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ICYB pdf - IASSC Certified Lean Six Sigma Yellow Belt Updated: 2024

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Exam Code: ICYB IASSC Certified Lean Six Sigma Yellow Belt pdf January 2024 by Killexams.com team

ICYB IASSC Certified Lean Six Sigma Yellow Belt

Exam: ICYB IASSC Certified Lean Six Sigma Yellow Belt

Exam Details:
- Number of Questions: The test consists of approximately 60 multiple-choice and true/false questions.
- Time: Candidates are given 2 hours to complete the exam.

Course Outline:
The IASSC Certified Lean Six Sigma Yellow Belt course is designed to provide professionals with an understanding of the fundamental concepts and principles of Lean Six Sigma methodology. The course covers the following topics:

1. Introduction to Lean Six Sigma
- Overview of Lean Six Sigma methodology
- Key principles and benefits of Lean Six Sigma
- Roles and responsibilities within a Lean Six Sigma project
- Integration of Lean and Six Sigma approaches

2. Define Phase
- Understanding the problem-solving process
- Defining project goals and objectives
- Identifying project stakeholders and their requirements
- Developing a project charter and scope statement

3. Measure Phase
- Collecting and analyzing process data
- Applying statistical tools for measurement
- Process mapping and value stream analysis
- Identifying process metrics and performance indicators

4. Analyze Phase
- Analyzing process data for root cause identification
- Applying statistical analysis techniques
- Identifying and prioritizing improvement opportunities
- Generating potential solutions and hypotheses

5. Strengthen Phase
- Designing and implementing process improvements
- Evaluating and selecting improvement solutions
- Piloting and testing improvement initiatives
- Developing implementation plans and monitoring progress

6. Control Phase
- Establishing control measures and standards
- Implementing process controls and monitoring systems
- Documenting and communicating process changes
- Sustaining and continuously improving the process

Exam Objectives:
The test aims to assess candidates' understanding and proficiency in the following areas:

1. Knowledge of Lean Six Sigma concepts and principles
2. Ability to apply problem-solving and process improvement methodologies
3. Proficiency in data collection, analysis, and statistical techniques
4. Competence in identifying and prioritizing improvement opportunities
5. Understanding of project management and control principles in Lean Six Sigma

Exam Syllabus:
The test syllabus covers the following topics:

- Introduction to Lean Six Sigma
- Lean Six Sigma methodology and benefits
- Roles and responsibilities in Lean Six Sigma projects
- Integration of Lean and Six Sigma approaches

- Define Phase
- Problem-solving process
- Project goals and objectives
- Stakeholder identification and requirements
- Project charter and scope statement development

- Measure Phase
- Process data collection and analysis
- Statistical tools for measurement
- Process mapping and value stream analysis
- Process metrics and performance indicators

- Analyze Phase
- Root cause identification
- Statistical analysis techniques
- Improvement opportunity identification
- Generating solutions and hypotheses

- Strengthen Phase
- Process improvement design and implementation
- Evaluation and selection of improvement solutions
- Piloting and testing improvement initiatives
- Implementation planning and progress monitoring

- Control Phase
- Control measures and standards
- Process controls and monitoring systems
- Documenting and communicating process changes
- Sustaining and continuous improvement

Candidates are expected to have a comprehensive understanding of these Topics to successfully pass the test and demonstrate their proficiency as Lean Six Sigma Yellow Belts according to IASSC standards.
IASSC Certified Lean Six Sigma Yellow Belt
Quality-Assurance Certified pdf

Other Quality-Assurance exams

CQIA Certified Quality Improvement Associate
CSQA Certified Software Quality Analyst (CSQA)
CSQE Certified Software Quality Engineer Certification (CSQE)
ICBB IASSC Certified Lean Six Sigma Black Belt
ICGB IASSC Certified Lean Six Sigma Green Belt
ICYB IASSC Certified Lean Six Sigma Yellow Belt

