MINISTRY OF EDUCATION AND TRAINING HO CHI MINH CITY UNIVERSITY OF TECHNOLOGY AND EDUCATION FACULTY FOR HIGH QUALITY TRAINING INDUSTRIAL MANAGEMENT ASSESSMENT OF APPLICATION SUPPLIER QUALITY MANAGEMENT PROCEDURE AT TERUMO BCT VIETNAM CO., LTD SUPERVISOR: MBA. HUYNH ANH TUAN STUDENT: HUYNH THAO UYEN SKL 0 0 8 1 9 7 Ho Chi Minh City, June, 2021 MINISTRY OF EDUCATION AND TRAINING HO CHI MINH CITY UNIVERSITY OF TECHNOLOGY AND EDUCATION FACULTY FOR HIGH QUALITY TRAINING GRADUATED THESIS ASSESSMENT OF APPLICATION SUPPLIER QUALITY MANAGEMENT PROCEDURE AT TERUMO BCT VIETNAM CO., LTD Instructor Master Huynh Anh Tuan Student Huynh Thao Uyen Student’s ID 17124124 Course 2017 Ho Chi Minh City, June 2021 i MINISTRY OF EDUCATION AND TRAINING HO CHI MINH CITY UNIVERSITY OF TECHNOLOGY AND EDUCATION FACULTY FOR HIGH QUALITY TRAINING GRADUATED THESIS ASSESSMENT OF APPLICATION SUPPLIER QUALITY MANAGEMENT PROCEDURE AT TERUMO BCT VIETNAM CO., LTD Instructor Master Huynh Anh Tuan Student Huynh Thao Uyen Student’s ID 17124124 Course 2017 Ho Chi Minh City, June 2021 ii THE SOCIALIST REPUBLIC OF VIET NAM Independence – Freedom - Happiness ----***---- Ho Chi Minh city, Jun15th, 2021 GRADUATE THESIS DUTIES Student’s name: Huynh Thao Uyen Student ID: 17124124 Major: Industrial Management Class: 17124CL1A Instructor: Master Huynh Anh Tuan Mobile: 0908 270 555 Topic’s receiving date Topic's submission date May 2nd 2019 July 2nd 2019 1. Topic: Assessment of Application Supplier Quality Management Procedure at Terumo BCT Vietnam Co. Initial data, documents: Supplier Quality Management procedure, Production procedures, Approval Supplier Master List, ….
Thesis’s content: Assessment of Application Supplier Quality Management Procedure at Terumo BCT Vietnam Co. From that giving evaluation: good points, limitation of process and improvement ideas for Supplier Quality team. Result: Graduate Thesis of Industrial Management Major 2017. LEADER OF SECTOR INSTRUCTOR i THE SOCIALIST REPUBLIC OF VIET NAM Independence – Freedom - Happiness ******* INSTRUCTOR’S EVALUATION FORM Student’s name: Huynh Thao Uyen.
Major: Industrial Management. Topic: Assessment of Application Supplier Quality Management Procedure at Terumo BCT Vietnam Co. Instructor’s name: Huynh Anh Tuan. Thesis’s content and implemented workload:.
Suggestion for defending?. Categories of evaluation:. Score: ……………… ( By words :. Ho Chi Minh City, date month year 2019 Instructor (Signature and full name) ii THE SOCIALIST REPUBLIC OF VIET NAM Independence – Freedom - Happiness ******* THESIS COMMITTEE'S EVALUATION FORM Student’s name: Huynh Thao Uyen.
Major: Industrial Management. Topic: Assessment of Application Supplier Quality Management Procedure at Terumo BCT Vietnam Co. Instructor’s name: Huynh Anh Tuan. Thesis’s content and implemented workload:.
Suggestion for defending. Categories of evaluation:. Ho Chi Minh City, date month year 2019 iii ACKNOWLEDGEMENT The author would like to thank Terumo BCT Vietnam Co., Ltd for giving me the opportunity to have a useful and memorable experience. In particular, the author is very enthusiastic in supporting the SQM group.
Thanks to Mr. Tuan Phan - Supplier Quality Management Assistant Manager and Ms. Kim Vo - Supplier Quality Assurance Staff for always helping and guiding the author. Thank you to Ms.
Giang Le - RQA supervisor, thanks to SQA team - Ms. Huong Tran, Ms. Anh Nguyen, Ms. Loan Doan, Ms.
Trang Nguyen; Thanks to the SQE team - Mr. Thu Nguyen, Mr. Man Nguyen for sharing their knowledge and experience enthusiastically, from which the author has a database to write this thesis. At the same time, thank the SQM members for trusting in assigning the tasks and training the author to complete the job well.
