Quality Outbreak

For my blog post I will discuss some quality issues related to the specialized pharmacies industry. The recent outbreak of meningitis and the growing number of deaths caused by contaminated steroid shots has been an obvious point for concern and improvement. Pharmaceuticals is an industry which needs to be consistent in every product they produce and really have no room for error. I feel using a Six sigma approach to quality would have avoided this situation in Massachusetts with the New England Compounding Center, the company accused of producing the tainted shots.

According to the Wall Street Journal article I read, titled “Meningitis Deaths Increase. Meningitis is an inflammation or infection of the protective membranes of the brain and spine (Dooren, 2012).”  http://online.wsj.com/article/SB10000872396390443294904578050854190916648.html?KEYWORDS=meningitis This outbreak could affect over 14,000 people and NECC is already linked to over 20 deaths caused by fungal meningitis due to contaminated shots.

The article goes on to discuss the FDA’s and CDC’s need for further regulation on the specialized pharmacies like these compounding centers. I feel using a six sigma approach to production to ensure no more than 3.4 defects per million operations. This approach to quality, while financially driven, is an excellent way to eliminate waste and improve core processes.

I’m sure if NECC was implementing a DMAIC process, they would be able to address the root cause of defects and remove the cause of defects, then further down the line control and maintain quality. However it appears NECC was not concerned with managing their quality and now could face criminal charges.

What is surprising to me is a medical company would not have stricter policies on sterile areas and managing quality of the product. A six sigma approach seems necessary for a company making drugs. According to recent reports, investigators found unclean conditions including visible black specks of fungus in steroids in what was supposed to be a sterile room.

Since the outbreak, Governor Patrick of Massachusetts has moved to revoke the licenses of the New England Compounding Center. Governor Patrick has also ordered the state pharmacy board to conduct surprise inspections and take more steps to better managing quality.

Another interesting point I found out was the company operated as a drug manufacturer by making drugs for wider use, rather than filling out patient specific prescriptions for specific doctors, which is all its license allowed.

So not only were they misusing their production means, they were also creating defective products the whole time. Situations like this show the critical need to use to better quality management practices throughout our society; healthcare and medicine especially, but also with everything really. No consumer expects to receive a faultily product.

So what can be done? Well I think hospitals can protect themselves by creating and controlling their own quality control standards for the medicine and equipment they use. Just in case something slips by the manufacturer, there will be a second line of defense to find the defect.


Is “Lean Government” the Solution to Economic Problems?

In the last class, we learned about Six Sigma, a methodology that is used to eliminate waste from business activities, while benefiting a company’s financial performance. Six Sigma uses the idea that all activities are processes that can be evaluated with the DMAIC process (define, measure, analyze, improve, and control). By using data analysis methods and focusing on customer knowledge and core processes, companies can reduce defects significantly, with the ideal target being 3.4 defects per million opportunities.

Private companies have been successfully using Six Sigma to improve their methods and reduce costs for years, and even service sector companies, like hospitals, are using Six Sigma to analyze their processes for areas of improvement and greatly reducing treatment times for patients. In class, we discussed Motorola’s introduction of the Six Sigma process and saw examples of how companies like Caterpillar have used Six Sigma to reduce defects and costs. Forbes.com ran an article a few months ago about the expanding types of organizations that are bettering their operations through Six Sigma, such as the Department of Defense and even Iowa’s state government. Looking at these cases, author Kellan Giuda, questions why top government is ignoring the proposition of using Six Sigma to reduce the national deficit in his article “Lean Government Six Sigma? Why Do Politicians Ignore it?”

As everyone is aware, the economic crisis in 2007 and 2008 has caused a lot of criticism on how the U.S. government functions. Because of this many advocacy groups, specifically seen when Newt Gingrich was running for candidacy, are arguing for higher-tier adoption of this system in order to reduce debt. The argument behind this movement is the $2.45 billion saved by the U.S. Military after introducing Six Sigma in 2008 and the Department of Defense’s integration of the system into their operations. Giuda believes that these cases prove that Six Sigma can be beneficial to organizations outside of the private sector, such as government agencies. He argues that this would provide an opportunity for top government officials to undertake the public debt problem head-on and that Lean Six Sigma is a viable solution for the problems the U.S. government faces.

Thousands of companies worldwide embrace Six Sigma as a tactical improvement system and seeing the various types of organizations that are implementing it shows the transferability of the system. Do you think that using Six Sigma would reduce costs in a national government? Would it be difficult to implement?



