2011年10月30日星期日

HKSQ’s World Quality Month Activities

November is World Quality Month. To celebrate the occasion, , HKSQ has organized or supported a series of activities including seminars and technical visits for its members and quality professionals in Hong Kong.


HKSQ’s World Quality Month Activities:

1. Seminar on “Service Quality”organized by HKSQ and co-organized by American Society for Quality (Hong Kong section) (ASQ-HK) on 4 November 2011.
2. Farm Visit 農場考察 organized by HKSQ, co-organized by ASQ-HK and Hong Kong Food Science and Technology Association (HKFSTA) on 5 November 2011.
3. Seminar onChange of Force” organized by HKSQ and co-organized by ASQ-HK on 21 November 2011.
4. Seminar: Business Excellence with Innovative Improvements organized by Hong Kong Science and Technology Parks (HKSTP) and supported by HKSQ on 22 November 2011.
5. HKQAA Symposium 2011 organized by Hong Kong Quality Assurance Agency (HKQAA) and supported by HKSQ on 25 November 2011.

HKSQ designed a World Quality Month (WQM) logo and developed a new page in 2011. The information for World Quality Month, Week and Day had summarized at http://qualityalchemist.blogspot.com/2011/10/information-for-world-quality-month.html

HKSQ - World Quality Month Logo
Designed by Double-U Design Consultant (wing_doubleu@yahoo.com.hk)

The concept behind the logo is explained below.
The alphabet "Q" is written by using style of China Calligraphy which highlights the nature of China Hong Kong; the alphabet "W&M" is presented in modern form.
That means the compromise between the traditional experience in China and advanced management technique in Hong Kong.
Black and traditional China red colors are the traditional colors of China Calligraphy.

Reference:
HKSQ – World Quality Month – http://www.hksq.org/world_quality_month.htm
ASQ – World Quality Month – http://worldqualitymonth.org/
CQI – World Quality Day – http://www.thecqi.org/worldqualityday


貧富懸殊:香港貧窮問題的成因與出路 (Lecture 7)

The lecture 7 of General Education and Public Affairs Certificate Course (通識及公共事務證書課程) was held on 29 October 2010. I would like to summarize using Chinese below.

第七課 (29 October 2011)
貧富懸殊:香港貧窮問題的成因與出路
馮可立教授主講(香港中文大學社會工作學系名譽副教授/新力量網絡理事)

馮教授在1974年開始做社會工作,後來到中文大學教書而他主要的研究是貧窮問題。在這個問題上,只考慮收入是沒有意思的。


馮教授認為貧窮的原因有兩類。
一、弱勢社群(welfare poor),他們沒有生產力,入不敷支;需要社會保障。
二、在職貧窮(working poor),財富分配懸殊,需要廉價的社會服務。
馮教授說在70年代時,低下階層用政府的廉價社會服務,他們之後儲蓄到金錢,增加了生活機會(life chances)。


世界銀行的絕對貧窮的計算是以第三世界最貧窮的國家來看。馮教授認為貧窮其實是相對性的。


香港曾經有過基本生活開支的研究來定綜援金額。這研究是由麥法新博士在1994年完成及發表的。
跟據國際勞工組織(ILO),工資中位數的一半便是貧窮線。馮教授說貧窮是生活的問題。貧窮有得捱,但最痛苦是貧病交織,就沒法子去捱。


香港低下階層目前遇到的三大問題如下:
一、生活機會(life chances
二、財政收入(income)停滯或下降
三、社會支援(social support)的不足


馮教授討論到社會的流動性。他說向上流動有兩個方法,一是讀書作專業,另一是找機會賺得第一桶金。但讀不了書的勞工,他們現在只有向橫流動又要面對非長工化的現實。


二元化勞動市場的存在已經被確認了。低技術工人的失業率遠高於專業人士。


馮教授用世界銀行的三大方向及一大機制作總結。
三大方向是穩定收入(Security),增加生活機會(Opportunity),及增加社會支援(Empowerment)。
一大機制是建立對窮人友善的市場(Poor-people friendly market)。


Reference:
新力量網絡SynergyNet - http://www.synergynet.org.hk/b5_index.php


2011年10月28日星期五

Training Course on Statistics for Method Validation

I attended a training course entitled "Statistics for Method Validation" which was organized by Hong Kong Accreditation Service (HKAS) on 27 Oct 2011. It was a very informative seminar not only theories review, but also experience sharing.


