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VQMS Pvt Ltd - A management Consulting Company and an Institution is one of the top Industrial training and Consulting platform for Feshers and Professionals.

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Appreciate your efforts you put in during training and I feel overall training was very successful . Rajat Mittal

Dear Sir, Thanks for all the effort that you put in to work with the Team and explain them in depth all the Practical applications of Lean management.Really appreciate your Guidance and personally thank you for taking the Time and working with the

Hello Sir ,Please accept our heartfelt thanks for all your support and guidance during our Lean 6 sigma project on defect management & control. It was a huge learning for the team and we benefitted a lot from your constant feedback & guidance. Although the project has gone through, what shall stay with us & reflect in our future projects as well; is the systematic & structured approach to problem solving & working transversally. Sincere Regards,

Dear VQMS Mgmt. Thanks.Your enthusiasm was our source of inspiration throughout, thank you very much for your continual support. Lean Six Sigma Black Belt programme conducted at VQMS Lab was really a great success and achievement in our knowledge and career. The Program was indeed a great learning in terms of understanding the concepts and application using Minitab..Sunil Kumar.

Many Thanks to Mr. Anuj for his patience in clarifying our doubts. In all it was a memorable experience!!! Thanks & Regards,..Navneet Kr

Quick Enquiry

Q. What is Six Sigma management? What are the existing defects in Medical industry? How six sigma beneficial in Medical industry?

Six Sigma is a valuable management strategy to improve business processes, reduce development and production costs, increase profit margin and improve customer satisfaction.

The purpose of this article is to describe how six sigma concept complement and support formal quality management systems (QMS) in the medical device industry.

A significant number of issues, which increase the development costs and times, is often found during different phases of a medical device life cycle. Some defects with high patient safety risk may result in dangerous and very costly product recalls.

I tried to addresses how Six Sigma techniques , when appropriately integrated into the QMS at medical device companies, can eliminate defects earlier in the medical device life cycle, identify major opportunities for cost savings, focus on customer needs and expectations, and improve the overall business processes.

The medical device industry faces a number of challenges and opportunities in the global medical device manufacturing market. Growing competition, regulatory scrutiny, pricing pressures, fast-moving competitive markets which require frequent design changes, more sophisticated customers, shorter time to market, assembly of small parts with complex geometry and tight tolerances, and difficult to work with materials etc.

Medical device manufacturing companies need to ensure that their products are safe, reliable and suitable for the intended purpose, and their quality management systems are effective and meet National or International regulatory requirements.

ISO 9001:2000 & ISO 13485:2003 standards are for medical device manufacturers has a strong focus on customer satisfaction and improvement, but with an added focus on safety. This explains why ISO 13485:2003, unlike ISO 9001:2000 requires medical device companies to maintain a risk management system

ISO 13485:2003 require the use of appropriate statistical techniques for establishing, controlling and verifying the acceptability of processes and products. Sampling plans shall be based on valid statistical rationale.

The use of valid statistical tools appropriate to the stages of a product life cycle can make a significant contribution to the improvement of quality and productivity in medical device manufacturing Industry.

Some examples of common used statistical tools and techniques are: statistical process control (SPC), design of experiments (DOE), sampling plans, trend analysis, simulation, process capability, hypothesis testing, regression, analysis of variance (ANOVA), acceptance sampling, forecasting, cumulative survival rate analysis, etc.

In Six Sigma we use a concept to effectively define, measure, analyze Improve and control variation.

Practically, Six Sigma is used to emphasize more than simply counting defects. It also includes a set of tools and techniques used to drive process improvement.

Six Sigma is guided by the following key principles: customer satisfaction, data and fact driven management, team-based problem solving, total employee involvement, clear definition and understanding of roles and personnel growth. Six Sigma focuses on process quality, which ultimately affects product quality.

The Six Sigma concepts can apply to a wide variety of processes. Six Sigma can be applied in any business small-, medium sized and large enterprises etc.

Many medical device manufacturers implementing lean and Six Sigma concepts to improve quality and productivity (Boston Scientific, Bausch & Lomb, and GE Healthcare etc.) presented that Six Sigma concept can be integrated with quality management systems.

Six Sigma and quality management system approach is to determine which are the benefits of QMS can provide as information source and which benefits can be realized through the documentation of Six Sigma approaches and results.

Key practices which can be used at medical device manufacturers for improving quality/processes include, but are not limited to:

Problem Solving Quality Tools and Techniques

Quality Circles and Improvement Teams

Voice of the Customer

Quality Function Deployment

Key Performance Indicators

Design of Experiments

Failure Modes and Effects Analysis

Malkit Rai, QA Manager