Where OpsManagement Falls Short



Operations managers often strive to improve the company’s performance in some way, but at times, their efforts become unsuccessful and often fall short of the company’s goal. In a WSJ article, it says that 60% of companies who have used the six-sigma process (a quality control procedure) have failed. When putting together a project plan, participants (employees) are often excited at the beginning to learn about the new procedures, but as they are pulled to their max, the excitement quickly dwindles and they lost motivation and the effort needed to complete the project successfully. This is referred to as the stretching phase of the six-sigma system. Towards the middle of the project was when top managers really get involved and begin monitoring the employees progress. During this time, the team focuses on precision rather than quantity. Once they perfect their tasks, their quantity is expected to begin going up and the project is seen as successful. During this middle phase however, is also when managers begin to over look other projects and focus on other groups of workers. This is when precision & production become unstable and the project begins to fail because employees record their achievements inaccurately. This is referred to as the yielding phase. During the third  stage of decline, failing, the project often gets stretched to its limits, excitement is no longer there, inaccuracies are constant, and the production is at a standstill. The project can no longer go on and can no longer be successful due to the lack of effort by the team members, executives, and advisers. At this point, it is common that the project has lost its funding due to its lack of progress.  It is suggested in this article that the improvement teams have no more than six to nine members and that they be monitored by an improvement supervisor who knows how to handle situations and projects like these. The article also suggests that executive employees monitor the successes and failures of the teams work in order to make accurate assessments on the status of the project. By relying on only one person (the executive) to record the accuracy of the project, the team is able to eliminate any inaccuracies that may have occurred. After assigning team members, projects should begin within six to eight weeks to ensure that they get the proper funding and attention needed to be successful. If projects push their start date out too far, it is common that the resources and funding needed will be spent elsewhere and that team members will loose interest and have conflicting goals with each-other.  What do you think the best way to set up a team is?





A poka – yoke yogurt



In our last class our professor discusses the concept of quality and attractive   packaging and how attractive packaging will distinguish a product from another product, which will lead to customer satisfaction. she show us how Heinz Ketchup design their small sample, which is really an attractive packaging and it was the first time to me to see that sample , these concept encourage met o see some of the leading product in Saudi Arabia marker and see dose the quality and  packaging really matter and Is it a part of operation manger work? I’m going to talk about al Marai Company; almarai is one of the biggest food exports in the Middle East, with consumers who see its product as a synonym for freshness and quality.

  Today, almarai is capable of serving top notch products to more than 43,500 outlets within the GCC on a daily basis.  , it is really a big operation to process it in one day, important to note that demand for food in Muslim countries increase during the holy month of RAMADAN. Demand for juice in KSA, for example rise by 20%. In addition, demand for food in KSA increasing during the Hajj season, which occurs 2 months after the end of Ramadan.

  One of the important reason for almarai to have these big operation is the high quality standard to produce their product  one of the method the company is implementing is a poka yoke technique which is to correct possible defect plus source inspection to prevent defects equal zero quality control, poka yoke help the operation manger and worker to process work right at the first time. These techniques can drive defects out of products and processes and substantially improve quality and reliability. It can be thought of as an extension of FMAE. It can also be use to fine tune improvements and process design form six- sigma. The use of simple poka-yoke ideas and method in product and process design can eliminate both human and mechanical errors.

 Almarai chooses combifit for its juices and yogurt, which was a turning point for the success of the company and it was an innovative packaging, the company decided to package its entire range of 1 liter long life juices in combifit premium cartons with combiTwist screw cap. This attention grabbing packaging offer Almarai the opportunity to position its products on retail shelves in a very eye catching way, really sitting it apart from the completion, which is perfectly packaged for customer tastes. ALMARAI has always been synonymous with freshness, quality and service. As an international organization, Almarai has also contributed significantly toward shaping the FMCG( fast moving consumer-good ) industry within the middle East. The company processing and distribution activities within the Middle East are unparalleled.

 The commitment to quality has not wavered since the company’s inception. The company has continued to invest in technology advanced production facilities and recruit right caliber people to better serve their coustomer.  

 Finally, Almarai is the first dairy farm in the world to have been accredited with ISO9002; Almarai also received the ISO9000award, across all its operating division including processing, technical research and development. Destruction and supply chain.

So do you think that packing is an important method to attract the customer? And what is more important the packaging of the product or the quality of the product it self?



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