documentation non conformances

8/7/2019 Documentation Non Conformances

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Non-Conformances

By Tim Sandle

http://www.pharmig.blogspot.com

Microbiological Documentation


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Documentation Errors

y Unclear quality systems.

y Inadequate procedures.

y Inadequate documentation for recording data.

y Data incorrectly recorded.y Documentation not adequately checked.

y Documentation poorly presented.


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y Increasingly a focus of regulators, such as, MHRA orFDA:y Such as CFR 820 Quality System Regulation;

y CFR 211.100 Written Procedures;

y USP Good Microbiology Laboratory Practice.


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y The next set of examples

have been taken from

FDA warning lettersissued in 2007 and 2008.

Sample Warning Letter


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y Proceduresy Inadequate instructions;

y Imprecise instructions

y Incubate for approximately one week

y Store at about 32oC.y Contradictory instructions (within a procedure and between

two similar procedures)


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y Procedures (continued)y Failure to perform regular

documentation reviewsy Your procedure stated that

the test should bewitnessed, whereas yourreport from states that the

test result has been verified.


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Documentation Errorsy Equipment calibration

y Calibration documentation for

the pipettor equipment lacked

sufficient detail identifying the

specific parameters that were

evaluated.

y No OOS was completed for the

equipment calibration.

y Log book not completed.


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y Completion of laboratory documentation

y Lack of contemporaneous documentation of process steps in

laboratory recordswhich led to improper completion of the

test.

y A page was missing from the laboratory notebook.

y The results presented in the written report were different

from the raw data.


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y The report form contained results which had been changed but

the changed result had not been signed or dated.

y The report form contained boxes for test results which

contained no information.

y An alteration was made to the document which was ineligible.


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y The test operator was away on vacation.The test result hadbeen signed as tested by by another operator who had notcompleted the test.There was no additional explanation.

y Documentation coding and version numbers containing errors.y Missing entries in log books (e.g. daily temperature checks).


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Documentation Errorsy Completion of

laboratory

documentationy Manual calculation not

checked by second analyst.

y Use of non-validatedspreadsheet for

calculations.


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y Change to pharmacopoeia criteria, SOP not updated.

y Change to SOP acceptance criteria not documented through

change control.


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Documentation Errorsy Electronic records

y Poor security

y Inadequate audit trails

y Unclear who made the change

and when the change was made.

y Electronic signatures not

required at critical stages

y Copies of documentation not

presented for inspection


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Human Error


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Human Error

y What is human error?

y 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

y Do the FDA accept human error?

y 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 thathuman beings think and work, and the design of the

systems with which they are required to work

(British Psychological Society, 2005)


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Human Error

y Common reasons for human error

y Learning gap errors why didnt people know what to do?

y Memory gap errors why did people know what to do but

didnt remember properly?

y 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

y Application errors when people know what they are doing,

why can they still make mistakes and apply the wrong action or

information?

y Omission errors why do people miss out a step in paperwork

or procedures?

y Decision errors why are inappropriate decisions made in a

given situation?


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Ways to minimise errors

y Reduce the amount of documentation

y Standardise documentation

y Spending time on reducing documentation errors

y Train staff using examplesy Electronic records


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Ways to minimise errorsy Having work forms designed in similar ways to

procedures

y Use of diagrams and process flow diagramsy Staff involvement in producing the documentation that

they will usey Use of staff development training schemes or other tools

e.g. Human Factors (a discipline that focuses on thosevariables that affect the performance of individuals usingequipment)

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