Analyse the non conformance procedure at terumo bct vietnam company limited

MINISTRY OF EDUCATION AND TRAINING HO CHI MINH CITY UNIVERSITY OF TECHNOLOGY AND EDUCATION FACULTY FOR HIGH QUALITY TRAINING INDUSTRIAL MANAGEMENT ANALYSE THE NON-CONFORMANCE PROCEDURE AT TERUMO BCT VIETNAM COMPANY LIMITED SUPERVISOR: MBA NGUYEN THI ANH VAN STUDENT: LE QUYNH TRANG SKL 0 2 Ho Chi Minh City, June, 2021 HO CHI MINH CITY UNIVERSITY OF TECHNOLOGY AND EDUCATION FACULTY OF ECONOMICS GRADUATION THESIS TOPIC: ANALYSE THE NON-CONFORMANCE PROCEDURE AT TERUMO BCT VIETNAM COMPANY LIMITED Student’s name: LE QUYNH TRANG Student’s ID: 17124212 Course: 2017 Major: INDUSTRIAL MANAGEMENT Instructor: MBA NGUYEN THI ANH VAN Ho Chi Minh city, June 2021 INSTRUCTION’S EVALUATION Tp HCM, date … month……year.… Instructor (signature and full name) i THESIS COMMITTEE'S EVALUATION Tp HCM, date …month…year…… Reviewer (Signature and full name) ii THANKS Author honestly thanks Terumo BCT Vietnam limited company for giving me opportunity to have a useful and memorable intern period Especially, author was graceful for enthusiastic supporting the Innovation & Development team Thank Mrs Nguyen Hoang Nhu Uyen, Supporting Product Engineering always helped and instructed author Thank Mrs Nguyen Hoang Nhu Uyen was whole-hearted to give tasks and train author to them well and learn many good lessons Thanking to them, author had more passion in quality field and define again my objectives and career path Author also thanked lecturer Nguyen Thi Anh Van for giving me a lot of meaningful advice and instructing right direction to research and complete this graduation thesis Besides, Author wants to give gratefulness to all lectures teaching industrial management in Ho Chi Minh City University of Technology and Education HCM City, date …month…year…… Student LE QUYNH TRANG iii GLOSSARY Abbreviation AQL CA CAPA CFT FL FMEA I&D Meaning Acceptance Quality Level Containment Action Corrective Action Preventive Action Cross Functional Team Flow line Failure Modes Effects Analysis Innovation & Development IPI In Process Inspection IR Irregularity Report NC Non-conformance P/N Part number PIC Person in Charge PQA Process Quality Assurance QC Quality Control QE Quality Engineer QRQC Quick Response Quick Control RQA Receiving Quality Assurance SCA Supplier Corrective Action SOP Standard Operating Procedure SQA Supplier Quality Assurance WH Warehouse WIN Work Instruction iv WIP Work In Procedure v DIRECTORY OF TABLE Table 2.1: Detectability ranking criteria 14 Table 2.2: Severity ranking criteria 14 Table 2.3: Occurrence ranking criteria 15 Table 2.4: Definition of risk 16 Table 2.5: Definition of risk management 17 Table 3.1: Relate Functional Responsibilities 23 Table 3.2: The Flow Chart steps Non-conformance implementation 26 Table 3.3: WIN Correction Plan 43 Table 3.4: WIN Disposition 44 Table 3.5: Time the form completion 46 Table 3.6: WIN the reaction plan for material issue 57 Table 3.7: Guide worker’s and don’t task 60 vi DIRECTORY OF FIGURE Figure 1.1: Terumo BCT Viet Nam Limited Company at Long Duc industrial park Figure 1.2: TBV Organization chart Figure 2.1: Internal and External Customer Figure 2.2: Design FMEA Worksheet 11 Figure 2.3: Process FMEA Worksheet 12 Figure 2.4: FMEA process 13 Figure 2.5: Risk Management Process 18 Figure 2.6: Risk management Check sheet 21 Figure 3.1: Good and No good Y-Connector components 29 Figure 3.2: Y-Connector in drawing 30 Figure 3.3: Appearance check machine 32 Figure 3.4: Connecting tube by cyclohexanone 33 Figure 3.5: Quick Respond Quick Control Form 36 Figure 3.6: Irregularly form 37 Figure 3.7: NC description form 39 Figure 3.8: Bracket and containment action form 41 Figure 3.9: Y Connector NC form 48 Figure 3.10: Embedded and Loose debris 49 Figure 3.11: Y Connector Bracket& Containment Action 51 Figure 3.12: Y Connector Risk, Quality Impact assessment 52 vii TABLE OF CONTENTS INSTRUCTION’S EVALUATION i THESIS COMMITTEE'S EVALUATION ii THANKS iii GLOSSARY iv DIRECTORY OF TABLE vi DIRECTORY OF FIGURE vii TABLE OF CONTENTS viii PREAMBLE 1 Reasons of subject selection Research objectives Research scope and subjects Research methodology Report structures CHAPTER 1: GENERAL INTRODUCTION ABOUT TERUMO BCT VIETNAM CO., LTD 1.1 Overview about Terumo Company 1.1.1 General introduction about global Terumo Company 1.1.2 Introduction about Terumo in Vietnam 1.1.2.1 Established history and development of TBV 1.1.2.2 Corporate mission and vision 1.1.2.3 Core Values 1.1.3 Organization chart CHAPTER 2: THEORETICAL BASIS 2.1 Quality 2.2 Quality Management 2.3 Failure mode and effect analysis (FMEA) 10 2.3.1 FMEA definitions & terms 10 2.3.2 FMEA methodology 12 2.4 Risk Management 16 2.4.1 Definition of risk 16 2.4.2 Definition of risk management 17 viii More