2016年4月29日星期五

HKIE-MI AGM Seminar on Developing an Innovation Workforce

The seminar entitled “Developing an Innovation Workforce” was organized by Hong Kong Institution of Engineers (HKIE) –Manufacturing & Industrial Division (MI) after AGM on 29 April 2016.  The immediately past chairman Ir. SC Ho reported the past years activities.  He said they were looking forward the fourth industrial revolution in 2015 and appreciated members’ contribution upto 40 technical seminars, Apps workshop and industrial visits in the last year.  He encourage us to participate the HKIE Conference 2016: Moving forward to 2025 Hong Kong Industrial Development, Technology and Innovation.


The new MI division chairman is Ir. Herman Chiu.


After the AGM, Ir. Dr. Victor Lo was the guest speaker and his topic named “Developing an innovative workforce”.  His aim is to explore new approaches to conventional quality management.  Moreover, he shared his vision that “I want to make greater China a better place for innovators” and his mission “To assist organizations to bring innovative ideas to quality life”. 


Then Dr. Lo shared his idea as follows:
1.      Develop a sound strategic plan
2.      Inspire eager internal and external partners
3.      Learn effective ways to innovate
4.      Solve painful customer problems
Innovation included Your Boss Support, Your Interest and Innovative Method.
(One slide in Chinese: 山不轉, 路轉; 路不轉, 人轉; 人不轉, 心轉.)


Dr. Lo asked a question “What is Innovation?”  There were many definitions.


We discussed about Innovation and Hon Ir. Dr. KW Lo also participated.  


Then he introduced his Innovation Conceptual Model included “Need”, “New”, “Function” and “Value” to break the psychological inertia. 


Dr. Lo said there were two systems for innovation methods that one is people centered innovation (using Design thinking) and the other is TRIZ (Theory of Inventive Problem Solving).  


He briefed TRIZ 5 pillars included “Functionality”, “Resources”, “Ideality”, “Contradiction” and “Evolution”; as well as, TRIZ 40 Innovative Principles.  


And then he mentioned the Design Thinking process included “Empathize”, “Define”, “Ideate”, “Prototype” and “Test” where “Empathy” is the heart of Design Thinking.


Finally, Dr. Lo introduced his Innovation Model included PKIR, 50+ project flash cards, Management System, TRIZ, People Centered Innovation, Mutual Respect and management philosophy; so as to support Innovation Quality Improvement (IQI).  


At the end, Dr. Lo used one diagram to conclude his talk and asked us to rethink about the following items:
-          Organization treats employees well…
-          People like working there…
-          Innovate to improve quality…
-          Provide better products / services…
-          Happier customers feel warm, secure job for everybody… etc. 


During Q&A, Dr. Lo invited Ir. Peter Chak to briefed the dream zone in Towngas. 


Ir. SC Ho presented a souvenir to Dr. Lo.


I also took a photo with Dr. Lo for memory.


Reference:
HKIE – MIE - http://mi.hkie.org.hk/
20150207: HKSQ & ISI Workshop of Innovative Total Quality Improvement (iTQI) - http://qualityalchemist.blogspot.hk/2015/02/hksq-isi-workshop-of-innovative-total.html


2016年4月27日星期三

The 7 HABITS of Highly Effective People Workshop

FranklinCovey was invited to provide a Workshop on the 7 HABITS of Highly Effective People on 12 & 27 April 2016. I would like to summarize what I learnt from the workshop for sharing.  This book was recognized as the most influential book of the 20th century by Chief Executive Magazine Reader Survey.


Ms. Sharon Lui (Principal Consultant, FranklinCovey) was our trainer. I took a photo with Ms. Lui for memory


Firstly, the definition of “Effectiveness” was mentioned as “The essence of effectiveness is that you get the results you want today in such a way that you can get even better results in the future.”    There are four key concepts included “Roots of Effectiveness”, “The Maturity Continuum”, “How to Change Your Habits” and “Paradigms and Principles of Effectiveness”.

The roots of effectiveness like the top of a tree.  Personality is outside (competence) and Character is inside (The roots).  The Maturity Continuum is a process of natural growth from dependence to independence and then achieved interdependence.  Sharon then briefed how to change your habits using the “Paradigms and Principles of Effectiveness” as the following See-Do-Get cycle.  


