Quality Alchemist (品質煉金術師): CQI

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2023年12月8日星期五

HKSQ Seminar – Quality Considerations on Cell Banks

HKSQ and TQM organized seminar named “Quality Considerations on Cell Banks” on 8^th Dec 2023. CQI is supporting organization. Advanced therapy products (ATP), such as CAR-T and stem cells, provide an exciting new class of therapeutics. As the number of cell banks both in development and approved continue to increase, this seminar is a fantastic way to learn more about the quality considerations in the industry, and the means to control associated risks and to ensure safe cell sources, product quality and patient safety. Before the seminar, Ms. Minda Chiang and I took a photo in front of the presentation topic.

Then we took a group photo with Dr. Jane Wong (Chairman, HKSQ) and Dr. Aaron Tong (Former Chairman, HKSQ).

I met Dr. David Ho (Laboratory Director, Celvita Cell Technology Company Ltd.) who knew this seminar was referred by Mr. Dominic Lam (CMA Testing).

Minda met her old colleagues Mr. Harry Yeung and Ms. Athena Chan.

In the beginning, Minda briefed some glossary such as human cells, tissues, and cellular and tissue-based products (HCT/Ps). Then she said the seminar focused on four topics and they were operational flow & critical controls, QA, Challenges in Cell Banks and Enablers.

She firstly briefed the operation flow from donor recruitment to collection to manufacturing and then to transplantation.

And then Minda mentioned three critical control including Personnel, Process Control and Quality Control. During contact donor, we should welcome, appreciate and respect all people including sexual minorities.

The second topic is QA. She introduced the most common accreditation programs in this industry including GMP, AABB, AATB, FACT, ISO 15189, ISO 20387 and CAP.

Three of accreditation programs (AABB, FACT & AATB) covered from Donor to manufacturing and then to the patient.

Finally, Minda shared some challenges in cell banks. They are regulations, infectious disease panels, experienced people, novel technologies, etc. Lastly, she introduced HKSQ as enabler to provide workshop on QMS in Cell Banks.

During Q&A, we discussed different scenarios.

At the end, a group photo of speaker and participant was taken for memory.

Reference:

HKSQ - https://hksq.org/

20150411: HKSQ Pharmaceutical Good Manufacturing Practices (GMP) Workshop

20130707: Technical Seminar on GMP in Food & Pharmaceutical Manufacturing Industry - https://qualityalchemist.blogspot.com/2013/07/technical-seminar-on-gmp-in-food.html

20101109: Industrial Guest Talk to BEng(Hon) in Total Quality Engineering, CityU - https://qualityalchemist.blogspot.com/2010/11/industrial-guest-talk-to-benghon-in.html

20100630: HKSQ Study Mission - KUNMING Pharmaceutical Corp - https://qualityalchemist.blogspot.com/2010/06/hksq-study-mission-kunming.html

2023年8月11日星期五

Visit to CQI/IRCA Headquarters London

Minda is CQI member and I am IRCA auditor. We visited the Chartered Quality Institute (CQI) and International Register of Certificated Auditors (IRCA) headquarters on 11^th Aug 2023. CQI/IRCA were located in central London and closed to Holborn. We took a photo in front of the entry on 90 Chancery Lane.

CQI located in the third floor.

We took a photo in the brand of CQI & IRCQ in the corridor.

Minda asked any staff inside the office.

When we inside the office, we need to sign the visitor logbook.

Then we took a photo in the main entry of the office.

We met Mr. Daniel Willmott and took a photo for memory.

CQI has 100 years in 2019.

Originally, it named Institute of Quality Assurance (IQA) in 1972 and then started operating as the Chartered Quality Institute (CQI) in 2007.

We observed a large office but empty. Daniel said all staff work from home since Covid period.

Reference:

CQI/IRCA - https://www.quality.org/

CQI Hong Kong branch – 英國特許質量協會-香港分會

HKSQ - https://hksq.org/

Previous CQI activities:

20211020: CQIHK Webinar - Hoshin Kanri – Policy for Purpose NOT Policy of Platitudes - https://qualityalchemist.blogspot.com/2021/10/cqihk-webinar-hoshin-kanri-policy-for.html

20201105: CQI Webinar – Principle of Risk - https://qualityalchemist.blogspot.com/2020/11/cqi-webinar-principle-of-risk.html

20201015: CQI Webinar - Top Tips for Remote internal auditing - https://qualityalchemist.blogspot.com/search/label/CQI

