Assessment Requirements for MSL977005 Validate test methods

Release: 1

Assessment Requirements for MSL977005 Validate test methods

Modification History

Release	Comments
Release 1	This version was released in MSL Laboratory Operations Training Package Release 2.0. Supersedes and equivalent to MSL977003 Contribute to validation of test methods. Range of conditions removed. Assessment requirements amended.

Performance Evidence

There must be evidence the candidate has completed the tasks outlined in the elements and performance criteria of this unit, and:

validated at least 2 test methods using authorised protocols to ensure they are based on sound scientific principles and are fit for purpose.

Knowledge Evidence

There must be evidence the candidate has knowledge of:

principles, concepts and workplace/regulatory requirements related to method validation and reporting

calculation steps, mathematical and statistical techniques used to analyse results

principles and procedures of testing equipment operation

characteristics, capabilities and limitations of equipment

variables which should be validated and criteria for choice

purposes of validation:

identification and impartial resolution of ethical issues, such as conflict of interest

ethical decision making

provision of products and services which match the operational and financial needs of stakeholders, including realistic quotes for work

accurate representation of skills, services, knowledge and qualifications of individuals and the organisation

acknowledgment of services and products developed by others, intellectual property (IP) and copyright

provision of unbiased, accurate and appropriately qualified information results

validation protocols:

checks that are considered to ensure performance characteristics of test method are scientifically sound

checks, including:

selectivity

linearity

range

sensitivity

limit of detection

limit of quantitation

accuracy

precision

recovery

ruggedness

assessment of the clarity and completeness of the description of the method

workplace and/or legal traceability requirements

awareness of environmental sustainability issues as they relate to the work task

legal, ethical and work health and safety (WHS) requirements specific to the work task.

Assessment Conditions

Skills must have been demonstrated in the workplace or in a simulated environment that reflects workplace conditions and contingencies. The following conditions must be met for this unit:

use of suitable facilities, equipment and resources, including:

a standard laboratory equipped with appropriate equipment, instruments, reagents, samples and test methods

validation protocols.

Assessors must satisfy the NVR/AQTF mandatory competency requirements for assessors.

Links

Training Package Companion Volumes - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=5c63a03b-4a6b-4ae5-9560-1e3c5f462baa