six sigma Attn ANUPAMA

June 4, 2008

Dear Anupama,

First up, thanks for nice wrap up, and keeping me involved in this research, secondly, I am really grateful of Dr Vijay for his support and motivation.

Regarding your query about Black Belt; like other programmes Six sigma specialists also have categorized its fields of professionals to many levels. For example, in martial arts (Karati, Tek Wando, King Fo) we have different types of belts (white, green, red etc). Also the Six Sigma professionals exist at every level – each with a different role to play. While implementations and roles may vary, here is a basic guide to who does what.

There are many consultants who is providing six sigma trainings in India like; A B C Business Solutions Pvt Ltd, BMG India, Business Strategic Solutions, DSS Systems & Software Technologies Limited, Indian Institute of Quality Management – IIQM, Indian Statistical Institute ,Institute of Quality Limited, Institute of Sigma Learning Pvt. Ltd, Kaul Associates, KPMG India, Omnex, Projects India, QAI India Limited, Six Sigma Alchemy (P) Ltd, Sigma Trainers and Consultants in Quality Improvement, Six Sigma Excellence, TQM International Pvt. Ltd and TreMyn

At the project level (Six Sigma), there are black belts, master black belts, green belts, yellow belts and white belts. These people conduct projects and implement improvements.

Black Belt: The Certified Six Sigma Black Belt is a professional who can explain Six Sigma philosophies and principles, including supporting systems and tools. A Black Belt should demonstrate team leadership, understand team dynamics and assign team member roles and responsibilities. Black Belts have a thorough understanding of all aspects of the DMAIC model in accordance with Six Sigma principles. They have basic knowledge of Lean enterprise concepts, are able to identify non-value-added elements and activities and are able to use specific tools

The Master Black Belt provides expert advice to process improvement teams regarding team dynamics, change management, process re-design strategies, performance improvement toolsets (especially those of Six Sigma and Lean), and technical expertise, such as statistical process control and data analysis. Initially the Master Black Belt will coach internal process improvement teams; however, as internal black belts are developed, the Master Black Belt will also provide guidance to process teams in the external health care community, to employ Lean Six Sigma tools in order to perk up the quality and safety of patient care.

Green Belt: Assists with data collection and analysis for Black Belt projects. Leads Green Belt projects or teams.

Master Black Belt: Trains and coaches Black Belts and Green Belts. Functions more at the Six Sigma program level by developing key metrics and the strategic direction. Acts as an organization’s Six Sigma technologist and internal consultant.

Yellow Belt: Participates as a project team member. Reviews process improvements that support the project.

White Belt: Can work on local problem-solving teams that support overall projects, but may not be part of a Six Sigma project team. Understands basic Six Sigma concepts from an awareness perspective.

Every project needs organizational support. Six Sigma executives and champions set the direction for selecting and deploying projects. They ensure, at a high level, that projects succeed, add value and fit within the organizational plan.

Champions: Translate the company’s vision, mission, goals and metrics to create an organizational deployment plan and identify individual projects. Identify resources and remove roadblocks.

Executives: Provide overall alignment by establishing the strategic focus of the Six Sigma program within the context of the organization’s culture and vision.

Best Regards

Bashaar

From: anupama sukhlecha <anupama_acad@...>Subject: six sigma in hospitals Attn Dr Bashaarnetrum Date: Wednesday, June 4, 2008, 10:41 PM

Dear Dr Bashaar,

I am replying to all your mails together.

The pros and cons you have listed present a true picture of this new methodology.

Whenever some new methodology is introduced, there are crticisms to begin with. Later, as we get adapted to new systems, we realize: "Wow, this is really wonderful-why didn't I get this idea before? It has brought wonderful results and that too at such a low cost!"

Coming to health sector, the methodology has to be modified from what we use in industry because, here we are dealing not with products, but life of patients. Steps could be differing with even level of health care-example whether it is Primary health centre, secondary, tertiary or a teaching hospital.

Communication between staff is very important. Medication error can occur at many steps-right from manufacturing to patient consuming the medicine. To minimise these errors, we need to have a good inter-hospital staff communication.

You have given a nice list of patient safety factors in your posting.

Dr Bashaar, while doing literature search, I found some terms like black belts...Would you like to elaborate on these?

-Anupama

Did you know? You can CHAT without downloading messenger. Click here

June 5, 2008

Thanks a lot Dr. Vijay, Dr. Anupama and Dr. Bashaar for this exciting, heart-throbbing discussion on Six Sigma in Healthcare. Trust me I am learning a lot from this new topic. Many a things discussed on this topic are absolutely new to me. I am still gaining before being able to contribute. All the best.

With regards

Dr. Geer M. Ishaq

Sr. Lecturer

Dept. of Pharmaceutical Sciences

University of Kashmir

Srinagar-190006 (J & K)

Ph: 9419970971, 9906673100

E-mail: ishaq@...

Website: http://ishaqgeer.googlepages.com

six sigma in hospitals Attn Dr Bashaarnetrumgroups (DOT) comDate: Wednesday, June 4, 2008, 10:41 PM

Dear Dr Bashaar,

I am replying to all your mails together.

The pros and cons you have listed present a true picture of this new methodology.

Whenever some new methodology is introduced, there are crticisms to begin with. Later, as we get adapted to new systems, we realize: "Wow, this is really wonderful-why didn't I get this idea before? It has brought wonderful results and that too at such a low cost!"

Coming to health sector, the methodology has to be modified from what we use in industry because, here we are dealing not with products, but life of patients. Steps could be differing with even level of health care-example whether it is Primary health centre, secondary, tertiary or a teaching hospital.

Communication between staff is very important. Medication error can occur at many steps-right from manufacturing to patient consuming the medicine. To minimise these errors, we need to have a good inter-hospital staff communication.

You have given a nice list of patient safety factors in your posting.

Dr Bashaar, while doing literature search, I found some terms like black belts...Would you like to elaborate on these?

-Anupama

Did you know? You can CHAT without downloading messenger. Click here Send free SMS to your Friends on Mobile from your Messenger. Download Now! http://messenger./download.php

June 5, 2008

Thanks a lot Dr. Vijay, Dr. Anupama and Dr. Bashaar for this exciting, heart-throbbing discussion on Six Sigma in Healthcare. Trust me I am enjoying and learning a lot from this new topic. Many a things discussed on this topic are absolutely new to me. I am still gaining before being able to contribute. All the best.

