2022年6月24日星期五

HKSQ Webinar – Why we need Inspection Service

The Hong Kong Society for Quality (HKSQ) organized a webinar named “Why we need Inspection Service” on 24th Jun 2022. Inspection is the most common method of attaining standardization, uniformity, and quality of workmanship on the product. The webinar aims to introduce inspection service based on acceptance quality level (AQL), different types of inspection and competence based on ISO 17020. The guest speaker was Dr. Jane WK Wong (Vice-chairman, HKSQ; Retail Sales Director, General Inspection Services Co., Ltd.) and she has over 30 years’ experience in inspection business. 


Firstly, Dr. Jane Wong briefed some reasons to employ inspection service such as reducing the risk, ensuring the contractual obligations, identifying the problem before shipment, etc. Then she mentioned the QA and QC in the global supply chain with certification, testing and inspection service.


Then she stated different types of inspection including “Pre-production Inspection (First Article Check)”, “During Production Inspection (DPI) / In-line Inspection” and “Pre-Shipment Inspection (PSI) / Final Random Inspection (FRI)” under different product categories.


After that Dr. Wong used a case to example inspection plan such as item A with 1200 pieces and 80 samples inspected. Number of cartons is 60 and number of drawn is square root of 60 ~ 8.


Finally, she employed case study on single sampling plans for normal inspection to explain the AQL inspection table.  Usually, customer would select general inspection level II where level I is smaller sample size and level III is larger sample size.  She further explained that reject if any critical defect is found because it related to safety. Major defect is some broken part of product and cannot sale.  Minor defect is some flaw but still can sale.


Lastly, she introduced the roadmap of inspection.


Before end of webinar, we had discussed many items during Q&A sessions as below.

-          Defects Per Million Opportunities (DPMO) employed in factory;

-          Proof of Concept (PoC) product is only one or two piece(s) that inspection body would communicate with customer to arrange pre-production inspection, etc.

We took a group photo for memory at the end.

Reference:

HKSQ - http://www.hksq.org

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2022年6月23日星期四

Webinar: Validation and Maintenance of cGMP Methods

 Webinar named “Validation and Maintenance of cGMP Methods” was organized by Mettler Toledo. The webinar chaired by Dr. Christoph Jansen (Key Account Manager MT Analytical, Global technical divisional, Mettler Toledo) and guest speaker was Dr. Bob McDowall (Director, R.D.McDowall Limited). His topic named “Method Validation for cGMP and ISO/IEC 17025 tests”.


Firstly, Dr. Bob McDowall briefed some terms and abbreviations including AIQ (analytical instrument qualification), URS (user requirement specification), 4Q model for qualification (DQ, IQ, OQ and PQ), etc. Then he briefed the different between procedure and method.


And then he mentioned the purpose of QC method to assure constant quality and patient safety under cGMP, CFR, Data Integrity, etc. He also explained the different between validation and verification.


After that measurement uncertainty was introduced according to ISO/IEC 17025. 


Finally, some cases of method validation are shared such as titration methods. It included sample size, limit of quantification (LOQ), ruggedness (robustness), etc.


The different between validation and qualification were also explained that qualification is for your instrument and validation is for processes, system and methods.


Lastly, data integrity model was introduced and he briefed the draft of USP<1220> that released in May 2022, as well as, its major changes.


At the end, some literatures are shared for reference.

Reference:

Mettler Toledo: https://www.mt.com/int/en/home.html

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2022年6月21日星期二

Webinar: Solving API Manufacturing Challenges with Flexible Containment

 Webinar named “Solving API Manufacturing Challenges with Flexible Containment” was organized by ILC Dover. This webinar discussed some of the common challenges faced in handling powders during HAPI/API manufacturing. Key strategies to mitigate risks associated with these issues was shared including how flexible containment solutions can optimize powder handling during chemical synthesis. Ms. Kayla Hager was the guest speaker.


Firstly, she introduced the whole process of chemical synthesis of Active Pharmaceutical Ingredients (APIs) from “Materials arrive” to “Pack off to oral solid dosage process”.


Then she briefed some common challenges including powder containment and dust mitigation, operational efficiency, sustainability and others.


Some controls for the contain at the source include “Control of the environment”, “Reduce airborne particulate”, “Protect operators”, “Reduce risk of cross contamination” and “Consider ergonomic”. Some steps of chemical synthesis under contain at the source showed as following diagram.


An intermediate bulk container (IBC) is a pallet mounted, industrial grade reusable container that is used for storing and transporting bulk liquids and powders. Cleaning IBC’s and Disposal of Flexible intermediate bulk containers (FIBC) were then discussed.


Ms.Hager said disposal of FIBC is more sustainable than stainless steel IBC for cleaning based on water consumption and energy consumption, as well as, cost of capital expenditure. For project time and complexity, IBC project needs 22 to 30 weeks but FIBC project only needs 8 to 10 weeks.


After that she briefed flexible containment solutions optimized powder handling during chemical synthesis under API process train.


Finally, she introduced the concept of “Quality by Design (QbD)”. She said the DoverPac and D100 systems maintain closed charging minimizing the risk of contamination and particularly cross contamination in a shared facility.


Reference:

ILC Dover - https://www.ilcdover.com/

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2022年6月18日星期六

OBORRI Webinar - Sanctions and Anti-sanctions: The Russian Case

Webinar named “Sanctions and Anti-sanctions: The Russian Case” was organized by One Belt One Road Research Institute (OBORRI), Chu Hai College of Higher Education on 18th Jun 2022. In the beginning, Prof. Oleksandr Rogach (Professor, One Belt One Road Research Institute, Chu Hai College & Taras Shevchenko National University of Kyiv, Ukraine) gave an opening speech and he introduce the topics’ background and guest speakers. 