The author also would like to thank lecturer Mr. Huynh Anh Tuan for giving me many useful advice and guidance for the correct direction to research and complete this Graduated thesis. In addition, the author would like to thank all lectures on industrial management at Ho Chi Minh City University of Technology and Education. iv TABLE OF CONTENTS GRADUATE THESIS DUTIES.
i INSTRUCTOR’S EVALUATION FORM. ii THESIS COMMITTEE'S EVALUATION FORM. ix LIST OF TABLE. x LIST OF FIGURE.
Reasons of subject selection. Research Subject and Scope. INTRODUCTION ABOUT TERUMOBCT VIETNAM. General About Terumo BCT Vietnam.
Established history and development of Terumo. Mission and vision. Quality policy and Quality objective FY 2020. Business Activities At TBV.
Blood and Cell Industry. Main Products at TBV. Customer and Distribution. Company Organizational Size.
Introduction Supplier Quality Management Function (SQM). Supplier Quality Management. Supplier Quality Management Activities. Selection of potential supplier(s).
Developing an approved suppliers list. Monitoring supplier performance. Poka-yoke method. Types of Poka Yoke.
Go – No Go Tool. ANALYSIS OF APPLICATION SUPPLIERS QUALITY MANAGEMENT PROCEDURE AT TBV. SOP for Supplier Quality Management (SQM). SOP for Planning for New Supplier(S) Evaluation.
SOP Purchasing Materials and Services. SOP for Supplier Audit. SOP for Supplier Release on System. SOP for First Article Inspection.
SOP for Supplier’s performance monitoring. SOP for Supplier Re-Evaluation. SOP for Supplier Corrective Action. SOP for Supplier Change Management.
SOP for Handling Quarantined Material. Assessment Application Suppliers Quality Management Procedure At TBV. Strength of SQM procedure. Limited of SQM procedure.
THE SOLUTIONS IMPROVE THE SUPPLIER QUALITY MANAGEMENT PROCEDURE AT TERUMO BCT VIETNAM CO. Apply the Go and No-go tool in material sorting. Supplier quality improvement. Apply standardized work for deviation data between SAP and ASL.
Apply Check sheet to fix missing scan records archive. Mapping Supplier level 1 and 2 by location. 84 vii Appendix 1: Document ID List. 84 Appendix 2: Approval Suppliers List (ASL).
85 Appendix 3: New Supplier Request Form. 86 Appendix 4: Supplier Approval Form. 88 Appendix 5: Business Survey Form. 91 Appendix 6: Supplier Audit Report.
106 Appendix 7: SOP for Receiving Material. 114 viii GLOSSARY ASL Approval Supplier List BCT Blood Cell Technologies CAPA Corrective action and Preventive action CR Complaint rate CRF Cross Function Team FY Fiscal Year N/A Not applicable NC Non-Conformance PIC Person In Charge PR Purchase Requisition QMS Quality Management System RQA Receiving Quality Assurance SCA Supplier corrective action SCM Supply Chain Management SME Subject Master Expert SOP Standard Operating Procedure SQA Supplier Quality Assurance SQE Supplier Quality Engineer SQM Supplier Quality Management TBV Terumo BCT Vietnam VCCR Vietnam Change Control Request WH Warehouse ix LIST OF TABLE Table 2.1: Supplier Quality Management Process Map .1: Update SAP check sheet .3: Review file scan check sheet. 78 x LIST OF FIGURE Figure 1.2: Group Logo (Source:Terumo.3: Trima Reveos (Source:Terumo.4: Blood Bag (Source:Terumo.5: Trima Disposable Sets (Source:Terumo.6: Blood bag manufacturing process (Source: Blood bag manufacturing process in Terumo BCT) .7: Trima manufacturing process (Source: Trima manufacturing process in Terumo BCT) .8: TBV Organizational structure (Source: TBV Introduction) .9: SQM Organizational structure .1: Supplier Quality: Selection and Development Flowchart Example (Source: What Is Supplier Quality? - ASQ) .2: Classify suppliers by risk level (Source: complianceonline.3: Types of Poka-yoke (Source: RNAautonomation.4: Go/No Go Gages (Source: DMC Daniels Manufacturing Corporation) 32 Figure 3.1: Supplier management overview (Source: SQM procedure VQS0006_E) .2: Flow chart Planning for New Supplier(S) Evaluation (Source: SQM procedure VQS00100_A) .3: Flow chart Purchasing Materials and Services (Source: SQM procedure VQS0011_E) .4: Flow chart Audit Supplier Procedure (Source: SQM procedure VQS00101_A) .5: Flow chart Supplier release on system (Source: SQM procedure VQS0010_A) .6: Flow chart First Article Inspection (Source: SQM procedure VQS00103_A) .7: Flow chart Supplier’s performance monitoring (Sources: procedure VQS00104_A) .8: Lot Acceptable Rate (Accountable for 15% of Overall score) (Source: SQM procedure VQS00104_A) .12: On-Time Delivery (Accountable for 20% of Overall score) .14: Evaluation criteria weight Late Delivery (Accountable for 15% of Overall score) (Source: SQM