Rising Growth and Challenges


This Month

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

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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

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

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  



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


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