Archive for the ‘Newsletters’ Category

Systematic Process Design

Tuesday, February 9th, 2021

Our newsletters provide information on business management systems and process improvement methods. These systems include our services such as ISO 9001 Management System, 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 future subject article in mind?
Systematic Operational Process Design
Systemic issues that can be the cause of product or service failure are often the result of a lack of a systemic approach for process design, management, and improvement. Too often people get blamed for adverse customer outcomes when it is the process that has not been properly designed to meet the requirements of the customer and other stakeholders.

A well designed organizational-wide Operational System supported by real time in-process performance measurement, such as dashboards or scorecards, contributed by front-line employees, can proactively serve to control and manage key work systems and processes. These interactions are used to reduce customer complaints, achieve the desired results and minimize defects, as well as improve productivity and efficiency.

Measurement, Performance Analysis and Knowledge Management

An effective Organizational Management System is supported by a robust Performance Measurement System that includes data and information for tracking daily operations, as well as progress on achieving strategic quality objectives and action plans.
Often over reaction by management to variation in data without a cyclical systematic Performance Analysis and Review Process, can lead organizations to focus on fire-fighting and micromanaging the “problem of the day”.

Sound Familiar? In fact this situation, where the senior and mid-level managers spend majority of their time to put out fires, prevails in most firms .This is “normal” to many in those circumstances. As a result, the managers and shop floor associates don’t bother to find a solution to the issue together. They are used to seeing all the decisions coming from the respective manager, or the engineering team from another separate department.

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

Metrics should reflect an overall performance of customer satisfaction, feedback from interested parties – Employees!, key work systems, process performance and action plans to address risks and opportunities.

Linking and Alignment with Strategy and Engagement

A well designed Management System strategically links business work systems and processes to supporting the overall organizational strategy, as well as aligning the Workforce through relationship management and engagement.

The most well-conceived strategy and action plans can be ineffective if there is a failure to link to the organization’s performance management system for motivation and incentive engagement with the Workforce. The importance of quality management as a leadership driver cannot be overemphasized. The alignment and integration with organizational strategy and relationship engagement can make the difference between a dysfunctional culture and the ability to achieve sustained breakthrough world class performance excellence.

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

Interested in further information and application? View our Breakthrough Improvement Model and Contact Us to learn more.

Customer Complaint Resolution
Complaints communicate customer perceptions of quality, and compose the largest determinant of customer satisfaction-Period! Unfortunately, the majority of complaint systems are completely reactive: You’re not reaching out to your customer—you’re relying on the customer to reach out to you. This is a risk laden proposition and for every complaint your organization receives, there may be four, five or more you’ll never ever know about.
 
Because of its reactive nature, a complaint system should be used in combination with one or two proactive tools. Here are some suggestions to help you implement an effective system that is capable of improving your customer satisfaction connection.

Get the Details!

In addition to your customer service personnel expressing empathy, the person receiving the complaint must gather the correct details. Exactly what went wrong? Allow the customer to provide a general description, then begin to drill down. Typical information includes the following details:
  • What was the exact nature of the problem? Generalities won’t cut it. The problem statement must provide enough detail and depth to facilitate investigation.
  • When did the problem occur? The date is certainly necessary, as might also be the time.
  • Where did the problem occur? The state, city, plant, retail outlet, department, production line and machine all might be important.
  • Who was involved in the situation? What roles did they play?
  • What product was involved? What were the part or style numbers?
  • Were there any specific batch numbers, serial numbers or other identifiers that provide traceability?
  • Was the problem isolated or generalized across all products?
Consistently gathering this expansion of information is difficult without a structured format. Most organizations custom-design complaint forms based on their individual needs and the most effective forms allow customers to go online and submit. Decide exactly what information you need to investigate customer complaints and take effective corrective action; then design your form around these needs.
Guidelines for Employee Engagement
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.
ISO 10018:2020 Quality Management – Guidance for People Engagement recognizes that it can be difficult encouraging staff to take up quality management systems and understand how they are relevant to their daily work. By focusing on better integration of engagement strategies, the standard provides a framework to enhance people’s involvement and competence within an organization, helping them to feel a valued part of it.

