Acronyms
What does CAPA stand for
Corrective and Preventative Action
True or False: All nonconformances require a CAPA.
False
What does GMP stand for?
Good Manufacturing Practice.
What type of audit is performed by your own company to check compliance?
Internal audit.
True or False: Missed entries should never be documented at all.
False — missed entries should be documented with explanation and date/time.
What does NCR stand for
Non Conformance Report
What tool is often used for root cause analysis?
5 Whys / Fishbone Diagram
What is the difference between GMP and cGMP?
cGMP = current GMP
What’s the difference between an internal audit and a supplier audit?
Internal = your own QMS; Supplier = evaluates vendor’s compliance.
What is the proper way to correct an error in a paper record?
Draw a single line through the error, initial, date, and provide the correct entry.
What does PFMEA stand for
Process Failure Mode Effective Analysis
Preventive action is different from corrective action because…?
Preventive action eliminates potential issues before they occur; corrective action addresses actual issues.
What is the difference between a procedure (SOP) and a record in GMP?
Procedure = instructions on how work is done; Record = documented proof the work was done.
What’s the difference between a major and minor audit finding?
Major = systemic/critical issue with compliance or safety; Minor = isolated/non-critical issue.
True or False: You can use tipp-ex to fix a mistake in a paper record.
False — corrections must be made with a single line through the error, initials, date, and corrected entry.
What does DHF stand for
Design History File
What are the possible sources that can trigger a CAPA? (4 answers)
Audit findings, complaints, nonconformances, deviations, trend data, supplier issues, risk assessments.
What is the difference between a form and record?
Form = blank template to capture information.
Record = completed form that shows the activity was done.
What’s the first thing an auditor typically does during an audit?
Opening meeting to explain scope, objectives, and plan.
What is meant by “data integrity” in documentation?
Ensuring data is accurate, complete, consistent, and trustworthy throughout its lifecycle.
What does AQL stand for
Acceptable Quality Limit
What’s an effectiveness check in a CAPA?
Verification that corrective action prevented recurrence
True or False: GMP only applies to the manufacturing floor.
FALSE. EVERYONE
What document does an auditor issue at the end of an audit to summarize findings?
Audit report.
What should be included in a correction note for a missed entry?
Reason for correction, date/time of actual event, date of entry, initials, and signature.