With regards

Dr. Geer M. Ishaq

Sr. Lecturer

Dept. of Pharmaceutical Sciences

University of Kashmir

Srinagar-190006 (J & K)

Ph: 9419970971, 9906673100

E-mail: ishaq@...

Website: http://ishaqgeer.googlepages.com

six sigma in hospitals Attn Dr Bashaarnetrumgroups (DOT) comDate: Wednesday, June 4, 2008, 10:41 PM

Dear Dr Bashaar,

I am replying to all your mails together.

The pros and cons you have listed present a true picture of this new methodology.

Whenever some new methodology is introduced, there are crticisms to begin with. Later, as we get adapted to new systems, we realize: "Wow, this is really wonderful-why didn't I get this idea before? It has brought wonderful results and that too at such a low cost!"

Coming to health sector, the methodology has to be modified from what we use in industry because, here we are dealing not with products, but life of patients. Steps could be differing with even level of health care-example whether it is Primary health centre, secondary, tertiary or a teaching hospital.

Communication between staff is very important. Medication error can occur at many steps-right from manufacturing to patient consuming the medicine. To minimise these errors, we need to have a good inter-hospital staff communication.

You have given a nice list of patient safety factors in your posting.

Dr Bashaar, while doing literature search, I found some terms like black belts...Would you like to elaborate on these?

-Anupama

Did you know? You can CHAT without downloading messenger. Click here

From Chandigarh to Chennai - find friends all over India. Click here.

June 5, 2008

Dear Dr Geer, All of us arelearning. So, you can contribute to the discussion in your way. -Anupama"Geer M. Ishaq" <ishaqgeer@...> wrote: Thanks a lot Dr. Vijay, Dr. Anupama and Dr. Bashaar for this exciting, heart-throbbing discussion on Six Sigma in Healthcare. Trust me I am enjoying and learning a lot from this new topic. Many a things discussed on this topic are absolutely new

to me. I am still gaining before being able to contribute. All the best. With regards Dr. Geer M. Ishaq Sr. Lecturer Dept. of Pharmaceutical Sciences University of Kashmir Srinagar-190006 (J & K) Ph: 9419970971, 9906673100 E-mail: ishaqkashmiruniversity (DOT) ac.in Website: http://ishaqgeer.googlepages.com six sigma in hospitals Attn Dr Bashaarnetrumgroups (DOT) comDate: Wednesday, June 4, 2008, 10:41 PM Dear Dr Bashaar, I am replying to all your mails together. The pros and cons you have listed present a true picture of this new methodology. Whenever some new methodology is introduced, there are crticisms to begin with.

Later, as we get adapted to new systems, we realize: "Wow, this is really wonderful-why didn't I get this idea before? It has brought wonderful results and that too at such a low cost!" Coming to health sector, the methodology has to be modified from what we use in industry because, here we are dealing not with products, but life of patients. Steps could be differing with even level of health care-example whether it is Primary health centre, secondary, tertiary or a teaching hospital. Communication between staff is very important. Medication error can occur at many steps-right from manufacturing to patient consuming the medicine. To minimise these errors, we need to have a good inter-hospital staff communication. You have given a nice list of patient safety factors in your posting. Dr Bashaar, while doing literature search, I found

some terms like black belts...Would you like to elaborate on these? -Anupama Did you know? You can CHAT without downloading messenger. Click here From Chandigarh to Chennai - find friends all over India. Click here.

Explore your hobbies and interests. Click here to begin.

June 5, 2008

Dear Dr Bashaar, Thanks for your informative posts. Some of us should definitely go and get trained from the consultants who train in six sigma concepts. Also thanks for enlightening us on master black belts, green belts...champions and executives. If we form a team on rational medicine use using six sigma concept, let us see which belt we will be assigned. Surely Vijay Sir is apt for the master black belt role. -AnupamaMohammad Bashaar <bashaarulfat@...> wrote: Dear Anupama, First up, thanks for nice wrap up, and keeping me involved in this research, secondly, I am really grateful of Dr Vijay for his support and motivation. Regarding your query about Black Belt; like other programmes Six sigma specialists also have categorized its fields of professionals to many levels. For example, in martial arts (Karati, Tek Wando, King Fo) we have different types of belts (white, green, red etc). Also the Six

Sigma professionals exist at every level – each with a different role to play. While implementations and roles may vary, here is a basic guide to who does what. There are many consultants who is providing six sigma trainings in India like; A B C Business Solutions Pvt Ltd, BMG India, Business Strategic Solutions, DSS Systems & Software Technologies Limited, Indian Institute of Quality Management – IIQM, Indian Statistical Institute ,Institute of Quality Limited, Institute of Sigma Learning Pvt. Ltd, Kaul Associates, KPMG India, Omnex, Projects India, QAI India Limited, Six Sigma Alchemy (P) Ltd, Sigma Trainers and Consultants in Quality Improvement, Six Sigma Excellence, TQM International Pvt. Ltd and TreMyn At the project level (Six Sigma), there

are black belts, master black belts, green belts, yellow belts and white belts. These people conduct projects and implement improvements. Black Belt: The Certified Six Sigma Black Belt is a professional who can explain Six Sigma philosophies and principles, including supporting systems and tools. A Black Belt should demonstrate team leadership, understand team dynamics and assign team member roles and responsibilities. Black Belts have a thorough understanding of all aspects of the DMAIC model in accordance with Six Sigma principles. They have basic knowledge of Lean enterprise concepts, are able to identify non-value-added elements and activities and are able to use specific tools The Master Black Belt provides expert advice to process improvement teams regarding team dynamics, change management, process re-design strategies, performance improvement toolsets (especially those of Six Sigma and Lean), and technical expertise, such as statistical process control and data analysis. Initially the Master Black Belt will coach internal process improvement teams; however, as internal black belts are developed, the Master Black Belt will also provide guidance to process teams in the external health care community, to employ Lean Six Sigma tools in order to perk up the quality and safety of patient care. Green Belt: Assists with data collection and analysis for Black Belt projects. Leads Green Belt projects

