non conformances with training
TRANSCRIPT
-
8/7/2019 Non Conformances With Training
1/21
Microbiological Documentation
Non-Conformances
By Tim Sandlewww.pharmig.blogspot.com
-
8/7/2019 Non Conformances With Training
2/21
Documentation Errors
Unclear quality systems.
Inadequate procedures.
Inadequate documentation for recording data.Data incorrectly recorded.
Documentation not adequately checked.
Documentation poorly presented.
-
8/7/2019 Non Conformances With Training
3/21
-
8/7/2019 Non Conformances With Training
4/21
Documentation Errors
The next set of examples have
been taken from FDA warning
letters issued in 2007 and
2008.
Sample Warning Letter
-
8/7/2019 Non Conformances With Training
5/21
Documentation Errors
Procedures
Inadequate instructions;
Imprecise instructions
Incubate for approximately one week
Store at about 32oC.
Contradictory instructions (within a procedure and between twosimilar procedures)
-
8/7/2019 Non Conformances With Training
6/21
Documentation Errors
Procedures (continued)
Failure to perform regulardocumentation reviews
Your procedure stated thatthe test should be witnessed,whereas your report fromstates that the test result hasbeen verified .
-
8/7/2019 Non Conformances With Training
7/21
Documentation Errors
Equipment calibration
Calibration documentation
forthe pipettorequipment
lacked sufficient detail
identifying the specific
parameters that were
evaluated.
No OOS was completed for
the equipment calibration.
Log book not completed.
-
8/7/2019 Non Conformances With Training
8/21
Documentation Errors
Validation
The validation study was completed before the acceptance criteriahad 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).
-
8/7/2019 Non Conformances With Training
9/21
Documentation Errors
Completion of laboratory documentation
Lack of contemporaneous documentation of process steps in
laboratory recordswhich 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.
-
8/7/2019 Non Conformances With Training
10/21
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.
-
8/7/2019 Non Conformances With Training
11/21
Documentation Errors
Completion of laboratory documentation
The test operator was away on vacation. The test result had beensigned 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).
-
8/7/2019 Non Conformances With Training
12/21
Documentation Errors
Completion of laboratorydocumentation
Manual calculation not
checked by secondanalyst.
Use of non-validatedspreadsheet forcalculations.
-
8/7/2019 Non Conformances With Training
13/21
Documentation Errors
Completion of laboratory documentation
Change to pharmacopoeia criteria, SOP not updated.
Change to SOP acceptance criteria not documented through change
control.
-
8/7/2019 Non Conformances With Training
14/21
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 notpresented for inspection
-
8/7/2019 Non Conformances With Training
15/21
Human Error
-
8/7/2019 Non Conformances With Training
16/21
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.
-
8/7/2019 Non Conformances With Training
17/21
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 ofthe systems with which they are required to work
(British Psychological Society, 2005)
-
8/7/2019 Non Conformances With Training
18/21
Human Error
Common reasons for human error
Learning gap errors why didnt people know what to do?
Memory gap errors why did people know what to do but didnt
remember properly?
Inconsistency errors why can there be variability in how people do
things, even when they know and remember what to do correctly?
-
8/7/2019 Non Conformances With Training
19/21
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?
-
8/7/2019 Non Conformances With Training
20/21
Ways to minimise errors
Reduce the amount of documentation
Standardise documentation
Spending time on reducing documentation errors
Train staff using examples
Electronic records
-
8/7/2019 Non Conformances With Training
21/21
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. HumanFactors (a discipline that focuses on those variables that affect theperformance of individuals using equipment)
www.pharmig.blogspot.com