Handling Quarantined Material flow chart
Reasons of subject selection
Effective quality management is essential for sustainable business development, ensuring the delivery of superior products and services that meet user satisfaction My aspiration to work in this field stems from a desire to enhance community quality of life I have had the opportunity to study quality management and supplier quality management procedures at Terumo BCT Vietnam Limited Company, which has a commendable supplier quality management system, though it faces some practical limitations Consequently, I am conducting research on the "Analysis of the Current Situation of Supplier Quality Management at Terumo BCT Vietnam Limited Company" to propose solutions that address these limitations and enhance the overall supplier quality management process.
Research objectives
- To understand about supplier quality management procedure of the medical device manufacturing company
- To analyze SQM procedure and evaluate good points, limitations of its implementation
- To recommend some suggestions to improve effectiveness of implementation procedure from an industrial management student outlook.
Research methodology
Research scope
- Research issue: SQM procedure and implementation
- Research time: from May 23th May 2018 to 8th January 2019.
Final thesis structure
- SQM procedure description and analysis to help readers clearly understand it
- Evaluation about good points and limitations about reality situation to learn by experience and have enormous valuable lessons about standard SQM procedure
- Suggestion of seven solutions to help the SQM improve effectiveness
The author must possess keen observational skills and conduct thorough research, engaging with SQM team members to discover intriguing insights Following this, the author drafts an outline and proposal, seeking approval from the team Subsequently, the author formulates evaluations and solutions to ensure the thesis is comprehensive and robust.
Problem solving methodology: determining root causes of problems and researching, finding out methods, proposals and tools to improve the present situation of SQM team
INTRODUCTION ABOUT TERUMO BCT VIET NAM LIMITED
Established history and development of TBV
Terumo BCT Viet Nam (TBV) limited company which belongs to Terumo Corporation founded in 1921 has had about 100 subsidiary companies to now
Terumo BCT, a leading global medical device manufacturer based in Lakewood, Colorado, has expanded its production capabilities with the opening of a new facility in Vietnam This strategic move allows Terumo BCT to manufacture its products in seven countries, including Belgium, China, India, Japan, Northern Ireland, the United States, and now Vietnam.
The factory will produce whole blood bags and disposables for automated collections Once fully staffed, the building is expected to accommodate more than 900 new associates
The completion of the new manufacturing facility underscores our dedication to customers worldwide, enhancing global capacity and advancing manufacturing techniques This facility in Vietnam will significantly improve product speed to market and strengthen our ability to meet customer needs, according to Craig Rinehardt, executive vice president of global operations at Terumo BCT.
Operation year: on July 14th
Nation of investment: America and Japan
Vision: Working together for better lives
Mission: We improve lives through innovation, quality and services enabled by our blood component
Address: A6, Long Duc Industrial Park, Long Thanh town, Dong Nai province
Figure 1.1 Terumo BCT Viet Nam Limited Company at Long Duc industrial park
Source: “Terumo BCT launches $100 million FDI facility near HCM City”, America
Function and business
Terumo BCT Vietnam, a part of a global leader in blood component and therapeutic apheresis technologies, serves customers in over 130 countries The company uniquely combines apheresis collections, whole blood processing, and pathogen reduction, believing in the untapped potential of blood to enhance patient care This conviction drives their innovation and collaboration with customers, as they strive for better lives by unlocking blood's potential Committed to being a responsible corporate citizen, Terumo BCT conducts its business to deliver social, environmental, and economic benefits Their dedication to discovery fuels a passion for innovative thinking, supporting education and research through community involvement and grants to improve treatment options They understand the significance of their work in advancing healthcare and are devoted to ensuring the availability of lifesaving blood worldwide while exceeding the expectations of their customers and the patients they serve.
Core product
Two main products TBV contribute to the society are blood bags and trima
Figure 1.2 One type of blood bag product (Collected picture)
Figure 1.3 Trima kit (collected picture) Core product manufacturing technology process:
Figure 1.4 Blood bag manufacturing process
Source: Company document, Blood bag manufacturing process
Figure 1.5 Trima Manufacturing process flow
Source: Company document, Trima manufacturing process
Management organization
Source: Company document, New associates onboarding, page 6
Function and responsibilities of each department
- Quality: ensuring and managing production activities and other activities in company bases on finished goods standard especially quality management system, ISO which the company committed and business‘s objectives
-Regulatory Affair (RA): help the company complete transition to ISO 13485: 2016, support milestones and successful TBV FDA inspection and Vietnamese regulatory
- Technical: release the new process, method and so on
Package Tranfer to WH Tray seal
Quality RA Technical SCM MKT Productio n
Project EHS ME GA IT FN
Supply Chain Management (SCM) involves the strategic planning of manufacturing and delivery schedules, coordinating the procurement of products and services requested by various departments, managing inventory effectively, and ensuring that goods are delivered with the right quality and timeliness.
- Marketing (MKT): person in charge of this department is a Japanese who takes responsibilities for expanding market
- Production: manufacturing required blood bags and trima quantity and quality
- Project: managing projects such as FDA inspection, factory expansion and so on
- Environment Health Safety (EHS): ensuring the whole company not happen incident and labor accident
- Maintenance Engineering (ME): implementing maintenance method and ensuring all machine supporting production and other activities are available and safe
- General Affair (GA): appointing responsibilities for canteen, good service, transportation, health care, health service, uniform, laundry and so on
- Information Technology (IT): support other departments solve problem software, hardware and system troubles and provide computing facilities according to policy of the company in order to protect confidential information
- Finance (FN): planning and implementing the optimal finance strategy and necessary specialist skill
Human Resources (HR): building personal policy and plan, recruiting employee, training, monitoring employee performance
Every department plays a crucial role in an organization, and their collaboration is essential for successful process implementation For example, the evaluation of suppliers becomes ineffective and inaccurate without the cooperation of the supply chain, finance, and quality departments.
Development strategy and direction of TBV
The company plans to expand its operations by constructing a new factory, significantly boosting its global supply of products, particularly blood bags This expansion is expected to increase the workforce by 1,000 employees, growing from 1,500 to 2,500 between 2017 and 2019.