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Quality-Assurance
ICYB
IASSC Certified Lean Six Sigma Yellow Belt
https://killexams.com/pass4sure/exam-detail/ICYB
Question: 112
The Control Plan is the road map to sustaining the improvements made through the
Lean Six Sigma project and should therefore involve keeping the __________ up
to date as a means of supporting the Response Plan in case a defect is noticed.
A. X-Y Diagram
B. Shewhart Chart
C. FMEA
D. Customer Service Plan
Answer: C
Question: 113
To minimize waste through the application of Lean Principles we do which of the
following?
A. Collect demo data
B. Keep the work area clean and organized
C. Calibrate our measurement tools
D. Survey the customer
Answer: B
Question: 114
A Lean Principle that states the process of eliminating waste is a continual process
requiring one to always be on the lookout for ways to reduce the seven elements of
waste is known as____________ .
A. Ishikawa
B. Kaizen
C. Kanban
D. Muda
Answer: B
37
Question: 115
An important factor in a viable _________ is to determine who, when and to what
level various personnel must be trained to maintain the improvements made to a
process.
A. Control Plan
B. FMEA
C. Standard Operating Procedure
D. Process Map
Answer: C
Question: 116
A Monitoring Plan put into place at the conclusion of a project will provide for
adequate systems with key metric readouts indicating out-of-spec conditions.
A. True
B. False
Answer: A
Question: 117
The Control Plan is created following the finalization of the Measure Phase and
can be closed when?
A. After the project costs have been recouped
B. When the Champion says so
C. Never, a Control Plan must stay in place
D. At the fiscal yearend of the business
Answer: C
38
Question: 118
Systems and structures are the basis for allowing people to change their behaviors
permanently and are accomplished through which of the following?
A. Documented performance objectives
B. Defined procedures
C. Accurate job descriptions
D. Incentive compensation
E. All of these answers are correct
Answer: E
Question: 119
To reduce the people or operator introduced defects into a process it is best if a Belt
can design and implement a means of ________________ into the process.
A. Measurement automation
B. Operator alertness
C. Full Automation
D. Constant supervision
Answer: C
Question: 120
Upon completion of a project a Belt must complete the Documentation Plan then
transfer responsibility for this to the ____________________.
A. Project Review Committee
B. Division Manager
C. Sales Team
D. Process Owner
Answer: D
39
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Quality-Assurance Certified pdf - BingNews https://killexams.com/pass4sure/exam-detail/ICYB Search results Quality-Assurance Certified pdf - BingNews https://killexams.com/pass4sure/exam-detail/ICYB https://killexams.com/exam_list/Quality-Assurance Quality Management and Assurance
Department

Safety, quality, environmental awareness and the fulfillment of legal requirements are not only central elements of the DLR guidelines. They are the basis of our work at the DLR site in Lampoldshausen. For us, the protection of people and the environment and the safe operation of the test bench facilities go hand in hand. That is why we have our own safety and environmental management systems, which are continuously being developed. In order to meet the high quality standards and continuous improvement in test operations and space research, the quality-relevant activities at the DLR Institute of Space Propulsion are monitored and promoted. We are certified according to DIN EN ISO 9001, DIN EN ISO 14001, DIN EN ISO 45001 and DIN EN ISO 50001.

Quality assurance in test operation

Safety, quality and environmental awareness

For us, the protection of people and the environment and the safe operation of the test bench systems go hand in hand.

The great market success of the European Ariane program is due in particular to increased quality and safety requirements in the space sector. The trend towards Europe-wide and international standardization of processes and compliance with mandatory requirements led to the establishment of a standardized safety, quality, environmental and energy management system. The Quality Managers support test bench operations in all project phases, from development to test operation and maintenance. For projects and test campaigns, the Quality Managers continuously develop the Product Assurance Plan based on customer-specific, regulatory, legal and internal requirements, monitor and support the implementation of requirements such as carrying out risk assessments, error and root cause analyses, lessons learned, tests, measures and the control of documented information. In addition, the quality of all departments is checked through internal audits, thus maintaining the high level of quality.

