Hong Kong Council for Testing and Certification Consultation Forum

I represented Hong Kong Society for Quality (HKSQ) to attend the Hong Kong Council for Testing and Certification (HKCTC) Consultation Forum on 27 November 2009.


Prof. P.C. Ching (Chairman – HKCTC) introduced the background of HKCTC and briefed the differences between Testing, Inspection, Certification and Accreditation.
The consultation forum aims to collect and exchange views from the testing and certification industry, major stakeholders and the public on the opportunities and challenges faced by the industry and the strategies to be developed for strengthening the capacity and capability.

Mr. John Hung (General Secretary – HKCTC) was a modulator and Mr. Terence S.S. Chan (Executive Administrator – HKAS) was responsible for technical consultation.

During the forum, needs and suggestions from different parties were shared, which would assist HKCTC to develop the related strategies. On behalf of Hong Kong Society for Quality (HKSQ), I appreciated the opportunity to share some ideas created by our members as follows:i) As many manufacturers in HK/China have to follow EU or USA standards for their business, instead of developing HK own standards, harmonization of the standards globally could be useful.ii) HKSQ concerned about the manpower development and practitioner training to support the long-term development of the Test & Certification industry. To develop a long-term plan, it is suggested HKCTC works with the UGC/IVE. Further, I shared my experience on testing & certification training to undergraduate. It is the fact that students understand the technical knowledge about testing in their undergraduate education. However, they could not demonstrate their insight of management system.

Some suggestions and discussion are summarized in several categories such as Policy, Education, Technical Aspects, etc.

Policy Suggestions / Discussions:
Hong Kong Jewelry Manufacturers' Association Limited (HKJMA) representative suggests both the capability in their industry and the industry status in the world should be improved and enhanced respectively.

A representative from a food company pointed out that oversea buyers are lack of awareness of the recognition of HOKLAS endorsed report. Mutual recognition of such test reports with oversea government was encouraged to enforce. He also shared that the pricing of testing of oversea laboratory was lower than that of local laboratory.

A cigarette company representative indicated that local assessor is not available for cigarette ingredients test. Moreover, the tax of cigarette samples for testing was suggested to waive.

Modernized Chinese Medicine International Association (MCMIA) representative mentioned the difficulties of TCM testing especially for TCM ingredients. Harmonization of test standards was emphasized. In addition, testing cost was suggested to consider as it was high to the TCM industry.

Bio-tech lab representative said they had developed different CRM/RM for the industry. He suggested unique techniques for niche market should be developed.

One participant raised it would be a great challenge to the industry to face complaint increased gradually after public has increased the awareness of testing and certification.

Another participant suggested supports should be provided to industry through land, rental, utilities such as electricity and water through sponsorship programs.

Education Suggestions / Discussions:
The Hong Kong Institute of Gemmology (HKIG) representative said that higher caliber testing talents are required for the industry. Funding or scholarship support was recommended.

Hong Kong Institute of Certified Auditors representative proposed to develop and recognize personal qualification such as assessor qualification.

The Hong Kong Jockey Club’s Racing Laboratory representative shared that the training on analytical chemistry to undergraduate students was found not sufficient.

An international listed company representative affirmed the direction to develop the recognized qualification for testing engineer / specialist should be defined by HKCTC.

Technical & Other Suggestions / Discussions:
One of certification bodies’ representative requested alignment between HKAS and CNAS for certification service could be developed such as CCC. He also suggested to develop the carbon footprint and GHG certification scheme.

Internet Professional Association (iProA) representative stated awareness on software testing should be enhanced, based on different standards such as ISO 9126, ISO/IEC 15939 and IEE 829, etc.

IEEE's Product Safety Engineering Society representative advised that calibration services of some specific equipment was only available in overseas, such as calibration of LED, Photonics, plastic hardness, etc

Hong Kong Jockey Club Institute of Chinese Medicine (HKJCICM) representative added the test scope was limited to TCM basic safety testing in existing HOKLAS accredited laboratories which was not enough for TCM industry.

