Archive for the ‘Newsletters’ Category

Effective Process Auditing

Monday, June 1st, 2020

This Month

 Events
 
No events or conferences are taking place due to the COVID-19 environment. Take care of yourself, better times ahead. 
 
However, we are in full operating assistance mode – Contact Us Today!   
 
        

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence
  • Executive Coaching
Improved Profits and Much More!

Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 QMS, AS9100 Aviation, Space and Defense, TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards, and more. 
 
Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do you have a topic of interest for a subject article in mind? Please let us know.

   

Effective Process Auditing
 

With the current business environment due to the pandemic, virtual auditing has been a hot topic with various webinars and articles. In this newsletter, we want to complement that focus on how experienced auditors have their own favorite questions to ask when auditing, and how auditors should pay attention to the human side of auditing.

Some auditors struggle with what are the most important audit questions to ask, including are my favorite questions providing the right objective evidence needs? Let’s take a look at what audit questions can help to evaluate your organizations effectiveness and overall performance. The following are some valuable examples.

1. How do you access product or service requirements?

Everyone has a product or service they perform. It can be internal or external, and it can be as simple as passing it on to your fellow co-worker on an assembly line. Ensuring product information, for example documentation be available at points of use. Having access to this information is extremely valuable and the ability to describe how the requirements are carried out.  Specific questions relating to requirements can include:
  • Are the product requirements complete?
  • How do you ensure that correct versions are available?
  • How do requirements get reviewed prior to acceptance?
  • How do you know that the product meets the stated requirements?
  • What happens when changes are made to product requirements, and how are you informed?

2. How are problems identified and prevented?

Correcting a problem can be simple. Define, identify the cause, and take the necessary action. However, preventing it from occurring can be more of a challenge. Examples include:
  • How do you document product or problems?
  • How is the data reviewed and is trending being conducted?
  • How do you communicate ideas for improvement?
  • What statistical methods being used?
  • How do you record an issue that may require corrective action?
  • Do you use a formal problem solving method?

3. How are customer complaints handled?

Customer complaints do happen. Customer complaints represent a large risk as well as a valuable opportunity to improve the organization. As always, it all depends on how the complaints are handled. This is especially relevant to “customer touch point” personnel such as sales people, customer service representatives, technical personnel, and top management.
The auditor must find proof of a systematic approach to dealing with complaints. This typically will include defined responsibilities for logging and tracking customer complaints (internal and external) clear problem statements with all relevant facts included, logical analysis and problem causes, and actions that address the causes.
Here are a few related questions:
  • What method is used to capture complaints?
  • What tools are used to identify the causes of complaints?
  • What is the largest complaint category in your respective area?
  • How are personnel trained to prevent complaints?
  • How are customers made aware of actions on their complaints?
  • Has the number of complaints changed over time?

4. How does top management review the organization’s performance?

Top management should regularly analyze data and trends that show current performance. Is your company becoming more efficient, effective, more competitive, and better at pleasing customers?
ISO 9001 specifically requires management review, with defined inputs and outputs. This does not mean that a separate review is the answer. Effective companies integrate operational reviews and the more timely and action-oriented the review is the better the results. Here are some related audit questions:
  • Who is involved in reviewing the organization’s performance?
  • Are documented actions visible and resources identified?
  • Are comprehensive records kept and distributed?
  • Are all the required inputs and outputs addressed?
  • Documented evidence of continual improvement recorded?
  • How are all personnel made aware of the actions and decisions made?
These process audit questions are just a few examples of what may work for your organization. The best questions for you to ask depends on your organizations priorities, risks, and customer requirements. Focus your audit process on what is relevant, and you will achieve tangible results.

Human Side of Auditing Process
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 This article discusses how auditors can be technically proficient, but struggle with the more human side of the auditing process. Proven techniques can help during interviews and make the auditee more comfortable. The following is a synopsis of a Quality Progress article – Which is Well Worth the Read and Practice! 

“The interview is more than a simple process of asking questions. It’s a relationship, however brief, between two people.”
 
The relationship starts the moment that you, the auditor or assessor, enter the room. There is never a second chance to make a good first impression: Did you enter with an expression of interest or suspicion? How confident did you appear? Did you introduce yourself or wait to be introduced? Did you take on the role of host or guest? Did you display enthusiasm? Your answers form the baseline of the interview relationship, and they determine the quality of the information you will obtain.
Let’s outline five underlying principles and techniques journalists use to conduct productive interviews:

1. Establish two-way trust: Work from the assumption the interviewee wants to share information and wants to make a valuable contribution to your audit or assessment results. Be professional, open and non-judgmental. While your subject may have his or her own agenda, set aside your concerns about that for the moment and try to put the person at ease. People need to feel confident you value what they offer and believe what they say-and that they can trust you.

2. Create a comfort zone: An interview should be relaxed and conversational. Social psychologists suggest we feel more comfortable around people who appear similar to us, with whom we feel familiar, who appear to like us and whose personalities are inherently attractive. If we try to conform to these ideas, there can be a real improvement in the quality of the interview.

By nature, people are unlikely to be open to complete strangers, so share a bit about who you are from the outset. Be prepared. Before you meet your interviewees, try to learn about their work and achievements. If you have the opportunity to meet them in their surroundings, look carefully around their offices and note photos, plaques or other memorabilia.

3. Pay attention: People who make eye contact while speaking are judged to be friendly, self-confident, mature and sincere, while non-lookers are judged as cold, pessimistic, defensive, evasive and immature.

In some instances, people look away when they are being evasive, but sometimes your subject may break the visual connection because he or she is thinking in a more introspective manner. To reestablish eye contact, lean forward as you ask your next question, arrange your face in a quizzical manner or make a hand gesture to draw the person’s attention back to you.

4. Paraphrase: During the interview, you might include an interviewee’s words and phrases in your questions. By paraphrasing, you indicate to your subject that you are listening and following. This technique creates empathy, suggests you are free of preconceptions and clarifies information for others who might be involved in the interview, such as representatives of partners, customers or suppliers. When you paraphrase, you speak the other person’s language, and it helps to convey shared meaning clearly.

5. Downplay yourself: The purpose of an interview is to gather information, not to talk about yourself. The best interviewers “concentrate on their interviewees so much that they almost become invisible. Use mirroring body language to establish rapport. If they sit back relaxed, you sit back relaxed. If they lean forward, you lean forward. it needs to be subtly done.

The best interviews do not just happen! They are the result of careful and conscientious preparation by the interviewer. Auditors must spend a great deal of time learning about the organization, the employees and the processes involved before asking the first question.
The best way to improve your interview skills is to practice-the more opportunities you have to ask questions, the better you will become at procuring the information you seek and your organization needs.

Building Success Through People

The term “people engagement” has been around for a couple of decades and is an often used buzzword, yet many organizations and managers are not entirely sure what it means. People engagement means much more than being present as an employee; it means making an active contribution, feeling genuinely valued and achieving quality outcomes for your organization.

Two ISO standards on people management have undergone an update to include useful steps on how the value of an employee can be enhanced, extended and nurtured. ISO 10015:2020 has become Quality management – Guidelines for competence management and people development, and ISO 10018:2020 is now Quality management – Guidelines for people engagement. Both International Standards present practical steps for managers and leaders to follow, adopt and measure. These standards are designed to be regularly referred to and not simply handed to employees in binders and then left to gather dust on the shelf.

Engaged organizations will have well-thought-out ways of developing their staff. Their aim is to have people there for a career, not just a job. Successful organizations often provide opportunities for staff to move to different areas within the organization to learn new skills and enhance their expertise.

These standards can be purchased at the ANSI Webstore.

Performance Metrics Mix
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Performance metrics are a vital part of managing an organization. Many organizations have a tendency to select metrics by copying what competitor’s measure, what is read in the business press, and what benchmark firms are using.

The best organizational metrics keep the focus on its strategic direction, not the direction in which others are going! 

The types of metrics and the right mix of metrics drives effective outcomes. For example, some metrics should focus on customer needs (externally focused, effectiveness metrics) and some on organizational needs (internally focused, efficiency metrics) so the organization can effectively balance the management of resources used to achieve the market results. An organization with high customer satisfaction and costs that create negative profitability is not going to be a sustainable venture.

Some metrics should be able to evaluate results (outcome or lagging metrics), while others should allow proactive management of the vital factors (process or leading metrics) that create those outcomes. For example, on-time delivery (an outcome) might be significantly impacted by equipment reliability (a leading indicator for delivery performance). However, equipment reliability is an outcome measure for the maintenance management process. As much as possible, metrics should be biased toward business drivers, such as process or leading indicators, instead of outcomes.
Once the desired metrics have been identified, the real work begins. Decisions must be made regarding:
  • Who owns the metric?
  • Where will the data be acquired and how often?
  • How might the raw data be manipulated (normalized) to allow more equivalent comparisons over time?
  • How often should the metrics be reported and analyzed for decision making?
Although it might sound simple, creating operational definitions is an important component of metric details. What is meant by the terms as expressed in mathematical terms (for example, numerator, and denominator and time boundaries)? A company might ask, “What is meant by on-time delivery?” When it is picked up by the carrier or when it arrives at the target location?  Clear measurement and accurate definitions are important to an organizations success.

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In the News

CFOs Preparing for Up to 30% Decline in Revenue

Gartner, the world’s leading research and advisory company survey shows 51% of CFOs Are Preparing for Up to 30% Decline in Revenue This Year Due to COVID-19.