20201002: CQI Webinar - Digital process transformation and the quality professional - https://qualityalchemist.blogspot.com/2020/10/cqi-webinar-digital-process.html

20200909: Chartered Quality Institute (CQI) AGM 2020 - https://qualityalchemist.blogspot.com/2020/09/chartered-quality-institute-cqi-agm-2020.html

20200728: CQI Webinar – Dare to think: guidelines for the effective quality manager - https://qualityalchemist.blogspot.com/2020/07/cqi-webinar-dare-to-think-guidelines.html

20200714: CQI Webinar - Risks ain't wot they used t'be - https://qualityalchemist.blogspot.com/2020/07/cqi-webinar-risks-aint-wot-they-used-tbe.html

20160514: The International Academy for Quality (IAQ) General Meeting and Dinner - https://qualityalchemist.blogspot.com/2016/05/the-international-academy-for-quality.html

20160531: IuPDI Seminar on SME O2O Business Transformation - https://qualityalchemist.blogspot.com/2016/05/iupdi-seminar-on-sme-o2o-business.html

20150608: Seminar on Enhancing Brands for Overseas Markets - https://qualityalchemist.blogspot.com/2015/06/seminar-on-enhancing-brands-for.html

20140426: CQI Site Visit to HK-ZhuHai-Macao Bridge - Reclamation Work - https://qualityalchemist.blogspot.com/2014/04/cqi-site-visit-to-hk-zhuhai-macao.html

20140714: IRCA & CQI Seminar on Risk Based Audit - https://qualityalchemist.blogspot.com/2014/07/irca-cqi-seminar-on-risk-based-audit.html

20130708: CQI Seminar "Quality is a Matter of Life or Death" - https://qualityalchemist.blogspot.com/2013/07/cqi-seminar-quality-is-matter-of-life.html

20121106: CQI Seminar on "Life after Quality" - https://qualityalchemist.blogspot.com/2012/11/cqi-seminar-on-life-after-quality.html

2021年10月20日星期三

CQIHK Webinar - Hoshin Kanri – Policy for Purpose NOT Policy of Platitudes

I was honor to be invited by Mr. Ian Streeter (Chair of the Chartered Quality Institute, Hong Kong Branch) to support their webinar named “Hoshin Kanri – Policy for Purpose NOT Policy of Platitudes” on 20^th Oct 2021. Dr. Gregory H. Watson (FCQI, CQP) is keynote speaker and Hong Kong Society for Quality (HKSQ) is one of supporting organizations.

Firstly, Dr. Watson introduced Hoshin Kanri (Policy Management) and explaned the Japanese way that management should set strategy based on evidence that has been interpreted by collective judgment.

Then Dr. Watson introduced 5 steps for assigning the rules in “Do-Check” cycle in the SDCA Daily management so as to create standard work.

And then he mentioned “Cycles of improvement” using Gemba (Onsite) 1, 2 & 3. Gemba 1 is work process level (for continual improvement), Gemba 2 is system level (for breakthrough) and Gemba 3 is governance level (for transformation) that implementing continuous states of structural change.

After that Dr. Watson briefed the Strategic Management by Policy (SMBP) that employed SDCA and PDCA cycle with Daily Management (JSQC-Std. 32-001(E): 2014) and Policy Management (JSQC-Std. 33-001(E): 2017). The managing the objectives of Hoshin Tenkai are strategy formulation developed the set of change projects that would deliver the desirable future state of organization performance. (Policy = Strategic Plan)

Finally, he stated the implementing an integrated approach from compliance level (Operational Excellence) through improvement projects to aspiration level (Business Excellence). Dr. Watson then quoted Hiroshi Osada’s “S-7 Toolkit” for strategy formulation to argue Porter’s misconception about Japanese lack of strategic thinking and planning (Michael E. Porter (1996) “What is Strategy?” Harvard Business Review, Dec, pp.62-78).

Lastly, Dr. Watson mentioned three “gifts” of management (3R’s) that stands for Direct Responsibility, Dedicated Resources and Decision Rights. He concluded that Hoshin enables implementing strategic change that adding value to process and people.

