Temperature mapping, also known as thermal mapping, designed with the aim of enabling organizations monitor and maintain the condition of an overall environment with respect to temperature level. It is a Good Manufacturing Practice (GMP) process which is intended to prevent fluctuation of temperature and humidity in a controlled environment such as a warehouse, refrigerator, or vehicle.
Temperature mapping represents an integral part of the validation process, an important element of a successful compliance strategy; demonstrating that the environment in question is well suitable for sensitive products, complying with Good Manufacturing Practice (GMP). Hence, a stringent approach to temperature validation should be adopted to enable an auditor or a regulatory body immediately see that environmental control procedures are in place whenever they visit your facility for inspection.
Examples of industries where temperature mapping should be adopted include pharmaceutical, food production, chemical production and packaging industries etc.
Temperature Mapping Vs Temperature Monitoring
Temperature mapping is performed by placing data loggers throughout a specified area for at least 24 hours to study how temperature and humidity is distributed, unlike temperature monitoring which uses fewer data loggers to provide continuous monitoring where product is stored.
Temperature monitoring is a customary practice implemented after a temperature mapping study exercise. The data obtained from both enables organizations identify inconsistencies and implement changes within the environment. Inconsistencies are caused usually by opening and closing of doors, heat generation from electronics, or faulty HVAC systems.
How necessary is Temperature Mapping?
The practice of temperature mapping can assist in preventing product and monetary loss, as well as improve overall quality and public safety. Temperature mapping should be incorporated as part of a company’s GMP guidelines to enable easy and prompt detection of inconsistencies and correcting areas with such inconsistencies in order to ensure proper storage conditions and regulatory compliance.
Areas Requiring Temperature Mapping
It is a good practice to conduct temperature mapping in areas where the quality of a product can be affected by temperature or humidity. Temperature inconsistencies can cause products denaturing, altering their properties (physical, chemical or biological), and thereby deeming them unusable. This can be costly for manufacturers and dangerous to the public health.
How to Conduct Temperature Mapping
Before mapping, the following question should be asked and answered:
The effectiveness of your answer to the questions above determine to a large extent, the effectiveness of your mapping exercise. After considering the questions above, the following steps can now be taken:
Again, temperature mapping should be taken all seriousness to prevent product wastage to your company and harm to the general public health.
Adebayo is a thought leader in continuous process improvement and manufacturing excellence. He is a Certified Six Sigma Master Black Belt (CSSMBB) Professional and Management Systems Lead Auditor (ISO 9001, 45001, ISO 22000/FSSC 22000 etc.) with strong experience leading various continuous improvement initiative in top manufacturing organizations.
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