The trainer was Mr. Dan Tholen (Statistical Consulting, A2LA Lead Auditor (PT) and Professionals in Proficiency Test) and his presentation mainly focused on method validation. There were two main standard series stated during the course. One is Clinical and Laboratory Standards Institute (CLSI) EP series for medical and the other is ISO series for general.



Mr. Dan Tholen explained method validation based on the following standards:

- ISO 5725: Accuracy (trueness and precision) of measurement methods

- Medical applications, CLSI EP5: Precision of quantitative methods and EP17: Limits of detection and quantitation

- Food microbiology: ISO 16140 - Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods



Then Mr. Dan Tholen stated the definition of Verification and Validation from VIM3: International Vocabulary of Metrology.

- 2.44 verification: provision of objective evidence that a given item fulfills specified requirements, taking any measurement uncertainty into consideration

- 2.45 validation: verification, where the specified requirements are adequate for a stated use


He said that 'validation' is subordinate to (or is a type of) 'verification'.


However, this interpretation was found different to ISO 9001 definition in Design and Development process. Verification (7.3.5) is checking that the results at the end of the design process meet the requirements identified as necessary at the beginning of the design process. It may be carried out on a stage-by-stage basis. Validation (7.3.6) is the process of checking that the final product or service will be capable of meeting or does meet the customers' and end-users' needs when used in the intended environment.


One of participants said the meaning of verification and validation in terms of Chinese are no confusion. They are "驗證" for verification and "確認" for validation.



After that Mr. Dan Tholen introduced the ISO 5725 series as follows.

Part 1: General principles and definitions

Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method

Part 3: Intermediate measures of the precision of a standard measurement method

Part 4: Basic methods for the determination of the trueness of a standard measurement method

Part 5: Alternative methods for the determination of the precision of a standard measurement method

Part 6: Use in practice of accuracy values



Repeatability (r) and Reproducibility (R) are the general principles of ISO 5725 which represent the extremes of precision (smallest and largest).


The definition of r conditions and R conditions, as well as intermediate precision condition are given in ISO 3534-2 (Statistics - Vocabulary and symbols - Part 2: Applied statistics).



After that he introduced the concept of Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ).

Based on CLS EP17, the definition of LoB, LoD and LoQ as below.

LoB - Highest measurement result that is likely to be observed (with a stated probability) for a blank sample.

LoD - Lowest amount of analyte in a sample that can be detected with (stated) probability, although perhaps not quantified as an exact value.

LoQ - Lowest amount of analyte in a sample that can be quantitatively determined with stated acceptable precision and trueness, under stated experimental conditions.



The following diagram explained how to use LoB, LoD and LoQ for reporting.

If the result is below LoB, it reports "Not detected".

If the result is between LoB and LoD, it reports "Detected but below LoQ". It is because the result distribution between LoB and LoQ is not quantified.

If the result is between LoD and LoQ, it also reports "Detected but below LoQ".

Only the result is above LoQ, it can report "As measured value".



Since patient's sample is usually individual, nonparametric statistic will be used in this approach.



CLSI EP 17 protocol is for all in one laboratory in which interlaboratory comparison study is not required. It could be manufacturer or test laboratory.



Q&A session



Reference:

HKAS Seminar: http://www.itc.gov.hk/en/quality/hkas/seminar.htm

CLSI EP5: Precision of quantitative methods

CLSI EP9: Method comparison and bias estimation using patient samples

CLSI EP17: Limits of detection and quantitation

ISO 5725: Accuracy (trueness and precision) of measurement methods

ISO 16140: Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods

ISO 3534-2: Statistics - Vocabulary and symbols - Part 2: Applied statistics

ISO 11843 series: Capability of detection



2011年10月27日星期四

HKSP 2nd Occupational Safety and Health Conference

The 2nd Occupational Safety and Health (OSH) Conference was held in Hong Kong Science and Technology Parks Corporation (HKSTPC) on 26 October 2011. The conference details were summarized as follows.



Mr. Ben LUI (Vice President, Projects & Facilities (P&F), HKSTPC) gave an welcoming speech. He introduced that HKSTPC had obtained OHSAS 18001 certification since 2009.



The first speaker was Mr. Kam LIU (Project Manager, Laboratory Service & Control of P&F, HKSTPC) and his topic entitled Guidelines for a Safe Laboratory Design.



