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Quality Assurance and Quality Control,
Uncertainty of Measurement,
and
Introducing ASPAC’s Inter-Laboratory
Proficiency Programmes (ILPP’s)
Roger Hill
Brisbane
17 October, 2019
Our Company
New Zealand’s largest privately
owned testing laboratory
• Started 1984 by Roger and
Anne Hill
• Three market sectors serviced
 Agriculture (30%)
 Environmental (50%)
 Food & Bio-analytical (20%)
• Now employ 430 staff
• 100% owned by staff working
there
Quality Assurance, Quality
Control and Laboratory
Accreditation
Quality Definitions
• The Quality Management System (QMS) is
the over-arching system that a laboratory (or
other business) puts in place.
• Quality Assurance (QA) is the planned and
systematic implementation of that QMS.
• Quality Control (QC) checks the lab methods
are performing as expected.
Quality Management System
• The QMS is usually documented in the
Laboratory Quality Manual
• Includes having documentation and processes
for:
- Staff training and management
- Clear documentation and document control
- Regular calibration and maintenance of all equipment
- Procedures for handling non-conforming work
- Regularly scheduled audits
- Use of QC checks with every batch of samples
- Having a formal Quality Policy statement
Quality Assurance
• This is the implementation of the QMS as
described in the Quality Manual.
• QA is in effect the umbrella under which QC
sits.
• “All staff have an important role to play in
the successful adoption of Quality
Assurance.”
What is Laboratory Accreditation?
• Laboratory accreditation provides an assurance to
customers that the laboratory has good quality
management systems in place.
• International Organisation for Standardisation (ISO) is
the most widely recognised entity for laboratory
accreditation.
• ISO publish Guides against which organisations are
audited. If compliant, accreditation will be granted.
• ISO/IEC Guide 17025: “General requirements for the
competence of testing and calibration laboratories”.
Quality Control at
Hill Laboratories
Quality Control
• QC is applied to the specific tests performed by the
laboratory, on an ongoing basis.
• QC tools used in agricultural testing at Hill
Laboratories are:
– Run blanks
– In-house QC samples
– Replicate analyses
– Certified Reference Materials (CRM’s)
– Inter-laboratory Comparison Programmes
(ILCP’s)
– Sample Exchanges
Run Blanks
• These are taken through the whole
process, but without a sample included.
• Detects contamination in reagents:
– If constant and very small, may be corrected for.
– If variable, suggests random contamination.
• Include at least two blanks. Often at the
start of the batch.
In-house QC samples
• Bulk samples usually prepared in-house
– From relatively uniform sampling area
– Thoroughly mixed
– Packed in manageable containers (e.g.500 mL)
– Establish Warning and Control Limits
• Run with every batch of samples.
• Normally, two different QC samples per
batch.
• Monitoring long-term stability.
Replicate analyses
• Provide an ongoing indication of analytical
precision (random error).
– Intra-batch, inter-batch
• Useful in quantifying analytical variability.
• Precision can be calculated using pairs of
data.
– Need to realise just what is included and what
is not.
Reference Materials (RM’s)
• May or may not be Certified. Certified means
it is traceable back to primary standards.
• Sourced from an external provider.
• Come with stated Consensus or Certified
analyte levels, usually with Uncertainty
Limits.
• An excellent external check on the laboratory
performance (accuracy).
Inter-Laboratory Proficiency
Programs (ILPP’s)
• Bulk Sample(s) are prepared, split into
multiple fractions, and sent to participating
labs to analyse.
• Each lab submits their results back to the
provider, who then statistically analyses the
dataset, identifying outliers and stragglers.
• Results sent back to each participant, who
can then see how they performed relative to
the other participants.
Sample Exchanges
• A ‘mini’ ILCP.
• Often quite informal.
• Two or more labs exchange samples and
compare results.
• Does not have the reassurance of a larger
number of labs participating, or the value of a
statistical evaluation.
• Still very useful.
The ‘External Check’
• Very important to have an external
check.
• Not until you do check yourself against
other laboratories can you be sure that
you are getting the right answer.
• By using either CRM’s, ILCP’s or Sample
Exchanges.
Questions?
