Risk-Based Thinking


This Month

 Our Events
AZTC Lunch and Learn. ISO 9001:2015 Revision and Update April 14th Phoenix,  AZ



Helpful Links

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

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. Subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions regarding content, or have a subject of interest for a future newsletter, please let us know.

Risk-Based Thinking

man-cliff-illustration.jpg Within an organization we generally conduct risk-based thinking when faced with a situation to get desired results.  If an organization can identify the risks within their processes, business, productivity, quality, and design and development, they can identify opportunities to prevent or reduce the risks.  This reduction should equate to improvement after successful implementation of specific actions, including increased profitability.


The future ISO 9001:2015 revision to be published in September 2015 makes risk management explicit by mentioning the term “risk” a total of 14 times within the requirements of clauses 4 through 10. This is the ongoing hot topic of discussion regarding the new revision.  The ISO/TC176/SC2, the committee members representing over 30 countries developing this revision, have defined how risk is explained in the introduction of ISO 9001:2015 standard.

Let’s take a look.  ISO 9001:2015 defines risk as the effect of uncertainty on an expected result.

  1. An effect is a deviation from the expected – positive or negative.
  2. Risk is about what could happen and what the effect of this happening might be
  3. Risk also considers how likely it is to take place.

The target of a management system is achieve conformity and customer satisfaction.  ISO 9001:2015 uses risk-based thinking to achieve this in the following way:

Clause 4 (Context) the organization is required to determine the risks which may affect this.

Clause 5 (Leadership) top management are required to commit to ensuring Clause 4 is followed.

Clause 6 (Planning) the organization is required to take action to identify risks and opportunities.

Clause 8 (Operation) the organization is required to implement processes to address risks and opportunities.

Clause 9 (Performance evaluation) the organization is required to monitor, measure, analyze and evaluate the risks and opportunities.

Clause 10 (Improvement) the organization is required to improve by responding to changes in risk.

These requirements are considered to cover the concept of preventive action (which has been replaced) and takes a wider view that looks at risks and opportunities. This approach requires risk based thinking and a risk driven approach to preventive action throughout the development and implementation of your future quality management system.

Why use risk-based thinking?

By considering risk throughout the organization the likelihood of achieving stated objectives is improved, output is more consistent and customers can be confident that they will receive the expected product or service.

Risk-based thinking therefore:

  • builds a strong knowledge base
  • establishes a proactive culture of improvement
  • assures consistency of quality of goods or services
  • improves customer confidence and satisfaction

The new risk thinking and requirements of ISO 9001:2015 will require improved commitment and more involvement with your top management team. This change will also facilitated some reduction in prescriptive requirements and their replacement by performance based requirements. Although risks have to identified and acted upon there is no requirement for formal risk assessment method, but will require documented information.

We will continue the conversation of risk-based thinking and further guidance in our next newsletter.

Core Processes Create Economic Value

The future revision of all major quality management system standards, for example ISO 9001 and AS9100 will require top management to be more involved with determining purpose, and strategic direction when identifying risks which can affect the organizations ability to meet objectives.

The main objective of an effective business system is to provide confidence in the organization’s ability to consistently provide customers with conforming goods and services, and to enhance customer satisfaction.

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.

Manufacturers Invest in New Technologies


More than half of manufacturing leaders are planning to invest in advanced manufacturing technologies in the next two years, according to SME’s Advanced Manufacturing Media.

The findings are part of the organization’s Advanced Manufacturing Opportunities Report, which highlights results of a survey published in March 2015 of manufacturing executives, engineers and managers on why companies are investing in and using advanced manufacturing technologies such as industrial robotics and additive manufacturing, or 3D printing.

“The survey results clearly show that advanced manufacturing is a priority for companies that want to remain competitive,” said Dave O’Neil, director of Advanced Manufacturing Media. “Our survey shows that the companies who have already made these investments have seen improvements in product quality, production speed and costs.”

Survey says …

When asked what is driving the need for advanced manufacturing improvements, 66 percent of respondents identified competitive advantage as the top factor. Other drivers included:

  • Growing business opportunities -65%

  • Improving production efficiencies-64%

  • Adapting to customer needs -57%

  • Improving quality – 57%


Companies already investing in advanced manufacturing have seen improvements in product quality and reliability, production speed, production costs and improved performance of finished products. Among the most popular areas for investment: advanced software, industrial robotics, advanced sensing, measurement and process control, and additive manufacturing.

In all, 54 percent of employees of large manufacturers, with more than 500 employees, said their company planned to invest more than $1 million in such technologies during the next two years, with another 25 percent planning to invest between $300,000 and $1 million. More than half of medium and small-sized manufacturers, meanwhile, plan to spend between $100,000 and $500,000 toward advanced manufacturing in the next two years.

Click here to download the Society of Manufacturing Engineers Advanced Manufacturing Opportunities Report in PDF.  


In the News
Anderson Painting and Powder Coating Company Achieves ISO 9001:2008 Certification  


Congratulations to our client receiving certification to ISO 9001:2008 from NQA, one of the leading ANAB accredited registrars for certifications.  Since 1963, Anderson Painting and Powder Coating Company has established a solid reputation for superior quality and service while meeting the requirements of domestic and international customers in a vast array of industries. 

Next Generation of Skilled Workers

The American Society for Quality, a leading authority on quality in all fields, organizations, and industries, issued more than 9,800 certifications in the United States in 2014 as part of a Manufacturing Institute partnership designed to help fill advanced manufacturing positions. “In this highly competitive global market, our manufacturers’ business success is tied directly to their ability to innovate, and the single most important factor in their innovation capacity is an educated and skilled workforce,” says Jennifer McNelly, president of The Manufacturing Institute.


ASQ offers 18 certifications, including Certified Quality Technician, Certified Quality Engineer, Certified Quality Inspector and, new in 2015, Certified Six Sigma Yellow Belt.

For more information about the Manufacturing Skills Certification System, visit the Manufacturing Institute Website.


Aero Engine Supply Chain Training Requirements

SAE International’s G-22 Aero Engine Supplier Quality (AESQ) announces the publication of the new AS13001: Supplier Self Release Training Requirements standard and the accompanying Common Training for Self-Release Delegates.

In the aerospace industry, supplier self-release is a process whereby a supplier has been provided the authority to act on behalf of a delegating organization to verify and release products without additional oversight from that delegating organization.

Commonly referred to as DSQR, SARA, SRP, and DQCR, among others. Each of these delegating organizations has historically managed unique training for the individuals responsible for the self-release of their product. Suppliers producing products for multiple delegating organizations would have to manage the burden of multiple training requirements.

The Aerospace Supplier Quality: Common Training for Self-Release Delegates course is available through SAE International and will be offered in multiple locations. For more information visit the SAE International Website.

Training Courses

View all our online Courses

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

Interested in what’s ahead for the ISO 9001:2015 Standard and other QMS standards to follow?
Register for our AZTC Lunch and Learn on April 14th in Phoenix. Whether your company is certified, or are just thinking of getting started, with over 1.3 million global registrations, this revision will have a direct impact towards your operational effectiveness and profit improvement. Lunch is provided.

Best regards,

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


Leave a Reply