CRAP Quality Management Systems 2

Question 1

What is the primary purpose of an internal audit within a QMS?

Accepted Answer

To assess whether the QMS conforms to planned arrangements and is effectively implemented

Answer

To satisfy customer requests for transparency

Answer

To prepare for FDA inspections only

Answer

To evaluate employee performance

Question 2

Under FDA's QSR, which record documents the production history of a specific device unit or batch?

Accepted Answer

Device History Record (DHR)

Answer

Device Master Record (DMR)

Answer

Design History File (DHF)

Answer

Quality Plan (QP)

Question 3

A supplier qualification program in a QMS typically requires which of the following as a minimum?

Accepted Answer

Evaluation of supplier capability to meet specified requirements

Answer

On-site audits of all suppliers annually

Answer

ISO certification for all suppliers

Answer

FDA registration of all suppliers

Question 4

Under ICH Q10, which lifecycle phase does the Pharmaceutical Quality System (PQS) cover?

Accepted Answer

Development, technology transfer, manufacturing, and discontinuation

Answer

Commercialization only

Answer

Pre-clinical studies only

Answer

Post-market surveillance only

Question 5

When a nonconforming product is identified during manufacturing, which action must be taken first according to QMS principles?

Accepted Answer

Identify, document, and segregate the nonconforming product

Answer

Destroy the product immediately

Answer

Notify the FDA immediately

Answer

Issue a customer complaint form

Question 6

Which element of a QMS ensures that measuring and monitoring equipment provides accurate data?

Accepted Answer

Calibration and measurement system controls

Answer

Design controls

Answer

Purchasing controls

Answer

Document control

Question 7

The concept of 'risk-based thinking' in ISO 9001:2015 requires organizations to:

Accepted Answer

Identify and address risks and opportunities that could affect QMS outcomes

Answer

Eliminate all risks to achieve zero defects

Answer

Only address risks identified during regulatory inspections

Answer

Document every possible risk regardless of likelihood