Process Challenges for 2019


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ASQ Lean and Six Sigma Conference Phoenix, AZ.  March 4-5, 2019.




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Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards. 
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 topic of interest for a subject article? Please let us know.

Process Challenges for 2019

Recently we attended an informative webinar hosted by  APQC (American Productivity & Quality Center) which helps organizations work smarter, faster, and with greater confidence. It is the world’s foremost authority in benchmarking, best practices, process and performance improvement, and knowledge management.

We have consistently found APQC studies and information to be a useful resource. The following is abbreviated information from this webinar, and consider these key points a value to our readers, no matter what your business industry.


At the close of 2018, APQC’s process and performance management group conducted its annual survey to understand the common challenges and priorities of practitioners in 2019. The survey looks at the top priorities and challenges in key process and performance topics like process frameworks, business process management, continuous improvement, strategy planning, measurement, and data and analytics. 
The survey showed the top business challenges in key topic areas to be:


  1. Business Process Management (BPM): 73%
  2. Continuous Improvement: 69%
  3. Data and Analytics: 60%
  4. Measurement: 55%

The top 3 challenges with Business Process Management include:

(1) Defining and mapping end-to-end processes: 37%. Documenting and overall effective mapping of company and customer value chains (end-to-end processes) with process measurements can’t be overstated as a strategic value to all organizations.

(2) Moving from a function-based to process thinking culture: 27%.  Functional-based, process-thinking, and process-based organizations are key concepts that help organizations define where they are on that process/function spectrum. Some aspects of the business can be functional-based while the organization is generally process-oriented.

(3) Engaging Leadership in Process Management: 28%. In most improvement approaches we’ve seen, the visibility and active involvement of leaders gets sporadic and can become passive. There are periodic progress reviews and an eventual final presentation but in the meantime, leaders are spending their attention on other things. Leaders have a lot of other priorities, but their waning attention to process management is typically because there’s not been a “proactive approach to engaging them”.


Continuous Improvement Challenges identified by APQC survey include:
  • 48% find a need to create a continuous improvement culture;
  • 43% find a need to identify, prioritize and select improvement opportunities;
  • 30% find a need to overcome organizational resistance to change.
Next month we will do a dive into these identified study needs and continue with these important findings. Stay tuned!     


Regulatory and Statutory Requirements

Operational and quality systems standards require an organization to identify and control the regulatory and statutory requirements applicable to its products and services. This determination is can be driven based on the business model, products and services produced, geographic locations, and customer requirements . 

The organization should demonstrate that the statutory and regulatory requirements applicable to its products and services have been properly identified, are available understood, and easily retrievable. These statutory and regulatory requirements can be derived from internal and external sources, including relevant information, and of course your interested parties.


These requirements should be identified and integrated within the resource management and identification processes, your product realization system, product and service processes, including what is relevant to the activities of the organization. The Management Review Meeting process can be used as a primary method of identification, new requirements and regulatory review

Requirements can include:
  • ensure that the organization has a methodology in place for identifying, maintaining and updating all applicable statutory and regulatory requirements; this includes proper record keeping;
  • ensure that these statutory and regulatory requirements are utilized as ‘process inputs’ while monitoring ‘process outputs’ for compliance with requirements.

Meeting regulatory and statutory requirements is serious business. If for example, an auditor become aware of any deliberate legal noncompliance that could affect the image and potential credibility of the business, during, or after the audit (including, for example, breach of antitrust law, labor law, health and safety or environmental regulations) then this should be taken into consideration and investigated further by the organization.

Effective Work Instructions
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

Work instructions and workmanship standards can be in the form of manuals, procedures, standards, data sheets, posted signs, photographs, product and material samples, and other such written documents and physical samples. External documents, such as published standards or equipment manufacturer manuals, can also be used as work instructions.

Work Instructions tell how to carry out a process or perform a task. They can instruct on how to set up and operate process equipment; change and inspect tooling;  handle materials; carry out an inspection or a test; or calibrate a measuring instrument. Work instructions may also relate to administrative and other non-production tasks.

