Case Analysis : Tylenol Recalls Essay

Concerning the quality of education offered and the employee’s needs to be an active participant in the quality improvement process, and thus they should feel that they are responsible for the quality provided. This implies that the employees should be encouraged to make suggestions that are geared towards improving the quality offered through airing their opinions without fearing the unknown circumstances that may arise such as reprisal. Moreover, there is the need for a systematic procedure that will help to will not only help to involve the workers but also will be keen towards soliciting their input. This is because the endeavor to improve the product quality is far much better compared to the cost of poor quality which exceeds the cost of attaining the best quality.

For Andrei Octavian PARASCHIVESCU and Florin Mihai CAPRIOARA, organizations that desire to implement a strategic quality management approach should consider both the strategic dimension of quality and the management strategy (2014, p 19). In fact, both writers stipulate ”Quality Management” aims to advance quality to meet patron’s requirements by controlling processes (Paraschivescu & Caprioara, 2014, p 21). Likewise, their ideas confirm that the production approach demands a strict input from workers. In doing so, quality improvement teams can measure and spot

In order to discuss this case, it is also important to know about McNeil Consumer Healthcare, the subsidiary of Johnson & Johnson and the producers of famous medicine "Tylenol". Tylenol was their best selling product; it was very much trusted by their consumers and they also earned huge profits from its sales in United States.

Senior leadership must determine and direct the level of quality that is acceptable within the organization. Leadership should prioritize areas of quality and use data based on benchmarks from other facilities. (Dlugacz, 2006). In addition the author states there are some important areas that must be monitored for quality. Compliance must be followed by leaders and all

Introduction: Since 2001, compounded drugs have caused more than 1,000 illnesses, and 87 deaths in the United States (cite 1). All of these unfortunate incidents were caused by errors during the manufacturing of compounded drugs, and in most cases, because of contamination. On the 25th of September 2013, the Drug Quality and Security Act, also known as H.R. 3204, was introduced, and three days later, was passed by the House of Representatives. On the 18th of November, this Act cleared the Senate. On the 27th of September, 2013, President Barack Obama signed the Drug Quality and Security Act into law (cite 2).

In the long run, these practices will ensure that consumers purchase an effective product that is not dangerous, otherwise, companies may face very serious consequences including recall, seizure, fines, jail time and of course, lost of profit. When the manufacturer believes they are equipped for an inspection, a highly specialized FDA staff examines the pharmaceutical manufacturing facilities and ensures that it is compliant with current Good Manufacturing Practice (cGMP) regulations. Here, the ICHQ7 guidelines, staff responsibilities and training will be discussed followed by how to manage a 483 and close out meeting.

During the Tylenol tampering scandal at Johnson and Johnson (1982) where seven people died, CEO James Burke and his team led a company culture that admitted the problem and set out to rectify it. He did not wait for the problem to fade away or just react to regional problems. He launched a Public Relations (PR) campaign and recalled several products whilst remaining calm and in control under the spotlight. He launched a further recall in 1986 costing Johnson and Johnson more than $200 million, when one person died after ingesting a capsule laced with cyanide (Yang, 2007). By doing so, James retained employee and customer loyalty. His achievement was of dealing with a crisis; he did not know cyanide was being planted into bottles, nevertheless he dealt with it. He remained trustworthy, transparent and engendered confidence. As an example, whilst at Johnson and Johnson, had James used questionable means for the success of the business, the organisation and the public would probably have forgiven him, following his conduct in the Tylenol tampering scandal. Not because they eventually forgot, but due to the importance in which

Brief surveys are conducted on a regular basis by the customer service department to ensure quality is consistent throughout the organization. The Federal Drug Administration (FDA) conducts audits of all manufacturing sites to ensure the proper goods manufacturing practices are followed. The FDA also reviews all standard operating procedures (SOPs) relating to product manufacturing and handling.

Tylenol, an over the counter prescription product from Johnson & Johnson, was one of the top brands in the analgesic market. Within the company, it was also a large income earner that commanded nearly 15% of the company’s total profits. That being the case, the 1982 crisis was not only a big blow to the brand, but also to the company as a whole. The crisis jeopardized the company’s existence; putting at risk a multi million investment which the investors had a lot of faith in. Irrespective of whether the crisis was due to malicious acts from ill motivated criminals or not, the company had to act swiftly to counter the legal issues which were ensuing and mitigate huge impending losses. It was really a trying moment for the top management of Johnson & Johnson and more so to the CEO, James Burke, who faced the toughest test of his managerial career during this time. Though the crisis was amicably solved, there were some legal issues that were imminent and some valuable lessons learnt from the episode.

The hypothalamus is the part of the brain that controls the core temperature of the human body. This organ which is located above the brainstem ensures that the body is kept at a temperature between 97.5 and 98.9 °F (36.4°C and 37.2°C). Small proteins known as pyrogens can stimulate prostaglandin release in the body and increase body temperature beyond this range. 1 These increases can be medication induced or due to other underlying pathophysiology. An increase beyond this temperature range can be classified as a fever. In infants, the gold standard for classification of a fever is a rectal temperature greater than 100.4°F. It is important to treat fever in an appropriate manner because infants with elevated body temperatures are at an increased risk of having febrile seizures especially if they have a history of these episodes. Acetaminophen is an over the counter medication that can be used to reduce fever in patients by inhibiting cyclooxygenase.

In a competitive market to which Johnson and Johnson operates, the smallest of errors can lead to consequences which can cut revenue. When large mistakes occur, millions of dollars are lost, and even worse, there is a loss of customer confidence. Johnson and Johnson has had numerous recalls in their consumer healthcare division recently, which rocked the organization’s once sound image, and diminished its profits. These recalls have hurt Johnson and Johnson’s stocks and cost the company about $900 million in sales last year (Rockoff, 2011).

Goal: Reduce product variance and the need for rework by implementing a company-wide quality control system that includes an element of Statistical Process Control. A secondary goal is to reduce waste by focusing on Lean

Once it was discovered and confirmed that the contaminated steroid injections originated from New England Compounding Company (NECC), an official investigation of the facility was conducted by the Massachusetts Health Department, FDA, and CDC. The investigation uncovered that NECC violated some standard procedural and sanitary pharmaceutical facility regulations: 1) Records suggest the company failed to sterilize products for even the minimum amount of time necessary to ensure sterility. 2) Mats used to trap dust and dirt just outside the company’s clean rooms were visibly soiled with assorted debris. 3) Hoods in the sterile compounding area were not properly cleaned. 4) Leaking boiler next to a clean room created an environment susceptible

The President Ralph Larsen has realized that Wengart has some major problems with the quality however he is focusing on the profitability instead of the longevity of the company. He needs to have the team focus on improving the quality problem or the company’s profits will continue to decrease. Larsen in the effort to improve the quality has decided to seek out help from an OD practitioner who suggests to Ralph to implement Top Quality Management (TQM). Larsen feels that this should be easy to implement and hands it off to Kent Kelly the Vice President. He feels that the TQM program was a matter of common sense (Brown, 2011, p. 365).

Implementation of excellent quality comes with a cost. The company must decide if it is really worth compromising the quality for revenue. If the quality costs exceeds the expected revenue of the company then the company must abandon implementing quality control mechanism. If otherwise, the quality would contribute to the product value and hence the revenue.