or teams. Master Black Belt: Trains and coaches Black Belts and Green Belts. Functions more at the Six Sigma program level by developing key metrics and the strategic direction. Acts as an organization’s Six Sigma technologist and internal consultant. Yellow Belt: Participates as a project team member. Reviews process improvements that support the project. White Belt: Can work on local problem-solving teams that support overall projects, but may not be part of a Six Sigma project team. Understands basic Six Sigma concepts from an awareness perspective. Every project needs organizational support. Six Sigma executives and champions set the direction for selecting and deploying projects. They ensure, at a high level, that projects succeed, add value and fit within the organizational plan. Champions: Translate the company’s vision, mission, goals and metrics to create an organizational deployment plan and identify individual projects. Identify resources and remove roadblocks. Executives: Provide overall alignment by establishing the strategic focus of the Six Sigma program within the context of the organization’s culture and vision. Best Regards Bashaar From: anupama sukhlecha <anupama_acad (DOT) co.in>Subject: six sigma

in hospitals Attn Dr Bashaarnetrum Date: Wednesday, June 4, 2008, 10:41 PM Dear Dr Bashaar, I am replying to all your mails together. The pros and cons you have listed present a true picture of this new methodology. Whenever some new methodology is introduced, there are crticisms to begin with. Later, as we get adapted to new systems, we realize: "Wow, this is really wonderful-why didn't I get this idea before? It has brought wonderful results and that too at such a low cost!" Coming to health sector, the methodology has to be modified from what we use in industry because, here we are dealing not with products, but life of patients. Steps could be differing with even level of health care-example whether it is Primary health centre, secondary, tertiary or a teaching hospital. Communication between staff is very important. Medication error can occur at many steps-right from manufacturing to patient consuming the medicine. To minimise these errors, we need to have a good inter-hospital staff communication. You have given a nice list of patient safety factors in your posting. Dr Bashaar, while doing literature search, I found some terms like black belts...Would you like to elaborate on these? -Anupama Did you know? You can CHAT without downloading messenger. Click here

Bollywood, fun, friendship, sports and more. You name it, we have it.

June 6, 2008

Dear Dr. Anupama:

Here is an article copied from PharmAsia focus on Lean Six Sigma principles in Pharmaceutical Manufacturing.

Pharmaceutical Manufacturers

Embracing Lean Six Sigma

Pharmaceutical manufacturers are looking to Lean Manufacturing and Six Sigma principles to help them boost operational efficiency and improve quality, while facilitating compliance.

E Danese Product Strategy Director, Life Sciences, Oracle, USA

Dennis Constantinou Senior Director, Life Sciences, Oracle, USA

Today, pharmaceutical manufacturers are focused, as never before, on reducing operational costs while ensuring compliance. Cost pressures are increasingly acute as many pharmaceutical manufacturers see a dwindling product pipeline, as well as greater competition from generics. To ensure that their bottom lines remain solid, pharmaceutical manufacturers are looking to increase the efficiency of their operational and manufacturing processesâ€”optimising resources, improving efficiency, reducing waste and controlling inventory. The regulatory climate is, at last, conducive to focusing on such changes, as the U.S. FDA as well as other regulatory bodies now support approaches that seek to reduce risk by building quality into the manufacturing process from the start, as opposed to relying on end-process testing. In this climate, pharma manufacturers are looking to Lean Manufacturing and Six Sigma principlesâ€”proven in other industriesâ€”to help them boost

operational efficiency and improve quality, while facilitating compliance.

Moving beyond the status quo

Despite the pharmaceutical industryâ€™s focus on quality, it has failed to keep up with other industries in terms of manufacturing efficiency and productivity, largely because of the cost and burden involved in revalidating any process changed in the spirit of improvement. Once manufacturers confirm or validate their processes as compliant, they traditionally have been very reticent to change them. The simple fact is that pharmaceutical manufacturers, which historically have enjoyed consistently robust profit margins, have had little economic incentive to introduce change.

The industryâ€™s focus on maintaining the status quo in its manufacturing environment has produced inefficiency and waste. It is estimated that the potential world-wide cost savings from efficiency improvement could be as high as US$ 90 billion. While Research and Development (R & D) is generally considered a major cost centre for the pharmaceutical industry, manufacturing quietly accounts for more than twice the expense of R & Dâ€”representing, on average, 36 percent of a pharmaceutical manufacturerâ€™s costs. The true cost of manufacturing becomes even more apparent when one considers the amount attributed to non-value-added activities and waste which is 80 percent and 50 percent, respectively.

Quality has also suffered under the status quo. It is interesting to consider that the number of drug recalls has risen sharply in recent yearsâ€”three-quarters of which are attributed to manufacturing defects. The reject percentage in the pharmaceutical industry ranges from 5 percent to 10 percent (<2 Sigma), compared to 0.0001 (6 Sigma) in the semiconductor industry. This reject-percentage costs the industry between US$ 4.5 billion and US$ 9 billion per year based on US$ 90 billion/year spent on manufacturing.

Several important factors have converged in recent years to jumpstart substantial change in how pharmaceutical manufacturers approach and manage their manufacturing operations. First, many manufacturers face a declining development pipeline as well as shrinking profit margins as they face increased competition from generic drug manufacturers. As such, they see a growing need to abandon the status quo to focus on improving productivity, efficiency and quality. At the same time, the U.S. FDA and other regulatory bodies are acknowledging that the industry has fallen behind other sectors in terms of efficiency and quality, and have begun to endorse a â€œquality by design modelâ€ that contrasts with the industryâ€™s historical â€œquality by testâ€ results approach. As part of this shift, the U.S. FDA launched its Process Analytical Technology (PAT) initiative, a risk-based guidance model that seeks to direct pharmaceutical manufacturers toward consistent

and predictable quality (higher sigmas). The PAT approach is to build in quality improvements on the factory floor through a deep understanding of how variable process attributes affect product quality at a fundamental level.