Lately the company is making great effort to reach FDA standard to export blood bag and trima to America
Introduction about quality department
Because products of TBV are implantable medical device seriously affecting to human health so that quality department is organized professional and conform ISO 13485:
2016 Organization chart of quality department:
Chart 1.2 Organization chart of quality department
Source: Company document, Organization chart
Organization chart of supplier quality management team
- Involve in planning, selecting, evaluating new supplier
- Defined the method , equipment for first article inspection
- Developing supplier in term of increase quality, reduce cost
CAPA handling- For Escalation CAPA
Measurement method and equipment validation
- Confirm the abnormal detected by production,
- Providing the solution…ex, change trace, sorting
Release new supplier/part in the system
- Issue report, release in SAP
Sorting when material detect problem
Handling the Nonconformance material in labeling
Method and equipment validation support
Chart 1.3 Organization chart of supplier quality management team
Source: Company document, Organization chart of SQM team
Supplier quality management (SQM) scope:
- Management external suppliers to ensure that purchased, subcontracted, or otherwise received products and services conform to quality requirements
- External suppliers: Supplier is not under the same Quality System internal quality audit => Internal supplier will not be scope of SQM (Material from this process to the other process)
- Quality requirement: All requirement can cause an effect on the quality, safety, and effectiveness of the finished device => All suppliers non-production will not be scope of SQM
SQM Function: Incoming inspection, Supplier Performance Monitoring, Supplier Corrective Action/ CAPA, Supplier Improvement, Supplier evaluation and approval
THEORETICAL BASIS
Quality
Quality in manufacturing is defined as a state of excellence, free from defects and significant variations, achieved through a strict commitment to standards that ensure product uniformity and meet customer requirements According to ISO 8402-1986, quality encompasses the totality of features and characteristics of a product or service that fulfill stated or implied needs For instance, if an automobile company discovers a defect and issues a recall, it can lead to a decline in customer trust and reliability, ultimately impacting production negatively.
Quality management
Quality management involves overseeing all activities necessary to achieve and maintain a desired level of excellence, as defined by Investopedia in 2018 This process encompasses the establishment of a quality policy, the creation and implementation of quality planning and assurance, as well as quality control and improvement Often referred to as total quality management (TQM), it aims to enhance overall organizational performance.
Quality management plays a crucial role in enhancing business partnerships by contributing to New Product Introduction (NPI) processes, which leads to higher success rates, increased customer satisfaction, and better financial outcomes While quality management is not directly responsible for manufacturing, its effective involvement in production planning and execution significantly boosts Overall Equipment Effectiveness and ensures timely delivery Additionally, monitoring Defective Parts Per Million (DPPM) is essential for maintaining product quality and operational efficiency.
Quality Symbiosis: Those that adopted processes that integrate quality across design, manufacturers and suppliers saw benefits for all
Quality management encompasses the development and execution of a quality policy, along with quality planning, assurance, control, and improvement Often referred to as total quality management (TQM), it aims to uphold a desired level of excellence, enhance customer satisfaction, and boost financial performance.
Supplier quality management
In 5 Key Metrics of Supplier Quality Management Plus 4 Steps of the Supplier Evaluation Process document, 2018, supplier Quality Management (SQM) shows a supplier‘s talent in the delivery of goods or services to satisfy a buyer‘s needs It seeks to ensure units ‗fit‘ to buyer‘s demands with no or little use of minimal inspection and adjustment.
Supplier quality assurance
Supplier Quality Assurance (SQA) is a collaborative process designed to ensure that suppliers consistently deliver goods or services that meet customer requirements By focusing on meeting agreed-upon standards, SQA aims to minimize the need for inspection or modifications, enhancing reliability and satisfaction.
Achieving quality requires dedicated effort, meticulous attention to detail, and adherence to established quality assurance principles This commitment must be paired with a genuine desire for excellence and the cultivation of an environment that fosters quality.
Quality assurance is more than a program; it is a philosophy, a way of life
Quality assurance, when treated solely as a mechanical program, is likely to fail; however, when embraced as a philosophy, it holds potential for success By integrating both the structured approach of a program and the insightful nature of a philosophy, organizations significantly enhance their ability to produce high-quality data.
The quality assurance process in a standard production workflow is depicted in Figure 1.2 It is essential to leverage experience to determine the necessary level of control required to ensure products meet the desired quality standards.
Random samples of the output are tested against specifications to determine whether to accept or reject a production lot, or to implement corrective actions in the process.
Figure 2.2 Production process quality assurance
Source: Taylor, John K (John Keenan), 1912
In his work, Taylor, John K emphasizes the significance of quality assurance in measurement processes, as depicted in Figure 1.3 Quality control procedures are essential for tuning and maintaining the system in a state of statistical control, ensuring it can produce an infinite number of measurements from any material, with the current data representing a typical sample Additionally, quality assessment procedures are implemented to evaluate the quality of the generated data.
Figure 2.3 Measurement process quality assurance Source: Taylor, John K (John Keenan), 1912
Evaluating the quality of data on unknown test materials is inherently challenging However, by maintaining the measurement system in statistical control and concurrently measuring known samples like reference materials (RM), we can effectively compare the results to reference values This comparison serves as a valuable method for assessing data quality.
12 performance of the measurement system and permit inferences to be made on the quality of the data for test samples
It should now be evident that statistics is an integral part of quality assurance In fact, what has really been discussed here is statistical assurance of quality
Effective quality assurance integrates both process and product audits, emphasizing the management of external and internal checks, supplier management, and product quality conformity throughout its lifecycle This article provides an overview of the Software Quality Assurance (SQA) process and highlights essential factors influencing its effectiveness, focusing specifically on product-related processes while acknowledging that SQA also applies to services.
Supplier Quality Management (SQM) encompasses the essential processes of selecting suppliers, fostering collaboration, monitoring performance, and driving continuous improvement While various industries may have specific requirements and variations in their SQM practices, they commonly utilize fundamental processes such as managing waivers and addressing Non-Conformances (NCs).
Supplier Correction Action Reports (SCARs), and Supplier Audits Supplier scorecards may be used to rate supplier performance and identify supplier risk
The Production Part Approval Process (PPAP) is increasingly adopted across various industries to verify that suppliers can consistently deliver products that meet established quality standards and production volumes This process plays a crucial role in identifying control measures necessary for maintaining product integrity.
Characteristics (CCs) is embedded in this process
Effective identification and monitoring of critical characteristics (CCs) is essential for manufacturing and engineering leaders aiming to enhance quality during the development process To facilitate secure communication of sensitive quality data, many companies are turning to supplier portals.
The dynamics of contract manufacturing have evolved significantly over the years, with suppliers increasingly engaging in the customer's New Product Introduction (NPI) process This shift often includes a more active role for suppliers in full product development and manufacturing outsourcing.
