Future of Management Systems

 Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                              September 2014


This Month
* The Future of Management Systems
* Show Me The Money!
* Standard Work – Lean Improvement
* In the News
* Training Courses



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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.   


The Future of Management Systems                 

Much has been written lately regarding the future ISO 9001:2015 Standard and its expanding requirements. If your company is certified to other recognized global standards, changes are also coming to for example, ISO 13485:2015 Medical Devices, 14001:2014 Environmental Management System, and the AS9100:2016 Aviation, Space and Defense Standard.


Who are the these revised standards going to affect? Everyone from certification bodies, third party auditors, certified companies, customers, supply chains, end users, and regulatory agencies. Before these revisions are published, we should all be talking the time to look  at current state requirements, and the effectiveness within your company for improving current operational systems.

We recently received information regarding the AS9100 Aviation, Space and Defense Standard-third party (CB) auditors lessons learned. Many of these can also be applied to other standards you may be operating under within your organization; these are not all AS9100 exclusive issues.  This information is very valuable and should be reviewed for inclusion into your current system.

  1. Taking exclusions to your system without proper justification.

  2. Interactions of Processes Map: Go beyond the Clause 7 requirements. Where are Clauses 4, 5, 6, and 8?

  3. The method of controlling records by/and/or retained by suppliers. What is the method?

  4. Quality objectives measurable with quality policy. What measurable methods are being used?

  5. Management Review: Lack of attendance, lack of documented action items, effective frequency, and only showing internal audit results- no external auditing activities.

  6. Job descriptions that are not controlled. Training records only exist for production personnel.

  7. No evidence that risks have been identified, and with mitigation plans defined.

  8. Customer specification requirements not addressed to who needs to know them.

  9. Approved supplier list does not include approval status or scope of approval. Periodic supplier reviews not always happening.

  10. Flow down to suppliers – records retention, process/product changes, and customer requirements.

  11. Missed operations and inspection status, including accountability of parts. Reference to work instructions and/or other documents. Inadequate environmental controls

  12. Equipment not in calibrated system being used. Delinquent equipment and no records of calibration validity.

  13. Internal audits not being done by defined procedure and time period. Untrained auditors used, inadequate corrective action, lack of follow-up on audit findings.

  14. Missed inspection steps and stamps used/sign-off. Unauthorized planning changes, and questionable sampling plans.

  15. Responsibility and authority for review and disposition of nonconforming product. Who makes NCP decisions?

  16. Lack of proper root cause and acceptable corrective action. Timely implementation and documented follow-up.

  17. Lack of customer complaint documentation.

  18. Lack of documented preventive action, timely actions taken, and documented follow-up.

Based on this information, what are the keys to a successful certification audit?

  • Effective process identification

  • Effective process measures and associated actions

  • Effective management reviews

  • Effective internal audits

  • Effective corrective action

  • Effective customer focus.

Looking to improve your operational and quality management system effectiveness? Contact us for all your improvement and training needs!


 Show Me The Money!                   


Fact: Standards have a Direct Impact on the Bottom Line. The theory that standards slow growth is bunk. Along with – it’s nothing but a paperwork shuffle, this is a waste of my company time, I don’t see any financial payback, and the list goes on. 

According to the ISO Website and numerous worldwide company case studies, standards are an economic opportunity. How do we know? Because these savings and advantages can be determined. A method to calculate the benefits of standards now enables companies to see how much they are making. And the figures are fascinating. 

How many times have you left a meeting and doubted that anything was actually going to change in your company’s strategy? This is all the more difficult when time and money are of the essence. All too often, we get together to flesh out a strategy and assess, among other things, how and where standards fit into the picture – and nothing is accomplished. It’s frustrating.

Some see standards as a passport to export markets, some as a necessary evil or a hoop to jump through, and others still as the priceless knowledge of experts. But whatever side of the fence you’re on, you will have to admit that standards are rarely described in numbers. Take, for instance, the percentage of increased sales or GDP growth that may result from their use. We know that numbers speak volumes, all the more so when there is a dollar or euro sign in front of them.


But is it even possible to quantify the benefits that standards bring? Short answer: Yes, it is. Standards have a direct impact on the bottom line, which you can calculate. 

This has been the focus of a long-term study by ISO and its members in which around 30 companies, and even one whole industry sector, have scrutinized the way they use standards and calculated the savings that have been made. The companies surveyed range from small businesses with 25 employees and an annual sales revenue of around 4.5 million, to conglomerates of several thousand employees with an annual revenue of more than 1.5 billion. They operate in a variety of business sectors, such as food, construction and telecommunications


To view numerous company case studies on the tangible benefits of standards such as ISO 9001, AS9100, and 14001 visit the British Assessment Bureau Website.



