Quality Control

Sanofi-aventis has a clear need for very specific quality control measures due to the stringent government regulations associated with the pharmaceutical business. While some companies may simply face the threat of an unhappy customer, pharmaceutical companies hold responsibility for the health and physical well-being of end users of their products. Also, due to the extremely expensive nature of new product development, they must carefully weigh and measure the potential upsides and downsides of entering into the development of a new product. There must be a system, or many systems, in place to ensure that quality prevails and resources are not squandered on projects destined to fail from the start.

Sanofi-aventis does subscribe to Six Sigma for certain areas of their company, which we will further discuss, however they also have their own permutation of quality control processes that is tailored to best suit their needs. They use a practice known as Industrial Quality and Compliance (IQC) Strategy. This strategy is the framework that they adhere to for any process that requires quality control, from the manufacturing of the pharmaceuticals, to the packaging, to the logistics of delivering the product. To develop any areas requiring quality control they follow the six steps within the strategy which are Define, Ensure, Empower, Integrate, Manage, Communicate. These steps are sanofi-aventis’ guidelines to quality control excellence no matter what the specific process may be.

In the first step of the process, Define, the exact requirements of the quality control process should be spelled out. This definition should also be supplemented by guidelines showing how these requirements should be met. These guidelines can take their lead from the best parts of other previously rolled out processes or policies from within the company and also possibly adopt ideas from sources outside the company. Part of this step is also to take note of and integrate current industry and regulatory trends into the process plan.

In the second step of the process, Ensure, involves auditing any sites involved in the process to ensure that they are capable of carrying out the proposed directives. It is necessary at this point to ensure each site has trained and experienced employees and provide support and training as needed. This is the step where they test out the feasibility of the process definition. If the resources or expense to implement the process is not worth the benefit, they may go back to the drawing board and repeat step one as needed. Once this step is checked off the list, they can then empower the sites to maintain the process and set up a way for continuing compliance to be reported. An escalation process for risk management is also developed. Training continues during the Empowerment step as these systems are implemented. The risk management aspect of the strategy continues into Step Five of the process, Integrate. At this time the escalation process for risk management is integrated and this process is continuously improved upon. At least once per year, new regulations and needs are considered and they too are encompassed in the quality control process. This allows the process to continue to evolve to meet the ever changing needs of the company.

The Management step of the process encompasses ensuring that the process is adhered to. It puts in place audit processes for suppliers and subcontractors, as well as internally, and spells out how discrepancies found in the audit process can be corrected. Finally comes Communication, which further deals with reportings of compliance and reviews with the teams at regular intervals. This part of the strategy also turns their quality process into a public relations tool in the sense that the process itself can be used to illustrate the company’s commitment to quality. Sanofi –aventis also maintains an intranet site for each of their processes as an information and training resourse.

As previously mentioned, sanofi-aventis does also subscribe to Six Sigma as a means of quality control, but they leave the research and development segment of the business out of it. Research and Development does require quality control, however it is also an intensely creative process. Many companies that forced this segment to deal with the restrictive nature of Six Sigma found themselves losing valuable employees as a result. Six Sigma is a very successful guideline for sanofi-aventis in addition to the idea of the IQC Strategy and they have embraced it. It allows the company to reduce wasted resources and keep their manufacturing processes lean by following the Six Sigma DMAIC steps, which are define, measure, analyze, improve and control. It helps sanofi-aventis to compete with Asian pharmaceutical companies that have the advantage of lower labor costs and less stringent environmental restrictions, by keeping the organization lean and mean.

Our suggestion with regards to areas for improvement would be to simplify their control processes by integrating the IQC Strategy and the Six Sigma methodology. In much the same way that they have created their own specific guideline in the form of the IQC, we feel it would help to streamline things by using a best-of type compilation of the two methods to form one unique, sanofi-aventis specific guideline. They can further foster employee dedication to the process by perhaps having periodic awards for employees that best demonstrate adherence to the methodology or for those who make a significant contribution to the processes improvement.