The road to Lean Six Sigma

As pharmaceutical manufacturers seek to transform manufacturing operations and enhance quality, many are turning to two highly regarded management approachesâ€”Lean Manufacturing and Six Sigmaâ€”that have proven effective in other industries, such as electronics and auto manufacturing. Lean Manufacturing focuses on eliminating manufacturing waste, with the objective of making manufacturers more responsive to customer demand and market changes. Six Sigma is a business process methodology that focuses on minimising variationâ€”in product and processâ€”to reduce product defects. Using the methodology, one standard deviation from the mean is one sigma; therefore, manufacturers operating at Â±6 sigma are operating at 99.9997 percent compliance. When pharmaceutical manufacturers implement Lean and Six Sigma concepts they have a powerful methodology to help them improve quality, compliance, productivity, costs and speedâ€”ultimately enabling them to bring

better products to market, faster and more cost effectively. To achieve transformation to a Lean Six Sigma environment, organisations must focus on change at three levelsâ€”operating systems, management systems, and mindsets / behaviours. (Figure 1) At the operating system level, manufacturers must understand demand levels, design lean production systems around material and information flow analysis (e.g., optimise layout), create tactical implementation plans, and develop standardised work charts and instructions.

When transitioning to a Lean Six Sigma environment, pharmaceutical companies must also assess their management systems at several different levels and direct changes that support Lean concepts. Transition teams must consider what management tools, including IT systems and communication tools, the company requires. The organisation must also consider how it will define or measure success, by setting Key Performance Indicators (KPIs) at different levels of production. It is also essential to create a highly visible problem resolution system to drive and institutionalise change. Finally, organisations must implement and scale these capabilities so that they span the entire value chainâ€”which is often dizzyingly complex and can extend beyond traditional organisational boundaries. The final arena for hangeâ€”transforming mindsets and behavioursâ€”is often the most challenging for many organisations. Individuals often fear, and in turn, resist change. This

truism is especially applicable in the pharmaceutical manufacturing industry, which has, until recently, thrived despite its focus on maintaining the status quo.

In transitioning to a Lean Six Sigma environment, it is critical that the management team defines and communicates a consistent mission, vision and value system throughout organisationâ€”always maintaining the customer focus. The transformation team should focus on achieving top-down buy-in by aligning resources to help build and transfer momentum across the organisation. Training cannot be overlooked. Transformation team must develop a comprehensive strategy that provides training opportunities at multiple points in the transformation as a means of achieving h4er organisational buy-in and competence from both management and the ranks.

The IT factor

IT factors heavily in the transition to a Lean Six Sigma enterprise and the subsequent journey of continuous improvement. Because of the complexity of the pharmaceutical manufacturing environment, organisations require flexible and interoperable IT systems that provide information, not just data, across the enterprise. In a Lean Six Sigma environment, information flows must complement and keep pace with physical flows to deliver the information needed (Figure 2).

The ability to mine data and interpret it efficiently, quickly and seamlessly is also very important. Using the data and turning it into information quickly enables pharmaceutical manufacturers to outperform their competition. Having the right data readily available when itâ€™s needed also makes it easier to respond to FDA inquiries.

IT supports several tenets essential to the implementation of a Lean Six Sigma environment, including:

Ensuring the integrity of data

Organisations require good data to make wise decisions. Most pharmaceutical manufacturers have IT environments with solutions from multiple IT vendors. These systems are often siloed, precluding the exchange of information. In addition, manufacturers often have multiple instances of applications across their various production facilities. For example, it is not unusual for pharmaceutical manufacturers to have separate data files for products and customers in different IT systems at different sites. This approach also precludes a comprehensive view of the enterprise, which is essential to a quality-by-design focus.

To obtain the end-to-end visibility needed in a Lean Six Sigma environment, pharma manufacturers must have an integration strategy for linking heterogeneous systems, creating a single source of trusted information that provides a complete picture of the operations.

A Lean Sigma Six environment requires complete confidence in the integrity of an enterpriseâ€™s supply chain, manufacturing and distribution-related data. As such, a single source of information is essential. It eliminates duplication and outdated information, driving informed decision-making and lower administrative costs. This approach also provides a streamlined audit trail in the event that a regulatory agency raises a product safety issue. For example, if a bad lot of drug compound is released into the market, a pharmaceutical manufacturer can quickly establish where the lot was manufactured, which equipment was used, the source of the ingredients, and the locations to which the compound was distributed. A single version of truth, which is helpful in all industries, is especially critical in regulated industries because it eliminates the need to synchronise multiple sources of redundant data and manage a host of different technologiesâ€”which

increase risk and complexity.

Building quality into the manufacturing process

Process and workflow automationâ€”which allow organisations to build quality into the processâ€”may be ITâ€™s single greatest contribution to enabling a Lean Six Sigma environment. Integrated IT infrastructures allow pharmaceutical manufacturers to rely less on manual checks, which present greater risk and variability, and more on automated checks that are built-in, enforced going forward, and can easily be audited by the FDA and other regulatory agencies. For instance, automation enables manufacturers to enforce electronic signature checkpoints during the processing of a production batch order and automatically notify key personnel of nonconformances, so that reviews and action can be undertaken quickly.

The capture and processing of in-line data is critical to a Lean Six Sigma environmentâ€”as well as PATâ€”because manufacturers must understand all sources of product variability. This understanding cannot be achieved without collecting data from every part of the supply chain and manufacturing process. For example, a manufacturerâ€™s probe sensor might sample the particle size of a batch of product during a granulation process. To make adjustments that would improve product quality or consistency, the manufacturer must determine how the particle size compares to previous batches and standardsâ€”a process that depends on the capture and analysis of in-line and benchmarked dataâ€”and understand how various possible process adjustments will impact all critical technical attributes of the material. An integrated IT infrastructure is essential to enabling manufacturers to capture the secure, analysable and actionable data needed to transform their

operations.Electronic record keeping plays an important role in helping pharmaceutical manufacturers build quality into the process. Paper records are cumbersome and expensive to circulate for review and approval when there are multiple staff members or departments involved in the process. This challenge is compounded in a global enterprise. Faster and cheaper product development, manufacturing and quality assurance turnaround is possible with electronic routing of signature requests anywhere, virtually and instantly. Electronic records also improve accuracy. There are limited means to prevent users from entering invalid data on paper forms beyond rigorous and time-consuming manual checking. Sophisticated electronic record systems, however, are adept at reducing data errors by providing users with lists of appropriate values from which to choose, and by validating data formats prior to accepting or saving the data into files or tables.

