Microbiological Documentation

Non-Conformances By Tim Sandle www.pharmig.blogspot.com

Documentation Errors
Unclear quality systems. Inadequate procedures. Inadequate documentation for recording data. Data incorrectly recorded. Documentation not adequately checked. Documentation poorly presented.

Documentation Errors
Increasingly a focus of regulators, such as, MHRA or FDA: Such as CFR 820 µQuality System Regulation¶; CFR 211.100 µWritten Procedures¶; USP <1117> Good Microbiology Laboratory Practice.

Documentation Errors

Sample Warning Letter
The next set of examples have been taken from FDA warning letters issued in 2007 and 2008.

Documentation Errors
Procedures

³Inadequate instructions´; Imprecise instructions

³Incubate for approximately one week´ ³Store at about 32oC´.
Contradictory instructions (within a procedure and between two similar procedures)

Documentation Errors
Procedures (continued) ³Failure to perform regular documentation reviews´ ³Your procedure stated that the test should be witnessed, whereas your report from states that the test result has been verified´.

Documentation Errors
Equipment calibration ³Calibration documentation for the pipettor equipment lacked sufficient detail identifying the specific parameters that were evaluated´. No OOS was completed for the equipment calibration. Log book not completed.

Documentation Errors
Validation ³The validation study was completed before the acceptance criteria had been set and the statistical method for the analysis of the data had been selected.´ The raw data provided was no thermal paper which had faded. The raw data could not be located (from laboratory or archive).

Documentation Errors
Completion of laboratory documentation ³Lack of contemporaneous documentation of process steps in laboratory records«which led to improper completion of the test.´ ³A page was missing from the laboratory notebook´. ³The results presented in the written report were different from the raw data´.

Documentation Errors
Completion of laboratory documentation The report form contained results which had been changed but the changed result had not been signed or dated. The report form contained boxes for test results which contained no information. An alteration was made to the document which was ineligible.

Documentation Errors
Completion of laboratory documentation ³The test operator was away on vacation. The test result had been signed as µtested by¶ by another operator who had not completed the test. There was no additional explanation´. Documentation coding and version numbers containing errors. Missing entries in log books (e.g. daily temperature checks).

Documentation Errors
Completion of laboratory documentation Manual calculation not checked by second analyst. Use of non-validated spreadsheet for calculations.

Documentation Errors
Completion of laboratory documentation Change to pharmacopoeia criteria, SOP not updated. Change to SOP acceptance criteria not documented through change control.

Documentation Errors
Electronic records Poor security Inadequate audit trails Unclear who made the change and when the change was made. Electronic signatures not required at critical stages Copies of documentation not presented for inspection

Human Error

Human Error
What is human error? One possible definition: µAn action or failure to act resulting in an unwanted outcome. In other words, when something goes wrong that you did not mean to happen.¶

Human Error
Do the FDA accept µhuman error?¶ BETWEEN 70% and 90% of workplace errors are attributed to µhuman error¶. Many of these human errors are actually due to a mismatch between the way that human beings think and work, and the design of the systems with which they are required to work (British Psychological Society, 2005)

Human Error
Common reasons for human error Learning gap errors ± why didn¶t people know what to do? Memory gap errors ± why did people know what to do but didn¶t remember properly? Inconsistency errors ± why can there be variability in how people do things, even when they know and remember what to do correctly?

Human Error
Application errors ± when people know what they are doing, why can they still make mistakes and apply the wrong action or information? Omission errors ± why do people miss out a step in paperwork or procedures? Decision errors ± why are inappropriate decisions made in a given situation?

Ways to minimise errors
Reduce the amount of documentation Standardise documentation Spending time on reducing documentation errors Train staff using examples Electronic records

Ways to minimise errors
Having work forms designed in similar ways to procedures Use of diagrams and process flow diagrams Staff involvement in producing the documentation that they will use Use of staff development training schemes or other tools e.g. Human Factors (a discipline that focuses on those variables that affect the performance of individuals using equipment)

www.pharmig.blogspot.com