Seminar on Technology Approaches to Quality Management

I attended the Seminar on Technology Approaches to Quality Management – with Case Studies in Medical Devices and Pharmaceuticals Industry, which organized by Biomedical Division of HKIE, HKPC and IEEE – EMBS Hong Kong Chapter, on 28 May 2010.


Mr Bryan MK SO (Hon Secretary, Biomedical Division of HKIE) introduced the speaker Mr. Matthew Kopecky (Director of Sales Support, Asia Pacific of Sparta Systems, Inc.).

The following slide showed the parallels in Quality Control and Quality Assurance.Quality Management Solution enables organizations to define, track and manage the data and process associated with business events and maintains seamless compliance.

The End to Eng Quality Management was mentioned.

Mr. Kopecky introduced the cores of quality management system (QMS) below:
- Event Management & CAPA (Corrective Action and Preventive Action),
- Complaints,
- Audits (internal & external), and
- Change Control.

For complaint, all events must be documented, assessed and potentially investigated.
There were three common complaint sources (or types) below.
1. Call Centers
2. Customer Inquiries
3. Field Service

The fishbone diagram for CAPA was shown as follows.

The complaint scenario flow was demonstrated.

Mr. Kopecky described different type of audit:
- Corporate Compliance Audits
- Internal Department (QA) audits
- Issue-specific Audit (e.g. specific in problem area)
- Audit to Confirm Effectiveness of Action (Follow-up audit)
- Supplier Quality Audit
- Financial Audit
- Computer Systems Validation (CSV) Related audit
- Third Party Audit (e.g. FDA, ISO, etc.)

One of the important core elements in QMS was “Change Control”. Because the process of requesting, implementing and documenting any change that might impact the quality of the product. Those change included Batch, Material, System, Supplier, Equipment, IT and Document.

And then he introduced an electronic quality management solution (EQMS) included selection criteria, deployment, integration, validation and training. It was because of the need of current day business trends (System requirements):
- Global Operations (Multiple sites & Languages)
- Expanding manufacturing and supply chains (Web-based and Scalable)
- Regulatory Pressures (Compliance with cGXP and meet regional & local regulations)
- Enterprise systems (Ability to integrate with other systems such as ERP, LIMS, CRM, etc.)

Six stage deployment methods were briefed and they were Analyze Requirements, Design & Build, Test, Validate, Train, and Go Live (or Support).

The integration of common ERP was provided through Integrated Enterprise Solutions.

Lastly, Mr. Kopecky shared case about Medical Device Product Complaint Management to us. He demonstrated EQMS fulfilled the following product requirements:
- Off-the-shelf, no or limited customization;
- Easily configurable such as user friendly, intuitive and minimum training;
- Compliance with auditing standards such as ISO, COSO rules, etc.; andCompatibility with EMEA’s IT platform.

Photo taken (Left: Mr. Matthew Kopecky and I)

For more information:
Sparta Systems, Inc.: http://www.spartasystems.com/

Regulatory Forum – Hong Kong Medical Device

I was invited to be one of speakers in the Regulatory Forum – HK Medical Device organized by BSI on 28 May 2010 and I would like to share the valuable forum details below.

In the beginning of the forum, Mr. Jack Wong (VP – Regulatory Affairs, BSI) gave an opening speech and introduced this Regulatory Forum. The forum is a regular meeting open to all companies or individuals with the following terms of reference since 2006.
- Providing Asian Harmonization Working Party (AHWP) updates by AHWP non-government and government representatives
- Maintaining a regular gathering of regulatory and non-regulatory staff in medical device fields, and
- Creating a platform for different trade associations, industries and DOH to discuss and updates the medical device regulatory development in Hong Kong.


The first speaker was Ms. Danielle Giroud (Founder, World Medical Device Organization) and her topic was “ISO 14155 update”.