A survey of 145 CFOs and senior finance leaders on April 12, 2020 revealed 51% of respondents said they were preparing for a revenue contraction of up to 30% this year due to the coronavirus pandemic.
Twenty-eight percent of respondents believe the impact to their organization’s revenue could be higher than 30%. “Most CFOs have told us they are using the most severe downside scenarios to inform their decisions right now.
This is leading CFOs to consider drastic cost management actions across April and May”, said Alexander Bant, practice vice president, research, for the Gartner Finance Practice. “When CFOs were asked how these downside scenarios are impacting their ability to fund long-term growth investments,  70% of CFOs said they are now showing caution in this area.”
For more information on this Gartner Survey visit the Gartner Newsroom.

Training Courses
 
Due to COVID-19 Virus course scheduling and delivery is currently suspended.  Let us know if you have a future Year 2020 training need. Stay Safe. 
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.
 

Remote Versus Virtual Audits – We’re conducting Virtual Audits- Are You?   

“Auditing of a virtual location is sometimes referred to as virtual auditing.” ISO 19011. Remote auditing use techniques such as interactive web-based collaboration, web meetings, teleconferences and/or electronic verification of the client’s processes. Remote audits refer to the use of ICT to gather information, interview an auditee, when “face-to-face” methods are not possible or desired. (ISO 19011)

ISO 9001 Auditing Practices Group Guidance on: REMOTE AUDITS – Link to PDF Guidance.

Best regards, 

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

Nonconformance Findings

Sunday, April 5th, 2020

This Month

 Events
No events or conferences are taking place due to the COVID-19 environment. Take care of yourself, better times ahead.               

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence
  • Executive Coaching
Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 QMS, AS9100 Aviation, Space and Defense, TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards, and more. 
 
Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do you have a topic of interest for a subject article in mind? Please let us know.

Certification Nonconformities
 

We recently attended a webinar conducted by a major global certification body that discussed the top findings found by lead auditors during QMS certification and surveillance audits. These findings would apply to management systems that operate under the requirements of the ISO 9001:2015 Global Standard. If you are not aware, all major QMS standards for example AS9100, ISO 14001, and ISO 13485 include this standard requirements.

The top five findings prioritized were identified for an annual cycle which included:

  1. 8.5.1 Control of production and service provision
  2. 7.1.5 Monitoring and measurement resources
  3. 7.2 Competence
  4. 8.1 Operational planning and control
  5. 7.1.3 Infrastructure
8.5.1 Control of production and service provision
Controls to prevent human error would vary based on the service or product type. This can include fixtures that are put in place or only the necessary tools being available in a work cell. Process monitoring and measuring instructions may be in various formats, such as Process sheets, Shop travelers, Test procedures, or similar documents used by the organization which meet the same intent. The validation methods employed by the organization should include, as applicable, defined criteria for review and approval of the processes, use of specific methods and procedures, and requirements for records.

7.1.5 Monitoring and measurement resources

Documented information can be maintained in a calibration database, spreadsheet, or through certificates. This documented information should include reference to the standards used, the results of any calibration or verification as well as when the resource is found not to be valid.

7.2 Competence

Competence requirements for individuals must be determined and can be defined in job descriptions, training records or similar documents.
The company can determine what is appropriate for a position; however, personnel selected must meet defined criteria. The Standard requires the organization to take action to satisfy identified competence needs. There are numerous methods for accomplishing this requirement. Competence needs should be defined for new employees as well as existing employees. Consideration should also be given to competence of temporary/subcontract employees where appropriate. Regardless of the method used, documented information must be retained.

8.1 Operational planning and control

Most organizations have defined processes, documentation, and other resources for product or service needs. When a new product or service is to be introduced, or an existing product is to be modified, consideration must be given to the need for new processes and resources, or the modification of existing processes and resources to fit the needs of the specific product. If the nature of the activities is not routine, then separate planning for each new order or contract may be needed.

The risks and opportunities that were determined in clause 6 must also be addressed. This could be done through methods such as FMEAs or a control plans. The output of the planning process can be referred to as a “Quality Plan”, “Project Plan”, or similar terminology. However, the specific format for the planning is up to the organization.

7.1.3 Infrastructure

Considerations for infrastructure can such things as:
Offices, production facilities, warehousing, and distribution centers, maintaining production machinery, measuring equipment, and handling and conveying equipment, any information technology required to accomplish the tasks should be identified, including hardware and software needs. Supporting services can include things such as building maintenance, maintenance of production machinery, transportation, communication or information technology support.

In our next issue, we will cover the remaining five documented nonconformances found, including areas of consideration for improving your operational system effectiveness.

Collaborating Partnerships
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85% of companies view partnerships and alliances as essential to their businesses, yet only 33 % of them have a formal & clear strategy for collaboration.

Collaborating with business partners successfully is not just about talking to them when there is an issue to be resolved. Rather, it’s a long-term commitment and work ethos that fosters an environment of trust between organizations and people.

From a business perspective, organizations will often seek partners that complement their capabilities to ensure that they meet the expectations of their stakeholders and, at the same time, gain access to new markets. Collaborating in business requires a commitment among parties to co-create opportunities that would lead to mutual and fair benefits for all. A recent study (2018 Global CEO Outlook) conducted by KPMG reports that global CEOs favour strategic alliances as the most important strategy to drive growth, making it an imperative for organizations to learn how to collaborate successfully.

 
A Management Systems Approach ISO 44001, Collaborative Business Relationship Management Systems – Requirements and framework.  
 
This standard provides the overall components of a management system for business relationships as well as operational process requirements. It bridges the gap between organizational cultures to form a more robust partnership or alliance, provide confidence to participants and lay a strong foundation for collaboration.
 
The International Standard features an eight-stage life cycle to ensure a disciplined approach to collaborative relationships which includes operational awareness, value creation, knowledge, internal assessment, partner selection, working together, staying together and exit strategies.
 
Interested?  You can purchase the ISO 44001 Standard at the ANSI Webstore

Customer Valued Feedback

Customer feedback is a real time process. It needs to be used proactively as an evaluation method to be performed on the way in which your company processes are managed, and its ability to provide meaningful information with which to judge the overall effectiveness of your organization.

We find that our clients often use customer scorecards which provide lagging process information on measures such as on-time-delivery, quality, and customer returns.  These measures do have value, but what are you doing to query your customers with real time information on their current and future needs, dissatisfaction, and what are the reasons you purchase from us?

How does your organization collect data to feed the customer process? There are many ways for an organization to monitor its customers’ perceptions. Some examples of techniques the organization can use include:

* face-to-face visits and evaluations;
* telephone calls or visits made periodically or after delivery of products and services;
* internal inquiries among the organization’s personnel who are in contact with customers;
* other contacts with customers, for example by service or installation personnel.

How is the data analyzed? Simply collecting data on customer perceptions is not sufficient – check how the data is analyzed and what conclusions are made with respect to the effectiveness of operations. 

Are there any trends? Is the situation stable, improving, or deteriorating? Are customer needs and expectations changing? Asking the organization about industry comparisons, or bench marking activities, in order to put customer feedback into perspective can be extremely valuable.  How does the information generated by this process feedback into the QMS as a whole? Organizations should be using the results of the customer feedback process to trigger correction, corrective and/or preventive actions and as one of the overall measures of effective operational performance. 

Lean Times for Improvement
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How can your organization take a strategic approach to improve processes during lean times?
  1. Identify the critical processes that produce the most value to your customers.
  2. Communicate with your customers and involve them with defining (or redefining) their needs and wants and adjust your outputs accordingly.
  3. Understand how your processes work.  Dissect your processes and identify the critical variables, inputs into outputs.  For example, people, material, methods, environment, hardware, software.
  4. Establish and/or review the criteria used for the operation of your processes For example, performance metrics related to process outputs, key variables, documentation used, or not used effectively, training effectiveness or lack of training validation.
  5. Use Lean tools and methods to aggressively eliminate waste in these processes.  For example, 5S, value steam mapping, error proofing, kaizen, visual management or kanban.
  6. Follow-up with Six Sigma tools to minimize process variation and improve the accuracy and predictability of your processes.  For example, process mapping, QFD, FMEA, control charts and SPC methods.
  7. Make process improvement a constant within your organization.  Reward people for their ideas and ensure they provide the highest quality product and service. This requires leadership determination and organizational commitment.
In the proactive mode, the organization that recognizes the need to continually improve its processes to meet the challenges of the future, even in these lean times is successful.  Successful organizations understand this – let it work for you and your organization!

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In the News

Lean Aids U.S. Hospitals Finances

More than half of public hospitals in the United States have adopted a lean strategy which has led to improved financial performance and efficiency. This is according to a national study published in late 2019 in the Journal of Healthcare Management.

Of the 288 public hospitals included in the study, 54.2% said they adopted lean methods, including daily huddles, plan-do-check-act cycles, visual management and use of standard work.

For more information from this survey visit the Journal of Healthcare Management

Manufacturing Leaders in Sustainability   

More than half of corporations recognized in an index of 100 most sustainable corporations in the world are manufacturing organizations.
The 2020 Global 100 – spearheaded by the Corporate Knights, a financial research and information firm includes 55 manufacturing organizations. For more information on the top 100 corporations visit the Corporate Knights Website.

Training Courses
 
Due to COVID-19 Virus course scheduling and delivery is currently suspended.  Stay safe. 
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.
 

