Questions of quality
Quality process management in a risk managed process area

Keywords including quality management, risk management and business process management, and acronyms such as DIN EN ISO 9000, TQM, Six Sigma, cGMP and FMEA are prominent in the pharmaceutical industry. Do we need all the buzzwords, or is it possible to simplify quality management?


No matter where you work — in R&D, clinical research, active substance manufacture, the medical equipment sector or in pharmaceutical finishing — compliance with the rules laid down by European, US and other regulatory authorities is the number one priority. Good Manufacturing Practice (GMP) and the DIN EN ISO 9000 family of standards are the state of the art in the pharmaceutical and medical device industries today.
In 2002 the Food and Drug Administration (FDA) published GMPs for the 21st Century: A Risk Based Approach. This was a fundamental review of the GMP guidelines, by then nearly 25 years old. The
document was also intended to aid international harmonization between FDA and other guidelines, mediated by the International Conference on Harmonisation (ICH). The first results of the harmonization approach are the draft EU directives Q8 Pharmaceutical Development (Quality by Design) and Q9 Risk Management. As elsewhere, risk management is now part of the life science industries.

The FDA defines a risk management program (RMP) as “…a strategic safety program designed to decrease product risk by using one or more interventions or tools”. The FDA expects every RMP to follow a
basic process of:
-learning about and interpreting a product’s benefits and risks”;
-designing and implementing interventions to minimize a product’s risks”;
-evaluating interventions in light of new knowledge that is acquired over time”; and
-revising interventions when appropriate.”
Risk management is a permanent process concerned with identifying, measuring, controlling and minimizing security risks during the lifetime of a product. A risk management program (RMP) is a strategic safety plan that uses tools or interventions to reduce the hazards presented by a product. When creating an RMP, it is necessary to consider the background, research, basic principles and the logic of establishing and developing the program. Methods including event tree analysis (ETA), failure mode effects analysis (FMEA), fault tree analysis (FTA), and hazard analysis and critical control points (HACCP) are appropriate for risk evaluation and risk management.
From the official perspective, both quality management and risk management systems are effective in helping to guarantee the security and effectiveness of pharmaceutical products and medical devices. It therefore makes sense to integrate risk management into existing quality management systems. Under this line of thinking, the quality management system would be extended by adding modules to identify foreseeable hazards; assess the risks from each hazard; eliminate the hazard, or if this is not possible, control the risk from the hazard; and review the risk assessment process. Every corporation should have a policy of responsible behavior towards customers, suppliers, co-workers and the environment. To deal with the manifold issues raised by such a policy, most companies operate a collection of different management systems, each with its own objectives and methods, and with a minimum of integration between the different systems. This wastes resources and can lead to conflict. It would be better to have an integrated, holistic management system, designed to reconcile the different demands.
The structure of ISO 9000:2000 allows it to handle GxP requirements, risk management, ISO 14001 environmental management and industrial safety. Use of a
single system in this way guarantees enterprise-wide consistency for the many
requirements covering responsibility, execution and documentation. The result would be a process-oriented, software-supported quality management system based on a process model of the entire
enterprise and linking documents, functions, people and sub-processes. This would be the first step towards true total quality management (TQM)