Staff competence and development should be a collective aspect of the organization and not just for specific individuals. People need to see the connection between their current work and how further training can provide more opportunities within the organization. If they see that their organization is investing in their skills through training and other career tracks, they will feel engaged.

So what organizations can benefit? ISO 10018 is applicable to any organization, regardless of its size, type or activity. Aimed at bringing quality management principles down to staff level, the standard is designed to be regularly referred to and not simply handed to employees in binders and then left to gather dust on the shelf.

You can purchase ISO 10018:2020 Quality Management – Guidance for People Engagement at the ANSI Webstore Here.

   
Performance Metrics
Performance metrics are a vital part of managing an organization. Many organizations have a tendency to select metrics by copying what competitors measure, what is read in the business press, and what benchmarked firms are using.
The best organizational metrics keep their focus on its strategic direction, not the direction in which others are going. Organizations should:
  • Define a competitive vision and a strategy to achieve it,
  • Set objectives aligned to the vision and strategy,
  • Create processes to deliver on that vision,
  • Set metrics that will monitor how well they are doing on the objectives. That will allow those managing the processes to keep them going in the right direction, and
  • Revise them over time to account for changes that impact their potential value.
A simple but important step in metrics selection is applying the Pareto Principle to ensure the critical measures are available, while not spending a lot of non-value added time on unnecessary noise.

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 with operating costs that create negative profitability, is not going to be a sustainable business.

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, or available personnel (leading indicators for delivery performance).

Once the desired metrics have been identified, effective 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 this may sound simple, we find that many organizations waver on creating operational definitions of what a metric details. In other words, what is meant by the terms as expressed in mathematical terms (for example, numerator, 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? Take the time to define common metric language. If not sure, ask your associates for the definition, you maybe very surprised to hear the differences.
In The News
Year 2021–2022 Baldrige Excellence Framework (Business/Nonprofit) Now Available
The revision features a renewed focus on organizational resilience, equity, and the fourth industrial revolution. Whether used as guidance in establishing an integrated performance management system or for self-assessing progress, Baldrige is about helping your organization innovate and improve, no matter your size or sector.
You can purchase the 2021–2022 Baldrige Excellence Framework on the NIST Website Here.

Four Indicators to Watch in Covid-19 Economic Recovery

Gallup Economics of Recovery study tracks four key indicators unavailable from government sources of economic data that are important for assessing Americans’ ability and willingness to participate in the country’s economy as consumers and employees amid the pandemic.
Training Courses
Due to COVID-19 Virus course scheduling is currently suspended. Let us know if you have an onsite Year 2021 training need, we can deliver! 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.

Make a Difference in 2021!
At this time of the New 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?

Within this pandemic business environment, it is even more important now to identify mutual win-win relationships with others, and to break out of your normal communications with your suppliers to identify how each of us can support one another during these times.

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.

Best regards,
Walter Tighe and SES Team  

Customer Experience Metric

Sunday, December 6th, 2020

Our newsletters provide information on business management systems and process improvement methods. These systems include our services such as ISO 9001 Management System, 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 future subject article in mind?
Customer Experience Metrics
While supply chain organizations have a variety of internal metrics in place, supply chain leaders must also take into consideration the customer experience, according to Gartner, Inc. a leading research and advisory company.
Supply chain leaders spend a lot of time working to understand and improve their internal operational metrics, but they rarely take the time to understand their impact on the customer.

That’s why it’s important to introduce customer experience metrics into the supply chain scorecard. For example, the customer is more interested in having an item delivered on the requested day and time than having it shipped on time. So, the first step is to define and measure your success using the same metrics as your customer does.

According to a Gartner survey among customer experience leaders, more than 60% said that their most important priority was to develop customer experience metrics and integrate them across all business units. The following three are a good starting point as customer-centric metrics suitable for the supply chain organization.

Customer Satisfaction (CSAT)
To determine the CSAT, customers are asked to rate their satisfaction with a product, solution, or service. The questions are often not standardized making benchmarking difficult. One option is to leverage the American Customer Satisfaction Index (ACSI). With the ASCI, it takes on average five years for a company to move by 1%. The score movement for a single company is often less than 2% in a decade, which means that benchmarking against industry peers is more important than trying to improve the score. Don’t make any short-term commitments, as the movement is very slow. Instead, use the index to benchmark against your industry peers and see how you compare.

