RISK ASSESSMENT: 

 
Insertion-withdrawal test fixture serves to ensure the load force of insertion and extraction of the
lead are less than 3.14 Lb (14 N). As per procedure, it is established that the first and last
S/N’s of each Work Order needs to be inspected with this fixture and record values. 
 
Considering a worst-case scenario where inspection is not performed, having the potential effect
of “Damaging of the connector into the device due to high insertion load”, the detected event can
be associated to hazard number  (refer to Rev. N).  , and having the potencial effect
of “Connector geometry not compliant to IS-1 standard by design or
manufacturing”, the detected event can be associated to hazard number _0470 (refer to Rev.
N).  
Produ Hazad N Hazard Situation  Probability estimation   
ct  um  method 
  Damaging of the connector into the device due to high    
insertion load 
_0470  Connector geometry not compliant to IS-1    
standard by design or manufacturing 
         
This failure mode represents an initial probability Level (IPL) of REM (REMOTE - it has never
occurred yet) and Initial severity level (ISL) of Significant (SIG). Therefore, according to
MD00013 Rev. P the resulting Initial Risk Level for failure (IRL) is IIIA, which
is “Acceptable Under Conditions”. 
 
The output of the inspection process (Insertion-Withdrawl Test) will
be controlled/inspected 100% with the insertion-withdrawl fixture and the pull tester (to ensure
that the load on the insertion and retraction of the lead are under 3.14lbf/14N), and the laser
micrometer to ensure that the OD of the connector sleeve is equal or less than *****. 
 
The same risk is found for   under risk management Rev. N (hazard number _0460) 
The exact same risk is found for   under risk management Rev. N, (hazard number _0470).