CRAP Quality Management Systems 3

Question 1

Under 21 CFR Part 820, which type of change to a device's design requires formal design control procedures?

Accepted Answer

Changes that could affect the device's safety or effectiveness

Answer

Only changes to labeling

Answer

Cosmetic changes to packaging color only

Answer

Administrative updates to the DMR

Question 2

Which of the following is a key output of the quality planning process in a QMS?

Accepted Answer

Quality objectives and processes needed to meet requirements

Answer

Customer satisfaction surveys

Answer

Annual revenue reports

Answer

Competitor benchmarking data

Question 3

An FDA Form 483 observation during a QMS inspection indicates:

Accepted Answer

Inspectional observations of conditions that may constitute regulatory violations

Answer

A criminal violation requiring immediate shutdown

Answer

Formal warning letter with mandatory corrective actions

Answer

Approval of the quality system

Question 4

In a QMS, document control procedures must ensure that:

Accepted Answer

Obsolete documents are removed from points of use and only current versions are available

Answer

All documents are available in print format only

Answer

Documents are accessible to all external stakeholders

Answer

All documents are approved by FDA before use

Question 5

Which metric is most useful for evaluating the effectiveness of a CAPA system?

Accepted Answer

Recurrence rate of nonconformities after CAPA closure

Answer

Number of CAPAs opened per year

Answer

Time to open a CAPA

Answer

Number of employees trained on CAPA procedures

Question 6

Under ISO 13485, which of the following is required for validation of software used in production and quality systems?

Accepted Answer

Documented procedures and validation protocols appropriate to intended use and risk

Answer

Validation is only required if the software is sold commercially

Answer

Only user acceptance testing performed by end users

Answer

FDA 510(k) clearance for all internal QMS software

Question 7

A quality system's effectiveness is best demonstrated through which combination of activities?

Accepted Answer

Management reviews, internal audits, CAPA closure, and customer feedback analysis

Answer

High production volume and low cost

Answer

Regulatory approvals obtained and no FDA Warning Letters

Answer

Employee headcount and training completion rates