The Maturity Continuum included all 7 habits is shown as following diagram.
7 Habits Principles:
Habit 1: Be Proactive
-          Responsibility, choice, accountability, initiative, resourcefulness
Habit 2: Begin with the End in Mind
-          Vision, commitment, purpose
Habit 3: Put First Things First
-          Focus, integrity, discipline, prioritization
Habit 4: Think Win-Win
-          Mutual benefit, fairness, abundance
Habit 5: Seek First to Understand, then to be Understood
-          Respect, mutual understanding, empathy, courage
Habit 6: Synergize
-          Creativity, cooperation, diversity, humility
Habit 7: Sharpen the Saw
-          Renewal, continuous improvement, balance


Habit 1: Be Proactive
The habit of personal responsibility has four highly effective practices
-          Pause and respond based on principles and desired results
-          Use proactive language
-          Focus on your Circle of Influence
-          Become a transition Person
Each of us makes our own weather.  We are freedom to choose the response based on stimulus. 
Proactive language is the language of leadership and it can expand our knowledge and experience, so as to make our Circle of Influence growth.


Transition person is someone who breaks unhealthy, harmful, abusive or ineffective learned behaviors and replaces them with proactive, helpful, effective behaviors.  


Habit 2: Begin with the End in Mind
The habit of personal vision with principles of effectiveness included Vision, Commitment and Purpose.  Its highly effective practice included to define outcomes before you act and to create and live by a Personal Mission Statement.  Personal Mission Statement is a written constitution by which you make all decisions for your life.
A Good Mission Statement is:
-          Based on principles of effectiveness
-          To clarify what is most important to you (your deepest values)
-          To provide direction and purpose
-          To address the most important aspects of your life
-          To represent the best in you
I remembered my first personal mission statement was a Chinese Poem when I was studying my 2nd Master degree in 1998.  I used this statement until now and shared to CityU alumni.


Habit 3: Put First Things First
The habit of personal management and its principles of effectiveness were Focus, Integrity, Discipline and Prioritization.  We used the Time Matrix to identify what task is important and urgent.  The matrix is separated into four areas named “Important (I)”, “Unimportant (UI)”, “Urgent (U)” and “Not Urgent (NU)”. 
Important: Activities that represent your mission, roles, values, and high-priority goals.
Urgent: Activities that require immediate attention.
The idea Time Matrix should be expanded the Q2 (NU & I) and eliminated Q4 (NU & UI).


Overview the first 3 habits, the summary is shown as follows.
Habit 1: You are the creator of your life
Habit 2: First creation
Habit 3: Second creation

The second part of training was held on 27 April 2016.  We reviewed the first three habits and started from Private Victory to Public Victory journey.  Ms. Sharon Lui introduced Emotional Bank Account (EBA) concept to us.  EBA measures the amount of trust in a relationship. Deposit to the account is through “Seek first to understand” and Withdrawal from the account is through “Assume you understand”.


Habit 4: Think Win-Win
The habit of mutual benefit and its principles included “Mutual Benefit”, “Fairness” and “Abundance”. Win-Win is a frame of mind and heart that constantly seeks mutual benefit in all human interactions.  Win-Win effective practice included the follow items:
-          Have an Abundance Mentality
-          Balance courage and consideration
-          Consider other people’s win as well as your own
-          Create Win-Win Agreements


Habit 5: Seek First to Understand, Then to Be Understood
The habit of Empathic Communication is based on the principles such as “Respect”, “Mutual Understanding”, “Empathy” and “Courage”.  Covey said we needed to avoid Autobiographical Listening which filtering what others say through their own story, experiences, biases, prejudices and values.  On the other hand, we should have “Empathic Listening” (Listening with the intent to understand) and ask “Clarifying Questions”.  Then state your point of view using “I” messages for seeking to be understood.


Habit 6: Synergize
The habit of creative cooperation includes principles of “Creativity”, “Cooperation”, “Diversity” and “Humility”. The path to synergy is to find value different first and then to seek the 3rd Alternative.


Habit 7: Sharpen the Saw
The habit of daily self-renewal is about preserving and enhancing the single greatest asset you have.  Mr. Sean Covey (Executive VP, FranklinCovey; Author, The 7 Habits of Highly Effective Teens and Happy Kids) briefed four dimensions of renewal and they were “Body”, “Heart”, “Mind” and “Spirit”. It is called the Daily Private Victory.  


There is a set of high quality training materials for 7 Habits training.


