Elements and Performance Criteria

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.
Codes of practice
Where reference is made to industry codes of practice, and/or Australian/international standards, it is expected the latest version will be used
Standards, codes, procedures and/or enterprise requirements
Standards, codes, procedures and/or enterprise requirements may include:
Australian and international standards, such as:
AS ISO 17025-2005 General requirements for the competence of testing and calibration laboratories
AS/NZS ISO 10005:2006 Quality management systems - Guidelines for quality plans
AS/NZS ISO 10012:2004 Measurement management systems - Requirements for measurement processes and measuring equipment
AS/NZS ISO 9000 Set:2008 Quality management systems set
AS 1199 Sampling procedures and tables for inspection by attributes
BS 5750 Quality systems
Australia New Zealand Food Standards (ANZFS) Code
Australian code of good manufacturing practice for medicinal products (GMP)
customer specific requirements/standards
enterprise and customer product specifications
National Association of Testing Authorities (NATA) Accreditation programs requirements
National Health and Medical Research Council (NHMRC) Guidelines
national measurement regulations and guidelines
principles of good laboratory practice (GLP)
quality manuals and procedures
Therapeutic Goods Regulations 1009
Quality control procedures
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
Methods for statistical analysis
Methods for statistical analysis may include:
means
median
mode
ranges
standard deviations
statistical sampling procedures
Problem solving techniques
Problem solving techniques may include:
identifying inputs and outputs
sequencing a process
identifying and rectifying a problem step
root cause analysis
implementing preventative strategies
Quality improvement tools and techniques
Quality improvement tools and techniques may include:
run charts, control charts, histograms and scattergrams to present routine quality control data
plan, do, check, act (PDCA)
Ishikawa fishbone diagrams and cause and effect diagrams
logic tree
similarity/difference analysis
Pareto charts and analysis
force field/strength weakness opportunities threats (SWOT) analysis
Sustainable energy principles and work practices
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
Communication may involve:
supervisors, managers and quality managers
administrative, laboratory and production personnel
internal/external contractors, customers and suppliers
Reporting
Reporting may include:
verbal responses
data entry into laboratory or enterprise database
brief written reports using enterprise proformas
Quality improvement opportunities
Quality improvement opportunities 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
Occupational health and safety (OHS) and environmental management requirements
OHS and environmental management requirements:
all operations must comply with enterprise OHS and environmental management requirements, which may be imposed through state/territory or federal legislation - these requirements must not be compromised at any time
all operations assume the potentially hazardous nature of samples and require standard precautions to be applied
where relevant, users should access and apply current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health

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

Critical aspects for assessment and evidence required to demonstrate competency in this unit
Assessors should ensure that candidates can:
use the enterprise's quality systems and business goals as a basis for decision making and action
apply all relevant procedures and regulatory requirements to ensure the quality and integrity of the products/services or data provided
apply and promote sustainable energy principles and work practices
detect non-conforming products or services in the work area
follow enterprise procedures for documenting and reporting information about quality
contribute effectively within a team to recognise and recommend improvements in productivity and quality
apply effective problem solving strategies
implement and monitor improved practices and procedures.

Context of and specific resources for assessment
This unit of competency is to be assessed in the workplace or simulated workplace environment.
This unit of competency may be assessed with:
MSL924001A Process and interpret data
MSL954001A Obtain representative samples in accordance with sampling plan
relevant MSL974000 series units of competency
relevant MSL975000 series units of competency.
Resources may include:
enterprise quality manual and procedures
quality control data/records
customer complaints and rectifications
candidate's supervisors and peers.

Method of assessment
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.
Where applicable, reasonable adjustment must be made to work environments and training situations to accommodate ethnicity, age, gender, demographics and disability.
Access must be provided to appropriate learning and/or assessment support when required.
The language, literacy and numeracy demands of assessment should not be greater than those required to undertake the unit of competency in a work like environment.

This competency in practice
Industry representatives have provided the case studies below to illustrate the practical application of this unit of competency and to show its relevance in a workplace setting.
Manufacturing
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.
Environmental
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.
Food processing
A company that produces apple juice uses 30-35% hydrogen peroxide (H2O2) to sterilise packaging. A mist of atomised H2O2 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 H2O2 was a critical sterilisation point where failure could occur. The concentration of H2O2 in the atomiser and in opened containers was unpredictable and several problems were found to contribute to this. H2O2 was left in the atomiser for up to several days between packaging runs. Containers of H2O2 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 H2O2.
The recommendations that emerged from the investigation were that:
fresh H2O2 should be used at the beginning of each packaging run
only one stock container of H2O2 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 H2O2 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.