Friday, April 29, 2016

The Fly in the Ointment - ISO 13485:2016

For those of you whose organization has a Quality Management System (QMS) and an
Environmental Management System (EMS), the act of integrating both systems into one can prove difficult. When ISO 14001:2015 was released, a sign of relief was heard around the world when it was discovered it followed the same High Level Structure (HLS) as ISO 9001:2015. But now, companies who have both ISO 9001 and ISO 13485 are facing pressure, and the unknown, in making it all work together.

ISO 13485:2016 is Here
ISO 13485:2016, which represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices, was released in February 2016. TAKE NOTE: This recently released standard isn’t following HLS. Instead, ISO 13485:2016 is following the same eight clauses it had in the past. A theory to explain this revolves around the idea that the HLS was incompatible with their attempt to focus on regulatory requirements.

Standards Integration
So, what is the impact on organizations with registrations to both ISO 9001 and ISO 13485? First, you will need to figure out how to integrate the various requirements and formatting of standards together. This might be a significant issue, especially if documents are numbered to match the standard.

FOR EXAMPLE: In ISO 9001:2015, purchasing (called ‘Externally Provided Processes, Products and Services’) is located in clause 8.4, whereas ISO 13485:2016 has it in clause 7.4. It leaves you wondering which number you choose.

Most of the changes from ISO 13485:2003 to ISO 13485:2016 include additional requirements to keep up with increasing governmental and regulatory requirements. Just like ISO 9001:2015, ISO 13485:2016 has an increased amount of change management activities, an understandable alteration since change always increases the risk of variation being introduced into the process. This variation is the cause of nonconformity.

Expanded Risk Management
Risk management has always been a requirement of ISO 13485, but it’s expanding. Now, in both corrective actions and preventive actions, there is a requirement to verify the action does not have any adverse effects. Another example is in clause 8.2.1 ‘Feedback’ where ISO 13485:2016 adds a requirement to use feedback in the risk management process.

Overall, adapting to the updated standard will not be a major issue if you are registered to ISO 13485 alone. Transitioning will be considerably more complex if integrating both ISO 9001 and ISO 13485. The good news is the Michigan Manufacturing Technology Center can assist in achieving the transition with minimal agony. Let the experts of the Michigan Manufacturing Technology Center assist you. To speak to a Quality Solutions Expert, call 888.414.6682 or email inquiry@mmtc.org.


Since 1991, MMTC has assisted Michigan’s small and medium-sized businesses compete and grow. Through personalized services fitted to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at www.mmtc.org.

Friday, April 22, 2016

Leadership and the 10 Fatal Flaws

Poor leadership when business is good can be hidden, but poor leadership in bad times is a recipe for
disaster. No matter how qualified an individual is to hold a position, or how prominent that position may be, they are still human like everyone else and have flaws.

Zenger and Folkman, in their book The Extraordinary Leader, observed that people challenged to improve their leadership effectiveness found that focusing on weaknesses is often the best approach to improvement. Weaknesses have a dramatic negative impact on perceptions of overall leadership effectiveness. These “Fatal Flaws” create a “Negative Halo effect” and absolutely, positively, must be fixed. There are 10, and here they are:

