Deviation RCA Beta version - By Alex Lenehan

Last updated 4 years ago First published 20 October, 2016

Health,Business,Technology,Deviation English Rating: ALL ages Shortest path: 3 nodes Longest path: 19 nodes Possible solutions: 22
Transcription
  • Where did the deviation occur? Maintenance or Construction. Completion of paperwork. Operation of Equipment. Other.
  • Coming Soon.
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  • Did the equipment operate within specifications? Yes. No.
  • Was the correct SOP used? No. Yes.
  • Was the SOP deviated from? No. Yes.
  • Was user trained in the SOP? No. Yes.
  • Is SOP comprehensible? Yes. No.
  • System Error: SOP not clear.
  • Was the deviation accidental? Yes. No.
  • Were all reagents/equipment labelled correctly? No. Yes.
  • System Error: Unclear labelling.
  • Was user distracted? No. Yes.
  • System Error: Distraction.
  • Human Error: Did not follow SOP.
  • Has the user provided an acceptable justification for the deviation? No. Yes.
  • See user for root cause.
  • Human Error: User intentially deviated from SOP without justifiction.
  • Was training availiable? No. Yes.
  • System Failure: Training not availiable for this process.
  • Was user aware that training was required for this process? No. Yes.
  • Human Error: User conducted test without required training.
  • System Failure: User was not aware of training requrements for process.
  • Was the SOP correct? No. Yes.
  • System Error: Incorrect SOP.
  • Were all reagents/equipment labelled correctly. No. Yes.
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  • Was the correct SOP availiable? No. Yes.
  • System Failure: SOP not availiable for this process.
  • Was the user trained in the process? No. Yes.
  • 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? No. Yes.
  • 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? No. Yes.
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