The first speaker was Mr Ryan Chan Ming Tai (Deputy Director General, Silk Road Economic Development Research Center) and his topic entitled “General background of the sanctions imposed on Russia”.  Firstly, Mr. Chan stated the background such as the Office of Foreign Assets Control (OFAC) of the US Department of the Treasury which enforces economic and trade sanctions.


Then Mr. Chan briefed the scope of sanctions on Russia and history of USA’s sanctions since 2014 including energy sector, financial sector, military goods, mercenaries and transportation.


And then he mentioned the impacts on aviation industry and international companies (e.g. McDonald’s, Coca-Cola and Starbucks). Then he introduced Russia’s defense against global sanctions.


After that the Russia’s key role in energy exports, global supply chain and global food crisis were discussed.


Since Russia is lacking high-tech products domestically, Mr. Chan showed the diagram of high-tech goods in 2019 and found that Europe is dominated. However, China involvement is expected to increase.


Finally, Mr. Ryan Chan using global value chain to explain Russia’s involvement in the global economy. Europe and Central Asian countries are most dependent on Russia’s large exported metal products that not only oil and gas.


Lastly, the role of Russia in the global supply chain was explained and Russia would gradually shift its focus to Asia.  He concluded the short-terms impacts including hyperinflation on energy and food, as well as, lower economy growth in the Euro zone. The long-terms impacts were dramatic reorganization of the global economy; localization, regionalization and politicization of production chain and supply chain by higher geopolitical risk and a fragmentation of the trade system.


The second speaker was Prof. Oleksandr Pidchosa (Associate Professor, One Belt One Road Research Institute, Chu Hai College & Taras Shevchenko National University of Kyiv, Ukraine) and his topic named “Russian Economy Under Sanctions: Implications for the Financial Sector”.  Firstly, he showed western expected results in the beginning of the sanctions but it didn’t happen.


Then Prof. Pidchosa briefed some background of Russia historical experience and competence in circumventing sanctions and could trace back to USSR in 1918.  Then he introduced the structure of Russia’s GDP in 2021.


And then he stated the current condition of Russia’s Economy that the macroeconomic stability of the country was not significantly affected, as well as, low unemployment rate (4%). As a result of Western actions, confidence was broken in the Jamaica monetary system, the US dollar, the Euro and Western financial institutions.


After that Russia solved the cross-border payments using SFPS (System for Transfer of Financial Messages) and the Chinese CIPS (Cross-Border Interbank Payment System) since 2017.  Russia and Iran, India & other counties had agreed to use national currencies.  Blockchain technology would be employed to replace SWIFT and planned to use the digital ruble in 2023. 


Those cryptocurrencies (along with physical gold) were considered as one of the options for conducting financial transactions.  Moreover, a mechanism for circumventing “Gold sanctions” was also mentioned because of sanctions on LME in London, COMEX in New York and Switzerland.


The diagram showed the comparison on the effect of sanctions through Russia’s unfriendly countries and friendly countries.


Finally, he mentioned about Hong Kong situation on Russia trading cases. Lastly, Prof. Pidchosa concluded that “In general, the question is not about sanctions and counter-sanction in long-term perspective, but about those tectonic shifts and processes launched in the global economy.”

Reference:

OBORRI - https://www.chuhai.edu.hk/node/1794

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2022年6月17日星期五

HKCIE Technical Visit to Exhibition Centre

 The technical visit to Exhibition Centre Station (港鐵會展站) was organized by Hong Kong Chinese Institute of Engineers (HKCIE) (香港中國工程師學會) on 17th Jun 2022. Hong Kong Society for Quality (HKSQ) was one of co-organizers. Before visit, we took a group photo before enter the station.


We met some HKSQ members and took a photo for memory.


In the beginning, MTR representatives briefed some background of the station to us and then led us to visit this historical station.


Firstly, the representative introduced the design of the wall that is different images of same sea view taken in different time because the view was missed after station establishment.


Then he briefed some historical stories of different stations to us.


After that some improvement in the station was mentioned such as real time space condition demonstration.


Even in front of toilet, real time space engagement and air quality level were demonstrated.


The China Calligraphy of Exhibition Centre was drawn by one of retired engineer in MTR and this style would extend to other stations.


And then the construction method for cross harbor railway tunnel was introduced. The detail link named “MTR East Rail Line Cross-Harbour Extension – Construction Challenges” at http://www.mtrealstations.com/QR/exclp/05_en.html .


Finally, we visited the bombs which discovered at the station work site and took a group photo for memory.


Dr. Aaron Tong (Chairman, HKCIE) and I presented flag and anniversary book to MTR representatives.


We are appreciated to MTR gift and it is a very beautiful face mask.


Reference:

Hong Kong Chinese Institute of Engineers - http://www.hkcie.org/

HKSQ - http://www.hksq.org

20171007: HKCIE Visit to Liantang/Heung Yuen Wai Boundary Control Point Construction Site - https://qualityalchemist.blogspot.com/2017/10/hkcie-visit-to-liantangheung-yuen-wai.html

20160229: HKCIE Seminar on Extenics (可拓學) - https://qualityalchemist.blogspot.com/2016/02/hkcie-seminar-on-extenics.html