The near shutdown of the American economy has caused QMS Certification Bodies to rethink how the certification process can be done with limited client resources. This is especially important for those organizations that need to maintain their existing certifications. The information that is coming from ANAB, our ISO technical representative here in the USA, is that Remote Auditing is highly encouraged.

First, understand that your certification body may enact one of two types of remote auditing: Full or Partial. Secondly, some certification bodies (i.e., registrars) will have the ultimate say as to which type will be utilized – not ANAB.

Finally, there are going to be limits set based on the type of certification. Please be sure to contact your registrar for further details and do not hesitate to reach out to us with questions or concerns. 

Best regards, 

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

Creating Culture of Excellence

Thursday, January 2nd, 2020

 

This Month

 Events
ASQ Lean and Six Sigma Conference Feb 24-25, 2020 Phoenix, Arizona
Information and Registration.     
 
        

 

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence
  • Executive Coaching

Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 QMS, AS9100 Aviation, Space and Defense, TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards, and more. 
 
Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do you have a topic of interest for a subject article this New Year?  Please let us know.

 

Creating Culture of Excellence
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As we begin a new decade, many businesses have already or are contemplating a new approach to improve employee engagement. Studies have shown that the more productive your employees are, the more successful you’ll be as a business. Engaged employees are those who are involved in, enthusiastic about and committed to their work and workplace.

However, studies have shown that an estimated 68% of U.S. workers are disengaged. Yet, 90% of leaders believe employee engagement will drive positive outcomes for the business, but only 25% have an employee engagement strategy in place.

For this article, let’s focus on Relationship Engagement 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.

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 management system approach.

 

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 engagement 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 and engagement 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 (are you dealing with this?) sound may impede the ability to provide the services that the Strategies and Engaged Workforce are attempting to provide.

 

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, customer satisfaction success, and effective Employee Engagement.

For more information on our approach, view our Breakthrough Performance Model. Contact us to discuss your strategic needs, and our proven success with achieving organizational excellence.

Read below our current client, R.E. Darling Company Performance Excellence Success… 

 

Performance Excellence Award

Tucson, AZ (December 16, 2019) The Southwest Alliance for Excellence (SWAE) announced today the recipients of the 2019 Performance Excellence Program Awards. SWAE advances improvement and excellence in organizations throughout Arizona, Nevada and Utah using the Baldrige Criteria.  

R.E. Darling Company (REDAR) has received a Commitment Award for Excellence! The Commitment Award recognizes organizations that demonstrate serious commitment to, and implementation of performance improvement principles.      

R.E. Darling, a Sustaining Edge Solutions Client Company, is a family owned and operated Arizona manufacturer of specialty rubber and composite products. Darling’s 170 employees provide the highest quality products and services to its customers in the aerospace, defense, and mining industries.     

“R.E. Darling is committed to implementing the principles of performance excellence under the Baldrige Framework,” said Gary Darling, President. “This is a tremendous accomplishment for our Performance Excellence Improvement teams, and all of the employees at Darling.” 

Congratulations to our client, R.E. Darling Company!  View all the SWAE 2019 Recipients of the Performance Excellence Program.

 

Medical Device Risk Management
Primarily intended for medical device manufacturers, this just revised ISO standard promotes the safety of devices and equipment used for medical purposes. It covers the risks of injury related to the health of patients, the operator and other persons, as well as potential damage to property, equipment and the environment. The standard was updated to better align with changes in medical device regulations around the world.

ISO 14971, Medical devices – Application of risk management to medical devices, specifies the terminology, principles and process for managing the risks associated with medical devices, including software as a medical device (SaMD) and in vitro diagnostic (IVD) medical products.

ISO 14971 helps manufacturers to identify the hazards and estimate the risks associated with a medical device, enabling them to control those risks and monitor the effectiveness of the controls they put in place.

ISO 14971, Medical devices – Application of risk management to medical devices can be purchased at the Techstreet Store.

 

Key Performance Indicators
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Focusing on the measurable elements of the business, key performance indicators, or KPIs, are critical to determining how well an organization is performing.  Eliminating waste, and delivering products and services on time can impact defects and delays. When involving a supply chain, often composed of numerous organizations, the complexities around measuring performance can be consistent.

To properly manage the supply chain, a series of KPIs is needed to uncover performance improvement opportunities.

Finished-product, first-pass quality yield for primary products

Finished-product, first-pass quality yield is an important KPI to monitor the quality and performance of the supply chain. First-pass yield measures how many units are completed in the first pass through the supply chain with no rework. If an organization decides not to measure final-product, first-pass yield, it risks high levels of process inefficiency and waste. First-pass yield helps companies capture and identify high-waste and low-efficiency areas for process improvement and additional monitoring.

Percentage of defective parts per million

Percentage of defective parts per million is a KPI that measures the amount of defective parts out of total parts produced. This KPI focuses on the quality of the process and output before the product or unit is shipped. In most supply chains, defective parts per million should be tracked on some form of control chart with an upper and lower limit-essentially, the expectation of how well the supply chain should operate. Defective part per million is often used in process improvement initiatives as a stake in the ground for performance.

 

Warranty costs (repair and replacement) as a percentage of sales

Warranty costs as a percentage of sales compares the cost spent on repairs and replacement of distributed units to sales. This metric focuses on the amount of units that are defective after distribution to the customer- rather than in process. The warranty costs KPI can be used to track the effectiveness of the quality of the product being produced. Warranty costs can have a huge impact on organizations. The parts being supplied might not be meeting the needs of the business, and ultimately the consumer. It is up to the leadership of the supply chain team to verify that the vendor or partner can meet the requirements of the component, and the requirements of cost effectiveness indicators allow for an organization to better manage and measure their cost effectiveness performance, both internally and externally.

Scrap and rework costs as a percentage of sales

The scrap and rework cost indicator measures the quality of and waste in the supply chain process. This KPI will be tied inherently to other process efficiency indicators, such as defective parts per million, as it measures the cost of poor quality. In any supply chain organization, a poorly managed process can lead to increased scrap and rework costs.

Organizations that currently don’t measure their supply chain effectiveness can put in place these necessary KPIs to boost their business, and by determining what the “right measurements” are and tie them to the drivers of your business.

 

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In the News
Top 15 Lean Conferences of 2020

There is no shortage of lean-related events in 2020, from small regional conferences, to workshops, to large international events that draw the world’s top thought leaders. This list captures what we believe to be the best events, run by the best organizations, for those seeking to learn and network in 2020. Each event is unique and, in most cases, targeted specifically to those in different positions of an organization (lean champions, executive leadership, human resources, accounting) and those with differing levels of lean experience.

 

Full Repeal of the Medical Device Tax 

On December 20. 2019, President Trump signed the bi-partisan 2020 Appropriations Act that includes the U.S. Government funding packages and other key pieces of legislation impacting our medical technology and healthcare communities.
 
The U.S. Senate passed legislation that includes a full repeal of the medical device tax – a 2.3% tax on a range of medical devices and products which previous research has shown to have minimal benefits for doctors, patients and manufacturers.

 

Without this burdensome tax, the U.S. medtech industry – the world leader in medical innovation – can focus now on developing the next generation of treatments and cures for patients in need, and creating good-paying, high-tech jobs in communities across the country.

 

 

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.
 

At this time of year it is natural to reflect on your annual performance and set personal and business goals for this New Year.

The question is 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.

Contact us to assist your organization with achieving your Year 2020 Business Goals!

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

 

Certification Body Service

Friday, November 1st, 2019

 

This Month

 Events
Register Now! Lunch and Learn – Achieving Breakthrough Performance
This Tuesday November 5, 2019 Tempe, AZ. 
Details and Promo Code below.     
 
ISO 9001:2015 Internal Auditor Training November 13-14, 2019-Tucson
Contact us for registration and special pricing   
      

 

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence
  • Executive Coaching

Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards. 
 
Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do you have a topic of interest for a subject article? Please let us know.

Certification Body Process Service
  man_and_woman_dancing.jpg

All organizations that are registered to management systems standards such as ISO 9001 or AS9100 have a Certification Body (CB), also known as a Registrar.  The CB is responsible for certifying the company and conducts onsite audits on a semi annual or annual basis. Some of these CB auditors do travel from other states to conduct surveillance or recertification audits.  Client contractual agreements made (usually covering a three-year period) often state that  the auditor will use the most “cost effective” methods for travel.

If you’re a quality systems professional with at least twenty plus years of experience, you remember the past stories about auditors receiving that special treatment, high dollar dinners, special gifts and fancy hotels. I can picture many of you reminiscing right now, remembering those days of gratuitous behavior.  We certainly do.

Many organizations are also aware that the majority of these auditors are working for the CB’s as a contract auditor- not a full time employee. The majority of CB’s do ensure that their auditors follow specific rules about spending, and they do a good job reviewing receipts and ensuring they comply with specific rules.

 

However, every so often we still hear about that one bad apple. A client of ours recently had an out-of-state auditor from a global CB arrive in a high end performance car (average daily rate ($150- $200.00). The auditor was from the East Coast (no prejudice, we were born there) flying to the West. The company he was auditing was a number of miles away from a major city or hotel service. He inquired prior to arriving where the “nicest hotel” could be found. Unknowing to our client, the auditor also stayed at a high price hotel and we can only imagine what the food bill amounted to. Remember, all auditor travel costs are charged to and paid for by the client.

 

We do know that this occurrence nowadays is a rarity, but be aware that it’s totally acceptable to question any charges that you feel go beyond the conventional.

