Examples of QRM in Thermal Validation
Autoclave Validation
Risk: Uneven temperature distribution could lead to incomplete sterilization.
QRM Application: Conduct risk assessments for load configurations and identify critical spots for temperature sensors to ensure uniform heat distribution.
Cold Chain Validation
Risk: Temperature excursions during storage or transport might compromise product quality.
QRM Application: Use risk-based mapping to monitor high-risk areas (e.g., door zones in storage units) and determine frequency of monitoring.
Warehouse Mapping
Risk: Inadequate temperature or humidity control in storage areas.
QRM Application: Perform risk assessments to define monitoring points, focusing on areas prone to temperature fluctuations, such as near HVAC vents or walls exposed to sunlight.
Process Validation for Freeze Dryers
Risk: Inconsistent freezing or drying might affect product stability.
QRM Application: Identify and mitigate risks related to temperature sensor calibration or placement during thermal profiling.
Calibration of Temperature Sensors
Risk: Faulty or uncalibrated sensors can lead to inaccurate data and failed validation.
QRM Application: Develop a risk-based calibration schedule, prioritizing sensors in critical processes over less critical ones.
Heat Distribution in Ovens
Risk: Poor heat distribution could result in uneven drying or sterilization.
QRM Application: Use QRM to assess risks of temperature deviations and determine the appropriate number and placement of thermocouples during validation.
Read also:
Resource Person: Yousef Housin