In the beginning, Mr. LIU introduced two types of laboratories that were Dry Lab and Wet Lab.


For Dry Lab, it involved work with computers, electronics and large instruments mainly; and it required accurate temperature and humidity control, stable vibration control and shield space. It did not require extensive piped services. Floor loading and ceiling heights were equipment driver. The photo showed the SEM, chamber and mechanical equipment in Dry Lab.



For Web Lab, it used of chemicals, drugs or other material or biological matter. It needed to utilize bench, sink, fume cupboard, biological safety cabinets. It was fitted with full range of piped services (i.e. Purified water, de-ionized water, compressed air, vacuum, carbon dioxide, nitrogen gas, hot and cold water, gas etc.).



Mr. LIU briefed the following major contribution to the hazardous conditions in laboratories:

- Ineffective exhaust ventilation & workplace practice

- Use of inefficient containment equipment

- Inexperience of designers

- Copied from previous project

- Owner keeping cost below budget



Then Hazard Tree was introduced as example to identify the release of contaminated air outside the laboratory.



Mr. LIU introduced the Laboratory Design which considered the following items:

- Building provision (e.g. Supporting facilities)

- Layout arrangement (e.g. Enough space for working)

- Barriers and containment design (Primary containment and Secondary containment)


The following diagram was barrier facility to provide positive air differential pressure to the laboratory (e.g. Specific-pathogen-free animals lab, cleanrooms for pharmaceutical, medical device, etc.)



The diagram below was show the containment facility which provided negative pressurization of the laboratory to protect the operators and general public.



There were two strategies for containment facilities included primary and secondary. Primary containment provided physical containment at the source (e.g. Safety cabinet, fume cupboard, air-supplied positive pressure personnel suit). Secondary containment was the room within which the primary barrier locates; dedicated supply and exhaust; filtration and decontamination systems.



Bad examples which affected the exhaust air performance.



Mr. LIU introduced the NIT testing about 2 hoods with different locations. It was found that hoods on same wall were worst affected; so it should separate hoods on the same walls by at least 4 feet. Hoods on opposite walls were found to be better than hoods on the same wall.



Bad design



Good design



Mr. LIU concluded two basic points which should be remembered:

I) Preventive maintenance - MUST be provided

II) Performance testing - MUST be provided


At the end, he mentioned other safety facilities which were commonly in the laboratory.



The second speaker was Mr. LAM Shi-kai (Director, University Safety and Environmental Office, The Chinese University of Hong Kong) and his topic named A Chemical Hygiene Programme for Laboratories.



Mr. LAM firstly introduced the recommendations by Labour Department such as Safety Management System with 14 elements based on BS 8800.



He said the Code of Practice (15 items) was no item related to laboratory.



But the guidance notes (28 items) had one item which stated Personal Protective Equipment (PPE) for use and handling of chemicals was related to laboratory.



Labour Department's ordinance and guidance were missing laboratory items such as Laser, Isotopes, Pathogens, Laboratory equipment, Hazardous properties of chemical, etc. Moreover, Mr. LAM identified 5 types of hazards in laboratories below:

- Physical; Chemical; Pathogenic; Ergonomic and Stress.


Then Mr. LAM introduced the Chemical Hygiene Plan (CHP) for laboratories which included 9 items.

- Policy

- Safety Organization

- Certification & Maintenance of Equipment

- Authorized operators

- Training & Supervision

- Database & Information

- Inspection & Review

- Personal Protective Equipment (PPE) & Emergency Equipment

- Special Operations


Safety Organization should have Authority, Power and Resource (including manpower)



Many items of CHP were governed by Chapter 509 and showed as follows.






Finally, Mr. LAM suggested to use similar laboratory accreditation practices (Vertical and Horizontal Audit) to inspect laboratory safety.


He defined Vertical Inspection was to select an operation and observe its conduction from the beginning to the end. It needed to look at the safety performance at each critical step.



Horizontal Inspection was defined to select a work section, e.g. An area, a work bench or a small laboratory to inspect the workplace, equipment and environment for safety.



Lastly, Mr. LAM emphasized the important of staff's safety awareness. He said "Adoption of Model CHP without adjustment has low acceptability among staff.


The third speaker was Ms. Sandy TANG (Assistant Environmental Protection Officer, Environment Protection Department) and her presentation was Waste Disposal (Chemical Waste) General Regulation.