 

 

Under the auspice of continuous improvement, we have queried our clients over the years about their CB experiences with regards to expectations and services provided. Problems range from administrative – leaving messages with no return call – to prescriptive auditors – issuing non-conformances for items not required or even identified within the Standard. For example, management review requires signatures of attendees. Examples of further comments received include:
  • Customer service person does not know how to reach the auditor when client calls.
  • Customer service person is not trained in the basic understanding of the subject standard inquiry or application process.
  • Client e-mails documentation for review to auditor with Gmail account and the e-mail is returned because file is too large.
  • Client receives advanced audit schedule and auditor does not follow-up with a call to confirm audit arrival, or if any questions; one week or even the day prior to the audit.

     

According to Quality Digest Magazine,the most important certification body customer satisfaction items are:
  1. Was the audit fair?
  2. Was the CB very responsive?
  3. Was the auditor professional?
  4. Was the auditor technically qualified?
  5. Was the auditor objective?
  6. Did the auditor understand how to apply ISO Standard to your business?
  7. Was the auditor a good communicator?
  8. Was the auditor realistic about applying ISO Standard to your company?
  9. Did the CB return calls in a timely manner?
According to the Quality Digest Magazine report, most companies are satisfied with their certification body.  However, taking the time and making the effort to select a service provider, and interviewing the auditor is worth the investment as you will reap the benefits for years to come.

 

Product and Process Audits
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Imagine you’re a supplier seeing a large spike in returns over a component with a high failure rate. After a complete investigation, you discover a production process which hasn’t been measuring an internal component to the proper diameter. Having already shipped numerous items, you realize the problem is far from over, putting your most important contract at serious business risk.

How did this happen? Your final inspector is performing a clear system of product audits and inspection. The hard fact is product inspections don’t always catch process issues responsible for defects. If your quality checks in manufacturing are centered on product audits, your process audits are even more important to quality conformance. Let’s look at the difference between product and process audits.

 

Non-conformances undetected early in the process are often passed through the supply chain causing major disruptions or could even be undetected until an incident occurs. There are critical control points which need to be monitored to prevent these issues.

Product audits usually take place after manufacturing is complete, but before the product reaches the customer. If a product doesn’t meet requirements or specifications, an auditor, or an inspector documents the findings and logs a non-conformance. While each company has its own methods for addressing non-conformances, the process typically includes:
  • Identifying the problem
  • Containing the non-conformance
  • Reworking or repairing the products, if possible
  • Disposing of nonconforming products if you can’t rework or repair them
  • Determining the disposition necessary for preventing recurrence of the nonconformance.

 

Product audits can help improve quality and customer satisfaction. However, finding defects after the product is built contributes directly to increased labor, material, and cycle time costs of inefficiency.

Process Audits focus on how your team plans, builds, packages and delivers your products. This approach provides a more comprehensive view of the value stream that product audits don’t, which only sample the finished output. Process audits look at details of the manufacturing process such as:

  • Planning steps
  • Fabrication methods
  • Safety measures
  • Temperature & environment settings
  • Measurement and documented methods criteria
  • Calibration of gauges
Even experienced team members can deviate from standard work instructions over time, leading to variation and quality issues. An effective manufacturing process audit system that ensures the highest level of quality requires both effective product and process audits.

Documented System Design
A critical question that many organizations face when starting a documented operational management system or improving a current one is “How much documentation is required?”

We find today in many cases that lessons learned from past year’s experiences is driving a “less is more” when it comes to management systems documentation. If we cannot rely on this standard telling us where and how much documentation to write, what can we base our decision on?

 
Do we base it on:
  • Documentation given to us to copy from another organization?
  • A canned template software program “ISO kits” found on the Internet?
  • A 2 page Quality Manual (or is that 4 pages) external firms are presenting to you?
The answer is in the risk associated with needing to control your business processes. What is the risk of a certain system or process not being controlled? Many factors come into play: personnel experience, competencies, turnover, task complexity, customer and regulatory requirements are just some to be considered.

No two management systems are quite the same. Documentation will look different; exclusions are taken for requirements that don’t apply. The number and diversity of procedures, work instructions, and forms, will always vary.

 
A standard’s structure should be a guide for the kinds of documents the organization should consider including within their system. We have seen too many cases where the requirements themselves are only used for guidance (example: verbatim standard language for policies) rather than a sequenced and integrated documentation focus for improving company competitiveness and profitability.
 
Use a risk management process applicable to your internal and external requirements, products and processes when developing documentation and the amount required. Remember, a healthy appreciation of the value of process control documentation is the difference between a certification hanging on the wall, or a sustained organization that always satisfies its customer needs.

 

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In the News
Register Now! 

 
Arizona Technology Council Lunch and Learn –

 

At this informative Lunch & Learn, attendees will learn how to develop a framework for evaluating and establishing breakthrough improvement within their organizations.
  • Understand the critical operational challenges affecting your organizations future.
  • Identify and take action against common business process gaps affecting customer relationships.
  • Learn the truth about the lack of industry employee engagement, the negative cost to business effectiveness and actionable questions.
  • Recognize best practices and lessons learned for achieving operational excellence.
Date: Tuesday November 5, 2019

Time: 11:30AM – 1:00PM

Location: BENCHMARK HEADQUARTERS

56 South Rockford Drive Tempe, Arizona

Click Here for more Event information and Registration. Use PROMO CODE “SUCCESSfor free registration. Lunch is included.

World Quality Month is Here!

 
November is World Quality Month!  It is a worldwide celebration of quality. It’s a time to showcase the advancement and valuable contributions quality professionals make in businesses, communities, and institutions. This month allows all to shine a light on the industry and the individuals striving to provide excellence through quality.
Visit the World Quality Month Website for current and ongoing information to be posted through November.

 

ISO 9001:2015 Process Based Internal Auditor Training  November 13-14, 2019 Tucson, AZ

Location: Azbil-BioVigilant Division 2005 W. Ruthruff Road. Contact us for registration and special pricing!
 

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.
 

At this time of year it is natural to reflect on your annual performance and set personal and business goals for the upcoming year.

The question is 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.

Let us know if we can assistance you with achieving your Year 2020 and beyond Business Goals!

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

 

Process Management Involvement

Monday, October 7th, 2019

 

This Month

 Events
 

Southern AZ Tech and Business Expo October 30, 2019 Tucson Convention Center. We are Exhibiting. Information and Registration.  

 
Lunch and Learn – Achieving Breakthrough Performance November 5, 2019 Tempe, AZ. 
 
See Below for Details on both Events.              

 

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training-onsite & online
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence
  • Executive Coaching
Improved Profits and More!
Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards. 
 
Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do you have a topic of interest for a subject article? Please let us know.

   

Process Management Involvement
  project management flow chart or mindmap - a sketch on a napkin with cup of coffee

In September 2019, the American Productivity & Quality Center (APQC) an international recognized resource for benchmarking and best practices, released the “People of Process Management” by Holly Lyke-Ho-Gland and Lochlyn Morgan. The goal of the survey was to gain insight on the people who support process management work. This survey also was to understand the demographics, skillset, and education of today’s process workers. The study included 726 participants in over 25 industries represented.

The process management study definition included participation in the following activities, for example defining, modeling, and deploying processes, implementing process improvement activities, and managing process improvement teams. The college education level with participants was 35% bachelor’s degree, with almost half of process people, 49% have a masters degree.

The majority of process teams, over 32% are stand alone departments that report to the executive team for oversight of the process department.  This was followed by either operations or I.T. department.  When asked Why Process Management – most process professionals were drawn toward a career in process management because of their desire to improve how work gets done as a capability to support other projects, or as an opportunity to further their career.

This finding is not surprising, the majority of process professionals, including our company personnel followed this career path. In reality, how many of us actually majored in process management? The study continued to showed 29% had a desire to make things better, with 17% saying it was a career opportunity. The respondents represent a wide spectrum of process responsibilities and their time spent on process management is evenly spread out across the spectrum with 40-100% time spent.

The majority of process people’s certifications reflect their core competencies-with 53% Lean and 53% project management, followed by 29% change management and 27% quality assurance.

So, where do people spend most of their time in process management?
  1. Process Mapping and Documentation- 14.5%,
  2. Business Analysis- 14.%,
  3. Facilitation, e.g., workshops- 12.1%,
  4. Problem scoping – 11.6%, and
  5. Project management 11.4%
When asked to what extent do they feel that they have a clear path for career advancement in their current organization, more than one quarter (29%) of respondents indicated that there is still much room for improvement, and almost half (47%) agree that they have a clear career path.

The vast majority do see themselves staying in the process management field. However, they do not see their positions changing drastically and will maintain management positions or work as internal consultants to provide process management services. The majority of survey respondents said their career path in process management was good with a Yes 84%, and a No 16%.

To gain more valuable information on this survey, visit the APQC website – People of Process Management: Survey Report.

 

Supply Chain Management
warehouse_assembly_workers.jpg

Due to the complex supply chains the aerospace sector has it is imperative that organizations have a robust supply chain management process to ensure that parts are produced to the highest quality, are on time and not counterfeit. No matter where you are in the supply chain ensure that you have adequate controls over your supply base.