Environmental protection: consistent and sustainable implementation

Thu, 23 Nov 2023 22:02:00 -0600 en text/html https://www.dlr.de/en/ra/about-us/departments/quality-management-and-assurance
Quality Assurance for Embedded Systems

By Ambuj Nandanwar, Softnautics

In this rapidly evolving technology, embedded systems have become the backbone of the modern world. From the subtle intelligence of smart home devices to the critical operations within healthcare and automotive industries, embedded systems are the quiet architects of our technological landscape. The seamless and error-free operation of these intricate systems is ensured by the meticulous application of Quality Assurance (QA). QA emerges as a paramount force in the development of embedded systems. In this article, we dissect the significance of QA in embedded systems, where precision and reliability are not just desired but mandatory. Join us as we navigate through various aspects of QA, exploring how QA shapes the robust functionality of embedded systems.

Embedded systems are specialized computing systems that are designed to perform dedicated functions or tasks within a larger system. Unlike general-purpose computers, embedded systems are tightly integrated into the devices they operate, making them essential components in various industries. They are the brains behind smart home devices, medical equipment, automotive systems, industrial machinery, and more. These systems ensure seamless and efficient operation without drawing much attention to themselves.

Significance of Quality Assurance in Embedded Systems

In embedded systems, QA involves a systematic process of ensuring that the developed systems meet specified requirements and operate flawlessly in their intended environments. The importance of QA for embedded systems can be emphasized by the following factors:

  • Reliability: Embedded systems often perform critical functions. Whether it's a pacemaker regulating a patient's heartbeat or the control system of an autonomous vehicle, reliability is non-negotiable. QA ensures that these systems operate with a high level of dependability and consistency. Some of the key test types in reliability testing.
    • Feature Testing
    • Regression Testing
    • Load Testing
  • Safety: Many embedded systems are deployed in environments where safety is paramount, such as in medical devices or automotive control systems. QA processes are designed to identify and reduce potential risks and hazards, ensuring that these systems comply with the safety standards. To achieve a safe state in an embedded system, the Hazard Analysis and Risk Assessment (HARA) method is applied to embedded systems when it comes to automotive and the healthcare sector, an additional layer of consideration is crucial in medical devices and systems, compliance with data security and patient privacy standards is of utmost importance. The Health Insurance Portability and Accountability Act (HIPAA) method is applied to ensure that healthcare information is handled securely and confidentially.
  • Compliance: Embedded systems must stick to industry specific regulations and standards. QA processes help verify that the developed systems comply with these regulations, whether they relate to healthcare, automotive safety, smart consumer electronics, or any other sector. Embedded systems undergo various compliance tests depending on the product nature, including regulatory, industry standards, and security compliance tests.
  • Performance: The performance of embedded systems is critical, especially when dealing with real-time applications. QA includes performance testing to ensure that these systems meet response time requirements and can handle the expected workload. Following are the types of performance testing.
    • Load testing
    • Stress testing
    • Scalability testing
    • Throughput testing

Evolution of QA in Embedded Systems

The technological landscape is dynamic, and embedded systems continue to evolve rapidly. Consequently, QA practices must also adapt to keep pace with these changes. Some key aspects of the evolution of QA in embedded systems include

  • Increased complexity: As embedded systems become more complex, with advanced features and connectivity options, QA processes need to address the growing complexity. This involves comprehensive testing methodologies and the incorporation of innovative testing tools.
  • Agile development practices: The adoption of agile methodologies in software development has influenced QA practices in embedded systems. This flexibility allows for more iterative and collaborative development, enabling faster adaptation to change requirements and reducing time-to-market.
  • Security concerns: With the increasing connectivity of embedded systems, security has become a paramount concern. QA processes now include rigorous security testing to identify and address vulnerabilities, protecting embedded systems from potential cyber threats.
  • Integration testing: Given the interconnected nature of modern embedded systems, integration testing has gained significance. QA teams focus on testing how different components and subsystems interact to ensure seamless operation.

Automated Testing in Embedded Systems

As embedded systems fall in complexity, traditional testing methods fall short of providing the speed and accuracy required for efficient development. This is where test automation steps in. Automated testing in embedded systems streamlines the verification process, significantly reducing time-to-market and enhancing overall efficiency. Also, incorporating machine learning algorithms to enhance and modify testing procedures over time, machine learning testing is an important aspect of automated testing. This helps to identify possible problems before they become more serious and increases efficiency.

