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Evidence Guide: MSL935003 - Authorise the issue of test results

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

 

MSL935003 - Authorise the issue of test results

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

Verify the accuracy of data and technical records

  1. Access relevant job instructions, data and technical records in laboratory information management system (LIMS)
  2. Confirm that technical records provide sufficient information to ensure traceability for the tests involved
  3. Compare data with expected values and identify any outliers
  4. Inspect data records to check the integrity of data entry, alterations, transfers and calculations
  5. Correct and initial any incorrect data records
  6. Sign off data records as correct
Access relevant job instructions, data and technical records in laboratory information management system (LIMS)

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Confirm that technical records provide sufficient information to ensure traceability for the tests involved

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Compare data with expected values and identify any outliers

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Inspect data records to check the integrity of data entry, alterations, transfers and calculations

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Correct and initial any incorrect data records

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Sign off data records as correct

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Determine if results are acceptable and within expectation

  1. Compare results with expected values and identify any significant differences
  2. Check the reliability of results by examining data, statistical analysis of data and results from repeat tests or duplicate samples
  3. Assess the significance of any documented observations of atypical test conditions or environment and/or sample appearance
  4. Check that all calculations are free from error
  5. Check that estimates of uncertainty are reasonable and consistent with the test method, client and/or product specification requirements
  6. Authorise the issue of results that meet the organisation's quality standards and are consistent with expectations
Compare results with expected values and identify any significant differences

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check the reliability of results by examining data, statistical analysis of data and results from repeat tests or duplicate samples

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assess the significance of any documented observations of atypical test conditions or environment and/or sample appearance

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check that all calculations are free from error

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check that estimates of uncertainty are reasonable and consistent with the test method, client and/or product specification requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Authorise the issue of results that meet the organisation's quality standards and are consistent with expectations

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Investigate unexpected or unacceptable results

  1. Examine records of pre-use checks and calibration performance to ensure that the equipment and/or instruments used meet test specifications and workplace requirements
  2. Establish whether human and/or environmental factors could have affected the reliability of results
  3. Check for obvious sources of interferences that may have occurred during measurements
  4. Retrieve stored samples (if available) and assess whether they are atypical or contaminated
  5. Perform control tests using the same, or new, samples to check unexpected results
  6. Authorise the issue of unexpected results that meet the organisation's quality standards
  7. Identify possible root causes of unacceptable results and appropriate preventative/corrective actions
  8. Report investigation outcomes and recommendations for improvements in accordance with workplace procedures
Examine records of pre-use checks and calibration performance to ensure that the equipment and/or instruments used meet test specifications and workplace requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Establish whether human and/or environmental factors could have affected the reliability of results

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check for obvious sources of interferences that may have occurred during measurements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Retrieve stored samples (if available) and assess whether they are atypical or contaminated

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Perform control tests using the same, or new, samples to check unexpected results

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Authorise the issue of unexpected results that meet the organisation's quality standards

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify possible root causes of unacceptable results and appropriate preventative/corrective actions

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Report investigation outcomes and recommendations for improvements in accordance with workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Liaise with clients about results

  1. Establish whether sampling procedures used by the client could contribute to unexpected/unacceptable results
  2. Arrange for new samples and/or re-testing as necessary
  3. Explain investigation outcomes and confidence level for unexpected test results
Establish whether sampling procedures used by the client could contribute to unexpected/unacceptable results

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Arrange for new samples and/or re-testing as necessary

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Explain investigation outcomes and confidence level for unexpected test results

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Evidence Guide

Elements describe the essential outcomes.

Performance criteria describe the performance needed to demonstrate achievement of the element.

1

Verify the accuracy of data and technical records

1.1

Access relevant job instructions, data and technical records in laboratory information management system (LIMS)

1.2

Confirm that technical records provide sufficient information to ensure traceability for the tests involved

1.3

Compare data with expected values and identify any outliers

1.4

Inspect data records to check the integrity of data entry, alterations, transfers and calculations

1.5

Correct and initial any incorrect data records

1.6

Sign off data records as correct

2

Determine if results are acceptable and within expectation

2.1

Compare results with expected values and identify any significant differences

2.2

Check the reliability of results by examining data, statistical analysis of data and results from repeat tests or duplicate samples

2.3

Assess the significance of any documented observations of atypical test conditions or environment and/or sample appearance

2.4

Check that all calculations are free from error

2.5

Check that estimates of uncertainty are reasonable and consistent with the test method, client and/or product specification requirements

