Record Keeping Basics

"If it's not written down, then it didn't happen" is a phrase I heard frequently from former managers and professors when I was a research assistant.  Learning to become a disciplined record keeper was vital to my success as a student scientist and researcher, and I am thankful to have learned from disciplined professors and mentors through the years.  My first formal research project was my masters thesis at the University of Illinois.  At the time of my graduation from the U of I, all graduate thesis projects were published.  Before I could begin my project, I had to attend an orientation, during which I was given the University's specific instructions about how to keep and store records, what the records should contain, and how to format the records to meet the minimum expectations of the university.  If I did not follow these instructions, then my research would be rejected, it would not be eligible for publication, and I would not earn the credit I needed to graduate.  As a result, I became a rules-oriented worker and thinker.  Many years later, when my career transitioned into Quality Assurance, I found it very uncomfortable to work in a lab without these strict rules in place.  I was surprised to learn that the standards used by food plant certifying bodies were not more prescriptive for the quality assurance lab.  Of course record keeping is expected, but the certifying body did not provide details on how to do it. The requirements were general, and the details were left to the lab to figure out. This is not a bad thing; this freedom allows professionals to customize the records according to their own needs.  I quickly learned that there is no one right way to maintain quality assurance lab records. Here are some suggestions for those of you just getting started.

• Recording raw data in a bound journal is still an acceptable way to keep data.  I found it interesting to learn that "a computer printout derived from data transferred to computer media from lab data sheets is NOT considered raw data"  by the FDA (www.fda.gov, Guidance For Industry).  Raw data refers to unanalyzed, unprocessed data.  While most QA labs store and report final results in formal lab reports or certificates of analysis (COAs), it is a good lab practice to keep raw data.  Many QA labs utilize various computer programs for electronic data storage so that the data can be easily transferred to other software programs. Electronic data journals are also available now.  While electronic storage is very convenient and minimizes the use of paper files, you must consider how this data will be protected and how to back it up.  After experiencing a minor scare recently, I can't recommend going totally paperless.  Record keeping is like oxygen ... you don't notice it until it's missing!  Consult a lawyer to determine if electronic data storage will work for your business.
• Maintaining data sheets in a 3-ring binder is also acceptable.  Binders are great for storing records that are constantly evolving, such as pest control and sanitation records.  
• Consistency is important.  Determine which parameters should be recorded for each analysis and make sure lab employees have been trained so that the raw data is recorded the same way each time the analysis is performed by each analyst.
• It is a good practice for the analyst to sign and date the data entry and to record the method or lab protocol number.  In some circumstances, it may be necessary to record the time of the entry.

Develop a method that will work best for your data, your team, your company, and your customers, and stick to it.

For more information about electronic data usage and considerations, refer to:
1) 21 CFR Part 11
http://www.accessdata.fda.gov/scripts/cdcs/cfcfr/CFRSearch.cfm?CFRPart=11rh/cfdo
When you get to this website, scroll down inside the box to number "11) Electronic Records; electronic signatures".

For more information about laboratory record keeping, refer to:
2) Good Record Keeping: Procedures For Academic Laboratory Settings
http://www.research.ufl.edu/otl/goodrecords.html

For some information about what types of records to save from a legal point of view, refer to:
3) Intellectual Property Audit Checklist
http://www.singletonlawfirm.com

For some instructions on how to prepare laboratory standard operating procedures, refer to:
4) http://www.fao.org/docrep/w7295e/w7295e04.htm