than 80% of components used in Trima are outsourcing Even though all materials must be passed an incoming inspection with AQL 2.5, production still find some issues related to materials The failure modes are variable that make IPI worker could not confirm it is a defect or not Then IPI worker will escalate to higher level (QE, supervisor…) for confirmation Normally it will take time to clarify (open IR, NC, even CAPA…), or IPI workers could not get support from higher level timely in night shift That could cause production downtime for waiting IPI worker clarify the issue  Human error TBV is a manufacturing plant of medical equipment, thus product quality is one of the most important policies Products created in each stage are checked carefully by the implementers and IPI staff, but according to the statistical results, human error is always among the top errors in TBV and tends to increase So, this is a risk in the product implementation process 4.2 Solutions 4.2.1 Create to task list Solution rationale: Depend on the first limitation about waiting time for completing the, the author recommends for sorting priority tasks by creating to task list Person in charge: Everyone Content conducting: Manufacturing will certainly have lots of urgent projects on a daily basis needing the employee to handle workweek, thus, the workload is also duplicated As people know, NC status may occur workaday, hence people are also skilling with the NC manipulation and procedure However, the issue is that taking a bit of time to review the filled information form and then intend to approve Here are steps that the author recommends to mitigate the first limitation:  Order your current task list: 55 The CFT should have a to list in front of the working desk or set up on the computer and combine with a remainder due Normally, before the owner opens a NC report, someone has organized a meeting with CFT to discuss this issue This is a reason that CFT can firstly review their to tasks list In addition, the owner can leverage the previous NC reports regarding the current failure mode or the things classified by reviewed CFT in accordance with their desire It can reduce the significantly classified time (if any) Effective of solution: It can reduce the significantly classified time NC report will be resolved quickly according to listed NC actions This mean will save time product bracketing, storage area and disposition of these product 4.2.2 WIN reaction plan for material issue The second recommendation that is the Quality Engineering (QE) should have a training to train for all of production responding better This recommendation is presented to respond to 2nd limitations - Purpose: When producing finds an abnormal material that requires IPI clarification, the IPI worker must contact to a higher level than usual Pending confirmation from higher levels, IPI will work with the manufacture of anomalous material grades to maintain production operations The purpose of this action is to instruct an TMP reaction plan, which provides guidance to the IPI unit isolating material/ abnormal WIPs/ FGs while awaiting inspection/ confirmation/ action from high parts than the other - Scope: Abnormal issue which can be detected by visual inspection with naked eyes - Person in charge: Quality Engineering - Responsibility: Production supervisors, leader, trainers must be trained and follow this instruction properly - How to conduct? This is a Flow Chart to follow: 56 Table 3.6: WIN the reaction plan for material issue Step Flowchart Description Abnormal found, start of procedure Stop line Identify the impact material/WIP Production SQM PQA QE R I I I R I I I R I S I R I I I I I I R R S S I R I I I R I I I R S R I N/A N/A N/A N/A Inform CFT No Risk assessment Yes Training for sorting Sorting Segregate the normal/ abnormal Call QRQC meeting & follow NC procedure 10 Close (Source: Edited and Collected Author) R- Responsible, A- Approver, S – Supporting, C – Consulted, I – Informed, N/A – No Applicable - The below description will clearly present about this Flow Chart: 57 The abnormal found When any abnormal found in production area which could cause stop production line, Production will start this procedure Stop line Supervisor will inform to operators stopping line Identify the impact material/ WIP Production will identify impacted materials/ WIPs by inform to all leaders and supervisor at impacted areas Then leaders and supervisor will check all other production lines for: + The using material have abnormal or not + Quantity of WIPs which were produced by abnormal material lot Inform CFT Production will inform CFT (SQM, QE, PQA) about the case by using Irregular Form (IR) or by email depend on the case Risk assessment - Production will identify risk level for impacted material and