Testing approaches for Embedded systems

Testing Approaches for Embedded Systems

The foundation of quality control for embedded systems is device and embedded testing. This entails an in-depth assessment of embedded devices to make sure they meet safety and compliance requirements and operate as intended. Embedded systems demand various testing approaches to cover diverse functionalities and applications.

  • Functional testing is used to make sure embedded systems accurately carry out their assigned tasks. With this method, every function is carefully inspected to ensure that it complies with the requirements of the system.
  • Performance testing examines the behavior of an embedded system in different scenarios. This is essential for applications like industrial machinery or automotive control systems where responsiveness in real-time is critical.
  • Safety and compliance testing is essential, especially in industries with strict regulations. Compliance with standards like ISO 26262 in automotive or MISRA-C in software development is non-negotiable to guarantee safety and reliability.

Leveraging machine learning in testing (ML testing)

Machine Learning (ML) is becoming more and more popular as a means of optimizing and automating testing procedures for embedded systems. AIML algorithms are used in test automation. Test time and effort are greatly reduced with ML-driven test automation. It can create and run test cases, find trends in test data, and even forecast possible problems by using past data. ML algorithms are capable of identifying anomalies and departures from typical system behavior. This is particularly helpful in locating minor problems that conventional testing might ignore.

As technology advances, so does the landscape of embedded systems. The future of Quality Assurance in embedded systems holds exciting prospects, with a continued emphasis on automation, machine learning, and agile testing methodologies.

In conclusion, the role of QA in the development of embedded systems is indispensable. It not only guarantees the reliability and safety of these systems but also evolves alongside technological advancements to address new challenges and opportunities in the ever-changing landscape of embedded technology.

Thu, 14 Dec 2023 00:50:00 -0600 en text/html https://www.design-reuse.com/articles/55406/quality-assurance-for-embedded-systems.html
Better beef through quality assurance certification

ISSUE

Livestock producers are continually looking for ways to ensure the sale of a quality product. And in a society where food products rapidly move across the nation, consumers must be able to trace that food back to its origin. The Beef Quality Assurance (BQA) certification is an excellent opportunity to Strengthen on both of these measures.

RESPONSE

At the 2020 Delaware Agriculture Week event, representatives from Pennsylvania’s Beef Council and the National Beef Quality Assurance program hosted a workshop targeted towards livestock producers. Topics discussed included the benefits of the BQA program and the importance of disease traceability during food recalls. 

Wed, 06 Sep 2023 12:13:00 -0500 en text/html https://www.udel.edu/academics/colleges/canr/cooperative-extension/first-state-impacts/better-beef-2020.html/
Indiana 4-H Livestock Quality Care

Quality Assurance programs are a great way to ensure our youth producers are creating a product we can be proud to consume. Any Indiana youth wishing to exhibit an animal at a county or state fair must have completed a Quality Assurance Certification. Youth have the option to complete an in-person Indiana 4-H Quality Livestock Care Course OR an online Youth for the Quality Care of Animals (YQCA) Course. County and State Fair will accept both of these options.

This requirement is set for youth exhibiting, Swine, Beef Cattle, Dairy Cattle, Sheep, Goats, Rabbits, and Poultry.

THE REQUIREMENTS:

Certification is a requirement (and it is very good practice) for youth planning to exhibit an animal (Swine, Beef Cattle, Dairy Cattle, Sheep, Goats, Rabbits, and Poultry) in the Lawrence County 4-H Fair (all other county fairs), the Indiana State Fair, and some open shows. You can check out handbook at “General Livestock Rules” for the most up to date details.

This requirement should not be viewed as just another rule, but rather as an important educational opportunity for 4-H livestock members. Making this an exhibition rule is how we are ensuring that 4-H members learn about quality assurance, but it really has nothing to do with animal exhibition. The real reason we are requiring this is so youth learn the best management practices with their animals. The goals of having 4-H members complete a quality assurance program include ensuring that youth will be more prepared to be ambassadors for animal agriculture in their role as youth livestock exhibitors; that animals from youth livestock programs are treated with the utmost care, and 4-H members are contributing to a safe, wholesome food supply.training-dates-quality-care.png

Thu, 30 Mar 2023 04:46:00 -0500 en text/html https://extension.purdue.edu/county/lawrence/4-h/4-h-livestock-quality-care.html
Certification of UK Doctors Would Strengthen Quality of Care Certification of UK doctors would help to Strengthen quality of care, say researchers in this week’s BMJ.

