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Evidence Guide: FDFPH2011A - Operate a granulation process

Student: __________________________________________________

Signature: _________________________________________________

Tips for gathering evidence to demonstrate your skills

The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!

From the Wiki University

 

FDFPH2011A - Operate a granulation process

What evidence can you provide to prove your understanding of each of the following citeria?

Prepare the granulation process for operation

  1. Materials are confirmed and available to meet operating requirements
  2. Cleaning and maintenance requirements and status are identified and confirmed
  3. Machine components and related attachments are fitted and adjusted to meet operating requirements
  4. Processing/operating parameters are entered as required to meet safety and production requirements
  5. Equipment performance is checked and adjusted as required
  6. Pre-start checks are carried out as required by workplace requirements
Materials are confirmed and available to meet operating requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Cleaning and maintenance requirements and status are identified and confirmed

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Machine components and related attachments are fitted and adjusted to meet operating requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Processing/operating parameters are entered as required to meet safety and production requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Equipment performance is checked and adjusted as required

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Pre-start checks are carried out as required by workplace requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Operate and monitor the granulation process

  1. The granulation process is started up and operated according to workplace specifications
  2. Equipment is monitored to identify variation in operating conditions
  3. Variation in equipment operation is identified and maintenance requirements are reported according to workplace reporting requirements
  4. The process is monitored to confirm that granulated product meets specifications
  5. Out-of-specification product/process outcomes are identified, rectified and/or reported to maintain the process within specification
  6. The work area is maintained according to housekeeping standards
  7. Work is conducted according to environmental standards
  8. Spillages are reported and removed according to standard operating procedures (SOPs)
  9. Workplace records are maintained according to workplace recording requirements
The granulation process is started up and operated according to workplace specifications

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Equipment is monitored to identify variation in operating conditions

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Variation in equipment operation is identified and maintenance requirements are reported according to workplace reporting requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

The process is monitored to confirm that granulated product meets specifications

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Out-of-specification product/process outcomes are identified, rectified and/or reported to maintain the process within specification

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

The work area is maintained according to housekeeping standards

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Work is conducted according to environmental standards

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Spillages are reported and removed according to standard operating procedures (SOPs)

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Workplace records are maintained according to workplace recording requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Shut down the granulation process

  1. End-of-batch procedures are completed in accordance with batch instructions and SOPs
  2. The process is shut down according to workplace procedures
  3. Maintenance requirements are identified and reported according to workplace reporting requirements
End-of-batch procedures are completed in accordance with batch instructions and SOPs

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

The process is shut down according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintenance requirements are identified and reported according to workplace reporting requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Evidence Guide

The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package.

Overview of assessment

Assessment must be carried out in a manner that recognises the cultural and literacy requirements of the assessee and is appropriate to the work performed. Competence in this unit must be achieved in accordance with food safety standards and regulations.

Critical aspects for assessment and evidence required to demonstrate competency in this unit

Evidence of ability to:

conduct pre-start checks on equipment used for granulation

start, operate, monitor and adjust process equipment to achieve required quality outcomes

take corrective action in response to typical faults and inconsistencies

complete workplace records as required

apply safe work practices and identify OHS hazards and controls

safely shut down equipment

apply food safety procedures to work practices.

Context of and specific resources for assessment

Assessment must occur in a real or simulated workplace where assessee has access to:

personal protective clothing and equipment

work procedures, including advice on safe work practices, GMP, SOPs and environmental requirements

information on equipment capacity and operating parameters

production schedule, batch instructions

specifications, control points and processing parameters

granulation process and related equipment and services

materials required for the granulation process

sampling schedules and test procedures and equipment as required

documentation and recording requirements and procedures

cleaning procedures, materials and equipment as required.

Method of assessment

This unit should be assessed together with core units and other units of competency relevant to the function or work role. Examples could be:

FDFOP2003A Clean equipment in place

FDFOP2004A Clean and sanitise equipment

FDFOP2011A Conduct routine maintenance

FDFOP2013A Apply sampling procedures

FDFOP2030A Operate a process control interface

MSL973001A Perform basic tests.

Guidance information for assessment

To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities.

