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.

Required skills

Required skills include:

verifying the accuracy and completeness of data, results and technical records

recognising significant trends in data and/or aberrant results

using statistical tests to estimate uncertainties and determine data acceptability

analysing sampling, sample preparation testing and/or calibration activities to identify potential causes of unacceptable data/results

applying effective problem solving strategies

recommending appropriate preventative/corrective actions to control potential/actual non-conforming work

following enterprise procedures for documenting and reporting information about quality

Required knowledge

Required knowledge includes:

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 and data acceptability) and sampling procedures

problem solving techniques androot cause analysis

enterprise and/or legal traceability requirements

relevant health, safety and environment requirements

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