Net Promoter Score (NPS)

The purpose of the NPS is to determine if the customer is an advocate to drive growth and would recommend a specific product or service. While companies should always aim for a high score, it’s important to note that there are cultural differences to consider. For example, in Europe and other countries it’s less common to give the highest rating for a satisfying experience than in North or Latin America. Don’t be surprised if the same product or service produces different NPS in different regions.

Customer Effort Score (CES)

This score works best in a service environment and measures how easy it is for the customer to do business with an organization, or to handle an issue. Customers can, for example, rate how a return process was handled or how fast they were able to talk with a customer service agent.
Investments in customer experience can take a couple of years to pay off in terms of increased customer loyalty. To help build the business case, look at metrics such as cost of service or compensation costs. These can help to justify the move to more customer-centric practices.
Outsourced Process Controls
What is considered an outsourced process? It can be described as a process that has been identified as needed for the quality management system, but one which the organization has chosen to be carried out by an external party.
An outsourced process can be performed by a supplier that is totally independent from the organization, or which is part of the same parent organization.

For example, a separate department or division not subject to the same quality management system. The process may be provided within the physical premises or work environment of the organization, or at an independent site. The nature of this control will depend on the importance of the outsourced process, the risk involved, and the competence of the supplier.

There are two situations that frequently must be considered when deciding the appropriate level of control of an outsourced process:

1. When an organization has the competence and ability to carry out a process, but chooses to outsource that process (for commercial or other reasons), the process control criteria should already have been defined and can be transposed into requirements for the supplier, if necessary.

2. When the organization does not have the competence to carry out the process itself, and chooses to outsource it, the organization has to ensure the controls proposed by the supplier of the outsourced process are adequate. In some cases, it may be necessary to involve external specialists in making this evaluation and/or conducting an onsite supplier audit.
It most cases, it is necessary to define some or all of the methods to be used for control of the outsourced processes in a contract between the organization and the supplier. To audit the outsourcing of your processes, you should be asking these types of questions:
  • Have any processes been outsourced?
  • What is your criteria for outsourcing?
  • How are the suppliers being evaluated?
  • Are relevant requirements assigned?
  • What outsourcing controls are in place?
  • How is risk considered in the controls?
  • How is supplier performance evaluated?
  • How are supplier problems handled?
A robust supplier nonconforming product process is also a must to ensure not only supplier accountability and proper disposition decision making, but also to be used as an effective method for conducting a supplier re-evaluation process with specific measurable objectives used.
Desired Problem-Solving Behaviors
No matter what type of product or service you deliver, we all have customers, and you are the supplier. Our decades of experience has taught us that too many organizations exhibit poor and inconsistent behavioral methods when it comes to the direct customer overall experience.

The following Desired Problem-Solving Behaviors for Suppliers should be your modus operandi:

1.   Know the details of how your product works in the customer’s process and product. Know how the failure modes of your product affect the customer. For a given thing that goes wrong with your process or product, what is the exact effect on the customer?
2.   React quickly to a customer notification. Suppliers should take a customer notification of a problem as an alarm for their organization. Containment should be a priority, with all investigation started after containment is achieved.
3.   Be sure to obtain as much detail from the customer as possible. Make sure you listen to your customer for the details of what is occurring. Make requests for data, samples, or further agreed upon objective evidence.
4.   Develop a plan for the problem-solving efforts and stick to it. Be realistic with your customer on the time frame that is needed for a thorough investigation and resolution of the problem. Once a plan is developed and agreed to, the timing must be considered sacred.
5.   Communicate with your customer regularly on the status of the problem-solving efforts. Make sure your customer knows exactly where you are in the problem-solving process. Ensure that your customer understands all that is being done, including verification of containment measures as the process proceeds.
New Year = Improved Performance
At year end, many businesses are rolling their sleeves-up developing revised management strategies and seeking methods for driving improved business performance in the coming year. Successful organizations understand that to thrive in an ever-changing business environment, they must identify key risks and opportunities to realize competitive gains.

A recent Best Practices Study focused on understanding leading practices and approaches for successful performance improvement.