England’s chief medical officer recently recommended certification of doctors to strengthen professional regulation. Specialist certification is a well established process in the United States that allows doctors to demonstrate achievements and competencies beyond the minimum acceptable standards required for licensing purposes. Certified status must be renewed every six to 10 years.

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But does certification Strengthen medical standards?

Kim Sutherland and Sheila Leatherman reviewed data on the effect of certification in the US on quality of care. A review of studies published between 1966 and 1999 found that over half showed positive and statistically significant associations between certification and superior outcomes. Since 1999, four well conducted studies have concluded that certification is associated with provision of higher quality care across a range of specialties.

Recent studies have also found that a lack of certification is associated with an increased risk of disciplinary action.

So, most of the available evidence seems to support rigorously conducted certification as a good method to Strengthen quality of care, say the authors. Renewable certification also provides a more transparent process for assessing skills, knowledge, and competence than the opaque principles of professionalism.

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Adopting certification as a key regulatory instrument in the UK will have important implications, they add. In the US much of the cost is borne by doctors themselves who are likely to benefit from the process. However, there may be an argument for some of the costs to be offset by the NHS.

As the NHS strives to Strengthen quality of care, it is important to consider the central part played by the professions, they write. Individual professional conduct, along with collective professional values, will always provide a patient with the best quality assurance. Certification, or validation within the UK context, provides a way to strengthen and bolster that vital protection and reassurance.

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Thu, 21 Dec 2023 22:27:00 -0600 en-US text/html https://www.medindia.net/news/certification-of-uk-doctors-would-improve-quality-of-care-13695-1.htm
The future of quality assurance and engineering – How AI is empowering software testers

By Dinesh Mohan

The future of quality assurance (QA) and engineering (QE) is undergoing a significant transformation. The focus now has shifted from mere cost-effectiveness and product quality to prioritising customer experience (CX). It’s no longer just about whether the software works but about how well it meets the experiential demands of users, necessitating a thorough understanding of the business, its services/products, and the technologies employed​. 

Recent findings from the Business Transformation Index 2023 reveal a concerning trend. 76% of firms are falling short on their business transformation initiatives with an alarming 66% missing the mark when it comes to criteria like—staying within budget, timely delivery, or solution reliability. This uptick from 50% in 2022, is a wake-up call highlighting the critical need for robust QA/QE practices, irrespective of the industry. Enter AI in QA—the game changer.

How can AI offer a turnaround?

No longer seen as just a final checkpoint, Quality Assurance and Engineering is now an integral part of the entire software development lifecycle. The narrative now is shift left or get left behind emphasising the importance of early and frequent testing. And AI is enabling this shift by automating various tasks. AI-powered tools analyse code, generate test cases, and execute tests automatically, freeing up testers to focus on more complex activities.

The integration of AI into QA engineering is empowering testers to:

• Automate repetitive tasks and focus on more strategic testing activities

• Move beyond reactive testing towards predictive analysis—predicting and preventing defects from occurring in the first place

• Optimise test data management and Strengthen test coverage

• Generate insightful test reports and provide actionable recommendations

• Collaborate effectively and share knowledge across teams

Artificial Intelligence (AI) as a transformative force also helps overcome the challenges of:

  • Budgetary Control: To provide cost-effective testing, minimise manual labour, and maximise resource allocation, software testers must embrace AI-driven QA/QE models.
  • Timely Delivery: A collaborative effort between human intuition and AI-driven insights lends a hand in identifying the potential bottlenecks early.
  • Solution Reliability: Analysis of vast datasets by AI facilitates predictive maintenance along with empowering testers to pre-emptively address potential software glitches or failures.

However, building a competent QA/QE practice isn’t just about ticking boxes; it’s also about fostering talent. The big question is: In this era of digital transformation-

Will AI-driven automation eclipse the need for human QA/QE professionals?

We’re witnessing a blurring of boundaries between industries. Innovations in one sector are rapidly influencing others. This crossover, while improving customer experience, challenges quality engineers to adapt to diverse technological landscapes​.

