Archive for the ‘Newsletters’ Category

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
 

 

The Cost of Quality

Monday, September 4th, 2017

 

This Month

 Events
 
ASQ Internal Audit Conference October 12-13, 2017 Dallas, TX 
 
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 9001:2008 Organizations: Time is running out! You have less than 1 year to transition to the ISO 9001:2015 Standard, and others.  Contact us for all your transition needs.    

The Cost of Quality
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We recently gave a presentation at the Aerospace and Defense CEO Network sponsored by the Arizona Technology Council. This subject was of great interest, so we would like to share a segment of the information presented. If interested in more information on this subject, let us know.

If you’re a first-line supervisor responsible for managing operations, you know how important operational metrics are to the effectiveness and longevity of your organization.

If you’re a corporate executive, you are often inundated with data, which makes it difficult to pull out relevant insights. We have found that most metrics on the executive dashboard are finance-related, executives for example, in manufacturing organizations need visibility into operational metrics to gain more control over their businesses. They are looking to understand the effect operational performance has on their organizations’ goals.

The impact quality has on a company’s success is often well understood. However, companies have traditionally struggled to establish metrics that can easily represent the effectiveness of quality in the organization.

Cost of Quality.  The definition of this metric is similar to the way it sounds. It measures the cost incurred by an organization to manufacture a quality product. Further narrowing things down, these costs come from two main categories: cost of good quality and cost of poor quality.  There are many different definitions of the Cost of Quality available, and many are lacking in scope or precision. To remedy this, we thought building on one of our favorite basic definitions (provided by ASQ, an organization we  are senior members) would be a good starting point.

At the highest level, there are two different terms in the Cost of Quality equation: the Cost of Good Quality (CoGQ) and the Cost of Poor Quality (CoPQ). This can be understood in the below formula:

CoQ = CoGQ + CoPQ

 

Let’s start with the Cost of Poor Quality. These are the traditional quality costs companies measure. Examples would include scrap, rework, and returned materials. To give this part of the equation more structure, we think of Poor Quality costs as having two different terms: Internal Failure Costs (IFC) and External Failure Costs (EFC). This can be understood by the following equation:

CoPQ = IFC + EXC, where: IFC = Scrap Costs + Rework Costs.

 

When it comes to the Cost of Good Quality, these are the costs that are much less likely to be measured by a company. Generally, these are the costs companies incur to ensure they are producing quality products. Again we break the Cost of Good Quality calculation into two different terms: Appraisal Costs (AC) and Prevention Costs (PC).

Appraisal Costs are the costs associated with measuring, evaluating or auditing products or services to assure conformance to quality standards and performance requirements. Activities that fall into this category include: Inspections, Testing, and Calibration. To measure these costs it is helpful to break them down into 3 broad categories, for example: percentage of Employee Costs, percentage of Software Costs, and percentage of Equipment Costs devoted to these activities.

Prevention Costs are the costs associated with all activities specifically designed to prevent poor quality in products or services. Activities that fall into this category include: Quality Planning, Risk Management, Continuous Improvement Team Activities, Corrective and Preventive Actions, Audit Management, and more. Again, to measure these costs it is helpful to break them down into 3 broad categories: percentage of Employee Costs, percentage of Software Costs, and percentage of Equipment Costs devoted to these activities.

What is the Quality Costs Advantage? Reducing the cost of poor quality is one of the Best Ways to increase a company’s profit. It prioritizes problems and provides a means to measure change and improvement. Furthermore, it promotes the effective use of resources, and provides incentives for doing the job right every time.

 

Rough Transition to IATF 16949

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Globally, there are more than 68,000 organizations certified to ISO/TS 16949:2009 that will need to undergo a transition audit to the International Automotive Task Force (IATF) international automotive quality standard, IATF 16949:2016.

According to an article by Omnex, there is a lot that can be  learned from these audits. What areas are receiving nonconformities? What surprises lie in these nonconformities? What are third-party auditors finding or not finding? For example, who thought “total productive maintenance” was going to be one of the top nonconformities?

The list of nonconformities can be used as a preventive measure to ensure key certification body  nonconformities are addressed before your transition audit.

 

Omnex has performed a large number of gap analysis audits for customers and will be comparing their findings to the list of registrar nonconformities. What were the top findings? How many of them still remain? Why are companies still receiving major nonconformities for “auditor competencies” and “customer-specific requirements” (CSRs).

Top five nonconformities

The top five nonconformities overall are “total productive maintenance” (48 nonconformities), “control plan” (38), “contingency plans” (37), “control of production service provision” (26), and “internal auditor competency” (23).

The two biggest surprises shown in this list are total productive maintenance (TPM) and control of production and service provision. The requirements for TPM (clause 8.5.1.5 of IATF 16949) have increased significantly from those of ISO/TS 16949. We can infer that when organizations are implementing IATF 16949, they have so much to update in other areas that maintenance is not getting the attention it needs.

Despite the many additional requirements found in IATF 16949, the third-party auditors are not overlooking the expanded requirements for TPM. Total productive maintenance has also made it to the top-five list of major nonconformities, showing that it is indeed an area that needs the attention of the IATF 16949 implementation champion.

Similarly, control of production and service provision (8.5.1 of IATF 16949) has requirements for “special processes” and “implementation of actions to prevent human error.” Control of production and service provision is showing the fourth most nonconformities of all areas in IATF 16949.

Based on automotive industry data, the top-five major nonconformance clauses are customer-specific requirements (7 nonconformities), internal auditor competency (7), quality management system (QMS) audit (7), TPM (6), and management review inputs (6)-see figure 2. Omnex gap analyses are also finding major nonconformities in CSRs, internal auditor competency, QMS audits, and management review inputs.

Management review inputs have not changed drastically enough in IATF 16949 to be resulting in so many major nonconformities. It has been determined that many of the majors are the result of a variety of issues with the ISO/TS 16949 management reviews.

For those unaware, IATF 16949:2016 includes all the requirements of ISO 9001:2015.  So whether or not your company is an automotive industry supplier, this information is still relevant to your organization. We will keep you informed of further results and findings.

What Do We Mean By Adding Value?
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Many businesses are developing revised management system strategies and seeking methods for driving improved business performance with transitioning efforts. One of the most important and underrated tangible methods for improving performance and saving cost is the internal audit process.

 

We hear so much about the importance of “adding value” during management systems audits, but what does this really mean? Is it possible to add value without compromising the integrity of the audit or change course from the internal audit checklist? In principle, all audits should add value, but this is not always the case. Truly effective audits don’t just concentrate on process weakness, but on process potential.

 

Some organizations have used the ISO series of standards to develop quality management systems that are integrated into the way they do business, and are useful in helping them to achieve their strategic business objectives – in other words they add value for the organization.

Conversely, other organizations may have simply created a bureaucratic set of procedures and records that do not reflect the reality of the way the organization actually works (example: download of free Google Stuff, using template fill-in-the-blanks documented systems) which simply adds costs, without being useful. In other words, they do not “add value”.

 

It is a question of approach:
 
A non-value-added approach asks “What procedures do we have to write to get the ISO 9001 certification?”
 
A “value-added” approach asks the question “How can we use our ISO 9001 (or any other standard) based management system to help us to improve our business?” Another to consider is “Can we effectively run our risk management requirements approach, or business system on non-documented processes?”

In order to “add value” an audit should be useful by: 

  • providing information to top management regarding the organization’s ability to meet strategic objectives;
  • identifying problems which, if resolved, will enhance the organization’s performance;
  • identifying improvement opportunities and possible areas of risk;
  • the organization’s customers by enhancing the organization’s ability to provide conforming product.

 

It is so important for an auditor to have a clear understanding of the organization’s strategic objectives, and to be able to put the audit within that context. The auditor needs to dedicate time for detailed discussions with top management, to define their expectations for the business, and to incorporate these expectations into the audit criteria.

Focus more on the process, and less on procedures. Some documented procedures, work instructions, check-lists etc. may be necessary in order for the organization to plan and control its processes, but the driving force should be process performance.

 

Focus more on results and less on records. In a similar fashion, some records may be necessary in order for the organization to provide objective evidence that its processes are effective (generating the planned results) but in order to add value, the auditor should be aware of and give credit for other forms of evidence.

Interested in moving your company process auditing system from compliance to improvement? Register for our process based internal auditor courses.  Contact us with any questions.  

 

 

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In the News
Standard for Electronic Documents Evolving  

   

The reason why PDF is today’s worldwide de facto standard for electronic documents – is the fact of standardization itself. PDF files are supposed to be entirely self-contained and interoperable, working equally well with PDF software from every vendor. End-users should be able to gain equivalent results irrespective of their choice of software. This core feature – PDF files always look and work the same way – is the dominant reason for the technology’s success .

ISO 32000-2, Document management – Portable document format – Part 2: PDF 2.0, is the first PDF specification developed entirely within the ISO guidelines and process. It’s clearer, cleaner, supports non-proprietary technologies and ensures a level playing field for software vendors that create, display, edit or otherwise process PDF electronic documents. In addition to staying true to PDF’s core value, PDF 2.0 provides a solid foundation for new use-cases, capabilities and workflows.
Purchase ISO 32000-2, Document Management at the ISO Store.

 

New Standard for Education Providers  

Today’s knowledge economy requires diverse training and learning services beyond the formal, national education system. A new standard aims to not only help providers improve their service, but provide recognition and credibility on the international market.

ISO 29993 Learning services outside formal education – Service requirements is designed to improve transparency and credibility in the market by providing the minimum requirements for internationally agreed levels of quality learning services.

Purchase ISO 29993 Learning services outside formal education 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.
 

Employee deficiencies in requisite skills

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)

If your organization hasn’t started your QMS Transition Process, it’s time to get moving!

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

 

Leading Performance Indicators

Wednesday, August 2nd, 2017

 

This Month

 Events
MFG DAY: Host  Event or Attend an Event-View Website   
 
Transition Time Is Running OUT! Contact us Now for All Your Company Needs.

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. 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.

Leading Performance Indicators

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Jim is the GM at a $65 million / 225 employees, electronics manufacturing firm in the Southwest (let us call it JR manufacturing). In a recent meeting Jim described everyday life at work.

