CRAP Quality Management Systems 2 — Questions and Answers
Question 1: What is the primary purpose of an internal audit within a QMS?
- To satisfy customer requests for transparency
- To assess whether the QMS conforms to planned arrangements and is effectively implemented (Correct answer)
- To prepare for FDA inspections only
- To evaluate employee performance
Correct answer: To assess whether the QMS conforms to planned arrangements and is effectively implemented
Internal audits provide an objective assessment of QMS conformance and effectiveness, enabling organizations to identify areas for improvement before external audits.
Question 2: Under FDA's QSR, which record documents the production history of a specific device unit or batch?
- Device Master Record (DMR)
- Design History File (DHF)
- Device History Record (DHR) (Correct answer)
- Quality Plan (QP)
Correct answer: Device History Record (DHR)
The DHR, per 21 CFR 820.184, documents the production history of each manufactured unit or batch, including dates, quantities, and acceptance activity records.
Question 3: A supplier qualification program in a QMS typically requires which of the following as a minimum?
- On-site audits of all suppliers annually
- Evaluation of supplier capability to meet specified requirements (Correct answer)
- ISO certification for all suppliers
- FDA registration of all suppliers
Correct answer: Evaluation of supplier capability to meet specified requirements
Supplier qualification requires evaluating whether suppliers can consistently meet quality, regulatory, and technical requirements before they are approved for use.
Question 4: Under ICH Q10, which lifecycle phase does the Pharmaceutical Quality System (PQS) cover?
- Commercialization only
- Development, technology transfer, manufacturing, and discontinuation (Correct answer)
- Pre-clinical studies only
- Post-market surveillance only
Correct answer: Development, technology transfer, manufacturing, and discontinuation
ICH Q10 applies across all phases of the pharmaceutical product lifecycle including development, technology transfer, commercial manufacturing, and product discontinuation.
Question 5: When a nonconforming product is identified during manufacturing, which action must be taken first according to QMS principles?
- Destroy the product immediately
- Identify, document, and segregate the nonconforming product (Correct answer)
- Notify the FDA immediately
- Issue a customer complaint form
Correct answer: Identify, document, and segregate the nonconforming product
Nonconforming products must first be identified, documented, and segregated to prevent unintended use or distribution, as required by 21 CFR 820.90.
Question 6: Which element of a QMS ensures that measuring and monitoring equipment provides accurate data?
- Design controls
- Calibration and measurement system controls (Correct answer)
- Purchasing controls
- Document control
Correct answer: Calibration and measurement system controls
Calibration programs ensure that inspection, measuring, and test equipment is calibrated at defined intervals to maintain measurement accuracy and data integrity.
Question 7: The concept of 'risk-based thinking' in ISO 9001:2015 requires organizations to:
- Eliminate all risks to achieve zero defects
- Identify and address risks and opportunities that could affect QMS outcomes (Correct answer)
- Only address risks identified during regulatory inspections
- Document every possible risk regardless of likelihood
Correct answer: Identify and address risks and opportunities that could affect QMS outcomes
Risk-based thinking requires proactive identification and management of risks and opportunities to prevent undesired outcomes and achieve improvement.
CRAP Quality Management Systems 2
What is the primary purpose of an internal audit within a QMS?