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 is relevant to experienced technical officers who may work individually or as part of a team.

Quality manuals and procedures may be based on standards, such as
ISO 9001, 9002 and 9003 series Quality management and assurance standards
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
NATA requirements of signatories
Good laboratory practice (GLP), good manufacturing practice (GMP), the British Standard BS 5750 and the OECD Principles of good laboratory practice
enterprise and customer product specifications
AS1199 Sampling procedures and tables for inspection by attributes
AS1399 Guide to AS1199.

Quality control procedures may include
standards imposed by regulatory and licensing bodies
enterprise quality procedures
working to a customer brief or batch card and associated quality procedures
checklists to monitor job progress against agreed time, costs and quality standards
preparation of sampling plans
the use of hold points to evaluate conformance
the use of inspection and test plans to check compliance.

Sustainable energy principles and work practices may include
examining work practices that use excessive electricity
switching off equipment when not in use
regularly cleaning filters
insulating rooms and buildings to reduce energy use
recycling and reusing materials wherever practicable
minimising process waste.

Communication may involve
supervisors, managers and quality managers
administrative, laboratory and production personnel
internal/external contractors, customers and suppliers.

Reporting may involve
verbal responses
data entry into laboratory or enterprise database
brief written reports using enterprise proformas.

Quality improvement opportunities that directly relate to the work of technical assistants and officers could include improved
production processes
hygiene and sanitation procedures
reductions in waste and re-work
laboratory layout and work flow
safety procedures
communication with customers
methods for sampling, testing and recording data.

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 potential 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. In particular, assessors should look to see that the candidate:

applies all relevant procedures and regulatory requirements to ensure the quality and integrity of the products/services or data they provide
applies and promotes sustainable energy principles and work practices
detects non-conforming products or services in the work area
follows enterprise procedures for documenting and reporting information about quality
contributes effectively within a team to recognise and recommend improvements in productivity and quality
applies effective problem solving strategies
implements and monitors improved practices and procedures.

Underpinning knowledge

Competency includes the ability to apply and explain:

specifications for laboratory products and services in the candidate's work area
quality requirements associated with the individual's job function and/or work area
scientific and technical knowledge underpinning the processes, procedures, equipment and instrumentation associated with the candidate's work tasks and duties
workplace procedures associated with the candidate's regular technical duties
methods for statistical analysis (means, median, mode, ranges, standard deviations) and statistical sampling procedures
sustainable energy principles
problem solving techniques, such as-
identifying inputs and outputs
sequencing a process
identifying and rectifying a problem step
root cause analysis
implementing preventative strategies
relevant health, safety and environment requirements.

The candidate should also demonstrate the ability to select and apply quality improvement tools and techniques, for example:

run charts, control charts, histograms and scattergrams to present routine QC data
PDCA (plan, do, check, act)
Ishikawa fishbone diagrams, cause and effect diagrams
logic tree
similarity/difference analysis
Pareto charts and analysis
force field/SWOT analysis.

Knowledge is also required of the:

layout of the enterprise, divisions and laboratory
organisational structure of the enterprise
lines of communication
role of laboratory services to the enterprise and customers.
An appreciation of the link between the enterprise's quality systems and business goals is required as a basis for decision making and action.

Specific industry

Additional knowledge requirements may apply for different industry sectors. For example, in the biomedical sector:

ethical requirements dealing with patient confidentiality
regulations pertaining to trapping, tagging and handling of animals (Code 64)
guidelines for pre-transfusion testing
OGTR Guidelines for large scale, small scale and planned release of genetically-manipulated organisms (Office of the Gene Technology Regulator).

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 documentation completed by the candidate as part of regular quality control
feedback from supervisors and/or customers regarding quality of products/services and/or data regularly provided by the candidate
observation of the candidate's performance and participation in quality improvement teams over time in the workplace
review of reports from quality improvement teams where the candidate's role is clearly outlined and verified
verified reports of improvements suggested and implemented by the candidate individually.
Those aspects of competency dealing with improvement processes could be assessed by the use of suitable simulations and/or a pilot plant and/or a range of case studies and scenarios.
In all cases, practical assessment should be supported by questions to assess essential knowledge and those aspects of competency which are difficult to assess directly. Questioning techniques should suit the language and literacy levels of the candidate.

Interdependent assessment of unit

This unit of competency may be assessed with:

PMLSAMP400B, PMLTEST400 and PMLTEST500 series units.

Resource implications

Resources may include:

enterprise quality manual and procedures
quality control data/records
customer complaints and rectifications
candidate's supervisors and peers.

This competency in practice
A quality improvement team at a chemical manufacturing plant was asked to propose a way of minimising the cost of disposing of chromium rich waste. Using appropriate techniques, the team narrowed the alternatives down to the option of burning the waste stream. An experienced technician agreed that this was feasible, but suggested that because the waste was petroleum high in chromium the team should consider the environmental implications. Subsequent research indicated that the permitted chromium levels in the incinerated air waste stream would not exceed 10 ppm, which was less than the air emission standards for the plant. The technician analysed samples of the air waste stream and determined that the chromium levels were below the regulatory standards. He/she then supported the team's suggestion.
The manager of an environmental testing laboratory believed that the team of laboratory technicians relied too much on external direction. As a result, the manager requested that whenever technicians asked for assistance they should also be ready to suggest a solution to the problem if at all possible. This strategy was implemented in a non-threatening manner and was accepted by the team. In time, the manager noted that many of the suggestions for solving problems and improving work practices that came from the team were effective and reasonable. Their skill in making realistic recommendations came from their familiarity with many of the issues that needed to be considered. It became the norm that the laboratory technicians were given public credit for suggesting successful strategies that improved safety, productivity and staff morale.
A company that produces apple juice uses 30-35% hydrogen peroxide (H 2O 2) to sterilise packaging. A mist of atomised H 2O 2 is sprayed into pre-formed cartons and later removed with a jet of hot sterile air. The laboratory manager was concerned that some batches of product were not sterile after standing at room temperature for several days. The cause of the failure in the sterilisation procedure was not apparent and a technical officer was asked to investigate this problem.
The technical officer examined each unit operation of juice manufacture and determined that the application of H 2O 2 was a critical sterilisation point where failure could occur. The concentration of H 2O 2 in the atomiser and in opened containers was unpredictable and several problems were found to contribute to this. H 2O 2 was left in the atomiser for up to several days between packaging runs. Containers of H 2O 2 were not always used sequentially, some being opened and then not used for a long time. The containers were stored at room temperature after opening and some may have become contaminated with atmospheric particulates that catalyse the breakdown of H 2O 2.

The recommendations that emerged from the investigation were that:

fresh H 2O 2 should be used at the beginning of each packaging run
only one stock container of H 2O 2 should be open at any one time and stored chilled, with residuals discarded after 14 days
care should be taken to exclude foreign material from the opened vessels of H 2O 2 and the atomiser.
In summary, the intolerance of the company to even low incidences of faulty product and the competency of the technical officer to investigate the processing stream resulted in increased product quality without significant cost.

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 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
(2)

Collecting analysing and organising information
(2)

Planning and organising activities
(2)

Working with others and in teams
(2)

Using mathematical ideas and techniques
(2)

Solving problems
(2)

Using technology
(2)