2.6

Authorise the issue of results that meet the organisation's quality standards and are consistent with expectations

3

Investigate unexpected or unacceptable results

3.1

Examine records of pre-use checks and calibration performance to ensure that the equipment and/or instruments used meet test specifications and workplace requirements

3.2

Establish whether human and/or environmental factors could have affected the reliability of results

3.3

Check for obvious sources of interferences that may have occurred during measurements

3.4

Retrieve stored samples (if available) and assess whether they are atypical or contaminated

3.5

Perform control tests using the same, or new, samples to check unexpected results

3.6

Authorise the issue of unexpected results that meet the organisation's quality standards

3.7

Identify possible root causes of unacceptable results and appropriate preventative/corrective actions

3.8

Report investigation outcomes and recommendations for improvements in accordance with workplace procedures

4

Liaise with clients about results

4.1

Establish whether sampling procedures used by the client could contribute to unexpected/unacceptable results

4.2

Arrange for new samples and/or re-testing as necessary

4.3

Explain investigation outcomes and confidence level for unexpected test results

Required Skills and Knowledge

Elements describe the essential outcomes.

Performance criteria describe the performance needed to demonstrate achievement of the element.

1

Verify the accuracy of data and technical records

1.1

Access relevant job instructions, data and technical records in laboratory information management system (LIMS)

1.2

Confirm that technical records provide sufficient information to ensure traceability for the tests involved

1.3

Compare data with expected values and identify any outliers

1.4

Inspect data records to check the integrity of data entry, alterations, transfers and calculations

1.5

Correct and initial any incorrect data records

1.6

Sign off data records as correct

2

Determine if results are acceptable and within expectation

2.1

Compare results with expected values and identify any significant differences

2.2

Check the reliability of results by examining data, statistical analysis of data and results from repeat tests or duplicate samples

2.3

Assess the significance of any documented observations of atypical test conditions or environment and/or sample appearance

2.4

Check that all calculations are free from error

2.5

Check that estimates of uncertainty are reasonable and consistent with the test method, client and/or product specification requirements

2.6

Authorise the issue of results that meet the organisation's quality standards and are consistent with expectations

3

Investigate unexpected or unacceptable results

3.1

Examine records of pre-use checks and calibration performance to ensure that the equipment and/or instruments used meet test specifications and workplace requirements

3.2

Establish whether human and/or environmental factors could have affected the reliability of results

3.3

Check for obvious sources of interferences that may have occurred during measurements

3.4

Retrieve stored samples (if available) and assess whether they are atypical or contaminated

3.5

Perform control tests using the same, or new, samples to check unexpected results

3.6

Authorise the issue of unexpected results that meet the organisation's quality standards

3.7

Identify possible root causes of unacceptable results and appropriate preventative/corrective actions

3.8

Report investigation outcomes and recommendations for improvements in accordance with workplace procedures

4

Liaise with clients about results

4.1

Establish whether sampling procedures used by the client could contribute to unexpected/unacceptable results

4.2

Arrange for new samples and/or re-testing as necessary

4.3

Explain investigation outcomes and confidence level for unexpected test results

Evidence of competence in this unit must satisfy all of the requirements of the elements and performance criteria, and include demonstration of:

verifying the accuracy and completeness of at least one (1) set of data, results and technical records for specified tests

issuing at least one (1) set of specified test results in accordance with authorisation and workplace procedures

reviewing at least one (1) set of records of sampling, sample preparation, testing and/or calibration activities to identify potential causes of unacceptable data/results

using statistical tests to estimate uncertainties and determine data acceptability

recognising unexpected or unacceptable data and results and then investigating the occurrence in a logical and efficient manner using effective problem-solving strategies

rectifying results that are not consistent with expected values

recommending appropriate preventative/corrective actions to control potential/actual non-conforming work

explaining technical details of sampling, test methods and results to clients

maintaining a professional approach and positive company/organisation image, including maintaining independence and an ability to resist improper influences.

Must provide evidence that demonstrates knowledge of:

workplace procedures for authorising the issue of specified test results

relevant reporting requirements, such as the ISO Guide to the Expression of Uncertainty in Measurement, National Association of Testing Authorities (NATA) and/or test methods

the confidence level required according to the National Measurement Act 1960 (e.g. 95% for most applications, but it may be higher)

scientific and technical knowledge of the samples, procedures, equipment, materials and instrumentation used to generate the specified test results and data

at least three (3) statistical tests used to estimate uncertainties and determine data acceptability

expected values for data and results and the uncertainty components for specified test methods

common sources of interference, human and environmental factors, sample preparation problems and relevant preventative/corrective actions associated with specified test results

confidentiality requirements relevant to job role

work health and safety (WHS) and environmental management requirements relevant to job role.