Quality control and quality assessment
Quality assurance consists of two separate but related activities: quality control and quality assessment Both must be operational and coordinated
The following definitions are offered
A quality assurance system is a set of activities designed to ensure that a product or service meets established quality standards, providing both producers and users with confidence in its reliability and performance.
Quality control encompasses a comprehensive system of activities designed to ensure that a product or service meets user requirements Its primary goal is to deliver quality that is satisfactory, reliable, and cost-effective.
2.5.2 Quality assessment: The overall system of activities whose purpose is to provide assurance that the overall quality control job is being done effectively
It involves a continuing evaluation of the products produced and of the performance of the production system Taylor, John K (John Keenan, 1912)
Balance Scorecard
Management practices aim to enhance traditional performance metrics by integrating future performance drivers, including customer satisfaction, human and intellectual capital development, and organizational learning However, standard balanced scorecards often overlook environmental factors This approach was introduced by Robert Kaplan and David Norton in 1996, aligning with the balanced scorecard definition provided by BusinessDictionary.
Quality promotion strategies
In qualitative research, two key strategies enhance the rigor and quality of the study: ensuring the authenticity of the data and the trustworthiness of the analysis These strategies closely parallel the concepts of validity and reliability found in quantitative research.
2.7.1 Authenticity of the data: refers to the quality of the data and data collection procedures Elements to consider include:
Sampling approach and participant selection to enable the research question to be addressed appropriately (see ―Selecting Participants‖ above) and reduce the potential of having a biased sample
Data triangulation involves utilizing various data sources to gain a more comprehensive understanding of the phenomenon under investigation This approach includes conducting interviews with both residents and faculty, as well as incorporating multiple residency sites and disciplines to enrich the analysis.
For sensitive topics, individual interviews are typically more suitable than focus groups, as they allow for a more in-depth exploration of the subject matter while respecting the participants' privacy and comfort.
Using interview and other guides that are not biased or leading, that do not ask questions in a way that may lead the participant to answer in a particular manner
The relationships between researchers and their study participants must be clearly defined, particularly in cases where a faculty member asks their own residents to take part in research This situation raises concerns about potential coercion, highlighting the need for transparency in the research process to ensure ethical participation.
To ensure the integrity of the data collected, researchers and team members must openly acknowledge their own biases and beliefs regarding the phenomenon being studied When necessary, employing a neutral third-party interviewer can help mitigate the influence of these biases on the research outcomes.
Trustworthiness of the analysis refers to the quality of data analysis Elements to consider when assessing the quality of analysis include:
The analysis process should be clearly outlined, detailing the roles of team members, the actions taken, and the timing and sequencing involved It is essential to explain how data codes or categories were developed, ensuring that the process adheres to best practices Additionally, a comparison of findings within and among transcripts should be included, along with the use of memos to document key decision points throughout the analysis.
Procedure for resolving differences in findings and among team members: this needs to be clearly described
Process for addressing the potential influence the researchers' views and beliefs may have upon the analysis
Use of a qualitative software program: if used, how was this used?
Five Key Metrics of Supplier Quality Management Plus four Steps of the
2.8.1 Five Key Metrics Used for Scoring SQM (from LNS Research)
The cost of quality is a crucial metric that evaluates the expenses involved in producing a quality product, categorized into good quality and poor quality costs Understanding the cost of quality definition, along with insights from enterprise quality management software, is essential for effectively measuring these metrics and improving overall product quality.
Overall Equipment Effectiveness (OEE) is a crucial metric that enhances visibility in key operational areas by employing the formula OEE = Availability × Efficiency × Quality This metric assesses the frequency with which an asset is available for production when it should be, as well as its capability to produce goods close to the theoretical maximum Additionally, OEE evaluates the percentage of products that meet quality specifications, providing a comprehensive view of operational performance.
In regulated industries such as medical devices, biotechnology, pharmaceuticals, food and beverage, automotive, and aerospace and defense, the compliance percentage of products is a critical metric This measurement reflects adherence to government regulations and internal guidelines, indicating the proportion of compliant products Given the constantly evolving compliance landscape, many companies face challenges in maintaining up-to-date compliance data.
Ensuring complete and on-time shipments is crucial for maintaining product quality and timely delivery While this metric may seem straightforward, companies employ various methods to measure it According to LNS Research, it is defined as the percentage of products delivered fully complete and on schedule.
New Product Introduction (NPI) is a crucial metric that measures the percentage of new products achieving volume, quality, and time objectives In competitive sectors such as consumer electronics and automotive, successfully launching new products is essential for gaining a competitive edge A company's profit growth is closely tied to its ability to manage new product introductions while consistently meeting NPI goals.
Executives are provided critical insight through the five key metrics into their supplier‘s financial and operational performance
2.8.2 Four Steps of the Supplier Evaluation Process
Step 1: Evaluation of Risk Criteria
To effectively compile your supplier risk portfolio, it's essential to conduct individualized risk assessments that evaluate each supplier's performance through various methods Globalization has transformed traditional on-site audits, making them costly unless suppliers are strategically located near one another An alternative approach is to implement a supplier quality agreement that stipulates the provision of data reports and audits on request or at designated times throughout the contract duration.
SQM plays a crucial role in the total cost of quality, prompting firms to incorporate Enterprise Quality Management Software (EQMS) into their solutions Integrating EQMS with suppliers and, where feasible, with their suppliers through shared web portals enhances real-time visibility and continuous performance evaluations However, this level of integration may seem excessive for smaller businesses that value their independence from larger corporations.
Supplier risk can be quantified through two main variables: the likelihood and impact of adverse events By evaluating performance indicators such as average response times for corrective actions, MRB inventory levels, delivery times, and customer complaints, suppliers can be rated comparatively Supplier Quality Management (SQM) significantly enhances this process by recording and providing access to data within its software, enabling firms to assess the probability of supplier failures in a standardized manner.
The second risk variable, impact, is heavily influenced by a supplier's importance to production and their final product Suppliers without substitute materials should be classified as high-risk, regardless of their performance levels If reliance on such a supplier is necessary, ensure it has significant weight in your risk portfolio; conversely, if the supplier is less critical to continuity, assign it a lower risk level.
When defining a strategic vision, it is crucial to consider Supplier Quality Management (SQM) as it allows for the quantification of supplier risks, enabling the prioritization of critical issues By treating external risks with the same importance as internal inefficiencies, organizations can implement closed-loop Corrective and Preventive Actions (CAPA) or deviation management techniques This approach not only mitigates supplier risks but also reduces the likelihood of future incidents.