The standards were shown as follows:
ISO 14155–1:2003 – Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14155–2:2003 – Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

Ms. Giroud said ISO 14155 would be updated and the objectives of the revision would clarify outstanding points after 2003 revision and try to reach some harmonization with ICH to improve overall compliance. Moreover, the structure of this revision would merge current part 2 into part 1 as a normative annex A; and it would be more focused on the workflow.

The scope of ISO 14155 is to address good clinical practices (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The revision of the standard added many new definitions such as blinding/masking, comparator, contract research organization, device deficiency … etc. Moreover, safety definitions had significantly changed except for serious adverse event.

In clinical investigation planning, risk assessment is referred to ISO 14971 as the basis for identification of anticipated adverse device effects. The timeline of new vision ISO 14155 was expected to be issued at the end of 2010.

I (Quality Manager, HKSTP) was the second speaker and my presentation title was “Report from Hong Kong Council for Testing and Certification”.

After the Testing and Certification Industry was identified by the Task Force on Economic Challenges (TFEC) as one of six economic areas, the Hong Kong Council for Testing and Certification (HKCTC) was established on 17 September 2009. The vision of HKCTC is for Hong Kong to develop into a testing and certification hub in the region by reinforcing the branding of “Tested in Hong Kong, Certified in Hong Kong”.

Selected Four Trades were considered good opportunities and they were Chinese Medicine, Construction Materials, Food and Jewellery. Moreover, two Emerging Trades were selected as Environmental Protection and Information & Communications Technologies (ICT).

The most important achievement of HKCTC was to pursue wider recognition by Mainland authorities through CEPA discussion (e.g. China Compulsory Certification (CCC) system). It was just announce to be included in CEPA supplementary document 7 today.

Then I briefed the role of HKSTP laboratories on the testing and certification industry which was recommended by HKCTC. They were:
- Science Park to step up promotion of their facilities available for shared use
- Science Park to facilitate the setting up of testing laboratories with special accommodation needs in IEs where necessary

After that the role of Hong Kong Society for Quality (HKSQ) was also introduced and HKSQ submitted the view summary to HKCTC and participated to Hong Kong Qualifications Framework (HKQF) for testing and certification industry.

The third speaker was Mr. Lewis Huen (Business Development Director – Healthcare, DKSH HK Ltd.) and his presentation entitled “Overview of Global – Consignment Inventory Management System used in the Healthcare Industry”.

Firstly, Mr. Huen briefed some service on echoplus for the healthcare industry included Customer Relationship Management (CRM), Sales Order Management (SOM), Merchandising Management (MM) and Consignment Inventory Management (CIM).

CIM was able to enhance the speed of stock count to reduce the time spent of field force in hospitals and it could directly integrate with SAP ERP to reduce admin workload and enhance accuracy and generate timely reports.

Mr. Huen shared Taiwan experience on CIM and their business solution would be customized for Pharma, OTC/Consumer Healthcare, Medical Devices, Diagnostics, Dental and Optical teams.


The fourth speaker was Mr. Matthew Kopecky (Director of Sales Support, Asia Pacific of Sparta Systems, Inc.) and his topic was “Technology Approaches to Quality Management”

Mr. Kopecky briefed the evolution of quality and some problems of point solutions. And then he introduced an electronic quality management solution (EQMS) included selection criteria, deployment, integration, validation and training.

EQMS was briefed and it helped to validating configurable enterprise architecture. Therefore, initial installation had performed Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ). After that any incremental processes needed to execute PQ only.

The next session was HKAPI update, Local Responsible Person (LRP) Panel and MDCO/HA update.

Ms. Sabrina Chan (Executive Director, HKAPI) represented the Hong Kong Association of The Pharmaceutical Industry (HKAPI) for industry update. HKAPI had established since 1968. She said that the mission of HKAPI is to ensure patients have expedient access to innovative and effective drugs to enhance better health and quality of life.

