Assignment Title: Operational Excellence Part 2 – Development of OE Model for Pharmaceutical Industry

Learning Outcomes:

The learning outcomes for this module are as follows,

1. Critically assess and appraise the established ‘Operational Excellence’ models utilized to drive business success across a range of industries today.
2. Evaluate the key factors that underpin a successful Operational Excellence (OE) implementation.
3. Design and Operational Excellence Assessment tool to gauge an organizations suitability and performance.
4. Evaluate a range of tools for scientific innovation and the generation of ideas and collaboration.
5. Apply the framework and tools for the development of strategy in an industrial situation.

Part 2 of the Assignment is to develop a conceptual model that identifies the critical parameters that are essential for the current and future success of any pharma business.

Assignment Brief:

• Based on your research of the pharmaceutical industry and the range of Operational Excellence models that exist, develop a unique conceptual Operational Excellence Assessment model that identifies the critical elements (e.g. regulation, process, culture, quality, risk, etc.) that are essential for current and future success in any pharma business and can be utilized to assess and drive improvement in such an organization.
• This model can be a combination of other models but cannot be an exact
  application of an existing OE model to the pharmaceutical industry.
• Using the Business Excellence Framework (BEF) document as a guide in terms of layout and detail, explain the model and the component elements under the following headings,
  1. Overview of the Business Model – Provide a brief introduction to the model, how it was developed, the conceptual components of the model, graphical representation of the model.
  2. Key Principles of the Model – Outline the key principles and high-level overview of the model, why are these principles important to the sector?
  3. Key Elements of the model – Outline in detail the elements of the model, what are the detailed component parts of the model? Examples of Elements could be Quality, Risk, Process, Safety, etc.
  4. Assessment of the Model – On the FDA.GOV website, select a pharmaceutical/medical device product that was recently recalled. Outline the problem identified and possible root cause. Identify how the model would have eliminated/reduced the possibility of this recall happening. Document any assumptions that you make.
  5. References – Provide a reference section outlining your sources. Embed your references in the body of the assignment – Use Harvard referencing.