Finally, Prof. Ching summarized today’s discussions to three infrastructure establishments as follows:
i) Development of human resource
ii) Improvement of laboratory equipment and test methodology
iii) Promotion Hong Kong testing and certification services to overseas
HKAS would try to participate in the development of international standards and make the industry known about the up-to-date information.

At the end, Miss Janet Wong (Commissioner of Innovation & Technology) said all factors of production including land & rental fee would be considered and discussed in the future.

A Smaller Carbon Footprint (HKQAA Symposium 2009)

I also joined the session 3 entitled “A smaller Carbon Footprint, A Cleaner Future” in HKQAA Symposium 2009 on 25th November 2009. We took a group photo with HKQAA friends for memory.



The program summary was shared below.

Ir. Roger Lai (President, Hong Kong Association of Energy Engineers) gave the opening speech. He encouraged entrepreneurs to put in greater investment in manufacturing of energy saving equipment and systems and government might use incentives such as tax rebate, tax deferment, etc, on carbon reduction and sustainable development.


The first speaker was Ms. Anissa Wong (JP, Director of Environmental Protection, EPD, HKGov) and her topic was “Building a Green Hong Kong”. She analyzed the greenhouse gas (GHG) situation in Hong Kong. The principal sources were power generation (62%), transportation sector (16%) and others (e.g. waste, industries). Then she explained EPD target was to reduce energy intensity by at least 25% by 2030 from the 2005 level. There were 6 strategies to achieve the target.
i) Raise Energy Efficiency
ii) Encourage the use of Cleaner Fuels
iii) Promote Cleaner Transportation
iv) Enhance Community Participation
v) Sound Waste Management
vi) Conserve the Nature

The second speaker was Ir. Yu Shuk Man (Senior Project Engineer, EMSD, HKGov) and his presentation title was “Building Energy Efficiency Funding Schemes”. He introduced two major schemes in EMSD and they were Energy-Cum-Carbon Audit (ECA) Scheme and Energy Efficiency Project (EEP) Scheme. He briefed the carbon audit and energy audit and their advantages.
Carbon Audit refers to the quantification of the Greenhouse Gases (GHG) emitted directly and indirectly.
Energy Audit reviews the energy system and ensures energy being used as efficiently as possible, and provides indications to derive a pragmatic approach to reduce unnecessary energy use.
The advantages of joining energy efficiency funding schemes were fulfilling social responsibility and achieving cost saving.

The third speaker was Mr. Peter Young who is the Head of Technical Services and Sustainability in Hongkong Land Limited. His topic was “Energy and Emission Reduction Programme of Hongkong Land”. According to Peter, Green Buildings is “Over entire lifecycle (construction, operation and demolition) supports the health and well being of the local, regional and global environment and of people around them”. Then he shared Kill-A-Watt Hongkong Land’s Energy Management Programme that reduced energy consumption by nearly 8% for the Central portfolio from 2005 to 2008. It also caused annual savings of HK$13 million and CO2 emission reduction of 12,500 tons, equivalent to 2,500 cars off the road.

Mr. Jor Fan (Environmental Management System Manager, Langham Place, Mongkok, HK) was the fourth speaker and his topic was “Carbon Footprint & EMS”. He started his speech from the statement “Greening our place starts with me…” (綠色朗豪由我創造...). He shared that carbon footprint is part of their EMS. During Green Promotion in Langham, the approach was supported and participated from Top to Bottom. To be a Greener Hotel, they employed green building design, greener equipment / technology, greener products, best waste management practice, etc. Their carbon audit report showed that GHG reduction was 1900 tonnes CO2 in 2008.

