services or processes before the work begins and for demonstrating to stakeholders how their requirements are going to be met.

 

ISO 10005:2018, Quality management – Guidelines for Quality  Plans, gives guidelines for establishing and applying quality plans, and it has just been updated to provide more guidance and more examples to be relevant to organizations of all shapes and sizes.  Roy Ackema, Leader of the working group that updated the standard, said that while it is not essential to have in place ISO 9001, ISO’s flagship standard for quality management systems, in order to benefit from the guidance of ISO 10005, the two standards are based on many of the same concepts and principles, making them highly complementary to each other.

“ISO 10005 was updated to reflect modern business practices,” he said. This includes improvements to the terminology and concepts as described in the 2015 version of ISO 9001, such as those related to addressing the needs and expectations of relevant parties and managing organizational knowledge.”

“It also offers more guidance on how to apply risk-based thinking to decide the processes, resources and methods to be used.”

You can purchase ISO 10005:2018, Quality management – Guidelines for Quality Plans at the TechStreet Store.

 

Improving Customer Satisfaction
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We all know that our customers are the primary reason for our successful companies, including our jobs. We also know that retaining loyal, happy customers is the key to any successful business, but the fickle consumer world is not always easy to please. A series of guidelines has just been published, bringing together international best practice on customer satisfaction.

 

From handling complaints to service with a smile, taking care of customers is a science in itself and one not to be taken lightly as it can have a dramatic effect on both staff morale and the bottom line. Studies abound that show that those companies that perform well in customer experience have higher revenues and returns on investments. Not to mention that most customers don’t go back to a company if they have a bad experience.

 

Getting the customer experience right, then, is imperative. A series of international standards dedicated to improving customer satisfaction has just been updated, to ensure the information is most relevant and reflects revisions to ISO’s flagship standard for quality, ISO 9001.
 
Stan Karapetrovic, Leader of the working group that revised the standards said they guide organizations on implementing effective systems to improve customer satisfaction.
“These guidelines were revised simultaneously, aligning both with ISO 9001 and with each other,” he said. “While each of the standards can be efficiently implemented by themselves, their integrated application is very effective as well.”
These standards are:

ISO 10001, Quality management – Customer satisfaction – Guidelines for codes of conduct for organizations.

 
ISO 10002, Quality management – Customer satisfaction – Guidelines for complaints handling in organizations.
 
ISO 10003, Quality management – Customer satisfaction – Guidelines for dispute resolution external to organizations.
 
ISO 10004, Quality management – Customer satisfaction – Guidelines for monitoring and measuring.
 
You can purchase these standards at the TechStreet Store.

 

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In the News
Global Employee Confidence in Business Conditions 

The business confidence index, which measures employees’ confidence in near-term business conditions and long-term economic prospects in their industry, registered at the highest levels in five years. In addition, key regions surveyed as part of this report – Asia, North America, Europe, Australia and New Zealand, and Latin America – showed an increase in employee perceptions of job opportunities in their current locations, industries and functions.

For more information, including employee intent to remain in current positions see the Gartner Press Release.

 

ISO 22000:2018 Food Safety Management System   

 

Food safety is about the prevention, elimination and control of foodborne hazards, from the site of production to the point of consumption. Since food safety hazards may be introduced at any stage of the process, every company in the food supply chain must exercise adequate hazard controls. In fact, food safety can only be maintained through the combined efforts of all parties: governments, producers, retailers and end consumers.

Aimed at all organizations in the food and feed industries, regardless of size or sector, ISO 22000:2018, Food safety management systems – Requirements for any organization in the food chain, translates food safety management into a continuously improving process. It takes a precautionary approach to food safety by helping to identify, prevent and reduce food borne hazards in the food and feed chains.

For more information view the ISO.org News.

Training Courses
 
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
 
Don’t see a course or schedule that fits your needs?  Contact us.
 

We have received some interesting feedback from our clients this year on their transition certification audit to the various standards we support. We are finding a variety of interpretations from certification body auditors in regards to requirements of standards, including the application of how the client company meets the requirement, and specific objective evidence reviewed.

Always be aware that if a nonconformance is written against your documentation and/or objective evidence, do ensure that the content of the language used in the write up by the auditor makes absolute sense to you, and your management team.  If not clear and understandable, bring it up immediately during your certification body auditor out brief, conducted at the very end of your audit process.

 

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642
 

 

Promoting Your Certification

Monday, June 4th, 2018

 

This Month

 Events
 

AZTC Aerospace and Manufacturing Conference. June 21, 2018 Phoenix, Arizona.    

      

 

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement

Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems, our services include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard. Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

 

Do You have a Subject of Interest for our Newsletter?  Please let us know.

 

Promoting Your Certification
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Certification to ISO 9001, AS9100, or another recognized global standard is highly useful as a marketing tool. While the main benefit to attaining certification is the improved accountability, efficiency and effectiveness it can bring, it is also a unique selling point and a great way of setting your business apart from your competition and marketplace.

While the general public has become more familiar with ISO standards and certification, a lot of its nuances and potential benefits will be lost on your audience if you don’t take steps to market them properly. Here are four of the do’s and don’ts of promoting your organization’s  certification to keep in mind.

 

Focus On Value
 
Achieving certification to a recognized management system is great, but what does it mean to your current customers, and your potential future customers? Make sure any messaging you put out to market your achievement is focused primarily on how your certification affects those who use your product or service. Here are some ideas:

 

  • Total Quality: Certification is all about repeatable, scalable processes – a certified quality management system ultimately means your customers can expect a more consistent experience every time they work with you. A predictable customer experience.
  • Lower Costs: Certified businesses are more efficient businesses – let your customers know that because you run a more cost-effective operation, you don’t need to cut corners to keep prices competitive.
  • Accountability: Certification also provides tools for addressing problems when they occur. While you don’t want your messaging to focus too heavily on this possibility, let your customers know that being certified by a third-party accredited certification body helps you achieve greater transparency, independent operations review, and supports a more effective communication process.
We understand that the specifics of your business and industry will determine how best to focus your messaging, but the key takeaway is that when promoting your certification, always put the Customer First!
Promote Your Certification in the Appropriate Forums
 
As important as social media is to broader marketing initiatives, its emphasis on short, impactful content means it is probably not the best place to promote your certification on an ongoing basis. Instead, consider white papers, case studies, your company website, and other forums where you can go into depth about the benefits it offers your customers.

When you’re sharing the release of these documents across your social media platforms, however, it’s an appropriate time to utilize hashtags that note your certification. Even if a reader doesn’t proceed with reading the content right away, they’ll see that hashtag and make the connection that your company is certified. You can tag the accredited certification body too, establishing a relationship with the team monitoring that organization’s accounts.

Use Consistent, Appropriate Branding 
 

Each accredited certification body has a unique registration mark or logo, which, with certain restrictions, you are entitled to incorporate into your branding.  For example, the ANSI-ASQ National Accreditation Board (ANAB) carries rules for incorporating their symbol, which vary by your accreditation type. A management systems accreditation, for example, cannot apply the ANAB symbol to any and all documents- only those that pertain to accredited activities.

Some places where you can often apply the logo of an accredited certification body include:
  • Your website
  • Your email signature
  • Your company letterhead
  • Your business card
  • Your building’s signage, front lobby and branded vehicles
  • Trade show or convention advertising

Whatever methods you use to promote your certification, approach it as you do your company marketing efforts. Strategic focus, consistent, and measurable.  Thanks to NQA for their insights towards the content of this article, and often overlooked important subject.

