Don’t get confused, No, I am not talking about ISO 17025. ISO 17025 is a comprehensive standard which guides you to achieve excellence in Laboratory Quality Management and unfortunately more than 90% of labs in India (even more) are not certified with ISO 17025, since it would take significant time and resources to get the lab certified with ISO 17025.
In this article, I will share my views on the required basics that are necessary to be present in the lab, where we engage in analysis of our Raw Material, Packaging Material, In Process and Finished Goods. These basics are applicable for the basic physiochemical labs. For high precision labs and advanced Microbiological labs, some other pre-requisites are required, which would be discussed in another article.
Lab is considered to be one of the cleanest places of your facility. Hence, Infrastructure of the lab must be maintained in such a way, so that it is cleanable, while not affecting the instruments, chemicals and testing conditions. Laboratory must be situated in a place that is free from disturbances (any vibrations etc.), cross contamination, etc.
A Laboratory must be capable of maintaining the ideal temperature and humidity in order to obtain the best results. Chemicals and instruments change their behaviour, if the required temperature and humidity is not maintained. This would eventually affect the results of the analysis. Temperature of the Laboratory must be maintained between 22-24 Degree Celsius and humidity up to 50%. Additionally, it is highly recommended that the temperature and humidity should be monitored and recorded frequently (once in 2 hours to achieve better results).
At the core, lab equipment must be capable of producing the desired result with accuracy. There have been multiple incidences where we would have seen that the equipment would not have been capable of producing the required results with accuracy. For example, the lower limit of a piece of chocolate is 25-50 grams. However, if the lab is capable of measuring the weight up to only one digit after decimal, then it would be incorrect and will produce wrong results. We must ensure this correctness for all the lab equipment.
The lab must establish a calibration programme, which shall be reviewed and adjusted as necessary, in order to maintain confidence in the status of calibration. Calibration records must also be maintained with all the basic data such as calibration done date / due date / done by etc. It is always recommended to put a sticker with this information on the equipment itself. Other than calibration, daily verification is also required for some equipment. Hence, follow the OEM’s (Original Equipment Manufacturer) recommendation without fail.
Chemicals and reagents must also be freshly prepared as per the given instructions. Most of the time, we miss to mention information such as prepared on / use by / prepared by, etc. It is simply a no brainer that using expired chemicals and reagents will not provide accurate results. The same goes with dry chemicals, as most of the labs keep using the chemicals without following the instructions on the expiry date. All chemicals come with expiry dates and if not mentioned, you can consider 5 years from the date of manufacturing / packing.
One of the most important parts in any analysis is the Test Method. Lab must absorb the test methods that are suitable for their type of products / materials etc. There are many national and international bodies which provide validated test methods for different uses. All methods, procedures and supporting documentation, such as instructions, standards, manuals and reference data relevant to the laboratory activities must be kept up to date and made readily available to the person.
In any event, the validated test method is not available, the laboratory must validate non-standard methods, laboratory-developed methods and standard methods used outside their intended scope or which has otherwise been modified. The validation shall be as extensive as it would be necessary to meet the needs of the given application or field of application.
People and Competency:
Selection of the associates (who are going to do the testing) must be based on their qualification, past experience of relevant testing, etc. However, if the selected candidate is well aware about the test methods, running equipment, etc., even in such cases he/ she must be trained again at the time of joining and must be tested for his/her competency .
Moreover, refresher training of the associates working in the lab must be done at least once in a year without fail. Error in testing among the associates performing the same tests can be done with a ring test. In a ring test, same test with same reagents / samples etc. is performed by every associate in the lab and subsequently the results are matched for conformance.
Additionally, in order to test the overall lab’s performance, lab must participate in the proficiency tests of certain tests. In proficiency test, external samples (of known result) are shared with lab by third party agencies and subsequently results are matched with some indices. This practice gives the required confidence to the lab about the accuracy of the results produced.
Other Required Processes:
Record and Document Control: All the SOPs / Test Methods / Test Results must be retained in a proper condition. All the test results must continue to be maintained till the shelf life of the product or the agreed internal frequencies.
Internal Audit: A quick internal audit of the lab would help the management identify the strengths and improvement areas of the lab as a process of continual improvement.
Corrective and Preventive Action: In case of any non-conformance observed in the laboratory related practices, there should be a corrective and preventive action process, which ensures that repetition of the observed issue can be avoided.
Further, all the safety measures must be in place in the lab, so that all personnel are safe while performing tests.
As mentioned above, these are the very basic requirements for food testing labs. We must work towards improving our lab practices year on year, so that we can strive to achieve excellence.
About the Author:
Food Safety Professional
Email ID: firstname.lastname@example.org
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