  • Not Inspiring Due To A Lack Of Energy And Enthusiasm
    • Energy levels stay low
    • Unenthusiastic and passive
    • Perceive additional assignments or initiatives as burdensome
    • Rarely volunteer or make suggestions for change
  • Accepting Mediocre Performance
    • Set minimal expectations
    • Believe mediocre performance is acceptable
    • Never look for opportunities to improve
  • Lack Of Clear Vision And Direction
    • Believe their job is merely to execute the objectives of the organization
    • Expect others to deal with strategy, vision, and direction
    • Fail to understand that subordinates want to know why something is required and how their work contributes to the success of the organization
    • Unwilling to take the time to communicate
  • Loss Of Trust
    • Make poor decisions
    • Promises are made and not kept
    • Decisions are made for personal gain and glory, not for the organization’s welfare
  • Not A Collaborative, Team Player
    • Difficulty in cooperating with other leaders
    • View work as competition and other leaders as opponents
    • Fail to develop positive relationships with peers
    • Fail to share information and resources
  • Not A Good Role Model (Failure To Walk The Talk)
    • Oppose the values and culture of the organization
    • Says one thing and does another
    • Fails to recognize the contributions and hard work of others
  • No Self-Development And Learning From Mistakes
    • Do not use failure as a learning experience
    • Continue to make the same mistakes
  • Lacking Interpersonal Skills
    • Are interpersonally inept
    • Lack social skills
    • Can be abrasive, insensitive, and arrogant
    • Have a lack of respect for peers and subordinates
  • Resistant To New Ideas
    • Rejects suggestions from peers and subordinates
    • Insist on doing things the same old way
    • Closed to new thinking
    • Create a climate of stagnation
    • Pretend to listen and do nothing
  • Focus Is On Self, Not The Development Of Others
    • Highly self-centered
    • Perceive he development of subordinates as optional
Zenger and Folkman found that while looking at a dataset of 11,129 leaders assessed on 16 differentiating competencies, 30% of the leaders had one or more fatal flaws. Leaders with one potential fatal flaw scored at the 37th percentile, those with two at the 27th, and those with three at the 22nd percentile in terms of overall leadership effectiveness. Weaknesses have a dramatic negative impact on perceptions of leadership effectiveness. Working on correcting these “fatal flaws” can have a dramatic improvement on an individual’s ability to lead!

Let the Michigan Manufacturing Technology Center Help
Ongoing training and development are critical to the lasting success of business leaders. Training should be a process, not a one-time event. Learn how to tackle employee and leadership relationship issues effectively. If your business needs assistance with supervisory development, MMTC offers a Supervisory Skills course. To search upcoming MMTC Supervisory Training Courses, visit www.mmtc.org/mmtc-event or call 888.414.6682.


About MMTC
Since 1991, MMTC has assisted Michigan’s small and medium-sized businesses compete and grow. Through personalized services fitted to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at www.mmtc.org.

Friday, April 15, 2016

Geometric Dimensioning and Tolerancing 101 for Manufacturers



Geometric Dimensioning and Tolerancing 101 for Manufacturers

It would be wonderful if we lived in a world where each part perfectly matched the design model. Unfortunately, there is no such thing as a perfect world! Although imperfections are a reality in the manufacturing world, it’s crucial to work towards continuously reducing project inadequacies. It is equally as important to specify a tolerable level of deviation from the ideal before a part becomes no longer usable. The problem many manufacturers face involves the lack of a common language to arrive at acceptable deviations and reduce imperfections.  

Understanding Geometric Dimensioning and Tolerancing (GD&T)

Geometrical Dimensioning and Tolerancing (GD&T) is a systematic way of defining and communicating tolerances. It uses a symbolic language with rules and principles for engineering drawings and computer-generated 3-D solid models to explicitly describe nominal geometry and allowable variations.

The language of GD&T consists of dimensions, tolerances, symbols, definitions, rules, and conventions precisely communicating the functional requirements for the location, orientation, size, and form of each feature of the design model. It ensures everyone is speaking the same language, including common definitions of the features or parts being discussed.

GD&T Benefits Manufacturers 

GD&T provides manufacturers with:
  • Increased Cost Savings
  • Lower Rejection Rates  
  • Centralized Record Keeping
  • Improved Design Clarity, Fit and Inspection Methods
  • More Realistic Tolerances
  • An Easily Understandable Compact Language

The common language enables designers to express themselves with greater accuracy when designing models. The production department understands the designer’s specification and intent because it uses the same language. Quality inspectors use the language to determine setup requirements. GD&T delivers the level of quality required and is a great insurance policy against shoddy fabrication, expensive rework and costly delays.

Getting Started

The critical first step in the implementation of GD&T is providing training to all employees who interpret engineering drawings. It is critical that everyone involved has a sufficient understanding of the GD&T because a system is only as strong as its weakest link. Designate and train experts from the design, manufacturing and quality control departments. These internal experts help resolve tolerance issues and provide guidance to the rest of the employees.

