NTISthis.com

Evidence Guide: PMAOPS390B - Operate a biochemical 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

 

PMAOPS390B - Operate a biochemical process

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

Prepare for work.

  1. Identify work requirements
  2. Identify and control hazards
  3. Coordinate with appropriate personnel
Identify work requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify and control hazards

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Coordinate with appropriate personnel

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Monitor and control the biochemical processes.

  1. Get information relevant to the operation of the biochemical process
  2. Identify changes in key variables
  3. Keep conditions within the optimum range
  4. Check performance of ancillaries such as agitation and heat exchange
  5. Recognise and interpret trends in bioreactor data/appearance
  6. Recognise the signs of potential and actual problems
  7. Identify the consequences to the bioreactor processes of the identified changes, trends and problems
  8. Take appropriate action to minimise the impact on safety, health, the environment and the business of potential and actual problems.
Get information relevant to the operation of the biochemical process

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify changes in key variables

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Keep conditions within the optimum range

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check performance of ancillaries such as agitation and heat exchange

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Recognise and interpret trends in bioreactor data/appearance

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Recognise the signs of potential and actual problems

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify the consequences to the bioreactor processes of the identified changes, trends and problems

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Take appropriate action to minimise the impact on safety, health, the environment and the business of potential and actual problems.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Ramp output up/down.

  1. Predict from rates and schedule when a change will be required
  2. Give advanced notice of change to work team
  3. Prepare plant for the change
  4. Predict the required amount of adjustment to cause the required change
  5. Make the change in a controlled manner without excessive variation
  6. Monitor the progress of the change and make minor adjustments as required.
Predict from rates and schedule when a change will be required

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Give advanced notice of change to work team

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare plant for the change

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Predict the required amount of adjustment to cause the required change

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Make the change in a controlled manner without excessive variation

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Monitor the progress of the change and make minor adjustments as required.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintain effectiveness of bioreactor system.

  1. Frequently and critically monitor bioreactor system throughout shift
  2. Use measured/indicated data and smell, sight, sound and feel as appropriate
  3. Identify critical equipment and processes
  4. Identify issues likely to impact on the whole plant performance and take appropriate action
  5. Predict impact of a change in the bioreactor system on other plant units/areas and communicate this to relevant people
  6. Predict impact of a change in the processing plant on the bioreactor
  7. Take appropriate action
Frequently and critically monitor bioreactor system throughout shift

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Use measured/indicated data and smell, sight, sound and feel as appropriate

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify critical equipment and processes

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify issues likely to impact on the whole plant performance and take appropriate action

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Predict impact of a change in the bioreactor system on other plant units/areas and communicate this to relevant people

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Predict impact of a change in the processing plant on the bioreactor

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Take appropriate action

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Shut down reaction systems.

  1. Determine type of shut down required
  2. Give advance warning of shut down where possible
  3. Change over individual items of equipment
  4. Shut down individual items of equipment and the entire bioreactor system
  5. Shut down to a stand-by condition if required
  6. Shut down for maintenance when required.
  7. Shut down in an emergency when required
Determine type of shut down required

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Give advance warning of shut down where possible

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Change over individual items of equipment

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Shut down individual items of equipment and the entire bioreactor system

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Shut down to a stand-by condition if required

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Shut down for maintenance when required.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Shut down in an emergency when required

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean reactors/vessels.

  1. Identify cleaning requirements
  2. Clean to requirements according to procedures
  3. Retain micro-organisms contained in the plant and prepare for reuse as appropriate
  4. Dispose of waste materials according to procedures.
Identify cleaning requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean to requirements according to procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Retain micro-organisms contained in the plant and prepare for reuse as appropriate

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Dispose of waste materials according to procedures.

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Isolate and de-isolate plant.

  1. Isolate plant
  2. Make safe for required work
  3. Check plant is ready to be returned to service
  4. Prepare plant for return to service.
Isolate plant

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Make safe for required work

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check plant is ready to be returned to service

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Prepare plant for return to service.

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, the Range Statement and the Assessment Guidelines for the Training Package.

Overview of assessment

Assessment of this unit should include demonstrated competence on actual plant and equipment in a work environment. The unit will be assessed in as holistic a manner as is practical and may be integrated with the assessment of other relevant units of competency. Assessment will occur over a range of situations which will include disruptions to normal, smooth operation.

Simulation may be required to allow for assessment of parts of this unit. Simulation should be based on the actual plant and will include walk-throughs of the relevant competency components. Simulations may also include the use of case studies/scenarios and role plays.

This unit of competency requires a significant body of knowledge which will be assessed through questioning and the use of what-if scenarios both on the plant (during demonstration of normal operations and walk-throughs of abnormal operations) and off the plant.