“At JR Manufacturing, time flies for everyone. The moment I walk in every morning, people come to me with different issues, ask my opinion on how to solve them and you have no idea what kind of issues are waiting for you daily. This is what makes it interesting and exciting. I am a hands-on kind of manager and I do get involved with everyday issues and my people appreciate that.”

 

Sounds familiar?

In fact, this situation, where the senior and mid-level managers spend majority of their time to put out fires, prevails in numerous organizations on a consistent basis.  This is “normal” to many in those circumstances.

Let’s take a look at the significant downsides to this style of management.

a) Jim’s recommendations mostly came from prior experience with little in-depth analysis of the current issue or data to back up his decisions. As a result, the managers and shop floor associates don’t bother to find a solution to the issue. They were used to seeing all the decisions coming from Jim. Jim needed to develop new customers and start a new product line. However, he was so busy with everyday issues; the growth of the business was suffering.

b) No one developed skills for root cause and problem solving; everything depends on Jim and two of his supervisors (the benefit of thorough root cause analysis, documentation and communication to standardize did not exist). How effective can a hands-on kind of manager be in this working environment?

c) All major key performance issues (such as customer quality issues and on-time delivery) are published at the end of the month and corrective actions are discussed at that time. Vital metrics are now lagging indicators, and could be changed to leading indicators if JR Manufacturing used Lean Daily Management and Problem Solving Techniques.

 

Daily Performance Management involves looking at issues on all key performance indicators from the day before, finding the root cause and putting in countermeasures. Issues from the day before are fresh in the minds of all involved and investigation of the problem will be much easier. Management of the issues and root cause analysis takes place where the issues occur.

Let’s look at an example of a visual dash-board display of performance indicators that helps managers to understand the “state of the union,” in a timely manner.

 

BDC Manufacturing (not a true company) has implemented active real time daily management to monitor safety, quality, delivery and cost (SQDC, as commonly called in a Lean organization). At every department (engineering, manufacturing, sales) you would find a 5 ft x 8 ft board that displays the results of 5 key performance indicators – the goals and month-to-date performance, results from the day before, pareto of issues, root causes and corrective actions to each issues, year-to- date performance. Each sheet is color coded. Green, means the goals are met and red means goals are not met.

 

Graphs on daily key performance indicators (KPI’s) charts are prepared with green and red marker pens. As a manager looking at this dash-board, it is clear he/she should spend the time on the most critical issue and try to understand what the root causes are. The visual dash-boards give a prioritization of issues to the management in a 15-second glance.

When the expectations are established by management and employees are expecting questions such as “why did this happened and what are you doing about it,” they will take ownership of the issues and find the solutions. The management is there only to counsel and make sure this process works. The senior management now can focus their attention to strategic issues such as business growth and customer relationship.

Next month we will discuss some good examples of solving problems at the department level. Contact us with any questions.

 

Process Management Ownership

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A process owner is a person who is given the responsibility and authority for managing a particular process.

Most organizations find it useful to appoint individual process owners and define their responsibilities as ensuring the implementation, maintenance and improvement of their specific process and its interactions with other processes.

However, this does not mean a process cannot be owned by a team, a group, or a particular department. Ensure that process ownership clarity clearly exists.

 

Process owners take an organization-wide view of their processes. They may not truly “own” the process in that some of the people who are involved in carrying out the process may not report to them.  Instead, the owner is responsible for the design of the process, in other words, how it is carried out, how it interacts with other processes and how it is measured. This responsibility is an on-going task..

 

Process owners have responsibility for their specific process, end-to-end. However, as stated earlier, this does not mean that all the staff involved in a process actually report to the process owner. Process owners usually have responsibility for most steps in the process and are able to influence other key areas outside their direct organizational control.

Process owners should ensure the following activities are completed:

 

– Describe its links and interactions with other processes
– Identify its documentation and training requirements
– Issue and maintain procedures, instructions and records
– Communicate process changes to all process owners
– Analyze performance data and set process/quality objectives
– Track progress against process performance targets
– Identify risks and opportunities with the current process

A process owner is the person immediately accountable for creating, sustaining and improving a particular process.  This always includes being responsible for the outcomes of the process.

Interested in more information on process owner responsibilities?  Contact us we have a valuable list.

 

What Are The Costs of Certification?
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Every time we meet a potential client one of the questions they ask is “how much does a certification audit going to cost?” Unfortunately there is no simple answer to this question as it depends entirely on your organization and the management system.

 

The number of employees has the biggest impact. It informs the certification body on the size of your organization and how many  users of the management system processes there are. This is important as it provides a starting point for the audit duration based on the IAF (International Accreditation Forum) document.

 

The scope of certification determines the activities you conduct as a business. It allows the risk identification associated with your company’s scope and the impact that the potential failure of the management system may have on your organization and the wider industry and community.  For example, there is much more risk associated with a quality or environmental management system failure in a power plant, than there would be should a similar management system fail in an office environment.

 

The number of sites or locations your organization operates from can impact costs. When you have multiple locations across the world it may be possible to sample your sites if they are all conducting the same activities. If however you have a unique process at a site, then an audit of that location each year may take place to ensure compliance within the scope.

Finally your quote may be impacted if you have integrated your management system with another standard. The introduction of Annex SL in 2015, as a common structure for management systems, has enabled and eased the process of integrating management systems and conducting integrated management system audits.  An organization that has chosen to integrate ISO 9001:2015, ISO 14001:2015 and OHSAS 18001:2007 for example, will find cost and time efficiencies compared to those who implement separate management systems for Quality, Environmental and Health and Safety.

 

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In the News
Medical Device Manufacturers Warned   

    

An FDA investigation was conducted from January to February 2017 at a class II medical device manufacturer. The FDA laid out several concerns in its April 21, 2017, warning letter, noting areas of CAPA noncompliance.  A review of past responses determined that unsatisfactory corrective actions were taken in clean-room filling operations, and testing and validation of heat-seal integrity. In both cases, the medical device manufacturer closed its observations but failed to provide validation of why production did not need to be halted at that time.

 

FDA warning letters to medical device manufacturers continue to offer convincing evidence that CAPA noncompliance remains a top concern.  For more detailed information see the complete article.

 

New Standards for Call Centers  
ISO 18295-1:2017-“Customer contact centers-Part 1: Requirements for customer contact centers”, specifies best practice for all contact centers, whether in-house or outsourced, on a range of areas to ensure a high level of service; these include communication with customers, complaints handling and employee engagement.
Complementing this, ISO 18295-2:2017-“Customer contact centers-Part 2: Requirements for clients using the services of customer contact centers,” is aimed at those organizations making use of the services of a customer contact center to ensure their customers’ expectations are being met through its effective engagement. It provides guidance on the types of information the organization needs to provide to achieve high levels of customer engagement.

To purchase these standard, visit the ISO Store.

 

The New ISO 37001 Standard   

Bribery and corruption are a $1 trillion drain on the global economy and a door-shutting event for companies unable to prevent rogue acts from destroying a company’s entire reputation.  But how do ethical, socially responsible organizations become more proactive? Can this whole topic be embraced as an opportunity as opposed to a problem?
ISO 37001:2016-“Anti-Bribery Management Systems,” like its siblings from the ISO portfolio of management systems standards, sets forth a clear, no-nonsense framework that organizations can use to help prevent bribery.

For more detailed information see the complete 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.
 

Transition Time Becoming Shorter. 

 

  1. COMPLEXITY – Do not underestimate the work involved! The changes are significant and will require an extensive evaluation of your existing system to ascertain the degree of conformity with the new risk based approach and further new requirements.
  2. TIME – Do not underestimate the time involved! The ISO 9001:2015 /AS9100D:2016, IATF, and … transition deadline of September 2018 (actually sooner based on your next CB audit) is not that far away!
  3. TEAMWORK – Involve the right people now.  This is NOT the Quality Manager’s Job, it’s Leadership. A successful transition and activities must be executed at the right time with the correct responsible parties.

If your organization hasn’t started yet, it’s time to get started!

 

Walter Tighe and SES Team

Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642
 

 

Systematic QMS – Strategic Approach

Thursday, June 1st, 2017

 

This Month

 Events
 
AADM Conference June 22, 2017 Scottsdale, AZ  ASU Skysong.  SES is a Sponsor and a Presenter.  See Details Below.

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. 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.

Systematic QMS – Strategic Approach

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In our prior article, April 2017 Relationship Engagement we spoke about Leadership Engagement as the 2nd of 3 management core competencies for creating a Culture of Excellence.

Customer and Workforce Engagement alone is not sufficient, and must be linked to the organization’s Strategy and supported by a systematic approach for operational Quality Management. This article explores a third key driver, the Quality Management System (QMS), as a systematic approach for linking strategy, relationship engagement, and day-to-day operational works systems and work process management for organizational effectiveness.

Leading organizations have learned to be strategy driven, engaging both the Workforce and Customers served by the enterprise, deploying work systems and processes aligned and guided by a leadership-driven Quality Management System.

QMS Systematic Approach for Process Design, Management & Improvement.

Systemic issues that can be the cause of product or service failure are often the result of a lack of a systemic approach for process design, management, and improvement. Too often people get blamed for adverse customer outcomes when it is the process that has not been properly designed to meet the requirements of the customer and other stakeholders.

A well designed organizational-wide Quality Management System supported by real time in-process performance measurement, such as dashboards or scorecards, can proactively serve to control and manage key work systems and processes to reduce customer complaints, achieve the desired results and minimize defects, service errors, rework, as well as improve value, productivity and efficiency.

 

QMS Measurement, Performance Analysis & Management Review.
An effective organizational Quality Management System is supported by a robust Performance Measurement System that includes data and information for tracking daily operations, as well as progress on achieving strategic quality objectives and action plans.

Often over reaction by management to variation in data without a cyclical systematic Performance Analysis and Review Process, can lead organizations to focus on fire-fighting and micromanaging the “problem of the day”. Metrics should reflect performance of customer satisfaction, feedback from interested parties, key work systems, process performance and action plans to address risks and opportunities.