Enabling rapid analysis and modelling to respond to change

Pharmaceutical manufacturers possess massive quantities of data on processes as far ranging as purchasing of office supplies and analysis of data from gas hromatographs. Many, however, cannot analyse or interpret paper-based or siloed information to identify important trends and drive improved manufacturing practices.

A single source of truth, coupled with advanced analytics, enables pharmaceutical manufacturers to run real-time analysis that yield the kind of business intelligence that reduces risk, helps to improve operating efficiency and agility, and streamlines compliance. For example, a manufacturer can use advanced analytics to conduct quality analysis, risk assessments, yield analysis, on-time production tracking, scrap reason analysis, cost comparisons by job, and comparisons of manufacturing plans and efficiencies between sites, to name just a few of the endless possibilities.

Instituting and controlling businesses processes and standard operating procedures

Removing variability in processes and materials is fundamental to a Lean Six Sigma environment. IT systems provide the information necessary to establish an environment that supports risk-based decisions. IT serves as a lens through which processes can be observed, monitored and measured. Only then, can manufacturers enable greater control over variability.

Process automation further enhances operational efficiencies. On the materials management front, an integrated IT infrastructure drives automation that enables manufacturers to enforce business rules that require materials to go through certain quality tests before they reach a customer, as opposed to relying on a paper document to confirm a test has been completed. Automating controls also reduces ongoing complexity, redundancy, the potential for operator error and, ultimately, waste.

Leading IT vendors, such as Oracle, are removing the complexity from process integration by leveraging Business Process Execution Language (BPEL), which allows manufacturers to build a process once and then apply it throughout the environment. BPEL is emerging as the standard for assembling a set of discrete services into an end-to-end process flow, radically reducing the cost and complexity of process integration initiatives.

Enabling a real-time demand-driven sales and operations planning process

A demand-driven model, which supports Lean Six Sigma principles, allows pharma manufacturers to postpone inventory build-up and reduce inventory carrying costs and the risk of a product expiring before sale. The transition from a make-to-stock approach to a demand-driven environment, however, has not been an easy one for many manufacturers.

Most companies today have a fragmented process for Sales and Operations Planning (S & OP). Each department tends to have its own process with critical company data stored on spreadsheets. Departmental plans are not aligned, and there is misalignment between how departments are measured and overall company objectives. For example, sales management is often measured on meeting a sales quota that may be achieved by selling products that the supply chain is unable to produce. This tends to lead to a very time-consuming and manual process of trying to come to agreement on â€œthe forecast.â€ This painful exercise typically yields an inaccurate forecast. The forecast is then â€œtossed over the wallâ€ to the supply chain to figure out how to expedite processes to meet the demand with no thought given to the profitability of the decisions. Further complicating the process is the fact that the â€œapprovedâ€ plans, which may exist on spreadsheets, are often

filed away, and have little relation to the actual plans being executed.

New IT solutions can help manufacturers address their complex S & OP needs by enabling them to bring all business areas together for the purpose of aligning supply with demand and delivering an operational plan designed to achieve a defined corporate business strategy. Some systems, for example, allow a direct linkage between sales orders and production batches, allowing users to create a batch reservation for a sales order. When the batch is completed, the reservation for the order line is converted into an inventory allocation and can then be confirmed and shipped. Alternatively, if there are no existing batches planned or in process for the required product, a user can initiate a request to create a batch specifically for that order. Automated workflow notifications keep the order entry personnel apprised of any changes to the production schedule that may impact their order.

Pharmaceutical manufacturers often have multiple manufacturing plants, warehouses, distribution centres, and transportation lanes and modes. Determining the best manufacturing, distribution and logistics choice becomes an exercise in selecting from among thousands of combinations. Dynamic inputs to the network design processâ€”such as fuel prices, currency exchange rates, real labour rates and seasonal demandâ€”further complicate the process. Advanced Strategic Network Optimisation (SNO) solutions can help manufacturers optimise choices and combinations. SNO solutions perform two distinct functions, simulating and optimising different supply chain configurations and creating dynamic sourcing rules to be used by downstream planning processes. These solutions, which combine a flexible supply chain modelling environment with highly tuned solver algorithms and visualisation capabilities, allow users to define, simulate and evaluate complex manufacturing,

distribution and transportation supply chain problemsâ€”before making costly mistakes.

Ensuring compliance and security

It is very difficult to determine corrective and preventative actions without a sound understanding of variability sources and estimates. The information required for a corrective and preventative action includes appropriate details of the event, the time and date of the nonconformance, the phase of the batch in which the nonconformance occurred, details of the incident or observation, level of criticality, and required follow up, as well as the signatures of various operator(s) and / or supervisors. This process, which is essential to both quality improvement and regulatory compliance, is costly and time consuming when completed manually.

It also presents many opportunities for data omission or the recording of incorrect data. Corrective and Preventive Action (CAPA) solutions manage issues to closure through an automated workflow, and provide appropriate documentation required for regulatory compliance.

Pharmaceutical manufacturers are on the cusp of realising the benefits that Lean Six Sigma practices can deliver to their organisations and the industry as a whole. To successfully transform their organisations, however, pharmaceutical manufacturers require greater visibility into their end-to-end operationsâ€”an objective that cannot readily be achieved through paper-based processes or disparate IT systems. To this end, pharmaceutical manufacturers increasingly look to integrated IT infrastructures to help them execute Lean Six Sigma paradigms and, ultimately, achieve new levels of operational efficiency, quality and corporate performance.

With regards

Dr. Geer M. Ishaq

Sr. Lecturer

Dept. of Pharmaceutical Sciences

University of Kashmir

Srinagar-190006 (J & K)

Ph: 9419970971, 9906673100

E-mail: ishaq@...

Website: http://ishaqgeer.googlepages.com

six sigma in hospitals Attn Dr Bashaarnetrumgroups (DOT) comDate: Wednesday, June 4, 2008, 10:41 PM

Dear Dr Bashaar,

I am replying to all your mails together.

The pros and cons you have listed present a true picture of this new methodology.

