IVT 18th Annual Validation Week R. Hinkel

Change Control and Configuration Management

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

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  

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.  

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  

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.  

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…)  

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  

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…  

   

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)  

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?  

   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?  

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  

   Thank You!