 Identifying Actionable Measures 
  1. Have senior management analyze business processes that have the greatest impact on strategic organizational imperatives. 
  2. Use collaboration systems that allow direct stakeholder feedback, and link measures to specific business processes.
  3. Align individual employee measures with departmental performance measures.
  4. Use a balance of leading and lagging indicators.
  5. Use fewer than 5 measures to access each business process. Include a diverse blend of cost, efficiency, and quality measures.  
Effective Measurement Through Staff Buy-In
  1. Involve staff in developing the measurement system, and provide employees with a documented road map of the measurement process and outcomes.
  2. Include process measures as part of performance appraisals, and connect measures with compensation.
  3. Use a variety of techniques (meetings, dashboards, scorecards) to communicate the importance of measurement to all employees. 
  4. Involve executive staff in communicating with employees about measurement. 
Success Factors
There are five factors that the best-practice organizations use to create successful measurement systems.
  1. A business process management (BPM) center of excellence.
  2. Strong alignment of the organization’s measures with its strategic objectives.
  3. Compensation and rewards linked to the achievement of metric targets/results.
  4. A process to provide measurement data to employees doing the work being measured.
  5. A culture of accountability for measures and results, and a centralized group responsible for analytics.     
Effective information is needed to focus attention on desired behaviors and results. Contributing employees at all levels need information that is sufficiently complete, accurate, and consistent in order to demonstrate results and be given the ability to focus on outcomes.
Certification Success
Congratulations to our client Phoenix Cable, Inc. for achieving certification to the ISO 9001:2015 Standard!! Phoenix Cable, Inc. (PCI) has been manufacturing custom cable and wire harnesses for twenty-six years. RF Cable Assemblies are one of their key specialties. Quality preparation and termination tooling combined with skilled assemblers with years of cable assembly experience enables them to offer customers a variety of precision coax cable assemblies. 

For more information and products visit the Phoenix Cable, Inc. Website.

Training Courses
Due to COVID-19 Virus course scheduling is currently suspended. Let us know if you have a future onsite Year 2021 training need, we can deliver! 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.

Make a Difference in 2021!
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.

Being Generic. Do you act, look, and sound like your top competitor? Sales material, customer approach, support center processes, website content, all similar? Look for an edge that breaks you away from the rest of the herd.
Happy Holidays and All the Best of the Coming Year!!
Best regards,
Walter Tighe and SES Team  

Context of the Organization

Wednesday, October 7th, 2020

Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 Management System, 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 future subject article in mind?
Context of the Organization
One of the major changes as a new requirement of the ISO 9001:2015 standard, including further quality system standards, is to Understand the Organization and its Content. We often still find today companies that are struggling with how to address this requirement. The requirement states that the organization will determine external and internal issues that are relevant to its purpose and its strategic direction, and that affect its ability to achieve the intended result(s) of its quality management system.

This includes the organization will monitor and review information about these external and internal issues. For the purpose of effective planning all organizations need to understand (1) its current status, (2) what it wants to achieve and when, and (3) its strategy on how to achieve it. If you don’t have a clear starting point, it will be difficult for your organization to achieve the desired destination for growth and sustainability.

There are a number of effective methods and supporting techniques for organizations to analyze their context. It will be very useful to retain documented information to help understand the rationale and level of understanding that challenges all companies. The information which may be helpful in this process can include:

  • Business plans
  • Review of strategic initiatives
  • Competitor analysis
  • Reports from business sectors
  • SWOT analysis
  • Minutes of Meetings
  • Action lists
  • Spreadsheets
  • External service provider reports
This process is the responsibility of the organization’s top management. It should be evident whether top management has adequately considered their organization’s context. The evidence of this may be adequately demonstrated by showing how the review outputs became the inputs into the planning process. The output from this activity should also be evident in the determined risks and opportunities regarding 6.1 Actions to address risks and opportunities requirement.
Along with organizational context, management also has to understand and determine how the organization decides on the requirements of interested parties which are relevant for the quality management system. Areas of consideration could be the range of interested parties considered, criteria to select relevant interested parties, and aspects to select relevant requirements. Examples of relevant interested parties are given in ISO 9000:2015, definition 3.2.3, and clarification related to these requirements is provided in ISO 9001:2015, Annex A, clause A.3.
 