Uncertainty of Measurement
Uncertainty of Measurement
(UoM)
• A very interesting and important subject. As
practicing analysts, we should understand this.
• For me personally, I have found it gives a deeper
understanding of what we are doing
• Enables us to answer the question, is the method
and result ‘fit for purpose’?
• ISO Guide 17025 states we must be able to provide
UoM data in circumstances where it may be critical.
Expressing UoM
UoM usually expressed
as the standard
deviation, or Co-
efficient of Variation.
Sometimes Expanded
UoM. Usually x2,
which for normally
distributed data,
corresponds to the 95%
Confidence Limit.
Determining UoM
• ‘Bottom Up’ approach
- Preferred by ISO
- Also called Uncertainty Budget
- ‘Fishbone’ approach
• ‘Top Down’ approach
- Uses real data, e.g. from QC samples
- Need to understand just what is covered
• Combination best
Simple Fishbone for soil test
Significant sources of uncertainty
for Olsen P
Significant sources of
uncertainty for extractable K
Variation covered by in-house
QC sample for ext K
In Summary….
• Understanding UoM is important to
improve your service, and to ensure
the tests are ‘fit for purpose’.
• It makes you a better analyst, by
having a deeper understanding of
your tests.
Questions?
ASPAC’s Inter-Laboratory
Proficiency Programmes
(ILPP’s)
ASPAC’s Purpose
• Formed in 1990, with a key purpose to
“promote excellence in all aspects of soil
and plant tissue analysis.”
• The ILPP’s have been a major contributor
in achieving this.
ASPAC ILPP’s
• Initially run through the State Chemistry
Laboratory in Melbourne
• One soil and one plant programme p.a.
• Six samples sent out for each programme.
• Results reported in a formal report (taking up
to 6 months to prepare)
• The ILPP’s were of major benefit, improving
consistency amongst laboratories.
ILPP changes
• In the early 2000’s, SCL were struggling to keep
the service running.
• Also, one programme a year not frequent
enough
• Six months too long to report back
• In 2003, programmes contracted out to Global
Proficiency Ltd in New Zealand, an ISO
accredited provider.
ILPP changes (contd)
• Each program now runs 3x a year, with four
samples per round.
• Results reported back within two weeks.
– More use to participants to address problems
• ASPAC have also introduced a Certification
Programme. Good performers issued a
Certificate of Proficiency, and are listed on
ASPAC’s Website.
Benefits of these changes
• We have seen definite improvement in
performance.
More recent developments
• In 2014, introduced a separate programme
for Acid Sulphate Soils
– One round p.a., of four soils
– Certification is also granted
• This year, introducing a soil Physical Analysis
programme (texture, water holding capacity.)
Questions?

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Item 4 aspac brisbane_workshop_qaqc_oct19

  • 1. Quality Assurance and Quality Control, Uncertainty of Measurement, and Introducing ASPAC’s Inter-Laboratory Proficiency Programmes (ILPP’s) Roger Hill Brisbane 17 October, 2019
  • 2. Our Company New Zealand’s largest privately owned testing laboratory • Started 1984 by Roger and Anne Hill • Three market sectors serviced  Agriculture (30%)  Environmental (50%)  Food & Bio-analytical (20%) • Now employ 430 staff • 100% owned by staff working there
  • 3. Quality Assurance, Quality Control and Laboratory Accreditation
  • 4. Quality Definitions • The Quality Management System (QMS) is the over-arching system that a laboratory (or other business) puts in place. • Quality Assurance (QA) is the planned and systematic implementation of that QMS. • Quality Control (QC) checks the lab methods are performing as expected.
  • 5. Quality Management System • The QMS is usually documented in the Laboratory Quality Manual • Includes having documentation and processes for: - Staff training and management - Clear documentation and document control - Regular calibration and maintenance of all equipment - Procedures for handling non-conforming work - Regularly scheduled audits - Use of QC checks with every batch of samples - Having a formal Quality Policy statement
  • 6. Quality Assurance • This is the implementation of the QMS as described in the Quality Manual. • QA is in effect the umbrella under which QC sits. • “All staff have an important role to play in the successful adoption of Quality Assurance.”