Q&A

Reference:

CQI Hong Kong branch – 英國特許質量協會-香港分會

HKSQ - https://hksq.org/

Previous CQI activities:

20201105: CQI Webinar – Principle of Risk - https://qualityalchemist.blogspot.com/2020/11/cqi-webinar-principle-of-risk.html

20201015: CQI Webinar - Top Tips for Remote internal auditing - https://qualityalchemist.blogspot.com/search/label/CQI

20201002: CQI Webinar - Digital process transformation and the quality professional - https://qualityalchemist.blogspot.com/2020/10/cqi-webinar-digital-process.html

20200909: Chartered Quality Institute (CQI) AGM 2020 - https://qualityalchemist.blogspot.com/2020/09/chartered-quality-institute-cqi-agm-2020.html

20200728: CQI Webinar – Dare to think: guidelines for the effective quality manager - https://qualityalchemist.blogspot.com/2020/07/cqi-webinar-dare-to-think-guidelines.html

20200714: CQI Webinar - Risks ain't wot they used t'be - https://qualityalchemist.blogspot.com/2020/07/cqi-webinar-risks-aint-wot-they-used-tbe.html

20160514: The International Academy for Quality (IAQ) General Meeting and Dinner - https://qualityalchemist.blogspot.com/2016/05/the-international-academy-for-quality.html

20160531: IuPDI Seminar on SME O2O Business Transformation - https://qualityalchemist.blogspot.com/2016/05/iupdi-seminar-on-sme-o2o-business.html

20150608: Seminar on Enhancing Brands for Overseas Markets - https://qualityalchemist.blogspot.com/2015/06/seminar-on-enhancing-brands-for.html

20140426: CQI Site Visit to HK-ZhuHai-Macao Bridge - Reclamation Work - https://qualityalchemist.blogspot.com/2014/04/cqi-site-visit-to-hk-zhuhai-macao.html

20140714: IRCA & CQI Seminar on Risk Based Audit - https://qualityalchemist.blogspot.com/2014/07/irca-cqi-seminar-on-risk-based-audit.html

20130708: CQI Seminar "Quality is a Matter of Life or Death" - https://qualityalchemist.blogspot.com/2013/07/cqi-seminar-quality-is-matter-of-life.html

20121106: CQI Seminar on "Life after Quality" - https://qualityalchemist.blogspot.com/2012/11/cqi-seminar-on-life-after-quality.html

2020年11月5日星期四

CQI Webinar – Principle of Risk

CQI Webinar named “Principle of Risk” was held on 5^th Nov 2020. I summarized it for sharing below. Mr. Alexander Woods was a facilitator to introduce the seminar and speaker – Mr. Martin Graham.

Mr. Martin Graham (NQA Training Manager / Lead Auditor) discussed what risk is and the principles of risk based thinking. Risk is defined as “the effect of uncertainty”. Risk and uncertainty typically come from people, process, product and infrastructure. He said “What is in doubt that could affect what we do with regard to our intended outcomes?” Then he introduced different type of risk including financial, compliance, human, Env/H&S, Perception, Operational and Infrastructure.

And then he discussed the action taken to address a risk, typically addressed an uncertainty. “Contextual Risks” is equivalence to “Relevant Uncertainties”. And he demonstrated different possible effects of uncertainty.

After that he mentioned “Risk-based Thinking” that allowed you to consider the current situation and the possibilities for, and impact(s), of change. It should be systematic within the management system (in any part of the system, process or functions) but not separate component. Identifying and addressing risks should be a proactive rather than a reactive process in preventing or reducing undesired effects. Its intended outcomes were objectives, policy, compliance, satisfaction, improvement and so on. Some tips were demonstrated.

Finally, Mr. Graham said preventive action is the result of effective risk assessment. There is no ‘correct’ methodology (some possible methods – SWOT, PESTLE, FMEA, ISO 31000, Cause and Effect, Brainstorming, etc.) but you need to make it work for and keep it relevant to your organization/process. You might not be able to eliminate the uncertainties but you could manage the effects. Moreover, he showed the risk clauses under ISO 9001:2015 and PDCA concept.

Lastly, he alerted us to keep risk management system if have under constant review and update especially in the key areas within the “Planning of Changes” clause. And he introduced the Risk-based thinking management programme included Identify (I), Analyse (A), Treat (T), Monitor (M) and Control (C) at the end.

