Clarification of process specifications
Recipe definitionA recipe comprises all raw material proportions, tolerance limits, and processing parameters required for a defined production step. Deviations outside the stored tolerance lead to automatic blocking of the batch release process.
Mixing ratioThe mixing ratio is specified as a weight percentage of the total batch. The calculation is based on the actual weighed quantities, not on the target specifications. This ensures that readjustments during the process remain traceable.
Quality indicatorQuality indicators such as viscosity, particle size, or pH value are calculated as the average of at least three measurement points per batch. Individual measurements outside the tolerance range are documented but only lead to a complaint when the defined deviation limit is exceeded.
Production parametersTemperature, pressure, stirring speed, and flow rate are recorded continuously and stored with a resolution of one second. Data is archived for at least 24 months and can be retrieved from the platform in an audit-proof manner.
Batch releaseReleasing a batch requires that all mandatory fields of the recipe are fully documented and that the measured values are within the stored tolerance limits. Manual release by authorized personnel remains possible in justified exceptional cases and is logged.
System availabilityThe platform is operated with an availability of 99.5% on an annual average. Planned maintenance windows are announced via the system at least 48 hours in advance. Emergency access for production-critical functions is available via the local user interface.