Range Statement

This field allows for different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.

Standards, codes, procedures and/or workplace requirements

Standards, codes, procedures and/or workplace requirements include the latest version of one or more of:

Australian and international standards covering the requirements for the competence of testing and calibration laboratories, quality management systems and plans, measurement management, accuracy of measurement methods and results, expression of uncertainty of measurement (GUM), quantifying uncertainty in analytical measurement, and sampling and testing methods

National Association of Testing Authorities (NATA) accreditation program requirements and any supplementary requirements for the relevant field of testing, NATA technical notes, policy circulars and guidelines

national measurement regulations and guidelines

specific codes, regulations guidelines, procedures and methods, such as Australia New Zealand Food Standards (ANZFS) Code, Australian code of good manufacturing practice for medicinal products (GMP), principles of good laboratory practice (GLP), National Health and Medical Research Council (NHMRC) Guidelines, and Therapeutic Goods Regulations

workplace documents, such as standard operating procedures (SOPs); quality and equipment manuals; calibration and maintenance schedules; material safety data sheets (MSDS) and safety procedures; material, production and product specifications; production and laboratory schedules; workplace recording and reporting procedures; waste minimisation and safe disposal procedures; inspection test plans and sampling plans for sites

customer-specific requirements/standards and customer quality plan

Technical records

Technical records include, but are not limited to, one or more of:

request forms, service agreements and contracts, clients notes, papers and feedback

worksheets, work books, check sheets and work notes, original observations, derived data and calculations, and control graphs

external and internal test reports, and calibration certificates

listing of data and the personnel responsible for sampling, performance of each test/calibration and checking of results

Statistical tests

Statistical tests include, but are not limited to, one or more of:

standard deviation, standard deviation of the mean, histograms and frequency plots

probability and normal probability plots

run charts and control charts, such as Shewhart and CuSum

regression methods for calibration, linearity checks and comparing analytical methods

analysis of variance (ANOVA)

data acceptability tests, such as T and F

Estimates of uncertainty

Estimates of uncertainty include, but are not limited to, one or more of:

calibration uncertainty

instability or drift in the calibrated instrument

repeatability of the results

resolution or readability of the instrument

environmental influences, such as temperature, air pressure, humidity, vibration, electrical noise and gravity

reference material uncertainty

factors arising from using an instrument under a different operating environment or procedures (e.g. orientation of a transducer and immersion depth of a temperature probe)

reproducibility of quality control data

Human and environmental factors

Human and environmental factors include, but are not limited to, one or more of:

technician preparing the sample and/or performing the test did not apply the test method correctly

inadequate attention to detail, fatigue and stress

inadequate hygiene and sterility

unacceptable dust, humidity, temperature and illumination levels

electromagnetic disturbances

variations to gas, electricity and water supply

unacceptable sound and vibration levels

Sources of interference

Sources of interference include, but are not limited to, one or more of:

spectral interference

physical interference

matrix effects

presence of contaminants

masking of analytes

Sample collection and preparation problems

Sample collection and preparation problems include, but are not limited to, one or more of:

use of incorrect sample containers

incorrect sample handling, storage or conditioning (filtered/non-filtered, temperature control and preservation), sample disturbance and sample segregation

incomplete sample preparation

incorrect particle size

incorrect matrix

incomplete digest

Preventative/corrective actions

Preventative/corrective actions include, but are not limited to, one or more of:

regular use of certified reference materials

internal quality controls using secondary reference materials

participation in inter-laboratory comparison or proficiency testing programs

replicate tests or calibrations using the same or different methods

re-testing or recalibration of retained items

correlation of results for different characteristics of an item

additional audits and management reviews

regular quality checks on consumables

increased staff observation, supervision and/or training

more detailed sample specifications, test methods and procedures

WHS and environmental management requirements

WHS and environmental management requirements include:

· complying with WHS and environmental management requirements at all times, which may be imposed through state/territory or federal legislation. These requirements must not be compromised at any time

· applying standard precautions relating to the potentially hazardous nature of samples

accessing and applying current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health, where relevant