Whenever some new methodology is introduced, there are crticisms to begin with. Later, as we get adapted to new systems, we realize: "Wow, this is really wonderful-why didn't I get this idea before? It has brought wonderful results and that too at such a low cost!"

Coming to health sector, the methodology has to be modified from what we use in industry because, here we are dealing not with products, but life of patients. Steps could be differing with even level of health care-example whether it is Primary health centre, secondary, tertiary or a teaching hospital.

Communication between staff is very important. Medication error can occur at many steps-right from manufacturing to patient consuming the medicine. To minimise these errors, we need to have a good inter-hospital staff communication.

You have given a nice list of patient safety factors in your posting.

Dr Bashaar, while doing literature search, I found some terms like black belts...Would you like to elaborate on these?

-Anupama

Did you know? You can CHAT without downloading messenger. Click here

From Chandigarh to Chennai - find friends all over India. Click here.

Explore your hobbies and interests. Click here to begin.

June 6, 2008

Dear Dr Geer, That's a nice article explaining the role of IT and BPEL to improve compliance and reduce costs in pharmaceutical industries. Could you also expand on the software used in six sigma methodology? -Anupama"Geer M. Ishaq" <ishaqgeer@...> wrote: Dear Dr. Anupama: Here is an article copied from PharmAsia focus on Lean

Six Sigma principles in Pharmaceutical Manufacturing. Pharmaceutical Manufacturers Embracing Lean Six Sigma Pharmaceutical manufacturers are looking to Lean Manufacturing and Six Sigma principles to help them boost operational efficiency and improve quality, while facilitating compliance. E Danese Product Strategy Director, Life Sciences, Oracle, USA Dennis Constantinou Senior Director, Life Sciences, Oracle, USA Today, pharmaceutical manufacturers are focused, as never before, on reducing operational costs while ensuring compliance. Cost pressures are increasingly acute as many pharmaceutical manufacturers see a dwindling product pipeline, as well as greater competition from generics. To ensure that their bottom lines remain solid, pharmaceutical manufacturers are looking to increase the efficiency of their operational and

manufacturing processesâ€”optimising resources, improving efficiency, reducing waste and controlling inventory. The regulatory climate is, at last, conducive to focusing on such changes, as the U.S. FDA as well as other regulatory bodies now support approaches that seek to reduce risk by building quality into the manufacturing process from the start, as opposed to relying on end-process testing. In this climate, pharma manufacturers are looking to Lean Manufacturing and Six Sigma principlesâ€”proven in other industriesâ€”to help them boost operational efficiency and improve quality, while facilitating compliance. Moving beyond the status quo Despite the pharmaceutical industryâ€™s focus on quality, it has failed to keep up with other industries in terms of manufacturing efficiency and productivity, largely because of the cost and burden involved in revalidating any process changed in the spirit of improvement. Once manufacturers confirm or validate

their processes as compliant, they traditionally have been very reticent to change them. The simple fact is that pharmaceutical manufacturers, which historically have enjoyed consistently robust profit margins, have had little economic incentive to introduce change. The industryâ€™s focus on maintaining the status quo in its manufacturing environment has produced inefficiency and waste. It is estimated that the potential world-wide cost savings from efficiency improvement could be as high as US$ 90 billion. While Research and Development (R & D) is generally considered a major cost centre for the pharmaceutical industry, manufacturing quietly accounts for more than twice the expense of R & Dâ€”representing, on average, 36 percent of a pharmaceutical manufacturerâ€™s costs. The true cost of manufacturing becomes even more apparent when one considers the amount attributed to non-value-added activities and waste which is 80 percent and 50 percent,

respectively. Quality has also suffered under the status quo. It is interesting to consider that the number of drug recalls has risen sharply in recent yearsâ€”three-quarters of which are attributed to manufacturing defects. The reject percentage in the pharmaceutical industry ranges from 5 percent to 10 percent (<2 Sigma), compared to 0.0001 (6 Sigma) in the semiconductor industry. This reject-percentage costs the industry between US$ 4.5 billion and US$ 9 billion per year based on US$ 90 billion/year spent on manufacturing. Several

important factors have converged in recent years to jumpstart substantial change in how pharmaceutical manufacturers approach and manage their manufacturing operations. First, many manufacturers face a declining development pipeline as well as shrinking profit margins as they face increased competition from generic drug manufacturers. As such, they see a growing need to abandon the status quo to focus on improving productivity, efficiency and quality. At the same time, the U.S. FDA and other regulatory bodies are acknowledging that the industry has fallen behind other sectors in terms of efficiency and quality, and have begun to endorse a â€œquality by design modelâ€ that contrasts with the industryâ€™s historical â€œquality by testâ€ results approach. As part of this shift, the U.S. FDA launched its Process Analytical Technology (PAT) initiative, a risk-based guidance model that seeks to direct pharmaceutical manufacturers toward consistent and predictable quality

(higher sigmas). The PAT approach is to build in quality improvements on the factory floor through a deep understanding of how variable process attributes affect product quality at a fundamental level. The road to Lean Six Sigma As pharmaceutical manufacturers seek to transform manufacturing operations and enhance quality, many are turning to two highly regarded management approachesâ€”Lean Manufacturing and Six Sigmaâ€”that have proven effective in other industries, such as electronics and auto manufacturing. Lean Manufacturing focuses on eliminating manufacturing waste, with the objective of making manufacturers more responsive to customer demand and market changes. Six Sigma is a business process methodology that focuses on minimising variationâ€”in product and processâ€”to reduce product defects. Using the methodology, one standard deviation from the mean is one sigma; therefore, manufacturers operating at Â±6 sigma are operating at 99.9997

percent compliance. When pharmaceutical manufacturers implement Lean and Six Sigma concepts they have a powerful methodology to help them improve quality, compliance, productivity, costs and speedâ€”ultimately enabling them to bring better products to market, faster and more cost effectively. To achieve transformation to a Lean Six Sigma environment, organisations must focus on change at three levelsâ€”operating systems, management systems, and mindsets / behaviours. (Figure 1) At the operating system level, manufacturers must understand demand levels, design lean production systems around material and information flow analysis (e.g., optimise layout), create tactical implementation plans, and develop standardised work charts and instructions. When transitioning to a Lean Six Sigma environment, pharmaceutical companies must also assess their management systems at several different levels and direct changes that support Lean concepts. Transition teams must