Trending measurement system results over time compared to valid benchmarks or goals help gage the magnitude of the gap to achieve the desired results. Findings from systematic leadership performance reviews can become opportunities for continuous improvement, innovation, intelligent risk taking, and cycles of organizational learning.

 

QMS Knowledge Management.

Over time, a systematic approach for applying “lessons learned” from repeated cycles of continuous improvement can help to build and leverage organizational knowledge. As data is translated into information and used for decision making, organizational learning can be embedded through the transfer of workforce knowledge and utilized in the innovation and strategic planning processes as a strategic advantage and opportunity.

The sharing of internal and competitor best practices can also accelerate organizational learning over time and provide a foundation for breakthrough change and innovation.

 

Linking and Aligning Quality Management with Strategy and Engagement.
A well designed QMS strategically links business work systems and processes to supporting the overall organizational strategy, as well as aligning the workforce through relationship management and engagement.

The most well-conceived strategy and action plans can be ineffective if there is a failure to link to the organization’s performance management system for motivation and incentivizing engagement with the workforce. The importance of quality management as a leadership driver cannot be overemphasized.

The alignment and integration with organizational strategy and relationship engagement can make the difference between a dysfunctional culture and the ability to achieve sustained breakthrough world class performance excellence.

 

Article Series 

In these series of articles, we described the three leadership core competencies and drivers to establish an effective organization and culture of excellence. Strategy, Engagement, and Quality Management were linked through an intentional alignment of organizational goals and objectives connecting senior leaders with the front line workers.

Senior leaders’ actions must establish the organizational discipline necessary to walk the talk and follow these guiding principles, if this approach is to be successful. Processes to support these approaches must become hardwired, so efforts don’t become the “flavor of the month”, but create a true transformational operating system, that will result in proven cost savings and customer satisfaction success.

 

This article was written by Sustaining Edge Solutions Senior Consultant, Dennis Stambaugh. Dennis has over 30 years in senior leadership roles within various business enterprises. Dennis brings extensive knowledge on a systems perspective and the use of leadership systems and quality frameworks to drive effective leadership strategy, relationship engagement, quality management, and continuous process improvement.
For any questions about this article or further information, email Dennis at dstambaugh@sustainingedge.com

 

We can deliver for your company Comprehensive Organizational Assessments of Leadership approaches and systems.  These are available to guide organizations toward improved organizational effectiveness.

 

Click Here to view our Breakthrough Improvement Model for Performance Excellence.  Contact us with any questions.

 

2017 Arizona AADM Conference

 

 

 

 
For members of the aerospace, aviation and defense and manufacturing community, the Arizona Technology Council (AZTC) is offering a major opportunity for you to connect with potential new partners and customers.

 

The Arizona Technology Council, Arizona Commerce Authority, and RevAZ are hosting the Sixth Annual Conference for Arizona’s Aerospace, Aviation, Defense and Manufacturing Community on Thursday, June 22, 2017 at ASU SkySong

 

For defense contractors, the event will be your chance to take the spotlight as you explain your needs with subcontractors. For smaller manufacturers and service providers, you will be able to talk directly with A&D decision-makers to learn how to best meet their requirements. 

 

Sustaining Edge Solutions is a Conference Sponsor and Presenter. 

For more information and registration visit The AZTC Website.  Get out and support the AZ manufacturing base!!  See you there.

ISO 9001:2015 and AS9100D:2016 Training

Are you looking for transition training, or internal auditor training? We also deliver senior management training, either onsite or online. Are you struggling with the new requirements definition, or how to implement them?  SES is here to help you with all your training, documentation, internal auditing, and implementation needs.  Contact us today!

 

The Seven Quality Management Principles
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Understanding the main principles behind the foundation of business standards, can not only work better for your organization, but you can also work on a more successful implementation of the requirements into your business system.

 

There are seven Quality Management Principles upon which the ISO9001:2015 and other standards requirements for Quality Management Systems are based. These are all considered equally important to running a good business management system. They are equally applicable to any product- or service-based organization.

 

CUSTOMER FOCUS
The goal of any company is to provide products or services to customers. A focus on the voice of the customer and their requirements is paramount. This starts with knowing your customers, ensuring there is communication with customers throughout your relationship, and continually measuring the satisfaction of all your customers.

 

LEADERSHIP – IMPORTANCE OF TOP MANAGEMENT
The more involvement of the senior leadership team in the business management system, the better the chance of success, accountability, and the more effective the end results. If top management is responsible for system effectiveness and directly contribute to the tangible benefits of the system, it is much more likely to be used, succeed, and sustain the future.
 
ENGAGEMENT OF PEOPLE
People throughout the organization create value. To ensure this, the business management system must focus on the competence of people to help them become engaged in the processes, and to  work towards meeting the strategic objectives of the organization.
 

 

THE PROCESS APPROACH
By looking at the organization as a system of smaller interrelated processes you can focus your efforts toward more consistent and predictable results on processes and their performance. Looking at the links in the chain can help you understand and control your processes, rather than them controlling you!

 

IMPROVEMENT
Companies that don’t improve / change, will not remain in business. Successful ones work always towards improvement. Goals and objectives need to be planned and SMART (Specific, Measurable, Attainable, Realistic, and Time-bound.) An organizational strategic improvement mindset is required today within the global business environment. 

 

EVIDENCE-BASED DECISION MAKING
Fact-based decision making is more likely to get the results you want. Executing decisions on analysis and evaluation of hard real data rather than an instincts, history, or gut feeling is far more superior and effective. 

 

RELATIONSHIP MANAGEMENT
Because the interaction with your interested parties such as customers, employees, and suppliers can influence the performance of an organization, it is key to manage these relationships. Successful companies see these relationships as solid partnerships, rather than strictly customer/supplier interactions. 

Understanding the principles of an effective quality management system is a vital step for your management team to utilize for product, process, and customer satisfaction attainment. 

 

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In the News
Feedback Sought for ISO Standards Survey  

 

The American National Standards Institute (ANSI) seeks stakeholder feedback to gather information for an International Organization for Standardization (ISO) survey, focused on service standards and management system standards.

The responses will be considered for a survey that highlights ISO’s strategy for service standardization, which was adopted in February 2016 to accomplish multifaceted results:

* Increase ISO’s visibility as a developer of International Standards for services;
* Support ISO members during challenges associated with the development of standards for services;
* Gain a better understanding of market interests and trends in the services sector.

You can fill out the ANSI survey via This Link by the deadline of Friday, June 30, 2017.

 

37 Workplaces that Stand Out From the Rest  

What separates great workplace cultures from the rest? Gallup has studied millions of employees around the world to answer this very question.

Gallup found that regardless of company size, location, culture or industry, the very best organizations all share one undeniable trait: They have an intense and intentional focus on engaging their employees.

That focus means more than administering a survey once or twice a year. While measurement is important and necessary, great workplaces know that engaging employees requires real strategy and commitment. They don’t simply promise a culture of engagement; they deliver on it

Click Here  to read the Gallup study results.

 

New ISO Standard – Organizational Resilience   
Resilience is the key for any business wanting to thrive in an ever-changing world. Climate change, economic crises and consumer trends are just some of the pitfalls that can dramatically affect the way an organization does business and survives. Organizational resilience is a company’s ability to absorb and adapt to that unpredictability, while continuing to deliver on the objectives it is there to achieve.

A new standard, ISO 22316, Security and resilience – Organizational resilience – Principles and attributes, provides a framework to help organizations future-proof their business, detailing key principles, attributes and activities that have been agreed on by experts from all around the world.

For more information, 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.
 

 Transition Time Becoming Shorter.    

 

  1. COMPLEXITY – Do not underestimate the work involved! The changes are significant and will require an extensive evaluation of your existing system to ascertain the degree of conformity with the new risk based approach and further new requirements.
  2. TIME – Do not underestimate the time involved! The ISO 9001:2015 /AS9100D:2016, IATF, and … transition deadline of September 2018 (actually sooner) is not that far away!
  3. TEAMWORK – Involve the right people now.  This is NOT the Quality Manager’s Job, or can be delegated to another one or ? individuals. Transition activities must be executed at the right time with the correct responsible parties!

If your organization hasn’t started yet, it’s time to get started.

 

Walter Tighe and SES Team

Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642
 

 

Documentation Development Methods

Wednesday, May 3rd, 2017

 

This Month

 Events
 
2017 Arizona A&D Conference and AS9100D Internal Auditor Training – Read Below…  

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. 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.

Documentation Development Methods

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

No matter what type of business, effective documentation is necessary for creating and delivering customer satisfaction and overall value. Many organizations are currently transitioning to various operational and quality system standards revisions. Right now is the best opportunity for you to take a critical look at your documented system for improvement.
  • Although there may be a few exceptions, most procedures shouldn’t exceed four pages. The actual procedure should start with page 1, not on the second or later. You should avoid having redundant statements within a procedure or between procedures and/or work instructions.
  • Procedures should refer to the appropriate documents (e.g. other procedures, work Instructions) or forms within the body of the procedure.  A list of associated documents that are relevant to the procedure content is helpful. However, an effective procedure will define these documents within the specific text area to improve employee understanding.
  • Make your forms self-explanatory and if needed, insert examples.  Your forms should always be electronic type forms if at all possible.
  • Eliminate policy. This is a procedure. Policy isn’t needed here; you already covered it in your level 1 policies.
  • Vocabulary / Definitions / Abbreviations: These can be addressed in the body of the procedure. When the user is reading the word or phrase in the specific area of concern, understanding and learning of these takes shape much better than having a laundry list as an appendix.
  • Procedures can contain electronic linkages to other documents (fact is, your documented system should) so that, if necessary, the user is only a click away from reading them and using the right stuff.
  • Insert responsibilities into the body of the procedure where the responsibilities are intended to be. Remember, your process as a flow from one action to the next. Having a list of responsible individuals/departments at the start of a procedure invites confusion and lack of organizational accountability.
  • Consider using tables and simplified flowcharts for grouping information for ease of use and process understanding.

 

  • Include the Purpose, Scope, and Procedure content  (consisting of responsibility and action), and revision record in the procedure.  Having a single laundry list of revisions on a separate document can invite errors.
  • Procedures should be subject to document control which includes approval, review, revision, and issuance.