procedure VQS00104_A) .16: “Approved To” Time Period of each risk level (Source: SQM procedure VQS00104_A) .17: Flow chart Supplier re-evaluation (Source: SQM procedure VQS00105) .18: Flow chart Supplier Corrective Action (Source: SQM procedure VQS00364_E) .19: SCA decision matrix (Source: SQM procedure VQS00364_E) .20: Supplier change management flow chart (Source: SQM procedure VQS00106_A) .21: Handling Quarantined Material flow chart (Source: SQM procedure VQS00107_E) .23: Suppliers by Risk Level .1: Worker is sorting in Quarantine area .2: Tube out of specification smaller than the other (source: Raw material failure mode document) .3: A set of pins from 1.4: Update SAP Flow chart .5: Mapping Supplier Level 1&2. Reasons of subject selection An organization decides to use a service or product from a supplier simply because they do not have the resources to produce themselves, do not have enough expertise, or the business should focus on what they are most powerful at.
This is a very common thing in manufacturing, especially with increasing specialization. These suppliers will outperform us in terms of price and quality, so using the supplier is essential. The purpose of a supplier quality management system is to create confidence in a supplier's ability to deliver products and services that meet standards and requirements over a long period of time, and it also helps better manage supplier relationships to understand and grow together for mutual benefits. Over the years, health and medicine have been more and more concerned with people and become the way of life for each of us.
Especially when the world faces many health challenges, the effects that can come from natural disasters, or most recently, the world economy and medicine have been affected hard by the Covid-19. And people found that medical device play an important role to assurance medical examination and treatment and have a direct impact on people's life and health. For medical device to meet specific requirements and specifications, enterprise must have a quality system in place to control and ensure this control is as expected. As a medical device manufacturing company, Terumo BCT Vietnam's priority is to manage quality from the input, "Do It Right In The First Time".
Any defect detected during inlet inspection will be rejected and worked with the supplier if assessed that affects product quality when put into production. Therefore, supplier quality management plays an important role in TVB. For these reasons, the author chooses the topic in this thesis as "Assessment Of Application Supplier Quality Management Procedure At Terumo BCT Vietnam Co. Research objectives - To comprehend supplier quality management procedures at TBV.
- To analyse the SQM procedure and evaluate good points, limitations of its base on reality implementation. - To recommend some suggestions to improve the effectiveness of the implementation procedure from the perspective of an SQM intern who has observed and had a real- world experience while doing this process. Research Methodology Analysing method summarizing experience, interviewing experts and collecting related documents 4. Research Subject and Scope - Subject: Supplier Quality management procedure of Terumo BCT Vietnam Company.
- Scope: The study focuses on the SQM department of Terumo Blood Cell Technologies Vietnam Co. from September 7th , 2020 - January 6th , 2021 5. Thesis structure The content of the thesis is divided into 4 chapters: Chapter 1: Introduction About Terumo BCT Vietnam. Chapter 2: Theoretical Basis.
Chapter 3: Analysis of Application Suppliers Quality Management Procedure At Terumo BCT Vietnam Co. Chapter 4: The Solutions Improve the Supplier Quality Management System At Terumo BCT Vietnam Co. INTRODUCTION ABOUT TERUMOBCT VIETNAM 1. General About Terumo BCT Vietnam 1.
Established history and development of Terumo ❖ Terumo Corporation .1: Terumo Corporation (Source: Terumo Report 2020) Terumo Corporation was founded in 1921 by several scientists and doctors, including Dr. Shibasaburo Kitasato, to produce clinical thermometers in Japan. These vital medical devices had previously been imported until they were cut off because of World War I. The lifelong spirit of Dr.
Kitasato, whose achievements received global recognition, is found in his statement: “Scientists should never feel self-satisfaction doing advanced research; the true objective is for the results to be put to use, thereby contributing to society.” 3 “Contributing to Society through Healthcare,” is both Terumo’s starting point and unchanging corporate mission.