Prioritize based upon risk (including time since last audit)
Pick the top five highest risk suppliers and schedule audits throughout the year
Hire another SQE for every fifteen suppliers that require onsite auditing
Step 3: Review of Supplier Audit Frequency
Manufacturer audits are primarily for control purposes and do not need to be repeated unless persistent issues arise that the supplier fails to address It is advisable to conduct annual audits of the top five suppliers, either by your team or through a subcontracted auditing firm Additionally, unplanned audits can provide valuable insights into a typical production day at the supplier's facility.
A key area is insuring a top management focus that is knowledgeable and understanding of the quality/auditing process across industry type Review their
Establishing a quality budget and an effective organizational structure is essential for achieving goals related to quality management It is crucial to identify who oversees quality initiatives, ensuring ongoing training and education, as well as maintaining an up-to-date Supplier Quality Manual The audit process should prioritize a balanced scorecard that measures cost, quality, and timeliness to drive continuous improvement.
SQM Programs‘ Evaluation of Suppliers Summary
To achieve efficient supply base optimization, companies must implement a comprehensive set of criteria that extends beyond mere cost considerations This includes adopting a risk-based approach to assess the criticality of each supplier and their potential for failure For sustained success in supplier quality metrics, it is essential to utilize audit tools and standardized risk applications within an enterprise system.
Best Practices in Supplier Quality Management
Manufacturing has significantly changed over the past decade and will continue to evolve In today's fast-paced business environment, leaders must adapt to emerging strategies to maintain a competitive edge.
Many of today‘s business pioneers are executing supplier quality management techniques to help answer some of the questions below
How do you hold quality issues under control when dealing with many suppliers? How do you figure out whether these suppliers are meeting quality standards?
How do you decrease quality expenses?
In light of these questions, we want to discuss seven best practices to consider for supplier quality management
Measure the Cost of Poor Supplier Quality
If item quality issues emerge, it is regularly the manufacturer who bears the cost of poor quality (COPQ), although the fault may lie with suppliers
According to an article by CIOReview, historical data and expert insights reveal that quality can influence 30 to 70 percent of a product's final cost Despite the substantial impact of these expenses on income, many organizations fail to consistently track and measure them, leading to ongoing losses due to low-quality outputs without a clear understanding of how to recoup these costs.
When assessing the cost of poor quality for suppliers, it is essential to evaluate both external and internal cost factors Companies that invest more resources in ensuring high quality experience fewer supplier quality problems, resulting in a reduced cost of poor quality.
Have Better Visibility Access into Supplier Quality with Technology
In today's expansive global supply chain, organizations struggle with limited visibility into supplier quality Leveraging technology to centralize supplier information can significantly improve this situation, as it allows for the mapping of each supplier to relevant product risks, issues, policies, and controls This comprehensive view of supplier quality enhances accountability and traceability, effectively addressing any emerging problems.
Technology enhances quality management by automating workflows and improving efficiency Advanced tools, such as mobile auditing applications, allow auditors to easily record their findings at remote supplier locations, even without internet access.
Support Supplier Risk Management with Quality Audits
In today's competitive business landscape, quality audits of suppliers are essential for ensuring compliance with high quality standards Instead of auditing all suppliers simultaneously, it's more efficient to categorize them by risk level and prioritize audit activities accordingly High-risk suppliers, critical to product quality and availability, necessitate more frequent on-site audits to verify their quality controls and measures Conversely, lower-risk suppliers, which have minimal direct impact on products, require fewer audits.
To effectively measure supplier quality performance, companies should implement a standardized set of supplier metrics and key performance indicators (KPIs) that are relevant across all departments This approach provides a comprehensive view of supply chain quality trends, highlighting areas that require attention and opportunities for investment and growth According to a study by McKinsey.com, nearly 40 percent of supplier quality issues stem from inadequate quality systems lacking well-defined KPIs.
Organizations utilize supplier scorecards to evaluate and rank supplier performance within the supply chain These tools are essential for monitoring supplier quality, identifying failures, and tracking improvements over time Additionally, fostering a collaborative approach to corrective action is crucial for enhancing overall supplier performance.
Timely resolution of supplier non-conformances and quality issues is crucial for optimal performance Establishing clear roles and robust internal processes is essential for initiating a Supplier Corrective Action Request (SCAR) to effectively implement preventive and corrective measures.
Issues frequently emerge when supplier corrective action requests are tossed at suppliers with no support or guidance, causing confusion and an ineffective response
A good approach is to collaborate closely with suppliers at each level, giving them details about the issue or non-conformance, and recommending appropriate corrective action with some suggestions
Justify Suppliers for Better Quality Control
Managing supplier quality becomes increasingly complex and costly as supply chains expand To address this challenge, optimizing the supply chain is essential, as it can enhance order, efficiency, and control in supplier quality management This process of supplier rationalization helps determine if the number of suppliers is appropriate and whether they possess the necessary capabilities to meet quality standards.
Supplier quality management goes beyond avoiding legal issues, expensive recalls, and penalties; it involves recognizing suppliers as an integral part of your business According to LNS, collaboration with suppliers ranks as the top or second highest concern across various industries.
Prioritizing the quality of suppliers as a key business function, aligned with comprehensive supplier relationship management, enables your organization to enhance overall performance, credibility, and quality across the enterprise.
Key Performance Indicator
A Key Performance Indicator (KPI) is a vital metric used to assess the effectiveness of specific activities or processes, serving as a benchmark to guide progress towards desired objectives.
Monitoring your newsletter's open rate is crucial, as it reflects the relevance and quality of your content By analyzing the percentage of recipients who open your newsletters, you can assess the effectiveness of your posts and make informed adjustments to meet your goals.
Concrete: The KPI should be tangible and it should have a specific goal
Measurable: If you can0t measure the KPI, it isn‘t a KPI
Reachable: Stay realistic when defining KPI that will determine your success
Relevant: Monitor only the things that really matter, don‘t waste time with indicators that do not contribute anything to your company
The most important KPIs in human resources
Talent retention is a key performance indicator (KPI) that reflects a company's job stability, providing insights into the average duration employees stay with the organization This metric is closely associated with various factors, including compensation and workplace culture.
High employee turnover not only incurs costs related to losing talent but also necessitates significant time and financial investment in recruiting new staff A high turnover rate indicates substantial expenses for employers To assess talent retention, compare the number of employees who joined the company within a specific timeframe to those who remained during that same period.
Employee turnover is often linked to the duration spent in the same position, as many individuals seek new opportunities when they perceive a lack of promotion prospects To assess this, companies can calculate the average time for advancement by dividing the total months employees have held similar roles by the number of employees in those positions.