 

After Writing a Procedure Consider the Following:
* Can the procedure be performed in the sequence it is defined?
* Can the user of the procedure locate and identify all the associated documents defined in the procedure?
* Can the user use the procedure effectively without needing direct assistance from someone else?
* Do words, phrases, and language used have a unique meaning to the procedure and the user?
* Are there any needs for special consideration of data collection and record keeping?

 

Have any of your own procedure suggestions? Share with us!  We will include them in our next newsletter.

 

2017 A&D Manufacturing Conference

 

 

 

 
For members of the aerospace, defense, aviation and manufacturing community, the Arizona Technology Council (AZTC) is offering a major opportunity for you to connect with potential new partners.

 

The Arizona Technology Council, Arizona Commerce Authority, and RevAZ are hosting the Sixth Annual Conference for Arizona’s Aerospace, Aviation, Defense and Manufacturing Community on Thursday, June 22, 2017 at ASU SkySong. Get out and support the AZ manufacturing base. 

 

Sustaining Edge Solutions is a Conference Sponsor and Presenter 
 
For more information and registration visit The AZTC Website See you there!   

 

AS9100D:2016 Process Based Internal Auditor Training   

May 16-17th, 2017. Hyatt Place Phoenix/Chandler Fashion Center 3535 W. Chandler Boulevard, Chandler. Lunch is included.  All students receive a comprehensive training binder and a certificate of completion is awarded.  Group discounts are available.

 
Course Registration ends May 12th – Enroll Now!

 

Guidelines for Effective Work Instructions
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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; feed, fasten or handle materials; carry out an inspection or 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.

 

Work instructions are often developed for specific user groups. There may be separate work instructions for others. Each work instruction would only contain information that is relevant to each user group. This approach ensures that staff is not overloaded with information – they only know what they need to know.

  
Features of well written work instructions include:
  • Less is more – avoid excessive wordage. Pictures in work instructions are effective.
  • Include document control – who generated the document, when the document was printed
  • Written by users – they are the obvious experts on “the how”
  • Easily understood – test them on other users.  
Have any of your own work instruction suggestions? Share with us! We will include them in our next newsletter.  

 

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In the News
ISO 45001 Occupational Health and Safety  

   

ISO 45001, Occupational Health and Safety Management Systems Requirements with guidance for use, will provide the requirements for implementing a management system and framework that reduces the risk of harm and ill health to employees. 

The standard is being developed by a committee of occupational health and safety experts and will follow in the footsteps of ISO’s other management systems approaches, such as ISO 14001 (environment) and ISO 9001 (quality). It will take into account other International Standards in this area including OHSAS 18001, and various national standards.

 

The second Draft International Standard (DIS) of ISO 45001 will be published on 19 May 2017 and the ballot period will end 13 July 2017. This voting stage enables ISO members involved in its development to vote on the current draft before moving closer to publication (expected February 2018). Anyone interested in commenting on the second draft can do so through their National ISO Member.

Six Sigma Pioneer Mikel Harry Dies at 65 
Mikel Harry, one of the early developers of Six Sigma, died on April 25, 2017, in Chandler, Arizona. He was 65. Harry, along with Bill Smith, was one of the architects of Six Sigma within Motorola. He was sometimes referred to as the “father of Six Sigma” although Harry referred to himself as the “godfather” of Six Sigma, and pointed to Motorola engineer Bill Smith as the true father of the six sigma methodology. 
For further reading see the Quality Digest Magazine Article.

 

International Standard for Sustainable Procurement  
Sustainable purchasing can improve supplier relations – and your business. ISO 20400 for sustainable procurement has just been published to help organizations make sustainable purchasing a way of life.
Procurement plays a large role in any organization, large or small. Who an organization buys from has just as big an impact on its performance as what it buys. Ensuring suppliers have sound and ethical practices – across everything from working conditions and risk management to their environmental impact – has the potential to not only make businesses work better, but to improve the lives of everyone in the communities where they are situated.
For more information and to make a purchase of the standard ISO 20400, Sustainable Procurement Guidance, the world’s first International Standard for sustainable procurement, 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.
 

 

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? Have you created a Strategic Business Plan for achieving operational excellence? Are your business processes in control and capable of producing what you 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 an exceptional year, and a mediocre year for you and your organization.

 

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

 

Relationship Engagement Culture

Sunday, April 2nd, 2017

 

This Month

 Events
 
AS9100D:2016 Aviation, Space and Defense Internal Auditor Training. May 16-17th, Chandler, AZ. Register Now!
 
       

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

Celebrating our 15th Year in Business in 2017!

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

 

 

Relationship Engagement Culture

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In our February newsletter, we spoke about Leadership Strategy as a management core competency for creating a Culture of Organizational Excellence.

 
This article focuses on Relationship Engagement as the second Key Driver of Culture, and the importance of establishing systematic processes for establishing role model Senior Leader Engagement. These processes include Listening to the Voice of the Customer, Engagement of the Workforce though goal-driven Performance Management, and Workforce Learning and Development systems.  

 

Engagement alone is not sufficient, and must be linked to the organization’s strategy and supported by a systematic approach for quality management. An effective organization must learn to be strategy driven, engaging both the workforce and customers served by the enterprise, and create alignment with work systems and processes though a senior leadership driven quality management system.

 

Senior Leadership Engagement

Leadership Engagement starts with serving as role models for the organization’s mission, vision and values. Leading organizations design Leadership Systems that translate Strategy into front-line accountable goals that are aligned with the workforce. Two-way communication systems are intentionally designed to communicate key decisions to the workforce and establish trust as the foundation for all relationships. An environment for success can be created with the cultivation of organizational learning, innovation, and intelligent risk taking. A focus on action and personal accountability helps set expectations for high performance and creating value for customers.

 

Voice of the Customer
 
With real time customer relationship management approaches emerging through the use of social media, senior leaders’ efforts in customer relationship management must go beyond merely listening to the voice of the customer through complaint management and service recovery, but learn to enhance engagement through customer input for new product and service development, as one example. Determining customer satisfaction and dissatisfaction with current or potential customers – is just the beginning.

Building and managing relationships requires a proactive approach to exceed expectations in each stage of the customer life cycle to increase engagement and leverage opportunity from competitors’ customers to build market share and enhance the brand image

 

Workforce Engagement

In many organizational the weak link to effective execution on strategy is the lack of workforce alignment to the achievement of goals to attain the desired quantitative results. Senior leader engagement beyond the human resource leader and department function is critical, as often time it is the senior leaders themselves who are not engaged or role-modeling the desired behaviors essential to creating a culture of excellence.

The workforce environment, employee benefits, policies, and job descriptions should be the “given” foundation. However, the highest performing organizations have defined their workforce engagement strategy through approaches that assess the drivers of engagement, to create a culture that empowers the workforce for innovation, intelligent risk taking, and rewards and recognizes high performance. A workforce Performance Management System supported by a Learning and Development System, reinforces new knowledge and skills, and aligns performance reviews with organizational goals.

 

Linking and Aligning Leadership Strategy with Workforce and Customers

What’s the secret sauce? With an overall effective organizational strategy deployed to the workforce to meet customer expectations, business effectiveness can be enhanced with deliberate and intentional measureable direction and progress. However, often dysfunctional Work Systems and Work Processes may impede the ability to provide the services that the Strategies and Engaged Workforce are attempting to provide.

The importance of a Quality Management System, as another linkage between Strategy and Workforce Engagement, will be expanded upon and explored more in our next month article.

 
For any questions about this article or further information, contact our Consultant Dennis at dstambaugh@sustainingedge.com
 
Our services include comprehensive organizational assessments of leadership approaches and systems. We are available to guide your organization toward improved organizational effectiveness.

 

Aviation, Space and Defense Training

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Is your company transitioning, or considering seeking certification to the AS9100D:2016 Aviation, Space and Defense Quality Management System Standard?

We are delivering our two-day AS9100D Process Based Internal Auditor Training on May 16-17th, 2017 at the Hyatt Place Phoenix/Chandler Fashion Center 3535 W. Chandler Boulevard, Chandler, AZ.  All students will receive a comprehensive workbook and a certificate of completion is awarded. Group discounts are available and lunch is included.

If not aware, all AS/EN/JISQ 9100 certification body audits will be to the new revision starting in June 2017 to ensure full implementation by September 2018. This new standard includes a variety of expanded requirements that internal auditors have never been required to review, and the need to ensure effective implementation and consistently meeting requirements.

For course description, registration and payment see our website.  Contact us with any questions.

____________________________________________________

 

We want to inform our readers that in our March Newsletter we advertised that The Arizona Technology Council (AZTC) was hosting the Sixth Annual Conference for Arizona’s Aerospace, Aviation, Defense and Manufacturing Community on Wednesday, April 5, 2017 at ASU SkySong.  We were informed by the AZTC after distribution, that this conference has been postponed to the June 2017 timeframe. Upon notification of the new conference date, we will inform our readers of the details.

 

 

The Signs of Poor Risk Management

Risk based thinking (RBT) is one of the most profound changes to ISO management systems in recent years, but is certainly not a psychological term. It is a clearly-bounded methodological 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”.
According to an article posted on the NQA website blog, the true purpose of RBT is more than just creating a systematic, precautionary approach. Instead, you should look at risk based thinking as a form of  organizational knowledge

 

In order for the organization to learn about new risk, it relies upon a program of internal audits and management reviews. Risks are therefore considered too infrequently to capture and control emergent threats.  Risks are also often managed centrally by a firm. Organizations commonly lack the insight, scope and flexibility to handle risks that occur at a grass-roots level. Decisions to prevent and mitigate risk can sometimes be delayed as employees do not have the capability to assess risk. Often this happens because employees do not feel empowered nor 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. The scope of information about the organizations risk is narrow.   
2.   Complexity – the organization is collecting enormous amounts of information about risk. 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. 
4.   Equivocality – 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 business units resist communicating information about risks across the organization. This typically leads to a condition of both uncertainty and equivocality. 

 

How to Fix the Problem? 
 
