10.2.1 The designer/manufacturer shall prepare a Safety Statement in compliance
                                 with LR’s ShipRight Procedure Risk Based Certification (RBC) process which,
                                 as a minimum, shall describe:
                              
                              
                              
                              
                                 - the boundary of the system intended to be assessed;
 
                                 - the risk management process intended to be followed;
 
                                 - the risk assessment tools intended to be used; and
 
                                 - the acceptance criteria that will be used to determine if a risk is
                                    tolerable.
                                 
 
                              
                              
                              
                              
                              The RBC process requires the designer/manufacturer to carry out a
                                 suitable and sufficient risk assessment based on own information and experience and
                                 information received from the Owner and/or Operator.
                              
                              
                              
                            
                           
                           
                           
                              
                              
                              10.2.2 It shall be ensured that the boundaries of the risk assessment are set
                                 wide enough to suitably and sufficiently assess the system which is defined as the
                                 OPTS and its components embedded in its environmental situation (e.g. mothership,
                                 integration of the OPTS into the mothership system, environmental conditions such as
                                 wind, H1/3, heel/trim, mothership accelerations, etc.). The system
                                 is required to be assessed in its entirety, and the boundaries are to be shifted
                                 until there are no parts or components having any influence on the OPTS and vice
                                 versa.
                              
                              
                              
                            
                           
                           
                           
                              
                              
                              10.2.3 It is the responsibility of the designer/manufacturer to ensure the
                                 intended process and acceptance criteria meet the requirements of the National
                                 Authority, the Owner/Operator and LR as given in the RBC. It is further required
                                 that the intended process and acceptance criteria are acceptable to the National
                                 Authority who may have requirements in addition to the methodology given in this
                                 Section and/or the RBC process.
                              
                              
                              
                            
                           
                           
                           
                              
                              
                              10.2.4 Performance requirements are to be developed for the OPTS and its components and
                                 critical elements in order that they will manage the identified hazards.
                              
                              
                              
                            
                           
                           
                           
                              
                              
                              10.2.5 The risk assessment shall clearly set out the boundaries of the system to be
                                 assessed. As a minimum, it should consider the safety of the system during normal
                                 operation, during emergency conditions and while the system is out-of-service. As a
                                 minimum, the assessment is required to:
                              
                              
                              
                              
                                 - demonstrate the system meets the performance requirements;
 
                                 - demonstrate the OPTS meets the performance requirements;
 
                                 - demonstrate the components of the OPTS meet the performance requirements;
 
                                 - take into account the interfaces between the OPTS and the mothership and the
                                    target unit;
                                 
 
                                 - identify the potential hazards to the safety and integrity of the system and
                                    OPTS and specifically quantify and rank these risks in terms of their
                                    consequence and frequency;
                                 
 
                                 - identify those risks that are unacceptable in relation to the defined
                                    performance requirements;
                                 
 
                                 - identify what prevention and/or mitigation actions are to be taken in order to
                                    reduce the risks that are unacceptable to a level tolerable to LR and the
                                    National Authority;
                                 
 
                                 - identify parts and/or components of the OPTS and the system that are critical in
                                    relation to the management of the identified risks and hazards;
                                 
 
                                 - clearly identify the hazards that may threaten the safety or integrity of the
                                    system and/or the OPTS, or otherwise endanger the Operators, personnel to be
                                    transferred, any crew members and other persons;
                                 
 
                                 - identify any additional testing or trials required to provide evidence the
                                    defined performance requirements can be met; and
                                 
 
                                 - describe the method by which any action points raised will be closed out and
                                    name the responsible persons.
                                 
 
                              
                              
                              
                            
                           
                           
                           
                              
                              
                              10.2.6 Suitable protective measures and safety features shall be introduced as a consequence
                                 of the risk assessment.
                              
                              
                              
                            
                           
                           
                           
                              
                              
                              10.2.7 The instructions for use of the OPTS shall be compiled based upon the findings of the
                                 risk assessment.
                              
                              
                              
                            
                           
                           
                           
                              
                              
                              10.2.8 The designer/manufacturer is responsible for communicating the output of the
                                 assessment to the Owner and/or Operator.
                              
                              
                              
                            
                           
                           
                           
                              
                              
                              10.2.9 The designer/manufacturer is responsible for implementing any mitigation measures
                                 relevant to the design of the OPTS. The Owner and/or Operator is responsible for
                                 implementing any mitigation measures relevant to the operation of the OPTS. One of
                                 the outcomes of the risk assessment shall be to establish who is responsible for
                                 which mitigation measures and the definition of the interfaces between the
                                 designer/manufacturer and the Owner and/or Operator.
                              
                              
                              
                            
                           
                           
                           
                              
                              
                              10.2.10 The risk assessment should be carried out in accordance with relevant and recognised
                                 National and International Standards. In particular, the following standards shall
                                 be taken into consideration as a minimum:
                                 
                                    - ISO 31000 Risk management;
                                    
 
                                    - EN 31010 Risk management – Risk assessment techniques;
                                    
 
                                    - ISO Guide 73 Risk management – Vocabulary; and
                                    
 
                                    - ISO 12100 Safety of machinery – General principles for design – Risk
                                          assessment and risk reduction.
                                    
 
                                 
                                 
                               
                              
                              
                            
                           
                           
                           
                              
                              
                              10.2.11 Whilst the designer/manufacturer may use specialised support to produce the risk
                                 assessment, they remain accountable for the production of the risk assessment and
                                 demonstrating that deviating from the prescribed requirements does not lead to an
                                 increase in risk.