Ms. Janice Lao (Environmental Manager, Cathay Pacific Airways Limited) was the fifth speaker and her presentation title was “Aviation Carbon Emission Reduction Strategy”. She mentioned the IATA four pillar strategies as follows:
I) Technology
- Airframe, engine
- Cleaner bio-fuels, new energy sources
II) Infrastructure
- Improve air routes, ATM & airport procedures
III) Aircraft operations
- Drive for maximum efficiency & minimum weight
IV) Economic instruments
- Incentives to finance technology R&D
- Carbon offsets & trading
Lastly, she said that they were the first Asian airline to offer a carbon offset scheme to passengers in 2007.

The sixth speaker was Ms. Katherine Lau (Head – Quality & Corporate Sustainability, Fuji Xerox (Hong Kong) Ltd.) and her topic entitled “Green Supply Chain Management”. She introduced the Eco-office concept including Optimization of “Output”, “Print-On-Demand” and “IT Devices & Document Management”.

The following photo showed the Eco-office concept.

Then she discussed the Green Purchasing and Green Commitment which includes Energy Saving Features, Resource Conservation Initiative and Chemical Risk Management.

The last speaker was Mr. Victor C.L. Kwong (Corporate HSE Manager, The Hong Kong & China Gas Company Limited). His topic was “Experience Sharing in Emission Reduction & Energy Efficiency Enhancement in Fuel Gas Industry”. In the beginning, he analyzed the fossil fuel emission of CO2, CO, NOx, Sox, Particulars and Mercury, etc. His company achieved ISO 14001 in 1999 and Carbon audit based on ISO 14064-1 has been performed recently.

Panel Discussion was performed at the end of session 3 of the symposium.

An Evolution of CSR Era (HKQAA Symposium 2009)

HKQAA Symposium 2009 was held from 24th to 25th November 2009 and it separated into 4 sessions. Hong Kong Society for Quality (HKSQ) was one of supporting organization. I represented the society to attend the symposium and the first session “An Evolution of CSR Era – After Economic Crisis” was summarized as follows.



The first speaker was Dr. Jorge Cajazeira (Chairman of the ISO Working Group for ISO 26000, ISO) and his topic was “Preview of ISO 26000 – A Future International Standard of Social Responsibility”. He pointed out that the standard ISO 26000 should be adopted in daily operation. It should be worked with stakeholders and considered for our next generation.


The second speaker was Mrs. Mimi Cunningham (Director of HR & Sustainability, The Hong Kong Jockey Club) and her topic was “Sustainability 125”. In the beginning, she quoted Obama’s statement “The choice we face is not between saving our environment and saving our economy. The choice we face is between prosperity and decline.” and Ban Ki-moon’s statement “Climate change is the pre-eminent geopolictical and economic issue of the 21st century. It rewrites the global equation for development, peace and prosperity”. Then she introduced HKJC approach to sustainability such as club’s business model, donation and fund to environmental programmes, etc. At the end, she shared the new TeleBet and CS centre at Tin Shui Wai.

Dr. YaoZhi Jan was the third speaker, who is Business Development Department Director in China Mobile Group Zhejiang Co., Ltd., and his speech entitled “The First GRI Reporting in China”. GRI stands for Global Reporting Initiative. The direction would be from corporate social responsibility to corporate sustainable development and then to country and society sustainable development. He concluded the CSR with “以天下之至誠而盡己之性，盡人之性，盡物之性”.

Mr. Peter Cheung (JP, Deputy Director of Intellectual Property, Intellectual Property Department, the Government of the HKSAR) was the forth speaker and his presentation title was “The Context, The Challenge and Resolution with CSR”. He shared the resolution of Corporate / Organizational Social Responsibility (CSR/OSR) by using an equation of “Business Performance” over “Stakeholder’s social, economic & environmental expectations”. He introduced some actions carried out by IPD’s CSR/OSR to fulfill the social expectations as follows:
i) No Fakes
ii) I Pledge
iii) Business Software Programmes
iv) Intellection Capital Management
v) Green Management

The fifth speaker was Dr. Glenn Frommer (Head of Sustainability Development, MTR Corporation Limited) and his topic entitled “Sustainability Reporting – the MTR Experience”. He briefed the background of MTR and how they developed the sustainability report. MTR employed different systems and were in the following sequence: Safety Management → Quality Management → Environmental Management → Asset Management → Risk Management → Sustainability Management.