Standard Work – Lean Improvement              


We are continuing our lean digest review this month with information on the  “Standard Work” method. 


Organizations develop standard work to document the proper way to perform an operation or task and make it easy for workers to do the task correctly. Standard work can be created for an entire process, or it can document the specific steps for each part of the process, such as standard work for issuing a purchase order. Lean teams may produce standard work through a process-improvement project (e.g., a Lean event team could create a new report template) or through other means. Once standard work is documented, employees can use that as the starting point for further improvement efforts.


Standard work can also make it easier for new employees to efficiently undertake their new duties. Developing standard work with the people who actually use it, evaluating it “in the field,” improving the documented practices over time, and reviewing it regularly are some best practices for standard work.  This tool represents the sequence of activities needed to perform a given operation, and forms the baseline that is essential for measuring progress later. Improvements made during, for example kaizen events are immediately documented as standard work to ensure that all employees understand and consistently implement the new process. Standard work (e.g., templates, forms, & process maps) ensures consistency and prevents errors. 



Standard work makes it easier for employees to work in an effective, efficient, safe, and compliant way. Consistent practices minimize errors and other problems. Standard work also eliminates reliance on “tribal knowledge,” and makes organizations more resilient and flexible to address their needs even if key staff leave or are not available.


Standard work supports the lean system of continuously improving capacities and efficiencies by defining 5 critical elements for every person doing the work.

    1. The customer demand.
    2. The most efficient work routine (steps).
    3. The cycle times required to complete work elements.
    4. All process quality checks required to minimize defects/errors.
    5. The exact amount of work in process required.



Looking for more information on Standard Work Methods? Contact Us.

In the News      

Medical Device Manufacturers- New FDA Guidance

Medical device manufacturers would be well-advised to address any risk with potential home-use products during their design phase, according to an August 2014 guidance from the FDA.

As the agency notes, “Failure to adequately consider potentially hazardous situations during the design of home-use devices may result in inappropriate use, use error, or incompatibilities between the use environment, the user, and the device,” states the guidance. “This could cause the device to malfunction, possibly contributing to death or serious injury.”

The guidance offers advice designed to address the entire manufacturing process-and beyond. It covers environmental issues, user issues, design issues, labeling challenges, post-market considerations, and the always-fun human factor.  The guidance offers advice designed to address the entire manufacturing process-and beyond. It covers environmental issues, user issues, design issues, labeling challenges, post-market considerations, and the always-fun human factor.


U.S. Factory Activity Expands at Fastest Pace in Over 4 Years   

The U.S. manufacturing sector expanded in August 2014, with the rate of growth exceeding expectations and moving at the fastest pace in more than four years, an industry report showed.

Financial data firm Markit said its preliminary or “flash” U.S. Manufacturing Purchasing Managers Index rose to 58 in August, which was its highest since April 2010, from 55.8 in July. Economists polled by Reuters expected a reading of 55.7. A reading above 50 signals expansion in economic activity.

The survey delivers further evidence that robust manufacturing growth momentum has been sustained through the third quarter, with overall business conditions improving at the fastest pace for over four years.


 Steps for Manufacturers to Increase Social Media and Sales    

For manufacturers, especially small companies, merely being on social media is not enough. Companies need to have a content strategy that is targeted, offers subject variety, and sufficiently engages to lead to sales and revenue. Building a loyal following and fan base online requires these four tactics.

According to Industry Market Trends, social media marketing gives manufacturers the opportunity to improve brand awareness, build brand loyalty, and increase sales, and right now, 87 percent of B2B marketers are taking advantage of opportunities. Fifty-four percent of B2B marketers  say that social media marketing efforts have generated leads, and 39 percent say that social media has generated revenue. Facebook, YouTube, and LinkedIn are the three most popular sites used by manufacturing marketers, according to the Content Marketing Institute.

The four tactics include:

1. Create Quality Content that Drives Awareness

2. Use Visual Content to Increase Engagement

3. Sell the Brand, not the Product

4. Respond to Users Quickly to Create Trust.

For more information on these tactics, visit the Thomas net Website.

Training Courses

To see the course description, schedule, and on-line registration click on the course title below. We deliver onsite training for all these courses and customized training to fit your specific needs.  We offer group discounts.  


View all our Courses

View Our Web Based E-Training Courses   

ISO 9001 Quality Management

Understanding and Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor 

Documenting Your Management System

AS9100 Aviation, Space and Defense

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100C:2009 Process Based Internal Auditor

Documenting Your Management System 

ISO/TS 16949 Automotive

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System 

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI 

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor 

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor 

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

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