 

Core Processes Create Value
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The current economic upturn and the always expanding  competitive market have created an enhanced awareness on how an organization creates the value needed by its products, markets and customer needs.

Becoming more efficient and effective is much more than eliminating process waste. Internal waste reduction may not be the primary need for an organizations markets or customers, thus waste reduction may not ensure continued sustainability of the organization.

A process management approach can help an organization prevent a narrow view of a business system. The process approach is a set of interrelated or interacting activities, that require specific input resources, monitoring and measurement opportunities (before, during, and after the process), in order to achieve consistent product and service. An organization wanting to improve its economic performance can use the process approach to link improvement to strategic goals.

The following questions is a good place to start:

  • What business are we in?
  • Who are our customers?
  • What do they do, and what do they expect from us (the value)?
  • What do we need to do to meet their unique requirements (capabilities)?
  • What is customer critical and what is less significant?
  • What are the critical core processes that will allow us to meet our specific capabilities?
  • Which core processes do we have, which do we need to create, and which do we need to manage better (process management)?
Let us not forget that the “economic value” or rationale is particularly important. Identifying the critical processes that need to be either created or improved to provide the needed strategic capabilities should drive the overall improvement effort and economic value.

This is the essence of process management-effectiveness of process = ability to achieve desired results, and efficiency of process = results achieved versus resources used.

Identifying the missing gaps and implementing the missing processes can be the quickest way to improve a system. The organization must ensure that process improvements are linked to strategy and core process execution. To be a success, an organization must continuously improve all its essential core processes to provide value and to always satisfy customer requirements.

Contact us for more information on how we can assist your organizational growth with an effective and proven process management approach.

 

Which Method Came First?
project management flow chart or mindmap - a sketch on a napkin with cup of coffee

We recently conducted a large process improvement project for a manufacturing client.  During the project a team member asked “Is Kaizen the same as Lean, and is Six Sigma on its way out?” I remember leading my first Kaizen/Lean project twenty-five years ago and hearing “Is Kaizen replacing TQM?” Not much has changed over the quality improvement timeline. Many enterprises whether service or manufacturing are looking for simplified answers and methods to cost reduction, improved quality and enhanced customer satisfaction.

 

It is not about what’s been around the longest, or some new improvement method you heard about that “everyone is doing.” It is about what your organization is facing today, and what it could be facing tomorrow if you do nothing. Do you have customer dissatisfaction, product returns or service issues, high operating costs? Maybe trying to improve cycle time, service delivery or reduce process waste? These are the type of questions you need to ask to determine what to do, and how to focus your resources to improve profit. 

 

Lean and Six Sigma have become the most widely known methods for creating breakthrough and sustained improvement. Keep in mind that these methods have evolved from previous proven methods created decades ago, which prompts the title of our article even further. 

 

Lean Improvement Through Waste Elimination

 

A lean core principal is based on creating a “pull system” to produce faster, rather than the traditional “push systems” used by most organizations. The goal is to always pull from the customer demand, not push to the customer and sub-optimize your capabilities. A method that started in manufacturing to reduce waste is now used to improve cycle time, and workflow in workplace and department performance, and reduce waste in hospitals, insurance companies, financial services, and nonprofit environments.

 

Value stream mapping is an important tool used in lean. It documents all the tasks (material and information flow) and process metrics (process time, cycle time, inherent costs, barriers) within a system including waste and non-value added activities. An example of a task level metric used in our lean events is called Complete and Accurate (%C&A).This equates to the time the downstream customer can perform the task without having to “CAC” the incoming work:

  • Correct information or material that was supplied
  • Add information that should have been supplied
  • Clarifyinformation that should or could have been clear.
The output metric is measured by the immediate downstream customer and all subsequent downstream customers. This process makes visible the problems or waste so that they can be eliminated, thereby making the processes faster and cheaper to deliver.
 
Creating “value” as seen by the eyes of the customer is the key component to lean. Providing value to the customer is why a supplier exists. Whatever does not provide value to the internal and external customer can be considered as process waste.
 
We will continue this requested and relevant topic in our next newsletter. Stay Tuned!

 

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In the News
Automatic ID and Data Capture Standards

The formation of a new Working Group – “Application of automatic identification and data capture standards.” is underway. As the U.S. member body to ISO, the American National Standards Institute (ANSI) encourages relevant stakeholders to get involved.

 

Automatic identification and data capture (AIDC) technologies are used to identify, record, and store information on billions of items on a global scale-for example, consumer products are tagged using bar coding and radio frequency identification (RFID). Automatic identification and data capture is used to support various industries, including retail, electronics, aerospace, transportation, and across the supply chain used for replenishment, storage, and quality control.
For more information visit the ISO/IEC JTC 1/SC 31 group website here.

 

Secrets of Business Success in New ISO Standard 

The average lifespan of businesses is shrinking, yet some have been around for hundreds of years. How to stay afloat in a rapidly changing world? A newly published standard aims to help.

The freshly published ISO 9004, Quality management – Quality of an organization – Guidance to achieve sustained success, divulges the secrets and strategies of some of the longest lasting businesses around the world to help other organizations prepare for such challenges, optimizing their performance at the same time.

 

ISO 9004 draws on the strategies, best practice and experience of some of the most successful businesses around the world to provide guidance for any business, regardless of size or genre. This includes how to anticipate future challenges and how to achieve a higher level of performance along the way.

The standard is a revised version of ISO 9004:2009, building on previous guidance to help organizations improve their overall performance by releasing the full potential of their quality management system.  It will help organizations move to the next level beyond ISO 9001 (quality management systems) by addressing topics such as the alignment and deployment of strategy, policy and objectives within the broader context of the organization’s vision, mission, values and culture.

We highly recommend the purchase of the new ISO 9004 Quality management – Quality of an organization guidance. For more information visit the ISO Online Browsing Platform Site.

 

Training Courses
 
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
 
Don’t see a course or schedule that fits your needs?  Contact us.
 

 

In a survey conducted by Deloitte, manufacturing employers reported that the most serious skill deficiencies of their current employees are:

* Technology and computer skills (70 percent)
* Problem-solving skills at (69 percent)
* Basic technical training at (67 percent)
* Math skills at (60 percent)

ISO 9001:2015 7.1.6 Organizational Knowledge states: When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.  Training will  always be an evolving need for all organizations – What are you doing to improve your employee skills and knowledge?

 

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642
 

 

ISO 31000:2018 Risk Management

Tuesday, May 1st, 2018

 

This Month

 Events
 

AZTC Aerospace and Manufacturing Conference. June 21, 2018 Phoenix, Arizona.    

      

 

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement

Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems, our services include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard. Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

 

Do You have a Subject of Interest for our Newsletter?  Please let us know. 

 

ISO 31000:2018 Risk Management
risk management flow chart drawn by hand isolated on blackboard

 

With all the management system standard transition activities occurring around the globe, the introduction of the newly revised ISO 31000:2018 Risk Management-Guidelines release is timely and appropriate.

The latest version delivers a clearer, shorter and more concise guide that will help organizations use risk management principles to improve planning and make better decisions. ISO 31000 is the document you will find referenced in, for example the ISO 9001:2015 Standard that can be used to create a formal documented risk management process; which we highly recommend and all our clients have completed.

 

Risk enters every decision in life, but clearly some decisions need a structured approach. For example, a manufacturing company may need to make risk judgements associated with a very complex customer requirements need. Dealing with risk can be integral for  ensuring delivery of product quality, and is fundamental to how an organization is managed at all levels.

