Change Control and Configuration Management IVT 18th Annual Validation Week R. Hinkel
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