Required Skills and Knowledge

Required skills

Ability to:

access workplace information to identify production requirements for the granulation process

select, fit and use personal protective clothing and/or equipment

confirm supply of necessary materials and services

conduct pre-start checks, such as inspecting equipment condition to identify any signs of wear, selecting appropriate settings and/or related parameters, cancelling isolation or lock outs as required, confirming line clearance and cleaning status, ensuring equipment is correctly configured for processing requirements, positioning sensors and controls correctly, ensuring any scheduled maintenance has been carried out, and confirming that all safety guards are in place and operational

verify raw materials with batch instructions

start, operate, monitor and adjust granulation process equipment to achieve required outcomes, including interpreting and implementing batch instructions, labelling product, calculating yield, monitoring control points and conducting inspections as required to confirm process remains within specification, such as:

granule size

moisture content

take corrective action in response to out-of-specification results

monitor supply and flow of materials to and from the granulation process

respond to and/or report equipment failure within level of responsibility

locate emergency stop functions on equipment

follow isolation and lock out/tag out procedures as required to take granulation process and related equipment off-line in preparation for cleaning and/or maintenance within level of responsibility

demonstrate batch/product changeovers

follow end-of-batch procedures including line clearance and cleaning, yield calculation, materials reconciliation and product labelling

complete workplace records as required

maintain work area to meet housekeeping standards

use process control systems according to enterprise procedures

collect samples and conduct tests according to enterprise procedures

conduct routine maintenance according to enterprise procedures

use oral communication skills/language competence to fulfil the job role as specified by the organisation, including questioning, active listening, asking for clarification and seeking advice from supervisor

work cooperatively within a culturally diverse workforce

Required knowledge

Knowledge of:

purpose and basic principles of the granulation process

basic operating principles of equipment, such as main equipment components, status and purpose of guards, equipment operating capacities and applications, and the purpose and location of sensors and related feedback instrumentation

services required and action to take if services are not available

types of raw materials used in the granulation process and related handling/segregation requirements, such as handling hazardous goods

stages and changes which occur during granulation

quality characteristics and legal requirements to be achieved by the granulation process

the flow of the granulation process and the effect of outputs on downstream pharmaceutical processes

operating requirements and parameters and corrective action required where operation is outside specified operating parameters

typical equipment faults and related causes, including signs and symptoms of faulty equipment and early warning signs of potential problems

methods used to monitor the granulation process, such as inspecting, measuring and testing as required by the process

inspection or test points (control points) in the granulation process and the related procedures and recording requirements

Good Manufacturing Practice (GMP) requirements associated with the granulation process and related control measures

common causes of variation and corrective action required

product/process changeover procedures and responsibilities

occupational health and safety (OHS) hazards and controls, including the limitations of protective clothing and equipment relevant to the work process

end-of-batch procedures, including procedures for calculating yield, materials reconciliation and action required if yield/reconciliation is not within prescribed limits, and product labelling responsibilities and procedures

requirements of different shutdowns as appropriate to the granulation process and workplace production requirements, including emergency and routine shutdowns and procedures to follow in the event of a power outage

line clearance, cleaning and sanitation procedures

isolation, lock out and tag out procedures and responsibilities

procedures and responsibility for reporting production and performance information

environmental issues and controls relevant to the granulation process, including waste collection and handling procedures related to the process

basic operating principles of process control, where relevant, including the relationship between control panels and systems and the physical equipment

sampling and testing associated with process monitoring and control where relevant

routine maintenance procedures where relevant

Range Statement

The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.

Policies and procedures

Work is carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements, and industrial awards and agreements

Legislative requirements

Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes:

relevant Good Manufacturing Practice (GMP) codes

the Therapeutic Goods Act and/or other relevant legislation

legislation covering environmental management, OHS, anti-discrimination and equal opportunity

Workplace information

Workplace information may include:

SOPs

specifications

production schedules and instructions

manufacturers' advice

standard forms and reports

Granulation

Granulation may be:

a dry or wet process or a combination

Granulation equipment

Granulation equipment may include:

granulators

mixers

blenders

dryers

oscillators

mills

sieves

Stock

Stock for the granulation process is supplied from the dispensing process and from bulk containers

Service

Services may include:

deionised/purified water

Work

Work may include:

exposure to dangerous and hazardous substances

Operation of equipment and processes

Operation of equipment and processes may require:

the use of process control panels and systems

Shutdown procedures

Shutdown procedures may include:

cleaning (in some cases cleaning may be carried out by a dedicated cleaning crew)

Services

Services may need to be confirmed. These depend on the nature of the process. Typical examples include:

power

steam

water

compressed and instrumentation air