Case Scenario:
You are a project manager of two projects for a facial care product development firm, ZJZ Cosmetics. ZJZ Cosmetics creates products for other firms to brand and market; they do not sell the products they create to the final customer, only business-to-business. You are in the research and development department and your research specialty is on improving the manufacturing process by investigating new product components. One of the projects you are managing is a "pure" research project. You are looking at five different compounds trying to determine which will be the most reliable and cost-effective base for a new make-up base.
Your other project is for one of your new clients, a pharmaceuticals firm. Your client will be using one of your existing products as the base for some medications that will be used to treat skin problems. This is an existing product for your client and one of the major revenue generators. The client moved to you as a supplier because of quality control problems with one of the former suppliers. The former supplier would deliver wrong product, expired product, product close to expiration, mislabeled product. It got to the point with the former supplier that the returns and waste were greater than the volume of proper, usable product.
You have been identified as the project manager for the project to implement quality control processes that will be used for the manufacture, monitoring, and distribution of this product. You are not sure if the research processes are considered part of the scope. Your new client will be auditing your quality processes and controls in 4 months, so everything must be ready by then.
This is a significant project for your company. This new client is the largest client for ZJZ Cosmetics, and if successful, this provides an entrance into a whole new market. Quality has always been addressed for existing products, but never at the level of rigor and discipline required for a pharmaceutical product regulated by multiple governments. Historically, ZJZ has been a flat organization, and all the department managers have been responsible for quality; there has been no quality department. It is not clear if a quality department will be created or not; that is part of the project's scope. This quality initiative dubbed Growth Through Quality (with the tagline of Excellent Product + Quality Processes = Future Growth) has been communicated to the entire company by the CEO. You know you have senior management's support.
You just met with your boss, Sharon, the vice president of research and development. Sharon emphasized that your project will be responsibility for:
- Defining the goals and scope of the quality initiative.
- Defining organizational structure, roles, and responsibilities relative to quality controls.
- Developing the quality policies, processes, procedures, and the associated controls.
- Communicating, training, and implementing the new procedures.
- Defining and implementing the quality measurement program.
Question
Part 1:
Your team reviewed the results of the pilot and determined the revised processes are acceptable, and they will correct the most critical label-related problems. They have determined, however, that the process is going to need to be monitored; spot-checking will be needed throughout the process, and some oversight is needed. The question on the table now is, "Do we need a quality department?" Sharon would like your thoughts on this question in preparation for a meeting with the team tomorrow on the same topic. Post your e-mail to Sharon with your answer and justification. If you decide that a quality department is needed, describe the roles and responsibilities within it. If not, determine how the oversight functions will be performed.
Part 2:
Prepare a detailed letter that will be sent from the CEO to all members of the management team outlining the quality program and the ways in which quality will be implemented. It should stress the roles of the quality department (if one is to be implemented) and the roles of the managers. The letter should describe the expectations the CEO has for the managers and the expectations the managers should share with their direct reports. The letter should also describe the progress made to-date on the initiative and the next steps that will take place.