Record Control - Using Laboratory Notebooks

Posted by admin 05/03/2016 0 Comment(s) Quality System,

Laboratory records are very important source of information for projects relating to developments and improvements. Therefore, these need to be preserved till the life of product.  Various quality system standards require these records to be maintained even beyond the life cycle of the product.   Therefore, it is a very important concern as how to use, maintain and preserve these records.


Laboratory note book is the basic documentation of activities done by any analyst, test engineer or technician.  Their notes and experimental data are recorded in it. Thus it is imperative that all the notebooks are properly preserved. The organizations where quality management systems are implemented, it is mandatory to control all the critical data and record.  Laboratory data is one of those critical records.  

A general conception, particularly in the organizations where quality management systems are implemented, is that data needs to be recorded in controlled record formats only.  This is a misunderstanding of beginners. The laboratory notebooks, in their raw form, are well acceptable as long as they are properly identified and maintained.  Here are some guidelines to control the laboratory notebooks.


A. Issuance: 

1. The notebooks should be issued to individuals by a central authority, may be quality assurance (QA) or the document an record control (DRC) section. 


2. Each notebook should be identified on the cover page with the name of individual to whom it has been issued, and a serial number. This helps keep track of number of notebooks issued, verify how many have been used and how many are in use.


3. Upon completion, the notebook may be returned to the issuing authority, or may be retained in the department for ready reference, as the need may be. 


4. It is advisable to use hardcovered, bound notebooks with pages serially numbered to prevent the practice to remove pages. It will also help in identifying missing pages due to somebody's mischief, if so happens.  Notebooks having spring or comb spine are not acceptable because these can be easily removed, and loose pages stolen  This may lead to loss of important data.  


B. Recording of Data


1. The use of pencil is not acceptable for data recording in many industries. They insist upon the use of ink pen to record the actual data.  If there is any change or correction, it may be struck off with a single line or cross mark.  Care should be taken not to conceal what was initially written rendering it illegible. However whenever such corrections are done, a small note should be written about the reason of correction. This gives authenticity to recorded data. 


2. The date of use should be mentioned on the page.  If the notebook is used or entries are made by an individual other than the person to whom the notebook was issued, it should be noted.


3. The user should identify the notebook with laboratory number, project number, sequence number, or other identification number as appropriate. 


4. The data entry and description of activity should be done in a manner that is easy for another analyst or test engineer to understand and derive the same result by referring to it only.


5. The laboratory notebook is always subject to inspection by internal as well as external agencies or organization.  Therefore, it is important to use and maintain the notebook in timely, aesthetic, legible, and valid manner. 


C. Preservation: 

Paper is prone to decay and deterioration with passage of time. Therefore appropriate measures should be taken for the storage of laboratory notebooks and other records (i.e. temperature and humidity controls; insect/pest control system at storage locations) to prevent from damage, tampering, loss, or degradation.  As an alternative, digitization of laboratory notebooks through scanning is also possible.

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