Validation Programme Optimisation
The key questions in planning a validation programme are:
- What to test?
- How long to test?
- How much to test?
- When to test?
Our approach begins by addressing the following issues:
- How do your customers use your product?
- How do customers vary in their usage?
- What is the target for your product?
- Without economic constraints the definition of the required sample sizes and test lengths would be simplified. In Reality the issue of cost optimisation strongly drives the definition of the validation programme. Budget and time limits are typically given even before the product is fully defined. Thus it is important to distribute the available resources according to the risks and consequences of the different potential failure modes. Through the correct focus and allocation of test effort, warranty costs can be minimised. By quantifying the cost and benefit of all activities, the management is supported in finding the optimum level of investment in the validation program.
- To support such activities, Uptime Engineering has developed the software solution Uptime LOCATE. Products are analysed though a top-down approach to identify potential problem areas. These weak points are classified according to failure mode and "physics of failure" models are used to describe the relationship between stress and damage. This provides a basis for assessment of the planned test contributions.
- The results are provided in the form of a quantified level of downtime risk for specific failures, which may be compared with defined targets. In case of deviations, the weak-points of the validation programme are located precisely so that a tailored, cost-effective and fast adaptation of the validation programme is possible.
- Uptime Engineering delivers a holistic view of the steps necessary to ensure that your product is suited to achieving maximum reliability over its operational lifetime.