The relevant requirements of those relevant interested parties should be evident as inputs into the planning process, as potential risks and opportunities. For example this could be defined from:
  • meeting minutes
  • program management interactions with customers
  • spreadsheets and databases
  • Sales and marketing personnel
  • external documentation
Specific methods that management personnel use to monitor and review information on the interested parties and their relevant requirements must be demonstrated. Establishing a solid foundation for shared understanding of an organizations purpose, strategic direction, interested parties, risks and opportunities will require a continuous active role within the leadership team and the quality group. Moving quality out of the quality department has now expanded more than ever before within quality systems compliance and effectiveness.
Occupational Health and Safety Metrics
According to the International Labor Organization, some 2.78 million people die as a result of work-related accidents or illness each year, on top of the hundreds of millions who suffer with injuries. The cost to all of society, therefore, is huge, giving rise to relevant laws and significant investments made in occupational health and safety. But how do you know such measures work and how well your staff are actually doing?

A new ISO document for occupational health and safety metrics has just been published. ISO/TS 24179, Human resource management – Occupational health and safety metrics, is the first of a large series of technical specifications (TS) and guidance documents to provide comparable measures for internal and external reporting in human resource management. It specifically relates to occupational health and safety data and highlights any issues that should be considered when interpreting it. This in turn, will not only help with decisions on appropriate interventions, but is also useful when reporting these to external stakeholders, such as regulators and investors.

The working group is currently in the process of developing specifications that cover around 70 different metrics, such as those for productivity, costs, recruitment, mobility and turnover. These will be useful tools for organizations to improve productivity, meet regulatory requirements and have a clearer picture of their performance across many areas in order to make the most effective decisions for the company and its employees.

ISO/TS 24179, Human Resource Management – Occupational Health and Safety Metrics can be purchased at the ANSI Webstore.

Common Symptoms Risk Management
Risks are also often managed centrally through management team channels. Organizations commonly lack the insight, scope and flexibility to handle risks that occur at a grass-roots level, where the work gets done. Decisions to prevent and mitigate risk can sometimes be delayed as employees do not have the capability to assess risk, or the time to define and reduce the risk. 
 
The following are common symptoms which could highlight to you that your approach to risk management could be improved:
  1. Uncertainty – the organization struggles to collect the right, or enough information about its risks. Checks are too infrequent, must be recurring and beyond annually. The scope of information about the organizations risk is narrow.
  2. Complexity – the organization is collecting enormous amounts of information about risk to the low level weeds areas. Decision makers cannot interpret the information. Opportunities are overlooked.
  3. Ambiguity – the organization is not able to formulate the correct questions in order to understand its risk. Additional information is useless because risk is not understood or documented effectively, and is some cases not documented at all.
  4. Lack of Common Language- there are multiple interpretations of risk between individuals across the organization. Risk management is mutually exclusive or in conflict. A power struggle usually ensues between individuals with conflicting views and beliefs.
  5. Silo mentality (larger organizations) – different departments resist communicating information about risks across the organization. This typically leads to a condition of both uncertainty and not my problem mentality.
Defining, mitigating and eliminating operational risk factors requires a holistic team approach. Get your employees at all levels involved!  
World Quality Day 2020
World Quality Day will be celebrated on November 12, 2020. It is a worldwide opportunity to shine the spotlight on individuals, teams and organizations that are deeply invested in creating and improving customer value.

In a world of ever-increasing customer expectations, competition and technological change, businesses are striving to be seen as ‘partners’ in the eyes of their stakeholders.

The quality profession supports businesses to develop a customer-centric quality culture that will help them to:
  • Recognize that it is the customer, not the company, that defines what quality means
  • Understand product and service quality through their customers eyes
  • Share their quality performance with customers
  • Collaborate with customers to improve product/service quality and resolve problems
World Quality Day gives us the opportunity to highlight how quality can help to create customer-focused organizations. Visit the World Quality Day Website for more information via videos, informing everyone of your plans, and a toolkit filled with resources. 
In The News
ISO 9001 User Survey 2020
The committee responsible for the development of the international standard, ISO 9001:2015—”Quality management systems—Requirements,” has announced a user survey to gather information on the value of ISO 9001:2015.

