Change Control/ MOC
Robust and consistent process for ensuring that potential consequences of any change are identified, assessed and managed as far as reasonably practicable.
What is Management of Change (MOC)?
The system used at LSS to record and track events, near misses, hazardous conditions, and observations & conversations.
What is Enablon (AZ SHE System)?
CAPAs should be written with S.M.A.R.T. concepts in mind. S.M.A.R.T. stands for what?
Specific, Measurable, Achievable, Realistic, Time-bound.
A process/tool used to identify and assess SHE hazards and to provide control recommendations.
What is a SHE Risk Assessment?
Problem solving tool used when human error is identified as a root cause.
What is HERCA?
The electronic system used to document and track changes.
What is Trackwise Operational Change Management System (OCM)
What is a Hazardous Condition?
Enablon, IDM, OCM (Change Control).
What electronic systems are available to track CAPA?
The systematic process for the assessment, control, communication and review of risks to the quality of the product across the product lifecycle.
What is Quality Risk Management (QRM)?
Readily available tools may be used for minor deviations. (List 3)
Routine GMP Documentation, Routine Data Trending, HERCA, Level Zero, 5 Whys, SME Impact Assessment, Personnel Interviews,
The change requires a SHE Assessment/SHE Risk Assessment.
When a change involves a safety concern, what assessment should be performed?
What is an Event?
In Enablon CAPAs can be applied to Events and Observations as this.
What are Action Plans in Enablon?
The factors used in the Risk Scoring Guide/Criteria to determine the level of risk. They are multiplied together to obtain a risk score.
What is Severity (QUA)/Impact (SHE) x Likelihood?
An event that is a departure of procedure or specification for which the risk, impact, root cause, or corrective action must be assessed.
What is a Deviation?
SHE, QA, Manufacturing, Validation, QC, F&E, Supply Chain
What are the departments that must be present during every Change Review Board meeting?
What is the Line Manager responsible for?
Assignee, Deliverables, Due date.
What are the 3 elements that must be included with all CAPAs?
Elimination is one method of ________ to reduce a risk to an acceptable level.
Control
Deviation that requires an investigation.
What is a Major Deviation?
If changes have been made or there are plans for any modification to the system, process, or procedure it will be necessary to perform this.
When is a Risk Assessment required?
What are Observations & Conversations?
Elimination, substitution, engineering controls, administrative controls, and PPE
What is the Hierarchy of Controls that should be considered when developing SHE CAPA?
Controls put into place to reduce or eliminate and manage the identified risks in the workplace.
What are CAPA (Corrective Action & Preventative Action)?
The person who first identified or discovered it.
Who must immediately inform the Department Manager, Supervisor or designee, and the department QA representative by direct communication or telephone once an event is discovered?