Assessment of application supplier quality management procedure at terumo bct vietnam co , ltd

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 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 Topic: Assessment of Application Supplier Quality Management Procedure at Terumo BCT Vietnam Co., Ltd 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., Ltd 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 Student’s ID: 17124124 Major: Industrial Management Topic: Assessment of Application Supplier Quality Management Procedure at Terumo BCT Vietnam Co., Ltd Instructor’s name: Huynh Anh Tuan EVALUATION Thesis’s content and implemented workload: Good points: Limitations: 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 Student’s ID: 17124124 Major: Industrial Management Topic: Assessment of Application Supplier Quality Management Procedure at Terumo BCT Vietnam Co., Ltd Instructor’s name: Huynh Anh Tuan EVALUATION Thesis’s content and implemented workload: Good points: Limitations: Suggestion for defending Categories of evaluation: Score: ……………… ( By words: ) 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 iii ACKNOWLEDGEMENT iv GLOSSARY ix LIST OF TABLE x LIST OF FIGURE xi INTRODUCTION 1 Reasons of subject selection Research objectives Research Methodology Research Subject and Scope Thesis structure CONTENT CHAPTER INTRODUCTION ABOUT TERUMOBCT VIETNAM 1.1 General About Terumo BCT Vietnam 1.1.1 Established history and development of Terumo 1.1.2 Mission and vision 1.1.3 Five Statements 1.1.4 Quality policy and Quality objective FY 2020 1.1.5 Core value 1.2 Business Activities At TBV 1.2.1 Blood and Cell Industry v 1.2.2 Main Products at TBV 1.2.3 Customer and Distribution 12 1.2.4 Production Process 13 1.3 Company Organizational Size 15 1.3.1 Organizational structure 15 1.3.2 Introduction Supplier Quality Management Function (SQM) 18 CHAPTER THEORETICAL BASIS 21 2.1 Quality 21 2.2 Supplier Quality Management 21 2.3 Supplier Quality Management Activities 22 2.3.1 Selection of potential supplier(s) 22 2.3.2 Developing an approved suppliers list 25 2.3.3 Suppliers Evaluation 27 2.3.4 Monitoring supplier performance 28 2.4 Poka-yoke method 30 2.4.1 Definition 30 2.4.2 Types of Poka Yoke 30 2.4.3 Go – No Go Tool 31 2.5 Flowchart 32 2.5.1 Definition 32 2.5.2 Flowcharting Symbols 32 CHAPTER ANALYSIS OF APPLICATION SUPPLIERS QUALITY MANAGEMENT PROCEDURE AT TBV 34 3.1 SOP for Supplier Quality Management (SQM) 34 vi 3.1.1 SOP for Planning for New Supplier(S) Evaluation 36 3.1.2 SOP Purchasing Materials and Services 38 3.1.3 SOP for Supplier Audit 40 3.1.4 SOP for Supplier Release on System 45 3.1.5 SOP for First Article Inspection 47 3.1.6 SOP for Supplier’s performance monitoring 50 3.1.7 SOP for Supplier Re-Evaluation 55 3.1.8 SOP for Supplier Corrective Action 58 3.1.9 SOP for Supplier Change Management 61 3.1.10 SOP for Handling Quarantined Material 63 3.2 Assessment Application Suppliers Quality Management Procedure At TBV 66 3.2.1 Strength of SQM procedure 66 3.2.2 Limited of SQM procedure 68 CHAPTER THE SOLUTIONS IMPROVE THE SUPPLIER QUALITY MANAGEMENT PROCEDURE AT TERUMO BCT VIETNAM CO., LTD 70 4.1 Apply the Go and No-go tool in material sorting 70 4.2 Supplier quality improvement 73 4.3 Apply standardized work for deviation data between SAP and ASL 73 4.4 Apply Check sheet to fix missing scan records archive 76 4.5 Mapping Supplier level and by location 78 CONCLUSION 80 REFERENCES 81 APPENDIXES 84 vii 7.9 Product Identification and Traceability 7.9.1 Is product identification and traceability documented and maintained?  Yes  No If yes, describe briefly 7.10 Production and Process Controls 7.10.1 Does the organization verify that incoming material is acceptable prior to moving  Yes  No  N/A it into manufacturing? 7.10.2 Are “Accept / Reject” quantities from  Yes  No  N/A your supplier’s materials recorded upon receipt? 7.10.3 Are products identified by a serial or lot number?  Yes  No  N/A 7.10.4 Is there a documented validation process  Yes  No  N/A in place? If yes, describe briefly 7.10.5 When changes or process deviations occur, what method is used to determine the need for re-validation? Please describe: 7.10.6 Is there a formal Environmental Control Program?  