| Start cycle phase(Select parameters/sterilization recipe) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Choosing the wrong recipe | Lack of care in choosing the formulation | Invalid cycle. Affects product sterility (re-sterilization) | 1. Different recipe names | 6 | Нэвтрэлт 5 | 10 | 300 | 1. Work instructions 2. Careful inspection before the cycle starts 3. Operator training | 2 | Нэвтрэлт 5 | 4 | 40 | 1. Work instructions 2. Careful inspection before starting the cycle 3. Operator training | user |
| Loss of product/packaging functionality and integrity due to unvalidated cycle parameters | 1. Different recipe names | 6 | 4 | 10 | 240 | 1. Work instructions 2. Careful inspection before the cycle starts 3. Operator training | 2 | 4 | 4 | 32 | 1. Work instructions 2. Careful inspection before starting the cycle 3. Operator training | user | |||
| Warm-up phase(Cabinet heating) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | Нэвтрэлт 5 | 3 дайсан | 2 | 30 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1. Heating timeout alarm 2. Automatic heating time compensation | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user | ||
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance 2. Calibration | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance 2. Calibration | user | ||
| 2 | The temperature inside the cabinet is too high | Temperature sensor failure | Affects product sterility (re-sterilization) | 1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | 4 | 2 | 48 | 1. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1. Preventive maintenance 2. Calibration | user |
| Insulation stage(Maintain cabinet temperature) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1. Heating timeout alarm 2. Circulating water pump overload alarm | Нэвтрэлт 5 | 3 дайсан | 2 | 30 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1. Heating timeout alarm | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user | ||
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1. Heating timeout alarm 2. Circulating water pump overload alarm | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance 2. Calibration | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance 2. Calibration | user | ||
| 2 | The temperature inside the cabinet is too high | Temperature sensor failure | Affects product sterility (re-sterilization) | 1. Heating timeout alarm 2. Circulating water pump overload alarm | 6 | 4 | 2 | 48 | 1. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1. Preventive maintenance 2. Calibration | user |
| 3 дайсан | Lack of time | Programming Errors | Repeat sterilization | 1. Automatic cycle inspection | 2 | 4 | 2 | 16 | none | ||||||
| Pre-vacuum stage(Removing air from the chamber allows the process to proceed below the EO flammability limit) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Not enough air removed | Low vacuum pump efficiency | The cycle is locked in one phase until it is restored and restarted after a standby period | 1. Pre-vacuum time over limit alarm 2. Vacuum pump overload alarm 3. Automatically detect water flow and shut down the waterless pump | Нэвтрэлт 5 | 3 дайсан | 2 | 30 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user |
| Wrong valve | The cycle is locked in one phase until it is restored and restarted after a standby period | 1. Pre-vacuum time over limit alarm 2. Vacuum pump overload alarm | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user | ||
| Pressure sensor failure | Flammable Zone Hazard | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance 2. Calibration | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance 2. Calibration | user | ||
| 2 | Too much vacuum | Pressure sensor failure | Product and/or packaging damage (classification) | 1. Redundant pressure sensor 2. Pressure difference alarm is issued when the pressure difference is greater than 1kpa. | 6 | 4 | 2 | 48 | 1. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1. Preventive maintenance 2. Calibration | user |
| Leak detection stage(Check the tightness of the box) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Cabinet leakage | Gasket leakage | No impact | 1. Leak test failure alarm 2. Process ends | 10 | Нэвтрэлт 5 | 2 | 100 | 1. Preventive maintenance | 3 дайсан | Нэвтрэлт 5 | 2 | 30 | 1. Preventive maintenance | user |
| Valve leakage | No impact | 1. Leak test failure alarm | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user | ||
| Circulation system air duct leakage | No impact | 1. Leak test failure alarm | 4 | 3 дайсан | 2 | 24 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance 2. Calibration | user | ||
| Nitrogen replacement stage(Fill the chamber with an inert gas to replace oxygen) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Not enough nitrogen entering the chamber | Insufficient nitrogen | The cycle is locked in one phase until it is restored and restarted after a standby period | End of process | 3 дайсан | 3 дайсан | 2 | 18 | N/A | ||||||
| Faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | N/A | 6 | 3 дайсан | 3 дайсан | 54 | 1. Preventive maintenance | 2 | 3 дайсан | 3 дайсан | 18 | 1. Preventive maintenance | user | ||
| Pressure sensor failure | Flammable Zone Hazard | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user | ||
| 2 | Too much nitrogen in the cabinet door | Faulty valve | EO concentration is lower than the validated value because during EO injection, if controlled by pressure (resterilization), additional N2 is injected | 1. Indoor high voltage alarm 2. End of process | 6 | Нэвтрэлт 5 | 4 | 120 | 1. Preventive maintenance | 2 | Нэвтрэлт 5 | 4 | 40 | 1. Preventive maintenance | user |
| Pressure transmitter failure | Too much EO gas injected. High EO residue. Extended degassing time me) | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance 2. Calibration | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance 2. Calibration | user | ||
| 3 дайсан | The cabinet temperature is higher than the upper limit t | Impact on product function (sorting) | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 4 | 2 | 48 | 1. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1. Preventive maintenance 2. Calibration | user | |
| 4 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1. Heating timeout alarm 2. Automatic heating time compensation | 6 | 3 дайсан | 3 дайсан | 54 | 1. Preventive maintenance | 2 | 3 дайсан | 3 дайсан | 18 | 1. Preventive maintenance | user | ||
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance 2. Calibration | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance 2. Calibration | user | ||
| Low carburetor temperature | Affects product sterility (re-sterilization) | 1. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation | 6 | 4 | 2 | 48 | 1. Preventive maintenance | 2 | 4 | 2 | 16 | 1. Preventive maintenance | user | ||
| Humidification stage(Increasing the humidity of the load by injecting steam) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Insufficient steam | Steam generator failure | Affects product sterility (re-sterilization) | 1. Alarm when steam pressure is lower than the limit | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance | user |
| Valve failure | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.Humidification frequency limit alarm | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance | user | ||
| Pressure transmitter/humidity sensor failure | Affects product sterility (re-sterilization) | 1. Redundant pressure/humidity sensor 2. Alarm when pressure/humidity difference exceeds limit | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance 2. Calibration | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance 2. Calibration | user | ||
| Filter clogged | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.Humidification frequency limit alarm | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance | user | ||
| 2 | Too much steam injection | Faulty valve | Excessive steam injection, wet cartons (sorting) | 1. Indoor high voltage alarm 2. End of process | 6 | Нэвтрэлт 5 | 4 | 120 | 1. Preventive maintenance | 2 | Нэвтрэлт 5 | 4 | 40 | 1. Preventive maintenance | user |
| Pressure transmitter/humidity sensor failure | Excessive steam injection, wet cartons (sorting) | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance 2. Calibration | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance 2. Calibration | user | ||
| 3 дайсан | Temperature is too high | Temperature sensor failure | Impact on product functions (ranking) | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 4 | 2 | 48 | 1. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1. Preventive maintenance 2. Calibration | user |
| 4 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked in one phase until it is restored and restarted after a standby period | 1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 4 | 2 | 16 | 1. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked in one phase until it is restored and restarted after a standby period | 1. Heating timeout alarm 2. Automatic heating time compensation | 6 | 3 дайсан | 3 дайсан | 54 | 1. Preventive maintenance | 2 | 3 дайсан | 3 дайсан | 18 | 1. Preventive maintenance | user | ||
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1. Heating timeout alarm 2. Circulating water pump overload alarm | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance 2. Calibration | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance 2. Calibration | user | ||
| Humidification dwell phase(Balanced humidity) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Lack of time | time out | Affects product sterility (re-sterilization) | 1. Automatic cycle inspection | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance | 1-1 | Нэвтрэлт 5 | 2 | 10 | 1. Preventive maintenance | user |
