Apply the IQ reasoning

20 distinct application questions. This open-book self-study assessment exposes its answer key in the source and below. The suggested practice target is 85% (17/20), not a regulatory threshold, IQ acceptance rule or proof of independent competence. Unanswered questions must be completed before scoring. Answers are not sent to a server.

1. A team verified the installed vessel against its accepted arrangement. Which conclusion is supported?Every future batch will meet its mixing specificationThe cleaning process removes all relevant residuesThe installed arrangement matches the reviewed scope

2. Two inspectors used different revisions of the instrument schedule. What should happen?Reconcile baseline revisions and assess affected checksCombine both checklists without evaluating the differencesUse the newest issue without checking its effective approval

3. An equipment tag matches but the manufacturer serial differs from the schedule. What is justified?Resolve the identity discrepancy before relying on the matchAccept the vessel because the site tag is the primary identifierReplace the schedule entry without investigating the difference

4. A drawing lacks the required removal clearance. How should a measured 300 mm be treated?As a universal GMP minimum for maintenance accessAs an observation whose acceptance criterion remains unresolvedAs proof that the manufacturer removal envelope is satisfied

5. A gasket certificate describes a lot that cannot be linked to the installed gasket. How should it be handled?Accept the certificate because supplier and material grade matchAccept the gasket because the vessel-body certificate is availableResolve the installed-gasket link before accepting the certificate

6. The installed material matches its specification. Which claim still needs separate evidence?The compared material identifier matches the specificationThe cleaning process is effective for the intended residuesThe identity record relates to the inspected component

7. A utility line is labelled correctly but connected to a different branch than the drawing specifies. What is appropriate?Record and investigate the connection discrepancyAccept the label as sufficient evidence of correct installationRevise the drawing to match without an impact assessment

8. A utility was qualified before a new vessel branch was added. What is needed for the extension?Automatic acceptance under the original utility reportConfirm source quality and omit branch-specific installation checksAssessment of the change and applicable verification scope

9. Indication is 40.4 °C and reference is 40.0 °C. Which signed error and simple comparison are correct?−0.4 °C; outside the fictional ±0.5 °C limit+0.4 °C; within the fictional ±0.5 °C limit+0.8 °C; outside the fictional ±0.5 °C limit

10. A current certificate has suitable range but identifies another instrument. What follows?Use it because the range covers the planned testResolve certificate applicability to the installed instrumentUse it because both instruments came from one supplier

11. An instrument is found outside its required calibration status after IQ measurements. What should be assessed?Whether a new calibration alone can replace the affected readingsWhether the signed observations can be accepted without impact reviewThe validity of affected measurements and required follow-up

12. The control-system version is recorded during IQ. Which next step is still needed as applicable?Validation of applicable functions and controls under the planAcceptance of all audit-trail behaviour from the version numberAcceptance of backup restoration from the version screenshot

13. A supplier manual covers a different installed model. What is the strongest response?File it because the product family is broadly similarUse the similar model instructions pending the next periodic reviewVerify applicability and obtain the required correct instructions

14. A factory test is proposed for reuse after transport and site assembly. What supports reuse?Applicable evidence plus justified configuration and impact reviewAn approved factory report without reviewing site configurationMatching model numbers without assessing transport or assembly

15. A photograph shows a readable nameplate but cannot be linked to any location or check. What is needed?Placement in the general vessel folder without a check referenceLink the image to the inspected item and its verification recordUse as sole identity evidence for every unit of the same model

16. A serial number was transposed in a handwritten record. Which correction is appropriate?Erase the entry and write the expected serial in its placeRewrite the page and discard the page with the original entryPreserve the original and make an attributed, dated correction

17. A protocol check was not performed because access was unsafe. Which status is accurate?Not checked, with the limitation and follow-up recordedPassed because the remaining equipment was satisfactoryNot applicable because inspection was inconvenient

18. An installed valve differs from the accepted specification. Which route is defensible?Edit the acceptance criterion to match the supplied valveRecord the finding, assess impact and authorize the responseClose the check when the supplier confirms receipt of the complaint

19. Nine of ten checks are supported, but gasket traceability remains open. What does 90% mean?Automatic OQ permission because it exceeds the practice targetComplete installation suitability if the missing record is promisedNumerical coverage only; it does not authorize the next stage

20. A proposed dry OQ activity is unaffected by an open wetted-system finding. What supports conditional progression?Documented no-significant-impact review and responsible authorizationThe project schedule and the supplier commitment to close the findingThe number of completed checks and the overall practice score

Answer key and explanations

1. The installed arrangement matches the reviewed scope — Limit the conclusion to installation evidence; performance and cleaning need their own studies.

2. Reconcile baseline revisions and assess affected checks — A consistent applicable baseline is needed to interpret the observations.

3. Resolve the identity discrepancy before relying on the match — A tag match does not resolve conflicting equipment identity.

4. As an observation whose acceptance criterion remains unresolved — The observed distance cannot create its own criterion; no universal 300 mm limit is taught.

5. Resolve the installed-gasket link before accepting the certificate — The missing item-to-evidence link must be resolved through an applicable controlled approach.

6. The cleaning process is effective for the intended residues — Matching material identity does not demonstrate cleaning effectiveness.

7. Record and investigate the connection discrepancy — A label does not correct an incorrect or unassessed physical connection.

8. Assessment of the change and applicable verification scope — The extension must be evaluated; previous qualification does not automatically cover a changed system.

9. +0.4 °C; within the fictional ±0.5 °C limit — Indication minus reference is +0.4 °C. This arithmetic is not a complete uncertainty or acceptance decision.

10. Resolve certificate applicability to the installed instrument — Identity, not just date and range, is necessary for applicability.

11. The validity of affected measurements and required follow-up — A new calibration record alone does not establish the validity of earlier evidence.

12. Validation of applicable functions and controls under the plan — Version identification does not demonstrate functional controls or complete Annex 11 compliance.

13. Verify applicability and obtain the required correct instructions — The handover needs instructions relevant to the installed model/configuration.

14. Applicable evidence plus justified configuration and impact review — Assess configuration, method, data and effects of transport/installation; retain required site checks.

15. Link the image to the inspected item and its verification record — An image needs a clear relationship to the relevant equipment and verification record.

16. Preserve the original and make an attributed, dated correction — Follow the approved procedure, preserve the original information and record a reason where appropriate.

17. Not checked, with the limitation and follow-up recorded — An incomplete check is distinct from a justified scope exclusion or a demonstrated pass.

18. Record the finding, assess impact and authorize the response — A discrepancy requires an evidence-based controlled response and defined verification.

19. Numerical coverage only; it does not authorize the next stage — 9/10 is 90%, but significance and activity-specific assessment govern the decision.

20. Documented no-significant-impact review and responsible authorization — Annex 15 §2.10 addresses conditional approval to proceed to the next qualification stage after a documented no-significant-impact assessment. Selecting a separately assessed dry OQ activity is a practical teaching recommendation, not an activity prescribed by that clause. The open finding remains open; responsible authorization is required.