consider what management tools, including IT systems and communication tools, the company requires. The organisation must also consider how it will define or measure success, by setting Key Performance Indicators (KPIs) at different levels of production. It is also essential to create a highly visible problem resolution system to drive and institutionalise change. Finally, organisations must implement and scale these capabilities so that they span the entire value chainâ€”which is often dizzyingly complex and can extend beyond traditional organisational boundaries. The final arena for hangeâ€”transforming mindsets and behavioursâ€”is often the most challenging for many organisations. Individuals often fear, and in turn, resist change. This truism is especially applicable in the pharmaceutical manufacturing industry, which has, until recently, thrived despite its focus on maintaining the status quo. In transitioning to a Lean Six Sigma environment, it is

critical that the management team defines and communicates a consistent mission, vision and value system throughout organisationâ€”always maintaining the customer focus. The transformation team should focus on achieving top-down buy-in by aligning resources to help build and transfer momentum across the organisation. Training cannot be overlooked. Transformation team must develop a comprehensive strategy that provides training opportunities at multiple points in the transformation as a means of achieving h4er organisational buy-in and competence from both management and the ranks. The IT factor IT factors heavily in the transition to a Lean Six Sigma enterprise and the subsequent journey of continuous improvement. Because of the complexity of the pharmaceutical manufacturing environment, organisations require flexible and interoperable IT systems that provide information, not just data, across the enterprise. In a Lean Six Sigma environment,

information flows must complement and keep pace with physical flows to deliver the information needed (Figure 2). The ability to mine data and interpret it efficiently, quickly and seamlessly is also very important. Using the data and turning it into information quickly enables pharmaceutical manufacturers to outperform their competition. Having the right data readily available when itâ€™s needed also makes it easier to respond to FDA inquiries. IT supports several tenets essential to the implementation of a Lean Six Sigma environment, including: Ensuring the

integrity of data Organisations require good data to make wise decisions. Most pharmaceutical manufacturers have IT environments with solutions from multiple IT vendors. These systems are often siloed, precluding the exchange of information. In addition, manufacturers often have multiple instances of applications across their various production facilities. For example, it is not unusual for pharmaceutical manufacturers to have separate data files for products and customers in different IT systems at different sites. This approach also precludes a comprehensive view of the enterprise, which is essential to a quality-by-design focus. To obtain the end-to-end visibility needed in a Lean Six Sigma environment, pharma manufacturers must have an integration strategy for linking heterogeneous systems, creating a single source of trusted information that provides a complete picture of the operations. A Lean Sigma Six environment requires

complete confidence in the integrity of an enterpriseâ€™s supply chain, manufacturing and distribution-related data. As such, a single source of information is essential. It eliminates duplication and outdated information, driving informed decision-making and lower administrative costs. This approach also provides a streamlined audit trail in the event that a regulatory agency raises a product safety issue. For example, if a bad lot of drug compound is released into the market, a pharmaceutical manufacturer can quickly establish where the lot was manufactured, which equipment was used, the source of the ingredients, and the locations to which the compound was distributed. A single version of truth, which is helpful in all industries, is especially critical in regulated industries because it eliminates the need to synchronise multiple sources of redundant data and manage a host of different technologiesâ€”which increase risk and complexity. Building quality into the manufacturing process Process and workflow automationâ€”which allow organisations to build quality into the processâ€”may be ITâ€™s single greatest contribution to enabling a Lean Six Sigma environment. Integrated IT infrastructures allow pharmaceutical manufacturers to rely less on manual checks, which present greater risk and variability, and more on automated checks that are built-in, enforced going forward, and can easily be audited by the FDA and other regulatory agencies. For instance, automation enables manufacturers to enforce electronic signature checkpoints during the processing of a production batch order and automatically notify key personnel of nonconformances, so that reviews and action can be undertaken quickly. The capture and processing of in-line data is critical to a Lean Six Sigma environmentâ€”as well as PATâ€”because manufacturers must understand all sources of product variability. This

understanding cannot be achieved without collecting data from every part of the supply chain and manufacturing process. For example, a manufacturerâ€™s probe sensor might sample the particle size of a batch of product during a granulation process. To make adjustments that would improve product quality or consistency, the manufacturer must determine how the particle size compares to previous batches and standardsâ€”a process that depends on the capture and analysis of in-line and benchmarked dataâ€”and understand how various possible process adjustments will impact all critical technical attributes of the material. An integrated IT infrastructure is essential to enabling manufacturers to capture the secure, analysable and actionable data needed to transform their operations.Electronic record keeping plays an important role in helping pharmaceutical manufacturers build quality into the process. Paper records are cumbersome and expensive to circulate for review and

approval when there are multiple staff members or departments involved in the process. This challenge is compounded in a global enterprise. Faster and cheaper product development, manufacturing and quality assurance turnaround is possible with electronic routing of signature requests anywhere, virtually and instantly. Electronic records also improve accuracy. There are limited means to prevent users from entering invalid data on paper forms beyond rigorous and time-consuming manual checking. Sophisticated electronic record systems, however, are adept at reducing data errors by providing users with lists of appropriate values from which to choose, and by validating data formats prior to accepting or saving the data into files or tables. Enabling rapid analysis and modelling to respond to change Pharmaceutical manufacturers possess massive quantities of data on processes as far ranging as purchasing of office supplies and analysis

of data from gas hromatographs. Many, however, cannot analyse or interpret paper-based or siloed information to identify important trends and drive improved manufacturing practices. A single source of truth, coupled with advanced analytics, enables pharmaceutical manufacturers to run real-time analysis that yield the kind of business intelligence that reduces risk, helps to improve operating efficiency and agility, and streamlines compliance. For example, a manufacturer can use advanced analytics to conduct quality analysis, risk assessments, yield analysis, on-time production tracking, scrap reason analysis, cost comparisons by job, and comparisons of manufacturing plans and efficiencies between sites, to name just a few of the endless possibilities. Instituting and controlling businesses processes and standard operating procedures Removing variability in processes and materials is fundamental to a Lean Six Sigma environment. IT systems

