Elements and Performance Criteria

The range of variables relates to the unit of competency as a whole. It allows for different work environments and situations that will affect performance.
Where reference is made to industry Codes of Practice, and/or Australian/international standards, it is expected the latest version will be used.
This unit of competency describes the work conducted by technical specialists who develop or adapt analyses and procedures to meet enterprise needs. This work may involve developing new testing methods or adapting existing methods to satisfy a testing need.
All operations must comply with relevant standards, appropriate procedures and/or enterprise requirements.

When developing new methods of analyses, the following information sources may be used
Australian and international standards, such as -
local or international enterprise sites
equipment manufacturer's specified methods
appropriate journals and Internet sites
National Measurement Act
Codes of Practice (such as GLP and GMP)
material safety data sheets (MSDSs)
standard operating procedures (SOPs)
equipment manuals
equipment startup, operation and shutdown procedures
calibration and maintenance schedules
quality manuals
enterprise recording and reporting procedures
production and laboratory schedules
material, production and product specifications.

New methods of analysis and related procedures may be required to
analyse raw materials
quality control or evaluate the stability of products
quality control or evaluate the stability of new formulations of existing products
use new technology
meet regulatory requirements
meet customer requirements
improve productivity
improve accuracy and precision.

Analyses could include
non-instrumental methods, such as gravimetric, titrimetric and qualitative tests
spectrometric methods, such as UV/visible, IR (including FTIR), NIR, AA, fluorescence
chromatographic methods, such as thin layer, paper, GC, HPLC, ion chromatography and electrophoresis
electrochemical methods, such as ion selective electrodes and polarography
assays based on biological properties or cell properties for enzyme antibody activity.
Procedures are directions for conducting analyses, either in hard copy or online format.

Concepts relating to method development include
determining and defining development objectives
relating chemical and physical characteristic of sample to possible assay methods
evaluating criteria to choose appropriate analytical method
sample cleanup and preparation techniques
preparation, setup and calibration of testing equipment
choice of appropriate detection system ensuring accuracy/precision criteria are achieved
optimisation of analysis conditions
generating, recording and reporting data in format which assists procedure writing.

Criteria for choice of method may also include
economic factors
safety considerations
resource factors, including equipment and personnel
regulatory, accreditation and registration considerations.

Health, safety and environment
All operations to which this unit applies are subject to stringent health, safety and environmental (HSE) 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.
All operations assume the potentially hazardous nature of samples and require standard precautions to be applied. Users should access and apply current industry understanding of infection control issued by the National Health and Medical Research Council and State and Territory Departments of Health. All operations are performed in accordance with standard operating procedures.

The Evidence Guide describes the underpinning knowledge and skills that must be demonstrated to prove competence.
Critical aspects of competency

Competency must be demonstrated in the ability to perform consistently at the required standard. Candidates must be able to develop or adapt analyses and procedures to meet requirements. In particular, the assessor should look to see that the candidate:

interprets a brief to determine testing requirements
applies theoretical concepts and practical principles to develop or adapt methods to meet requirements
evaluates existing testing procedures against new testing requirements
uses appropriate procedures to research alternative methods
makes recommendations for modification of existing procedures or development of new procedures based on sound principles
follows enterprise procedures to document and circulate new procedures.

Underpinning knowledge

Competency includes the ability to apply and explain:

detailed knowledge of theoretical and practical basis of test/analysis
principles and practices of operation of a range of testing equipment
characteristics, capabilities and limitations of equipment
relative advantages/disadvantages of different analytical methods
theoretical procedures for method development
method validation requirements
enterprise and regulatory testing requirements
relevant health, safety and environment requirements.

Assessment context and methods
This unit of competency is to be assessed in the workplace or simulated workplace environment.

The following assessment methods are suggested:

review of development or adaptation of methods completed by candidate
review of workplace development briefs completed by candidate
feedback from supervisors and/or clients
oral or written questioning to assess underpinning knowledge of analyses, instrument operation, procedures and problem solving techniques.

Interdependent assessment of unit

This unit of competency may be assessed with:

PMLTEST700B Contribute to the development of products and applications
PMLTEST701B Troubleshoot equipment and production processes
PMLTEST702B Contribute to validation of test methods.

Resource implications

Resources may include:

standard laboratory equipped with appropriate equipment, reagents, samples and test methods
online data search facilities.

This competency in practice
Technical specialists often have to apply their practical and theoretical knowledge of laboratory instrumentation to adapt or develop methods to solve specific problems. For example, a technical specialist in a consulting laboratory was asked to determine why heat-sealing bags were not sealing properly. Using infrared spectroscopy, the specialist ran spectra on several samples and noticed a difference in the coating on the bags which didn't seal compared with the coating on bags which sealed correctly. The spectra indicated that the coatings were different polymers. The technical specialist notified the supplier of the sealing problem and new bags were forwarded. To ensure that the problem didn't occur again, an infrared spectroscopy test method was developed to ensure that the correct polymer coating was on the new bags. As a result, production flowed smoothly when bags were delivered to the production line.
A laboratory manager determined that there is sufficient demand for a particular enzyme activity assay. Currently, this assay is performed manually by kinetic assay using a spectrometer. A senior technical officer has been given the task of converting the method to one that can be run on an automated biochemical analyser. The method will be translated to instructions regarding wavelength, absorbance increase or decrease, time of reading and intervals of the readings, sequence of addition of the reagents and sample, ratio of the volumes (they will be reduced in the automated procedure) and incubation conditions.
The water activity of food is affected by temperature. The measurement of water activity takes considerable time, due in part to the time required for the sample to reach the specified test temperature in the instrument. A technician suggested that the test time could be reduced if the samples were presented to the instrument at the test temperature, rather than room temperature. She/he also raised concerns about water loss which could occur while raising the sample to test temperature. The technician planned an investigation and ran tests using standard Greenspan salts to compare results from normal testing with testing using pre-warm samples. Pre-warm samples held for 30 minutes in a pre-warm cabinet gave different results from the normal test method samples. However, samples held for 15 minutes in the pre-warm cabinet did not. A test method was subsequently introduced with samples being held for a maximum of 10 minutes in a pre-warm cabinet prior to being loaded into the water activity instrument. This gave excellent statistical correlation with the normal method and provided increased throughput of samples.

The seven key competencies represent generic skills considered for effective work participation. The bracketed numbering against each of the key competencies indicates the performance level required in this unit. These are stand-alone levels and do not correspond to levels in the Australian Qualifications Framework (AQF).
Level (1) represents the competence to undertake tasks effectively
Level (2) represents the competence to manage tasks
Level (3) represents the competence to use concepts for evaluating and reshaping tasks.
Communicating ideas and information
(3)

Collecting analysing and organising information
(3)

Planning and organising activities
(3)

Working with others and in teams
(3)

Using mathematical ideas and techniques
(3)

Solving problems
(3)

Using technology
(3)