When the AS91xx series of standards were originally released they were never intended to be implemented so far down the supply chain, they were only intended for the top tier suppliers. However, over time the requirements have flowed down to every organization who touches aerospace parts no matter how small or large.
Due to the complex supply chains the aerospace sector now has it is imperative that organizations have a robust supply chain management process to ensure that parts are produced to the highest quality requirements, are on time and are not counterfeit.Every organization has to ensure that they have effective supply chain controls in place to not only meet standard requirements but to evolve their business.

 

Non-conformances undetected early in the process are often passed through the supply chain causing major disruptions or could even be undetected until an incident occurs. There are critical control points which need to be monitored to prevent these issues.

There are 8 key elements of supply chain management:

  • Supplier approval and surveillance process
  • Contract review process
  • Production planning and First Article Inspection
  • On-going Product and Process Verification
  • Monitoring performance
  • Change management
  • Manufacturing process control
  • Corrective action management
For more extensive information on this topic, visit the NQA Website.

 

Have You Found the Root Cause Yet?
We frequently ask or hear others ask that question. Root cause analysis (RCA) is an old subject and is familiar to many people. If your company is certified to a major global quality standard, you hear it very often and you most likely have contributed to a corrective action using it.
The phrase “root cause” can be somewhat misleading. Many who use it are unaware of the concept’s larger context. Asked what root cause means, some typically respond with:
  • “It is what is really happening.”
  • “It is the one thing that causes everything else.”
  • “It’s the light switch. When you flip it, the lights go on.”
According to Gary Jing, these explanations imply there is one specific thing that is the originator of the considered effects, and the origination is absolute, meaning unconditional and inevitable. This absolute origination is usually referred to as the root cause. The challenge to people is to know when and where to stop drilling down through the infinite layers of cause and effect and conclude they have reached a root cause.

The clue resides in the typical business mind-set. It’s similar to selecting something that can yield a high return on investment (ROI), for example. That is how most businesses make decisions.

One key to unlock the root cause chest is called the span-of-control or sphere-of-influence principle.

Span of Control: The span-of-control principle prescribes that you should try to operate within the span of control (your full authority) as much as possible. The causes within the span of control usually provide the highest leverage, or ROI. In practice, the span-of-control principle can be used to identify where to stop drilling down the chain of causation and to select the preferred root causes to pursue.

Sphere of Influence: Similarly, if a cause is outside the sphere of influence (persuasion only), it’s a good indication you can stop drilling because working beyond that generates no returns. That’s not to say you’ll always give up in this case. The focus then must be shifted to expanding the influence boundaries to enclose the cause currently outside of your influence. In my experience, the sphere of influence is frequently the dominating factor in root cause selection.

Many people have not thought much about the deeper meaning of root cause and, therefore, are not clear on when and where to stop searching for root causes. The so-called root causes are what people subjectively choose to serve in the role of origination. The task to pursue the root cause is really the task to decide when and where to terminate the chain of causation to generate high ROI.

 

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In the News
Southern Arizona Tech and Business EXPO  

Join over 500 business leaders in discovering new technologies, great products, innovative and emerging Arizona-based tech companies and much more at the largest Tech + Business Expo in Tucson, showcasing over 85 booths!
  • Connect and network with your peers.
  • Learn about the amazing technology from a variety of companies in optics, biotech, mining, aviation, machining, robotics, aerospace, IT and more!
  • Discuss global technology issues with your peers and leaders in our industry.
Looking to make new business opportunities, and network with various industry personnel – Don’t miss this event!  Sustaining Edge Solutions is an EXPO Exhibitor – Drop by our Booth and Visit Us!!

 

Date: Wednesday, October 30, 2019

Time: 12:00 – 6:00 PM

Location: Tucson Convention Center 

 

Arizona Technology Council Lunch and Learn –

At this informative Lunch & Learn, attendees will learn how to develop a framework for evaluating and establishing breakthrough improvement within their organizations.

  • Understand the critical operational challenges affecting your organizations future.
  • Identify and take action against common business process gaps affecting customer relationships.
  • Learn the truth about the lack of industry employee engagement, the negative cost to business effectiveness and actionable questions.
  • Recognize best practices and lessons learned for achieving operational excellence.
Date: Tuesday November 5, 2019

Time: 11:30AM – 1:00PM

Location: BENCHMARK HEADQUARTERS

56 South Rockford Drive Tempe, Arizona

For more event information and Event Registration, visit the Arizona Technology Council Website.   See You THERE!

 

 

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.
 

With the Year 2020 approaching all of us, business planning is in full swing. 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?

Times change, your business may need to consider some new, and tried and true strategies:
1.  Understand what your customers really care about
2.  Every business today needs to get their message out.
Original Content Creation and Social Selling continues to grow through websites, LinkedIn, Facebook and other channels.
3.  Collect the right information to strengthen your customer knowledge.
4.  Establish a stable sales and operational management system.
5.  Keep Customer Prospecting.
If you only pay attention to current customers, you will suffer long-term opportunities, to your competition’s delight. When businesses grow to a certain size, any management team can get into a mode of not needing to prospect all the time. Few people like to prospect for new customers, but you have to do it continuously!

 

Best regards,

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

 

Audit Planning and Preparation

Friday, September 6th, 2019

 

This Month

 Events
 

Southern AZ Tech and Business Expo October 30, 2019 Tucson Convention Center. We are Exhibiting. Information and Registration.  

 
Lunch and Learn – Achieving Breakthrough Performance November 5, 2019 Tempe, AZ. See Below for Details  

 


      

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training-onsite & online
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence
  • Executive Coaching
Improved Profits and More!
Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards. 
 
Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do you have a topic of interest for a subject article? Please let us know.

Audit Planning and Preparation
  laptop-couple.jpg

If your organization is certified to one or more globally recognized operational standards, at a minimum your certification body auditor(s) visits you for an annual audit. And of course, depending on the size of your organization it could be a short audit, or multiple days of onsite auditing. An effective organization should take the time to plan and prepare for every external audit prior to execution. An ineffective organization runs around the the  week prior screaming “The Auditor is coming, the Auditor is coming!”  Where do you fit in?    

The following are tips for planning and preparing for your next external audit:            

1. Read the last audit report in preparation – Your audit report contains useful information regarding the Auditors impression, facts, results, and opportunities of how things looked last year.

2. Ensure that any corrective actions required have been addressed and closed out – Your Auditor will ask to see evidence that previously raised nonconformities have been closed effectively, so have the objective evidence ready. If not done properly, great chance you will be receiving a major nonconformity.

3. Have you taken advantage of any opportunities for improvement (OFI’s) identified in the report? These nuggets are raised to help you improve your systems and your business effectiveness.  Many of our clients actually raise their OFIs to an internal corrective action status, when real value is determined by the management team.

4. Is your documented management system fully up to date and reflecting changes that have happened in your business? For example, interested parties, business issues, risk and opportunities? Ensure that any pertinent updates follow your document control and records needs.

5. Have any changes occurred in the business – your Auditor will be interested in understanding what is different in the organization.  For example, personnel, business expansion, growth, regulatory additions. Be prepared to provide a summary.

6. Are you current with required process controls? For example, internal audits, your management reviews, calibration of measuring equipment? Ensure effective compliance. A formal calendar is a great way to remember important process events and make sure they happen in a timely manner.

7. Have you reviewed and communicated to your team the  CB audit plan? Make it a priority to yourself and others as to what the Auditor is planning to do – can you foresee any problems with the plan? If so contact the Auditor to discuss the planned arrangements.

8. Ensure appropriate staff are available to support the audit as required. This staff is Beyond the Quality Department!  Circulate the plan to people that need to be available – particularly ensure departments where the process and access to records is restricted to a small number of individuals – are these people available at the required time, if not who is going to step up?

9. Is a customer site visit required?  Some visits require the processes to be witnessed on a customer site. Example can be installation, maintenance of equipment or the provision of a service.  If a site visit is to be required, the plan will say so.  Investigate the availability of suitable sites and secure your customer’s permission to be on site with your Auditor. Find out where your Auditor is travelling from and plan accordingly.

10. Breath!! Your Auditor is there to work with you, assist with process improvements, and opportunities to help you get the most from your management systems.

Desperately wanting to improve your internal audit effectiveness, including preparation, methods, and achieving measurable results?  We deliver classroom and onsite internal auditor training, and provide outsourced internal audit services.  Contact Us, and make a difference in your internal audit effectiveness!           

 

I. T. Service Management

An IT service management system (ITSMS) is a strategic tool to help organizations improve efficiencies, optimize the use of technologies, save money and provide many other benefits that go beyond IT. The ISO and IEC’s 20000 series provides international best-thinking for an effective ITSMS. Parts of the series have just been updated.

Some of the world’s most knowledgeable experts on ITSMS worked together to develop ISO/IEC 20000-1, Information technology – Service management – Part 1: Service management system requirements. It is a valuable tool for organizations wanting to implement or maintain an ITSMS. Following its revision late last year, two guidance documents in the series have been updated and another has been developed.

ISO/IEC 20000-2, Information technology – Service management – Part 2: Guidance on the application of service management systems. and ISO/IEC 20000-3, Information technology – Service management. They provide important information and recommendations for service providers to conform to the requirements of ISO/IEC 20000-1. This includes service management policies, objectives, plans, service management processes, process interfaces, documentation and resources. Both documents take into account the high level structure, which is a structure common to all ISO management system standards.

You can purchase these standards at the ANSI Webstore.