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

Competence must be demonstrated in the ability to recognise and analyse potential situations requiring action and then in implementing appropriate corrective action. The emphasis should be on the ability to stay out of trouble rather than on recovery from a disaster.

Consistent performance should be demonstrated. In particular look to see that:

early warning signs of equipment/processes needing attention or with potential problems are recognised

the range of possible causes can be identified and analysed and the most likely cause determined

appropriate action is taken to ensure a timely return to full performance

obvious problems in related plant areas are recognised and an appropriate contribution made to their solution.

These aspects may be best assessed using a range of scenarios/case studies/what-ifs as the stimulus with a walk-through forming part of the response. These assessment activities should include a range of problems, including new, unusual and improbable situations which may have been generated from the past incident history of the plant, incidents on similar plants around the world, hazard analysis activities and similar sources.

Context of and specific resources for assessment

Assessment will require access to an operating plant over an extended period of time, or a suitable method of gathering evidence of operating ability over a range of situations. A bank of scenarios/case studies/what-ifs will be required as will a bank of questions which will be used to probe the reasoning behind the observable actions.

Method of assessment

In all plants it may be appropriate to assess this unit concurrently with relevant teamwork and communication units.

Guidance information for assessment

Assessment processes and techniques must be culturally appropriate and appropriate to the oracy, language and literacy capacity of the assessee and the work being performed.

Required Skills and Knowledge

This describes the essential skills and knowledge and their level, required for this unit.

Required skills

efficient and effective operation of plant/equipment

hazard analysis

completing plant records

communication

problem solving

Required knowledge

Competence includes an understanding of the bioreactor system and its integral equipment to the level needed to control the system and recognise and resolve problems. In particular it includes the ability to:

identify all items on a schematic of the bioreactor system and describe the function of each

describe the nature/condition of materials entering and leaving each stage of the process, the changes which have occurred in that stage and why they have occurred

state the biochemical changes which are occurring in each stage and the methods of controlling them

describe methods of ramping up/down in to change output and the advantages and disadvantages of each.

Required knowledge also includes:

principles of operation of plant/equipment

physics, chemistry, biochemistry and microbiology relevant to the process unit and the materials processed

process parameters and limits, eg temperature, pressure, flow, pH

duty of care obligations

hierarchy of control

communication protocols, eg radio, phone, computer, paper, permissions/authorities

routine problems, faults and their resolution

relevant alarms and actions

plant process idiosyncrasies

correct methods of starting, stopping, operating and controlling process

corrective action appropriate to the problem cause

function and troubleshooting of major components and their problems

types and causes of problems within operator's scope of skill level and responsibility.

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. Add any essential operating conditions that may be present with training and assessment depending on the work situation, needs if the candidate, accessibility of the item, and local industry and regional contexts.

Codes of practice/ standards

Where reference is made to industry codes of practice, and/or Australian/international standards, the latest version must be used.

Context

This unit of competency includes all such items of equipment and unit operations which form part of the bioreactor system. For your plant this may include (select relevant items):

pumps (feed and dosing pumps)

utilities and services such as air

agitators

air/gas supply/removal

temperature control equipment such as heaters, coolers, heat exchangers

other equipment integral to the operation of the bioreactor system.

Typical problems

Typical problems for your plant may include:

sudden changes in feed (rate, composition, concentration)

changes in required production rate

changes in ambient conditions, eg summer to winter operation

handling a plant shutdown without allowing the micro-organisms to die

control of degree of agitation

settling/removal/recycling of micro-organisms.

feed variations

instrument failure/wrong reading

electrical failure

mechanical failure

operational problem.

Key variable

Key variables include:

feed

desired output

temperature

agitation

aeration (if appropriate)

microorganism/enzyme

Appropriate action

Appropriate action includes:

determining problems needing action

determining possible fault causes

rectifying problem using appropriate solution within area of responsibility

following through items initiated until final resolution has occurred

reporting problems outside area of responsibility to designated person.

Procedures

Procedures may be written, verbal, computer-based or in some other form. They include:

all work instructions

standard operating procedures

formulas/recipes

batch sheets

temporary instructions

any similar instructions provided for the smooth running of the plant.

For the purposes of this Training Package, 'procedures' also includes good operating practice as may be defined by industry codes of practice (eg Responsible Care) and government regulations.

Health, safety and environment (HSE)

All operations to which this unit applies are subject to stringent health, safety and environment requirements, which may be imposed through State or Federal legislation, and these must not be compromised at any time. Where there is an apparent conflict between Performance Criteria and HSE requirements, the HSE requirements take precedence.