Decision Making Proposal - App Pharmaceuticals

I. APP Pharmaceuticals

APP Pharmaceuticals (APP) strives to lade in the United States and Canada to be a leader for injectable pharmaceuticals. The company, philosophy is to provide excellent products and services by hiring dedicated and committed employees to meet our customers' needs. Our primary goal is to improve the health and care of patients who use our pharmaceutical products.

II. Background/Overview of APP Pharmaceuticals

APP was established in 1996 and has quickly become one of the industry leaders in providing one stop shopping for very commonly used products to very special products to meet the needs of a wide range of patients. There market produces 142 products in over 400 doses and formulations. A few of the clinical areas they cover are: Cardiac Care, Dialysis, Emergency, Intensive Care, OB/GYN, Operating Rooms, Oncology, Orthopedics, Pediatrics, Psychiatry and Radiology. (APP Pharmaceuticals, unkown)

APP is the number three generic injectable supplier in the United States, and the only U.S. generic company with a dedicated cephalosporin injectable plant. APP currently employees over 1800 employees in North America with manufacturing facilities in Melrose Park, Illinois, Grand Island, New York, Raleigh, North Carolina. The corporate headquarters, science production and technology center is located in Skokie, Illinois. (APP Pharmaceuticals, unkown)

As mentioned previously has 140 products and these products range can be classified into 3 families of pharmaceutical families which are Herapin, Diprivan and Naropin.

The focus on the quality management begins with the supplier. The supplier for Heparin uses an Active Pharmaceutical Ingredient (API) along with a very update to date purification technology and provides trustworthy traceability to materials. SP's supplier ensures USP testing is performed prior to shipping any product to us.

Once the product arrives at their manufacturing site another round of USP testing for quality and purity is again conducted. The product is filled into vials and a thorough inspection is completed before packaging and labeling is performed. Once the final product tests are completed the product is again inspected and tested to ensure USP standards are met.

III. Introduction to the Problem

APP has recently experienced quality issues that have resulted in compromised patient safety, poor customer service, citations from the Food and Drug Administration (FDA) and producing substandard products. Most specifically the challenge has been with the Heparin. The initial analysis performed as regards to the Heparin quality issues can be defined into two categories patient safety and contamination of the Heparin.

On February 29, 2012 the Food and Drug Administration (FDA) reported "under 'a fine mess.' the FDA has tagged SP Pharmaceuticals for so many systemic problems -insects; vials with missing labels; failed assays; contamination; floating particles and a failure to file reports or follow-up complaints - that the agency has instructed the executive team to "undertake a comprehensive and global assessment," according to a warning letter issued last week."

"The letter, in fact, reads like a how-to list - how to screw up, in this case. What is likely to generate wider notice, though, is a reference to problems a potential trend of failed assay results for different batches of both the active pharmaceutical ingredient and finished product. Now, the FDA wants APP to submit a three-year history of test results and subsequent internal investigations." (Pickett, 2012)

Furthermore, it has been reported to the Institute of Safe Medical Practices (ISMP) Heparin is second for errors that are attributed to labels and packaging. A dosage mistake in a patient is considered very harmful. Hence there is no room for errors in administering the correct dosage. (APP Pharmaceuticals, 2011)

Medication Errors

Figure 1

Upon initial examination of APP Pharmaceuticals the quality issues can be traced back to APP's corporate culture, strategy and a lack of well defined performance metrics. If you were to examine quality "The Toyota Way" you will find that the bases for adding value to customers and society is based on what they call the 4 P's. They are Philosophy (long-term thinking), Process (eliminate waste), People and partners (respect, challenge, and grow them) and Problem solving (continuous improvement and learning). (Liker, 2008)

As quality consultants we believe that if APP addresses of lack of a corporate philosophy and strategy that is quality mindful the company can move forward and plan to tackle the causes of the safety and quality problems. More specifically APP should drive for zero contamination issues and safety issues, related to Heparin. Between APP and the quality consultants, we will create processes and teach a team how to use tools that will enable the development of new behaviors from the top down. The residual effects will be improved customer satisfaction, an increase in safety and a higher quality product.

IV. Literature Review -Philosophy, Culture and Strategy

There are many researchers and scholars who believe that the implementation of the lean and six sigma project should be enough to resolve quality issues. However, if you examine the "Toyota Way" you will find that it is suggest that these tools alone will not sustain a company long term. Following is a definition of culture that demonstrates the Toyota Way well:

"The pattern of basic assumptions that a given group as invented, discovered, or developed in learning to cope with its problems of external adaptation and internal integration, and that have worked well enough to be considered valid, and therefore, to be taught to new members as the correct way to perceive, think, and feel in relations to those problems." (Liker, 2008)

After reading and studying this definition it is obvious that culture reaches "deep into how all members of the organization perceive, think and even feel." It is also understood that are deeper aspects of culture that are not evident at the surface. (Liker, 2008) To understand this concept we will look briefly at Edgar Schein's and his three levels of culture.

Schein's Three Levels of Culture