Absenteeism is a key indicator that tracks employee absences due to delays, sick leave, and both excused and unexcused reasons By analyzing this data, businesses can forecast potential absenteeism rates and assess their impact on overall costs, based on the average value of hours worked.
The average recruitment time refers to the duration from when an employee departs to when a suitable replacement is selected While it is possible to streamline this hiring process, various factors must be considered to ensure effective optimization.
Investing in employee education and training directly enhances company performance by implementing targeted strategies that boost productivity This approach aims to elevate employee loyalty and satisfaction, fostering a more engaged workforce.
The Average Time to Achieve Goal KPI evaluates workforce efficiency by measuring the duration required for employees to complete specific tasks and objectives established for their roles within the organization.
Measuring workplace accidents is crucial for preventing future incidents and enhancing safety protocols By analyzing key indicators, organizations can identify trends and implement effective strategies to minimize risks and protect employees.
REALITY SITUATION OF SUPPLIER QUALITY MANAGEMENT
Supplier quality management procedure and its process map
Source: Company document, SOP for supplier quality management procedure, page 9
The SQM team consistently develops effective strategies to select and manage suppliers, ensuring they deliver high-quality products and services that meet all business needs while minimizing risks.
Supplier added to SAP system and ASL
Potential to impact product quality and/or safety?
3.1.2 Supplier quality management process map
Planning for New Supplier(s) Evaluation
Supplier Audit Supplier Release on System
Define what is to be obtained: specifications, part requirements, procedure, work instructions…
Identify potential suppliers, risk(s) and controls
Select potential supplier(s) based on investigation about their business and operational capability (logistics, quality, technical risks…)
Evaluate and make final decision (acceptable or not) for potential supplier(s) that meet specified requirements, including quality requirements
Define the type and extent of control to be exercised over product/services and supplier(s)
Establish checkpoints to monitor the supplier‘s performance and maintain records of acceptable suppliers
Communicate between manufacture and suppliers to resolve the problems or develop process, quality of product, services obtained from suppliers
SU P P LI ER Q U A LI TY M A N A GE M EN T (SQM )
Chart 3.2 Supplier quality management process map
Source: Company document, SOP for supplier quality management procedure, page
The SQM team established a rigorous procedure to ensure that all purchased, subcontracted, or received products and services meet specified requirements By achieving these objectives, the production and supply chain departments can operate smoothly, facilitating rapid company growth.
Process is very detailed owing to including all subsequent procedures to instruct employees do their tasks right
Effectively identifying and managing supplier risks involves tailoring strategies based on the risk level associated with the parts and services they provide Suppliers are categorized according to their risk levels, enabling businesses to implement appropriate risk management practices.
Level 1: may have a high direct impact on product quality or safety, regulatory compliance, or business continuity
Level 2: may have a moderate or indirect impact on product quality or safety, regulatory compliance, or business continuity
Level 3: may have a low risk of impact on product quality or safety, regulatory compliance, or business continuity
Level 4: does not impact product quality or safety, regulatory compliance, or business continuity
In case supplier provides different parts or services with difference level, the highest risk impact level will be selected for supplier level
M.K Service Trading Co., Ltd supplier provides sending sample to suppliers service Therefore, that supplier belongs to risk level 4 supplier list
Taikisha Vietnam Engineering INC is risk level 3 due to providing calibration filter
NIPPON Express Vietnam Co., Ltd provides third party logistic service so that it is risk level 2 supplier
One of risk level 1 is Kelpac company providing raw materials
- Audit plan and implementation by skilled and experienced team
- Supplier performance monitoring with specific criteria and approriate actions need to be taken
- Re-evaluation: complete well supplier documentation re-evaluated
- Using SAP effectively to release and manage supplier
- Specification is not still defined specifically, totally and consistently for each material so that some issues occurred but they are not mentioned in the specification of contracts with suppliers
- Sometimes SQM team deal with troubles due to working effectiveness of CFT members
- Documentation of re-evaluated supplier is not still stored on system and ticked label and check-list to find easily
- Some suppliers TBV has not had plan to business still exist in approval supplier list.
SOP for planning for new supplier(s) evaluation
Terumo BCT Vietnam aims to implement a strategic plan that defines the scope of controls for products and services sourced from both direct and indirect suppliers at levels 1 and 2 The company seeks to clarify specific outcomes expected from suppliers, establish measurable success criteria, and outline a timeline for project completion.
Flowchart Description End- user SQM SCM Financ e
Issue the New Supplier Request Form by end-user
Documentation via Planning Form and get the signature
Chart 3.3 Planning for New supplier(s) evaluation flow chart
Source: Company document, SOP for planning for new supplier evaluation, page 4
In Step 6, "Perform Planning Meeting," the Cross-Functional Team (CFT) must identify potential risks related to the products or services being procured This involves gathering technical and process information, as well as identifying potential suppliers and their contact details During the risk identification process, the CFT should consider various factors to effectively assess and control these risks.
- Is the part custom built or Off-the-shelf?
- How complex is the part to manufacture?
- What is the criticality of the part?
- Does the supplier currently manufacture parts for medical device regulated industry or is this their first?
The flow chart provides detailed steps that guide users effectively, enabling the Supply Chain Management (SCM) team to select suppliers for purchasing the right products and services at the best prices Additionally, Supplier Quality Management (SQM) can accurately manage suppliers based on risk assessment and control measures.
The selection of new suppliers is executed with careful consideration and formality through effective meetings, ensuring that all members of the Cross-Functional Team (CFT) collaborate and support one another in developing a robust supplier planning strategy.
Specification in Planning form is not sufficient to cover all problems may be occurred
End-users often struggle to accurately define risk levels in the new supplier request form and planning form, resulting in a lack of awareness regarding the importance of risk identification Many end-users fail to provide detailed descriptions of products or services, such as their use in cleanrooms, which leads the Supplier Quality Management (SQM) team to incorrectly assess risk levels Consequently, this mismanagement affects how risks are handled, as most end-users are unsure of how to complete the majority of sections in the new supplier request form.
In Phase 2 of the supplier selection process, it is the responsibility of the Supply Chain Management (SCM) team to identify and choose potential suppliers who meet the company's requirements, provide competitive pricing, and deliver high-quality products The Supplier Quality Management (SQM) team actively supports the SCM team by addressing quality-related concerns, ensuring a thorough evaluation of potential suppliers.