 

The following are the main changes of ISO 31000 since the previous edition:
  • Review of the principles of risk management, which are the key criteria for its success;
  • Focus on leadership by top management who should ensure that risk management is integrated into all organizational activities, starting with the governance of the organization;
  • Greater emphasis on the iterative nature of risk management, drawing on new experiences, knowledge and analysis for the revision of process elements, actions and controls at each stage of the process;
  • Streamlining of the content with greater focus on sustaining an open systems model that regularly exchanges feedback with its external environment to fit multiple needs and contexts.
Each section of the standard was reviewed in the spirit of clarity, using simpler language to facilitate understanding and make it accessible to all stakeholders. The 2018 version places a greater focus on creating and protecting value as the key driver of risk management and features other related principles such as continual improvement, the inclusion of stakeholders, being customized to the organization and consideration of human and cultural factors.

 

Jason Brown, Chair of technical committee ISO/TC 262 on risk management that developed the standard, says: ISO 31000 provides a risk management framework that supports all activities, including decision making across all levels of the organization. The ISO 31000 framework and its processes should be integrated with management systems to ensure consistency and the effectiveness of management control across all areas of the organization.” This would include strategy and planning, organizational resilience, IT, corporate governance, HR, compliance, quality, health and safety, business continuity, crisis management and security.

 

We do recommend that you consider purchasing this effective risk management guideline. It can be purchased here through the ANSI Web Store.

 

Advanced Manufacturing Trends
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Within the manufacturing industry and service industry there will always be a relentless pursuit of a reduction in speed, cost and agility while maintaining quality. With this I mind, the industry’s landscape continues to quickly change as new technologies enter the market, new strategies are adopted, and consumer preferences continually evolve.

Below are a few of the current trends to watch in the advanced manufacturing arena.

 

Global Market Insights predicts that the 3D scanning market will be worth more than $10 billion by 2024 and will continue to transform the design-to-manufacturing process. It will become a vital piece of technology for manufacturing companies looking for accurate and precise ways to inspect and measure products and parts for quality control purposes.

The medical, automotive, and aerospace industries are all driving the use of 3D scanning for quality control because these sectors demand perfection and the technology can easily detect even the smallest of imperfections. Using metrology tools like 3D scanning can save time and money and have proven to increase accuracy. In a market with stiff competition, minimizing mistakes is vital for client retention.

Although Artificial Intelligence (AI) may frighten some people, it is here to stay. In manufacturing, humans will always be needed because a robot can’t solve problems the way a human can, especially when it comes to the creative process of designing. On the other hand, the use of AI can be helpful for more repetitive, tedious tasks and for aiding in the design process.

 

AI can also be extremely beneficial for complicated designs. Take, for example, designing an airplane with more than 300,000 parts. It’s imperative that every piece fits together perfectly, down to the last bolt. Using AI technology in the design process takes away a lot of the guesswork and tedium involved in measuring not only individual components but also complex assemblies.

Product life spans are getting shorter and the time to market is decreasing. Product developers are moving away from mass production and toward low-volume manufacturing, which encompasses the production of 50 to 100,000 parts. Many companies are enjoying a wide array of benefits when choosing the adoption of low-volume manufacturing. 

The idea of rapid prototyping and low-volume production runs as part of its supply chain is growing in appeal. This allows a company to make last-minute decisions regarding, for example color and other attributes of its products. This strategy allows manufacturers to fine tune a product to more closely match market trends just before a product’s release, and target a certain design that are regionally specific to local tastes.

These three trends promise improvements in accuracy, speed, and design flexibility for the manufacturing industry. It’ll be interesting to see these innovations mature in the marketplace.

 

ISO 9004-Managing for Sustained Success
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ISO 9001:2015 provides a framework for a systematic approach to managing an organization’s processes so that their products or services are consistent and meet client expectations. 

 

ISO 9004:2018 is intended to help organizations extend the benefits of their quality management system (QMS) to all interested parties, helping to give sustained success.

 

In communicating the difference between the two, we have always stated with our clients, and in our training courses that ISO 9004 provides insight into how organizations can take their operational and quality management system to the next level.

 

ISO 9004:2018 Guidance to Achieve Sustained Success is a document which provides a self-assessment tool to review the extent to which the organization has adopted the concepts in this document. This document is applicable to any organization, regardless of its size, type and activity. Factors affecting an organization’s success continually emerge, evolve, increase or diminish over the years, and adapting to these changes is important for sustained success. Examples include social responsibility, environmental and cultural factors, in addition to those that might have been previously considered, such as efficiency, quality and agility; taken together, these factors are part of the organization’s context.

 

Subsequent clauses provide examples that go beyond traditional quality guidance. The effect is a highly impactful document that offers answers to questions about how an organization can grow and grow and achieve success.

 

For example, for organizations still struggling with context,  ISO 9004:2018 combines the interactions of interested parties and internal and external forces in an expanded list of market and operational possibilities that many organizations may find very helpful.

 

ISO 9004:2018 is the fourth edition of the standard for achieving sustained success, and it cancels and replaces the 2009 version of the same document. This standard update was necessary due to the need to include a few key concepts, and it was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee 2, Quality systems.
 
You can purchase ISO 9004:2018 through the ANSI Web Store.

 

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In the News
Employees Going Above and Beyond at Work at All-Time Low

Employee performance and effort are now at the lowest levels seen since 2010, according to CEB, now Gartner. In Q4 2017, 19.7 percent of U.S. employees said that they have a high willingness to go above and beyond their job expectations, significantly down from the 24 percent of employees who indicated that level of job effort in Q3 2017.

Employee surveys conducted to develop the recent Global Talent Monitor report signified that this drop in workforce discretionary effort is based on a combination of factors, including U.S. employees’ impressions that there are few opportunities to grow within their current positions, a widening wage gap between company executives and the average worker, absence of notable raises and bonuses, and the lack of rewards or outcomes from the work employees have already invested into the organization.

 

Click Here to read the complete Gartner Press Release.

 

The International Auditor Symposium  

Exemplar Global is delivering an online auditor event from May 7 to 18, 24 hours a day, seven days a week from wherever you are located. Register for the IAS 2018 today to learn the key differences between ISO 9001:2015 and ISO 9001:2008-including what you need to know about the transition-and the latest information about IATF 18949, AS9100, and TL 9000.

For more information and registration, visit the IAS 2018 Website.

 

Training Courses
 
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
 
Don’t see a course or schedule that fits your needs?  Contact us.
 

Many of us are want to increase our productivity within our careers. Can you be more productive? Why aren’t you being more productive?

A recent study was conducted with interesting results of (1) Know your best working hours, (2) Visualize your goals and expected outcomes, (3) Set out your daily goals, (4) Choose a playlist of music favorites, (5) Use nature to improve your focus, and (6) Choose snacks that improve your brain focus.

Here’s to a Successful Continued Productivity Year!

 

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642
 

 

Identifying Process Nonconformity

Saturday, February 3rd, 2018

 

This Month

 Events
 
PMI Tucson “5S” Pillars of a Lean Workplace. Feb 13, 2018. Walter Tighe Presenter    
 
Lean and Six Sigma Conference
February 26-27, 2018 Phoenix, AZ
 
ISO 9001 World Conference April 4-6, 2018 Las Vegas, NV  


Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement

Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems, our services include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard, and others. Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.
Do You have a Subject of Interest for our Newsletter?  Please let us know.

 

ATTENTION Transitioning Organizations: Time is running out! The New Year is here and you have just a few months left to transition to your business requirements new standard. Contact us now for all your gap assessment, onsite training, documentation development and internal audit needs.     

