1.
State what is meant by ISO 17025.
[1 mark]
- competence of testing and calibration labs
JD SCIENCE
GLP, GMP and laboratory quality
Indicative marking points. Award marks for equivalent scientific or mathematical wording. Do not issue this sheet with the student worksheet.
2.
State what is meant by a non-conformance.
[1 mark]
- result or process outside the quality system
3.
State what is meant by CAPA.
[1 mark]
- corrective and preventive action
4.
State what is meant by internal audit.
[1 mark]
- the lab checks itself against procedures
5.
State what is meant by training records.
[1 mark]
- proof a person is competent
6.
State what is meant by document control.
[1 mark]
- only current SOPs in use
7.
State what is meant by equipment log.
[1 mark]
- use, calibration, maintenance, faults
8.
State what is meant by change control.
[1 mark]
- planned change is risk-assessed and approved
9.
State what is meant by contamination control.
[1 mark]
- segregate dirty and clean, colour-code
10.
State what is meant by customer complaint.
[1 mark]
- treated as a quality event
11.
Pat is asked about ISO 17025 in a Pearson Laboratory Sciences paper.
(a) [2 marks]
- accreditation
(b) [3 marks]
- methods, uncertainty, impartiality
12.
Pat is asked about a non-conformance in a Pearson Laboratory Sciences paper.
(a) [2 marks]
- must be logged and investigated
(b) [3 marks]
- CAPA follows
13.
Pat is asked about CAPA in a Pearson Laboratory Sciences paper.
(a) [2 marks]
- fix the cause, stop it recurring
(b) [3 marks]
- auditors look for this
14.
Pat is asked about internal audit in a Pearson Laboratory Sciences paper.
(a) [2 marks]
- independent of the work being audited
(b) [3 marks]
- finds gaps before an external audit
15.
Pat is asked about training records in a Pearson Laboratory Sciences paper.
(a) [2 marks]
- sign-off on each method
(b) [3 marks]
- do not run a method untrained
16.
Pat is asked about document control in a Pearson Laboratory Sciences paper.
(a) [2 marks]
- obsolete copies withdrawn
(b) [3 marks]
- version on every page
17.
An audit finds 4 of 50 SOPs expired. Percentage?
[3 marks]
- Final answer: 8%
18.
Calibration due every 12 months. Next date after March 2026?
[3 marks]
- Final answer: March 2027
19.
A CAPA target is 10 days. Closed in 8. Days spare?
[3 marks]
- Final answer: 2
20.
OOS rate 3 in 150 batches. Percentage?
[3 marks]
- Final answer: 2%
21.
Training matrix: 18 methods, competent in 15. Percentage?
[3 marks]
- Final answer: 83%
22.
A fridge must be 2–8 °C. A logger shows 1.5 °C. In spec?
[3 marks]
- Final answer: no
23.
Pat carries out a T-Level occupational task on GLP, GMP and laboratory quality. This is a typical Pearson required-practical style question.
(a) [2 marks]
- Independent: the factor being investigated
- Dependent: the measured result or quality check
(b) [2 marks]
- follow the SOP and keep other variables constant
- so the test is fair / only one variable is changed
(c) [2 marks]
- not recording the batch/lot number or operator ID
24.
Pat carries out writing or following an SOP for GLP, GMP and laboratory quality. This is a typical Pearson required-practical style question.
(a) [2 marks]
- Independent: a step in the method
- Dependent: whether the acceptance criteria are met
(b) [2 marks]
- same calibrated instrument
- so the test is fair / only one variable is changed
(c) [2 marks]
- skipping a verification check
25.
Pat carries out a COSHH / risk-assessment review for GLP, GMP and laboratory quality. This is a typical Pearson required-practical style question.
(a) [2 marks]
- Independent: hazard
- Dependent: control measure effectiveness
(b) [2 marks]
- same PPE and waste route
- so the test is fair / only one variable is changed
(c) [2 marks]
- using expired reagents or the wrong waste stream
26.
Pat carries out data review in a LIMS or quality log for GLP, GMP and laboratory quality. This is a typical Pearson required-practical style question.
(a) [2 marks]
- Independent: sample ID
- Dependent: result vs specification
(b) [2 marks]
- same calculation method
- so the test is fair / only one variable is changed
(c) [2 marks]
- transcription error between the instrument and the LIMS
27.
Compare ISO 17025 with internal audit.
[4 marks]
- competence of testing and calibration labs
- the lab checks itself against procedures
- state one workplace implication
28.
Compare a non-conformance with training records.
[4 marks]
- result or process outside the quality system
- proof a person is competent
- state one workplace implication
29.
Compare CAPA with document control.
[4 marks]
- corrective and preventive action
- only current SOPs in use
- state one workplace implication
30.
Compare internal audit with equipment log.
[4 marks]
- the lab checks itself against procedures
- use, calibration, maintenance, faults
- state one workplace implication
31.
Apply your knowledge of equipment log to this situation: supports traceability
[3 marks]
- supports traceability
32.
Apply your knowledge of change control to this situation: software, method, supplier
[3 marks]
- software, method, supplier