| Nitrogen cushion stage(Fill the chamber with inert gas to dilute the oxygen) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Not enough nitrogen entering the cabinet | Lack of nitrogen | The cycle is locked in one phase until it is restored and restarted after a standby period | 1. Check N2 pressure before starting the cycle 2. Alarm when N2 pressure is lower than the limit | 3 дайсан | 3 дайсан | 2 | 18 | 0 | ||||||
| Valve failure | The cycle is locked in one phase until it is restored and restarted after a standby period | none | 6 | 3 дайсан | 3 дайсан | 54 | 1. Preventive maintenance | 2 | 3 дайсан | 3 дайсан | 18 | user | 1. Preventive maintenance | ||
| Pressure sensor failure | Flammable Zone Hazard | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | user | 1. Preventive maintenance | ||
| 2 | Too much nitrogen injected into the cabinet | Faulty valve | EO concentration is lower than the validated value because during EO injection, if controlled by pressure (resterilization), additional N2 is injected | 1. Indoor high voltage alarm 2. End of process | 6 | Нэвтрэлт 5 | 4 | 120 | 1. Preventive maintenance | 2 | Нэвтрэлт 5 | 4 | 40 | user | 1. Preventive maintenance |
| Pressure transmitter failure | Too much EO gas injected. High EO residue. (Extend degassing time) | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance 2. Calibration | 2 | Нэвтрэлт 5 | 2 | 20 | user | 1. Preventive maintenance 2. Calibration | ||
| 3 дайсан | The temperature inside the cabinet exceeds the upper limit | Temperature sensor failure | Impact on product function (sorting) | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 4 | 2 | 48 | 1. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | user | 1. Preventive maintenance 2. Calibration |
| 4 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | user | 1. Preventive maintenance |
| Electric heating tube failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 дайсан | 3 дайсан | 54 | 1. Preventive maintenance | 2 | 3 дайсан | 3 дайсан | 18 | user | 1. Preventive maintenance | ||
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance 2. Calibration | 2 | Нэвтрэлт 5 | 2 | 20 | user | 1. Preventive maintenance 2. Calibration | ||
| Low carburetor temperature | Affects product sterility (re-sterilization) | 1. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation | 6 | 4 | 2 | 48 | 1. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | user | 1. Preventive maintenance 2. Calibration | ||
| EO injection stage(Fill the cabinet with EO gas) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Not enough ethylene oxide is entering the cabinet | Missing EO | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1.EO cylinder hole alarm 2.EO injection timeout alarm | 10 | Нэвтрэлт 5 | 2 | 100 | 1. Operator training 2. EO weight check before cycle start | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Operator training 2. EO weight check before cycle start | user |
| Faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.EO injection timeout alarm | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance | user | ||
| EO pipeline leakage | Batches that exceed the qualification period may be sterilized again | none | 6 | Нэвтрэлт 5 | 3 дайсан | 90 | 1. Preventive maintenance 2. LEL EO detector alarm | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance 2. LEL EO detector alarm | user | ||
| Pressure sensor failure | EO concentration is lower than the validation value (re-sterilization) | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance 2. Calibration | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance 2. Calibration | user | ||
| 2 | Liquid EO enters the cabinet | Low carburetor temperature | The cycle is locked in one phase until it is restored and restarted after a standby period | 1. The carburetor temperature is lower than the limit alarm | 6 | 4 | 2 | 48 | 1. Preventive maintenance | 2 | 4 | 2 | 16 | 1. Preventive maintenance | user |
| Not enough water in the carburetor due to a faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | 1. The carburetor water level is lower than the limit alarm | 6 | 4 | 2 | 48 | 1. Preventive maintenance | 2 | 4 | 2 | 16 | 1. Preventive maintenance | user | ||
| 3 дайсан | Too much ethylene oxide input in the cabinet | Faulty valve | Longer quarantine, requiring additional testing | 1. Indoor high voltage alarm | 6 | 3 дайсан | 3 дайсан | 54 | 1. Preventive maintenance 2. EO residual inspection | 2 | 3 дайсан | 3 дайсан | 18 | 1. Preventive maintenance 2. EO residual inspection | user |
| Pressure sensor failure | Longer quarantine, requiring additional testing | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance 2. Calibration | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance 2. Calibration | user | ||
| 4 | The temperature inside the cabinet exceeds the upper limit | Temperature sensor failure | Impact on product function (sorting) | 1. Redundant temperature sensor 2. Chamber high temperature alarm 3. Temperature difference exceeds limit alarm | 6 | 4 | 2 | 48 | 1. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1. Preventive maintenance 2. Calibration | user |
