QA/QC Flashcards
What is Quality Control?
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.
What is Quality Assurance?
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
When are Quality Control tests performed?
- Beginning of each shift
- After analyser has been serviced
- When reagent lots are change
- When patient results seem inappropriate
- As indicated by manufacturer
What are some Pre-Analytical Error examples?
- Missing samples
- Wrong ID on sample
- Contamination of sample
- Clotted / insufficient amount for testing
What are some Analytical Error examples?
- Equipment malfunction
- SOPs not followed
- Undetected failure of the quality control
- Sample mix ups
What are some Post-Analytical Error examples?
- Delayed/missed reaction in reporting results
- Incorrect interpretation
- Inappropriate/inadequate follow up plan
What are the 3 types of error that QA covers?
1) Pre-Analytical Error
2) Analytical Error
3) Post-Analytical Error
What is the type of error that QA covers?
Specific DAILY steps to minimise Analytical Error
What does QA focus on?
QA aims to prevent defects with a focus on the process used to make the product. It is a proactive quality process.
What does QC focus on?
QC aims to identify (and correct) defects in the finished product. Quality control, therefore, is a reactive process.
What does QA mean?
QA is a set of activities for ensuring quality in the processes by which products are developed.
What does QC mean?
QC is a set of activities for ensuring quality in products. The activities focus on identifying defects in the actual products produced.
How is QA done?
Establish a good quality management system and the assessment of its adequacy. Periodic conformance audits of the operations of the system.
How is QC done?
Finding & eliminating sources of quality problems through tools & equipment so that customer’s requirements are continually met.