SOP for supplier audit
TBV conducts a comprehensive supplier audit process to identify potential risks and implement control measures for both new direct suppliers and indirect suppliers classified as risk levels 1, 2, and 3 This process encompasses detailed planning of the audit program through to the completion of the audit, ensuring a thorough evaluation of the performance of approved suppliers.
No Flowchart Description CFT SQA SCM Other
Monthly check the yearly audit schedule
Confirm audit date with supplier
Invite the audit team for planning
9 Send schedule form to supplier I R I I
12 Follow up the from actions I R I I
Chart 3.4 Supplier audit flow chart Source: Company document, SOP for supplier audit, page 6
This procedure is implemented in context below:
- Suppliers with performance concerns/ for cause audit
- New business with an existing supplier
- New significant equipment/tooling purchase
- Decision by members of the CFT
- Convenient timing associated with another trip
The SQM team holds the primary responsibility for managing audit findings, while the supplier is tasked with implementing the necessary corrective actions Successful audits necessitate collaboration between the SQM, SCM, and relevant departments to ensure effective support and resolution.
Analysis step 2 ―Create yearly audit schedule‖:
+ What: plan to review all level 1 and level 2 suppliers
+ When: each fiscal year (April 1 - March 31)
On-site audits are conducted at the facilities of suppliers, while off-site audits and surveys are performed in collaboration with TBV through email and various other methods.
+ Why: due for reassessment in that fiscal year, and might also include suppliers not due for reassessment but that should be considered for an audit for additional reasons
When an on-site audit is impractical, unfeasible, or unnecessary, appropriate justification must be documented in the supplier's file This justification should detail how the overall risk profile remains unaffected by foregoing the on-site audit, allowing for the application of a remote audit instead.
Audit planning in step 7 ―Create audit planning form‖ including:
+ Schedule audit with the supplier
+ Send the schedule details to the supplier
+ Estimate the duration of audit, travel organization, planning and preparation of the agenda
- Process Audit on the line (Verify supplier‘s competency in technical processes and systems)
- Review the previous 2 years external and internal quality audit reports and annual management review minutes
- Identify systematic or recurring problems that affects customer expectation
- Analyze the root cause and preventive measures for recurrence at company level led by senior management
- Technical processes – focus on supplier‘s competency on core processes
+ Verbal assessment feedback by TBV (e.g strengths, observations and Non - Conformances)
+ Agree on follow up action points by both sides, if any
Step 11 and 12: Making audit report and follow up the form actions
- Release Supplier Audit Report - within 15 working days
- Update Supplier Audit Report with supplier response (Corrective/Preventive actions)
The supplier audit procedure is comprehensive and requires effective implementation To achieve optimal results, it is essential for the cross-functional team to collaborate and ensure that each member is trained in supplier audit skills.
The audit process is strengthened by a detailed yearly schedule and effective monthly controls, ensuring a specific and clear audit plan The team is well-prepared for implementation, adhering to the timeline and formally executing procedures to achieve accurate results for supplier acceptance.
Limitations: skill of audit team must be improve to save time, budget and raise the quality and effectiveness, awareness of supplier is low.
SOP for supplier release on system
The process for releasing suppliers in the SAP system involves archiving documents that serve as evidence of the evaluation and selection of potential suppliers, contractors, and consultants This selection is based on their ability to meet specified quality requirements and other criteria.
3.4.2 The standard requirement document for release
It depends on supplier type and their risk level That will make supplier quality management effective and appropriate
No Flowchart Description Other SQM SCM Supplie r
Receive Supplier Approval Form (Appendix 5, BOR 901)
5 Feedback to supplier or related people N/A R N/A N/A
6 Release the supplier in the system N/A R I I
7 Scan all listed document and archiving in specify folder N/A R N/A N/A
Chart 3.5 Supplier release on system flow chart Source: Company document, SOP for supplier release on system, page 4
Explanation steps of this flow chart:
- The assigned SQM staff reviews the Supplier Approval Form to assure that the information is appropriate, accurate, and complete based on available information
- If there is lack of the document, assigned SQM need to feedback to the supplier or other related within 5 working days
- Use code to create a new supplier in SAP Fill in all required fields in SAP based on release information
- Assigned SQM scan all listed document in approval form and archive both hard and soft version into specify folder
- Notify the requestor/buyer by email what the new supplier number is
It is a detailed process I consider it will be better to add ―Is the information inappropriate, inaccurate and uncompleted ?‖ to the user check information more carefully
Effective supplier data management was successfully implemented through SAP, enabling the SQM team to efficiently save resources and quickly access information This efficiency is largely due to the tailored data requirements for each supplier, which vary based on their type and risk level.
Limitations: Collecting required document, scanning all listed document and archiving in specify folder take the time long time.
SOP for Supplier‘s performance monitoring
To describe the process by which TBV evaluates the performance of Approved Suppliers through periodic reassessments, the Supplier Performance Scorecard System
Supplier performance will be assessed through the Supplier Performance Scorecard System, which utilizes a Scorecard Form to report on quality and delivery metrics The results from this scorecard will guide the Cross-Functional Team (CFT) in taking appropriate actions to manage both direct and indirect supplier risks categorized as levels 1, 2, and 3.
