DQ practical workbook
Develop a controlled review baseline, traceability row, finding register and handover decision.
Fictional V-201 oral-liquid vessel only. Do not enter confidential site or patient data. Answers are not stored or transmitted; print before closing.
DQ traceability template (CSV) · Design findings template (CSV)
Activity 1 · What DQ decides — and what it does not
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Classify three statements: the drawing includes a drain; the installed drain matches the drawing; the defined cleaning cycle removes residues. Explain the evidence needed for each.
Model reasoning
Design review checks the proposed drain and its rationale. IQ checks installation against the approved design. Cleaning validation needs a justified study and executed evidence; a drawing does not prove cleaning effectiveness.
Activity 2 · Build a controlled design-review baseline
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Prepare a baseline register containing five documents, revision/status, owner and one unresolved question.
Model reasoning
Include URS, arrangement drawing, piping/instrument diagram, functional specification and risk record. Mark missing or draft inputs explicitly; assign the batch-range question to the process owner and identify affected mixing conclusions.
Activity 3 · Trace a requirement to a design decision
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Complete one DQ traceability row for R-03. Explain why three ±0.2 °C components do not automatically meet a ±0.5 °C chain requirement.
Model reasoning
Worst-case sum is 0.6 °C. Record the design gap, evidence reference and supplier action. Reassess revised components and retain installation/assembled-chain verification. Do not treat this sum as a full uncertainty budget.
Activity 4 · Review contact materials and cleanability
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Write a design finding for an outlet pocket and a separate question for an unspecified gasket.
Model reasoning
Reference the drawing and contact-component list. Request cleaning/drainage rationale or redesign for the pocket, and compatibility evidence for the gasket. Assign engineering/cleaning and materials specialists; retain later verification.
Activity 5 · Review instruments, controls and failure responses
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Draw a shared-sensor chain and write a test intention for its failure response and recovery.
Model reasoning
Show the common sensor feeding both functions. Identify the fault, intended safe response, alarm information and reset/restart behaviour. Assess independence according to risk; do not demand it universally.
Activity 6 · Review utility and installation interfaces
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Fill an interface register for jacket utility, instrument access and transfer connection.
Model reasoning
For each interface record required input, design evidence, supplying owner, accepting owner, mismatch and action. Do not replace missing duty/rating data with catalogue values.
Activity 7 · Use risk to focus the design review
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Compare a missing transfer interlock with a duplicated drawing title. Explain review priority and required evidence without inventing scores.
Model reasoning
The interlock concern has a potential quality mechanism and needs process/control expertise and verification planning. The title issue needs document reconciliation and impact review; determine whether it also hides a configuration error.
Activity 8 · Evaluate supplier evidence without transferring accountability
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Review a supplier report that uses a different controller version and omits a fault challenge. Write two distinct findings.
Model reasoning
One finding addresses configuration applicability; the other addresses protocol coverage. Request change information, assess affected functions and specify the missing site-reviewed challenge or justified evidence.
Activity 9 · Handle design findings and changes
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Write a closure entry for a revised gasket and decide whether the next proposed activity can proceed.
Model reasoning
Identify original finding, new material/evidence revision, suitability rationale, reviewer and later identity/cleaning checks. Assess the specific next activity; do not equate conditional progression with routine-use approval.
Activity 10 · Capstone: defend the DQ handover
Suggested time: 20 minutes. Revisit the narrated lesson and worked example before responding.
Write a 150–250 word DQ decision memo for the eight-supported/two-open capstone. Distinguish routine use from one proposed limited next activity.
Model reasoning
Do not accept a complete favourable DQ conclusion while the gasket and sensor-response gaps are unresolved. Record scope and baseline, assign material/control actions, assess the specific proposed activity and keep IQ/OQ dependencies explicit. Eight of ten is 80% coverage, not a GMP acceptance criterion.
Capstone rubric
Give each dimension 0 (missing), 1 (partial) or 2 (supported): controlled baseline; requirement/evidence links; risk and unresolved gaps; owned actions; scope-specific conclusion. This 10-point self-review rubric is not a competency certification. Invented evidence or unsupported routine-use approval requires correction irrespective of the score.