Choose the right risk management tools: Digitization, globalization, and competitive rivalry have changed the nature of business – almost beyond recognition in recent years. Risks are no longer linear, and many of the tools developed to provide risk management in the past decades may not work. The right management tools enable organizations to evaluate risk, to share this information internally, and to provide legitimate intelligence that may aid business development.

 

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. Fundamentally your approach must accept risk as a systemic property in a 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.
 
Transition into a risk-intelligent business:  This can take a considerable length of time and experience. The value of implementing an ISO management system (in particular the new 2015 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.
 

We want to add that it is of critical importance that all Systems Managers, not only Quality Managers must not only understand risk, but also adopt a risk based approach to both thinking and internal auditing.  

 

Internal Audit Evidence Collection
strategy

According to the definition, an audit is a “process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled”. That means that the competent auditor will prepare for the audit in order to know what kind of evidence he or she needs to look for, and will be able to seek out that evidence rather than requiring the auditee to “serve up the evidence”.
 

The competent auditor will take care of the following aspects during the audit planning:

 

a) Comprehend the auditee’s structure, business and management practices;
b) Understand the auditee’s processes;
c) Risk based thinking relevant to the industry sector or specific to the organization;
d) Pre-evaluation of statutory and regulatory requirements;
e) Consider the effect of the audit activities on the auditee’s processes;
f) Identify possible audit evidence to look for in the audit work documents;
g) Adequate time allocation.

During the audit process, it is the auditor who has to evaluate compliance or noncompliance based on the audit evidence collected. That means that if the auditor is not capable of finding evidence of conformity it should not necessarily be taken to infer that the auditee does not comply with the audit criteria.

 

During the audit, the auditor should always keep in mind the definition of “audit evidence” and the principle of an “evidence-based approach.
  
Objective evidence: as defined in ISO 9000, is “data supporting the existence or verity of something. Objective evidence can be obtained through observation, measurement, test, or by other means. Objective evidence for the purpose of audit generally consists of records, statements of fact or other information which are relevant to the audit criteria and verifiable.

 

Evidence-based approach: the rational method for reaching reliable and reproducible audit conclusions in a systematic audit process. Audit evidence should be verifiable. It will in general be based on samples of the information available since an audit is conducted during a finite period of time and with finite resources. An appropriate use of sampling should be applied, since this is closely related to the confidence that can be placed in the audit conclusions.

 

Auditors should be aware that objective evidence does not necessarily depend on the existence of documented information, except where specifically mentioned in ISO 9001. In other cases is up to the organization to determine what documented information is necessary in order to provide this objective evidence.

 

 

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In the News
Management System for Educational Organizations    

     

While an educational organization can never guarantee the success of its learners, there are a number of ways that it can more effectively meet their needs and contribute to better learning outcomes.

 
ISO 21001, Educational organizations, – Management systems for educational organizations – Requirements with guidance for use, is a management system standard that is partially aligned with ISO 9001:2015 for quality management systems. It provides a common management tool for educational organizations aiming to improve their processes and address the needs and expectations of those who use their services.
 
The future standard will also help educational providers align their activities effectively with their mission and vision and offer more personalized learning, both of which benefit not only learners but, thanks to improved processes and a system in place for their improvement across time, educators, parents and other stakeholders who will also reap results from the more consistent outputs. For more information, visit the ISO Website.

 

Encouraging News:  Hiring Is Up

 
There’s encouraging news on the jobs front: Hiring has picked up. Gallup’s U.S. Job Creation Index represents the percentage of workers who say their employers are hiring new people minus the percentage who say their employers are letting people go. In 2012, the Job Creation Index averaged +18. For the first three quarters of 2016, it averaged +32.

 

And worker optimism is on the rise. Typically, when a relatively high number of employees voluntarily leave their job, this signals greater confidence among workers who believe they have more and better options. The number of Americans voluntarily leaving their job in August 2012 was 2.1 million. In December 2015, BLS data showed that the number of Americans who voluntarily left their job reached a post-recession high of nearly 3.1 million workers. In August 2016, the number still stood at 3 million workers.

For the most recent State of the American Workplace report, visit the Gallup 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.
 

 

Transition Start Murky At Your Company?  

 

Shouldn’t be.  Time is running out – Get started – We can assist you with the following and more…
  
1. Identify the gaps needing to be addressed with the new requirements.
2. Develop an effective implementation plan.
3. Provide appropriate training and awareness for all parties that have an impact on organizational effectiveness. 
4. Update your existing documented management system to meet the requirements and provide verification of effectiveness.
5. Conduct and document a complete system internal audit to ensure all internal requirements are being met, which includes the new standard requirements, customer, and any applicable business regulatory requirements.
6. Communicate with your CB for transition schedule and arrangements.      

   

Plan and Execute a Successful Transition Now! 

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

 

Lean Daily Management Methods

Wednesday, March 1st, 2017

 

This Month

 Events
 
ISO 9001:2015 Internal Auditor Training  March 13-14th. Chandler, AZ.
Seats Still Available!
       

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, IATF 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.

 

Celebrating our 15th Year in Business in 2017.

 

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

 

Lean Daily Management

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Lean production is an organizational improvement philosophy and set of methods that originated in manufacturing but has expanded to many service sectors and government. Lean enables organizations to work more effectively and efficiently by identifying and eliminating waste in processes which can equate to reduced operating costs and improved customer satisfaction.

Lean methods vary considerably in function, level of effort, and complexity. They can range from quick fix actions your organization can implement regularly with minimal effort or team participation, to week-long events that require more in-depth planning, participation and a variety of formal tools.

Designed to reduce waste and improve efficiency, Lean methods can be used for a variety of purposes-from making your own working environment less cluttered, think 5S to designing and implementing faster and less complex ways of delivering your customer services.

 

Let’s take a high level look at the different types of Lean methods we have used with clients that produced measurable results:

 

Simple, Structured Methods for Workplace Improvements

Lean methods, including standard work, and visual controls, are relatively easy to implement, but provide some defined structure for process improvements. These can be thought of as “Lean Daily Management” methods, since they can be implemented at any time to facilitate continuous improvement, either during or outside lean events.

For example, the 5S method can help to de-clutter and organize a workspace, making it more efficient. Standard work helps to ensure that improvements are documented and made common practice for process owners. Standardized work answers the 5W+1H of a process – the who, what, when, where, why, and how.

 

Event-Based Improvement Methods
Several Lean methods are implemented as “improvement events” lasting anywhere from a one to five days, or more. Two common types of Lean events are Kaizen events and Value Stream Mapping. These team-based methods are very powerful methods for driving improvement in processes. Although the intense period of activity in an event is focused in a few days, keep in mind that events require substantial preparation and follow-up work to be a proven success.

 

Advanced Lean Methods 
More advanced Lean methods include Six Sigma, Strategy Deployment, and Lean Process Design. Six Sigma projects depend on a number of tools for analyzing problems involving multiple variables. These methods can require more technical expertise than typical lean events.

Finding the Method for Your Improvement Goals

Before choosing a method, it can be very helpful to have a clear sense of the initial scope of your project so you can more readily identify the method that is best suited for your needs and goals.  It is important to match your goals to the function of method, as well as to the level of resources required. 

To achieve improvement you have to start somewhere.

Here’s A Question: What type of problem do you have?  I don’t know, what’s a simple method?

 

Process Walk

A process walk, also referred to as a waste walk, or shadowing is a rapid technique to help you identify wastes in your everyday operations. A cross-functional team of employees walks through the work area over a short period of time, identifying opportunities to reduce waste and introduce improvements as they progress.
Improvements can usually be implemented rapidly, resulting in quick gains. This method can help to engage employees in spotting waste in their day-to-day activities after the initial treasure hunt or process walk.

Typical Duration: A process walk is usually conducted in one day or less.

Identify the employees who are involved with the process. Have the group walk through the workplace with clipboards, while team members write down wastes as they identify them. Some questions to ask during the walk include:

  • What inputs and outputs do you see in the process?
  • Where do the outputs go?
  • What is the typical process time?
  • How many items are currently waiting to be processed?
  • What causes delays or problems?
  • What “DOWNTIME” wastes do you see, and what causes them?

Looking for assistance or more information on simplified lean daily management methods?  Let us know.   

Arizona Manufacturing Conference

Interested in growing your business and creating relationships?
 
For all members of the aerospace, defense, aviation and manufacturing community, the Arizona Technology Council (AZTC) is offering a major opportunity for you to connect with potential new partners in April.
 
The Arizona Technology Council, Arizona Commerce Authority (ACA) and RevAZ are hosting the sixth annual Conference for Arizona’s Aerospace, Aviation, Defense and Manufacturing Community on Wednesday, April 5, 2017 at ASU SkySong.
 
Sustaining Edge Solutions is a Conference Sponsor and Presenter.
 

For defense contractors, the event will be your chance to take the spotlight as you explain your needs with subcontractors. For smaller manufacturers and service providers, you will be able to talk directly with A&D decision-makers to learn how to best meet their requirements.

Get out and Show Your Support for the AZ Manufacturing Base! For more information and Registration.

 

Who Are Our Interested Parties?
 

ISO 9001:2015 Section 4.2 defines the Requirements of Understanding the Needs of Interested Parties.
 
It goes on to tell us that due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

 

  • the interested parties that are relevant to the quality management system;
  • the requirements of these interested parties that are relevant to the quality management system. The organization will monitor and review information about these interested parties and their relevant requirements.

 

An “interested party”, according to ISO 9000:2015, 3.2.3, is a person or organization that can affect, be affected by, or perceive itself to be affected by, a decision or activity. 
Why the new Need?  From a business perspective, the valid reasons for defining these parties is that an interested party may affect an organization’s ability to consistently provide customer products and services that meet customer and applicable legal or regulatory requirements.  

ISO/TS 9002:2016, a guidelines standard for applying ISO 9001:2015, says to develop your list of relevant interested parties you should consider the parties:

  • possible influence or impact on your performance or decisions;
  • ability to create risks and opportunities;
  • possible influences or impact on your industry;
  • ability to affect you through their decisions or activities.
All organizations deal with a variety of interested parties, no one size fits all approach applies to any business. Let’s say my company provides precision machining.  Our relevant interested parties – well of course are our customers, and might include our suppliers, business partners, regulatory agency requirements, associations, and competitors.     