No Flowchart Description SQM SCM Other
2 Collect the data/information related to
Collect the data/information related to Delivery score
4 Consolidate Quality and Delivery score R I I
5 Meeting with SCM to have final
6 Send SPS to Direct supplier R I I
7 Send SPS to Indirect supplier I R I
Chart 3.6 Supplier’s performance monitoring flow chart Source: Company document, SOP for Supplier’s performance monitoring, page 10
- Scorecards will be issued on a quarterly basis for Level 1 and Level 2 suppliers and on a yearly basis for Level 3 suppliers (see Table 1)
- Scorecards will evaluate short-term performance indicated by a quarterly score and long-term performance monitored by a rolling four quarters score
- Short and long-term scores will determine supplier management activities These activities include Corrective Actions, Supplier Visits/Audits and Internal CAPA escalation
- Supplier management activities will be determined and tracked using the SPS System
- SQM will responsible for Quality score and SCM will responsible for Delivery score
- Scorecard results shall be stored in the appropriate supplier files maintained by SQM
- SQM and SCM will manage the Recommended Actions generated as an output of the SPS process
Table 3.1 Supplier Scorecard Frequency Source: Company document, SOP for Supplier’s Performance Monitoring, page 2
- Lot Acceptable Rate (Accountable for 15% of Overall score)
Lot Acceptable Rate will be calculated as a percentage of total quantity accepted during the period divided by total quantity delivered during that period
Lot Acceptable Rate (%) Score Overall score
Table 3.2 Lot Acceptable Rate (Accountable for 15% of Overall score)
Source: Company document, SOP for Supplier’s Performance Monitoring, page 2
- New SCA (Accountable for 15% of Overall score)
New SCA issue will be counted by the number of distinct SCA created that the supplier received during the assessment period from SQM
New SCA Score Overall score
Table 3.3 New SCA (Accountable for 15% of Overall score)
Source: Company document (2018), SOP for Supplier’s Performance Monitoring, page 3
- Overdue SCA (Accountable for 15% of Overall score)
Score based on the number of late SCA responses from the supplier
Overdue SCA Score Overall score
Table 3.4 Overdue SCA (Accountable for 15% of Overall score)
Source: Company document (2018), SOP for Supplier’s Performance Monitoring, page 3
- Repeat SCA (Accountable for 20% of Overall score)
Repeat SCA will be counted by the SCA that closed but it still happen again during the assessment period
Repeat SCA Score Overall score
Table 3.5 Repeat SCA (Accountable for 20% of Overall score)
Source: Company document (2018), SOP for Supplier’s Performance Monitoring, page 3
- On-Time Delivery (Accountable for 20% of Overall score)
On-Time Delivery will calculate as a percentage of the total quantity of on time shipments during the period divided by total quantity of shipments during that period
On-time Delivery (%) Score Overall score
Table 3.6 On-Time Delivery (Accountable for 20% of Overall score)
Source: Company document (2018), SOP for Supplier’s Performance Monitoring, page 4
- Late Delivery (Accountable for 15% of Overall score)
Late Delivery will be counted by the number of late shipments from supplier during the assessment period
Late Delivery Score Overall score
Table 3.7 Late Delivery (Accountable for 15% of Overall score)
Source: Company document (2018), SOP for Supplier’s Performance Monitoring, page 4
Source: Company document (2018), SOP for Supplier’s Performance Monitoring, page 5
The Overall Score for the Quarter is calculated by summing the quality and delivery scores, represented by the formula: Overall Score = Lot Acceptance Rate score + New SCA score + Overdue SCA score + Repeat SCA score + On-time Delivery score + Late Delivery score.
- Four Quarter Average: The Four Quarter Average will be calculated where historical data is available
Level 1 & 2 Actions Level 1 & 2 Actions Level 3 Actions
Source: Company document (2018), SOP for Supplier’s Performance Monitoring, page 6
- Action taken to improve supplier performance is valid for one year unless Recommended Action increases in severity Action taken in a previous quarter may be
The CFT is responsible for assessing the Supplier Performance Scorecard to manage supplier relationships effectively If the CFT concludes that no action is necessary, they will provide justification, which will be documented alongside the scorecard.
Evaluation implementation of supplier‘s performance monitoring
Implementing supplier performance monitoring is streamlined and effective when clear criteria and appropriate actions are established The team adheres strictly to these guidelines and effectively utilizes the Balanced Scorecard and other tools to accurately assess supplier capacity This approach enhances the quality of products and services, ultimately leading to superior TBV finished goods.
All members of the team can implement evaluation and monitoring supplier quality owing to detailed steps and instruction
SQM and SCM team always join hand together to carry out this procedure well so that
2 teams can limit the troubles may happen
The team saves time and other resources thank to suitable requirements about time period to re-evaluation and documentation for each risk level
Re-evaluation is carried out accurately and punctually due to good plan and formal implementation
SQM team and company quite depend on some suppliers so that the actions taken are not effective
Delays in receiving essential information from suppliers can significantly impact the manufacturing and delivery schedule, especially if the team decides to block these suppliers due to a lack of feedback.
SOP for supplier re-evaluation
To establish the direction for re-evaluation all supplier in the Supplier Approval List, to ensure supplier still meet TBV requirement
No Flowchart Description SME SQM SCM
2 Monthly monitoring the ASL list and list out all supplier need to be re-evaluation R I I
Set up the monthly meeting to define the criteria for evaluation
7 Documentation the result, archive and update in the SAP system S R S
8 Inform the result to related department S R S
9 Follow up the action and updated the status S R S
Chart 3.7 Supplier re-evaluation flow chart Source: Company document (2018), SOP for supplier re-evaluation, page 4
The flow chart illustrates that the SQM team has established a systematic procedure for re-evaluation, which is tailored according to the supplier type and their associated risk level This approach ensures effective management of suppliers while optimizing the team's resources.
All Approved Suppliers will undergo periodic reassessment according to their risk levels, with a minimum frequency outlined in the accompanying table Suppliers can submit reassessment documentation up to one month in advance to extend their current 'Approved To' date.
‗Approved To‘ dates are maintained in the Vendor Master Record in the ERP (Enterprise Resource Planning) system
Supplier Risk Level “Approved To” Time Period
Table 3.10 “Approved To” Time Period of each risk level Source: Company document (2018), SOP for supplier re-evaluation, page 1
3.6.3.1 Re-evaluation requirements for suppliers with Risk Level 1, 2 or 3
- SQA staffs monitor the ASL list every month and list out all supplier need to re- evaluation
- SQA staff will setup the CFT team, normally including Supplier Quality Management, Supply Chain Management, subject master expert
- Designed SQA will hold the meeting with the CFT team to make the re-evaluation preparation
The CFT will assess the supplier's performance since the last evaluation to decide if a reassessment is necessary This evaluation encompasses various factors, including quality trends, business and financial health, on-time delivery, management ownership, contractual agreements, reference checks, quality lab assessments, on-site evaluation outcomes, supplier remote audits, business surveys, and distribution agreements.
3.6.3.2 Re-evaluation requirements for suppliers with Risk Level 4
The Purchasing, SQA, and SME teams will assess the supplier's activities since the last evaluation to confirm their ongoing business relationship with TBV and ensure alignment with the current Supplier Classification in terms of Type and Risk.
3.6.3.3 Re-evaluation action can include but is not limited to
No Action, Change Supplier Approval Status, Corrective Action, Supplier Visit, On- Site Audit, CAPA
- Re-evaluation and action will be documented on the Supplier Re-evaluation Form and submitted to SQA with an approved, Approved Supplier Form
Evaluation application reality of SOP for supplier re-evaluation
The team effectively executed a well-structured plan to re-evaluate suppliers, with dedicated members working diligently to complete the task efficiently and fulfill all documentation requirements This effort resulted in commendation from the mock Food and Drug Administration auditors in August, highlighting the team's success and the company's commitment to quality standards.
