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
A1c4 Incorrect / absent registration data Human error or negligence Reduced traceability / data loss 1 3 2 6 Witnessing 1 3 1 3 A.2 Sperm preparation A2a Patient identification A1a1 Patient mismatch Incorrect labelling due to human error Sperm mismatch 5 1 5 25 Witnessing, the patient signs his own labels 5 1 1 5 A2b Sample identification A2b1 Biological sample mismatch Correctly labelled, but tube mismatch due to human error mismatch 5 1 5 25 Colour code and witnessing 5 1 1 5 A2c Sample processing A2c1 Not working or uncalibrated equipment Technical failure Sample damage 2 3 1 6 Calibration and maintenance of all critical instruments 2 2 1 4 A2c2 Time and conditions not respected Lack of training or operator's negligence Sample damage 4 2 1 8 Staff training 4 1 1 4 A2c3 Incorrect media preparation Lack of training or operator's negligence Sample contamination / impaired semen quality 4 2 2 16 training 4 1 2 8 A2c4 Incorrect/absent registration data Human error or negligence Reduced traceability / data loss 1 3 2 6 Witnessing 1 3 1 3 A.3 IVF or ICSI A3a Sample identification A3a1 Biological sample mismatch Incorrect labelling due to error Oocyte and sperm mismatch 5 1 5 25 Witnessing 5 1 1 5 A3b Sample processing A3b1 Not working or uncalibrated equipment Technical failure Sample damage 2 3 1 6 Calibration and maintenance of all critical instruments 2 2 1 4
A3b2 Defective equipment (denuding and manipulation pipette) Lack of training or operator's negligence Sample loss 2 3 2 12 Test the equipment before use 2 3 1 6 A3b3 Time and conditions not respected Lack of training or operator's negligence Sample damage 4 3 1 12 Staff training 4 2 1 8 A3b4 Incorrect media preparation Lack of training or operator's negligence Sample contamination / impaired oocyte quality 4 2 2 16 Staff training 4 1 2 8 A3b5 Incorrect/absent registration data Human error or negligence Reduced traceability / data loss 1 3 2 6 Witnessing 1 3 1 3 A.4 Embryo culture A4a Sample identification A4a1 Biological sample mismatch Incorrect labelling due to human error Embryo mismatch 5 1 5 25 Witnessing 5 1 1 5 A4b Sample processing A4b1 Not working or uncalibrated equipment Technical failure Sample damage 2 3 1 6 Calibration and maintenance of all critical instruments 2 2 1 4 A4b2 Defective equipment (denuding and manipulation pipette) Lack of training or operator's negligence Sample loss 2 3 2 12 Test the pipette before use 2 3 1 6 A4b3 Incorrect assessment Error of assessment by laboratory staff Incorrect clinical choice 2 2 2 8 Witnessing - check embryos before transfer 2 1 1 2
A5c4 Incorrect media preparation Lack of training or operator's negligence Sample contamination / impaired embryo implantation 4 2 2 16 Staff training 4 1 2 8 A5c5 Incorrect / absent registration data Human error or negligence Reduced traceability / data loss 1 3 2 6 Witnessing 1 3 1 3 A.6 Cryopreservation of embryos A6a Sample identification A6a1 Biological sample mismatch Incorrect labelling due to human error Mismatch of cryopreserved embryos 5 1 5 25 Witnessing 5 1 1 5 A6b Sample processing A6b1 Not working or uncalibrated equipment Technical failure Sample damage 2 3 1 6 Calibration, maintenance of all critical instruments, liquid nitrogen level monitoring (Spylog system) 2 2 1 4 A6b2 Defective equipment (denuding and manipulation pipette) Lack of training or operator's negligence Sample loss 2 3 2 12 Test the equipment before use 2 3 1 6 A6b3 Time and conditions not respected Lack of training or operator's negligence Sample damage 4 3 1 12 Staff training 4 2 1 8 A6b4 Incorrect media preparation Lack of training or operator's negligence Sample contamination and/or impaired embryo quality 4 2 2 16 Staff training 4 1 2 8
A9b2 Defective equipment (denuding and manipulation pipette) Lack of training or operator's negligence Sample loss 2 3 2 12 Test the equipment before use 2 3 1 6 A9b3 Time and conditions not respected Lack of training or operator's negligence Sample damage 4 3 1 12 Staff training 4 2 1 8 A9b4 Incorrect media preparation Lack of training or operator's negligence Sample contamination / impaired gamete quality 4 2 2 16 Staff training 4 1 2 8 A9b5 Incorrect / absent registration data error or negligence Reduced traceability / data loss 1 3 2 6 Witnessing 1 3 1 3 A.10 Embryo biopsy A10a Sample identification A10a1 Biological sample mismatch Incorrect labelling due to error Embryo mismatch 5 1 5 25 Witnessing 5 1 1 5 A10b Embryo identification after biopsy A10b1 Biological sample mismatch Mismatch between biopsied / cryopreserved embryo and related cell biopsy Embryo mismatch 5 1 5 25 Witnessing 5 1 1 5 A10c Sample processing Not working or uncalibrated equipment Technical failure Sample damage 2 3 1 6 Calibration and maintenance of all critical instruments 2 2 1 4 A10c2 Defective equipment (denuding and manipulation pipette) Lack of training or operator's negligence Sample loss 2 3 2 12 Test the equipment before use 2 3 1 6 A10c3 Time and conditions not respected Lack of training or operator's negligence Sample damage 4 3 1 12 Staff training 4 2 1 8
A10c4 Incorrect media preparation Lack of training or operator's negligence Sample contamination / impaired embryo quality 4 2 2 16 training 4 1 2 8 A10c5 Incorrect / absent registration data Human error or negligence Reduced traceability / data loss 1 3 2 6 Witnessing 1 3 1 3 A.11 Tubing A11a Sample identification A11a1 Biological sample mismatch Tube with incorrect ID due to human error Embryo mismatch 5 1 5 25 Witnessing 5 1 1 5 Tube with incorrect embryo number due to human error Genetic analysis mismatch 5 1 5 25 Witnessing 5 1 1 5 A11b Sample processing A11b1 Not working or uncalibrated equipment Technical failure Sample damage 2 3 1 6 Calibration and maintenance of all critical instruments 2 2 1 4 A11b2 Defective equipment (denuding and manipulation pipette) Lack of training or operator's negligence Sample loss 2 3 2 12 Test the equipment before use 2 3 1 6 A11b3 Time and conditions not respected Lack of training or operator's negligence Sample damage 4 3 1 12 Staff training 4 2 1 8 A11b4 Incorrect media preparation Lack of training or operator's negligence Sample contamination / biopsied cells damaged 4 2 2 16 Staff training 4 1 2 8