Yes  No  N/A 7.10.7 How often are environmental controls inspected? Please describe: 7.10.8 Does the production and process controls conform to GMP (EUDRALEX Vol  Yes  No 101 IV Part II Basic Requirements for Active  N/A Substances or other)? If yes, ensure a copy of GMP certification and/or last FDA inspection is attached to this survey 7.11 Inspection, Measuring, and Test Equipment 7.11.1 All inspection and/or test equipment used to accept product must be calibrated Is such equipment calibrated and on a preventive  Yes  No  N/A maintenance schedule? In-house Subcontracted Both If yes, where is equipment calibrated? Is the customer notified when an out-ofcalibration condition may have allowed  Yes  No  N/A defective product to be shipped? Is a product identified as to its inspection and  Yes  No  N/A test status throughout all stages of production? Are products identified and dispositioned for  Yes  No  N/A non-conformance when necessary? 7.11.2 Where product has acceptance criteria, what method is used to prevent shipment of non-conforming product? Please describe: 7.11.3 Is there a documented system to initiate, investigate and provide solutions for customer  Yes  No complaints? 7.11.4 Is there a method to assure products are shipped in accordance with customer 102 specifications and does such method require products to be shipped with appropriate certification/conformance (e.g., Certificates of Analysis or Certificates of Compliance), inspection and/or test data? Please explain: 7.12 Corrective and Preventive Action 7.12.1 Do you have a corrective and preventive  Yes  No action process? 7.12.2 Are internal audits performed on the quality system?  Yes  No 7.12.3 Are audit results documented?  Yes  No 7.12.4 Is the effectiveness of  Yes  No corrective/preventive actions verified and? available for review? 7.13 Handling, Storage, and Distribution Controls 7.13.1 Is there a specific warehouse configuration to segregate products and prevent damage, deterioration or contamination? If yes,  Yes  No  N/A describe briefly 7.13.2 Do you follow the requirements for handling and storage of chemicals per the MSD  Yes  No  N/A for each? 7.13.3 Are purchase orders reviewed before final release of products? 7.13.4 Are distribution records maintained?  Yes  No  N/A  Yes  No 103 If yes, distribution records indicate traceable information (e.g., control numbers of products  Yes  No  N/A shipped; destination of shipment)? 7.14 Statistical Techniques 7.14.1 Is there an established procedure for  Yes  No  N/A employing statistical methodology in the quality system? If yes, describe briefly Terumo BCT Contact Person: The undersigned officer or representative of the Company named in item above hereby certified that he or she has provided answers to the above listed questions to the best of his or her knowledge Supplier Signature: Printed Name: Title: Date: For Terumo BCT Personnel Exclusive Use: Date questionnaire received: Additional relevant information or comments provided by Terumo BCT Vietnam personnel: 104 Terumo BCT Vietnam Title Employee Number Date Quality Representative Purchasing Representative Finance Representative 105 Appendix 6: Supplier Audit Report Supplier: Location: Product: Report Date: Name: Dept.: Audit Date: To: Participants Phone: Function: Participants from Function: supplier: Participants from Terumo: Function: Audit reason: Release System Product Process Meeting/Visit: audit: audit: audit: audit: Audit No Action needed (No tasks for the supplier) result Corrective Action without Terumo BCT coaching (Supplier implement tasks independently and reports to Terumo BCT) Corrective Action with Terumo BCT coaching (Implementation of supplier tasks is supported and controlled by Terumo BCT) Not Acceptable (Supplier is refused or is to be phased out) Facts: 106 Summary of audit results: Tasks and recommendation: Completed by: To by: Until: Approved by 107 Supplier General Information Type of off-site audit Remote audit Survey Performed by: Performed Date: Company Details Company Name Date Contact Person(s) Phone # Contact email Company Website Type of products/services provided to Terumo TBV (list products) Business address Manufacturing facility address: No of Employees No of years in business Applicable Quality Standards or Regulations (Please attach copies of current certificates if applicable) CAP ISO 13485 21 CFR 820 Accreditation ISO 9001 21 CFR 210 ISO 17025 21 CFR 606 42 CFR 493 (CLIA) Other – Specify: 21 CFR 58 (GLP) Other – Specify: Supply Details Is there product or service supplied custom to Yes Terumo TBV? Is there an existing Supply Agreement for the delivery of this product or service? Is there an existing Quality Agreement for the delivery of this product or service? Is there a specification/drawing/instruction issued by Terumo TBV for the product or service Yes – Date signed: No Yes – Date signed: No Yes No supplied? Off-Site Audit Questions Does the company have a documented Quality Manual? Yes – Document #: No – Explain: Is a documented Quality Policy in place? Yes – Document #: No – Explain: Does the company have a procedure for controlling documents issued by Terumo TBV including specification, labels and procedures? Yes – Document #: No – Explain: Records stored on-site, protected from damage Check the corresponding Records stored off-site, protected from answers that apply to records: damage Electronic records backed-up Does the company maintain Device History Records or other quality control records? Yes – Document #: No – Explain: Does the company have retention period for documents and records? Yes – Document #: No – Explain: Does the company have an established procedure for change control? Yes – Document #: No – Explain: No Is there a system in place for customer notification for all changes to products, processes and facilities? Yes – Document #: No – Explain: Have there been any major Yes changes to your production No facility or processes in the past Comments: 12 months? 10 Are the roles and responsibilities of the management team available and documented? Yes – Document #: No – Explain: 11 Does the company have a documented procedure for conducting management review, including review of quality trends? Yes – Document #: No – Explain: 12 If yes, how often are these meeting held? Explain: 13 Does the company have documented job description for all staff positions? Yes – Document #: No – Explain: 14 Is there a documented training plan for each staff member to develop and maintain job competencies? Yes – Document #: No – Explain: 15 Does the company have documented procedures for maintenance and upkeep of its infrastructure? Yes – Document #: No – Explain: 16 Does the company have a documented procedure for approval and monitoring of supplier and subcontractors? List any sub-contractors used for Terumo TBV products/services 17 Does the company have documented procedures for meeting the installation and servicing, and other distribution requirements? Yes – Document #: No – Explain: Subcontractors: Yes – Document #: No – Explain: 18 Does the company document validation procedures? Is there a system to validate new products for operation equipment? Yes – Document #: No – Explain: 19 Does the company have established procedures for release of products? Yes – Document #: No – Explain: 20 Does the company have a documented procedure for control of calibrated equipment? Yes – Document #: No – Explain: 21 Is there an independent quality unit or department responsible for quality oversight? Yes – Document #: No – Explain: 22 Are there documented procedures for the services supplied to Terumo TBV? Yes – Document #: No – Explain: 23 Is traceability maintained throughout the entire manufacturing process or provision of service? Yes – Document #: No – Explain: 24 Does the company have documented procedures for documenting and identifying root cause and correcting non-conformances for its products and processes (including services provided)? Yes – Document #: No – Explain: 25 Does the company have a documented procedure to bracket nonconformances? Yes – Document #: No – Explain: 26 Does the company have a documented procedure for handling customer complaints? Yes – Document #: No – Explain: 27 Does the company have documented procedures for conducting Internal Audits? Yes – Document #: No – Explain: 28 Does the Company have documented procedures for identifying, documenting and assessing effectiveness of Corrective and Preventive Actions (CAPA)? Yes – Document #: No – Explain: Audit Result Terumo TBV Approval ACCEPTABLE ACCEPTABLE WITH CORRECTIVE ACTION SCA #: Results: SITE AUDIT Recommended Rationale: NOT ACCEPTABLE Terumo TBV comments Cross Functional Team Approval Function Approval Signature Associate # Date Appendix 7: SOP for Receiving Material Flow chart Receiving Material Procedure (Source: SQM procedure) S K L 0