BOTTOM LINE: Implementing GD&T helps improve output. GD&T is rumored to be complex but the process is actually simple. The complexity of your parts drives the complexity of GD&T. Consider this - many complex interrelated features require a precise language capable of describing allowable variation in size, form orientation and location relationships. The more intricate your output is, the more it begs for GD&T!

Let MMTC Help

MMTC offers GD&T services and training to Michigan manufacturers. For more information, call 888.414.6682, visit www.mmtc.org or email inquiry@mmtc.org. Start reducing inadequacies in this imperfect world!

Since 1991, MMTC has assisted Michigan’s small and medium-sized businesses successfully compete and grow. Through personalized services fitted to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at on the web at www.mmtc.org.


Friday, April 8, 2016

Lean Manufacturing – Don’t Leave Home Without it!

In today’s age, it is amazing that some manufacturers have not yet heard of “Lean”. The question is: How are they surviving in today’s competitive market without it? The issue is that, in many ways, the customer sets pricing. If manufacturers want to be profitable, they must find ways to become more efficient and effective with internal manufacturing processes.

Target Pricing
Lean works to drive down your costs; therefore the every penny you save is added directly to your profit. Companies that implement Lean typically make significant cost savings which have a very real impact on the company’s profitability. View the diagram below:



Lean Methodology
The following are a few of the Lean methodologies which can have a significant impact on your company’s bottom line:

5S and Visual Management: Completing the five pillars of 5S (Sort, Set in Order, Shine, Standardize, and Sustain) including auditing and communicating results, can have a positive impact on available square footage, machine wellness, safety, reduced lead time, and employee satisfaction and engagement. Operators take less time looking for the tools they need to do their job because they are provided at the point of use. Any time an operator walks away from their job, for any reason, it is waste and prohibits them from performing their value added tasks. Visual Management helps control raw, work in process, and finished good inventory by setting controllable min/max levels, along with many other benefits.

Standard Work: Standard Work is the best, agreed upon use of people, equipment, and resources to get the job done. Without Standard Work, the end result could be the same, but the way individuals achieve those results could be vastly different and contain a lot of waste. The true cost to an organization without Standard Work is that quality may suffer. The need to replace products because of rework and scrap can be very expensive and time consuming. Identifying the “one best way” means everyone learns and performs their tasks the same way, reducing variation and abnormalities which lead to defects. Simply stated, if employees (both on the shop floor and in the office) follow the Standard Work for their process, chances for mistakes and organizational costs are minimized.

Single Minute Exchange of Dies (SMED)/Quick Changeover (QCO): Consider the definition of SMED or QCO as the time it takes from when the last good piece was run on a piece of equipment until the first good piece of the next part is run on that same piece of equipment. When equipment is down and not running parts during certain periods of time, you are losing capacity. Depending on the product you produce and the equipment you use, this can be a matter of hours! If you could reduce that time utilizing SMED activities, the door opens for increased capacity, reduced overtime, on-time shipments, and more efficiently utilized resources. Imagine your bottom line if you could reduce the time it takes to perform a changeover by 50%!

Total Productive Maintenance (TPM): Consider TPM as the opportunity to create capacity. It is a machine wellness program that looks to keep equipment running properly. When a company has unscheduled downtime, speed loss, or quality loss, profitability can be affected for obvious reasons including defects, late delivery, added costs, and capacity loss. See diagram below.


These examples are but a few of the lean methodologies which can help bring increased profitability to your organization. Learn more about how to create a lean enterprise using these tools by contacting MMTC. MMTC offers a variety of Lean Business Solutions. For more information, call 888.414.6682, visit www.mmtc.org or email inquiry@mmtc.org. Allow your company to be more competitive in a challenging world!


Since 1991, MMTC has assisted Michigan’s small and medium-sized businesses compete and grow. Through personalized services fitted to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at www.mmtc.org.

