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 1000-1998 The international system of units (SI) and its application
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/NZS ISO 9001:2008 Quality management systems - Requirements
ISO 5725 Accuracy (trueness and precision) of measurement methods and results
ISO/IEC Guide 98-3:2008 Uncertainty of measurement - Part 3 Guide to the expression of uncertainty in measurement (GUM)
Eurachem/CITAC Guide CG4 Quantifying uncertainty in analytical measurement
national measurement regulations and guidelines
Australian code of good manufacturing practice for medicinal products (GMP)
enterprise recording and reporting procedures
equipment startup, operation and shutdown procedures
material safety data sheets (MSDS)
National Association of Testing Authorities (NATA) Accreditation programs requirements
principles of good laboratory practice (GLP)
production and laboratory schedules
quality manuals, equipment and procedures manuals
standard operating procedures (SOPs) and published preparation methods
Technical records
Technical records consist of data and information generated during sampling, testing and/or calibrations which indicate whether quality or process parameters have been achieved. They may include:
request forms, service agreements and contracts
worksheets, work books, check sheets and work notes
original observations, derived data and calculations
control graphs
external, internal test reports and calibration certificates
clients notes, papers and feedback
listing of data and the personnel responsible for sampling, performance of each test/calibration and checking of results
Charts, tables and statistical tests
Charts, tables and statistical tests may include:
run charts and control charts
histograms, frequency plots, stem and leaf plots, boxplots and scatter plots
probability and normal probability plots
Pareto diagrams, Stewhart control charts and CuSum control charts
regression methods for calibration, linearity checks and comparing analytical methods
analysis of variance (ANOVA)
data acceptability tests, such as Q, T and Youden
Instrument calibration/ performance records
Instrument calibration/performance records may include:
checks that equipment/instrument complies with specifications
dates, results and copies of reports and certificates of calibrations, adjustments, acceptance criteria and due date of next calibration
maintenance plan, maintenance carried out to date
damage, malfunction, modification or repairs
Sources of interferences
Sources of interferences may include:
spectral interference (e.g. in inductively coupled plasma)
physical interference (e.g. in atomic absorption spectroscopy)
matrix effects
presence of contaminants
masking of analytes
Human and environmental factors
Human and environmental factors may include:
lack of operator competence and/or training
inadequate attention to detail, fatigue and stress
inadequate hygiene and sterility
unacceptable dust, humidity, temperature and illumination levels
electromagnetic disturbances
variations to gas, electricity and water supply
unacceptable sound and vibration levels
Sample preparation problems
Sample preparation problems could result from:
incomplete preparation
segregation
sample disturbance
incorrect sample containers
incorrect sample handling (filtered/non-filtered, temperature control and preservation)
incorrect particle size
incorrect matrix
incomplete digest
Preventative/corrective actions
Preventative/corrective actions could include:
regular use of certified reference materials
internal quality controls using secondary reference materials
participation in inter-laboratory comparison or proficiency testing programs
replicate tests or calibrations using the same or different methods
retesting or recalibration of retained items
correlation of results for different characteristics of an item
additional audits and management reviews
regular quality checks on consumables
enhanced staff observation, supervision and/or training
more detailed sample specifications, test methods and procedures
feedback from clients on improving quality system, testing and calibration activities
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:
verify the accuracy and completeness of data, results and technical records
recognise significant trends in data and/or aberrant results
use statistical tests to estimate uncertainties and determine data acceptability
analyse sampling, sample preparation testing and/or calibration activities to identify potential causes of unacceptable data/results
apply effective problem solving strategies
recommend appropriate preventative/corrective actions to control potential/actual non-conforming work
follow enterprise procedures for documenting and reporting information about quality.

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:
MSL925001A Analyse data and report results
relevant MSL974000 series units of competency
relevant MSL975000 series units of competency.
Resources may include:
data files and technical records, and laboratory information management system (LIMS)
appropriate software
enterprise quality manual and procedures
access to samples, sampling equipment and test equipment/instruments/materials.

Method of assessment
The following assessment methods are suggested:
review of verified records and reports generated by the candidate
feedback from supervisors and peers about the candidate's ability to monitor the quality of test results and data
questioning to assess understanding of trends in data, sources of uncertainty, and preventative/corrective actions.
In all cases, practical assessment should be supported by questions to assess underpinning 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 their relevance in a workplace setting.
Manufacturing
The person conducting final quality assurance activities is responsible for ensuring that the results of each calibration or test carried out by the laboratory are reported accurately, unambiguously, clearly and objectively in accordance with specific instructions in the test or calibration method. Test reports and calibration certificates are checked for mistakes, including the correct transfer of data from original worksheets and to ensure all relevant information is documented and is the result of valid measurements. Quality inspectors are also ultimately responsible to their clients for the quality of work produced by outsourced subcontractors.
Environmental
A laboratory regularly collects carbon monoxide (CO) data as part of an air monitoring program. The laboratory operates several remote air sampling sites that take CO samples every three seconds using standard methods. The measurements are stored in data loggers and downloaded to the laboratory's computer every 24 hours. Using a standard software package, the laboratory technician generates 1 hour and 24 hour averages for each site. They then graph the results over a one year period and use the appropriate Australian Air Quality Standard to determine exceedances for the 1 hour and 24 hour averages. To ensure that any exceedances are genuine, the technician carefully checks factors, such as equipment calibration procedures, seasonal variations in data, artefacts, equipment downtime and maintenance of monitoring equipment over the past year. The verified data and exceedances are reported and compared with previous years' exceedances to determine long term trends in air quality at the sampling sites.