Reference:
Stephen R. Covey - https://www.stephencovey.com/
Youtube Lectures: The 7 Habits Of Highly Effective People - Dr Stephen R Covey - https://www.youtube.com/playlist?list=PLNdzRp0OXa8SBzHtlQxgm7IiJDCYVHOVl


2016年4月25日星期一

HKSTP Seminar on Medical Device Regulatory Affairs and Quality Assurance

HKSTP organized a seminar named “Medical Device Regulatory Affairs and Quality Assurance” on 25 April 2016.  This seminar is set to tackle the increasingly complicated International, Asian and European medical device regulations and quality requirements.  The seminar aims to share knowledge on medical devices regulations in major jurisdictions such as US, Europe, ASEAN and Hong Kong, as well as how to maintain and apply them and avoid the pitfalls form both practical and academic perspectives.  I took a photo with Prof. Albert Poon at the end of seminar for memory.


Prof. Albert Poon (Professor of Practice (Biomedical Engineering), Interdisciplinary Division of Biomedical Engineering, Faculty of Engineering, PolyU; Associate Specialist, Medical Device Program of SGS Academy) was the first speaker and his topic entitled “Medical Device Regulation and Life Cycle Management”.  Prof. Poon said the figures in the left hand side of the first slide demonstrated today’s topics included Regulations (FDA, CE), Hong Kong Medical Device Regulation Choice and Design Control which followed US or EU in R&D area.


Firstly, Prof. Poon mentioned the Ideal Healthcare System included Safe, Effective, Patient Centered, Timely, Efficient and Equitable.  He added the most important was the intended purpose of MD.  Then he introduced the MD Life Cycle as follows.
1.      Innovation, R&D
2.      Product Realization, Commercialization
3.      Proof of Quality, Effectiveness and Safety
4.      Clinical Trials, Evaluation and Product Performance
5.      Product Safety and Risk Classification
6.      Quality and Risk Management
7.      Industry Self-Discipline (In HK, 手中無劍, 心中有劍.)
8.      Regulation
9.      Management


Prof. Poon described the Health Technology Management included R&D, Regulations, Assessment and Management.  He explained Health Technology Assessment (HTA) is the systematic evaluation of properties, effects, and/or impacts of health technology.  


The following diagram showed the Health Technology tree which classified different types of health technology.  Then Prof. Poon told us the important ingredients for a successful implementation of HTA at the country levels, which were good governance, funding, adequate staffing and good collaboration with partners.


Product life span of a medical device was discussed which included Manufacturer, Vendor and User.  


Aspects of MD Life Cycle Management are shown as following diagram. Where
HTA = Health Technology Assessment
HTR = Health Technology Regulation
HTM = Health Technology Management
QMS = Quality Management System; RM = Risk Management


After that Prof. Poon explained two types for MD regulation which one followed US FDA and the other followed EU CE Mark.  EU CE Mark is based on system approach.  Prof. Poon then briefed the Medical Device registration in USA (21 CFR 800-1299) and EU system (AIMD, MDD & IVDD).  Finally, he briefed the harmonization of regulation of MD and IVD.  


Lastly, Prof. Poon introduced types of medical equipment (see diagram) and 10 categories which defined by HA below.
1.      Chemistry analyzers and laboratory equipment
2.      Gas incubator and safety cabinet
3.      Cardiac diagnostic and monitoring equipment
4.      Eye, ear, nose and throat equipment
5.      Non-cardiac diagnostic, monitoring and surgical equipment
6.      Infusion pump
7.      Ventilator
8.      Physiotherapy equipment
9.      Renal equipment
10.  Miscellaneous (e.g. nebulizers, scalers)


Mr. Kelvin Sze (Certification Officer, SGS Hong Kong) was the second speaker and his topic named “ISO 13485 Quality Management System Introduction”.  He told us three elements regulatory bodies were most concerned that were Safety, Effectiveness and Quality Assurance.  


Firstly, Mr. Sze compared different regulation of Medical Device included USA, China, EU and Hong Kong Proposed Framework.  Hong Kong’s one is only human and based on Global Harmonization Task Force (GHTF) and ISO 13485.


Then Mr. Sze compared ISO 9001 and ISO 13485.  It observed that ISO 13485 required consistently to meet customer requirements, in which customer included the regulatory bodies.  Moreover, customer satisfaction and continual improvement were de-emphasized.  ISO 13485 is not focus on continual improvement but emphasized to maintain the effectiveness of the QMS.  