According to a press release from ISO/Technical Committee 176/Subcommittee 2, ISO 9001:2015 is currently undergoing a formal “systematic review” that is due to close on Dec. 2, 2020.

Following the review, ISO/TC 176/SC2 will have up to six months in which to decide whether the standard should be “confirmed” (i.e., left unchanged), be revised or amended, or be withdrawn.

The goal is to capture:
• Data on the value to organizations of implementing a quality management system in with the requirements of the current 2015 edition of ISO 9001
• Data on its advantages and disadvantages
• User opinions on how to ensure this standard remains relevant in the future

In addition, ISO/TC 176 has been giving consideration to “future concepts” for quality. SC2 would like to test the acceptability of such concepts with users, for potential inclusion in a future edition of ISO 9001.

The committee invites all categories of users of ISO 9001 from all over the world to participate in a global survey about ISO 9001’s future. For your convenience, the survey has been developed in 13 languages on SurveyMonkey; choose the language that is most convenient for you using the language link in the upper right corner of the survey page. 

Training Courses
Due to COVID-19 Virus course scheduling is currently suspended. Let us know if you have a future onsite Year 2020 training need, we can deliver. 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.

Remote Versus Virtual Audits  
With the current business environment, Virtual and/or Remote Auditing is currently the norm. “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.

There is much discussion lately around the future and validity of virtual certification body auditing, whether conducting a surveillance audit, or initial certification audit. We have found through our reading solid arguments on both sides of the perceived value. If virtual auditing does become the new normal, the value to the client can definitely include less travel cost. We have a number of clients that have told us this cost has not incur this year. It will be interesting to see what the end result will be down the road, and whether this process will actually produce effective compliance and robust objective evidence needs for certified companies, customers, and certification bodies.

ISO 9001 Auditing Practices Group Guidance on: REMOTE AUDITS

Best regards,
Walter Tighe and SES Team  

Quality and Industry 4.0

Monday, August 17th, 2020

Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 Management System, 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 future subject article in mind?
Quality and Industry 4.0
Quality 4.0 comes from the idea that globally the world is in the fourth industrial revolution. The term Industry 4.0 was coined in 2011 at the Hannover Fair. Industry 4.0 is often called the Fourth Industrial Revolution. “By enabling “smart factories”, the fourth industrial revolution creates a world in which virtual and physical systems of manufacturing globally cooperate with each other in a flexible way.” (1) Quality 4.0 represents the quality practices associated with Industry 4.0.

According to article by James Kline, PH.D. July 25, 2020, the expectation is that the Internet of Things will combine with robotics and big data to increase the automation of industrial activities. A 2018 ASQ study noted the following changes Industry 4.0 will bring for example to the manufacturing floor.

  • Integrated cyber-physical interfaces automate working environments.
  • Automated processes deal with end to end systems.
  • Humans serve only in positions where human judgment cannot be automated and human interactions cannot be simulated.
  • Machines learn to learn (artificial intelligence).
Implications for Quality Profession
The shift occurring on the production line, is having a significant impact on the quality profession. One fundamental consequence is that robots will be conducting 100% quality inspections. Except in rare situations, the sampling of products for quality control purposes will not be needed. This will result in the reduction of quality inspectors and the need for certifications like ISO 9001.

The ASQ study emphasizes that the quality profession must move from data analyst to “data wrangler”. This is to be accomplished by engaging with new technologies. Fortunately, quality professionals are well positioned because they have deep skills in several areas Industry 4.0 will emphasize. These are:

  • Systems thinking
  • Data-driven decision making
  • Leadership for organizational learning, and
  • Statistics
Further Quality 4.0 differences from present include:
  • Quality shifts its control-oriented focus from the process operators to the process designers.
  • Machines learn how to self-regulate and manage their own productivity and quality.
  • Human performance is essential; the emphasis shifts from production to system design and integration with the business system.
This transformation has its challenges. For example, as for “leadership for organizational learning”, within an organization a quality professional generally is low on the decision-making ladder. Their leadership impact will therefore be limited. As for “organizational learning”, what it means and how quality professionals are to contribute is not well defined in ASQ’s report. Further, in some cases when quality professionals go outside the bounds of the quality management system, they can be outside their area of expertise. When they step outside their area of expertise, it becomes harder to keep other professionals from encroaching on those areas. As the study found, companies implementing Industry 4.0 will have to provide a number of skill upgrades.

