It is common for anyone to judge the sophistication and reputation of a laboratory by its :
- Landscaping and architectural design
- Availability of modern sophisticated facilities
- Adherence to committed time frames for analysis
- Trained manpower
- Pleasant and sweet talking customer support staff
These factors do contribute towards a laboratory’s reputation but in real terms it is more important that records of all laboratory activities are strictly maintained. Some laboratory activities may appear to be too mundane for recording purpose but with experience you will realize that adherence to record keeping activities can come to your rescue in embarrassing and difficult situations.
Let me make a start by listing out activities which must be recorded without fail:
- Record all analysis activities in your laboratory notebook. These should include calculations, weight slips, chromatograms and spectra, Records help future workers to learn from your mistakes so even negative results are equally important.
- Record of temperature, humidity and atmospheric pressure (in case necessary) on periodic basis
- Record of sample receipt and disposal
- Record of calibration of test instruments, weighing balances and thermometers
- Logbook records on usage of instruments, balances, pH meters, etc
- Record on consumption of reference materials and working standards
- Record inspection of safety devices such as fire extinguishers, safety showers, etc
- Daily record on effluent treatment activities
- Installation record of various instruments including IQ, OQ and PQ
- Validation of chemists and methods adopted as standard test procedures
- Date of preparation of reagents and standards along with their validity record
- Daily housekeeping records
Now it is time to discuss the situations in which you are going to thank yourself for record keeping of your Laboratory activities.
Registering your inventions – honest recording of all laboratory activities are a great help in registration for patents.
Medical laboratory testing – your analysis reports on patient samples will decide the future course of treatment. In case of doubt or marginal results your data can be questioned on the analysis technique, conditions of test, calibration of instruments and your documentation will provide the necessary support.
Forensic analysis – it is of utmost importance for forensic analysts to maintain records of all laboratory activities because your results can be questioned in a court of law. Your analysis reports can form basis for conviction in criminal cases.
Industrial analysis – industrial chemists are daily posed the question whether the material is passing or failing. Your verdict based on your documented reports can mean profit or loss of enormous magnitude to your organization in addition to serving the interests of the consumer
Environmental monitoring – the analysis results in a way affect all of us irrespective of our social status as we all depend on quality of natural resources such as air, water and agricultural produce.
As you observe from above examples all analytical data is equally important for ensuring good quality of life. The data is reliable only if records are properly maintained to support its validity.
Audits constitute an essential part of laboratory operations. Auditors rely on your documented records only and it is almost impossible to convince them on verbal statements. Auditors firmly believe
‘ IF YOU HAVE NOT DOCUMENTED IT,YOU HAVE NOT DONE IT’
The only option left to come out of audit exercises successfully is to record your data honestly and concurrent to the activity.
I hope you will agree with the contents of this article. Please leave your suggestions and comments.