There were 68 members and distributed as follows:
- Full membership: 38 R&D based multinational companies;
- Affiliate membership: 2 R&D based multinational companies with no pharmaceutical product launched in Hong Kong; and
- Associate membership: 28 companies providing services to full members.

One of important update was the implementation of the Pharmaceutical Review recommendation that Department of Health (DOH) would hire more than 70 pharmacists at the stage.

Other updates included:
- The industry supported the first annual symposium on Pharmacovigilance which was organized by CUHK on 18 March 2010.
- Cooperation agreement on the Control of Pharmaceutical Product and Medical Device between SFDA and DH on 24 May 2010.
- HKAPI encouraged clinical trial in Hong Kong. A paper submitted to the Innovation and Technology Commission (ITC) regarding develop Hong Kong as clinical trial centre.

For pharmaceutical industry, there were 4 years transition period to PIC/S (GMP standard) in Hong Kong and 3 years transition period to EMEA standard in China.

Mr. Camon Sin (Director – Greater China in Medtronic and Chair of HK LRP Panel) and his topic was “LRP Panel – An Update on 28th May 2010 at the HKMDRF”.

Mr. Sin updated the last panel meeting on 13th Apr 2010 that Mr. Billy Wong (Vice-chair, LRP Panel) shared his experience on ISO 9001 and ISO 13485. Moreover, LRP Panel Website was established and parked at the Hong Kong Medical Device Regulatory Forum website within BSI Group.

Moreover, two documents were released by MDCO on 23 April 2010 and they were:
- TR-004: Essential Principles of Safety & Performance of Medical Devices
- TR-005: Additional Medical Device Labeling Requirements


Finally, Mr. S.Y. Lam (Sr. Electronics Engineer, MDCO of DOH) updated recently situation and also shared some HR changed in MDCO. He recognized that the regulation forum was good communication channel between industry and regulatory body.

For more information:
Hong Kong Regulatory Forum: http://www.bsigroup.cn/HongKongRegForum
Local Responsible Person (LRP) Panel: http://www.bsigroup.cn/zh-cn/Training/Training-course-areas/Medical-devices/About_LRP_Panel/
World Medical Device Organization: www.wmdo.org
Hong Kong Science and Technology Parks (HKSTP) – Laboratories: www.lab.hkstp.org
Hong Kong Society for Quality (HKSQ): www.hksq.org
HKSQ's suggestions to the testing & certification industry at http://www.hksq.org/news.htm
DKSH Hong Kong Limited: www.dksh.com
Sparta Systems, Inc.: www.spartasystems.com
The Hong Kong Association of The Pharmaceutical Industry (HKAPI): www.hkapi.hk
Medtronic Medical Appliance Technology & Service (Shanghai) Ltd.: www.medtronic.com
Medical Device Control Office of DOH: www.mdco.gov.hk

Introduction of HKSQ Certified Laboratory Quality Specialist (CLabQS) to MSc (Analytical Chemistry) Student, HKBU

I was glad to be the second speaker to introduce Hong Kong Society for Quality (HKSQ) and HKSQ Certified Laboratory Quality Specialist (CLabQS) to HKBU MSc students on 25 May 2010. My topic was “Develop Your Quality Profession with Hong Kong Society for Quality”.


In the beginning, I briefed HKSQ history and the relationship of America Society for Quality (ASQ). HKSQ is a non-profit making organization and formed in 1986. HKSQ initially was known as Hong Kong Group of American Society for Quality Control (ASQC) International Chapter. In 1989, it was renamed to Hong Kong Society for Quality Control (HKSQC) as a consequence of increasing local involvement. HKSQC then renamed to Hong Kong Society for Quality (HKSQ) in 1997.

We had strong international connection as such Worldpartner of ASQ and Founding Member of Asia Network for Quality (ANQ).

For ANQ, we joined ANQ Congress in different Asia countries every year.

Then I mentioned different visits, seminars, workshops and training arranged by HKSQ to enhance knowledge of quality.

