DM Definitions
What principles guide Good Documentation Practices and what does it stand for? (hint: an acronym)
ALCOA
attributable, legible, contemporaneous, original, accurate
PDCA stands for
Plan, Do, Check, Act
What does CV01N do?
creates a document
Document approved with QN
ZD2
What QMS Topic is Deviation Management?
Topic 3.5
What is the definition of an incident?
undesired or unplanned event or occurrence; no impact to product quality, quality system, or validated state
Lean principles are centered around the idea of kaizen. What does kaizen mean?
continuous improvement
T-code for editing QNs
QM02
Document approved independent of QN
ZD4
Deviation Notification and Classification SOP number
SOP-140
ECF stands for
Event & Causal Factor Tool
a trigger to an established standard (i.e., a red flag prior to the last box of product left to trigger reordering process) is known as a?
kanban
Investigation code in SAP
IVST
How do you approve a document in MIDAS?
Go to MIDAS inbox, double click on document, click finish, choose meaning and outcome, sign off
Deviation Management at West Point SOP number
SOP-17030
True or False: deviations are typically the result of a human not paying attention
False - looking past the human error will likely show a flaw in a process; humans are not robots so processes should be designed with humans in mind, not the other way around
STAR stands for
Stop, Think, Act, Review
Quality Assessment Task Code
Task 060
When would you check out a document?
When a revision is required and/or a document is rejected
Work Instruction for Quality Notification Management
WI-069
CAPA stands for
Corrective and Preventive Actions
Term for error proof (i.e., separating diesel from gas at the gas station so it cannot be mistakenly used)
Poka Yoke
RCA Task Code
Task 105
Product/Process is for ____ and Protocol is for ____
ZD2, ZD4
Conducting Human Related Investigation SOP number
SOP-14322