Investigation Excellence
This tool uses repeated questioning to drill down to the underlying cause of an issue.
What is the 5 Whys method?
This regulatory agency visited TCF03 during the EMA inspection in 2025.
Who is the FDA?
This method evaluates training effectiveness through direct demonstration of ability (e.g., practical performance).
What is a skills assessment?
A recurring deviation occurring multiple times may indicate the need for one of these.
What is a CAPA?
*DAILY DOUBLE*
CAR-T therapy begins with collection of these cells from a patient.
What are T cells?
An investigation concludes that a CTS made an error because they were distracted. The next question investigators should ask is
What allowed the distraction to result in the error?
During an inspection, you do not know the answer to a question. What is your response to the inspector?
What is “I don’t know but I can find out”?
This designation requires completion of curriculum requirements documented in LMS before performing GMP tasks.
What is Qualification?
This demonstrates that a CAPA actually solved the problem.
What is effectiveness verification?
In autologous cell therapy, every lot is unique because of this
What is patient starting material?
Three operators perform the same task incorrectly over six months. The investigation identifies all three as "not following procedure."
What is an inadequate root cause?
The most effective inspection preparation strategy is maintaining this.
What is maintaining a state of inspection readiness?
*DAILY DOUBLE*
A user performs work under another employee's login credentials. This is a violation of what ALCOA principle.
What is Attributable?
Before implementing a major change, Quality often evaluates this to determine potential risks.
What is a risk assessment?
Every quality system at Kite exists to protect this group.
Who are the patients?
Multiple unrelated deviations involve different personnel but the same manufacturing step. Investigators should focus on this common factor.
What is the process?
This FDA document represents inspectional observations and is not a final agency determination of regulatory violations.
What is a Form 483?
This higher-level status requires prerequisite completion plus documented evidence such as work samples or data.
What is Certification?
Implementing retraining alone is often considered weak because it does not address this.
What is the root cause?
Upon harvest, a Critical Quality Attribute does not meet the final product specification. The lot must be evaluated in this forum.
What is the Material Review Board (MRB)?
*DAILY DOUBLE*
A deviation appears isolated, but trend data reveals similar events over 12 months.
What is evidence of a systemic issue?
The internationally recognized standard for Quality Management Systems (QMS).
What is ISO 9001?
CFR Part 11 requires these controls to ensure only authorized individuals can use a system, electronically sign records, or perform operations
What are access controls?
This group cannot request Regulatory Submission until the Change Control Implementation Plan is approved
Who are Change Owners?
These three identifiers are unique to each batch manufactured at Kite
What is Patient ID, Cell Order Number and COI number (or Lot number)?