After that the Certified Laboratory Quality Specialist (CLabQS) was introduced and the requirements were shown as follows:
Be an HKSQ member in good standing & have 3 year related laboratory experience (verified by company letters), and
• Successfully passed Quality Management for Laboratory certificate course offered by HKSQ in previous 5 years (certification fee: free); or
• By exemption: successfully completed a course accredited by HKSQ in previous 5 years (certification fee: HK$300)
Where accredited course in Hong Kong Baptist University:
• CHEM 7250 Laboratory Management

Recently, HKSQ prepared Testing and Certification Industry summary to Hong Kong Council for Testing and Certification (HKCTC) and was also involved to develop the qualifications framework for Testing and Certification Industry through the Hong Kong Qualifications Framework (HKQF).

Therefore, it is highly recommended to join HKSQ and to apply CLabQS qualification.

For more information:
MSc in AC: http://chem.hkbu.edu.hk/msc/
CLabQS: http://www.hksq.org/cert_hksq_clabqs.htm
QMforLab: http://www.hksq.org/nevents.htm

“Doping Control for Horseracing” Seminar – MSc in Analytical Chemistry, HKBU

I attended the seminar entitled “Doping Control for Horseracing” organized by Department of Chemistry, Hong Kong Baptist University (HKBU) and then I was also invited to be the second speaker to introduce Hong Kong Society for Quality (HKSQ) and HKSQ certified quality professional to MSc students.


In the beginning, Dr. Kelvin Leung (Asst. Professor – Dept. of Chemistry, HKBU) gave an opening speech.

The first speaker was Dr. Emmie N.M. Ho (Racing Chemist, The Hong Kong Jockey Club) and her topic was “Doping Control for Horseracing”.

Dr. Ho introduced the racing laboratory department to us. There were 45 staff including 32 degree holders (PhD x7, MSc x9 and BSc x16), 6 Fellows and 4 Professional Members of the Association of Official Racing Chemists (AORC), 3 Fellows and 7 Members of the Royal Society of Chemistry, and 1 Fellow of the Forensic Science Society. Moreover, about HK$60M worth of major facilities were investigated, including 29 modern mass spectrometers that generated “chemical fingerprints” for drug identification.

The role of HKJC racing laboratory is to detect prohibited substances according to the relevant rules of racing or equestrian competitions (it tested over 18,000 official samples in 2008-2009). The laboratory was accredited according to ISO/IEC 17025 for testing equine, canine and human bodily fluids and reported no “false positives” in its 39 yrs history. It is a world leader in research on equine drug testing, producing over 40 papers within the past 7 years.

Then Dr. Ho briefed the objectives and rules of doping control, doping control analysis in the Racing Laboratory and common chemical techniques employed.

The objectives of doping control are to protect the integrity of the sport, the industry and the public. Prohibited substances (PS) for racehorses in Hong Kong were adopted from Article 6 of the International Agreement on Breeding, Racing and Wagering (Produced by the IFHA, International Federation of Horseracing Authorities).

The following countries were agreed the Article 6.

Specimens were included Urine, Blood and Saliva. The following is the window of detection of drug use in human data.

Blood collection containers (A barcodes would be assigned after collection)

Urine collected from horse

Urine containers after collection

Human urine sample vs Horse urine sample

What constitutes a “Positive” finding?
1. Non-threshold substances: Any level (concentration) of a Prohibited Substance found to be present in a sample.
2. Threshold substances: The level of a Prohibited Substance found in a sample must exceed the threshold set by the relevant rules.

Dr. Ho mentioned some common chemical techniques employed in doping control analyses. There were separated into three approaches as follows.
1. Screening (efficient and simple, wide drug coverage, sensitive)
2. Confirmation (qualitative, definitive, specific)
3. Quantification (where relevant; accurate, need to estimate uncertainty of measurement)

For sample extraction, one of common techniques was Liquid-Liquid Extraction (LLE) that partitioned sample between a hydrophilic aqueous phase and a hydrophobic organic phase.

