A complexity analysis model for management of Good Manufacturing Practice and ISO 9000-2001 compliancy simultaneous projects. Case study in the pharmaceutical industry

Quality improvement is definitively one of the major leading forces nowadays. In the manufacturing industry, the globalisation trend forces companies to modify their processes in order to comply to specific quality regulations. In pharmaceutical industry, the FDA Good Manufacturing Practices (GMPs) represent a landmark in defining the Quality Product, which is a complex multifaceted concept (“In conformity with identity, purity, physical shape and stability requirements” Code of Federal Regulations, 2000). Even if the FDA regulation has been defined for U.S. market, lots of European companies are starting to implement GMPs compliancy projects. The European UNI EN ISO 9000-2001 regulation concentrates anyway on Quality Assurance, which is defined as a mean to make stakeholders confident about compliancy to their requirements. ISO 9000-2001 and GMPs regulations are neither in antithesis nor in alternative, but are complementary; pharmaceutical companies are now persuaded that Quality Assurance is a strategic objective as well as Quality Product, to be pursued by process optimisation and by production planning and control. Any modification in the process structure of an industrial plant in order to meet the requirement of a quality regulation requires a deep commitment and big expenditures; when the aim is the complete compliancy to two main regulations such as US GMPs and EU ISO 9000-2001 the project management is definitively critical. This paper aims to develop a project evaluation and management model for a program of plant adaptation to meet simultaneously both GMPs and ISO 9000-2001 standards; such model is based on a complexity analysis procedure for process modification and updating, and it is focused on the exploitation of the potential synergies among the adaptation project activities. The proposed model is divided in three main phases: firstly, quality requirements are disaggregated according to relevant operative areas, in order to outline adaptation activities characteristics. Then, the second phase aims to estimate the impact on each operative area performance of the relative adaptation activities; for this purpose, activities complexity is evaluated using specific indicators and weighted through cost elements. Finally, the model concludes with gap analysis procedure which is used to plan a coordinated and optimised simultaneous adaptation project management. The model has been tested in a pharmaceutical company that was already GMPs compliance since ’90 and during 2000 was adapting its production process for a GMPs review and for the first ISO external audit. We applied our proposal to both the adaptation projects and we succeeded in obtaining important confirmation about achievable benefits in terms of reducing costs and activities balancing.