divide into: + High risk: transfer to step + Low risk: consider for next procedure Training for sorting Leader/ Supervisor/ Trainers should fill IR number (if any) and other information in Reaction Training Form), then provide training to sorting operators - Operators who are assigned to sorting must be trained before they start - In training document must present clearly two problems: + Tolerance accepted error + Tolerance abnormal error Sorting 58 Leaders/ Supervisor set up the sorting station depend on the actual situation Operators start sorting to segregate the abnormal and normal material/ WIP Recording sorting in Form Segregate the abnormal and normal The abnormal material/ WIP will be put on hold waiting for confirmation from CFT The normal material/ WIP will be used as normal QRQC meeting & follow NC procedure CFT refer to Non-conformance Procedure to conduct the QRQC meeting 10 Close  Effective of solution Creating temporary response plans addresses a lot of quality related issues raw materials in case of night shift or no one in charge of the issues quality of raw materials Because Quality Engineer and Quality Higher level work during office hours IPI workers track the change and having authority to make decisions when arise problems 4.2.3 Training for IPI worker Solution rationale: Depend on the third limitation about human error, the author recommend that the relate function team hold training course for workers Because during the manufacturing certainly will happen arise problems Therefore, all of this training will help workers make sure what they need to do? In that, the important thing is the trainer must guide throughout and deliveries a speech easily If they were trained fully, they would defect precisely issues, enhance working – experience As mentioned in good points, factors about human is extremely important, thus resolve the human problems will reduce so much relate wastes, improve product quality However, the human errors only decrease the lower without completely annihilated Person in charge: Training and Quality Section, Manufacturing Supervisor, IPI worker Supervisor Conducting content: 59 - Manufacturing Training Section combine with Quality Section hold a training for employee and workers in clean room and meeting room - Training content: Train for workers and IPI staff, what they should and shouldn't Training time about 45 minutes for theory, 75 minutes for practice Repeat time months / time Table 3.7: Guide worker’s and don’t task Shouldn’t Should Do not make self-willed change work Strictly steps follow the public job instructions No subjective evenly for the familiar Read work instructions before operation because errors can occur in performing no matter when Don't trust your memory Please read Always pay attention throughout and adhere to work instructions working period Don't believe in experience because Inform to Supervisor if found or have errors can be caused by the most any problem in working process experienced members Evenly whether you think a problem that needs improvement Training for IPI: If IPI detects any no workers follow the process or subjective no compliance should be separated from the working location and conduct re-training Training methods: Changing training methods for workers, instead of only training through the process by words and please letting them sit and listen, it will create a feeling bored and hardly absorb the problem The Training Department shall add pictures and videos to the training process, this will help workers visualize the problem that the Training Department want to delivery to on our own In the job instructions board should add pictures of the type common mistakes at the stage they do, and critical errors have been put into NC to they can identify the error, pay attention to it, and not repeat the same error 60 The production and quality management department discusses and make decisions about the IPI employee responsibilities and scope Clear division of responsibilities IPI staff will help them focus on the primary tasks, the workload Then, it improves and decreases the number of employees and cost for the quality department 4.2.4 Increase the AQL index for incoming inspection Solution rationale: The current procedure in TBV of sample size determination at incoming inspection is controlled by AQL index Almost NCs is occurred on a daily basis in manufacturing, it comes from a variety of different sources including materials etc Thus, the author wants to recommend a proposal that it should be increasing the AQL index This can help tighten once any abnormal things This proposal intends to normal inspection level This mean, normal inspection will be used at the start of inspection unless otherwise directly by the responsible authority For example: You