Risk Analysis

The aim of risk analysis is to identify, analyze and assess what failures could potentially occur at a later stage in order to prevent them. Risk analysis is always required when qualification and validation of systems and units in a new or modified plant in the pharmaceutical industry have to be carried out.

A&D AS Solutions Process Industries has sound expertise in the pharmaceutical sector and GMP environment, which has already been exploited in numerous projects. In the area of risk analysis, this expertise covers:

• deciding on the scope and depth of qualification
• identifying quality-relevant and process-critical parameters
• determining potential risks – preventively, systematically and completely by the following methods:
  • failure mode and effects analysis (FMEA)
  • hazard analysis and critical control point (HACCP) or
  • modifications of these methods.

As a customer of A&D AS Solutions Process Industries, you will benefit from our many years' experience with these methods. With a professional risk analysis, you will achieve significant cost savings because the results can be taken into account early on in the planning stage. Another advantage is that we offer plant design, qualification and validation from a single source. This integration of competencies reduces not only your costs – but also your risks.