Quality Assurance & Quality Control (14) Flashcards
Quality assurance?
= the policies, procedures and actions established to provide & maintain a degree of confidence in data integrity & accuracy.
What do we mean when we say that quality assurance is a dynamic process?/ What does “dynamic” imply?
= consistent application & monitoring of these procedures.
Components of quality assurance system? (7) [in order]
• Management system.
• Training.
• Standard operating procedures.
• Sampling.
• Housekeeping.
• Equipment maintenance & calibration.
• Reporting of results.
Factors influencing quality in PRE-ANALYTICAL? (6)
• Correct sample.
• Correct sampling procedures.
• Correct labeling.
• Correct quantity.
• Correct transport.
• Correct storage.
Factors influencing quality in ANALYTICAL? (6)
• Laboratory professionals.
• Reagents.
• Equipment.
• Method selection (SOP).
• Records.
• Bio-safety.
Factors influencing quality in POST-ANALYTICAL? (4)
• Recording.
• Interpretation.
• Turn-around time.
• Reporting.
Non-conformance vs Non-compliance?
● Non-conformance =
●Non-compliance =
Components of a correct label? (7)
• Sample ID.
• Sample date.
• Sampled by date.
• Bar code.
• Bottle number.
• Preparation description (…ml & unacidified).
• Analyses requested (alkalinity; pH; acidity).
Why is an analytic balance used in labs?
For increased accuracy (4 decimals).
External bodies of calibration?
Certificate of Calibration.
Internal bodies of calibration?
Table of best balances values.
Types of quality management systems? (6)
• ISO 9001.
• ISO 17025.
• ISO 14001.
• ISO 22000.
• ISO 50001.
• OHSAS (ISO 45001).
ISO 9001?
= quality management system.
ISO 17025?
= laboratory quality system.
ISO 14001?
= environmental management system.