He stated the heart of sustainability as following picture.

The last speaker was Mr. Connie Sham (Senior Manager of Strategic Business, HKQAA) and her topic was “Aligning Organization’s CSR Practices with ISO 26000”.

She introduced the Hong Kong CSR Advocate Index which consolidated ISO/DIS 26000 into 40 recommended CSR practices. There were 5 scoring categories:
i) Starting phase
ii) Forming phase
iii) Implementing phase
iv) Confirming phase
v) Improving phase

Finally, she concluded CSR would enforce business process to produce an overall better impact to the society and it is a commitment to improve business practice.

ISO 14971 Risk Management for Medical Device Manufacturer Seminar

Hong Kong Society for Quality and SGS co-organized a seminar “ISO 14971 Risk Management for Medical Device Manufacturer” on 24th November 2009. The details are summarized as follows.

In the beginning, Dr. Albert Tsang (past-chairman – HKSQ) introduced two speakers for the seminar. Mr. Marvin Lee is the Product Manager in Systems & Services Certification, SGS and he is also the member of Quality and Regulatory Affairs Panel in Hong Kong Medical and Healthcare Device Industries Association (HKMHDIA). Mr. Sam Wong is the Assistant General Manager in Vincent Medical Mfg. Co., Ltd.



Marvin gave the first talk entitled “ISO 14971 Application of Risk Management to Medical Devices – Introduction”. He showed the global requirements on risk management application including The FDA Quality Systems Regulation (USA), 93/42/EEC Annex I (EU), Canadian Medical Device Regulation 1998 (Canada), MHLW Ministerial Ordinance No.169, 2004 (Japan), etc.

Global Harmonization Task Force (GHTF) has encouraged members to use SG3/N15R8/2005 – Implementation of Risk Management Principles and Activities within a Quality Management System (http://www.ghtf.org/). Even though ISO 13485:2003 did not require to use ISO 14971 risk management standard mandatory, ISO 14971 is still broadly accepted and used as risk management system in medical device industries.

The history of risk management standard development for medical device was shown as follows:
- EN 1441:1997 Medical Devices Risk Analysis
- ISO 14971:2000 (1st edition) on 3 Dec 2000
- ISO 14971:2000/Amd.1:2003 (amendment) on 28 Feb 2003
- ISO 14971:2007 (2nd edition) on 1 March 2007

The diagram showed the risk management process.

There are three critical documents required for risk management, namely Risk Management File (RMF), Risk Management Plan (RMP) and Risk Management Report (RMR).

RMF consists of quality records to document the results of all risk management activities. Generally, it includes the background information and references to support the decision during risk analysis.

RMP consists of the scope of the plan (which identified the device and its lifetime), who is responsible to, risk acceptability criteria design and verification plan, as well as, post-production information collection.

RMR should be issued before design or manufacture and it provides traceability from each hazard to risk control measures. Overall residual risk is recorded in the report and demonstrates the product is safe for its intended use.

Lastly, Marvin also briefed the 15 steps to ISO 14971. They are
1. Risk management plan establishment
2. Intended use / purpose and identification of characteristics related to the medical device safety
3. Identification of known or foreseeable hazards
4. Estimation risk in each hazard
5. Risk evaluation
6. Risk reduction
7. Option analysis
8. Implementation of risk control measures
9. Residual risk evaluation
10. Risk/benefit analysis
11. Risk arising from risk control measures
12. completeness of risk evaluation
13. Overall residual risk evaluation
14. Risk management report
15. Post-production information.

Sam shared his experience in the implementation of ISO 14971 in Vincent Medical Mfg. Co., Ltd. He explained the reasons of his company to seek the risk management standard certification. It was because the certification could strengthen the product design safety by using advance systematic approach and considering more technical aspects during the design. Moreover, it was also the market trend for customer satisfaction and demonstrated the company commitment on product safety. It not only enhances product quality awareness and inter-department communication, but also communication with customer.