| Нэвтрэлт 5 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1. Heating timeout alarm 2. Automatic heating time compensation | 6 | 3 дайсан | 3 дайсан | 54 | 1. Preventive maintenance | 2 | 3 дайсан | 3 дайсан | 18 | 1. Preventive maintenance | user | ||
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance 2. Calibration | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance 2. Calibration | user | ||
| Low carburetor temperature | Affects product sterility (re-sterilization) | 1. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation | 6 | 4 | 2 | 48 | 1. Preventive maintenance | 2 | 4 | 2 | 16 | 1. Preventive maintenance | user | ||
| Nitrogen cap stage(Add N2 to cover EO) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Not enough nitrogen entering the cabinet | Lack of nitrogen | The cycle is locked in one phase until it is restored and restarted after a standby period | 1. Check N2 pressure before starting the cycle 2. Alarm when N2 pressure is lower than the limit | 3 дайсан | 3 дайсан | 2 | 18 | N/A | ||||||
| Valve failure | The cycle is locked in one phase until it is restored and restarted after a standby period | none | 6 | 3 дайсан | 3 дайсан | 54 | 1. Preventive maintenance | 2 | 3 дайсан | 3 дайсан | 18 | 1. Preventive maintenance | user | ||
| Pressure sensor failure | Flammable Zone Hazard | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user | ||
| 2 | Too much nitrogen injected into the cabinet | Faulty valve | The cabin is under positive pressure. This cycle will end. | 1. Indoor high voltage alarm 2. End of process | 6 | Нэвтрэлт 5 | 4 | 120 | 1. Preventive maintenance | 2 | Нэвтрэлт 5 | 4 | 40 | 1. Preventive maintenance | user |
| 3 дайсан | The temperature inside the cabinet exceeds the upper limit | Temperature sensor failure | Affects product sterility (re-sterilization) | 1. Redundant temperature sensor 2. Chamber high temperature alarm 3. Temperature difference exceeds limit alarm | 6 | 4 | 2 | 48 | 1. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1. Preventive maintenance 2. Calibration | user |
| 4 | The box temperature is lower than the lower limit value | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1. Heating timeout alarm 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1. Heating timeout alarm 2. Automatic heating time compensation | 6 | 3 дайсан | 3 дайсан | 54 | 1. Preventive maintenance | 2 | 3 дайсан | 3 дайсан | 18 | 1. Preventive maintenance | user | ||
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance 2. Calibration | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance 2. Calibration | user | ||
| Low carburetor temperature | Affects product sterility (re-sterilization) | 1. Alarm when the carburetor temperature is lower than the limit 2. Automatic heating time compensation | 6 | 4 | 2 | 48 | 1. Preventive maintenance | 2 | 4 | 2 | 16 | 1. Preventive maintenance | user | ||
| EO exposure stage(Disinfect the product) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Lack of time | Programming Errors | Repeat sterilization | 1. Automatic cycle inspection | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance | 1-1 | Нэвтрэлт 5 | 2 | 10 | 1. Preventive maintenance | user |
| 2 | The box temperature is lower than the lower limit t | Hot water circulation pump failure | The cycle is locked at one stage until it is restored and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | Heating timeout 2. Circulating water pump overload alarm 3. Automatic heating time compensation | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user |
| Electric heating tube failure | The cycle is locked in one phase until it is resumed and restarted after a standby period. Batches that have exceeded the qualified cycle may be sterilized again. | 1. Heating timeout alarm 2. Automatic heating time compensation | 6 | 3 дайсан | 3 дайсан | 54 | 1. Preventive maintenance | 2 | 3 дайсан | 3 дайсан | 18 | 1. Preventive maintenance | user | ||
| Temperature sensor failure | Affects product sterility (re-sterilization) | 1. Redundant temperature sensor 2. Temperature difference exceeds limit alarm | 6 | Нэвтрэлт 5 | 2 | 60 | 1. Preventive maintenance 2. Calibration | 2 | Нэвтрэлт 5 | 2 | 20 | 1. Preventive maintenance 2. Calibration | user | ||
| 3 дайсан | The temperature inside the cabinet exceeds the upper limit | Temperature sensor failure | Affects product sterility (re-sterilization) | 1. Redundant temperature sensor 2. Chamber high temperature alarm 3. Temperature alarm | 6 | 4 | 2 | 48 | 1. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1. Preventive maintenance 2. Calibration | user |
| 4 | Not getting a sufficiently homogeneous EO mixture | Circulation fan failure | Affects product sterility (re-sterilization) | 1. Low speed alarm | 6 | Нэвтрэлт 5 | 3 дайсан | 90 | 1. Preventive maintenance | 2 | Нэвтрэлт 5 | 3 дайсан | 30 | 1. Preventive maintenance | user |