Identifying Process Nonconformity

With all the management system transitioning activities occurring around the globe we thought this is a very appropriate time to discuss what every transitioning company should effectively be doing – Internal Audits.

 
The focus of any management system audit is to determine if the management system has been developed, is effectively implemented and is being maintained. An organization becomes certified on the basis that it has effectively implemented a management system that conforms to the requirements of ISO 9001, AS9100, ISO 13485, or any other global management system. 
 

Internal auditors should maintain a positive approach and look for the facts, not faults. However, when the audit evidence determines that there is a nonconformity, then it is important that the nonconformity is documented and correctly. What is a nonconformity?

According to the definition in ISO 9000 a nonconformity is “non-fulfillment of a requirement”. There are three parts to a well-documented nonconformity:
  • the audit evidence to support auditor findings;
  • a record of the requirement against which the nonconformity is detected;
  • the statement of nonconformity.
While all of these need to be addressed, in actual practice, it is the audit evidence that is the first part to be identified and  documented. This is because a competent auditor will observe situations that they feel may be a potential nonconformity during an audit, even though it may not be 100 percent certain at that point in time.

If there is no audit evidence – there is no nonconformity. If there is evidence – it must be documented as a nonconformity.  Take caution of being, what is referred to as “soft auditing”. Another classification, e.g. “observations”, “opportunities for improvement”,  and “recommendations” can be useful, but only use appropriately.

The audit evidence should be documented and be sufficiently detailed, to enable the audited organization to find and confirm exactly what the auditor observed.
The next step the auditor will need to take is to identify and record the specific requirement that is not being met. Remember, a nonconformity is non-fulfillment of a requirement, so if the auditor cannot identify a requirement, then the auditor cannot raise a nonconformity.

The final (and most important) part of documenting a nonconformity is the writing of a statement of nonconformity.

The statement of nonconformity drives the cause analysis, correction and corrective action by the organization, so it needs to be precise.  The statement of nonconformity should be easily understood and interpretation properly, and be related to the system issue.

The following is a 4 step process we use and is very effective. It is also a topic of exercise during all our process based internal auditor training courses:
  1. Source of requirement (e.g. procedure ref., quality manual ref., clause of standard, position of person responsible who has made an oral statement of requirements, etc.)
  2. The specific requirement (e.g. relevant excerpt of procedure, quality manual, clause of standard, content of oral statement, etc.)
  3. Source of the evidence which conflicts with the requirement (e.g. identity of record(s), process identity, position of person responsible providing an oral statement of requirements, etc.)
  4. The actual evidence which conflicts with the requirements (e.g. relevant excerpt of record(s), examples off process, content of oral statement, etc.)

 

If all four of these parts of the nonconformity are well documented, the auditee, or any other knowledgeable person, will be always be able to read and understand the nonconformity.

In order to provide traceability, facilitate progress reviews, and evidence of completion of corrective actions and its effectiveness, it is essential that nonconformities are recorded and documented in a systematic manner.  Similar to internal root cause analysis methods also used.

Interested in more information on this process?

Seeking improved performance on your company internal audit system and nonconformity effectiveness? Register for our Process Based Internal Auditor training – onsite or classroom. Contact us, we are here to support your future management system transition training and business improvement needs.

 

Process Nonconformity Review

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In reviewing the response of a process to a nonconformity, the auditor should confirm that documented information and objective evidence for all three parts (correction, analysis of the cause, and corrective action) are provided by the organization, and are appropriate, before accepting the response. Important elements to verify in the review of process nonconformity include: 

  • statements of actions; are they clear and concise?
  • descriptions of actions; are they thorough and do they accurately reference specific documents, procedures etc., as appropriate?
  • the use of the past tense (was, has or have been, were), as an indicator that the actions taken have been completed.
  • the date of completion of the corrective actions; past dates should be found that indicate that the actions have been taken (dates indicating future action are not good practice).
  • evidence supporting the claim that a corrective action has been fully and effectively implemented and that the corrective action has been performed in the way that it was described. This is the most overlooked and weakest link of many nonconformance issues. 

Additionally, the auditor should verify that the organization has ensured that the corrective action taken does not itself create further problems relating to product or service quality, or to implementation of the QMS. Effective corrective action should prevent the recurrence of the nonconformity, by eliminating the root cause.

Analysis of the causes of detected nonconformities may identify potential nonconformities on a wider scale in other areas of the organization and provide input for planning based on risk based thinking. Another reason why communication of nonconformities should be shared throughout the organization – think management review.

Closing nonconformities:  As nonconformities tend to be individual in their nature, a variety of methods or activities may be used to demonstrate the effectiveness of actions taken. For example, some will require direct examination on site (which may require the need for additional site visits), while others may be closed-off remotely (by review of submitted documentary evidence).

 

Before deciding to agree to close a nonconformity, an auditor should review what the organization did in respect of containment, correction, cause analysis and corrective action results. The auditor needs to ensure that there is objective evidence (including supporting documentation) to demonstrate that the described corrective action has been fully implemented and is effective in preventing the nonconformity from re-occurring. Only once the situation is satisfactory, should the nonconformity be closed, and shared within the organization.

 

Top Predictions for Global Manufacturing
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By 2020, 60% of manufacturers will rely on digital platforms which will support as much as 30% of their overall revenue.

 
Industry Week recently published  report, “IDC FutureScape: Worldwide Manufacturing Predictions 2018,”  surveying the global manufacturing landscape.  When creating its predictions the firm examined ecosystems and experiences, greater intelligence in operational assets and processes, data capitalization, the convergence of information technology (IT) and operations.

Technologies that will have the greatest impact include cloud, mobile, big data and analytics, and internet of things (IoT). Manufacturers also have high expectations for the business value of technologies that are in earlier stages of adoption, such as robotics, cognitive computing/artificial intelligence (AI), 3D printing, augmented reality/virtual reality (AR/VR), and even blockchain.

Over the next few years, IDC identified some of the most notable changes in the industry:
  • Redefining how businesses design (or define), deliver and monetize products and services
  • Developing new contextualized and customized experiences for customers, employees and partners
  • Increasing coordination and collaboration between IT and line-of-business organizations, as well as among ecosystem participants
  • Changing the nature of work and how it’s accomplished with people, process, and technology coming together.
While the predictions offered largely focus on the near- to midterm (2018-2021), the impact of many of these will be felt for years to come.  
 
For more information on IDC’s worldwide manufacturing 2018 predictions and beyond you can read the full report located here.

 

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In the News
Sustainability in the Automotive Supply Chain

Updated document provides guidance to automotive supplier partners concerning the latest industry expectations in sustainability.

The Automotive Industry Action Group (AIAG) and Drive Sustainability today announced an updated version of the “Automotive Industry Guiding Principles to Enhance Sustainability Performance in the Supply Chain.” This collaboration between AIAG, Drive Sustainability and key automotive organizations provides guidance to our valued supplier partners concerning the latest industry expectations. Additionally, a supplementary reference document was created to provide further explanation and examples for the updated principles.

Free online courses and assessments along with additional options for AIAG members can be accessed. Click here  to read more information and to access the document.

 

ISO 45001 Occupational Health and Safety Standard  

Over 7,600 people die each day from work-related accidents or diseases – that’s over 2.78 million every year.

The burden of occupational injuries and diseases is significant, both for employers and the wider economy, resulting in losses from early retirements, staff absence and rising insurance premiums.

To combat the problem, ISO is developing a new standard, ISO 45001, Occupational health and safety management systems – Requirements, that will help organizations reduce this burden by providing a framework to improve employee safety, reduce workplace risks and create better, safer working conditions, all over the world.

