+--------------+-------------------------------------------------------+
| Process      |                                                       |
| Checklist    |                                                       |
| for          |                                                       |
| Operations   |                                                       |
+--------------+-------------------------------------------------------+
| Overview     | In the Operations phase, the device is in use as part |
|              | of the system. Assurance is concerned with:           |
|              |                                                       |
|              | -   Identification of anomalies and determination of  |
|              |     the root cause.                                   |
|              |                                                       |
|              | -   Changes in operations that can affect the complex |
|              |     electronics or invalidate previous testing.       |
|              |                                                       |
|              | -   Analysis of problems to identify trends           |
+--------------+-------------------------------------------------------+
| Entrance     | The following criteria should be met prior to         |
| Criteria     | beginning the Operations phase for complex            |
|              | electronics:                                          |
|              |                                                       |
|              | -   The system has successfully completed all         |
|              |     verifications.                                    |
|              |                                                       |
|              | -   Operations procedures are written, approved, and  |
|              |     configuration controlled.                         |
+--------------+-------------------------------------------------------+
| Responsible  | Operator -- Document anomalies and problems. Update   |
| Personnel    | operations manuals.                                   |
|              |                                                       |
|              | Design Engineer -- Assist in root cause analysis.     |
|              |                                                       |
|              | Quality Assurance -- Perform the process and product  |
|              | assurance activities listed below.                    |
+--------------+-------------------------------------------------------+
| Not all      |                                                       |
| steps listed |                                                       |
| below have   |                                                       |
| to be        |                                                       |
| completed    |                                                       |
| s            |                                                       |
| equentially. |                                                       |
| When a step  |                                                       |
| is finished, |                                                       |
| the          |                                                       |
| completion   |                                                       |
| date is      |                                                       |
| added to the |                                                       |
| table below, |                                                       |
| along with   |                                                       |
| initials of  |                                                       |
| the          |                                                       |
| assurance    |                                                       |
| rep          |                                                       |
| resentative. |                                                       |
+--------------+-------------------------------------------------------+

NOTE: For Maintenance, Modifications, or Upgrades, see the "Process
Checklist for Modifications.doc" checklist.

  ----------------------------------------------------------------------------------
  ID             Process Step                                    Completion   QA
                                                                 Date         
  -------------- ----------------------------------------------- ------------ ------
  1              Entrance Criteria are met.                                   

  2              Review operations procedures to ensure that                  
                 processes for anomaly identification and                     
                 recording are included.                                      

  3              Review operational and maintenance procedures                
                 for inclusion of any workarounds or other                    
                 information that was discovered during                       
                 development and testing.                                     

  4              Verify that the Problem Reporting and                        
                 Corrective Action system is being used for                   
                 identified problems and unexplained anomalies.               

  5              Assist in determining the root cause of                      
                 problems. Consider the design of the complex                 
                 electronics and possible failure modes. Support              
                 Failure Review Boards.                                       

  6              Review changes to operational procedures.                    
                 Ensure that the changes will not use the                     
                 complex electronics in unverified ways. Ensure               
                 that changes in how the system is used will not              
                 provide untested inputs to the complex                       
                 electronics.                                                 

  7              Perform Problem Trend Analysis on system                     
                 elements that include complex electronics.                   

  8              Verify the Change Control process is                         
                 operational. Ensure all changes to complex                   
                 electronics design (code) are analyzed and                   
                 approved before implementation. Perform an                   
                 impact analysis on the changes.                              

  Review any                                                                  
  updates to                                                                  
  these plans.                                                                
  Ensure that                                                                 
  new                                                                         
  information is                                                              
  incorporated                                                                
  in the plans.                                                               

  9              Maintenance Manual                                           

  10             Operations or User Manual                                    

  11             Training Plan                                                

  12             Exit Criteria are met.                                       
  ----------------------------------------------------------------------------------

+--------------+-------------------------------------------------------+
| Exit         | At the end of the Operations phase, the following     |
| Criteria     | criteria should be met:                               |
|              |                                                       |
|              | -   The system is decommissioned.                     |
+--------------+-------------------------------------------------------+

  --------------- ------------------------------------- ----------- ----------
  Documentation                                                     
  Status                                                            

  Document ID     Document Name                         Revision    Date

                  Operations or User Manual                         

                  Problem Reporting and Corrective                  
                  Action Process                                    

                  Training Plan                                     

                  Maintenance Manual (or Plan)                      
  --------------- ------------------------------------- ----------- ----------