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 ‘Quality System Regulation’;

CFR 211.100 ‘Written 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
“Inadequate instructions”;
Imprecise instructions
“Incubate for approximately one week”
“Store at about 32oC”.
Contradictory instructions (within a procedure and between two
similar procedures)

 
Documentation Errors

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

Equipment calibration
“Calibration 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
“The 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

“Lack of contemporaneous documentation of process steps in
laboratory records…which led to improper completion of the test.”
“A page was missing from the laboratory notebook”.
“The 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

“The test operator was away on vacation. The test result had been
signed as ‘tested 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:

‘An 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 ‘human error?’

BETWEEN 70% and 90% of workplace errors are attributed to ‘human
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)

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