initially apply an AQL of 6.5 for minor defects to an order of 400 tablet PCs you’re importing This corresponds to an acceptance point of minor defects for a sample size of 50 units Then multiple QC inspections have all found or minor defects in the sample, which you decide is actually too many You could raise your standard, tolerating only or fewer minor defects in the future, by changing your AQL for minor defects to 4.0 (Source: George Huan, 2018) Person in charge: RQA Content conducting: The material will not be pushed for inspecting 100 percent for all of this, partly it is also due the huge quantities and it will be much more costly and time-consuming, thus sample size is a vital factor To determine the present sample which is tested is also a big deal Here are the proposal by the author: According to the solution header, when increasing the AQL index, this deem to be the worst acceptable level will be reduced in total sample size But how to implement this change to apply for plant: Statistic the abnormal 61 The RQA team or regarding division should trace history data and quarterly statistic failure mode from input materials or the NC report statistic are created due to material errors Working with the supplier Current supplier New supplier - It may tighten the AQL standard if - Changing the quality standard, it means will be higher than normal There make the number of defects brought into being previous accepted shipments doesn’t fit you sure will not eliminate 100% defect but your it can be an acceptance limit, eventually just assure quality expectations - Make a compromise with both parties - Clear conversation with the new supplier about being your expected about updating the new AQL index AQL standard with supplier prior to for QC inspection - In case, if the defective material incur production to make sure product quality many batch No., It should propose expectations and enclose your request that they ought to inspect and validate about purchase order is clear upfront their process again to determine any - Discussing AQLs with your supplier in advance also ensures your supplier can problems impact or change in their actually fulfill your requirements process Otherwise changing the new supplier Conduct the changing implementation plan In this step, we need to do: - Execute the change request: this action is to request the change and will be assessed and approved by CFT - Execute the change notice: this action will manage the implementation plan for changing - Update the regarding document 62 When all of the document is finalized and effective, the manufacturing can apply this change onward Effective of solution: - Inspected unit quantities in each batch No will be fixed - This can help business have higher reliability and confidence for releasing this component in production also higher There also reduces failure mode in produce and helps the defected materials less 63 CONCLUSION Quality of goods and/or products is the most critical in manufacturing medical devices, especially blood bags because of in-person affect to user needs It is hard to avoid the whole issues regarding quality in process steps at different locations in the production process Thus, In- Process and incoming Inspection have an very important role about product quality assurance in manufacturing also output design In addition to, it will be have lots of happened issues during manufacturing This graduation thesis about "Analyze the Non-conformance procedure at Terumo BCT Vietnam company Limited" showing an overview picture about inspection activities and how to manage Non-conformance in medical devices manufacturing company In this report, the author showed own knowledge and a bit experience about quality and NC procedure of Terumo BCT Vietnam limited company Graduation thesis is chance for me to research and have various viewpoints about Quality field such as pFMEA and dFMEA Application, Risk Assessment, Impact Assessment, Sampling Plan, Quality Control, Quality Assurance, In Process Inspection activities with comparison between theory and reality After all I have overall viewpoints about inspection activities in manufacturing area and could give some recommendations, solutions for reduce the non-conformance and/or abnormal thing will be better with more resource, detail analysis to complete by TBV in the future 64 APPENDIX Table 1: Risk Assessment Matrix Severity Negligible Moderate Serious Critical Catastrophic Probability Likelihood Frequency or Predicted 65 LIST OF REFERENCES Online Browsing Platform (OBP) Organization (2009) Iso 31000:2009 (en) Risk management — Principles and guidelines Retrieved from iso.org: https://www.iso.org/obp/ui/#iso:std:iso:31000:ed-1:v1:en Quaity-One International (n.d.) 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