Reference:

CQI-HK - http://www.thecqi.org.hk/

CQI-UK - http://www.thecqi.org/

20121106: CQI Seminar on "Life after Quality" - https://qualityalchemist.blogspot.com/2012/11/cqi-seminar-on-life-after-quality.html

20130708: CQI Seminar "Quality is a Matter of Life or Death" - https://qualityalchemist.blogspot.com/2013/07/cqi-seminar-quality-is-matter-of-life.html

20140714: IRCA & CQI Seminar on Risk Based Audit - https://qualityalchemist.blogspot.com/2014/07/irca-cqi-seminar-on-risk-based-audit.html

20140426: CQI Site Visit to HK-ZhuHai-Macao Bridge - Reclamation Work - https://qualityalchemist.blogspot.com/2014/04/cqi-site-visit-to-hk-zhuhai-macao.html

20150608: Seminar on Enhancing Brands for Overseas Markets - https://qualityalchemist.blogspot.com/2015/06/seminar-on-enhancing-brands-for.html

20160531: IuPDI Seminar on SME O2O Business Transformation - https://qualityalchemist.blogspot.com/2016/05/iupdi-seminar-on-sme-o2o-business.html

20160514: The International Academy for Quality (IAQ) General Meeting and Dinner - https://qualityalchemist.blogspot.com/2016/05/the-international-academy-for-quality.html

20200714: CQI Webinar - Risks ain't wot they used t'be - https://qualityalchemist.blogspot.com/2020/07/cqi-webinar-risks-aint-wot-they-used-tbe.html

20200728: CQI Webinar – Dare to think: guidelines for the effective quality manager - https://qualityalchemist.blogspot.com/2020/07/cqi-webinar-dare-to-think-guidelines.html

20200909: Chartered Quality Institute (CQI) AGM 2020 - https://qualityalchemist.blogspot.com/2020/09/chartered-quality-institute-cqi-agm-2020.html

20201002: CQI Webinar - Digital process transformation and the quality professional - https://qualityalchemist.blogspot.com/2020/10/cqi-webinar-digital-process.html

20201015: CQI Webinar - Top Tips for Remote internal auditing - https://qualityalchemist.blogspot.com/search/label/CQI

2020年10月15日星期四

CQI Webinar - Top Tips for Remote internal auditing

CQI Webinar named “Top Tips for Remote internal auditing” was held on 15^th Oct 2020. I summarized it for sharing below. Before the seminar, Mr. Alexander Woods as facilitator to introduce the seminar and speaker – Ms. Judith Hargreaves.

Firstly, Ms. Judith Hargreaves (NQA Regional Assessor) introduced NQA background that is top 3 of CB in UK. In this talk, she would like to share the effective internal auditing. She shared her auditing steps included confirming the scope, desktop or live - paperwork and checklist or improvement tools.

Then she mentioned the Pros & Cons of remote auditing in the following table.

And then she discussed the planning for remote audit including the best method to view the information and communication with your customer. Moreover, the members involvement of customer team should be agreed in advance on audit dates through detailed plan. The plan included Date & Time, Location/Department/Function, Method, and Indicative Records Required.

During inviting confirmation and participation, it should ensure everybody knew their role for the day of audit and availability. Test the communication methods such as Zoom or Skype should be performed before audit.

Ms. Judith Hargreaves always asked us to keep it simple, effective and enjoy the audit. After that she shared some tips in Context, Leadership, Planning, Support and Operations, as well as, Performance Evaluation & Improvement.

i) Documented information (e.g. Quality Manual) could be assessed via email, verified through internal audit.

ii) For leadership, based on the quality policy to discuss risk, roles & responsibilities, customer focus. (Remark: Your role is really to verify you are doing what you say you are and you have information to check without heaps of paperwork to review.)

iii) Quality objectives are the only required documented information which can be emailed over and then discussed. (Can we verify if these are effective?)

iv) We can be emailed documented information for monitoring & measuring resources (7.1.5.1), calibration equipment (7.1.5.2), competence & training matrixes (7.2) and documented information control (7.5)

v) In operations, could customer arranged virtual tour such as using mobile, camera or even drone. (But it should be safe!)

vi) Sampling orders should considered compliance at random. Could it be online and screenshare?

vii) Performance evaluation on documented information, management review and internal audits as well as non-conformances should be considered.

Finally, Ms. Judith Hargreaves shared some key points for participate to take away below.

i) If document could get by email, we had time to review it and prepare a bank of informed questions for audit use.

ii) Conversation is still very important.

iii) External auditor managed audit day exactly and internal audit to conduct the audit in a relaxed timeframe.

iv) Be aware of information security (e.g. GDPR)!

At the end, Ms. Judith Hargreaves showed NQA services to support company work / return to work safely.