To understand the requirements of the relevant interested parties, you can use the following methods to gather information: 

  • review of orders received
  • review of legal requirements with compliance department
  • involvement in lobbying and networking
  • participation in relevant associations
  • evaluation of benchmarking
  • market surveillance review
  • supply chain relationships review 
  • analyzing customer surveys and feedback-good and bad.

Examples of requirements of the relevant interested parties can be: 

  • customer requirements on quality, price, availability, and delivery
  • contracts with customers and external providers
  • industry codes and standards
  • permits and licenses
  • product requirements – safety and regulatory 
  • employee rules and policies

 

The standard does require that you also have effective systems in place to monitor and review the relevant requirements of your interested parties. As always, your interested parties and relevant requirements and needs can change over time due to markets and other factors.  

 

ISO 31000 Risk Management Revision
strategy

The revision of ISO 31000:2009, Risk management – Principles and guidelines, has moved one step further to Draft International Standard (DIS) stage where the draft is now available for public comment.
 
What does it mean? And what happened in the revision process since the Committee Draft (CD) stage in March 2015?
 
The revision work follows a distinct objective: to make things easier and clearer. This is achieved by using a simple language to express the fundamentals of risk management in a way that is coherent and understandable to users.
 
We and many others agree – No Simplicity in the current, multi-numerous documents that ISO has released over the years on risk management guidelines and methods.   
 
The standard provides guidelines on the benefits and values of effective and efficient risk management, and should help organizations better understand and deal with the uncertainties they face in the pursuit of their objectives.
 
The major task was finding the right balance between giving sufficiently detailed guidance and writing an entire textbook. With this in mind, the text has been reduced to its fundamental concepts to create a shorter, clearer and more concise document that is easier to read whilst remaining widely applicable.

That’s not to say that the specific meanings or sectorial jargons that are important to certain users have disappeared. On the contrary, providing more detail and precise information has been an essential aspect of the revision.

To avoid weighing down the standard and making it too complex, it was decided to reduce the terminology of ISO 31000 to the bare bone concepts and move certain terms to ISO Guide 73, Risk management – Vocabulary, which deals specifically with risk management terminology and is intended to be read alongside ISO 31000.

The next step in the process will be to finalize the revision work to reach the Final Draft International Standard (FDIS) stage. The new version of ISO 31000 is expected to be published at the end of 2017 or early 2018.  Looking forward to it – We will keep all our readers informed.

 

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In the News
 

2017 Baldrige Examiner Training Experience    
       

The Baldrige Performance Excellence Program is offering (for a fee) a limited number of seats for their 2017 examiner training course through its Baldrige Examiner Training Experience (BETE) program. BETE attendees learn the same methods and techniques used by examiners and network directly with the examiners and Baldrige staff members throughout the training week, without ever having to serve as an examiner.

You can choose the week that best fits your schedule, but don’t delay in registering because seats are limited and will be filled on a first-come, first-served basis. The registration deadline is March 31, 2017, for U.S. domestic attendees. For more information or to register, contact the Baldrige Program at baldrige@nist.gov.

 

ISO 45001 Making Progress
 

ISO 45001 is back on schedule to be published in 2017 and will soon be joining a suite of management systems standards including ISO 14001 and ISO 9001 for environment and quality systems respectively.

ISO 45001 is the international standard that will replace the current occupational health and safety management system standard OHSAS 18001.

There have been a number of delays on  this planned international standard ISO 45001, due to the rejection by the International standards bodies, which led to some commentators to suggest that there could be further delays. However, a five-day meeting held in Vienna discussed more than 3,000 comments on DIS1 and the revised changes will lead to the issue of the second draft version (DIS2).

Once ready DIS2 will be sent to the national standards bodies for translation and publication before being released to the public for a two month consultation and national voting.

The next meeting is scheduled for 18th – 23rd September in Malacca, Malaysia. This means a final draft could be published in the middle of the year and if the draft is agreed then, the final text could be published by the end of 2017.

 

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.
 

Transition Becoming A Scary Word At Your Company?  

Shouldn’t be.  Get started Now!  We can assist you with the following and more…

  
1. Identify the gaps needing to be addressed with the new requirements.
2. Develop an effective implementation plan.
3. Provide appropriate training and awareness for all parties that have an impact on organizational effectiveness. 
4. Update your existing documented management system to meet the requirements and provide verification of effectiveness.
5. Conduct and document a complete system internal audit to ensure all internal requirements are being met, which includes the new standard requirements, customer, and any applicable business regulatory requirements.
6. Communicate with your CB for transition schedule and arrangements – Your Job 🙂      

 

Plan for a successful transition now! 

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

 

Systematic Performance Improvement

Thursday, February 2nd, 2017

 

This Month

 Events
 
ISO 9001:2015 Internal Auditor Training  March 13-14th. Chandler, 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. Subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

This month, February 2017 is Sustaining Edge Solutions 15th Year in Business! We are so proud to achieve this business milestone and extend our sincere thanks to all our clients and newsletter readers. You are the reason for our continued success.Thank you!

Systematic Performance Improvement

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In our January Newsletter, we spoke about the Top 3 Leadership Drivers for transforming your organizational culture; Strategy, Relationship Engagement, and Quality Management.

Strategy is the first of three Leadership Core Competencies serving as one of 3 Key Drivers for achieving a culture for organizational effectiveness and excellence. This article focuses on the importance of Leadership establishing Organizational Intention through a systematic approach for Strategic Thinking, Strategy Development and the measurement of objectives to assess Strategy Implementation.

Strategic Thinking

When business strategies are extensions of the core mission, vision and values, measurable goals can be articulated to guide organizational performance in the desired direction. Often strategic plans are formulated in closed rooms, then gather dust on CEOs book shelves as the business resumes a “crisis management” reactive culture from year to year. Directed action planning and taking intelligent risk require that the CEO establish senior leadership discipline to maintain the desired direction, but adapt with innovation and agility as changing circumstances may require for sustainability.

 

Strategy Development
There is power in an organization whose senior leaders have the discipline to follow a strategic planning process. Annual assessment of the business internal and external context will enable the senior leaders to identify issues arising from operational, technological, environmental, political, regulatory, and competitive environmental factors. Strategic advantages and challenges can then be considered from a data-driven assessment that incorporates innovation thinking to identify intelligent risks and strategic opportunities that may lead to business growth, despite competitive pressures

 

Once strategies are identified, the organization can leverage its core competencies through work systems development to facilitate the accomplishment of strategic objectives designed to meet its key customer requirements. Measureable Objectives and Goals and timetables for accomplishing action plans can help leverage strategic advantages and opportunities within business short and long term planning horizons.
 

Strategy Implementation

Many Strategic Plans do not get implemented due to inadequate Action Plan Development and Accountability to assure deployment. Action Plans must align to strategic objectives and utilize a measurement system with benchmarked metrics that help stretch operations for Breakthrough Performance. Financial planning must systematically ensure resources are allocated to manage any risk associated with the strategy to ensure financial viability.

Workforce plans must also be developed to address potential impacts on workforce capability and capacity needs. Real time response is needed to modify action plans, if changing circumstances in the external business environment or internal organizational operations require a rapid shift.

 

Linking and Aligning Strategy
Strategy alone, however, is not sufficient, and must be supported by a more holistic integrated approach for internal and external relationship management. An effective organization must learn to simultaneously engage the both the Workforce and Customers of the enterprise. Often the most well-conceived strategy and action planning will be ineffective, if there is a failure to link to the organization’s performance management system to help motivate and incentivize engagement with the workforce.

Relationship engagement with employees, as well as the business key customers, is a critical leadership competency, and is not merely the function of a human resources department or Director. More on relationship engagement as a leadership competency and driver will be shared in the next article in this series.

 

Next Steps

Throughout 2017 in a series of articles, we will go into more detail for each of the top 3 key leadership competencies and the synergy needed for organizational alignment and integration. These are often the “missing links” and internal blind spots, when identified and addressed with action plans by senior leaders, can make the difference between a dysfunctional culture and breakthrough world class performance excellence.

 

This article was written by Sustaining Edge Solutions Senior Consultant, Dennis Stambaugh. Dennis has over 30 years in senior leadership roles within business organizations. Dennis brings extensive knowledge on a systems perspective and the use of quality frameworks to drive effective leadership strategy, cost reduction, and continuous improvement.

 
For any questions about this article or further information, email Dennis at dstambaugh@sustainingedge.com  

 

We deliver Comprehensive Organizational Assessments of Leadership approaches and systems are available to guide organizations toward improved organizational effectiveness.

Click Here to view our Breakthrough Improvement Model for Performance Excellence Achievement.

 

Transition Time Becoming Shorter

 

What’s your company transition timeline?  Have you started, or are you still thinking we have plenty of time left?

Whether you are transitioning to ISO 9001:2015, AS9100D, ISO 14001:2015, or IATF 16949, you have very little time to implement the new requirements.
Here are dates you need to know:
  • All ISO 9001 audits after June 2017 will be to ISO 9001:2015
  • All AS9100 audits after June 15, 2017 will be to the new revision D
  • All ISO/TS 16949 audits after October 1, 2017 will be to IATF 16949:2016

Will you be ready?

We can assist your organization with your transition needs.  Our services include training, gap assessment, documentation and requirements development, internal auditing and much more. 

 

For more information see our transitioning services details. To discuss your specific needs, please contact us.

 

ISO 9001:2015 Internal Auditor Training. March 13-14, 2015. Location:  Hyatt Place Phoenix/Chandler Fashion Center 3535 W. Chandler Boulevard, Chandler. Lunch is included, students receive course material and a certificate of training. Group discounts are available.     

 

IATF Strategy-ISO/TS to IATF 16949
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IATF 16949:2016  has undergone a major revision and was released in October 2016 as the First Edition of IATF 16949.

IATF does replace the current ISO/TS 16949, defining the requirements of a quality management system for organizations in the automotive industry supply chain.