The standard has been developed by a committee of occupational health and safety experts, and will follow other generic management system approaches such as ISO 14001 and ISO 9001.  It is scheduled to be released in March 2018.

 

Training Courses
 
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
 
Don’t see a course or schedule that fits your needs?  Contact us.
 

Many of us are want to increase our productivity within our careers. Can you be more productive? Why aren’t you being more productive?

A recent study was conducted with interesting results of (1) Know your best working hours, (2) Visualize your goals and expected outcomes, (3) Set out your daily goals, (4) Choose a playlist of music favorites, (5) Use nature to improve your focus, and (6) Choose snacks that improve your brain focus.
Here’s to a Successful Productivity Year!

 

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642
 

 

Rising Growth and Challenges

Monday, January 1st, 2018

 

This Month

 Events
 
Lean and Six Sigma Conference
February 26-27, 2018 Phoenix, AZ
 
ISO 9001 World Conference April 4-6, 2018 Las Vegas, NV  
 
 


Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement

Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems, our services include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard, and others. Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

 

Do You have a Subject of Interest for our Newsletter?  Please let us know.

 

ATTENTION ISO 9001 and AS9100 Organizations: Time is running out! The New Year is here and you have just a few months left to transition to the new standard. Contact us now for all your gap assessment, onsite training, documentation development and internal audit needs.     

Rising Growth and Challenges
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The aviation, space, and defense industries continue to demonstrate exponential growth potential and a long-term forecast for success.  Aerospace is poised to be the next gigantic market opportunity for manufacturers and service providers. Demand for increased efficiency, security, quality, and durability has taken off in recent years, resulting in high margins and operating profits.

Arizona our home state, has more than 1,200 aerospace and defense companies.  According to a 2016 study by the International Trade Administration, a nearly $400 million increase in aircraft, engines and parts exports in Arizona has taken place since previous years. Although consistently rising demand is good for business, it also manifests some challenges for all aviation, space, and defense manufacturers.

 

We recently attended an informative webinar from Intertek on this subject, and wanted to share this information as a relevant topic for many of our industry client companies and readers.  

 

The Challenges

First, there are just too many parts for an aviation company to produce themselves. The average aircraft possesses 1.2 million to 3 million components, while wide body aircraft require even more parts. Simultaneously, stringent aerospace requirements are calling for faster, more efficient aircraft with smaller bodies. As a result, aerospace companies must account for every one of these parts, ensuring that they meet the strict delivery and manufacturing requirements set in place.

Despite the overwhelming production backlog, the demand for aircraft is perpetually rising. In response, aviation, space, and defense companies are seeking to identify high-quality suppliers to build global partnerships for the next century.

Vast numbers of qualified original equipment manufacturers (OEMs) and first tier suppliers exist; however, these suppliers often operate within different industries and are not certified to produce and sell aerospace parts. Whether they realize it or not, many of these companies are standing at the threshold of the aviation, space, and defense industry.

 

Second, limitations in production pose a huge challenge for aerospace companies in that many OEMs across industries are only certified to ISO 9001. Although ISO 9001 is a strong indicator of quality excellence, it is not advanced enough to match aerospace guidelines. However, ISO 9001 is the foundation for AS9100. OEMs and other suppliers already certified to the ISO 9001 quality management system can address the further requirements and meet the minimum requirements for doing business as aerospace suppliers.

Aviation, space, and defense companies don’t only want external suppliers; they need them. From parts and services to electronic components, protective materials, and onboard equipment, there is no shortage of ways to enter this industry.

Defense organizations are intensifying their efforts to eliminate security threats. Space exploration projects are no longer exclusive to the government. Private space companies with immense capital are emerging and competing with NASA. Change in the industry has caused the aerospace requirements in regards to the AS9100 standard to be more cohesive with ISO 9001, and to make the transition easier for potential suppliers.

 

Trillions of dollars in aircraft backlog has generated opportunities that were not necessarily as accessible to external OEMs and suppliers. Heavy reliance on safety, ingenuity, and efficiency has generated a push for continual improvement within these industries, which has opened a floodgate of demand from individuals, private companies, and government organizations.

 

We have recently found that a number of our ISO 9001 clients have taken the journey to AS9100 to expand business opportunities and revenue growth. Acting on this opportunity before the competition can will give you the advantage of tapping into this global network and reaching your business goals.

Looking for information on the differences between ISO 9001:2015 and AS9100D:2016?  Interested in training or system development to AS9100D? Contact us with your questions and to discuss your services needs.

Evidence for Risk Compliance

Close up on a file tab with the word ISO 9001 focus on the main text and blur effect. Concept image for illustration of Quality Standards
 

One of the many questions we are asked working with our clients regarding their management system transition, or new development process is: What types of evidence can we use to demonstrate effective risk compliance for certification?    

 
Identifying what the particular risk is to the business can be challenging. This includes what actions are used to mitigate the risks, in addition showing how the results (evidence) are monitored.   
 
Examples of evidence that could confirm compliance  effectiveness could include:  

Number of complaints for this year and last year;

  • Have these been categorized correctly?
  • Have the numbers increased or decreased?
  • Has previous improvements had an impact?
Further examples asking the same questions above could include;
  • Number of audit findings between this year and last?
  • Number of product nonconformities between this year and last?
Number of service provider issues for this year and last year?
  • Increase in business between this year and last?
  • Is this in new clients, or is there an increase in new clients?  
Requirements from regulatory bodies; 
  • Is there any monitoring that is required associated with your company activities?
  • Is there evidence that agreements are being adhered to?

 

Typical types of evidence can include:
  • Results from surveys of companies who use their services
  • Complaints and feedback from companies who use their services
  • Staff surveys and feedback

 

Monitoring and measurement can include reviews of:

  • Services
  • Complaints
  • Audits
  • Comparative information
  • Risk assessments
  • Reporting and learning from incidents
  • Information from regulators, inspections or accreditation schemes
  • Action plans and monitoring improvements.

 

To understand what’s required, the particular clause in the  ISO 9001:2015 standard states: 
6.1 Actions to address risks and opportunities
 

6.1.1. When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:
 
a) give assurance that the quality management system can achieve its intended result(s)
b) enhance desirable effects;

c) prevent, or reduce, undesired effects
d) achieve improvement.
 

6.1.2 The organization shall plan:

a) actions to address the risks and opportunities;
b) How to
1.  Integrate and implement the actions into its quality management system processes;
2.  Evaluate the effectiveness of these actions.   

 

Health and Safety Standard
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March 2013 saw the initial proposal stage for the ISO aligned Health & Safety Standard and with an expected final publication date of March 2018 it has been a long time coming but we are nearing the home stretch. 

Health & safety professionals and organizations all over the world have been eagerly awaiting the publication of the final draft.

 
ISO 45001 Standard (International standard for health & safety management systems) and the final approval stage is now available to see with only very minor changes expected to come out. 

ISO 45001 will be replacing OHSAS 18001 and organizations currently certified to OHSAS 18001 are expected to have the typical three year period in which to migrate over to ISO 45001. The new standard is intended to be applicable to any organization irrespective of size, type and nature and all of its requirements are designed to be integrated into a business’s own pre-existing management processes.

