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Technical Records

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Guest user Created:   Jun 19, 2020 Last commented:   Jun 22, 2020

Technical Records

Hello, I hope you are well.
I am looking for guidance regarding the completion of technical records in terms of leaving blanks in sections that are not required, e.g. a temperature monitoring record will have 2 blank rows out of every 7 as the temperature is not recorded at the weekends. I want technicians to write N/A in cells that do not need completing but want to back that up with a Standard reference. Is that the sort of question you can answer?

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Tracey Evans Jun 22, 2020

This is a good question. It is an example of the need to take a risk-based approach to creating records. I can’t tell from your question if the temperature monitoring relates to a piece of equipment (e.g. an incubator oven or water bath); or environmental conditions (e.g. room temperature). Either way, you need to look at the risks of not recording something of importance, and equally risk of recording something like "n/a" and having to justify during review or audits, that in fact it was not applicable. It is therefore advisable to avoid using n/a on a technical record. 

To resolve  this issue, consider the purpose of the record and therefore it’s design. There are three questions here – why the data / information needs to be recorded, what must be recordered and when ?  If the purpose relates to a manual operation, e.g. to verify a temperature specification was met for glassware used for the preparation of samples; then the recorded temperature must cover the duration of the activity. If the need, as in this example, always excludes recording data outside of operational hours, then an option could be to redesign the form so that there is no need to record over weekedends, thus avoiding using "n/a". You would document in a procedure or test method, why and when the particular temperature record needs to be supplied.  Generally, you could state for equipment, the need to manually record temperature “before use”; while  general environmental conditions like room temperature and humidity are recorded “at the beginning and end of each shift”.

Don’t forget if there are specific risks, such as temperature fluctuations which could affect the validity of the results; then the temperature should be recorded at the time, not just at the beginning of shift. If the activity affected by temperature extends outside of operational hours, then the use of a min and max recording may be required, or even live temperature loggers. Consider, for example, the risk of a refrigerator housing valuable reference bacterial cultures or sample, failing on a saturday morning and only being discovered on a monday morning.

For more information, see the ISO 17025 toolkit document templates:  Facilities and Environmental Condition Procedure  and Equipment and Calibration Procedure at https://advisera.com/17025academy/documentation/facilities-and-environmental-condition-procedure/ and https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure// as well as the article What does ISO 17025:2017 require for laboratory measurement equipment and related procedures? at https://advisera.com/17025academy/blog/2019/07/25/iso-17025-measurement-requirements-of-the-standard/

Some additional information is available in the ISO 17025 Expert Community question regarding Environmental conditions for testing and calibration laboratories, available  at https://community.advisera.com/topic/environmental-conditions-for-testing-and-calibration-laboratories/

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