In support of this change, the International Automotive Task Force (IATF) has also published a transition strategy document and also taken the opportunity to release an updated version of the Rules for achieving and maintaining IATF recognition, known as Rules – 5th Edition.

IATF 16949 will fully respect ISO 9001:2015 structure and requirements, however, IATF 16949 is not a stand-alone quality management standard, but is implemented as a supplement to, and is to be used in conjunction with, ISO 9001:2015. Information from the IATF document includes

  • After 1st October 2017 no audits (initial, surveillance, recertification or transfer) shall be conducted to ISO/TS 16949:2009.
  • Organizations shall transition to the new IATF 16949 standard in line with their current audit cycle i.e. at the next planned surveillance or recertification
  • The transition audit shall be the duration of a recertification audit and shall comply with all requirements defined in the IATF Rules, section 6.8. A (new) subsequent audit cycle starts from the last day of the transition audit
  • Organizations can have initial audits to ISO/TS 16949:2009 until 1st October 2017, but their certificates will only be valid until 14th September 2018
  • Organizations may upgrade from ISO 9001:2015 to the new IATF 16949:2016 standard. It is not possible to upgrade from ISO 9001:2008
  • Organizations with an existing Letter of Conformance will need to have a full initial audit when moving to the new IATF 16949:2016 standard 
There a number of new requirements to the new standard, for example product safety, human factors, risk and contingency plans.  We are here to support your transition needs.  Contact us for further information and assistance. 

 

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In the News
Auditing Standard Under Revision   

   

Organizations are increasingly turning to management systems, in a quest to be more effective and save time and money. Many companies have several different management systems, each focusing on different areas, such as IT, information security, quality and environmental management. ISO 19011, Guidelines for Auditing Management Systems, will help with the effective audit of those management systems to ensure continuous improvement, allowing harmonization across systems and a uniform approach of the auditing process where there are multiple systems in place.

The standard is currently being revised to reflect the growing number of management system standards (MSS) and the recent revisions of some of the most widely used, such as ISO 9001 for quality and ISO 14001 for the environment. It has just reached Committee Draft (CD) stage, meaning those countries involved in its revision have an opportunity to make comments on the draft.
ISO 19011 also provides guidance on external audits, including certification and supplier, which support the implementation of the MSS.  The revised version of ISO 19011 is due to be published in 2018.

 

Manufacturing USA Spurs R&D Innovation

Manufacturing USA is working. That’s the overarching conclusion of an independent study conducted by Deloitte with funding from the U.S. Department of Defense.

 

Seven specific recommendations for improvements from the study focus on developing strategies for long-term growth and sustainability, maintaining institute focus on U.S. national priorities, making the most of existing programs in workforce development and other resources, and more.

Manufacturing USA is working. That’s the overarching conclusion of an independent study a major focus of the Manufacturing USA network is workforce development-ensuring that there are enough workers with the right skills to meet the needs of advanced manufacturers. The report notes that baby-boomer retirement; the technical complexity of manufacturing work, science, technology, engineering, and math (STEM) skills deficit among students; and persistent negative perceptions make it difficult for companies to fill critical roles in a timely manner.

The report highlights the institutes’ most effective initiatives that reduce the talent gap through industry workforce assessments, community engagement events, post-secondary apprenticeship programs, and coordination on the creation of effective industry-based and skill-based credentials.

 

To view and download the report “Manufacturing USA: A Third-Party Evaluation of Program Design and Progress view here.

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 are the Steps for Success with Transitioning your Current Management System?

1. Identify the gaps needing to be addressed with the new requirements.
2. Develop an effective implementation plan.
3. Provide appropriate training and awareness for all parties that have an impact on organizational effectiveness.
4. Update your existing documented management system to meet the requirements and provide verification of effectiveness.
5. Conduct and document a complete system internal audit to ensure all internal requirements are being met, which includes the new standard requirements, customer, and any applicable business regulatory requirements.
6. Communicate with your CB for transition schedule and arrangements.

 

Plan for a successful transition now! 

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

 

 

Drivers for Performance Excellence

Friday, January 6th, 2017

 

This Month

 Events
 
 
February 27-28, 2017 Phoenix, Arizona.  See You There!  

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. 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.

Drivers For Performance Excellence

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Welcome to 2017! At this time of year it is natural to reflect on your organization’s annual performance and set business goals for the New Year. The question is what kind of results do you want to create for yourself and your business?

2017 Top 3 Leadership Drivers for Performance Excellence

Introduction

These 3 Top Leadership New Year’s Resolutions can serve as the Key Drivers for achieving a culture for organizational effectiveness and excellence. Planning, Human Resources, and Quality are often “siloed” under different Corporate “Executives and Departments” to provide oversight, however an Intentional Alignment and Integration of Strategy, Engagement and Quality Processes can create Systems Synergy for effectiveness.

 

Strategic Thinking
When business strategies are extensions of the core mission, vision and values, measurable goals can be articulated to guide organizational performance in the desired direction. Often strategic plans are formulated in closed rooms, then gather dust on CEOs’ book shelves as the business resumes a “crisis management” reactive culture from year-to-year.

Directed action planning and taking intelligent risks require that the CEO establish senior leadership discipline to maintain the desired direction, but adapt with innovation and agility, as changing circumstances may require for sustainability.

 

Relationship Engagement
Business strategic thinking and direction must be translated into actions that engage employees toward purposeful action, while providing valued products or services that engage customers. Moving beyond reactive “complaint management” to creating proactive opportunities for listening to the “voice of the customer” can help employees engage in their work through relationship management approaches.

Balancing between internal employee engagement and customer relationship management can serve as two wings of the same bird to help establish trust, essential for effective relationships.

 

Quality Management
It has been said that quality is “everyone’s job”, however many organizations silo the “quality function” under a senior executive or department. Work systems and processes must be intentionally designed to provide value for the service rendered. This becomes more than an operational “policy and procedure manual”, but a defined systematic approach to infuse innovation, continuous improvement, and knowledge management for organizational learning over time. Quality then becomes “the way we do business“.

 

Next Steps

Throughout 2017  in a series of articles, we will go into more detail for each of the top 3 key leadership competencies and the synergy needed for organizational alignment and integration. These are often the “missing links” and internal blind spots, when identified and addressed with action plans by senior leaders, can make the difference between a dysfunctional culture and breakthrough world class performance excellence.

 

This article was written by Sustaining Edge Solutions Senior Consultant, Dennis Stambaugh. Dennis has over 30 years in senior leadership roles within business organizations. Dennis brings extensive knowledge on a systems perspective and the use of quality frameworks to drive effective leadership strategy, cost reduction, and continuous improvement.
 
For any questions about this article or further information, email Dennis at dstambaugh@sustainingedge.com  

Click Here to view our Breakthrough Improvement Model.

 

ISO 9001:2015 Minimal Documentation?

Per ISO 9000 a Document – is information (meaningful data) and its supporting medium. Each organization determines the extent of documentation needed to demonstrate fulfillment of QMS requirements and the documentation medium it wants to use.  Which equates to hard copy or electronic, your choice.

So, is ISO 9001:2015 Really Promoting Minimal Documentation?   

Remember the objectives/purposes of a QMS and its processes are to:
  • Consistently provide products and services that meet requirements;
  • Enhance customer satisfaction through the effective application of the system.
Effectiveness (according to ISO 9000:2015 3.7.11) is the Extent to which planned activities are realized and planned results are achieved.
  • Planned Activities – (processes & monitoring and measurement methods to achieve products and services per 4.4.1c)
  • Planned Results – (evaluation to ensure that processes/methods achieve their intended results e.g., requirements, objectives per 9.1.3)
If your current company documentation is meeting, and hopefully exceeding your planned activities and results (procedures) why eliminate it?

Point:  Now that the standard does not mention Preventive Action, do you eliminate your preventive action procedure and methods? Think twice, many of our clients have seen a large financial and safety payback with preventive measures, and are keeping their preventive action system, why eliminate it?

The extent of documented information is really dependent on multiple factors of an organization such as:

  • The type and size of the organization
  • The complexity and interaction of processes and/or of products and their control
  • Customer, applicable statutory and/or regulatory requirements
  • The demonstrated ability of personnel, and the extent required
Let’s take a further look into the ISO 9001:2015 “Documented Information” requirements.

ISO 9001:2015 – 4.4.2 Quality Management System And Its Processes

To the extent necessary, the organization shall:
a) maintain documented information to support the operation of processes
b) retain documented information to have confidence that the processes are being carried out as planned

ISO 9001:2015 – 7.5.1 Documented Information General

The organization’s quality management system shall include:
a) documented information required by the standard
b) documented information determined as being necessary for the effectiveness of the quality management system

Point: In the end is the ISO 9001:2015 Standard truly driving minimal documentation given the fuller context of the requirements and the need to establish effectiveness?  We don’t think so, and neither should your organization.

Have questions?  Contact Us.

 

ISO/TS 9002:2016 Guidelines
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The new standard, ISO/TS 9002:2016, Guidelines for the Application of ISO 9001:2015, provides guidance on the intent of requirement clauses 4 through 10 of ISO 9001:2015.

This document gives examples of what an organization can do, but it does not add new requirements to ISO 9001. The examples in this document are not definitive and only represent possibilities, not all of which are necessarily suitable for every organization.

ISO 9001 contains requirements that can be objectively audited or evaluated. This document includes examples, descriptions and options that aid both in the implementation of a quality management system and in strengthening its relation to the overall management system of an organization.

As the requirements of ISO 9001 are generic, this document can be used by organizations of all types, sizes, levels of maturity and in all sectors and geographic locations. However, the way an organization applies the guidance can vary based on factors such as the size or the complexity of the organization, the management model it adopts, the range of the organization’s activities and the nature of the risks and opportunities it encounters.

While the guidelines in this document are consistent with the ISO 9001 quality management system model, they are not intended to provide interpretations of the requirements of ISO 9001 or be used for audit or evaluation purposes.

You can purchase ISO/TS 9002:2016 at this website, and others.

