non conformances with training

8/7/2019 Non Conformances With Training

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Microbiological Documentation

Non-Conformances

By Tim Sandlewww.pharmig.blogspot.com


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Documentation Errors

Unclear quality systems.

Inadequate procedures.

Inadequate documentation for recording data.Data incorrectly recorded.

Documentation not adequately checked.

Documentation poorly presented.


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The next set of examples have

been taken from FDA warning

letters issued in 2007 and

2008.

Sample Warning Letter


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Procedures

Inadequate instructions;

Imprecise instructions

Incubate for approximately one week

Store at about 32oC.

Contradictory instructions (within a procedure and between twosimilar procedures)


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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 .


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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.


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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).


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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.


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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.


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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).


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Completion of laboratorydocumentation

Manual calculation not

checked by secondanalyst.

Use of non-validatedspreadsheet forcalculations.


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Change to pharmacopoeia criteria, SOP not updated.

Change to SOP acceptance criteria not documented through change

control.


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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


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Human Error


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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.


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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)


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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?


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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?


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Ways to minimise errors

Reduce the amount of documentation

Standardise documentation

Spending time on reducing documentation errors

Train staff using examples

Electronic records


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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)

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