He analyzed four difficulties and obstacles during the implementation as follows:
i) Understanding of ISO 14971
Sam said they need a consultant to coach the whole project.
ii) Technical Knowledge Acquisition
Technical training for staff is also needed.
iii) Resources
Resources need including Human, Money and Time Investment.
iv) Maintenance
It needs top management commitment to maintain the long run program.

He lastly summarized some advantages after implemented ISO 14971.
i) Less risk from product on end-user
ii) More consideration during product design and manufacturing
iii) Less lost come from product safety (such as product recall)
iv) Increase customer confidence
v) Reduce the difficulty on product registration


The last session was “Introduction to CE Mark Certification”. Marvin introduced the CE marking which is a “Passport” of products to market in European Union (EU). The EC Directives related to Medical devices as follows:
93/42/EEC Medical devices
98/79/EEC In vitro diagnostic medical devices
90/385/EEC Active implant able medical devices

The follow table showed the classification of medical devices.

The souvenir presented to Mr. Marvin Lee

The souvenir presented to Mr. Sam Wong

Group photo

Related activities:
Visit two Mainland Medical Devices Manufacturers

Useful linkage for product recall
Hong Kong – Medical Device Control Office
http://www.mdco.gov.hk/tc_chi/press/press.html
http://www.mdco.gov.hk/tc_chi/recalls/recalls.html
USA – FDA – CDRH
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cfm
Australia – TGA
http://www.tga.gov.au/recalls/index.htm
Canada – Health Canada
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/index_e.html

Quality Management talks for HKU students

I was glad to be invited by Dr. Aaron Tong to introduce Quality Management in Hong Kong Science Park Laboratories for the year 2 student (Logistics and Industry Engineer students, HKU) as part of the lecture entitled “Global Quality and International Quality Awards” on 20 Nov 2009.


Dr. Aaron Tong briefed the Global Quality concept and different quality awards in USA, Europe, Japan & HK, such as Malcolm Baldrige National Quality Award, European Foundation for Quality Management (EFQM) Award, Deming Prize, Hong Kong Industry Award – Quality & Productivity, etc.

In my session, implementation of the quality management (ISO 9001) in Technology Support Centre in Hong Kong Science and Technology Parks (HKSTP) was introduced. The execution of Eight Quality Principle in our laboratories was also illustrated. They are:
i) Customer focus
ii) Leadership
iii) Involvement of people
iv) Process approach
v) System approach to management
vi) Continual improvement
vii) Factual approach to decision making
viii) Mutually beneficial supplier relationships

Then ISO 17025 quality management system adopted in our IC Failure Analysis Laboratory and Reliability Laboratory were discussed.

Lastly, I shared the quality movement in Hong Kong and the career path of quality professionals through the introduction of Hong Kong Society for Quality (HKSQ).

The 21st Century is the world of Information Technology. Now, students learn computer in primary school or even earlier, and play games in facebook (e.g. Restaurant city). Some of their teachers play with students through this platform to enhance communication. Therefore, I encouraged students to use information technology for innovation such as blog, twitter, facebook, linkedIn, wikipedia, etc.

2009 Celebration Dinner of EngD Graduands

EngD Society and the MEEM department jointly organized the “2009 Celebration Dinner of Engineering Doctorate (EngD) Graduands” to recognize the outstanding achievements of six EngD graduands. I am glad to be invited by one of graduands Dr. Danny Tang Wah Hau to join the celebration dinner. The following photos recorded the memory of our joyful.

Photo of all EngD students



Photo of Professors and EngD students

Dr. Danny Tang and I

Dr. TW Liu, Dr. Raymond Leung and I

Dr. KS Chin (Asso. Professors) and his students

At the end, Dr. Fok (Former Chairman of EngD Society) gave a talk and shared the development of EngD Society.


