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.
All operations must comply with relevant standards, appropriate procedures and/or enterprise requirements.

These procedures include or may have been prepared from
Australian and international standards, such as -
AS ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
ISO 5725-11, 6 Accuracy (trueness and precision) of measurement methods and results
ISO 9000-1 Quality management and quality assurance standards Part 1 - Guidelines for selection and use
ISO 9004-1 Quality management and quality system elements Part 1 - Guidelines
ISO 9004-4 Quality management and quality system elements Part 4 - Guidelines for quality improvement
ISO 10012 Quality assurance requirements measurement equipment
guide to the expression of uncertainty in measurement, issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAC, IUPAP, OIML
industry/sector specific guides, such as Eurachem/CITAC Guide on 'Quantifying Uncertainty in Analytical Measuement'
Codes of Practice (such as GLP and GMP)
material safety data sheets (MSDSs)
standard operating procedures (SOPs) and published preparation methods
quality manuals, equipment and procedures manuals
equipment startup, operation and shutdown
enterprise recording and reporting procedures
production and laboratory schedules.

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, contracts
worksheets, work books, check sheets, work notes
original observations, derived data, 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, checking of results.

Charts, tables and statistical tests could include
run charts, control charts
histograms, frequency plots, stem and leaf plots, boxplots, scatter plots
probability, normal probability plots
Pareto diagrams, Stewhart control charts, CuSum control charts
regression methods for calibration, linearity checks, comparing analytical methods
analysis of variance (ANOVA)
data acceptability tests, such as Q, T and Youden.

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 could include
spectral interference (for example, in ICP)
physical interference (for example, in AAS)
matrix effects
presence of contaminants
masking of analytes.

Human and environmental factors could include
lack of operator competence and/or training
inadequate attention to detail, fatigue, stress
inadequate hygiene, sterility
unacceptable dust, humidity, temperature, illumination levels
electromagnetic disturbances
variations to gas, electricity and water supply
unacceptable sound and vibration levels.

Sample preparation problems could result from
incomplete preparation
segregation
sample disturbance
incorrect sample containers
incorrect sample handling (filtered/non filtered, temperature control, preservation)
incorrect particle size
incorrect matrix
incomplete digest.

Preventative/corrective actions could include
regular use of certified reference materials
internal quality controls using secondary reference materials
participation in interlaboratory 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, 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.

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

verifies the accuracy and completeness of data, results and technical records
recognises significant trends in data and/or aberrant results
uses statistical tests to estimate uncertainties and determine data acceptability
analyses sampling, sample preparation testing and/or calibration activities to identify potential causes of unacceptable data/results
applies effective problem solving strategies
recommends appropriate preventative/corrective actions to control potential/actual non conforming work
follows enterprise procedures for documenting and reporting information about quality.

Underpinning knowledge

Competency includes the ability to apply and explain:

characteristic properties of the materials in question
specifications for samples, tests and/or calibration activities under investigation
scientific and technical knowledge of the procedures, equipment, materials and instrumentation used to generate the test results and data
methods for statistical analysis of data (means, ranges, standard deviations, confidence limits, data acceptability) and sampling procedures
problem solving techniques, cause analysis
enterprise and/or legal traceability 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 verified records and reports generated by 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, 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. Questioning techniques should suit the language and literacy levels of the candidate.

Interdependent assessment of unit

This unit of competency may be assessed with:

PMLDATA500B Analyse data and report results
relevant PMLTEST400 or PMLTEST 500 series units of competency.

Resource implications

Resources may include:

data files and technical records, laboratory information management system
appropriate software
enterprise quality manual and procedures
access to samples, sampling equipment, test equipment/instruments/materials.

This competency in practice
A calibration technician/specialist has completed testing an instrument and places it with the test report on the completed work quality inspection bench. The laboratory quality inspector (who may be the laboratory supervisor) physically examines the item to ensure all accessories have been applied. The inspector checks the test report for validity and correctness and ensures any abnormalities or departures from normal or specified conditions are reported appropriately. Data transfers and calculations are confirmed for accuracy in accordance with standard operating procedures, industry guidelines and the laboratory's accreditation requirements. The inspection also includes ensuring all relevant databases are updated a nd client confidentiality is maintained. Finalisation of the inspection includes signing the certificates and reports. Upon successful inspection, the item is forwarded to another area for subsequent administration and dispatch to the client.
The person conducting final quality assurance activities is responsible to ensure 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 work sheets 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 quality of work produced by outsourced subcontractors.
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 3 seconds using standard methods. The measurements are stored in data loggers and downloaded to the laboratory's computer every 24 hrs. Using a standard software package, the laboratory technician generates 1 hr and 24 hr averages for each site. They then graph the results over a one year period and uses the appropriate Australian Air Quality Standard to determine exceedances for the 1 hr and 24 hr 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.

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
(2)

Collecting analysing and organising information
(3)

Planning and organising activities
(2)

Working with others and in teams
(2)

Using mathematical ideas and techniques
(3)

Solving problems
(3)

Using technology
(2)