Application
This unit of competency describes the skills and knowledge to critically assess the accuracy of data and validity of test results prior to formally authorising their release to the client. It involves the statistical analysis of data and information generated during calibration, sampling and testing to determine whether quality and/or process parameters have been achieved. Personnel are required to investigate and, if necessary, rectify results that are not consistent with expected values.
This unit applies to laboratory personnel working in all industry sectors who are approved by their organisation to authorise the results obtained for specific test methods. In many instances, these personnel are known as 'signatories' or 'delegates' for the tests involved. The scope of tests authorised in each case will be determined by the specialised knowledge, technical competence and experience of the personnel involved.
No licensing or certification requirements exist at the time of publication. However, regulations and/or external accreditation requirements for laboratory operations exist, so local requirements should be checked. Relevant legislation, industry standards and codes of practice within Australia must also be applied.
Elements and Performance Criteria
Elements describe the essential outcomes. | Performance criteria describe the performance needed to demonstrate achievement of the element. | ||
1 | Verify the accuracy of data and technical records | 1.1 | Access relevant job instructions, data and technical records in laboratory information management system (LIMS) |
1.2 | Confirm that technical records provide sufficient information to ensure traceability for the tests involved | ||
1.3 | Compare data with expected values and identify any outliers | ||
1.4 | Inspect data records to check the integrity of data entry, alterations, transfers and calculations | ||
1.5 | Correct and initial any incorrect data records | ||
1.6 | Sign off data records as correct | ||
2 | Determine if results are acceptable and within expectation | 2.1 | Compare results with expected values and identify any significant differences |
2.2 | Check the reliability of results by examining data, statistical analysis of data and results from repeat tests or duplicate samples | ||
2.3 | Assess the significance of any documented observations of atypical test conditions or environment and/or sample appearance | ||
2.4 | Check that all calculations are free from error | ||
2.5 | Check that estimates of uncertainty are reasonable and consistent with the test method, client and/or product specification requirements | ||
2.6 | Authorise the issue of results that meet the organisation's quality standards and are consistent with expectations | ||
3 | Investigate unexpected or unacceptable results | 3.1 | Examine records of pre-use checks and calibration performance to ensure that the equipment and/or instruments used meet test specifications and workplace requirements |
3.2 | Establish whether human and/or environmental factors could have affected the reliability of results | ||
3.3 | Check for obvious sources of interferences that may have occurred during measurements | ||
3.4 | Retrieve stored samples (if available) and assess whether they are atypical or contaminated | ||
3.5 | Perform control tests using the same, or new, samples to check unexpected results | ||
3.6 | Authorise the issue of unexpected results that meet the organisation's quality standards | ||
3.7 | Identify possible root causes of unacceptable results and appropriate preventative/corrective actions | ||
3.8 | Report investigation outcomes and recommendations for improvements in accordance with workplace procedures | ||
4 | Liaise with clients about results | 4.1 | Establish whether sampling procedures used by the client could contribute to unexpected/unacceptable results |
4.2 | Arrange for new samples and/or re-testing as necessary | ||
4.3 | Explain investigation outcomes and confidence level for unexpected test results | ||
Foundation Skills
This section describes those language, literacy, numeracy and employment skills that are essential to performance.
Oral communication skills to recommend appropriate preventative/corrective actions to control potential/actual non-conforming work
Numeracy skills to:
use statistical tests to estimate uncertainties and determine data acceptability
recognise unexpected or unacceptable data and results and then
rectifying results that are not consistent with expected values
Problem-solving skills to use effective strategies to investigate unexpected occurrences in a logical and efficient manner.
Foundation skills essential to performance are explicit in the performance criteria of this unit of competency.
Competency Field
Quality