Failure Mode and Effects Analysis FMEA Risk Analysis Example Failure Mode and Effects Analysis FMEA Risk Analysis Example by kellena89

VIEWS: 0 PAGES: 1

									                                              Failure Mode and Effects Analysis (FMEA) Risk Analysis Example
                                                                   Acupuncture Needles

                                                                                                                                                     Transfer
                                    Inspect             Load needles               Load                    Run               Unload
                                                                                                                                                     bags to
                                    needles             into autoclave           autoclave               program            autoclave
                                                                                                                                                    packaging
                                                             bags



 Process        Failure                           Sev                                                          Prob     Risk
                                     Effect                     Cause                   Controls                                                 Recommended Actions
  Step           Mode                             1-3                                                           1-3    Index
                                                          Insufficient
                                                                                                                   1    1
                              Patient injury -            sampling plan
                                                   2
                              bruise                      Operator error                                                        Provide training and visual guidance on inspection
                                                                                                                   2    4
                                                          (missed defect)                                                       techniques
                                                          Insufficient
                              Patient injury –                                                                     1    3
             Defective                                    sampling plan
                              broken needle        3
Inspection   needle is        under skin                  Operator error                                                        Provide training and visual guidance on inspection
             missed                                                                                                2    6
                                                          (missed defect)                                                       techniques
                                                          Insufficient
                                                                                                                   1    1
                                                          sampling plan
                              Unusable needle      1
                                                          Operator error                                                        Provide training and visual guidance on inspection
                                                                                                                   2    2
                                                          (missed defect)                                                       techniques
                                                                              Document states to distribute
                                                                                                                   2    6       Add load diagram to document
             Load is not      Incomplete                                      load evenly
                                                   3      Operator Error
             balanced         sterilization
                                                                              Bioburden QC testing                 1    3       Validate bioburden test method

                                                                              Document provides
                                                                                                                   2    6       Validate load capacities
             Unit is over-    Incomplete                                      load/program matrix
Load                                               3      Operator Error
             loaded           sterilization
autoclave                                                                     Bioburden QC testing                 1    3       Validate bioburden test method

                                                                              Document provides
                                                                                                                   2    2       Validate load capacity
                              Deformed needle                                 load/program matrix
             Unit is under-
                              housing –            1      Operator Error
             loaded                                                           Visual inspection during
                              unusable needle                                 packaging/ assembly                  2    2
                                                                              operation

                                                                              Lot file review includes
             Incorrect                                                                                             2    6       Fix batch sizes and use a single program
                              Incomplete                                      equipment printout review
             program is                            3      Operator Error
                              sterilization
             selected
                                                                              Bioburden QC testing                 1    3       Validate bioburden test method
Run
autoclave                                          3      Equipment failure   Preventive maintenance               1    3
             Entire cycle     Incomplete
program      is not run       sterilization
                                                   3      Power failure                                            2    6       Connect to emergency generator; allow repeat run
             Cycle does
             not meet         Incomplete                  Equipment is out
                                                   3                          Annual calibration check             2    6       Run each cycle with biological indicators
             max              sterilization               of calibration
             temperature

								
To top