SQA SQA Inspector Roles and Responsibilities 1 — Questions and Answers
Question 1: What is the primary professional mission of the Society of Quality Assurance (SQA)?
- To advance quality assurance in the regulated research community through education, networking, and professional development (Correct answer)
- To enforce GLP regulations on behalf of the FDA
- To certify GLP laboratories as FDA-compliant
- To conduct third-party GLP audits for regulatory agencies
Correct answer: To advance quality assurance in the regulated research community through education, networking, and professional development
SQA's mission is to support QA professionals in regulated research through education, community, and professional growth.
Question 2: Which professional designation is offered by SQA to recognize demonstrated competency in quality assurance?
- Certified Quality Auditor in GLP (CQAGLP) through SQA's certification program
- Registered Quality Assurance Professional (RQAP-GLP) (Correct answer)
- Certified GLP Compliance Officer (CGCO)
- Licensed Quality Inspector (LQI)
Correct answer: Registered Quality Assurance Professional (RQAP-GLP)
SQA offers the Registered Quality Assurance Professional – GLP (RQAP-GLP) credential to recognize QA professionals in nonclinical research.
Question 3: Under GLP, the QAU must maintain a record of all inspections performed. What must this record include?
- Date of inspection, study inspected, phase of study inspected, and name of inspector (Correct answer)
- Only the date and inspector name
- Study director approval and sponsor name only
- Findings only, without dates or personnel information
Correct answer: Date of inspection, study inspected, phase of study inspected, and name of inspector
GLP requires inspection records to document the date, study or process inspected, phase or aspect inspected, and the QAU inspector's name.
Question 4: What is a key ethical requirement for a GLP quality assurance professional regarding conflicts of interest?
- The QAU must be organizationally independent of the studies it audits to avoid conflicts of interest (Correct answer)
- The QAU may conduct studies provided they report findings objectively
- Conflicts of interest are allowed if disclosed in the QAU statement
- The Study Director and QAU may be the same person for small facilities
Correct answer: The QAU must be organizationally independent of the studies it audits to avoid conflicts of interest
GLP explicitly requires QAU independence from study conduct to prevent conflicts of interest from compromising audit objectivity.
Question 5: When a GLP QA professional identifies a serious noncompliance during an in-process study inspection, what is the immediate required action?
- Inform the Study Director and Test Facility Management promptly so corrective action can be taken (Correct answer)
- Halt the study immediately without notification
- Submit a report directly to the FDA
- Document the finding and wait until the final report to disclose it
Correct answer: Inform the Study Director and Test Facility Management promptly so corrective action can be taken
Serious noncompliances must be promptly escalated to the Study Director and management so the impact can be assessed and corrected in real time.
Question 6: Which behavior best exemplifies professional integrity for a GLP quality assurance inspector?
- Reporting all findings accurately and completely, even when pressured to soften or omit them (Correct answer)
- Focusing only on findings that affect study conclusions
- Adjusting findings based on the study's regulatory importance
- Omitting minor findings to maintain a positive relationship with study personnel
Correct answer: Reporting all findings accurately and completely, even when pressured to soften or omit them
Professional integrity requires complete and accurate reporting of all findings regardless of external pressure or relationship dynamics.
SQA SQA Inspector Roles and Responsibilities 1
What is the primary professional mission of the Society of Quality Assurance (SQA)?