After that Mr. Sze summarized the change in the new standard ISO 13485:2016 below:
New requirements (where risk management is in all clauses)
-  Cl. 4.2.3 Medical Device File
-  Cl. 6.2 Human resources
-  Cl. 6.4 Work environment and Contamination control
- Cl. 7.3.8 Design and development transfer
-  Cl. 7.3.9 Control of design and development change
- Cl. 7.3.10 Design and development files
- Cl. 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems
- Cl. 8.2.2 Complaint handling
- Cl. 8.2.3 Reporting to regulatory authorities
- Cl. 8.3.2 Actions in response to nonconforming product detected before delivery
-  Cl. 8.3.3 Actions in response to nonconforming product detected after delivery


Finally, Mr. Sze briefed the EU regulation Update and some main topics were shown in the following diagram.  


Lastly, Mr. Sze introduced SGS professional certificate in Medical Device RA/QA programme to us. 


During Q&A, I asked a question if Cl. 7.3.10 Design and development files equivalence to FDA Design History File (DHF).  Mr. Sze said the requirements were similar but the format was different which case was same as EU Technical File.  He also mentioned the old standard ISO 13485:2003 will update to ISO 13485:2016.  Until now, EN ISO 13485:2012 (included Annex 2A, 2B & 2C) was employed in Europe. (In EU, regulatory bodies only concerned EN ISO 13485:2012 which had harmonized.)

Reference:
20091124: ISO 14971 Risk Management for Medical Device Manufacturer Seminar - http://qualityalchemist.blogspot.hk/2009/11/iso-14971-risk-management-for-medical.html



2016年4月19日星期二

Performance Management and Advanced Coaching Workshop

LMI academy was invited again to provide a Performance Management and Advanced Coaching Skills Workshop on 19 April 2016. I was one of participants and would like to summarize what we learnt from the workshop.  Mr. Dick Yip (Principal Consultant, LMI) was our trainer.  He had provided two innovation training to us in 2015.


In the beginning, he briefed the components of Advanced Coaching Skill which included Performance Management Cycle (Goal Setting Review Appraisal Follow-up) and Process & Skill Sets (Opening, Self-Appraisal, Feedback (and Coaching) and Action Planning).

Then Mr. Dick Yip told us the definition of “Coaching” that is a structured approach to facilitate skill development of another person.  It was like a bus to take a passenger from one place to another.  After than Mr. Yip briefed the roles and responsibilities of Coacher that he would facilitate exploration and consolidate learning; observe, listen and question to raise the coachee’s self-awareness; and suspend judgment and inclination to give direction to enables the learner to set their own goals, to identify actions that they were committed to, and to assess their own progress; as well as encourage the learner to develop personal responsibility and accountability and to continually improve their performance.


Mr. Dick Yip led us to discuss different concepts on coaching and we separated into different answers and explained why we selected.  

After that Mr. Yip explained the Process and Skill Set through the cycle (Opening, Self-Appraisal, Feedback (and Coaching) and Action Planning).  And he introduced the root cause finding technique named TRAP (Trouble, Result, Alternative and Payoff).  


I was invited to be one actor in the role play to handle with trouble staff.  


We used TRAP and then Mr. Yip using the following table explained Dos and Don’ts in each step.


Finally, Mr. Yip summarized the coaching process from Root Cause Analysis to Idea Generation.  For Root Cause Analysis, some common tools were discussed such as 5W1H, 5 WHY, etc.  For Idea Generation, he introduced + - 1 0 to us that means Do more (+), Do less (-), Start (1) and Stop (0).  


Another Root Cause Analysis was from three elements that were Attitude (Heart), Skills (Body) and Knowledge (Brain).  


At the end, Mr. Yip quoted Winston Churchill (Nobel Prize for Literature Winner (1874-1965) statement that “I am always ready to learn although I do not always like being taught.”  He concluded the basic techniques were “Always talk less than your subordinate” and “Let subordinate to speak first”.  We should enhance our soft skills on Active Listening and Questioning as following table.


Reference:
20150203: Innovative Thinking Workshop – Thinkertoys - http://qualityalchemist.blogspot.hk/2015/02/hkstp-innovative-thinking-workshop.html
20150714: Team Synergy and Creative Problem Solving Workshop - http://qualityalchemist.blogspot.hk/2015/07/team-synergy-and-creative-problem.html



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