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Deviation RCA Beta version - By Alex Lenehan

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Last updated 8 years ago

First published 20 October, 2016

Deviation

English Rating: ALL ages Shortest path: 3 nodes Longest path: 19 nodes Possible solutions: 22

Alex Lenehan

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Where did the deviation occur? Operation of Equipment. Completion of paperwork. Maintenance or Construction. Other.
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Did the equipment operate within specifications? Yes. No.
Was the correct SOP used? Yes. No.
Was the SOP deviated from? Yes. No.
Was user trained in the SOP? Yes. No.
Is SOP comprehensible? Yes. No.
System Error: SOP not clear.
Was the deviation accidental? Yes. No.
Were all reagents/equipment labelled correctly? Yes. No.
System Error: Unclear labelling.
Was user distracted? Yes. No.
System Error: Distraction.
Human Error: Did not follow SOP.
Has the user provided an acceptable justification for the deviation? Yes. No.
See user for root cause.
Human Error: User intentially deviated from SOP without justifiction.
Was training availiable? Yes. No.
System Failure: Training not availiable for this process.
Was user aware that training was required for this process? Yes. No.
Human Error: User conducted test without required training.
System Failure: User was not aware of training requrements for process.
Was the SOP correct? Yes. No.
System Error: Incorrect SOP.
Were all reagents/equipment labelled correctly. Yes. No.
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Was the correct SOP availiable? Yes. No.
System Failure: SOP not availiable for this process.
Was the user trained in the process? Yes. No.
Human Error: Trained user did not follow available SOP.
Was training availiable? Yes. No.
System Failure: Training not availiable for this process.
Was user aware that training was required for this process? Yes. No.
Human Error: User conducted test without required training.
System Failure: User was not aware of training requrements for process.
Was the equipment within calibration dates? Yes. No.
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