More information:
Introduction of Engineer Doctorate (Engineering Management) in CityU

Workshop on Advanced Methods in Food Microbiology and Chemistry

Food safety and security become more and more important in our daily life in Hong Kong. Therefore, one of suggestions from industry to Hong Kong Council of Testing and Certification (HKCEC) is to enhance Food Testing and Legislation. To benefit management of food safety and security, a Workshop on Advanced Methods in Food Microbiology and Chemistry was introduced by Dr. Richard Cheung (Workshop leader) in BCH Dept., City University of Hong Kong (CityU) and co-organized by Hong Kong Productivity Council (HKPC) from 10 to 12 Nov 2009. Hong Kong Society for Quality was one of the supporting organizations. Dr. KS Chin (Asso. Prof, MEEM Dept. in CityU) and Dr. Aaron Tong (Managing Director, TQM Consultants Co. Ltd.) represented HKSQ to present a talk named “Quality Assurance in Food Industry”. I attended the morning session on 12 Nov 2009 and summarized as follows.



Dr. KS Chin shared some fundamental quality knowledge such as quality control, quality assurance, and quality audit. Moreover, he briefed the concept of Total Quality Engineering. After that he discussed some good practices for food safety including:
- GAP: Good Agricultural Practices
- GHP: Good Handling Practices
- GMP: Good Manufacturing Practices
- HACCP: Hazard Analysis Critical Control Points
- ISO 9001
- ISO 22000, etc.

At the end, he mentioned the procedures and methods of quality control in Food Industry. Preventive measures were emphasized to ensure raw material quality.

Then Dr. Aaron Tong shared his consultancy experience in food industry. He introduced different types of food testing such as Microbiology Analysis, Chemical Analysis, Pesticides, Antibiotics, Food Additives, Heavy Metals and GMO. He also showed different food related certification schemes including HACCP/GMP, ISO 22000, BRC, IFS, Global-GAP, ISO 9001, ISO 14001 and OHSAS 18001, etc.

He selected some QA/QC programs which are designed specifically for Food Industries as follows:
1. Food Processing 5S Management System
2. HACCP Assessment
3. LEAN Manufacturing in Food Production
4. Procurement Management
5. Supply Chain Management

During Q&A session, I asked any common faults has been found in food industry. Dr. Tong said it was cross-contamination due to limitation of storage / working area. It is very specific in Hong Kong. One of the suggested solutions was to separate food processing steps in time-based management.

The topic of Dr. Michael Lam (Asso. Professor in BCH Dept., CityU) was “Detection of Paralytic Shellfish Toxins & Other Algal Toxins”. In the beginning, some food safety problems was reminded as follows:
- Natural (bio-) toxins such as mycotoxins, marine biotoxins, cyanogenic glycosides and toxins in poisonous mushrooms;
- Metals, metalloids and organometallic compounds such as lead, mercury, arsenic, etc;
- Persistent Organic Pollutants (POPs) such as organochlorine pesticides, polychlorinated, dioxins, etc.

There were some shellfish poisoning introduced as follows:
- Amnesic Shellfish Poisoning (ASP)
- Diarrheic Shellfish Poisoning (DSP)
- Neurotoxic Shellfish Poisoning (NSP)
- Paralytic Shellfish Poisoning (PSP)

After that he introduced some analytical methods for shellfish poisoning toxin such as AOAC 2005.06 for PSP. The Oshima method for saxitoxin determination uses HPLC post-column derviatization fluorescent detection (Throughput ~ 0.5 hr per injection). The trend is to use LCMS which can analyze different toxins per injection (Throughput ~ 2hr per injection). But the standard is very expensive such as Ciguatoxin which costs HK$9000 per 1 microgram.

During lunch, I talked with Prof. Daniel Fung (Professor of Food Science, Kansas State University). He is a pioneer in the field of Rapid Methods and Automation in Food Microbiology. It is pity that I did not attend his talk entitled “World Market Trends and Prediction of the Future of Rapid Methods in Food Microbiology”.

I hope that kind of excellence workshop could be performed regularly.