1.
State what is meant by ISO 17025. [1]
JD SCIENCE
Health, safety, GLP and quality
Answer all questions. Show working. Answers are in a separate file on the Worksheets page — do not look at them until you have finished.
2.
State what is meant by a non-conformance. [1]
3.
State what is meant by CAPA. [1]
4.
State what is meant by internal audit. [1]
5.
State what is meant by training records. [1]
6.
State what is meant by document control. [1]
7.
State what is meant by equipment log. [1]
8.
State what is meant by change control. [1]
9.
State what is meant by contamination control. [1]
10.
State what is meant by customer complaint. [1]
11.
Noah is asked about ISO 17025 in a NCFE Laboratory Sciences paper.
(a) Describe ISO 17025. [2]
(b) Explain why ISO 17025 is important in this topic. [3]
12.
Noah is asked about a non-conformance in a NCFE Laboratory Sciences paper.
(a) Describe a non-conformance. [2]
(b) Explain why a non-conformance is important in this topic. [3]
13.
Noah is asked about CAPA in a NCFE Laboratory Sciences paper.
(a) Describe CAPA. [2]
(b) Explain why CAPA is important in this topic. [3]
14.
Noah is asked about internal audit in a NCFE Laboratory Sciences paper.
(a) Describe internal audit. [2]
(b) Explain why internal audit is important in this topic. [3]
15.
Noah is asked about training records in a NCFE Laboratory Sciences paper.
(a) Describe training records. [2]
(b) Explain why training records is important in this topic. [3]
16.
Noah is asked about document control in a NCFE Laboratory Sciences paper.
(a) Describe document control. [2]
(b) Explain why document control is important in this topic. [3]
17.
An audit finds 4 of 50 SOPs expired. Percentage? [3]
18.
Calibration due every 12 months. Next date after March 2026? [3]
19.
A CAPA target is 10 days. Closed in 8. Days spare? [3]
20.
OOS rate 3 in 150 batches. Percentage? [3]
21.
Training matrix: 18 methods, competent in 15. Percentage? [3]
22.
A fridge must be 2–8 °C. A logger shows 1.5 °C. In spec? [3]
23.
Noah carries out a T-Level occupational task on GLP, GMP and laboratory quality. This is a typical NCFE required-practical style question.
(a) Identify the independent variable and the dependent variable. [2]
(b) State one control variable and explain why it must be controlled. [2]
(c) Suggest one improvement or source of error and how it affects the result. [2]
24.
Noah carries out writing or following an SOP for GLP, GMP and laboratory quality. This is a typical NCFE required-practical style question.
(a) Identify the independent variable and the dependent variable. [2]
(b) State one control variable and explain why it must be controlled. [2]
(c) Suggest one improvement or source of error and how it affects the result. [2]
25.
Noah carries out a COSHH / risk-assessment review for GLP, GMP and laboratory quality. This is a typical NCFE required-practical style question.
(a) Identify the independent variable and the dependent variable. [2]
(b) State one control variable and explain why it must be controlled. [2]
(c) Suggest one improvement or source of error and how it affects the result. [2]
26.
Noah carries out data review in a LIMS or quality log for GLP, GMP and laboratory quality. This is a typical NCFE required-practical style question.
(a) Identify the independent variable and the dependent variable. [2]
(b) State one control variable and explain why it must be controlled. [2]
(c) Suggest one improvement or source of error and how it affects the result. [2]
27.
Compare ISO 17025 with internal audit. [4]
28.
Compare a non-conformance with training records. [4]
29.
Compare CAPA with document control. [4]
30.
Compare internal audit with equipment log. [4]
31.
Apply your knowledge of equipment log to this situation: supports traceability [3]
32.
Apply your knowledge of change control to this situation: software, method, supplier [3]