 

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In the News
2017-2018 Baldrige Excellence Framework  

 

The Baldrige Performance Excellence Program has released the 2017-2018 Baldrige Excellence Framework (Business/Nonprofit). The 2017-2018 Baldrige Excellence Framework (Education) and 2017-2018 Baldrige Excellence Framework (Health Care) will be released in mid-January 2017.

All three versions include the Baldrige Criteria for Performance Excellence, core values and concepts, and guidelines for evaluating your organization’s processes and results.
Revisions to the Baldrige Excellence Framework, as with previous editions, aim to reflect the leading edge of validated leadership and performance practice.

The 2017-2018 Baldrige Criteria feature a renewed focus on

  • managing all of the components of your organization as a unified whole;
  • managing cybersecurity risks to data, information, and systems; and
  • understanding the role of risk management within a systems perspective of organizational performance management.
Tale of Two Salaries – Quality Professionals 

After last year’s significant increase, the average salary for quality professionals in 2016 remained nearly flat; the increase is described as “barely visible” in the 

ASQ Quality Progress magazine’s 30th annual salary survey.

While salaries in the United States remain flat, the percentage of respondents dissatisfied with their salaries decreased from 35 percent in 2015 to 27 percent this year

– the lowest level since QP began monitoring employee satisfaction in 2014. Furthermore, respondents are most satisfied with their pay when their employers pay for quality-related training and ASQ certifications, demonstrating that they value employees who hold ASQ certifications, and have top management who actively support quality.

Salary survey results are featured in the December 2016 issue of Quality Progress magazine, the flagship publication of ASQ – the leading global authority on quality in all fields, organizations and industries.

For more detailed information view the ASQ 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.
 

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 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 an exceptional year, and a mediocre year for you and your organization.

The Best of the New Year to You!

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

 

AS9110:2016 and AS9120 Released

Saturday, December 3rd, 2016

 

This Month

 Events
 
 
February 27-28, 2017 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 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.

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

AS9110:2016 and AS9120 Released

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The International Aerospace Quality Group (IAQG) has now published AS9110:2016 and AS9120:2016. This completes the revision of the core Aerospace Standards and represents the revised quality standard for aviation, defense and space organizations.

AS9110 QMS Aerospace Requirements for Maintenance Organizations is intended for use by organizations whose primary business is providing maintenance, repair, and overhaul services for aviation sector products. It is tailored for organizations with repair station certification, however it is also suitable for non-certificated organizations, including those that provide maintenance, repair, and overhaul services for military aviation products.

AS9120 QMS Aerospace Requirements for Stockist Distributors is intended for use by organizations that procure parts, materials, and assemblies and sell these products to a customer in the aviation, space, and defense industries. This standard is not intended for organizations that rework or repair products.

The revisions have incorporated essential changes made to international quality management system standard ISO 9001:2015 and additional Aerospace, Space and Defense stakeholder requirements. This will ultimately drive effective operations in increasingly complex environments. Organizations currently certified to AS9100/9110/9120 will need to successfully switch to the relevant 2016 revision by September 2018.

Added requirements beyond ISO 9001:2015 revision include:

Risk Management merged current 9110 requirements with the new ISO requirements and emphasis on risks in operational processes as well as risks during transition period

Product safety / Safety management added in a separate clause and in selected areas with safety performance evaluation requested.

Counterfeit Part and Suspected Unapproved Parts prevention added in a separate clause and in selected areas. Introduction of unsalvageable parts.

New terms introduced in 9110 include “Competent Authority”, “Continuing Airworthiness Management”, “Dismantling”, “Life Limited Part”, “Maintenance Data”, “Product Safety” (same as in 9100), “Qualified Person” and “Unapproved Part”.

 We are here to support all your transition requirements. Contact us for all your AS9100, AS9110 and AS9120 needs.

Quality Objectives – Management Review

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ISO 9001:2015 now requires when planning to achieve its quality objectives, the organization will determine:
  • what will be done,
  • what resources will be required,
  • who will be responsible,
  • when will it be completed,  
  • how the results will be evaluated.

 

Most likely, your organization was already doing this, but how well, and how effective is the question.

 

An organization needs to verify that the overall quality objectives:

  • have been defined,
  • reflect the quality policy,
  • are substantially logical,
  • are aligned and compatible with the organization’s context and strategic direction,
  • and are aligned with its overall business objectives, including customer expectations. 

 

There is no specified way of identifying or documenting quality objectives, as these may appear for example, through business plans, management review outputs, annual budgets. It is up to

the management team to define that the objectives are adequately documented. Evidence should exist to show the way the quality objectives are suitably cascaded throughout the organization’s structure and processes, linking the general strategic objectives to management objectives and down to specific operational activities.

Standards require top management to review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The management review is a process that should be conducted and audited utilizing the process approach. Organizations need to be able to demonstrate that they have evaluated the effectiveness of actions taken to address risks and opportunities during management review.

Based on factors such as size and organizational complexity an overall management review can be a complex process carried out at various levels in the organization. It will always be a process generated by top management with inputs from all levels in the organization. These activities could vary from daily, weekly, monthly, and organizational unit meetings to simple discussions or reports.

The Value of Documented Systems
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Why do so many organizations spend valuable time and resources generating and maintaining documented systems? Asking to see documentation often results in responses about no one reads this bureaucratic or time-consuming paperwork.

 
The following are key benefits to help understand the importance of documentation in all operational processes:

 

1. Accountability: If a process requires documentation, it is much more likely to occur and be utilized. Effective documentation identifies process connections. For example, contract approval would require a documented review of the terms before being accepted.

2. Completeness: If standard forms or checklists are incorporated into a process, these tools become roadmaps to ensure process consistency. Good documentation should show a clear relationship of required inputs and outputs. For example, a machinist might feel tempted to omit measurement data to speed product delivery. But if the inspector ensures the documentation is complete, the process owner will have to include all data requirements to complete the job.   
 
3. Consistency: If given the chance, individuals will complete a given task in many ways. A consistent approach creates organizational efficiency. For example, if a form being used is understood and standardized, the processes used to create the documentation also are standardized.

 

5. Communication: Documentation increases the communication flow between team members. With the increased speed of project activities using e-mail and software, the need for documentation is ever increasing. For example, good meeting minutes and documented action plans allow individuals accessibility to electronic information formats at all times.

 

6. Record: A documented record of actions, decisions, product data can provide the necessary information for years later and protect the company and its employees. For example, a customer’s claim of design error can end up in litigation. If good records are kept, the records would be invaluable for any subsequent actions.

Remember, if documentation is required and not yet completed, the task is not done. The doing and documenting of systems and processes are complementary and very necessary. Thanks to Dan Domalik for his information insights.

Customer Complaint Information
  

An effective organization requires a robust customer complaint system. Complaints communicate customer perceptions of quality, and  compose the largest determinant of customer satisfaction.

Unfortunately, the majority of complaint systems are completely reactive: You’re not reaching out to your customer-you’re relying on the customer to reach out to you. This is a risk laden proposition and for every complaint your organization receives, there may be four, five or more you’ll never know about.

 

Because of its reactive nature, a complaint system should be used in combination with one or two proactive tools.

Here are some suggestions to help you implement an effective system that is capable of improving your customer satisfaction connection.
Get the Details!

 

In addition to your customer service personnel expressing empathy, the person receiving the complaint must gather the correct details. Exactly what went wrong? Allow the customer to provide a general description, then begin to drill down. Typical information includes the following details:

  • What was the exact nature of the problem? Generalities won’t cut it. The problem statement must provide enough detail and depth to facilitate investigation.
  • When did the problem occur? The date is certainly necessary, as might also be the time.
  • Where did the problem occur? The state, city, plant, retail outlet, department, production line and machine all might be important.
  • Who was involved in the situation? What roles did they play?
  • What product was involved? What were the part or style numbers?
  • Were there any specific batch numbers, serial numbers or other identifiers that provide traceability?
  • Was the problem isolated or generalized across all products?

Consistently gathering this expansion of information is difficult without a structured format. Most organizations custom-design complaint forms based on their individual needs and the most effective forms allow customers to go online and submit.  Decide exactly what information you need to investigate customer complaints and take effective corrective action; then design your form around these needs.

 

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In the News
 

Is Job Hopping Inevitable?
       

It’s fair to say that many millennials are job-hoppers.  According to Gallup 6 of 10 members of this generation say they’re open to different job opportunities; only one in two plan to be with their company one year from now; and 50% say they’d consider taking a job with a different company for a raise of 20% or less.

Job-hopping among millennials (born between 1980 and 1996) is problematic because these workers currently make up 38% of the U.S. workforce; some estimate that they will make up as much as 75% of it by 2025.

This job-hopping reality is harsh, but leaders should not accept it as the new norm. Not all millennials are prone to leave, and their engagement at work is at the heart of the issue. Millennials who are engaged at work are 26% less likely than millennials who aren’t engaged to say they would consider taking a job with a different company for a raise of 20% or less. Engaged millennials are also 64% less likely than actively disengaged millennials to say they will switch jobs if the job market improves in the next 12 months.

For more information, visit the Gallup Website.

 

ISO 9001:2015 Transition Progress

We recently viewed a webinar presented by the ISO/TC 176 working group defining results of certification body audits to the new standard.  Witnessed results included:  

 

  1. Not fully established internal and external issues,
  2. Changes to internal and external issues are not a management review requirement/input.  Any upcoming changes or concerns with current system?    
  3. Lack of a balance of issues, other than a focus on product,
  4. What are the organizations largest concerns, including opportunities?  Note: Action may not be required on each external and internal issue.
  5. What are you doing to address growth opportunities?   

These results are key objective evidence requirements of ISO 9001:2015, including industry specific QMS standards.  Ensure your organization takes a comprehensive review of these needed requirements.

 

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.
 

During the ISO 9001:2015 transition webinar we viewed last month, which is referenced above, the speaker stated that just over 10 percent of organizations have successfully transitioned to the new ISO 9001:2015  and 14001:2015 EMS standards.

If your organization has not begun or started to plan the transition for 2017, your time line is getting shorter!

Remember, future certification body audits from June 2017 will be conducted to the ISO 9001:2015 requirements. This timeframe also includes further QMS industry-specific standards.

Happy Holidays and Best Regards,

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