FBPPHM3019 — Operate a chromatography manufacturing process

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What an assessment for FBPPHM3019 must cover

47 assessable components: 4 elements (20 performance criteria), 13 performance evidence and 11 knowledge evidence requirements, plus 3 foundation skills. An audit-defensible tool maps every question and task back to these — that mapping is the coverage matrix Auditori generates alongside the assessment.

Elements & performance criteria

1 Prepare chromatography equipment for operation

1.1Identify production requirements from workplace documentation
1.2Confirm materials meet production requirements
1.3Confirm required facilities, storage, equipment and personnel are available
1.4Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures
1.5Clean, assemble and adjust equipment according to workplace procedures and operation and maintenance manual
1.6Set equipment components and related instrumentation to meet production requirements
1.7Conduct pre-start checks according to workplace procedures
1.8Complete equipment status reports according to workplace procedures

2 Prepare samples and load products

2.1Conduct pre-sampling tests and interpret test results to confirm process operation
2.2Identify and report out of limit test results according to workplace procedures
2.3Load product and pack into columns according to specifications and production requirements

3 Operate and monitor separation process

3.1Start up and monitor separation process to confirm process cycles occur in correct sequence according to specifications and production requirements
3.2Identify and report out of limit products or processes according to workplace procedures
3.3Confirm separation of solution meets specifications
3.4Conduct process according to safety and environmental requirements
3.5Complete documentation according to workplace requirements

4 Shut down separation process

4.1Confirm isolation and lock out procedures and product and process changeovers for shutting down
4.2Safely shut down process
4.3Clean work area according to workplace procedures
4.4Complete records according to workplace procedures

Performance evidence

accessed workplace information to confirm requirements for the process
selected, fitted and used personal protective equipment and contamination prevention clothing
conducted pre-start checks required for the safe operation of a chromatography separation process, including: - carried out required area or line clearances - inspected equipment condition to identify signs of wear - confirmed all safety equipment in place and operational - confirmed that equipment is clean or sanitised - confirmed that equipment is correctly configured for processing requirements
performed procedures for packing columns and for loading material into columns
started, operated, monitored and adjusted a process to achieve required outcomes
conducted in-process control checks to confirm the process remains within limits
maintained security, integrity and traceability of: - samples - sub-samples - documentation
followed isolation and lock out procedures to take process and related equipment off-line in preparation for cleaning and maintenance according to workplace procedures
performed product and process changeovers, including demonstrating column storage procedures
taken corrective action in response to out-of-specification results
safely shut down the process according to workplace procedures
cleaned and maintained work area to meet workplace cleaning standards and environmental requirement
completed records according to workplace procedures

Knowledge evidence

stages of the chromatography separation process, including: - the purpose, methods and outcomes of each stage - quality characteristics achievable by the separation process - methods of analysis
basic operating principles, requirements and parameters of chromatography equipment, including: - main equipment components, operating capacities and applications - consequences of incorrect equipment preparation, such as incorrectly positioned non-return valve, supply pump failure and air in the column - typical equipment faults and related causes, including signs and symptoms of faulty equipment and early warning signs of potential problems - line clearance cleaning and sanitation procedures - functions and limitations of personal protective equipment and contamination prevention clothing - pre-start check requirements, including: - carrying out required area or line clearances - inspecting equipment condition to identify signs of wear - confirming all safety equipment is in place and operational - confirming that equipment is clean or sanitised - confirming that equipment is correctly configured for processing requirements
sample test methods analysis and interpretation of results
implications and actions taken if results are out-of-specification
procedures used for: - collecting in process samples as specified in documentation appropriate to columns and process requirements - interpreting traces and corrective action where traces are not within specifications
typical profile for a production cycle and events to be monitored during the cycle
common causes of out-of-specification product or process and corrective actions required
procedures and requirements of different shutdowns, including: - an understanding of the requirements for column storage - emergency and routine shutdowns - procedures to follow in the event of power outage
isolation, lock out and tag out procedures and responsibilities
Good Manufacturing Practice (GMP) requirements associated with a separation process and related control measures
requirements for completion of workplace documentation

Foundation skills

Reading: Identify relevant information from workplace documentation and interpret requirements for the chromatography separation process
Writing: Complete workplace documentation using appropriate language and in required format
Numeracy: Interpret specifications for number of cycles and flow meters

Unit content sourced from training.gov.au — © Commonwealth of Australia, licensed under CC BY 4.0. Auditori is not affiliated with the Department of Employment and Workplace Relations.

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Questions about assessing FBPPHM3019

What does an assessment tool for FBPPHM3019 need to cover?

To satisfy the Principles of Assessment and Rules of Evidence, an assessment for FBPPHM3019 needs to address all 47 unit components: 4 elements with 20 performance criteria, 13 performance evidence requirements, 11 knowledge evidence requirements, and the foundation skills. A coverage matrix mapping each question and task to these components is what an auditor looks for.

How does Auditori generate an assessment tool for FBPPHM3019?

Auditori pulls the current release of FBPPHM3019 from training.gov.au and generates a complete package: candidate assessment, assessor guide with model answers and observation criteria, and a coverage matrix mapping every component. A suitably qualified person then reviews and approves the draft in a built-in workflow — consistent with ASQA's guidance on AI use in VET — before export as branded PDF and editable Word.

Is the first assessment tool really free?

Yes. Every new account includes one free credit — enough to generate the complete assessment tool for FBPPHM3019 — with no card and no subscription required. After that it's pay-as-you-go per unit.

Can I check my existing FBPPHM3019 assessment instead of generating a new one?

Yes — upload your existing assessment or learner guide and Auditori maps it against every element, performance criterion, PE and KE of FBPPHM3019, showing exactly what's covered and what's missing. Mapping costs a quarter of a credit.

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