| Product positioning very close to the cavity wall | Affects product sterility (re-sterilization) | 1.Guardrail is used to prevent the product from contacting the cavity wall | 2 | Нэвтрэлт 5 | 3 дайсан | 30 | 0 | N/A | |||||||
| EO Removal Phase(Create vacuum/remove sterilization gas) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Not purging enough gas | Inefficient vacuum pump | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.EO removal timeout alarm 2.Vacuum pump overload alarm 3.Automatically detect water flow and shut down the waterless pump | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user |
| Faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.EO removal timeout alarm 2.Vacuum pump overload alarm | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user | ||
| Pressure sensor failure | Longer isolation time and additional testing required due to less EO gas being removed | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance 2. Calibration | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance 2. Calibration | user | ||
| 2 | Exhaust too much gas | Pressure sensor failure | Product and/or packaging damage (classification) | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 4 | 2 | 48 | 1. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1. Preventive maintenance 2. Calibration | user |
| Nitrogen purge stage(Ensure that the indoor environment is not flammable) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Not enough nitrogen entering the chamber | Lack of nitrogen | The cycle is locked in one phase until it is restored and restarted after a standby period | 1. Check N2 pressure before starting the cycle 2. Alarm when N2 pressure is lower than the limit | 3 дайсан | 3 дайсан | 2 | 18 | N/A | ||||||
| Faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | none | 6 | 3 дайсан | 3 дайсан | 54 | 1. Preventive maintenance | 2 | 3 дайсан | 3 дайсан | 18 | 1. Preventive maintenance | user | ||
| Pressure sensor failure | Flammable Zone Hazard | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user | ||
| Longer quarantines require additional testing | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user | |||
| Air cleaning stage(Create vacuum/remove residual sterilization gas, eliminate residual EO) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Not purging enough gas | Inefficient vacuum pump | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.EO removal timeout alarm 2.Vacuum pump overload alarm 3.Automatically detect water flow and shut down the waterless pump | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user |
| Faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | 1.EO removal timeout alarm 2.Vacuum pump overload alarm | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance | user | ||
| Pressure sensor failure | Longer isolation time and additional testing required due to less EO gas being removed | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance 2. Calibration | 2 | 3 дайсан | 2 | 12 | 1. Preventive maintenance 2. Calibration | user | ||
| 2 | Exhaust too much gas | Pressure sensor failure | Product and/or packaging damage (classification) | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 4 | 2 | 48 | 1. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1. Preventive maintenance 2. Calibration | user |
| 3 дайсан | Insufficient air in the cabin | Faulty valve | The cycle is locked in one phase until it is restored and restarted after a standby period | 1. Gas injection time over limit alarm | 6 | 4 | 3 дайсан | 72 | 1. Preventive maintenance | 2 | 4 | 3 дайсан | 24 | 1. Preventive maintenance | user |
| Filter clogged | The cycle is locked in one phase until it is restored and restarted after a standby period | 1. Gas injection time over limit alarm | 6 | 4 | 3 дайсан | 72 | 1. Preventive maintenance | 2 | 4 | 3 дайсан | 24 | 1. Preventive maintenance | user | ||
| Pressure sensor failure | Longer quarantines require additional testing | 1. Redundant pressure sensor 2. Alarm when pressure difference exceeds limit | 6 | 3 дайсан | 2 | 36 | 1. Preventive maintenance 2. Calibration | 2 | 4 | 2 | 16 | 1. Preventive maintenance 2. Calibration | user | ||
| Removal stage(Remove residue from the product) | |||||||||||||||
| Serial number | Potentially risky content | Risk assessment under existing process conditions | Risk assessment of the results after taking measures | Recommended Actions | Responsibilities and current status | ||||||||||
| Fault name | Cause | Failure Impact | Control Now | event | Severity | examine | Risk Prioritization | Take action | event | Severity | examine | Risk Prioritization | |||
| 1-1 | Aeration time is less than the specified time | Programming Errors | Repeat sterilization | 1. Automatic cycle inspection | 2 | 3 дайсан | 2 | 12 | 1. Restart your computer regularly | 1-1 | 3 дайсан | 2 | 6 | 1. Restart your computer regularly | user |
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