Concepts of Quality Management and Quality Assurance in Analytical Research Projects and Non Routine Analysis

Abstract

Contrary to routine analysis, where the sample matrix and concentration range of the analyte are known, the analytical method has been validated and is tried - the method is fit-for-purpose - analysis in non-routine situations and in R&D may be a tortuous problem solving process. Although many basic quality elements are the same as in routine analysis, unknown factors such as unpredictable behaviour of the sample, unknown composition of the matrix and interdependance with the analyte, even uncertainty about the choice of the instrumental method, require not only a new focus on existing quality elements, but - due to the unpredictability of the analytical procedure and extent of effort - also additional organisational quality elements.

The uncertainties in non-routine analysis and R&D require careful consideration of the problem and required or available analytical techniques, planning and organisation of work, supervision of the analytical progress and adequate presentation and quality of results. Project management allows structuring of all aspects - both technical and organisational - of non-routine and R&D work and defines responsibilities and competences of the personnel.

Analytical task quality elements are:

• Phase 1 Preparation and planning before starting work

  Definition of task and project design

  Project design and research plan

  Resource management of task

• Phase 2 Work in progress

  Progress review/monitoring analysis

The novelty and uncertainties of analytical research and non-routine analysis require additional effort to assure quality. Acceptance of established concepts of quality management and project management is urged.