 

Organizational Knowledge
corner-office-man.jpg
Organizational Knowledge is a resource needed for any successful organization to support its business strategy, to obtain business objectives, maintain personnel competencies and conformity of products and services.  It is now addressed in an explicit way in ISO 9001, AS9100, and other standards as a requirement. 
This has been a recurring issues with some of our client certification audits, so let’s bring some clarity here. 
 
Organizational Knowledge is the specific knowledge of the organization, coming either from its collective experience or from the individual experience of its personnel. In an explicit or implicit way this knowledge is, or can be, used to attain the organization’s objectives. Organizational knowledge may be recorded for example in documented information, imbedded in the processes, products and services of the organization.
 

The requirements for organizational knowledge in the context of a QMS can be summarized by the knowledge needed for the operation of QMS processes and to achieve conformity of products and services. Consider internal and external sources, such as:

  • learning from failures, near miss situations and successes;
  • gathering knowledge from customers, suppliers and partners;
  • capturing knowledge that exists within the organization, e.g. through mentoring, succession planning;
  • sharing organizational knowledge with relevant interested parties to ensure sustainability of the organization;
  • updating the necessary organizational knowledge based on the result of improvements.
  • Knowledge coming from conferences, networking, seminars, or other external events.

ISO 9001:2015 requirement 7.1.6 Organizational Knowledge is much more than maintaining training records. Specifics do require addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.

 

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In the News
Arizona Technology Council Lunch and Learn –

 

At this informative Lunch & Learn, attendees will learn how to develop a framework for evaluating and establishing breakthrough improvement within their organizations.

  • Understand the critical operational challenges affecting your organizations future.
  • Identify and take action against common business process gaps affecting customer relationships.
  • Learn the truth about the lack of industry employee engagement, the negative cost to business effectiveness and actionable questions.
  • Recognize best practices and lessons learned for achieving operational excellence.   

Date: Tuesday November 5, 2019

Time: 11:30AM – 1:00PM

Location: BENCHMARK HEADQUARTERS

56 South Rockford Drive Tempe, Arizona

 

Manufacturing Day – October 4, 2019 

Held annually on the first Friday in October, Manufacturing Day helps show the reality of modern manufacturing careers by encouraging thousands of companies and educational institutions around the nation to open their doors to students, parents, teachers and community leaders.

Manufacturing Day addresses common misperceptions about manufacturing by giving manufacturers an opportunity to open their doors and show, in a coordinated effort, what manufacturing is – and what it isn’t. By working together during and after MFG DAY, manufacturers will begin to address the skilled labor shortage they face, connect with future generations, take charge of the public image of manufacturing, and ensure the ongoing prosperity of the whole industry!  Get Involved!!

For much more information, visit the MFG Day National Website.  For our home state of Arizona Events and Posting of Your Event, visit the Arizona Manufacturers Month 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.
 

With the strong economy many companies are finding it difficult to attract qualified employees, and/or their current employees are seeking greener pastures. 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)

In today’s business environment addressing changing needs and trends, can help determine knowledge gaps and and determine how to acquire or access any necessary additional knowledge and resources needs. Training will always be an evolving need for all organizations. What are you doing to improve your employee skills and knowledge?

Best regards,

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

 

Creating Value With Innovation

Thursday, August 1st, 2019

 

This Month

 Events
 

 Southern AZ Tech and Business Expo October 30, 2019 Tucson Convention Center. We are Exhibiting. Information and Registration.   

 


      

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training-onsite & online
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence
  • Executive Coaching
Improved Profits and More!
Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards. 
 
Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do you have a topic of interest for a subject article? Please let us know.

Creating Value With Innovation
 

Innovation can be defined as making meaningful change to improve products, processes, or organizational effectiveness to create new value. Innovation can involve adopting an idea, process, technology, product, or business model with the purpose of creating new value. Innovation benefits from a supportive environment and a process identifying opportunities.

Innovation is often associated with technological advances.  However, the outcome of innovation is much more broader than a single entity.  Innovation drives  “breakthrough improvement” in results, products or processes. A good example of innovation in our service industry is engaging with a start-up. A start-up company President informs us he wants to build his operational system foundation around a globally recognized quality standard-without being told to do so by his future customers, now that’s innovation!

Innovation and incremental continuous improvement are different, but have complementary concepts.  Successful organizations use both methods to improve performance.

One of the most efficient ways of capturing thoughts and changes within all the layers of an organization is through implementing an innovation management system approach.

The first International Standard for such systems has just been published.

ISO 56002 Innovation Management – Innovation Management System – Guidance, covers all aspects of innovation management, from how to generate those first sparks of an idea, right through to selling something new in the marketplace. It considers the context that an organization is working in, the culture, strategy, processes and impact. It crosses many types of activities including products and services, business models, organizational innovation and more, and is applicable to all types of organization, regardless of size or type.

A challenge is to identify what will give the organization the competitive edge and create value for the future, and thus which strategic actions to take. By providing guidance on how to best capture ideas, test them effectively and manage the risks and opportunities associated, ISO 56002 can help organizations create new value propositions and maximize their potential in a structured way.

You can purchase ISO 56002 Innovation Management at the ANSI Webstore.

What signifies Organizational Breakthrough Innovation and Improvement?  We consider it a dynamic, decisive movement to a new higher level of business performance. Developing an effective systematic approach is critical for achieving scalable profit growth.  For more information, view our Breakthrough Improvement Approach and contact us to develop your organizational plan.       

 

Risk Assessment Techniques
risk management flow chart drawn by hand isolated on blackboard

In 2018, a revision to ISO 31000 Risk Management-Guidelines was released in a timely and appropriate fashion, considering the new risk and opportunity management requirements in global management standards. This version delivered a clearer, shorter and more concise guide that helped organizations use risk management principles to improve planning and make better decisions.

Just published – IEC 31010 Risk management expands its range of applications and adds more detail than ever before. It complements ISO 31000, Risk management.  IEC 31010 describes the process to be followed when assessing risk, from defining the scope to delivering a report. It introduces a wide range of techniques for identifying and understanding risk in a business or technical context.
The IEC and ISO risk management toolbox features internationally agreed standards with best practice and benchmarks on how to manage risk, as well as a risk management framework, agreed principles and processes.  The standard is useful both as part of a process to manage risk and when comparing options and opportunities so that decisions are based on a good understanding of risk.

We recommend that you take a look at this effective wide range of techniques for identifying and understanding risk in a business or technical context. 

You can purchase IEC 31010:2019 Risk Management at the ANSI Webstore.

 

The Customer is Always Right
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Companies have tried different approaches to get-and keep-customers. “The customer is always right,” is possibly the first worldwide slogan to make customers feel special but usually in response to something gone wrong. 

A survey was conducted that pointed out some interesting gaps in customer service. The survey polled more than 600 quality and customer service professionals worldwide. 

 
The survey found that companies are much more likely to invest their resources in areas other than customer service. Only four percent of survey participants rank customer service initiatives as a top priority compared to 38 percent for new product or service development, 18 percent for information technology, and 13 percent for marketing and advertising.

The majority of companies (36 percent) also responded that they have not created a management-level customer service position to help manage the customer service experience, while 28 percent say that service is managed through the customer service department, and 20 percent say that it is part of the quality department responsibility.

 
The survey respondents offered these nuggets of advice for improving customer service experiences:
  • Change the approach to customers from a transactional focus to building long-term partnerships.
  • Consider a rapid response team charged with identifying and resolving customer service issues.
  • Systematize responses to customer complaints such as using a standard form for root cause analysis. Try to analyze failures to see if systematic issues can be resolved.
  • Educate product teams on what the customers’ expectations are and what the team’s priority is.
  • Make sure to share service survey analysis with upper management so they can support changes in service delivery.
  • Address issues as timely as possible-in the moment is preferred.
How do you envision customer experience and quality playing a shared role in your organization? Pass on your ideas to those who can help make it happen!

 

AIAG & VDA FMEA Handbook
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Suppliers to the Automotive Industry understand the needs and requirements of core tools application for managing FMEAs, Control Plans, and PPAP documents. A new much anticipated document was just published in June 2019.  

The AIAG & VDA FMEA Handbook is the new automotive industry reference manual for Failure Mode and Effects Analysis, it is to be used as a guide to assist suppliers in the development of Design FMEA, Process FMEA, and Supplemental FMEA for Monitoring and System Response

Developed with a global team of OEM and Tier 1 Supplier Matter Experts (SME’s) it incorporates best practices from both AIAG and VDA methodologies into a harmonized, structured approach.  This new handbook combines AIAG and VDA FMEA methodologies with OEM requirements and added new severity, occurrence and detection criteria within the ranking tables. Other important change from the last revision to the new manual involves the addition of a 7th step for communicating actions taken to reduce risks. 

Additional important changes include the following:
  • Totally revised Severity, Occurrence and Detection Tables.
  • The Action Priority (AP) methodology and Tables to replace RPN.
  • New Form Sheets (spreadsheet users) and Software Report Views (software users).
  • Change point highlights from both the AIAG 4th edition FMEA Manual and the VDA Volume 4 FMEA Manual.
From the increased focus on function-based FMEAs to the additional tools and guidance provided to support a more robust methodology, this new handbook provides consistent direction and guidance to all automotive suppliers.  Visit the AIAG Store for all your publications and tools support needs. 

 

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In the News
Congratulations to our Clients M&R Sheet Metal and Manufacturing, and Unmanned Systems Source for Achieving AS9100 Aviation, Space and Defense Certification!

