Just how it is mentioned by many prior in this discussion thread, if the equipment in the manufacturing plant is damaged to the point of ineffectiveness, a root cause analysis would need to be conducted to identify the problem, perform a preventative maintenance and get the equipment fixed and properly calibrated according to the SOP’s for this machine according to what the processing instructions has for their operators. In addition a to the process risk management, an investigation will look into how the failure accord since these processing equipment is maintenance and calibrated according to the maintenance schedule. I believe that the batch of products would need to be tested to spec to ensure that there isn’t any variability.