Quality systems

Question 1

Define quality in manufacturing (simple).

Answer 1

Meeting the customer’s needs and specifications consistently and safely, at the agreed cost and time.

Question 2

What is a Quality Management System (QMS)?

Answer 2

A set of policies, processes, and records used to plan, control, and improve how an organisation meets customer and regulatory requirements.

Question 3

Name a widely used QMS standard.

Answer 3

ISO 9001 (quality management systems).

Question 4

Quality Assurance (QA) vs Quality Control (QC).

Answer 4

QA = proactive systems and processes to prevent defects; QC = checking the product to find defects (inspection/testing).

Question 5

What is PDCA?

Answer 5

Plan–Do–Check–Act: a cycle for continuous improvement of processes and outcomes.

Question 6

Purpose of a procedure vs work instruction.

Answer 6

Procedure = ‘what/when/who’ at a high level; Work instruction/SOP = detailed ‘how to’ steps at the workstation.

Question 7

What is a control plan?

Answer 7

A document listing key product/process characteristics, how they’re controlled or measured, frequency, and reaction plans.

Question 8

What is an inspection plan?

Answer 8

A schedule of checks, measurements, sampling, and acceptance criteria used to verify parts at goods-in, in‑process, or final stages.

Question 9

Define tolerance and specification limit.

Answer 9

Tolerance = allowed variation around a nominal; Specification limits = min/max values a characteristic must meet to be conforming.

Question 10

What is a first article inspection (FAI)?

Answer 10

A full check on the first part off a setup or process to verify drawings, tooling, and programs before volume.

Question 11

Give two examples of measuring equipment in a workshop.

Answer 11

Vernier calipers/micrometers for size; go/no‑go gauges for quick pass/fail.

Question 12

Why calibrate measuring equipment?

Answer 12

To ensure measurements are accurate and traceable, so decisions about conformity are reliable.

Question 13

What is an MSA R&R study (simple)?

Answer 13

Measurement System Analysis—Repeatability & Reproducibility checks whether the measuring process is consistent across people and time.

Question 14

What is SPC?

Answer 14

Statistical Process Control—using control charts to monitor process variation and detect special causes before defects occur.

Question 15

Name two common SPC charts for variable data.

Answer 15

X‑bar & R charts and X‑bar & S charts.

Question 16

Cp vs Cpk—simple meaning.

Answer 16

Cp = potential capability if centred; Cpk = actual capability considering how centred the process is within the spec limits.

Question 17

What is a nonconformance?

Answer 17

A failure to meet a requirement (specification, drawing, procedure, or regulation).

Question 18

NCR—what does it stand for and include?

Answer 18

Non‑Conformance Report: details of the issue, quantity, lot, evidence, disposition (rework, repair, use‑as‑is, scrap), and corrective action link.

Question 19

What is containment in problem solving?

Answer 19

Immediate action to isolate suspect product (quarantine/hold) and prevent further escapes while root cause is found.

Question 20

5 Whys—purpose.

Answer 20

A simple root‑cause tool that asks ‘why?’ repeatedly until the underlying cause is revealed.

Question 21

Fishbone/Ishikawa diagram—what is it for?

Answer 21

A cause‑and‑effect diagram that groups potential causes (e.g., Methods, Machines, Materials, Manpower, Measurement, Environment).

Question 22

What is CAPA?

Answer 22

Corrective and Preventive Action—actions to remove root cause(s) of existing or potential nonconformities and stop recurrence.

Question 23

8D at a glance (very simple).

Answer 23

Form a team, describe problem, contain, find root cause, choose/verify corrective, implement, prevent recurrence, congratulate team.

Question 24

What is traceability?

Answer 24

Ability to track materials and parts from supplier through production to customer (e.g., batch, heat, serial numbers).

Question 25

Document control—why important?

Answer 25

Ensures only the latest approved drawings/SOPs are used; prevents errors from outdated information.

Question 26

What is a revision on a drawing?

Answer 26

The version identifier that records controlled changes; linked to a change note/ECN with date and description.

Question 27

Internal vs external audit (simple).

Answer 27

Internal = done by the organisation to check its QMS; External = by customers or certification bodies to verify compliance.

Question 28

Audit evidence—what counts?

Answer 28

Objective evidence such as records, measurements, training logs, or observed practice that confirms requirements are met.

Question 29

Supplier quality—two controls.

Answer 29

Supplier approval/assessment and incoming inspection (with clear specifications and sampling).

Question 30

Sampling—what is AQL (simple)?

Answer 30

Acceptance Quality Limit—defines how many defects are acceptable in a sample to accept a lot at a chosen risk level.

Question 31

What is risk‑based thinking in ISO 9001 terms (simple)?

Answer 31

Planning and acting to address risks/opportunities so processes are robust and outcomes consistent.

Question 32

What is FMEA (basic)?

Answer 32

Failure Mode and Effects Analysis—lists potential failure modes, their effects and causes, and prioritises actions using Severity, Occurrence, Detection (RPN).

Question 33

Training & competence—what records to keep?

Answer 33

Role requirements, induction/safety training, skills matrices, and evidence of assessment/authorisation.

Question 34

Visual management—give two examples.

Answer 34

Quality ‘hold’ areas with red tags; status boards/Andon lights to signal issues quickly.

Question 35

Cost of Quality—four categories (simple).

Answer 35

Prevention, Appraisal, Internal Failure (scrap/rework), External Failure (returns/warranty).

Question 36

5S—how does it support quality?

Answer 36

Organised, clean workspaces reduce errors, make defects visible, and keep gauges/tools controlled and available.

Question 37

Poka‑yoke—what is it?

Answer 37

Error‑proofing: designing processes or fixtures so mistakes are prevented or become impossible.

Question 38

Calibration label—what should be on it?

Answer 38

Instrument ID, calibration date, due date, and status; sometimes a QR/code for the certificate.

Question 39

Control of nonconforming product—two rules.

Answer 39

Clearly identify and segregate (quarantine) suspect items; do not ship/use until disposition is approved and recorded.

Question 40

School example (batch): how to assure quality on the laser cutter?

Answer 40

Use a setup/first‑article checklist (material, focus, test cut) and record one sample per nest for traceability.

Question 41

School example (lathe): prevent scrap on diameters.

Answer 41

Use standard speeds/feeds, take trial cut and measure with vernier before final pass; record sizes on an in‑process sheet.

Question 42

Acceptance criteria vs workmanship standard.

Answer 42

Acceptance criteria = numeric limits (e.g., Ø10.00±0.10); workmanship = visual/finish expectations (e.g., no burrs, edges chamfered).

Question 43

Go/no‑go example (quick check).

Answer 43

Use a plug gauge for a hole: ‘go’ end must enter; ‘no‑go’ end must not—simple pass/fail control.

Question 44

When should you raise an ECN (Engineering Change Notice)?

Answer 44

When a design/process change affects form, fit, function, safety, or documentation—so all records and versions align.

Question 45

What is a quality policy?

Answer 45

A short statement of the organisation’s quality aims and commitment; it guides objectives and actions.

Question 46

Quality objectives—one example for a class project.

Answer 46

‘≥95% of parts pass final inspection first time’ with a plan to track and improve.