The new standard has been designed to help companies achieve the following:
  • Identify workplace hazards and implement effective preventive controls
  • Prevent injury and ill-health among your workforce
  • Reduce lost time accidents therefore cost saving
  • Evaluation of  compliance with legislative requirements
  •  Improves the safety culture
  • Identify areas for training and competency requirements
  • Improve productivity
  • Assist with pre-qualification processes from your customers
  • Promote corporate responsibility  

 

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In the News
Just Released: ISO/IEC 17025:2017  

 
The ISO/IEC 17025:2017 GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATORIES has been updated, taking into account the latest changes in laboratory environment and work practices.

What are the main changes?

 

  • The scope has been revised to cover testing, calibration and sampling associated with subsequent calibration and testing
  • The process approach matches that of new standards such as ISO 9001, ISO 15189 and ISO/IEC 17021-1
  • The standard has now a stronger focus on information technologies and incorporates the use of computer Risk Management New Version Ahead
  • Systems, electronic records and the production of electronic results and reporting
  • A new chapter introduces the concept of risk-based thinking.

 

For more information and to purchase ISO/IEC 17025:2017, see the ANSI Website.

 

Year 2018 Challenge – Shortage of Skilled Workers

For the first time since 2013, the shortage of skilled workers overtakes the economy as the greatest hurdle manufacturers anticipate facing in the year ahead, according to the ASQ 2018 Manufacturing Outlook Survey.

According to the survey, 41 percent of manufacturers say finding skilled workers will be the No. 1 challenge in 2018, compared to 30 percent who say the economy will be their biggest hurdle.

More than 650 manufacturing professionals responded to ASQ’s 2018 Manufacturing Outlook Survey, which was conducted online in October and November 2017. Respondents represent a multitude of industries, including automotive, medical device, aerospace, and oil and gas.

For more information on this survey, visit the ASQ Website.

 

Training Courses
 
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
 
Don’t see a course or schedule that fits your needs?  Contact us.
 

Another new year is upon us. Will it be more of the same for you?

 
Think big for a change! The really positive thinker can achieve the impossible. It’s called a quantum leap. Give the following some thought…

 

  • You don’t have to be content with improving things gradually or incrementally.
  • Focus on the ends, not the means. You don’t have to know how you’re going to get there, only where you want to go.
  • There’s no gain without pain. The road will be bumpy.
  • Be aware of your comfort zones. If you’re comfortable, you’re not stretching yourself.
Ask yourself: What were some of the things I did this year that were non-productive; things that, given another chance, I wouldn’t do? What will I commit to doing differently in 2018?

 

Here’s to a Successful New Year!

 

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642
 

 

Establishing a Mature Quality Culture

Friday, December 1st, 2017

 

This Month

 Events
 
Lean and Six Sigma Conference
February 26-27, 2018 Phoenix, AZ  
 
 


Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement

Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems, our services include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard, and others. Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.
Do You have a Subject of Interest for our Newsletter?  Please let us know.

 

ATTENTION ISO 9001 and AS9100 Organizations: Time is running out! The New Year is approaching and you have just a few months left to transition to the new standard. Contact us now for all your gap assessment, onsite training, documentation development and internal audit needs.     

Establishing a Mature Quality Culture
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As the new year approaches, it may be time for your organization to do a review of your current quality culture. No matter where your organization is on the journey, breaking down old habits and gaining sustainable long term growth requires hard work, including a long-term change outlook.

According to Eric Stoop, a contributing writer to Quality Progress the following are the most important habits of a mature quality culture. These are valuable points, and we have added a few of our own thoughts and insights to this topic.    

 

1. Walking the talk on quality
 
It’s a mistake to think aspirational messages like “quality first” are enough to lead your organization to a quality culture. Change is only possible when leaders are engaged at every level, consistently demonstrating quality principles in action, including and a consistently applied message; beyond for example, “What’s our quality policy?”
In practical terms, this means leaders must:

* Make frequent and highly visible appearances on the plant floor. Understand the department objectives and their outputs.  
* Be curious and engage in nonjudgmental conversations about quality. What does quality mean and how do you demonstrate it?
* Roll up their sleeves to help when necessary. As a prior Quality Manager, I remember sweeping the work center floor during Kaizen events and being asked by a senior manager “Why are you doing that?”
* Avoid behavior that puts cost, output, or schedule above quality. If you say quality is the top priority, but your actions indicate otherwise, your credibility is lost.

 

2. Energizing your team
 
Not everyone is going to be excited about quality or having additional work. Yet, in a mature quality culture, leaders find ways to energize the team and get people on board.
 
Strategies include:

 * Harnessing the competitive spirit: Instead of discussing how quality drives savings, tap into people’s competitive nature. Talk about blowing the competition away, or saving the company from failure in a mission-critical product launch.
Making quality personal: Connect your team’s work to the bigger picture. Is it protecting driver safety? Defending national security? Contributing to our soldiers in the field? The last thing you want is people thinking they just make a widget.
* Sharing expectations and results: Everyone needs to know his or her role in improving quality. Just as important, people need to see the results. Scorecards are a key tool in showing people their work has a measurable impact. Sharing process information with the workforce and allowing the workforce to improve their processes is vital to a sustained quality culture.

 

3. Focusing on processes
 
Across all industries, a culture of quality demands a proactive approach aimed at preventing problems rather than putting out fires. That’s difficult when quality people only conduct rear-facing product inspections, which is why mature quality cultures look at upstream processes.
 
Organizations that continuously review core and high-risk processes before errors lead to defects are proactive. Checking and rechecking areas linked to previous quality, customer and safety issues fosters process standardization and reduces variation. This consistency is a hallmark of a sustained quality culture.

 

4. Monitoring and measurement

 
Mature quality cultures invest time and resources into proactive monitoring and measurement. It sounds obvious, yet according to studies only one in three companies track the cost of quality, one of the most important operational metrics.
 
Beyond just looking at failure costs, mature organizations develop leading indicators that provide early warning of problems. For example, analyzing your process metrics and internal audit data might reveal correlations between:

 * Audit completion rates and defective parts  
* Time to closure for corrective action, time to effective resolution for customer, and significant quality escapes
* Number of annual audits and customer returns.  Process or product errors and internal audit results.  
Your metrics will be unique to your organization, but the goal is the same. When you see leading indicators slipping, you must take action before customers are affected.

 

5. Encouraging openness
 
When you look at companies with mature quality cultures, you’ll see they don’t shy away from problems.
They know that finding problems before they leave the plant is far better than having the customer discover them.
How do you create a culture of openness?

 * Staying calm when you discover mistakes: If you fly off the handle, people will hide problems from you.
* Involving management: Having leadership participate in internal audits (and becoming trained internal auditors) shows a commitment to quality at the highest level. That inspires people to open up with their own observations and improvement suggestions.
* Quickly resolving problems: When someone identifies an issue, or a suggestion for improvement you follow up with timely corrective or preventive action. Otherwise, people see no point in sharing.

 

Companies that treat quality as a cost instead of an investment are penny-wise and pound-foolish. Conversely, mature quality cultures give their teams the time and budget to pursue quality improvement projects. That may mean cutting back the red tape, but it can also lead to huge breakthroughs.
 
Mature companies reward these successes with recognition and even financial incentives. When employees are taking the initiative to pour their energy into these projects, your quality culture will become the new business as usual.  You will move beyond projects and become a world class organization.  

For more information – According to Harvard Business Reviewless than half of employees say their organization exhibits a culture of quality.  

 

Q&A ISO 9001:2015 Webinar

 

Since the ISO 9001:2015 Standard was published, Certification Bodies have conducted a number of webinars on the subject.

 
One of the largest certification bodies in the world-NQA, recently conducted this webinar.  As a member company of the NQA Associate Consultant Register, we want to share some of this valuable information that was passed on to webinar attendees. 
 
