Change control and configuration

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Change control and configuration

  1. 1. Change Control and Configuration Management IVT 18th Annual Validation Week R. Hinkel
  2. 2. Agenda  •  Change Control –  What is it? –  Change or No Change –  Why Do you Care? –  How Many Do You Have? –  How Many Is Too Many –  Musts•  Configuration Management –  What is it? –  Why Do You Care? –  Examples –  Where is it Found? –  Musts
  3. 3. Change  Control  –  What  Is  it?  •  Defini6on  –  A  formal  process  used  to  ensure  that  changes   to  a  product  or  system  are  introduced  in  a  controlled  and   coordinated  manner.    •  Addi6ons  •  Dele6ons  •  Modifica6ons  •  Re6re  
  4. 4. Change  Control  (Change  or  No   Change)  •  Are  the  Following  Changes  or  No  Changes   –  Replacing  Like  for  Like  Equipment   –  Upda6ng  SoKware   –  Removing  a  User  from  a  IT  System   –  Changing  Filters  (Different  Material  Composi6on)   –  Your  Examples…  •  Recommenda6on:    Include  Rules  (Examples)   in  your  Change  Control  SOP.  
  5. 5. Change  Control  –  Why  Do  You  Care?  •  Change  Costs  Money   –  Takes  Time   –  Takes  Resources  •  May  Cause  Confusion   –  May  Impact  Morale  •  What  is  Your  Company’s  Tolerance?   –  Resources  Available  to  Make  Changes   –  Response  to  Customer  Needs  /  Wants  •  It’s  the  Law  •  Change  Control  Can  Either  Help  or  Hurt  Your   Reputa6on  
  6. 6. Change  Control  -­‐  How  Many  Do  You   Have?  •  Companies  Rarely  Just  Have  One  •  Examples   –  Document  Control   –  Engineering  Control   –  Design  Control   –  IT  Change  Control  •  How  Many  Does  Your  Company  Have?  •  Recommenda6on:    Op6mize  the  Number  of   Change  Process.  
  7. 7. Change  Control  –  How  Many  Is  Too   Many?  •  Depends  on:   –  Do  the  Processes  “Talk”  to  One  Another   –  Are  the  Processes  Documented  and  Controlled   Preven6ng:   •  Overlap   •  User  Community  Confusion   •  Some  Changes  Not  Being  Captured   –  What  Is  the  Rela6onship  Between  Processes   •  Peer  to  Peer   •  Parent  to  Child   •  Other  Quality  Processes  (CAPA,  Devia6ons,  etc…)  
  8. 8. Change  Control  –  Musts  •  Define  and  Control  Your  Change  Processes   –  Scope   –  Document  the  Process  (Flow  Charts  are  Helpful)   –  Rela6onship  With  Other  Processes   –  Metrics   –  Timelines   –  Deadline  Extension  Process  •  Guidance  to  User  Community   –  What  Process  to  Use  When   –  Examples  (What  is  /  What  is  Not  a  Change)   –  Set  Wriben  Rules  
  9. 9. Configura6on  Management  –  What  is   it?    •  (CM)  is  a  process  for  establishing  and  maintaining   consistency  of  a  product’s  performance  and   func6onal  and  physical  abributes  with  its   requirements,  design  and  opera6onal   informa6on  throughout  its  life.   1-­‐-­‐Wikipedia•  Product  =  Equipment  ,  Systems,  SoKware,  etc…      
  10. 10. Configura6on  Management  –  Why  Do   You  Care?    •  Unregulated  Configura6ons  Changes  Can  Lead   to  “Surprises”   –  Loss  of  Service   –  Security  Breaches   –  Can  You  Name  Some?  •  Properly  Maintaining  Configura6ons  Requires   Money  (Time,  Resources)  
  11. 11. Configura6on  Management  -­‐  Examples    •  Car  Radio  Pre-­‐set  Sta6ons  •  Car  Mirror  Seengs  •  Security  Profiles  •  SoKware  Configura6on  “Turning  On  /  Off”   func6onality  and  features  •  Can  You  Name  Some  Examples?  
  12. 12.    Configura6on  Management  –  Where   is  it  Found?      •  Within  Valida6on  Documenta6on  (IQ,  OQ,  PQ)  •  Within  Engineering  Documenta6on  •  Within  Design  Documenta6on  •  Within  Separate  CM  system  •  Within  the  System  SoKware  •  Can  You  Name  Any  Others?  
  13. 13. Configura6on  Management  –  Musts  •  Must  Know  Where  They  are  Documented?  •  Must  Have  Them  Under  Change  Management  •  Must  be  able  to  Link  Configura6on  Seengs  to   Tes6ng.  •  Must  Understand  the  Rela6onship  Between   Different  Configura6on  Seengs  within  a   System  
  14. 14.  Thank You!

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