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Temperature Incident Form Version: 2, Updated: 3.10.21 Effective: March, 2021Temperature Incident Troubleshooting RecordComplete this report to gather information vaccine manufacturers will need to
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How to fill out out-of-range temperature incidents
How to fill out out-of-range temperature incidents
01
Document the incident including date, time, location, and specific details of the temperature deviation
02
Determine the root cause of the out-of-range temperature incident
03
Take corrective action to address the issue and prevent it from happening again
04
Notify relevant stakeholders about the incident and the steps taken to resolve it
Who needs out-of-range temperature incidents?
01
Manufacturing facilities handling temperature-sensitive products
02
Pharmaceutical companies storing vaccines or medications
03
Food industry ensuring the safety of perishable goods
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What is out-of-range temperature incidents?
Out-of-range temperature incidents refer to occurrences when the temperature of a product or environment falls outside the predefined acceptable limits, which can affect quality and safety.
Who is required to file out-of-range temperature incidents?
Typically, facilities that handle perishable goods, such as food and pharmaceuticals, are required to file out-of-range temperature incidents.
How to fill out out-of-range temperature incidents?
To fill out out-of-range temperature incidents, document the date and time of the incident, the specific temperature recorded, the product affected, the duration of the temperature deviation, and any actions taken to mitigate the issue.
What is the purpose of out-of-range temperature incidents?
The purpose of reporting out-of-range temperature incidents is to ensure compliance with safety standards, protect public health, and maintain the integrity of temperature-sensitive products.
What information must be reported on out-of-range temperature incidents?
Information that must be reported includes the incident date, product details, temperature readings, duration of the incident, and corrective actions taken.
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