The fear that AI might render human QA professionals obsolete is, in my opinion, unfounded. Instead, AI is redefining career paths in QA/QE. Testers equipped with AI proficiency are today invaluable assets.

In fact, the changing dynamics have led many companies to rethink the traditional developer-tester ratio. Consider this, ten years ago, a typical ratio of QA testers to developers might have been 1:10 or 2:10. This means that for every 10 developers, there would be 1 or 2 QA testers. Fast forward to today, this ratio is starting to shift, and it is not uncommon to see ratios of 3:10 or 5:10. This means that there are now more QA testers for every developer. 

This ratio is likely to continue to increase in the future due to the increasing complexity of software, the growing importance of quality, and the rise of agile development methodologies.

While automation is gaining momentum, the human element in software testing remains irreplaceable. AI can smartly automate processes, but can never wholly replicate the nuanced understanding and decision-making capabilities of a human tester. Manual testing is absolutely necessary in cases such as—exploratory testing, usability testing, security testing, edge-case testing, providing a second layer of validation, identifying new test cases, and providing feedback to developers.

The future of QA/QE in the AI-Augmented world

It’s true that the comparison between manual and automated testing might currently lean heavily towards automation, yet we can’t overlook the value of manual intervention. The undeniable fact is that AI can revolutionise Technology but the ingenuity, creativity, and intuitive power of People remain the most crucial and irreplaceable parts of the Process.

Quick, efficient delivery of high-quality products/services is a hallmark of successful businesses. And a synergistic approach where AI and automation enhance human capabilities rather than replace them is central to this achievement.

In a future where AI and human ingenuity coalesce to redefine software testing, how can we use technological advancements as a springboard for innovation and excellence?

The author is head of delivery and operations, digital practice, Expleo

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Sat, 09 Dec 2023 05:00:00 -0600 en text/html https://www.financialexpress.com/business/digital-transformation-the-future-of-quality-assurance-and-engineering-how-ai-is-empowering-software-testers-3333465/
How to build an efficient vendor management process in 2024

In a recent Deloitte survey, 52% of executives expressed outsourcing various business functions, such as manufacturing and supply chain procurement, and 76% of executives are outsourcing IT vendor functions, including cybersecurity and help desk support. 

As outsourcing continues to become more commonplace, vendor management strategies will play a critical role in how well a company adapts to the changing landscape.

What is vendor management?

Vendor management refers to companies’ processes to optimize and streamline the working relationship between their internal team and third-party providers. 

While it differs in every company, depending on the type of product or service that’s outsourced, vendor management encompasses everything from long-term contracts to routine monitoring. It spans the entire scope of the relationship, including initial research, assessment, and day-to-day coordination. 

Ultimately, vendor management aims to help companies achieve cost savings, mitigate risks, and ensure that all third parties deliver on expectations and values.

4 Steps of effective vendor management

Companies that work with vendors typically have some sort of process in place, whether it’s ad hoc or a series of prescriptive steps. The most effective vendor management system usually involves the following:

1. Identify business requirements 

All stakeholders should discuss and outline their goal in working with a vendor and the results a vendor is expected to deliver. Identifying the vendor’s proposed role can help assess its importance and highlight any other concerns the business needs to address before entering a new contract. 

During this step, stakeholders can discuss budget constraints, timelines, certification requirements, and other vendor specifications. Companies that deal with multiple vendors can also determine whether there are existing contract terms that can be expanded to provide the desired service.

2. Evaluate and select vendors

Once the company has finalized its business requirements, it can search for potential vendors. This requires some time, as it involves collecting a range of vendors, assessing the quality of their previous work, sourcing prices, and other research tasks.

For some companies, deciding on the right vendor can be as simple as selecting the one that best fulfills the business requirements. Other times, a company may have a bidding process, where vendors within a consideration set are invited to submit proposals on how the requirements will be met. 

No matter the process, vendors should be thoroughly assessed according to their capabilities and expertise, ease of communication, reliability, and overall value they offer the company. 

3. Onboard your selected vendors

Approved vendors enter a contract stage, usually overseen by legal and finance teams, including payment paperwork and background checks. 