Immunoassays such as Enzyme-Linked ImmunoSorbent Assay (ELISA) test was introduced for drug screening.

The screening of acidic drugs by using full scan GC/MS and screening of insulin by MRM LC/MS were also briefed.

Finally, Dr. Ho made the following conclusions:
· The ultimate aim of a doping control system is not to achieve high incidents of positive findings and sanctions, but rather
· Minimum violations, resulting from the deterrent of a highly-effective and well-respected medication control and drug testing program.

For more information:
MSc in AC: http://chem.hkbu.edu.hk/msc/
CLabQS: http://www.hksq.org/cert_hksq_clabqs.htm

QMforLab: http://www.hksq.org/nevents.htm

Lectures on Pharmacy Legislation (Lec 05)

I attended the last Lecture of Pharmacy Legislation on 14 May 2010. The topics were “Dangerous Drugs Ordinance (Cap. 134) on Classification & Sale of Dangerous Drugs (DD)”.


Definition of DD is drugs or substances specified in First Schedule, Part I.
It included the following substances.
1. a) Opioids (Opioids are narcotic drugs that are generally prescribed to manage pain.) (鴉片類)
- Benzodiazepines (It relieves nervousness, tension, and other symptoms by slowing the central nervous system.) (苯二氮是一種抗焦慮症的藥)
- Hypnotics (An agent that causes sleep) (安眠藥)
- Amphetamines (A colorless, volatile liquid, C9H13N, used as a central nervous system stimulant in the treatment of certain conditions, such as attention deficit hyperactivity disorder, depression, and narcolepsy, and abused illegally as a stimulant.) (苯丙胺 (alpha-methyl-phenethylamine) - 俗稱安非他命)
- Hallucinogens (A drug or chemical that causes alterations in perception (usually visual), mood, and thought.) (迷幻劑)
b) Structurally derived from tryptamine (色胺,β-吲哚基乙胺)
c) Structurally derived from phenethylamine (苯乙胺)
d) Structurally derived from fentanyl (芬太尼, 一种止痛剂)
e) Structurally derived from pethidine (哌鱼替啶)
2. any stereoisomer of (1) not being dextromethorphan or dextrophan;
3. any ester or ether of (1) or (2);
4. any salt of (1), (2) or (3);
5. concentrate of poppy straw (罌粟稈)
6. medicinal opium (鴉片)
7. prep., mixture, extract or other substance containing (1) to (6);
8. opium or opium water;
9. coca leaves (古柯葉);
10. poppy straw (罌粟稈);
11. cannabis (大麻) & cannabis resin (大麻樹脂)

First Schedule, Part II is shown as follow.
13. Preparation of not more than (<) one of the substances in (19) or (20) (in Part III), when a) no or negligible risk of abuse & cannot be recovered by readily means; & b) <100mg per dose unit & <0.5% in undivided preparation.
14. Preparation of <0.1% of cocaine (Cocaine is a highly addictive central nervous system stimulant extracted from the leaves of the coca plant, Erythroxylon coca. -可卡因), & (a);
15. Preparation of medicinal opium or morphine (嗎啡) with <0.2% morphine, & (a);
16. Preparation <> atropine sulphate (硫酸阿托品) 25mcg;
17. Dover’s powder containing 10% opium powder;
18. Mixtures containing < one of the preparations in (13) to (17).

