Quality Assurance & Quality Control (14) Flashcards

1
Q

Quality assurance?

A

= the policies, procedures and actions established to provide & maintain a degree of confidence in data integrity & accuracy.

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2
Q

What do we mean when we say that quality assurance is a dynamic process?/ What does “dynamic” imply?

A

= consistent application & monitoring of these procedures.

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3
Q

Components of quality assurance system? (7) [in order]

A

• Management system.
• Training.
• Standard operating procedures.
• Sampling.
• Housekeeping.
• Equipment maintenance & calibration.
• Reporting of results.

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4
Q

Factors influencing quality in PRE-ANALYTICAL? (6)

A

• Correct sample.
• Correct sampling procedures.
• Correct labeling.
• Correct quantity.
• Correct transport.
• Correct storage.

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5
Q

Factors influencing quality in ANALYTICAL? (6)

A

• Laboratory professionals.
• Reagents.
• Equipment.
• Method selection (SOP).
• Records.
• Bio-safety.

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6
Q

Factors influencing quality in POST-ANALYTICAL? (4)

A

• Recording.
• Interpretation.
• Turn-around time.
• Reporting.

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7
Q

Non-conformance vs Non-compliance?

A

● Non-conformance =

●Non-compliance =

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8
Q

Components of a correct label? (7)

A

• Sample ID.
• Sample date.
• Sampled by date.
• Bar code.
• Bottle number.
• Preparation description (…ml & unacidified).
• Analyses requested (alkalinity; pH; acidity).

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9
Q

Why is an analytic balance used in labs?

A

For increased accuracy (4 decimals).

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10
Q

External bodies of calibration?

A

Certificate of Calibration.

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11
Q

Internal bodies of calibration?

A

Table of best balances values.

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12
Q

Types of quality management systems? (6)

A

• ISO 9001.
• ISO 17025.
• ISO 14001.
• ISO 22000.
• ISO 50001.
• OHSAS (ISO 45001).

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13
Q

ISO 9001?

A

= quality management system.

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14
Q

ISO 17025?

A

= laboratory quality system.

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15
Q

ISO 14001?

A

= environmental management system.

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16
Q

ISO 22000?

A

= food safety management.

17
Q

ISO 50001?

A

= energy management system.

18
Q

OHSAS (ISO 45001)?

A

= Occupational Health and Safety Management System.

19
Q

ISO 9001 purpose?

A

Helps ensure that customers get consistent, good quality products & services.

20
Q

ISO 17025 purpose?

A

Specifies that the general requirements for the competence to carry out tests, calibrations & sampling.

21
Q

ISO 14001 purposes? (3)

A

• Improves environmental performance.
• Manages environmental responsibilities.
• Achieves environmental objectives for sustainability.

22
Q

ISO 22000 purpose?

A

Ensures that food is safe at the time of human consumption.

23
Q

ISO 50001 purpose?

A

Achieves continual improvement of energy performance, energy efficiency, etc.

24
Q

OHSAS (ISO 45001) purposes? (2)

A

• Develops & implements OH&S policy and objectives.
• Identifies risks & mitigates measures.

25
Q

Lay out Laboratory workflow? (3)

A

Pre-analytic
|
Analytic
|
Post-analytic

26
Q

Important thing to note about Documentation of QA system?

A

IF IT’S NOT DOCUMENTED, YOU HAVE NOT DONE IT!!

27
Q

Quality control?

A

= sample/procedure intended to verify performance characteristics of a system.

28
Q

Purpose of quality control?

A

Ensures that the monitoring data sufficiently represents the condition of the target waters when the sample was sampled.

29
Q

Egs of quality controls? (3)

A

• Blanks.
• Duplicates.
• Spiked samples.

30
Q

Blanks?

A

= high purity water.

31
Q

Blanks purpose?

A

Assesses the contamination from a particular part of the process.

32
Q

Duplicates?

A

= dividing a sample collected from a sampling point.

33
Q

Duplicates purpose?

A

Measures the precision or repeatability of the analytical process in the laboratory.

34
Q

Spiked samples?

A

= known amount of a particular parameter added to a sub-sample.

35
Q

What to note in Role of Inter-laboratory Proficiency Testing?

A

SABS.

36
Q

SABS stands for?

A

South African Bureau of Standards.

37
Q

SABS purpose?

A

Develops, promotes & maintains SANS.

38
Q

SANS stands for?

A

South African National Standards.

39
Q

SABS features? (3)

A

• Assesses accuracy using z-scoring.
• Synthetic samples.
• Tested by other laboratories in the country.