Once this step is complete, vendors can be onboarded into the appropriate systems and business processes. All essential vendor information must be collected and inputted, facilitated by select points of contact managing the entire workflow

Depending on the amount of access needed, vendor onboarding can take a significant amount of internal coordination and resources. However, onboarding sets the foundation for a successful supplier relationship and is one of the most important stages in vendor management. 

4. Assess vendor performance

As with any business contract, vendors should undergo a periodic performance management check against initial business objectives. It’s important to have all stakeholders assess their individual interactions and experiences to evaluate all areas of the vendor management process. 

Vendor management software can be used to pool the necessary information together in one place, making it easier to assess different factors. By looking at the full scope, including submitted deliverables and total vendor costs, companies can gain necessary insights to Strengthen supplier performance and determine whether or not to renew the contract.

Challenges of managing vendors

Whether you engage one or multiple third parties, vendor and supplier relationship management can be a challenging process. Every vendor requires their own operational guidelines, evaluation, and review process. Understanding the challenges of vendor management can help companies see the most success. 

Vendor compliance and reputation risk

All vendors come with their own modes of operation that must align with your own, particularly when it comes to regulatory compliance and quality standards. 

These two factors, if not in sync, can lead to significant consequences. Making sure third parties adhere to all regulations required by your vendor risk management team can help prevent unnecessary exposure. If necessary, request the vendor to undergo an audit or submit adequate certification or other verification. 

As for quality of work, this should ideally be Verified during the vendor evaluation process through product samples or trial runs. It’s also recommended to perform random quality assurance checks, especially at the start, to determine whether the work continues to uphold your standards. 

Decreased visibility

Perhaps the biggest change when working with vendors is lack of the visibility available with internal teams. Even with assessments and reports, a lot of information can slip through the cracks. 

Lack of vendor automation

While working with vendors lightens a company’s workload, it creates new tasks that are frequently not addressed. 

For example, companies often use manual methods to keep track of vendor contracts and information. If any information becomes outdated, there’s a high likelihood of important documentation or payments being sent to the wrong accounts. This only compounds when working with multiple vendors.

Setting up vendor management automations helps maintain updated information, such as upcoming contract renewals, expiring certifications, and vendor fees and terms changes.

Vendor management best practices

Even if your company doesn’t have complete control over a third party’s operations, there are several ways to optimize the vendor management process. Here are some best practices that can keep you and your vendors on the same page:

Establish a vendor management policy

Vendor management plays an important role that’s expected to scale even more in years to come. Companies should create a living document that outlines their vendor management policy to establish a reliable system.

A policy helps formulate initial guidelines and involves internal stakeholders in specific steps throughout the vendor management process. 

Set vendor selection standards 

In time, you will better understand what vendors are a good fit with company culture and are more likely to deliver value. It may be specific expertise, industry experience, or technical qualification.

Regardless of the criteria, a qualified set of standards can be applied whenever a new vendor is undergoing evaluation. Knowing what factors to consider can contribute to vendor management success, even if you only need one or two outsourced tasks. 

Take a proactive approach 

It’s easy to assume external contractors don’t need as much collaboration or feedback. However, nurturing relationships is a large part of effective vendor management.

Establish clear expectations from the beginning by sharing your business requirements and addressing any concerns or questions. Explain how your companies will work together and what key performance indicators (KPIs) will be used to measure success. 

Even after the project kicks off, maintaining open communication can help further maximize the benefit of vendor relationships. Most importantly, deliver honest feedback and discuss areas of improvement, especially if any issues or problems arise.

Measure vendor performance

While vendors can help lighten the internal load of a company, they do require a separate managing and monitoring process. 

Develop a way for stakeholders to evaluate vendor performance against the initial business goal and performance metrics to determine whether vendors are meeting expectations, underperforming, or delivering above the expected value. Companies can also look at cultural fit and how well the vendor was able to cooperate and adapt to unexpected changes. 

A thorough assessment of the vendor lifecycle can provide guidance for a company’s upcoming contract negotiations and potentially secure better rates. 

