Avoiding common Mistakes in Mapping Projects

For applications that are subjected to the GxP quality guidelines within regulated industries, mapping is essential to decide where, within an area, testing, production, storage and distribution can be carried out based upon a scientific risk-based assessment, using the results from a mapping study.

Listed are some of the most common mistakes made while conducting a mapping project. Many sources discuss the mapping process and are not focused on what not to do. Let’s discuss what to avoid, or what not to do, during the mapping process.

The Mistake of Random Logger Placement 

If forced to pick the one biggest mistake, it would be omitting the creation of a methodical layout, or pattern, for the mapping. Random placement, or placement without any thought to other variables in the environment (i.e. an air duct, or fan), can cause a significant amount of rework. Regarding the sensor pattern, not thinking three dimensionally, or not placing sensors where product will be present are both problematic. For example, placing a sensor or logger at the midpoint of a space based on the assumption the measurement will be some type of “average” reading between the points is not correct placement. This type of assumption is contradictory to the fundamental reason for a mapping which is to actually know what those temperatures are at those specific points.

The Mistake of Not Using Enough Sensors or Loggers

For some large mapping projects that require local data logging, the costs of equipment can rise quickly. It is always prudent to remember that, although the mapping equipment and process may be costly, it is usually minimal compared to the cost of product failure, or a product recall caused by inadequate mapping or monitoring.

The Mistake of Poor or Inadequate Planning

Do not set impossible or unnecessarily difficult pass/fail criteria. The criteria should be chosen based on the product limit and not the storage environment itself.

Set reasonable limits based upon the logging system capabilities and the product quality limits when formulating any mapping plan. Unreasonable expectations lead to a lot of wasted time and effort trying to meet improper mapping pass/fail limits. Make sure the equipment or system can meet your protocol criteria.

The Mistake of Overly Complex or Imprecise Mapping Protocols

Protocols should be clear and concise. If a drawing or picture can be added for clarity, do it. If a compound sentence can be reduced to two or three sentences, consider doing it. Remember that although you may be executing the mapping protocol that you are writing, others may need to use your protocol document in the future. The clearer your document, the less scrutiny it will receive.

The Mistakes Made in Data Collection and Reporting

Once all of the data is collected a report should be generated. It is not enough to just collect the data and reference it in the report. This practice will almost certainly invite additional data review. The data should also be checked to ensure that the data collected matches what was originally stated in your documents.

If the reporting system can flag out of limit data, or graph data, consider including those in your data report.

The Mistake of inferior Calibration Equipment

Think about the calibration. Use calibration equipment for the sensors that are more precise than those used during the mapping. A calibration check against an inferior piece of equipment (less precise) does not allow for properly calibrated or checked sensors used in the mapping project. If calibration is not proper, any person reviewing the mapping data might call into question the entire mapping execution, especially if some of your data is close to a pass/fail limit.

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