The need for work instructions for a given production process can be determined on the basis of the following considerations:

  • Ability to verify results of the process: Work instructions are effective for special processes, i.e., those processes the results of which cannot be fully verified by subsequent nondestructive inspections (such as welding, plating, painting, casting, cleaning, etc.).  
  • Importance of the process: Work instructions are effective for processes that are critical to the safety, fit, and function of the product. This may include packaging operations. 
  • Complexity of the process: Work instructions are effective for processes where various process parameters must be set up and/or maintained at specified levels; where operators are required to program the process equipment; where tool changes are involved; or where, for any other reason, operation of the process is fairly complex and requires specific process setup instructions and/or operating data. 
  • Process operator qualifications: Process operator qualifications, experience, and training are considered in determining whether work instructions are required, and how detailed they ought to be. Qualification and training of all designated operators, including other shifts and possible replacements, are considered.
  • History of quality problems: Work instructions may be required for processes that have a history of quality problems, especially when these problems can be associated with the lack of adequate instructions.
Features of well written work instructions include: (1) Less is more – avoid excessive wordage, pictures in work instructions are effective, (2) Document Control, (3) Written by the Users, and (4) Easily understood – test them on other users! 


Information Security Controls

Software attacks, theft of intellectual property or sabotage are just some of the many information security risks that organizations face. And the consequences can be huge.

For any organization, information is one of its most valuable assets and data breaches can cost heavily in terms of lost business and cleaning up the damage. Controls in place need to be rigorous enough to protect it, and monitored regularly to keep up with changing risks.
Developed by ISO and the International Electrotechnical Commission (IEC), ISO/IEC TS 27008, Information technology – Security techniques – Guidelines for the assessment of information security controls, provides guidance on assessing the controls in place to ensure they are fit for purpose, effective and efficient, and in line with company objectives.


ISO/IEC TS 27008 is of benefit to organizations of all types and sizes, be they public, private or not-for-profit, and complements the information security management system defined in ISO/IEC 27001.


To purchase ISO/IEC TS 27008, visit the ANSI Webstore.



In the News
Achieving Breakthrough Performance  

Our AZTC Lunch and Learn Event “Achieving Breakthrough Performance”on January 23, 2019 in Tucson was a big success! We had thirty-eight attendees with great interaction, questions and plenty of brisket for lunch. We want to give a big thanks to Brother John’s Beer, Bourbon and BBQ and Sponsor – The Arizona Technology Council who contributed to our success.  We are looking at conducting this same event in Phoenix later this year. Any questions or interest in our presentation, please contact us.


ASQ Lean and Six Sigma Conference 2019 


The ASQ Lean and Six Sigma Conference will be held on March 4-5, 2019  in Phoenix, Arizona. Do you have technical proficiencies and leadership responsibilities within your organization? Are you actively involved in process improvement, organizational change, and development dynamics related to a successful lean and Six Sigma culture? This conference is for you!

For more information and to register visit the conference website.  See you there!


Standard for Human Capital Reporting 

An organization is only as good as its people – which is why the workforce of a company is often one of its largest costs. But measuring the true return on that investment can be a tricky business. It just got a lot easier with the first International Standard for human capital reporting.

It is well known that effective human resources (HR) strategies can have a positive impact on organizational performance. And with workforce costs making up to 70 % of an organization’s expenditure, it is important to get that strategy right.
ISO 30414, Human resource management – Guidelines for internal and external human capital reporting, is the first International Standard that allows an organization to get a clear view of the actual contribution of its human capital

For more information and purchase of ISO 30414 visit the ANSI Webstore.

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 find it interesting that the APQC survey showed the top business challenge, a key topic area to be Business Process Management (BPM) with a 73% challenge response rate. Since the early 1990s, the transformation of BPM within the quality management continuum initially focused on the automation of business processes with the use of information technology. 

In the new age, BPM has since been extended to integrate human-driven processes in which human interaction takes place in series or parallel with the use of technology.  In that sense, the challenge today maybe the need to advance human interaction and knowledge integration with BPM. For example, a workflow management system.  


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


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