Final thoughts

Vendors can deliver great business value when correctly planned and supported like any other business function. Vendor management builds reliable processes and criteria to ensure a mutually beneficial business relationship. 

By systemizing the evaluation, onboarding, and review process, vendor management increases the odds of success for internal and external teams.

This article originally appeared on the QuickBooks Resource Center and was syndicated by MediaFeed.org.

Featured Image Credit: DepositPhotos.com.

Tue, 02 Jan 2024 04:41:00 -0600 Katrina Dalao en-US text/html https://mediafeed.org/how-to-build-an-efficient-vendor-management-process-in-2024/ Highest Quality Standard: ESFM USA® Achieves ISO 9001 Certification No result found, try new keyword!CHARLOTTE, N.C.--(BUSINESS WIRE)--ESFM has been awarded ISO 9001 certification ... clients have for their business,” Director of Quality Assurance Victoria Griffin said. Sun, 17 Dec 2023 18:02:00 -0600 https://www.businesswire.com/news/home/20231218438874/en/Highest-Quality-Standard-ESFM-USA%C2%AE-Achieves-ISO-9001-Certification Ketryx Rakes In $14M to Speed Up Medical Device Development & Quality Assurance

The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower.

The startup, named Ketryx, announced the close of a $14 million Series A funding round on Tuesday. The round, which brings the company’s total funding amount to $18 million, was led by Lightspeed Venture Partners.

Ketryx, which was founded in 2021, is based in Somerville, Massachusetts and Vienna, Austria. It’s on a mission to make medical software quality assurance less error-prone, said CEO Erez Kaminski.

“Humans make mistakes. Computers do not. Traditional quality assurance uses humans to manually check thousands to tens of thousands of different line items before a product can go live. The average length of a 510k document according to the FDA is now over 2,000 pages, and we have customers who have submissions in the realm of 10,000 pages,” he explained.

With numbers this large, just a 0.1% error rate means that 10 errors would be made in a submission with 10,000 line items, Kaminski pointed out. 

The infrastructure and processes that medical device makers use for quality assurance “were simply not built” for the complexity of today’s software, he declared. Because of this, device manufacturers lack the tools they need to release and monitor software at scale, especially when it comes to new AI models.

Traditional quality assurance methods are also time-consuming, with the process taking months or sometimes years for a single device, Kaminski added.

“Now imagine that these companies want to release software monthly instead of annually. Or weekly — in most of the tech industry, it’s done daily today. They now have to go through all of these checks at the same cadence. This simply isn’t possible when documentation and quality checks are done manually,” he said.

To address these issues, Ketryx created a platform — designed around FDA regulations and quality standards — that automates much of the work required from medical device companies’ development and quality teams.

“Ketryx connects with modern development tools like Jira, GitHub, and AWS. As developers work in these preferred tools, Ketryx automatically generates all of the FDA-required documentation directly from these tools and enforces the company’s quality procedures in them as well,” Kaminski explained.

This allows developers to work without having to reference procedures or keep manual records, he pointed out. 

Ketryx’s target customers are companies that make medical devices or sell software as medical device (SaMD). Some of the customers listed on the startup’s website include Talkiatry, Beacon Biosignals, Galen Robotics and DocBox.

In Kaminski’s view, Ketryx’s biggest competitors are companies’ internal teams in charge of creating home-grown systems or augmenting general-purpose tools to accommodate regulated software development.

“Similar to the reasons why teams purchase Shopify instead of building their own e-commerce application, Ketryx offers the promise of staying in sync with the market. As FDA regulations and submission requirements change, Ketryx has the scale and purpose to make updates that quickly help teams stay in compliance. So too, as the use of AI/ML progresses and software tools improve, Ketryx will make these rapidly available for use in this regulated environment,” he declared.

Additionally, Ketryx differs from internal solutions because it automatically generates FDA-compliant documentation, as well as automates the enforcement of standard operating procedures, Kaminski said. He also said that his startup is constantly increasing the number of native integrations available on its platform, something that “in-house teams wouldn’t have the resources to complete.”

Photo: marchmeena29, Getty Images

Mon, 04 Dec 2023 16:05:00 -0600 en-US text/html https://medcitynews.com/2023/12/medical-device-fda-healthcare/




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