Ms. TANG's presentation included Legislative Control, chemical waste producer, collection and disposal, and trip ticket system. For Legislative Control, Waste Disposal Ordinance (Cap. 354) and CWR regulation were employed.



Under the ordinance, the chemical waste was classified in schedule 1 as Part A and Part B. Part A chemical waste were very toxic / environmentally persistent, which required special disposal arrangement.



Part B chemical waste covered the majority of chemical waste and no prior notification required. The following diagram showed some common Part B chemical waste.



EPD used the principle of "Cradle to Grave" to control on Chemical Waste.



Then Ms. TANG briefed the proper packaging requirement which based on "Code of Practice on the Packaging, Labelling and Storage of Chemical Wastes". The following table showed the recommended containers for different chemical waste.



Ms. TANG also stated the requirement of Proper Label.



Good example for the proper packed and labelled chemical waste



Good example for the proper storage



Two waste disposal sites were introduced. (Chemical Waste Treatment Centre (CWTC) and Landfill)



Finally, the trip ticket system was mentioned from collection, transportation to disposal.



Ms. Miranda Kwan (Deputy Director, Systems & Services Certification at SGS Hong Kong Ltd.) was invited to present the first ISO 50001 Energy Management System certification to HKSTPC in Hong Kong. It was a milestone of HKSTPC to enhance our energy utilization.



After received the ISO 50001 certification, all team members took a group photo to memory this achievement.



After tea break, the first speaker of second part of conference was Ms. Joanne YUNG (Environmental Protection Officer, Environment Protection Department) and her topic was Clinical Waste Control Scheme in Hong Kong.



Ms. YUNG introduced the clinical waste control scheme in which legislative procedure was completed on 1 Aug 2011.



There were 5 key elements in the scheme.

1. Statutory licensing framework for waste collectors and disposal facility operators

2. Waste producers to consign clinical waste to licensed collectors or a licensed disposal facility (HCP means Healthcare Professionals such as registered medical pracitioners, dentists, veterinary surgeons, etc.)

3. Promulgate Code of Practices (CoPs) to provide guidance for clinical waste producers and waste collectors (It separated into Major and Small Clinical Waste Producers)

4. Rip Ticket system to track waste movement

5. Designate the Chemical Waste Treatment Centre (CWTC) to treat clinical waste and charge for use of the facility



The definition of clinical waste was shown as following diagram.



There were some common sources of clinical waste classified as six groups below.

Group 1- Used or contaminated sharps

Group 2 - Laboratory waste

Group 3 - Human and animal tissues

Group 4 - Infectious materials

Group 5 - Dressings

Group 6 - Other wastes


The example table for clinical waste was shown.



The clinical waste had packaging requirement in different group.


Group 1 example



Other groups example



The warning sign for storage area was shown as follows.



Lastly, she introduced the trip ticket system which was found one more form than chemical waste because of the additional "Collection Point".



The second speaker of second part was Mr. Derek Armstrong CHAN (Assistant Divisional Officer, Fire Services Department) and his title named Dangerous Goods Ordinance and Its Latest Development.



He introduced the existing control of dangerous good (DG) under the Dangerous Goods Ordinance (Cap 295) which was enacted in 1956 and amended in 2002.



The existing classification of DG were mentioned.



Mr. CHAN introduced the scope of the DG (Amendment) Ordinance to us.



New classification and label would be proposed for legislative procedure. The following photos showed the proposed classification, DG list, warning packing and labelling which would match UN standard.








Finally, Mr. CHAN added it would have 24 months grace period once the new amended ordinance effective.


The last speaker was Mr. LI Kwok-ching (Occupational Safety Officer I, Labour Department) and his presentation entitled Major Safety Regulations related to Chemical Safety in Workplace.



Mr. LI mainly described the FIU (DG) Regulation in Cap 59 A&B.



He reviewed the annually industrial accident rate from 2000 to 2009. The trend was decreasing.



However, the mortality rate of accident was found to be steady from 2000 to 2009.



After that Mr. LI stated the responsibility of employer and employee.




At the end, Q&A session was held for exchanging safety ideas with participants.


After the conference, we led participants to visit our laboratories.


For more information:

HKSTP Laboratories - www.lab.hkstp.org

Occupational Safety and Health Training Centre - http://www.labour.gov.hk/eng/osh/content5.htm



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