Quality Management

The four dimensions of quality include design, conformance, availability, and field service.

Quality of Design

Design is primary the responsibility of a cross-functional design team. Sanofi-aventis' approach to quality by design include the following elements:

• Identifying, through e.g., prior knowledge, experimentation, and risk assessment, the material attributes and process parameters that can have an effect on product.
  
• Determining the cross-functional relationships that link material attributes and process parameters to product.
  
• A systematic evaluation is derived through their marketing department, understanding and refining of the formulation through the Research and Development and industrial manufacturing process adhering to specification.
  
• Using the enhanced product and process understanding in combination with quality risk management, they establish an appropriate control strategy which, include a proposal for design space(s) and/or real-time release testing.
  

Such systematic approaches have achieved the desired quality of their products and have helped the regulators to better understand the company’s strategy. For example, a cross-functional team of experts could work together to develop an Ishikawa (fishbone) diagram that identifies potential variables which can have an impact on the desired quality attribute. The team could then rank the variables based on probability, severity, and detect ability using failure mode effects analysis (FMEA) or similar tools based on prior knowledge and initial experimental data. Design of experiments or other experimental approaches could then be used to evaluate the impact of the higher ranked variables, to gain greater understanding of the process, and to develop a proper control strategy.

Quality of Conformance

A related dimension of quality is confor­mance, or the degree to which a product's design and operating characteristics match pre-established standards. Both internal and external elements are involved. Within sanofi-aventis, conformance is commonly measured by the incidence of defects: the proportion of all units that fail to meet specifications. Industrial Quality and Compliance Chemistry assures that all active pharmaceutical ingredients, including feed grade products, are manufactured and controlled in compliance with sanofi-aventis quality standards and regulatory requirements.

Availability & Reliability

In terms of availability, it defines the continuity of service to the customer. The availability of their product is guided by statistical number generated through marketing. These variables and procurements from suppliers drives the batch production of their products instantaneously.

Reliability which is also a comparative dimension of quality, reflects the probability of a product's failing within a specified period of time. These may refer to the amount of doses that is prescribed before the effect wore out. For example, it would be reliable if sanofi-aventis claimed that 2 pills of Ambien CR could put someone to sleep in 2 hours and it actually did. These measures would require a product to be in use for an extensive period of time because they are more relevant to durable goods than they are to products and services that are consumed instantly. It could also refer to the primary operating characteristics of a product. For sanofi-aventis, drugs would be traits like providing instant relief from ailments, non or less side effect, safe handling, and comfort of use. This dimension of quality combines ele­ments of both the product and user-based approaches. The connection between performance and quality, however, is more ambiguous. Whether performance differ­ences are perceived as quality differences normally depends on individual prefer­ences. In these terms, the reliability of a product would correspond to its objective charac­teristics, while the relationship between per­formance and quality would reflect individ­ual reactions

Field Service

The fourth and final component of quality is field service. This is termed “Lifecycle Management.” It involves reactive issues like problem solving and corrective actions relating to consumers. In all cases, sanofi-aventis' products and services were designed to meet patients’ needs and the intended application. They guarantee the shelf life of their products to consumers through their integrity. A product that fails frequently is likely to be scrapped earlier than one that is more reli­able. Consumers of their products are actively compensated for proven cases of drug reactivity. Sanofi-aventis has also established Regional QU management which is responsible for communicating the findings of the Local Recall Committee’s assessment to the R&D Recall Committee within 48 hours and providing the ultimate recall decision back to the Q&C GMP QU Site Head. Immediately upon identification or notification of a possible recall situation, all suspect products must be placed in quarantine status pending a full investigation. They have demonstrated competence in all their undertakings.

Their level of competence and promptness in the delivery of their products, which is available worldwide, is immeasurable.

Quality Systems at sanofi-aventis

Sanofi-aventis embraced the Six Sigma methodology in 2000 and have run their processes using DMAIC. Currently, sanofi-aventis adopted a hybrid quality system called IQC (Industrial Quality Compliance). This was designed to bridge the inadequacies of Six Sigma experienced with their Research and Development process.

Recommendations for Quality Improvement

Sanofi-aventis is still struggling with on-time delivery. Management mainly sees manufacturing as a cost center. About 40% of the plant equipment is over 10 years old and some are manually operated. Elements in the operational excellence toolkit, such as Quality by Design, Process Analytical Technology and advanced process control are being underutilized. Models are not yet flexible enough to adjust production capacities based on demand. In addition, regulatory compliance and plant safety were lower this year.

If aanofi-aventis wants to increase the benefits of quality, company leadership must make operational excellence a priority. Leadership, especially at the C-level, is critical in reducing product prices, improving product quality, improving operational and manufacturing flexibility, accelerating production speed, and improving workplace safety.

Undoubtedly, obtuse integration of manufacturing with other operations will result in the greatest benefits of operational excellence.