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Simulated workplace
Scenario · Pharmaceutical Manufacturing

Review a batch record and investigate a hardness deviation

You are the Production Supervisor in the compression suite at Western Sydney.

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The situation

What has happened

Batch WS-26-0412, paracetamol 500 milligram tablets for a contract customer, was stopped at hour three of compression when an in process tablet hardness result fell outside the limit in the batch manufacturing record. The batch is on hold, a deviation has been raised and engineering is checking the compression force sensor on tablet press 1. The batch record contains the dispensing, granulation, drying, blending and compression steps with second person verification. Rohan Mehta needs the production review completed, every finding listed, the deviation assessed and an investigation drafted with the data needed to decide whether the batch can be released, reworked or rejected. The customer expects a position by Friday.

Your brief. Complete the production review of the batch manufacturing record against the good manufacturing practice policy and the batch release procedure, assess the hardness deviation, draft the deviation investigation with root cause options and data requirements, and record everything in the register so quality can decide the disposition.
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Tasks

Deliverables

  • Production review findings list
  • Draft deviation investigation
  • Updated register and batch record entries
  • Briefing for the site manager and customer

Documents to use

Systems to use

Production Batch Records

Every food, beverage and pharmaceutical batch from planning to release, with line, quantity, status and the notes that support release.

Non-conformance and CAPA Register

Register of every non-conformance, deviation, complaint and safety incident with investigation, corrective and preventive action and closure status.

Maintenance and Calibration Requests

Breakdown, preventive, calibration and hygienic design requests on plant and instruments at all three sites.

For trainers and assessors

Units of competency

Current on training.gov.au for the Food, Beverage and Pharmaceutical as at 10 September 2026.

FBPPHM4001Monitor and maintain Good Manufacturing Practice requirements
FBPPHM4002Prepare and review workplace documentation to support Good Manufacturing Practice requirements
FBPPHM4006Respond to non-conformance
FBPPHM4004Participate in change control procedures

Qualifications

FBP40522Certificate IV in Pharmaceutical Manufacturing
Assessor notes

What to look for

Evidence guide

Look for a systematic review that catches documentation findings as well as the hardness result, a trend analysis rather than a single data point, root cause options that connect process data to the result, and a clear separation between what is established and what is still open. The briefing must not promise a disposition before the data supports it.

The student's evidence summary lists every record they created or changed in the systems named above, their notes and the tasks they ticked. Verify it against the deliverables and your own assessment tool.