Application Note

Minimizing Errors Through Standardization Of GXP And R&D Laboratory Measurement Processes

Source: Waters Corporation

Electronic balances, pH Meters, titrators, etc. constitute standard equipment for most analytical laboratories. Traditionally, analysts operate these electronic devices manually and transcribe results into a paper SOP form or paper notebook. The manual transcription of these results is both a common source of error and inherently inefficient due to the redundancy of effort. A 1996 study indicates that the median laboratory transcription error rate is approximately 1-3% and may be as high as 39%.1 Laboratories implementing Lean Six Sigma and adhering to GxP regulations seek to standardize processes to eliminate errors and maintain consistent quality.

A straightforward procedure for reducing errors and maintaining document consistency while working with electronic devices such as balances and pH meters, involves connecting these electronic devices, directly to electronic SOP forms or notebooks; spreadsheets; and instrument acquistion system sample lists. This approach works to reduce manual transcription errors and standardizes data handling to reduce variability, thus addressing the major tenants of Lean Processes.