MOC
The principle of properly assessing, addressing and controlling the impacts of any proposed changes to the workplace before the changes take place.
What is Management of Change
Complete Final Approval of Global Management of Change (MOC)
Who is the VP of Quality
The NRP will be responsible for leading but shall not complete without the participation of the multidiscipline group
What is the Impact Risk Assessment
Develops and Implement Global Deviation Procedure
Who is Global Quality Systems Manager (GQSM)
When a situation occurs that requires technical or administrative departure from normal Business Management System processes and procedures
What is a deviation?
System used to document and track changes.
What is Master Control
Complete Final Approval of Site Management of Change (MOC)
Who is Site Quality Manager?
Severity and Likelihood combined
What is risk rating?
Initiate Deviations
Who is ILC Dover LP Employee?
Guidance that provides requirements for maintaining Deviation Records
What is Control of Records MSP-G-52
When a change involves a safety concern, this assessment should be performed before startup.
What is Pre-Startup Safety Review (PSSR)
Who is Nominated Responsible Person/ Quality Representative?
When does Master Control not require you to complete the risk/impact assessment, but it is a requirement of ILC Dover LP
What is Planned Deviations?
Participate in Multidiscipline team to complete Investigation
Participate in Multidiscipline team Risk Assessment
Complete Deviation Approval
Who are Directors/Functional Managers?
Tracking, trending, and reporting of deviations at predetermine frequency
What is Management Review MSP-G-24
Risk/Impact meetings must have these departments present.
What is Quality and EHS
Develop and Implement Global Management of Change Procedure to ensure full control of GMP changes in compliance to Global BMS.
Track Global Deviations to completion and report out during Management Review
Who is the Global Quality Systems Manager
Even if you have plans that will mitigate or eliminate this it must be identified.
What is risk?
shall maintain ownership of planned deviation until actions item task have been received back from assignee(s)
Who is Initiator
Policy deviations start with POl
Management System Process deviations start with – MSP
Procedure deviation starts with- PRO
Validation deviations start with- VAL
What is deviation title prefix?
Multidiscipline group meets to discuss what could happen and rates the likelihood and severity
What is Impact/Risk Assessment
Adhere to this procedure for MOC of GMP related activities
Participate in Multidiscipline team Risk Assessment
Act as Nominated Responsible Person
Who is ILC Dover LP Employees
Completion of this including ratings and actions is mandatory in MOCs and Deviations
What is Temp 23-17 Risk Analysis Template
Shall receive an email notification of assigned task from Master Control
Shall receive a task in my task inbox of Master Control
Who is Action Item Assignee (AIA)
These users have access to their sites and global FBS Deviation vault
Who is Master Control Power users