QA/QC

Question 1

What is Quality Control?

Answer 1

Steps taken to ensure the validity of a SPECIFIC test procedure. Equipment in-house is tested with samples of ‘known’ values for comparison of
accuracy.

Question 2

What is Quality Assurance?

Answer 2

A broader set of controls ensuring the final results are correct. Eg: the correct test is performed on the correct sample
Eg: Interpreted correctly
External monitoring of standards often also performed – samples to external labs

Question 3

When are Quality Control tests performed?

Answer 3

• Beginning of each shift
• After analyser has been serviced
• When reagent lots are change
• When patient results seem inappropriate
• As indicated by manufacturer

Question 4

What are some Pre-Analytical Error examples?

Answer 4

• Missing samples
• Wrong ID on sample
• Contamination of sample
• Clotted / insufficient amount for testing

Question 5

What are some Analytical Error examples?

Answer 5

• Equipment malfunction
• SOPs not followed
• Undetected failure of the quality control
• Sample mix ups

Question 6

What are some Post-Analytical Error examples?

Answer 6

• Delayed/missed reaction in reporting results
• Incorrect interpretation
• Inappropriate/inadequate follow up plan

Question 7

What are the 3 types of error that QA covers?

Answer 7

1) Pre-Analytical Error
2) Analytical Error
3) Post-Analytical Error

Question 8

What is the type of error that QA covers?

Answer 8

Specific DAILY steps to minimise Analytical Error

Question 9

What does QA focus on?

Answer 9

QA aims to prevent defects with a focus on the process used to make the product. It is a proactive quality process.

Question 10

What does QC focus on?

Answer 10

QC aims to identify (and correct) defects in the finished product. Quality control, therefore, is a reactive process.

Question 11

What does QA mean?

Answer 11

QA is a set of activities for ensuring quality in the processes by which products are developed.

Question 12

What does QC mean?

Answer 12

QC is a set of activities for ensuring quality in products. The activities focus on identifying defects in the actual products produced.

Question 13

How is QA done?

Answer 13

Establish a good quality management system and the assessment of its adequacy. Periodic conformance audits of the operations of the system.

Question 14

How is QC done?

Answer 14

Finding & eliminating sources of quality problems through tools & equipment so that customer’s requirements are continually met.