Friday, April 1, 2016

Market Research: The Foundation of A Successful Growth Strategy

Manufacturers are continuously looking to diversify their customer base, expand into new markets, and grow business. Conducting market research is a crucial component of developing a strong growth strategy.

The importance of market research is often times overlooked. A small part of this is due to human nature. Developing new products, brainstorming innovations, and marketing new ideas are all generally very exciting, while researching and surveying are often thought of as a “little less glamorous.” However, your growth initiatives will fall flat without extracting and evaluating relevant data from current and potential customers.

An Organized, Multi-Pronged Approach
Market research entails more than just calling a couple of customers and asking them about their needs. The true process is a formalized, organized effort to assemble critical data about your potential targets. The goal is to develop a systematic and sustainable approach towards a continuous generation of new products, marketing concepts, and/or process improvements while reducing the risks typically associated with such activities. Market research uses a combination of both qualitative and quantitative methods to gain important insight:

  • Quantitative methods include tactics like structured customer surveys or online questionnaires to provide quantifiable statistical data. It helps manufacturers drive decisions based on numbers.
  • Qualitative methods help organizations understand the “human aspects” of their targets. This approach includes tactics like focus group discussions and individual, in depth interviews to help manufacturers understand the reasons, motivations, and emotions of their targets.

SWOT Analysis
SWOT analysis
Doing a business SWOT analysis is a long-standing and essential part of market research. This analysis helps companies evaluate internal and external factors, both positive and negative, impacting an organization’s ability to overcome its competition.

  1. S – Strengths: Internal business characteristics of a manufacturer which fundamentally provide an advantage. Examples include having a tech-savvy team, good reputation within the community, or strong cash flow.
  1. W – Weaknesses: Internal business characteristics of a manufacturer which fundamentally provide a disadvantage. Examples include having a very inexperienced team filled with new hires or deteriorating infrastructure.
  1. O – Opportunities: External factors a manufacturer can leverage to gain a bigger advantage. Examples include new tax credits introduced for manufacturers or an emerging generation of customers who support environmentally conscious companies. 
  1. T – Threats: External factors which could lead to challenges for a manufacturer. Examples include a competitor receiving a public award or a pricing spike from suppliers.

Market Research Services Available for Michigan Manufacturers
MMTC’s Market Research team helps small and medium sized organizations acquire and analyze data. By extracting and analyzing data from multiple sources, the Market Research team can help you identify promising markets and customers, and qualify and develop lists of priority customer leads.

Database Research
Customer Surveys
The MMTC research team subscribes to proprietary databases and online search tools to create a clear picture of the markets you serve or seek to serve.
  • Overall market size and growth potential
  • Key OEM’s and suppliers
  • Geographic distribution of customers and competitors
  • Industry regulations and trends
  • Distribution channels
  • Pre-screened lists of target customers
Online surveys and in depth telephone interviewing help you understand your customers and anticipate their needs.
  • Measure customer satisfaction
  • Understand awareness and perceptions of your company and its products compared to competitors
  • Identify improvement opportunities
  • Gauge customer demand for new products
  • Target marketing messages to customers

Don’t overlook this very important step of the growth process. Click here to learn more about MMTC’s Market Intelligence and Research solutions or contact us at inquiry@mmtc.org or 888.414.6682 today!

Join MMTC at a FREE Overview Event 
Join MMTC April 21, 2016 for EXPLORE: The Competitive Intelligence Advantage, an overview event focused on competitive intelligence & the benefit of research to your business. Competitive intelligence helps business leaders make stronger strategic decisions and can help you answer:
• Who are our direct competitors?
• What substitute products or services exist?
• What are our strengths compared to the competition?
• What products or services should we offer?


Since 1991, MMTC has assisted Michigan’s small and medium-sized businesses successfully compete and grow. Through personalized services fitted to meet the needs of clients, we develop more effective business leaders, drive product and process innovation, promote company-wide operational excellence and foster creative strategies for business growth and greater profitability. Find us at www.mmtc.org.