CAPA Process Fundamentals 2

Question 1

In CAPA process fundamentals, what is the primary purpose of a process map or flowchart?

Accepted Answer

To visually depict process steps, inputs, outputs, and decision points

Answer

Process maps visually depict steps, inputs, outputs, and decision points, making it easier to identify where nonconformances occur.

Question 2

Which process input category in an Ishikawa diagram refers to the tools and equipment used in a process?

Accepted Answer

Machine

Answer

In the 6M Ishikawa framework, 'Machine' refers to tools, equipment, and technology used in the process.

Question 3

A process is considered 'capable' when:

Accepted Answer

Its Cpk index is greater than or equal to 1.33

Answer

Process capability is measured by the Cpk index; a value ≥1.33 indicates the process consistently meets specification limits.

Question 4

What distinguishes a special cause of variation from a common cause in process analysis?

Accepted Answer

Special causes are sporadic, assignable events outside normal process variation

Answer

Special causes are sporadic, identifiable events that fall outside the normal random variation inherent in a stable process.

Question 5

When performing a CAPA on a process, the 'Measure' phase in DMAIC is primarily concerned with:

Accepted Answer

Collecting baseline process performance data

Answer

The Measure phase focuses on collecting current, baseline data to quantify the problem and process performance before improvement.

(CAPA) Corrective and Preventive Action Certified Practice Test