Q&A

Reference:

CQI-HK - http://www.thecqi.org.hk/

CQI-UK - http://www.thecqi.org/

20121106: CQI Seminar on "Life after Quality" - https://qualityalchemist.blogspot.com/2012/11/cqi-seminar-on-life-after-quality.html

20130708: CQI Seminar "Quality is a Matter of Life or Death" - https://qualityalchemist.blogspot.com/2013/07/cqi-seminar-quality-is-matter-of-life.html

20140714: IRCA & CQI Seminar on Risk Based Audit - https://qualityalchemist.blogspot.com/2014/07/irca-cqi-seminar-on-risk-based-audit.html

20140426: CQI Site Visit to HK-ZhuHai-Macao Bridge - Reclamation Work - https://qualityalchemist.blogspot.com/2014/04/cqi-site-visit-to-hk-zhuhai-macao.html

20150608: Seminar on Enhancing Brands for Overseas Markets - https://qualityalchemist.blogspot.com/2015/06/seminar-on-enhancing-brands-for.html

20160531: IuPDI Seminar on SME O2O Business Transformation - https://qualityalchemist.blogspot.com/2016/05/iupdi-seminar-on-sme-o2o-business.html

20160514: The International Academy for Quality (IAQ) General Meeting and Dinner - https://qualityalchemist.blogspot.com/2016/05/the-international-academy-for-quality.html

20200714: CQI Webinar - Risks ain't wot they used t'be - https://qualityalchemist.blogspot.com/2020/07/cqi-webinar-risks-aint-wot-they-used-tbe.html

20200728: CQI Webinar – Dare to think: guidelines for the effective quality manager - https://qualityalchemist.blogspot.com/2020/07/cqi-webinar-dare-to-think-guidelines.html

20200909: Chartered Quality Institute (CQI) AGM 2020 - https://qualityalchemist.blogspot.com/2020/09/chartered-quality-institute-cqi-agm-2020.html

20201002: CQI Webinar - Digital process transformation and the quality professional - https://qualityalchemist.blogspot.com/2020/10/cqi-webinar-digital-process.html

2020年10月2日星期五

CQI Webinar - Digital process transformation and the quality professional

CQI Webinar named “Digital process transformation and the quality professional” was held on 30^th Sep 2020. I was missed on that time but review the record through CQI website again and summarized it for sharing below. The guest speaker was Mr. Rich Seddon (Managing Partner, PMI) and his expertise in digital process transformation (DPT)

Firstly, Mr. Seddon briefed the PMI definition on digital process transformation that included to enhance efficiency, effectiveness and customer experience of different business processes.

Then he mentioned some of existing solution including IoT, Big Data, 3D Printing, AR, Mobile Technology, Cloud-based services, AI & ML, and Process Automation, etc.

And then Mr. Seddon shared his insights for success such as Strategic Goals + Voice of the Customer + Process Knowledge. He also added “don’t ignore the basics such as PDSA”.

After that he demonstrated some disciplines which enabled success from “Understand Side” and “Measure Side”.

Mr. Seddon showed different case study for demonstration of their DPT. Those examples including sub-component manufacturing company, professional service company, multi-site retailer, … etc. He also used poll to survey with the participants about which department responsible to DPT. Most of participants selected “Business Improvement Team”.

Finally, he discussed nine successful factors for DPT below.

1. New Risks? Digital Process transformation can offer significant gains. But it can also introduce new risks.

2. You’re not done. It is not a one time activity, as with all effective improvement, it is continuous.

3. Visibility. Many of the new tools are not centrally visible, so how do we ascertain the quality?

4. Ready for it? This is innovation in its purtest form. Is your business read and able to allow rapid deployment of new processes?

5. Clarity & Speed. Be clear on your governance process … if every decision has to go through multiple layers of management, issues cannot be detected and corrected quickly.

6. Skills Development. Understanding the skills requirements is vital. Do you have the right people with the right knowledge to implement and execute?

7. Identify Talent. Can be found in some unlikely places, spread the responsibility, use it as a development opportunity.

8. Be prepared to change course. Agility and willingness to change course are crucial to success.

9. Big I.T. may not be the answer. Understand the art of the possible based on the problem you’re trying to solve, don’t be led by system functionality alone.

Lastly, Mr. Rich Seddon showed us the successful example that brought to life from confirm & collect using the app to analyse & understand performace in automated dashboards.