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Evidence Guide: MSL977003A - Contribute to validation of test methods

Student: __________________________________________________

Signature: _________________________________________________

Tips for gathering evidence to demonstrate your skills

The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!

From the Wiki University

 

MSL977003A - Contribute to validation of test methods

What evidence can you provide to prove your understanding of each of the following citeria?

Confirm equipment, including computer systems, has been qualified and validated

  1. Confirm that latest editions of manufacturer's specifications and operating instructions are present
  2. Confirm that equipment is installed according to manufacturer's specifications
  3. Confirm that equipment operating instructions exist and conform to manufacturer's specifications
  4. Confirm that equipment operates according to manufacturer's design specifications
  5. Verify that equipment calibration complies with appropriate standards
  6. Confirm equipment/computer systems are validated
  7. Confirm method has an acceptable level of uncertainty
Confirm that latest editions of manufacturer's specifications and operating instructions are present

Completed
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Confirm that equipment is installed according to manufacturer's specifications

Completed
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Confirm that equipment operating instructions exist and conform to manufacturer's specifications

Completed
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Confirm that equipment operates according to manufacturer's design specifications

Completed
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Verify that equipment calibration complies with appropriate standards

Completed
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Confirm equipment/computer systems are validated

Completed
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Confirm method has an acceptable level of uncertainty

Completed
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Validate test method according to defined protocol

  1. Develop validation test protocol in consultation with appropriate personnel
  2. Ensure protocol is authorised by appropriate personnel
  3. Validate test method according to validation protocol
Develop validation test protocol in consultation with appropriate personnel

Completed
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Ensure protocol is authorised by appropriate personnel

Completed
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Validate test method according to validation protocol

Completed
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Evaluate and record results

  1. Evaluate validation results to confirm suitability of testing method
  2. Obtain approval for evaluation recommendations from appropriate personnel
  3. Record and file validation records
  4. Issue validated method according to enterprise procedures
  5. Evaluate staff training needs and record appropriately
  6. Recommend update of relevant documentation as a result of the validation
Evaluate validation results to confirm suitability of testing method

Completed
Date:

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Evidence:

 

 

 

 

 

 

 

Obtain approval for evaluation recommendations from appropriate personnel

Completed
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Record and file validation records

Completed
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Issue validated method according to enterprise procedures

Completed
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Evaluate staff training needs and record appropriately

Completed
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Recommend update of relevant documentation as a result of the validation

Completed
Date:

Teacher:
Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Evidence Guide

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.

Required Skills and Knowledge

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

Range Statement

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