Robust Design

FMEA and the Design Knowledge Matrix are most effective mitigating design risks when used with other robust design tools. FMEA best practice suggests the use of P-Diagrams to identify noise factors as a source of potential failure. Test coverage / robustness checklists ensure failure modes are detected by appropriate release tests.

Optimized Test Coverage

In most organizations tests required to release newly developed products or services have grown over the years. This leads to a situation where some requirements are tested twice, using different tests. Tests for other requirements may be insufficient. A test coverage checklist helps ensure all requirements are covered, while providing an opportunity to eliminate unnecessary duplicate testing.

Exact Prediction

Cause-Effect matrices are high-level approximations. They help generate understanding but do not reflect true behavior. Models obtained from scientific knowledge or response surface experiments can replace the initial matrix knowledge, adding precise description of behavior.

Qualica Planning Suite permits documentation of transfer functions known a priori or obtained from experiments. Once those functions are known they can be used for sensitivity analysis and propagation of error calculations.

Statistical Tolerancing

Propagation of error analysis is essential for correct (i.e. optimized, statistical) tolerancing in engineering as well as for Design Space definition in pharmaceutical process development.