Application
This unit of competency describes the skills and knowledge to validate test methods following defined protocols to ensure that they are based on sound scientific principles and are fit for the purpose for which they are to be used.
This unit applies to senior technical officers, laboratory supervisors and technical specialists working in all industry sectors. All operations are performed in accordance with laboratory and/or workplace procedures. Validation includes all those procedures which ascertain a method's technical soundness, performance and suitability for its intended use. Validation is a documented program which provides a high degree of assurance that a specific testing method will consistently produce a reliable result. The nature of the testing method may be physical, chemical, microbiological or a combination of these. The quality of the test method is built in during its design stage, validated in its development stage, and confirmed in its 'use' stage.
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 | Confirm equipment has been qualified and validated | 1.1 | Confirm that latest editions of manufacturer specifications and operating instructions are present |
1.2 | Confirm that equipment, including computer systems, is installed according to manufacturer specifications | ||
1.3 | Confirm that equipment operating instructions exist and conform to manufacturer specifications | ||
1.4 | Confirm that equipment operates according to manufacturer design specifications | ||
1.5 | Verify that equipment calibration complies with appropriate standards | ||
1.6 | Confirm equipment and computer systems are validated | ||
1.7 | Confirm method has an acceptable level of uncertainty | ||
2 | Validate test method according to defined protocol | 2.1 | Develop validation test protocol in consultation with appropriate personnel |
2.2 | Seek authorisation from protocol from appropriate personnel | ||
2.3 | Validate test method according to validation protocol | ||
3 | Evaluate and record results | 3.1 | Evaluate validation results to confirm suitability of testing method |
3.2 | Obtain approval for evaluation recommendations from appropriate personnel | ||
3.3 | Record and file validation records | ||
3.4 | Issue validated method according to workplace procedures | ||
3.5 | Evaluate staff training needs and document appropriately | ||
3.6 | Recommend update of relevant documentation as a result of the validation | ||
Foundation Skills
This section describes those language, literacy, numeracy and employment skills that are essential to performance.
Learning skills to conduct literature searches on background chemistry/physics/biology/immunology of materials to be evaluated, including likely impurities and degradation products
Numeracy skills to:
optimise and calibrate equipment to manufacturer specifications
perform required calculations using appropriate equations, units, uncertainties and precision
use relevant mathematical and statistical techniques to analyse results
present large amounts of data, validation results and recommendations in appropriate formats for review and authorisation
Foundation skills essential to performance are explicit in the performance criteria of this unit of competency.
Competency Field
Testing