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.
This unit of competency describes the work conducted by technical specialists who validate analytical methods as part of their job.
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.
Test methods requiring validation include new recognised standard test methods and existing test methods which have been modified or new enterprise test methods.
Validation protocols include those checks which should be considered to ensure performance characteristics of test method are scientifically sound. Examples of checks include selectivity, linearity, range, sensitivity, limit of detection, limit of quantitation, accuracy, precision, recovery, ruggedness and robustness. Validation may also include an assessment of the clarity and completeness of the description of the method.
All operations are performed in accordance with laboratory and/or enterprise procedures.

These procedures include or have been prepared from
Australian and international standards, such as-
'Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of Analysis', Fourth (Final) Draft; J. of Anal. Chem., Vol 72, No 4, 694-704
United States Pharmacopoeia: General information (1225), Validation of Compendial Methods
ICH Q2 A&B Int. Conf. Harmonisation Guidelines for Method Validation
NATA guidelines on validation
Codes of Practice (such as GLP and GMP)
National Measurement Act
material safety data sheets (MSDSs)
standard operating procedures (SOPs)
enterprise recording and reporting procedures
equipment manuals
equipment startup, operation and shutdown procedures
calibration and maintenance schedules
quality manuals
production and laboratory schedules
material, production and product specifications.

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. Candidates must be able to validate test methods as fit for purpose following a validation protocol established in consultation with appropriate personnel.

In particular, the assessor should look to see that the candidate:

conducts literature searches on background chemistry/physics/biology/immunology of materials to be evaluated, including likely impurities and degradation products
starts up, set up/optimise, calibrate and operate equipment to manufacturer's specifications
prepares test samples and standards for validation
carries out validation tests as per validation protocol
applies theoretical knowledge and appropriate statistics to interpret validation data and reach correct conclusions
records results and communicates recommendations as per enterprise procedures
arranges large amounts of data into logical format so other technical personnel can review and reach the same valid conclusions
follows OHS and environmental management procedures and GLP.

Underpinning knowledge

Competency includes the ability to apply and explain:

principles, concepts and enterprise/regulatory requirements related to method validation
traceability -, including legal requirements for traceability
detailed knowledge of principles and procedures of testing equipment operation
characteristics, capabilities and limitations of equipment
variables which should be validated and criteria for choice
mathematical/statistical evaluation of results and present data and results in appropriate formats
enterprise/regulatory requirement regarding validation and reporting
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:

completion of validation brief or validation proficiency test
review of workplace validation briefs completed by candidate
feedback from supervisors and/or clients
oral or written questioning to assess underpinning knowledge of equipment operation, methods and procedures, and problem solving techniques.
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:

PMLTEST700B Contribute to the development of products and applications
PMLTEST703B Develop or adapt analyses and procedures
PMLTEST701B Troubleshoot equipment and production processes.

Resource implications

Resources may include:

standard laboratory equipped with appropriate equipment, reagents, samples and test methods
validation protocol.

This competency in practice
A technical specialist was developing a method for testing samples taken while monitoring a workplace for glutaraldehyde, a toxic chemical. The samples were collected in air monitoring cassettes and on glass fibre filters impregnated with 2,4-dinitrophenylhydrazine. The filters were desorbed with acetonitrile and the DNPH derivative analysed by high-performance liquid chromatography (HPLC) at 365nm. The new method was validated by checking and documenting factors, such as selectivity, linearity, range, limit of detection, accuracy, precision, recovery and ruggedness. Although this involved considerable work, the specialist was confident that the testing method would deliver reliable results after completing the validation.
A number of pituitary hormone assays are to be converted from radioimmunoassay (RIA) to enzyme linked immunosorbent assay (ELISA). Both configurations of assays are available in kit form but the laboratory manager would like the new procedures validated. The task has been given to a senior technical officer. The project involves comparison of the average and variance of results obtained for a number of quality control sera. The variance and precision of the signal output (counts per minute for RIA, absorbance for ELISA) are examined as well as sensitivity estimates for both assays. All investigations are documented and reported in the laboratory notes for accreditation audit purposes.

A food research laboratory uses the following instrumental techniques:

ultraviolet-visible spectrometer for colour analysis
high performance liquid chromatography for food preservative analysis
inductively coupled plasma-atomic emission spectrometry and flame atomic absorption analysis for metal contaminant analysis.
Each of the above methods is validated to assure that it is are based on sound scientific principles and will deliver results appropriate to requirements. Factors, such as accuracy, linearity, range, limit of detection, precision, recovery, ruggedness and selectivity are evaluated and documented. This investigation provides confidence that methods are used within their limits of detection, are linear and selective over the required range, and deliver suitable accuracy and precision. The investigation is documented, as per enterprise requirements, and provides detailed reference for accreditation, audit and future laboratory use.

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
(3)

Collecting analysing and organising information
(3)

Planning and organising activities
(3)

Working with others and in teams
(3)

Using mathematical ideas and techniques
(3)

Solving problems
(3)

Using technology
(3)