Self-inspections in Research

Abstract

The implementation of a consolidated and integrated quality management system in Research and Development and innovation (R&D) provides a conceptual framework for the evaluation and continuous improvement of the projects carried out. It is also a key element in ensuring the effectiveness and validity of the results. Research often fails to give the priority it deserves (1). It is assumed that it is more beneficial to invest all the time and resources exclusively in scientific investigation. This represents a missed opportunity to improve team coordination and increase project success (2,3). From the main international regulations such as ISO 9001, UNE 16602, ICH Q8, ICH Q9, ICH Q10, among others, the most reference points in the research have been selected and unified to produce an auditable questionnaire. It consists of 19 different sections with a total of 167 yes/no/ongoing/NA answer questions. It focuses exclusively on the audit of research personnel and their activities. Thus, it allows to create a global and current idea of the management system in R&D and the organization and to evaluate its degree of compliance. Based on the questionnaire, four audits were carried out on three different study groups: the Service of Development of Medicines, the Unit of Pharmaceutical Technology and the Pharmaceutical Chemistry Laboratory. The audit has made it possible to compare and analyse in detail the different levels of compliance and to identify the strengths and weaknesses of each organization. It has also proven useful in assessing the current status of organizations and highlighting areas of optimization. Keywords: Quality Audit, Quality Management System, ISO 9001, UNE 16602.