provide the information necessary to establish an environment that supports risk-based decisions. IT serves as a lens through which processes can be observed, monitored and measured. Only then, can manufacturers enable greater control over variability. Process automation further enhances operational efficiencies. On the materials management front, an integrated IT infrastructure drives automation that enables manufacturers to enforce business rules that require materials to go through certain quality tests before they reach a customer, as opposed to relying on a paper document to confirm a test has been completed. Automating controls also reduces ongoing complexity, redundancy, the potential for operator error and, ultimately, waste. Leading IT vendors, such as Oracle, are removing the complexity from process integration by leveraging Business Process Execution Language (BPEL), which allows manufacturers to build a process once and then apply it

throughout the environment. BPEL is emerging as the standard for assembling a set of discrete services into an end-to-end process flow, radically reducing the cost and complexity of process integration initiatives. Enabling a real-time demand-driven sales and operations planning process A demand-driven model, which supports Lean Six Sigma principles, allows pharma manufacturers to postpone inventory build-up and reduce inventory carrying costs and the risk of a product expiring before sale. The transition from a make-to-stock approach to a demand-driven environment, however, has not been an easy one for many manufacturers. Most companies today have a fragmented process for Sales and Operations Planning (S & OP). Each department tends to have its own process with critical company data stored on spreadsheets. Departmental plans are not aligned, and there is misalignment between how departments are measured and overall

company objectives. For example, sales management is often measured on meeting a sales quota that may be achieved by selling products that the supply chain is unable to produce. This tends to lead to a very time-consuming and manual process of trying to come to agreement on â€œthe forecast.â€ This painful exercise typically yields an inaccurate forecast. The forecast is then â€œtossed over the wallâ€ to the supply chain to figure out how to expedite processes to meet the demand with no thought given to the profitability of the decisions. Further complicating the process is the fact that the â€œapprovedâ€ plans, which may exist on spreadsheets, are often filed away, and have little relation to the actual plans being executed. New IT solutions can help manufacturers address their complex S & OP needs by enabling them to bring all business areas together for the purpose of aligning supply with demand and delivering an operational plan

designed to achieve a defined corporate business strategy. Some systems, for example, allow a direct linkage between sales orders and production batches, allowing users to create a batch reservation for a sales order. When the batch is completed, the reservation for the order line is converted into an inventory allocation and can then be confirmed and shipped. Alternatively, if there are no existing batches planned or in process for the required product, a user can initiate a request to create a batch specifically for that order. Automated workflow notifications keep the order entry personnel apprised of any changes to the production schedule that may impact their order. Pharmaceutical manufacturers often have multiple manufacturing plants, warehouses, distribution centres, and transportation lanes and modes. Determining the best manufacturing, distribution and logistics choice becomes an exercise in selecting from among thousands of combinations. Dynamic

inputs to the network design processâ€”such as fuel prices, currency exchange rates, real labour rates and seasonal demandâ€”further complicate the process. Advanced Strategic Network Optimisation (SNO) solutions can help manufacturers optimise choices and combinations. SNO solutions perform two distinct functions, simulating and optimising different supply chain configurations and creating dynamic sourcing rules to be used by downstream planning processes. These solutions, which combine a flexible supply chain modelling environment with highly tuned solver algorithms and visualisation capabilities, allow users to define, simulate and evaluate complex manufacturing, distribution and transportation supply chain problemsâ€”before making costly mistakes. Ensuring compliance and security It is very difficult to determine corrective and preventative actions without a sound understanding of variability sources and estimates. The

information required for a corrective and preventative action includes appropriate details of the event, the time and date of the nonconformance, the phase of the batch in which the nonconformance occurred, details of the incident or observation, level of criticality, and required follow up, as well as the signatures of various operator(s) and / or supervisors. This process, which is essential to both quality improvement and regulatory compliance, is costly and time consuming when completed manually. It also presents many opportunities for data omission or the recording of incorrect data. Corrective and Preventive Action (CAPA) solutions manage issues to closure through an automated workflow, and provide appropriate documentation required for regulatory compliance. Pharmaceutical manufacturers are on the cusp of realising the benefits that Lean Six Sigma practices can deliver to their organisations and the industry as a whole. To successfully

transform their organisations, however, pharmaceutical manufacturers require greater visibility into their end-to-end operationsâ€”an objective that cannot readily be achieved through paper-based processes or disparate IT systems. To this end, pharmaceutical manufacturers increasingly look to integrated IT infrastructures to help them execute Lean Six Sigma paradigms and, ultimately, achieve new levels of operational efficiency, quality and corporate performance. With regards Dr. Geer M. Ishaq Sr. Lecturer Dept. of Pharmaceutical Sciences University of Kashmir Srinagar-190006 (J & K) Ph: 9419970971, 9906673100 E-mail: ishaqkashmiruniversity (DOT) ac.in Website: http://ishaqgeer.googlepages.com six sigma in hospitals Attn Dr Bashaarnetrumgroups (DOT) comDate: Wednesday, June 4, 2008, 10:41 PM Dear Dr Bashaar, I am replying to all your mails together. The pros and cons you have listed present a true picture of this new methodology. Whenever some new methodology is introduced, there are crticisms to begin with. Later, as we get adapted to new systems, we realize: "Wow, this is really wonderful-why didn't I get this idea before? It has brought wonderful results and that too at such a low cost!" Coming to health sector, the

methodology has to be modified from what we use in industry because, here we are dealing not with products, but life of patients. Steps could be differing with even level of health care-example whether it is Primary health centre, secondary, tertiary or a teaching hospital. Communication between staff is very important. Medication error can occur at many steps-right from manufacturing to patient consuming the medicine. To minimise these errors, we need to have a good inter-hospital staff communication. You have given a nice list of patient safety factors in your posting. Dr Bashaar, while doing literature search, I found some terms like black belts...Would you like to elaborate on these? -Anupama Did you know? You can CHAT without downloading messenger. Click here From Chandigarh to Chennai - find friends all over India. Click here. Explore your hobbies and interests. Click here to begin. Explore your hobbies and interests. Click here to begin.

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June 6, 2008