M&R Sheet Metal & Mfg., Inc. in Tucson has embraced rigorous standards of excellence in all its precision-manufactured products since 1983. The company has been ISO 9001 certified since 2013, and now is certified to the AS9100D Standard.    
 
Unmanned Systems Source in Tucson is an e-commerce company with the fastest growing selection of unmanned vehicles, parts, products, components, and systems. It is positioned as a single source of supply and information and serves commercial, governmental and public sector markets. For more information and product review visit the Unmanned Systems Source Website.   

 

July 19, 2019 News Release NIST Public Affairs Office:
 
The Commerce Department’s National Institute of Standards and Technology (NIST) has named Dennis G. Stambaugh, of Sustaining Edge Solutions, Inc. in Tucson, Arizona, as a member of the Board of Examiners for the 2019 Malcolm Baldrige National Quality Award.  The Baldrige Performance Excellence Program-which provides value to U.S. organizations and the nation’s economy at a benefit-to-cost ratio of at least 820 to 1 owes much of its success to the hundreds of dedicated volunteers who serve as examiners each year.
 
Gartner Identifies the Top 8 Supply Chain Technology Trends.
 
Gartner’s top strategic supply chain technology trends have broad industry impact, but have not yet been widely adopted. They might be experiencing significant changes or reaching critical tipping points in capability or maturity.
 
The top 8 supply chain technology trends in 2019 are: (1) Artificial Intelligence… Read More.

 

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.
 

Every business today needs to get their message out.

Original Content Creation and Social Selling continues to grow through websites such as LinkedIn, Facebook and other channels. Here are some survey findings one social selling company recently assembled on activity in the sector:
  • 79% of salespeople who use social media outsell those who don’t.
  • 53% of buyers said they listen to peer recommendations before they make a purchase.
  • 65% of buyers feel the vendor’s content had an impact on their final purchase decision.
These trends will continue to grow. Thought content-from blog posts to videos-that create a sense of excitement among consumers will only become more crucial.
Businesses with the most compelling, original voices will rise above the noise!

Best regards, 

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

 

Process Risk Analysis

Sunday, June 2nd, 2019

 

 
This Month

 Events
 

 AZTC Aerospace, Defense & MFG Conference June 20th, Scottsdale AZ.

 


 

      

 

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training-onsite & online
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence
  • Executive Coaching
Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards. 
 
Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

 

Do you have a topic of interest for a subject article? Please let us know.
   

Process Risk Analysis
  risk management flow chart drawn by hand isolated on blackboard

Process risk can come from many sources. Organizational process risk can result in unintended consequences, including what is affected. Understanding risk with a focus on process analysis can help you understand what could go wrong with a process, and what to do about it.

Risk analysis is usually driven by two variables: likelihood and impact. A risk that is highly likely to happen and would be highly disruptive to the business may require process improvement or contingency planning.  A risk management process generally consist of three main steps:         
  1. Identify risks- A risk is an effect of uncertainty on objectives, a deviation from the expected. The deviation could jeopardize success, cost or time, or a strategic goal. A process risk must be identified, and controlled by management within a formal system.
  2. Analyze risks – Risk analysis starts with proven methods.  For example a risk analysis table, risk cube, or an FMEA driving an assessment of potential outcomes. Risk analysis takes place when managers review the identified risk, assess its likelihood and impact, and determine severity based on a known scale of thresholds.
  3. Risk response – Follow the likelihood and potential impact of the risk. Managers can brainstorm possible mitigation and contingency actions. This can include a review of performance data history to identify risk response.  Maintaining a list of common risk sources by specific categories we have found can create an effective risk identification. Process risks affected could be product quality, schedule, equipment, customer satisfaction, and others.    
ISO:9001:2015 states that an organization will plan actions to address risks and opportunities – determine internal and external issues, including needs and expectations of interested parties. The following is an example of an approach we used with a start-up company in determining these requirements and risk factors.  
  1. What are your markets or market sectors?
  2. Are there any regulations or standards you have to plan for/work with? 
  3. Do you have any indispensable partners? 
  4. What does your perfect customer look like? What kind of customers are you after?    
  5. Who makes up your core team?  External/Internal-employees?  
  6. What’s the worse that can happen with your work environment? Defining the company scope of the management system first helps with this question.      

 

Does it all add up when you write the answers to these questions down? Is there a clear linkage between the company scope statement, context and interested parties? This would include risk identification and risk analysis using a proven method such as a risk table or a SWOT model.  This method is an interesting twist we picked up at a conference recently from other conventional methods we and you most likely have used to determine these requirements. 
 
Any thoughts on the value here, tell us what you think?     

 

ISO 14001 Guidance Document
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Implementing an Environmental Management System (EMS) based on the ISO 14001 standard may seem like a large task, but that doesn’t mean it is just for major industries in any market. Breaking it down into phases is the key. A newly revised guidance document just published helps businesses of all shapes and sizes put an EMS in place in the way that suits them – and reap the benefits every step of the way. 

ISO 14005:2019, Environmental Management Systems – Guidelines for a flexible approach to phased implementation, provides small to medium size companies with a means to overcome this by enabling them to meet the requirements of an EMS in a phased, flexible way that is adapted to their specific needs. It allows them to start benefiting from the very beginning while ultimately meeting the requirements of the ISO 14001 EMS Standard.

 

The standard has just been revised to ensure it is up to date and continues to meet market needs.  Improving environmental performance is made easier with formal systems in place. However, small and medium-sized enterprises often find EMS implementation difficult due to fewer staff and resources.

ISO 14005:2019 allows companies to easily measure the business value and benefits of implementing an EMS and ensuring they get a return on their investment.  You can purchase the ISO 14005 EMS Guidelines document at the ANSI Webstore.  Contact us with your ISO 14001

questions, or seeking assistance with implementing an effective ISO 14001 Environmental Management Systems for your organization.

 

Metrics That Matter
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If you’re a first-line supervisor responsible for managing operations, you know how important operational metrics are to the life 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. Although most metrics on the executive dashboard are finance-related, executives 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.

 

Whatever method you use, it should be fine with the auditor.  There are no rules on how you should present this information, and you chose whatever suits your business.

Cost of QualityThe 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 actively involved with as 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).
 
Keep that Appraisal Costs and Prevention Costs in mind.  We will continue this article in our next issue.  Don’t want to wait? Give us an email / phone call metrics that matter shout!   

 

Customer Complaints – Justified?

Has your organization decided that it’s a good idea to classify customer complaints according to whether they are “justified?” We have seen this occurrence take place this year during audits where a complaint due to using a product beyond its capability took place. The company felt it wasn’t necessary to utilize their corrective actions system for identification and resolution.

 
If I’m a customer, all my complaints are justified. If you try to tell me that my complaint is “unjustified,” it’s only going to make me angrier than I already am! Once the customer experiences a problem, it becomes the company’s problem. Regardless of the fault of the problem, customer satisfaction has been affected, and action must be taken.

 

Reporting Back to Your Customer. Customers want to know what action has been taken. After all, the customer had a negative experience related to something they spent their hard-earned money on. They even took the time to tell the organization about it. Now they’re curious. What are you going to do about it? If your organization is interested in turning the negative experience into a positive one, someone must take the time to report back to the customer. The communication should include these three key elements:

 

  1. The results of the investigation into the problem;
  2. The action taken; and
  3. A statement of thanks for reporting the problem.
Reporting action back to the customer closes the loop on the issue. It also lets the customer know that you take his or her feedback seriously and are committed to making improvements. In some cases, it will determine whether your organization remains a supplier to this customer.

 

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In the News
2019 Aerospace, Aviation, Defense and Manufacturing Conference.  Thursday, June 20th in Scottsdale at ASU SkySong.

 
The Arizona Technology Council, Arizona Commerce Authority and the Arizona MEP are hosting the eighth annual Conference for Arizona’s Aerospace, Aviation, Defense + Manufacturing community.  Attendees will gain a full understanding of the latest trends, challenges, and forecasts in the aerospace manufacturing industry, and hear insider knowledge from industry professionals. From amazing exhibitors to keynote speakers, expert panels, and great networking, this is an event you do not want to miss!
Review Agenda and Registration.  We are Attending- See you There!

 Exemplar Global Online Auditor Expo

The Online Auditor Expo is the new name for the International Auditor Symposium. Now in it’s third year, The Online Auditor Expo is a comprehensive online conference for auditing and standards professionals.
The event is 100 percent online and will run 24 hours a day, seven days a week for the entire month of June, 2019. The Online Auditor Expo will consist of numerous pre-recorded sessions covering a variety of auditing topics such as quality, auditing skills, environment, occupational health and safety, and future technologies. Register and pay $99 USD today to enjoy a month of auditing and standards content at your fingertips. Current Exemplar Global certified professionals are elligible for free registration.
    

   

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.
 

Why are some people more productive than others?

MIT Sloan Executive Education conducted a survey of 20,000 people from six different continents on why some people are more productive than others.
Interesting result- On geography, the average productivity score for respondents from North America was in the middle of the pack, even though Americans tend to work longer hours. In fact, the North American score was significantly lower than the average productivity scores for respondents from Europe, Asia, and Australia. For more information visit the MIT Sloan Executive Education Blog.
          

Best regards,

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

 

ISO 45001 OH&S Standard

Monday, April 1st, 2019

 

This Month

 Events
 

 World Conference on Quality and Improvement May 20-22, 2019 Ft. Worth, Texas

 

 

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence
  • Executive Coaching
Improved Profits and More!
Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards. 
 
Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do you have a topic of interest for a subject article? Please let us know.

ISO 45001 OH&S Standard
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We have now surpassed the one year mark since the publication of the ISO 45001 Occupational Health and Safety Standard. In 2021 OHSAS 18001, the predecessor will be withdrawn leaving ISO 45001 as the primary global OH&S management system standard.

ISO 45001:2018 is a new International standard which provides a framework, regardless of size, activity and geographical location, to manage and continuously improve Occupational Health and Safety (OH&S) within your organization.  The risk based approach standard introduces the common Annex SL structure compatible with other ISO standard such as ISO 9001, ISO 14001 Environmental, and ISO 27001 Information Security.  Implementing ISO 45001 within these certification standard allows your organization to create an integrated management system (ISM) approach. ISO 45001 is not, and should not be treated as an add-on system.       

Positive benefits of an effective 45001 system include:

Leadership ability to assess OH&S risk and opportunities, monitor and review safety performance and set objectives for continual improvement within the “context” of organizational activities. This may include, for example, worker health promotion campaigns or the monitoring of the OH&S effects of products and services provided;

The standard promotes worker participation when identifying hazards, elimination or reducing risk by implementation of controls integrated with other business process. This approach can improve safety culture, minimize risk and embed best practice resulting in increased productivity;

The standard provides a structure to monitor and review compliance obligations to ensure the organization is legally compliant including products and services.

To get the most of your OH&S System Design:

Develop the management system as a tool to protect workers and business interests and not just to satisfy the standard;
 

Inform interested parties and workers of their objectives when implementing the standard to gain ‘buy in’ and generate a positive safety culture;

 
When designing processes ensure that they are relevant to the environment they are intended to be used. In other words, do not over complicate the system;
 

Implementation of this standard is not a burden on your organization. Risk based thinking with the participation of workers should improve safety culture and productivity.

By adopting a systematic approach including worker participation, the organization can integrate OH&S within its business processes which will contribute to prevention of accidents and long and short term ill health effects. This standard provides a platform to develop a positive safety culture leading to worker well being.

Contact us with questions, including assistance with your ISO 45001 journey. The Year 2021 is approaching, begin planning now for your successful transition process.     

 

Performance Excellence Recognition
 

On February 6, 2019, the R.E. Darling Company, Inc., a Tucson, Arizona-based Sustaining Edge Solutions client was recognized for its Performance Excellence achievement at the 2018 Southwest Alliance for Excellence (SWAE) Sharing of Best Practices and Awards Luncheon at the East Valley Institute for Technology in Mesa, Arizona. 

R.E. Darling Co. is a small business manufacturer of specialty rubber and composite products serving aerospace, defense, and industrial customers. Gary Darling, CEO (second from left with team members) accepted the award on behalf of R.E. Darling Co., Inc. and recognized the 5 Performance Excellence Improvement (PEI) Teams who have been instrumental in guiding the company Performance Excellence efforts.

 

Level 1 Recognition is given by SWAE www.swae.org to organizations in Arizona, Utah and Nevada for development of an organizational profile that describes the organization, its strategic context, competitive environment and performance improvement system. Based on an initial Baldrige-based Excellence Assessment provided by SES, the REDAR 5 PEI Teams are following a multi-year road map journey through the SWAE Steps to Excellence Levels 2, 3, and 4 to become eligible to apply for the Malcolm Baldrige National Quality Award.

 

On-going SES team coaching and “best practice” guidance is being provided by our Senior Management Consultant Dennis Stambaugh, MHA, who has over 15 years of experience with the Baldrige Framework and Criteria for Performance Excellence and currently serves on the Baldrige National Quality Award Board of Examiners. 
 
SES provides Baldrige-based Gap Assessments, Executive Coaching and Breakthrough Performance Methodologies. This includes Performance Excellence Team and Award application facilitation to partner with organizations from all business sectors (manufacturing, healthcare, education, service, and government) to guide their Journey for culture change and sustained operational excellence.
 
Congratulations to our client R.E. Darling Co.!  For further information on performance excellence and our services, Contact Us.

 

Key Process Identification

Many of us are aware that recognized operational and quality system standards have informed us for years that the organization shall determine the sequence and interaction – processes needed for the quality management system, and their application throughout the organization, description of processes, and further interpretation.

This document within the management system is the interaction flowchart (or description of processes). Within the aerospace scheme, these are the processes which will be documented as Process Effectiveness Assessment Report (PEAR) and process indicators need to be in place for each PEAR. 

 
Your key processes can typically be sales, purchasing, production and design, but can vary greatly depending on the organization and the product and service. An external auditor should not tell you that you are wrong about your processes, you as an organization will determine your processes that suit your needs, you can even call them anything you like that’s specific to the business. You don’t need to use the example of Sales; your organization may use terminology such as “getting the business” etc. However, auditors will raise issues should your processes not be clearly defined. Also, there is no requirement you must include the numbers of the applicable standard you are addressing. All your determined processes should interact with each other to deliver the high-level process/scope of the business.
 
4.4.1 (c) Determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; – This is the element that most people overlook “Performance Indicators”. Once you have determined your processes you need to determine the criteria and methods needed to demonstrate that these processes are being operated effectively and that everything is in control as planned.
 
Whatever your key process indicators are insert into your interaction flowchart, or description of processes. Auditors want to see clear identification of a process metric within your key indicators. There are various methods that can be used for monitoring the KPIs identified by an organization.
 

Whatever method you use, it should be fine with the auditor.  There are no rules on how you should present this information, and you chose whatever suits your business.

 

Human-Centered Organization
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Gone are the days when the workplace was built around a fairly straightforward structure, consisting of employer, employee, customer. The winds of technological change may be sweeping away traditional models, but ISO 27501 is helping managers build a more sustainable one for the future.

From the advent of the Internet to what is now known as the Fourth Industrial Revolution, the latest cutting-edge technologies – among them robotics, artificial intelligence (AI), the Internet of Things – are fundamentally changing how we live, work and relate to each other. The issue for business in this new era is not totally about the bottom line, or even just corporate social responsibility, it is also about taking a human-centered approach to the future of work and finding the right tools to ensure that organizations are successful and sustainable.

ISO 27501:2019 The human-centered organization – Guidance for managers, can help organizations to meet these challenges. In this brave new world, organizations will not only have an impact on their customers but also on other stakeholders, including employees, their families and the wider community.

The standard is based on ISO 27500, which explains to executive board members the values and beliefs that make an organization human-centered. The standard’s requirements and recommendations are intended to be applicable to organizations large or small, and in the public or private sector.

It outlines managers’ responsibilities that range from the organizational strategy to the development of procedures and processes that enable a human-centered focus to the implementation of those procedures and processes.  You can purchase this challenging guidance document from the ANSI Store.      

 

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In the News
Sixteen Manufacturing Conferences to Attend in Year 2019.    

Conferences are a great way for you and your team to network with others, find more customers, demo exciting new technologies, learn about topics that interest you, and gain valuable insights from industry experts. Thankfully, there’s no shortage of events happening in 2019!

Visit the Manufacturing Network Website for information on this top conferences.

Quality Training Limited in Healthcare   

Only 33% of healthcare quality professionals said that all staff in their organizations have received training and education.  This is according to an inaugural survey published by the National Association for Healthcare Quality (NAHQ).  The survey also asked respondents the one thing they would do to improve quality at their organizations.  Nearly half, 47% said their healthcare organizations need to align all healthcare professionals.
    
For more from the survey visit the NAHQ 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.
 

Continuous Improvement Challenges identified by the American Productivity & Quality Center survey include:

  • 48% find a need to create a continuous improvement culture;
  • 43% find a need to identify, prioritize and select improvement opportunities;
  • 30% find a need to overcome organizational resistance to change.

Interesting how the survey results found that a continuous improvement culture is a greater need that resistance to change. We think that many organizations still view continuous improvement in a project context, rather than the way we always strive daily to run our business.  The management thinking and language of we need to start a process improvement project, or let’s conduct a black belt project can contribute to this lack of creating a continuous improvement culture.

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

 

Process Challenges for 2019

Thursday, February 7th, 2019

 

This Month

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

 

      

 

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What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence
  • Executive Coaching
Improved Profits and More!
Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards. 
 
Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do you have a topic of interest for a subject article? Please let us know.

Process Challenges for 2019
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Recently we attended an informative webinar hosted by  APQC (American Productivity & Quality Center) which helps organizations work smarter, faster, and with greater confidence. It is the world’s foremost authority in benchmarking, best practices, process and performance improvement, and knowledge management.

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

 

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

 

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

The top 3 challenges with Business Process Management include:

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

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

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

 

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

 

Regulatory and Statutory Requirements
 

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

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

 

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

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

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

Effective Work Instructions
Close up on a file tab with the word ISO 9001 focus on the main text and blur effect. Concept image for illustration of Quality Standards

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

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

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

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

 

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

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

 

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

 

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

 

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In the News
Achieving Breakthrough Performance  

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

 

ASQ Lean and Six Sigma Conference 2019 
       

 

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

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

 

Standard for Human Capital Reporting 
 

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

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

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

Training Courses
 
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
 
Don’t see a course or schedule that fits your needs?  Contact us.
 
We find it interesting that the APQC survey showed the top business challenge, a key topic area to be Business Process Management (BPM) with a 73% challenge response rate. Since the early 1990s, the transformation of BPM within the quality management continuum initially focused on the automation of business processes with the use of information technology. 
 

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

 

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