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WorksheetsQuality Quiz 2024
Total questions: 20
Worksheet time: 10mins
The colour code used for 30°C/75%RH storage condition is _____________.
Green
Red
Blue
Yellow
In GDP SOP, whenever option to be selected, the relevant option should be ______ to denote it is selected
Ticked
Encircled
Underlined
All of the above
In ALCOA principle, “C” stands for _____________
Compliance
Completed
Contemporaneous
Complied
FMECA means
Failure mode effect and cause analysis
Failure Management effect and cause analysis
Failure mode efficient and cause analysis
Failure mode effect and criticality analysis
What does the acronym DMAIC stand for in the context of quality improvement?
Define, Monitor, Analyze, Integrate, Control
Discover, Measure, Assess, Implement, Collaborate
Develop, Manage, Audit, Improve, Communicate
Define, Measure, Analyze, Improve, Control
Which factor is not considered in Risk categorization?
Occurrence
Detectability
Severity
Risk
Action taken to eliminate the cause of an existing non-conformity, defect or other undesirable situation in order to avoid recurrence is called as
Preventive Action
Corrective Action
Control Action
Reaction
ICH Q9 talks about
Stability Studies
Quality Risk Management
Quality Systems
Good Manufacturing Practice
______________ is used to find the correlation between two variables (numerical data)
Cause and effect diagram
Scatter diagram
Histogram
Pareto Chart
What is the Theme of World Quality Week 2024
From Quality Conscious to Performance
From Quality Awareness to Performance
From Quality Compliance to performance
From Quality Conscience to Performance
If RPN score is between 100 – 342, then the existing risk control is considered as
Unacceptable
Undesirable
Acceptable
Intolerable
Light sensitive products are handled under ______________ light
LED
Sodium Vapor
Sun
All of the above
What is meant by PAI status in FDA INSPECTION?
Post Action Indicated
Preventive Action Indicated
Pre Approval Inspection
Post Approval Inspection
What is the primary objective of a quality system?
To reduce manufacturing costs
To eliminate the need for quality control personnel
To meet regulatory requirements
To ensure consistent quality of products and services
What does the acronym SIPOC stand for in Six Sigma?
Supplier, Input, Process, Output, Customer
Seek, Identify, Plan, Organize, Control
Standardize, Improve, Prevent, Optimize, Control
System, Inspection, Procedure, Output, Certification
What is the primary goal of Failure Mode and Effects Analysis (FMEA) in quality management?
Reduce waste and minimize defects
Improve teamwork and collaboration
Identify potential failures and their impact
Maximize production efficiency
Which of the following is defined as the "systematic activities provided by the organization to ensure that a product or service will satisfy the given requirements for quality"?
Quality Assurance (QA)
Quality Control (QC)
Quality Management (QM)
Quality Management System (QMS)
What is FDA Form 484?
Notice of Inspection
Observation
Receipt of sample
Warning letter
Who first thought of Zero defect?
William Edwards Deming
Joseph M Juran
Philip Crosby
Feigenbaum
A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect quality system, samples storage and testing, validation status, EHS and approved procedures
Deviation
CAPA
Laboratory investigation
Change control
