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.