First Schedule, Part III is shown as follow.
19. The following substances namely:
- Acetyldihydrocodeine (It is an opiate derivative developed in Germany around 1900 as a cough suppressant and analgesic.) (醋氢可待因)
- Dextropropoxyphene (It is an analgesic in the opioid category.) (右旋丙氧芬, 一种镇痛药)
- Ethylmorphine (It (also known as codethyline, dionine, and ethyl morphine) is an opiate narcotic analgesic (pain killer).) (乙基嗎啡)
- Nicocodine (It developed as a cough suppressant) (烟酰可待因)
- Pholcodine (It helps suppress unproductive coughs and also acts as an antifungal agent.) (福尔可定)
- Codeine (An alkaloid narcotic, C18H21NO3, derived from opium or morphine and used as a cough suppressant, analgesic, and hypnotic.) (可待因, 採自鴉片的鎮痛止咳劑)
- Dihydrocodeine (双氢可待因)
- Norcodeine (去甲可待因)
- Propiram (丙吡胺, 镇痛药)
20. Any salt of a substance in (19);
21. Any preparation … containing any of substance in (19) or (20);
22. Any preparation in First Schedule, Part II.

First Schedule, Part IV is shown as follow.
Preparation <0.1% cocaine being a preparation compounded with one or more other ingredients in such a way that the preparation has no or a negligible risk of abuse and that the substance contained therein cannot be recovered by applicable means or in a yield which would constitute a risk of health.

Summary figure is shown.

Legal Classification of Preparation containing DD
e.g.
Codeine Syrup 30mg/5ml % Legal Classification
Codeine Syrup 9mg/5ml
Codeine 15mg Tablet (500mg)
Pholcodine Syrup 0.9%

Dangerous Drugs required registering and preserving registers & documents for 2 years from the last entry date.

For more information:
Pharmaceutical Services Website at www.psdh.gov.hk

Qualifications Framework for Testing and Certification Industry Consultation Forum

Today, I represented Hong Kong Society for Quality (HKSQ) and Hong Kong Science and Technology Parks (HKSTP) to attend the consultation forum of Qualifications Framework for Testing and Certification Industry. I would like to share the forum below.



Firstly, Dr. Lo (VP – VTC) gave an opening speech. After that Mr. Patrick Pang (Chief Manager – Qualifications Framework Secretariat) introduced Qualifications Framework (QF) to us.

The Qualifications Framework (QF) has been officially launched on 5 May 2008. The QF is a cross-sectoral hierarchy covering both academic and vocational qualifications required by various industries. The QF is a hierarchy (7 levels) that orders and supports qualifications of academic, vocational and continuing education. To strengthen the industries' leading role in the development of vocational training so as to enhance the effectiveness of the latter, Specification of Competency Standards (SCSs) are formulated by the respective industries.

The scope of QF


The Education Bureau (EDB) is assisting various industries to set up their Industry Training Advisory Committees (ITACs) in stages, which consist of representatives from employers, employees and relevant professional bodies. So far, ITACs have been formed for thirteen industries, namely Printing & Publishing, Watch & Clock, Chinese Catering, Hairdressing, Property Management, Electrical & Mechanical Services, Jewellery, Information & Communications Technology, Automotive, Beauty, Logistics, Banking and Import & Export.

After established SCS, the training programmes and related qualifications will be recognized under the QF if they are quality assured by the Hong Kong Council for Accreditation of Academic and Vocational Qualifications (HKCAAVQ).

The first speaker for Testing and Certification Industry was Mr. W.K. Lee (Director, Castco Certification Services Limited) and his topic entitled “Testing, Inspection and Certification”. He shared the report information from Hong Kong Council of Testing and Certification (HKCTC).

He pointed out some challenges in the industry such as retention of talents, qualification recognition, etc. He expected QF to be a common platform for professional competence recognition.

After that Mr. Lee shared the experience of forming SCS in Jewellery Industry and Mr. Chu shared the experience of establishing QF in Electrical & Mechanical Services.

During Q&A session, HKSQ, HKICA and HKBU representatives had shared their views on QF in Testing and Certification industry.



We discussed that the professional competence recognition were not only in academic side (e.g. PhD) but also in the industry experience.

(I represented HKSQ & HKSTP to share some related information.)

For more information:
http://www.hkqf.gov.hk/guie/HKQF_intro.asp
http://www.hkqf.gov.hk/guie/RC_evt_20100520.asp