Assessor Resource

MSL977003A
Contribute to validation of test methods

Assessment tool

Version 1.0
Issue Date: March 2024


This unit of competency is applicable to senior technical officers, laboratory supervisors and technical specialists working in all industry sectors. All operations are performed in accordance with laboratory and/or enterprise 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.

Industry representatives have provided case studies to illustrate the practical application of this unit of competency and to show its relevance in a workplace setting. These can be found at the end of this unit of competency under the section 'This competency in practice'.

This unit of competency covers the ability 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.

You may want to include more information here about the target group and the purpose of the assessments (eg formative, summative, recognition)

Prerequisites

MSL976003A

Evaluate and select appropriate test methods and/or procedures


Employability Skills

This unit contains employability skills.




Evidence Required

List the assessment methods to be used and the context and resources required for assessment. Copy and paste the relevant sections from the evidence guide below and then re-write these in plain English.

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:

validate test methods as fit for purpose following a validation protocol established in consultation with appropriate personnel

conduct literature searches on background chemistry/physics/biology/immunology of materials to be evaluated, including likely impurities and degradation products

start up, set up/optimise, calibrate and operate equipment to manufacturer's specifications

prepare test samples and standards for validation

carry out validation tests according tothe validation protocol

apply theoretical knowledge and appropriate statistics to interpret validation data and reach correct conclusions

record results and communicate recommendations according to enterprise procedures

arrange large amounts of data into logical format so other technical personnel can review and reach the same valid conclusions

follow OHS and environmental management procedures and principles of GLP.

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:

MSL977001A Contribute to the development of products and applications

MSL977002A Troubleshoot equipment and production processes

MSL977004A Develop or adapt analyses and procedures

MSL925002A Analyse measurements and estimate uncertainties.

Resources may include:

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

validation protocol.

Method of assessment

The following assessment methods are suggested:

completion of validation brief or validation proficiency test

review of workplace validation briefs completed by the 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.

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 its relevance in a workplace setting.

Manufacturing

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 highperformance 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.

Biomedical

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.

Food processing

A food research laboratory uses the following instrumental techniques:

ultraviolet-visible (UV-VIS) spectrometer for colour analysis

HPLC 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 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, according to enterprise requirements, and provides detailed reference for accreditation, audit and future laboratory use.


Submission Requirements

List each assessment task's title, type (eg project, observation/demonstration, essay, assingnment, checklist) and due date here

Assessment task 1: [title]      Due date:

(add new lines for each of the assessment tasks)


Assessment Tasks

Copy and paste from the following data to produce each assessment task. Write these in plain English and spell out how, when and where the task is to be carried out, under what conditions, and what resources are needed. Include guidelines about how well the candidate has to perform a task for it to be judged satisfactory.

Required skills

Required skills include:

validating test methods as fit for purpose following a validation protocol established in consultation with appropriate personnel

conducting literature searches on background chemistry/physics/biology/immunology of materials to be evaluated, including likely impurities and degradation products

starting up, setting up/optimising, calibrating and operating equipment to manufacturer's specifications

preparing test samples and standards for validation

carrying out validation tests according tothe validation protocol

applying theoretical knowledge and appropriate statistics to interpret validation data and reach correct conclusions

recording results and communicating recommendations according to enterprise procedures

arranging large amounts of data into logical format so other technical personnel can review and reach the same valid conclusions

followingoccupational health and safety (OHS) and environmental management procedures and principles of good laboratory practice (GLP)

Required knowledge

Required knowledge includes:

principles, concepts and enterprise/regulatory requirements related to method validation

traceability, including legal requirements for traceability

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

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 10013-2003 Guidelines for quality management system documentation

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 14000 Set:2005 Environmental management standards set

AS/NZS ISO 9000 Set:2008 Quality management systems set

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

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

ICH Q2A: Validation of Analytical Procedures - Guideline for industry

United States Pharmacopoeia (USB) General chapter - Validation of Compendial Methods (1225)

OHS national standards and codes of practice

principles of good laboratory practice (GLP)

Australia New Zealand Food Standards (ANZFS) Code

Australian code of Good Manufacturing Practice for medicinal products (GMP)

Australian Dangerous Goods Code

Australian Quarantine and Inspection Service (AQIS) Export Control (Orders) Regulations 1982 and Import Guidelines

gene technology regulations

maintenance and confidentiality of records

National Association of Testing Authorities (NATA) Accreditation programs requirements

national environment protection measures

National Health and Medical Research Council (NHMRC) Guidelines

national measurement regulations and guidelines

Therapeutic Goods Regulations 1009

Test methods requiring validation

Test methods requiring validation may include:

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 and copyright

provision of unbiased, accurate and appropriately qualified information results

Validation protocols include:

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

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

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

Copy and paste from the following performance criteria to create an observation checklist for each task. When you have finished writing your assessment tool every one of these must have been addressed, preferably several times in a variety of contexts. To ensure this occurs download the assessment matrix for the unit; enter each assessment task as a column header and place check marks against each performance criteria that task addresses.

Observation Checklist

Tasks to be observed according to workplace/college/TAFE policy and procedures, relevant legislation and Codes of Practice Yes No Comments/feedback
Confirm that latest editions of manufacturer's specifications and operating instructions are present 
Confirm that equipment is installed according to manufacturer's specifications 
Confirm that equipment operating instructions exist and conform to manufacturer's specifications 
Confirm that equipment operates according to manufacturer's design specifications 
Verify that equipment calibration complies with appropriate standards 
Confirm equipment/computer systems are validated 
Confirm method has an acceptable level of uncertainty 
Develop validation test protocol in consultation with appropriate personnel 
Ensure protocol is authorised by appropriate personnel 
Validate test method according to validation protocol 
Evaluate validation results to confirm suitability of testing method 
Obtain approval for evaluation recommendations from appropriate personnel 
Record and file validation records 
Issue validated method according to enterprise procedures 
Evaluate staff training needs and record appropriately 
Recommend update of relevant documentation as a result of the validation 

Forms

Assessment Cover Sheet

MSL977003A - Contribute to validation of test methods
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Assessment Record Sheet

MSL977003A - Contribute to validation of test methods

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