IF YOU DISCLAIMED CLAUSE 7.3 OF THE OLD STANDARD, CAN WE DO THE SAME WITH THE NEW STANDARD?
 
All references to “exclusions” in ISO 9001:2008 sub-clause 1.2 “Application” have been removed. This is because all of the requirements in ISO 9001:2015 are intended to be applicable to all Organizations and any products and services. 

However, ISO 9001:2015, Annex A.5 recognizes that there may be circumstances where it is impossible for an Organization to conform to a specific requirement – for example, where it does not operate a “required” process.

 
In the case of claiming Clause 7.3 – Design and Development as an exclusion against the ISO 9001:2008, this can still be claimed as not applicable against the ISO 9001:2015 Standard under Clause 8.3 as long as it is justified accordingly.

 

IF YOU DON’T DOCUMENT YOUR INTERESTED PARTIES, HOW CAN YOU PROVIDE OBJECTIVE EVIDENCE THAT YOU HAVE REVIEWED IT?
 
The easiest way to provide objective evidence that you have reviewed your particular Interested Parties is to document the discussion within the minutes taken during your formal Management Review meetings.  Having already produced a documented list of typical Interested Parties and their needs and expectations allows a focus for subsequent meetings.
 
There is nothing within the 2015 Standard which prevents you from just adding a “last reviewed date” to the documented list of Interested Parties which coincides with the date of the last Management Review meeting to confirm this approach.

HOW DO YOU REVIEW RISK IN A MANAGEMENT REVIEW?

One suggested way is to create a Risk Register which lists and prioritizes all the identified Risks i.e. Business, Process, Product, Service, Internal, External etc.  Once this Register has been established and internally sanctioned by Top Management, the same Register can be used to review the current status during each subsequent Management Review.

WILL AUDITORS BE LOOKING FOR FORMAL TRAINING AS AN AUDITOR TO THE NEW STANDARD?

The requirements of the 2015 Standard is a significant enhancement of what was the requirements of the 2008 Standard therefore it is highly recommended that existing Internal Auditors undertake some form of conversion training.  ISO 19011 states that, in terms of determining Auditor competence; Auditors should possess the knowledge and skills necessary to achieve the intended results of the audits they are expected to perform.

ISO 9001 and 14001 – 2015 CB Audits
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A notice from the International Accreditation Forum (IAF) that an official resolution has been reached regarding audits performed to ISO 9001:2008 and ISO 14001:2004.

A key aspect of this resolution was the following mandate:

“Effective March 15, 2018, all audits performed to ISO 9001 or ISO 14001 must be performed to the 2015 revision.”

  

As the three-year transition for ISO 9001 and ISO 14001 moves into its final year, IAF (the global association for developing the principles and practices for the conduct of conformity assessment) has passed a resolution that as of 15 March 2018, conformity assessment bodies must conduct all ISO 9001 and ISO 14001 initial, surveillance and recertification audits to the new versions – ISO 9001:2015 and ISO 14001:2015.

Any organizations who need to move to the new version of ISO 9001 and ISO 14001 should contact their conformity assessment body as soon as possible to make arrangements for their audit.

  
This resolution does not mandate that your transition audit to either standard be performed prior to March 15, 2018, only that the older revision will no longer be available after that date.

Note that failure to achieve certification to the 2015 standard by the deadline means that your certification is no longer valid and this may affect your ability to supply to all markets.

 

A copy of this resolution can be obtained from the IAF Here.

 

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In the News
ISO 45001 OHS Standard Update  

 
ISO 45001 Occupational health and safety management systems-Requirements with guidance for use-should be approved early next year and standards such as OHSAS 18001 and AS/NZS 4801 will be phased out over the following three years. However, this new standard shouldn’t be treated as the same as the standards that preceded it. Top management should start thinking about the changes ISO 45001 will mean for them.

ISO 45001 introduces a requirement to “maintain knowledge and understanding of its compliance status with legal and other requirements,” which is a new obligation as OHSAS 18001 only requires periodic evaluations. This in itself may be challenging for organizations that only perform this activity periodically. 

 

Risk Management New Version Ahead    

A new version of ISO 31000 is due to be unveiled early next year. As the threat of risk grows for governments, organizations, and the public alike, how can the new, streamlined standard help make our future more secure?

To meet this wide array of new challenges, organizations, big and small, around the world, have realized the importance of integrating risk management into their business strategy. Accordingly, the general scope of ISO 31000 – the first-born in the family of risk management standards – was not developed for a particular industry group, management system or subject matter field, but rather to provide best-practice structure and guidance to all operations concerned with risk management.

For more information on ISO 31000, see the ISO Website.

Training Courses
 
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
 
Don’t see a course or schedule that fits your needs?  Contact us.
 

Another new year is upon us. Will it be more of the same for you?

 
Think big for a change! The really positive thinker can achieve the impossible. It’s called a quantum leap. Give the following some thought…

 

  • You don’t have to be content with improving things gradually or incrementally. 
  • Focus on the ends, not the means. You don’t have to know how you’re going to get there, only where you want to go.
  • There’s no gain without pain. The road will be bumpy.
  • Be aware of your comfort zones. If you’re comfortable, you’re not stretching yourself.
Ask yourself: What were some of the things I did this year that were non-productive; things that, given another chance, I wouldn’t do? What will I commit to doing differently in 2018?

 

Happy Holidays!

Walter Tighe and SES Team  
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642
 

 

Organizational Risk Management

Sunday, October 1st, 2017

 

This Month

 Events
 
AZTC Southern Arizona Tech and Business Expo 
October 25, 2017 Tucson, AZ  
 
Baldrige Fall 2017 Conference October 26-27 Tempe, AZ  
 


Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement

Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard, and others. Further subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do You have a Subject of Interest for our Newsletter?  Please let us know.

 

ATTENTION ISO 9001 and AS9100 Organizations: Time is running out! You have less than 1 year to transition to the new standard. Contact us for all your transition needs.    

Organizational Risk Management

Risk based thinking (RBT) is one of the most substantial changes to ISO management system standards in many years. It is a clearly-bounded methodology approach that distributes risk across the full scope of a management system as an integrated business function. The International Organization for Standardization (ISO) has this to say on RBT:

“Risk based thinking ensures these risks are identified, considered and controlled throughout the design and use of the quality management system”.

Although the function of risk based thinking is to manage risk at various critical stages and relationships with your products and services, the true purpose of risk based thinking is more than just creating a systematic, precautionary approach for your organization.

Instead, you should look at risk based thinking as a form of acquiring and maintaining organizational knowledge. This is important because a badly managed organizational system is immediately apparent to users, customers and investors, who often look for so much from you than just your certification status. This is one of the reasons why risk based thinking features so heavily in updated standards like ISO 9001:2015 and ISO 14001:2015, and the highly anticipated future ISO 45001 Health and safety management system standard.

Faulty-managed organizational risk can start when an organization designs a purely linear process for risk management. This is appropriate and to some extent logical during the implementation of a new management system, but once the management system becomes established it can become a considerable burden, and sub-optimization takes place

During the implementation process risks are considered and managed through a series of periodic fixes – as opposed to an iterative process. Systems like this suffer from a lack of agility and can become predictable non-value added activity.

In order for the organization to learn about new risk, it can mostly rely upon a system of internal audits and management reviews. Is a single annual management review meeting an iterative process? Risks are therefore considered too infrequently to capture and control real time threats.