+ The team still manage some suppliers that the company have does not plan to business with them no longer because they are not notified about those plan
The presence of CFT members in their work areas, coupled with their already heavy workloads due to manual processes, often leads to wasted time and hinders overall progress.
SOP for Supplier Corrective Action
This procedure describes the process and requirements for initiation, execution, and closure of Supplier Corrective Actions (SCA)
- Input: Provision of nonconforming product/service, customer complaint against supplied component/service, audit Non-Conformance, Supplier Scorecard result, CAPA investigation
- Output: Completed Supplier Corrective Action activity
Employees, contractors, and consultants who interact with potential suppliers must comprehend and apply this procedure This includes roles within Supplier Quality, Receiving Quality Assurance, Purchasing, Quality Assurance, Quality Labs, Workplace Resources, and Operations Engineering, as well as relevant responsibilities for contractors and consultants.
Chart 3.8 Supplier Corrective Action flow chart Source: Company document (2018), SOP for Supplier Corrective Action, page 8
Evaluation application reality of SOP supplier corrective action
The team prioritizes the effective implementation of supplier corrective action requests while also collaborating with relevant individuals and teams to address issues, including nonconforming products or services and customer complaints regarding supplied items.
43 component/service, audit Non-Conformance, Supplier Scorecard result, CAPA investigation and improve supplier quality
Limitations: some requested actions could not be taken because that will have bad effect to manufacturing plan.
SOP for supplier change management
The evaluation process for change notifications from direct and indirect suppliers at levels 1, 2, and 3 is crucial for effectively managing changes and mitigating risks This structured approach helps prevent unintended consequences arising from supplier-related changes.
No Flowchart Description Other SQM SCM Supplier
2 Inform the change notification to TBV SCM I I I R
Purchasing receives a change notification from supplier I I R I
Follows up with supplier to understand scope of change I R I S
Assess impact to TBV of the change (see section
Issue the VCCR and inform to supplier the final decision I R I I
Chart 3.9 Supplier change management flow chart Source: Company document (2018), SOP for Supplier change management, page 3
- Information to obtain from supplier: the supplier must provide the following information about the proposed change:
+ Description of the change What exactly will be changed in the process that is currently used to produce the supplied product?
+ Release Notes, Datasheets, Drawings, Production Roadmap, last time buy, form-fit- function detail, upgrade options/process/logistics, cost, lead time, warranty
- Evaluation of the change from supplier
+ SCM receives a change notification from supplier, follows up with supplier to understand scope of change
+ If the change related to item mention on section 2.1, SCM will inform to SQM department
+ SQM department will issue the VCCR, the next action will follow the VCCR procedure
+ SQM will inform to supplier the final approval of change notification
- Good points: the team are very enthusiastic to support related team to complete change form to update and take proper action on time
The SQM team continues to oversee certain suppliers with whom the company no longer plans to engage in business Due to a lack of communication regarding the status of these suppliers, end-users are unaware that they need to complete the master supplier change form and submit it to the SQM team.
The SQM team don‘t know some new products or services are bought from existing supplier That leads to risk level and controls change.
SOP for Handling Quarantined Material
This article outlines the procedure for managing claims related to quarantined materials from both direct and indirect suppliers, specifically at levels 1 and 2 The primary focus is on the handling of quarantined materials at TBV, while problem-solving aspects will be addressed through the SCA procedure.
No Flowchart Description Pro SQM SCM WH
2 Receive the problem notification and verify with specification I R N/A N/A
4 Inform to related department, and stop the process I R N/A N/A
5 Move from WIP (0022) stock to available stock
6 Move the affected quantity to quarantine area I I I R
7 Check the quantity, stick quarantine label, enter in SAP blocked quantity I R I I
8 Bracket checking and block the related material when appropriate I R I I
9 Is sorting needed for this part? I R I I
10 Define sorting criteria, sorting record I R I I
12 Release the good part, send back the defect part to quarantine warehouse location I R I I
13 Is the part to be returned to the supplier? I R I I
14 Stick the scrap label and inform to Warehouse, then move the part out of quarantine location I R I I
15 Inform to SCM for next step I R I I
Chart 3.10 Handling Quarantined Material flow chart Source: Company document (2018), SOP for Handling Quarantined Material, page 4
* Determining the need to trigger the Claim Handling process
A claim handling process can be initiated whenever there is suspicion of non-conformance in a product, process, or service provided by a supplier Common scenarios that may trigger this procedure include issues with product quality, service delivery failures, or deviations from agreed specifications.
• Provision of Non-Conforming product/service
• Customer complaint against supplied component/service
• Quality notification from incoming process
The designated SQA personnel evaluates the Quality Notification and determines the necessity of a Supplier Corrective Action (SCA), ensuring that the SCA form's information is appropriate, accurate, and comprehensive based on the available data Subsequent problem-solving actions will adhere to the established SCA procedure.
- The assigned SQA staff will verify the information, compare with the standard to determine the material is out of specification or within the specification
- In case the parts within specification, SQA staff will inform to related department and stop the process
- If the notification is confirmed (out of specification), production will move materials from WIP (0022) stock to available stock (0001) Then SQM staff move from 0001 to Quarantined location (0005)
- Production and Warehouse support to send the material back to the quarantine area then inform to SQA staff
- Assigned SQA staff will check the quantity, stick quarantine label, enter in SAP blocked quantity warehouse
- Assigned SQA staff check the bracket and block the related material if need
- When all part was quarantined, depend on the manufacturing situation, the quarantined part can be treat as below:
• If there is no more part for production running, the part can be considering to sort
• The sorting criteria shall define clearly, the record of the result of sorting shall documented
• The defect part will stick quarantined label and send back to quarantined area for waiting next step (scrap or return to vendor)
• Assigned SQA staff will send the SCA form to supplier and prove to supplier that problem come from supplier
• If the problem was confirmed by supplier, Assigned SQA staff will inform to SCM to return the part to vendor
• Assigned SQA staff will stick the scrap label on the box, then inform to warehouse to move out of quarantine area
Owing to the handling quarantined material procedure, materials are manage strictly Evaluation implementation SOP for Handling Quarantined Material
The SQM team effectively mitigates challenges related to warehouse space and forklift truck availability by implementing a handling procedure for quarantined materials, ensuring that only these materials occupy the warehouse area Additionally, the proper organization of materials in designated locations aligns with SAP information, simplifying material management.
- Limitations: The plan of SQM team sometimes is badly affected due to warehouse area limit, forklift truck availability and warehouse human resource supporting
