Phase Activity Failure mode Cause Effect S O D RPN Corrective action S O D RPN Refer to sheet Refer to What factors could Why could it What be Scores for Actions to limit or Revised scores sheet result in the activity or manifest the failure the assessment of eliminate the following the ‘process’ process not being mode? consequences severity, failure mode introduction ‘process’ completed? of the failure occurrence of For example: (i) clinical mode if and detection improvements activities incorrect, present? of the failure delayed or omitted, (ii) mode. operating defects of the RPN = S × O × equipment, (iii) D unsuitable environments. A.1 Oocyte A1a Patient A1a1 Patient mismatch Incorrect labelling Oocyte 5 1 5 25 Witnessing, the 5 1 1 5 retrieval identification due to human error mismatch patient signs her own labels A1b Sample A1b1 Biological sample Correctly labelled, Oocyte 5 1 5 25 Colour code and 5 1 1 5 identification mismatch but tube mismatch mismatch witnessing due to error A1c1 A1c Not Sample working or Technical failure Sample damage 2 3 1 6 Calibration and 2 2 1 4 uncalibrated processing equipment maintenance of all critical instruments A1c2 Time and Lack of training or Sample damage 3 2 2 12 training 3 1 2 6 conditions not operator's respected negligence A1c3 Incorrect media Lack of training or Sample 4 2 2 16 training 4 1 2 8 preparation operator's contamination / negligence impaired embryo development
Phase Activity Failure mode Cause Effect S O D RPN Corrective action S O D RPN Refer to sheet ‘process’ Refer to sheet ‘process’ What factors could result in the activity or process not being completed? For example: (i) clinical activities incorrect, delayed or omitted, (ii) operating defects of the equipment, (iii) unsuitable environments. Why could it manifest the failure mode? What be the consequences of the failure mode if present? Scores for assessment of severity, occurrence and detection of the failure mode. RPN = S × O × D Actions to limit or eliminate the failure mode Revised scores following the introduction of improvements A.1 Oocyte retrieval A1a Patient identification A1a1 Patient mismatch Incorrect labelling due to human error Oocyte mismatch 5 1 5 25 Witnessing, the patient signs her own labels 5 1 1 5 A1b Sample identification A1b1 Biological sample mismatch Correctly labelled, but tube mismatch due to error Oocyte mismatch 5 1 5 25 Colour code and witnessing 5 1 1 5 A1c Sample processing A1c1 Not working or uncalibrated equipment Technical failure Sample damage 2 3 1 6 Calibration and maintenance of all critical instruments 2 2 1 4 A1c2 Time and conditions not respected Lack of training or operator's negligence Sample damage 3 2 2 12 training 3 1 2 6 A1c3 Incorrect media preparation Lack of training or operator's negligence Sample contamination / impaired embryo development 4 2 2 16 training 4 1 2 8
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