Risks are also often managed centrally. Organizations commonly lack the insight, scope and flexibility to handle risks that occur at a grass-roots level, where the work gets done. Decisions to prevent and mitigate risk can sometimes be delayed as employees do not have the capability to assess risk, or the time to define and reduce the risk.  Often this happens because employees do not feel empowered or confident to take preventative and corrective action in the first place.

There are 5 common symptoms which could highlight to you that your approach to risk management could be improved:

1.    Uncertainty – the organization struggles to collect the right, or enough information about its risks. Checks are too infrequent, must be recurring and beyond annually. The scope of information about the organizations risk is narrow.

2.    Complexity – the organization is collecting enormous amounts of information about risk to the low level weeds areas. Decision makers cannot interpret the information. Opportunities are overlooked.
3.    Ambiguity – the organization is not able to formulate the correct questions in order to understand its risk. Additional information is useless because risk is not understood or documented effectively, and is some cases not documented at all.
4.    Lack of Common Language- there are multiple interpretations of risk between individuals across the organization. Risk management is mutually exclusive or in conflict. A power struggle usually ensues between individuals with conflicting views and beliefs.
5.    Silo mentality (larger organizations) – different departments resist communicating information about risks across the organization. This typically leads to a condition of both uncertainty and not my problem mentality.

 

HOW TO FIX THE PROBLEM

Choose the right risk management tools. Experiment with different approaches while your management system is in operation.

Understand the standards.  You need to correctly interpret the terminology applied to ISO management systems. Risk is not always stated explicitly in each ISO standard. Terms like “suitable” and “appropriate” will often imply that you need to demonstrate a balanced approach towards risk based thinking.You should also assume that risk identification can have a positive impact, Opportunity- and that it can even provide workable business opportunities. Your approach must accept risk as a systemic entity in your management system. You need to consider all of the functional aspects of your management system, and how effectively risks are identified and controlled in real-time.

Transitioning into a risk-intelligent business can take a considerable length of time and experience. The value of implementing an ISO management system (in particular the new 2015 and 2016 standards) is that it determines the focus for a Risk-Based approach. But it does not tell you which business tools to apply – this choice is yours.

 

Steps to Continual Improvement

Continual improvement is a type of change that is focused on increasing the effectiveness and/or efficiency of an organization to fulfill its policies and objectives. It is not limited to quality initiatives. Improvement in business strategy, business results, and customer, employee, and supplier business relationships can be subject to continual improvement. Putting it simply, it means getting better all the time.

What continual improvement is not. Improvement is not about using a set of tools and techniques. Improvement is not going through the motions of organizing improvement teams and training people. Improvement is a result, so it can only be claimed after there has been a beneficial change in an organization’s performance.

Clause 10 Improvement under the ISO 9001:2015 Standard requires an organization to “determine and select opportunities for improvement.”  An example could be gradual, incremental or breakthrough. Continuous improvement is gradual never-ending change, whereas continual improvement is incremental change.

Types of improvements are call Kaizen Events, Lean, and Six Sigma improvement is common place.
Breakthroughs are improvements, but in one giant leap – a step change. However, the method of achievement is the same, but breakthroughs tend to arise out of chance discoveries and could take years before being made.

When should continual improvement be started? All managerial activity is directed either at control or at improvement. Managers are either devoting their efforts at maintaining performance, preventing change, or creating change, breakthrough, or improvement. If businesses stand still, they will lose their competitive edge, so improvements must be made to keep pace and stay in business. Every system, program, or project should provide for an improvement cycle. Therefore, when an objective has been achieved, work should commence on identifying what is meeting the requirements of the process, and what better ways of doing it.

There is no improvement without measurement. An organization must establish current performance before embarking on any improvement. If it does not, it will have no baseline from which to determine efforts.
There are ten steps to undertaking continual improvement:
  1. Determine current performance.
  2. Establish a need to improve.
  3. Obtain commitment and define the improvement objective.
  4. Organize the diagnostic resources.
  5. Carry out research and analysis to discover the cause of current performance.
  6. Define and test solutions that will accomplish the improvement objective.
  7. Produce improvement plans which specify how and by whom the changes will be implemented.
  8. Identify and overcome any resistance to the change.
  9. Implement the change.
  10. Put in place controls to hold new levels of performance, and repeat step one.
Continual improvement is far more than a set of techniques. For many organizations, it involves a radical change in attitudes. The defense of the status quo, and resistance to innovation, cannot be treated as normal management behavior. A fear of reprisals for reporting problems has to be replaced by congratulating people for identifying an opportunity to improve. Hoarding of good ideas within departmental walls must be a thing of the past as people share their knowledge and experience in the search for greater collective success.

 

Reinventing Innovation Findings
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In a global study conducted by PwC of executives stated their businesses are collaborating with a broader set of stakeholders to recap greater rewards from their innovation efforts.

PwC surveyed over 1,200 executives in 44 countries, asking them about their innovation strategy, operating models, culture, metrics, and more to understand how innovating companies are seeking to create business value and financial returns on their efforts.

The majority of respondents clearly think that bringing more parties into the innovation sandbox is a smart idea. It can deliver significant benefits, from improving innovation’s alignment with business strategy, to accessing fresh ideas and critical talent, to failing faster and getting new innovations to market sooner.

In a world where industry disruption is increasingly the norm, not an anomaly, virtually no company can ignore the imperative to innovate. Failing to do so is an invitation to lose business.

The study results showed that:
  • 54% of the executives we surveyed struggle to align innovation strategy with business strategy;
  • 61% of our survey respondents are embracing open innovation to generate new ideas;
  • 72% of respondents say they’re not out-innovating their competitors.
Key Finding – Strategy, not size, matters in innovation spend.
To read more of the study and to view the Innovation Benchmark 2017 Report, visit the PwC Website.    

 

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In the News
National Manufacturing Day – October 6, 2017 

 
Manufacturing Day is a celebration of modern manufacturing meant to inspire the next generation of manufacturers. Manufacturing Day occurs in October – this year Manufacturing Day is Oct 6, 2017.

Join thousands of manufacturers and events as they open their doors to show the public modern manufacturing.  Visit the Manufacturing Day Website  for more information and events in your area.

 

Medical Device Sector New Handbook   

The handbook ISO 13485:2016 – Medical devices – A practical guide written by a group of technical experts from ISO’s technical committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. Tthe handbook provides users with practical guidance and accurate interpretation of the requirements specified in the ISO 13485:2016, Medical devices -Quality management systems – Requirements for regulatory purposes.

Mapped to the structure of ISO 13485:2016, the new handbook offers step-by-step guidance for all organizations in the medical devices sector wishing to implement and maintain a quality management system. It covers guidance applicable to various stages of a medical product’s life cycle, including the gathering of customer requirements, design, development, production, supply chain, installation, servicing and post-market surveillance of medical devices.
Aimed at all organizations, regardless of size and the nature of their business, it helps create a level playing field and facilitate the market access of their products globally. The handbook can be used as the go-to reference when questions arise about specific requirements, their interpretation, and implementation strategies

Purchase 13485:2016 – Medical devices – A practical guide at the ISO Store.

 

Training Courses
 
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
 
Don’t see a course or schedule that fits your needs?  Contact us.
 

What kind of results do you want to create for yourself and your business?

Do you have customers coming back for more of your product or service? Do you have a set of ideal customers you want to cultivate? Are your business processes in control and capable of producing what you, your employees, and your customers require on a continuous basis?

The demands of today’s business environment have caused many of us to shift our approach from thinking as a professional to acting as an entrepreneur. Avoiding past mistakes and taking the time to plan your next moves can make the difference between failure, or sustainable growth for your organization.

 

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642