For more information on Quality 4.0, visit the ASQ Website.

Process Owner R&R
To understand the term “process owner”, let’s begin with the definition of a process. A Process is a set of interrelated or interacting activities which transforms inputs into outputs. The inputs of a process are the outputs from other processes. And, processes are planned and carried out under controlled conditions to add value.

A Process Owner is a person who is given the responsibility and authority for managing a particular process. Most organizations find it useful to appoint individual process owners and define their responsibilities as ensuring the implementation, maintenance, and improvement of their specific process and its interactions with other processes.

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

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

Process owners can use the Plan-Do-Check-Act methodology to improve their processes: 1) planning what to do and how to do it, 2) doing what was planned, 3) checking the results to see if things happened according to plan, and 4) acting to improve the process the next cycle.

In summary, a Process Owner is the person immediately accountable for creating, sustaining, and improving a particular process, as well as, being responsible for the outcomes of the process. 
Analysis and Evaluation Auditing
Analyzing data is an essential activity for improving your system and its processes, as well as, your products and services. Data collection has no purpose if the data isn’t examined, evaluated, analyzed, and converted into proposals for decision making.

The term “analysis” can be defined as the breaking up of something complex into its various simple elements. The reason to separate something into its elements is to determine either their nature (qualitative analysis) or their proportions (quantitative analysis). Therefore, we analyze the data to show the quality management system is effective (achieving planned results) and to spot where improvements can be made. It is not enough to just collect the data, we must analyze it and reach some conclusions.

As a result of the monitoring and measurement activities called for by ISO 9001:2015, 9.1.3, Analysis and Evaluation you will have collected a lot of data, which can be analyzed to indicate trends. Any trends you may find could suggest where there are problems in your quality management system and indicate areas where improvements are needed.

Analysis of data can help to determine the root cause of existing or potential problems, and thereby guide decisions about corrective and preventive actions need for improvement. For an effective evaluation by management of the total performance of an organization, data from all parts of the organization should be integrated and analyzed.

The overall performance should be presented in a format that is suitable for different levels of the organization. The results of this analysis and auditing can be used to determine:

  • Trends; customer satisfaction (and satisfaction of other interested parties)
  • Process effectiveness and efficiency; supplier contribution
  • Success of performance improvement objectives
  • Economics of quality, financial, and market-related performance
  • Performance bench marking; competitiveness
Performance Metrics Mix
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.
In The News
ISO 9001 User Survey 2020
The committee responsible for the development of the international standard, ISO 9001:2015—”Quality management systems—Requirements,” has announced a user survey to gather information on the value of ISO 9001:2015.

According to a press release from ISO/Technical Committee 176/Subcommittee 2, ISO 9001:2015 is currently undergoing a formal “systematic review” that is due to close on Dec. 2, 2020. Following the review, ISO/TC 176/SC2 will have up to six months in which to decide whether the standard should be “confirmed” (i.e., left unchanged), be revised or amended, or be withdrawn.

The goal is to capture:

• Data on the value to organizations of implementing a quality management system in accordance with the requirements of the current 2015 edition of ISO 9001
• Data on its advantages and disadvantages
• User opinions on how to ensure this standard remains relevant in the future

In addition, ISO/TC 176 has been giving consideration to “future concepts” for quality. SC2 would like to test the acceptability of such concepts with users, for potential inclusion in a future edition of ISO 9001.

The committee invites all categories of users of ISO 9001 from all over the world to participate in a global survey about ISO 9001’s future. For your convenience, the survey has been developed in 13 languages on SurveyMonkey; choose the language that is most convenient for you using the language link in the upper right corner of the survey page. 

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.

Remote Versus Virtual Audits – We’re conducting Virtual Audits- Are You?  
With the current business environment, Virtual and/or Remote Auditing is currently the norm. “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

Best regards,
Walter Tighe and SES Team  

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.

news3.jpg

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
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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
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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
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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
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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