  • 7. What is Laboratory Accreditation? • Laboratory accreditation provides an assurance to customers that the laboratory has good quality management systems in place. • International Organisation for Standardisation (ISO) is the most widely recognised entity for laboratory accreditation. • ISO publish Guides against which organisations are audited. If compliant, accreditation will be granted. • ISO/IEC Guide 17025: “General requirements for the competence of testing and calibration laboratories”.
  • 8. Quality Control at Hill Laboratories
  • 9. Quality Control • QC is applied to the specific tests performed by the laboratory, on an ongoing basis. • QC tools used in agricultural testing at Hill Laboratories are: – Run blanks – In-house QC samples – Replicate analyses – Certified Reference Materials (CRM’s) – Inter-laboratory Comparison Programmes (ILCP’s) – Sample Exchanges
  • 10. Run Blanks • These are taken through the whole process, but without a sample included. • Detects contamination in reagents: – If constant and very small, may be corrected for. – If variable, suggests random contamination. • Include at least two blanks. Often at the start of the batch.
  • 11. In-house QC samples • Bulk samples usually prepared in-house – From relatively uniform sampling area – Thoroughly mixed – Packed in manageable containers (e.g.500 mL) – Establish Warning and Control Limits • Run with every batch of samples. • Normally, two different QC samples per batch. • Monitoring long-term stability.
  • 12. Replicate analyses • Provide an ongoing indication of analytical precision (random error). – Intra-batch, inter-batch • Useful in quantifying analytical variability. • Precision can be calculated using pairs of data. – Need to realise just what is included and what is not.
  • 13. Reference Materials (RM’s) • May or may not be Certified. Certified means it is traceable back to primary standards. • Sourced from an external provider. • Come with stated Consensus or Certified analyte levels, usually with Uncertainty Limits. • An excellent external check on the laboratory performance (accuracy).
  • 14. Inter-Laboratory Proficiency Programs (ILPP’s) • Bulk Sample(s) are prepared, split into multiple fractions, and sent to participating labs to analyse. • Each lab submits their results back to the provider, who then statistically analyses the dataset, identifying outliers and stragglers. • Results sent back to each participant, who can then see how they performed relative to the other participants.
  • 15. Sample Exchanges • A ‘mini’ ILCP. • Often quite informal. • Two or more labs exchange samples and compare results. • Does not have the reassurance of a larger number of labs participating, or the value of a statistical evaluation. • Still very useful.
  • 16. The ‘External Check’ • Very important to have an external check. • Not until you do check yourself against other laboratories can you be sure that you are getting the right answer. • By using either CRM’s, ILCP’s or Sample Exchanges.
  • 19. Uncertainty of Measurement (UoM) • A very interesting and important subject. As practicing analysts, we should understand this. • For me personally, I have found it gives a deeper understanding of what we are doing • Enables us to answer the question, is the method and result ‘fit for purpose’? • ISO Guide 17025 states we must be able to provide UoM data in circumstances where it may be critical.
  • 20. Expressing UoM UoM usually expressed as the standard deviation, or Co- efficient of Variation. Sometimes Expanded UoM. Usually x2, which for normally distributed data, corresponds to the 95% Confidence Limit.
  • 21. Determining UoM • ‘Bottom Up’ approach - Preferred by ISO - Also called Uncertainty Budget - ‘Fishbone’ approach • ‘Top Down’ approach - Uses real data, e.g. from QC samples - Need to understand just what is covered • Combination best
  • 22. Simple Fishbone for soil test
  • 23. Significant sources of uncertainty for Olsen P
  • 25. Variation covered by in-house QC sample for ext K
  • 26. In Summary…. • Understanding UoM is important to improve your service, and to ensure the tests are ‘fit for purpose’. • It makes you a better analyst, by having a deeper understanding of your tests.
  • 29. ASPAC’s Purpose • Formed in 1990, with a key purpose to “promote excellence in all aspects of soil and plant tissue analysis.” • The ILPP’s have been a major contributor in achieving this.
  • 30. ASPAC ILPP’s • Initially run through the State Chemistry Laboratory in Melbourne • One soil and one plant programme p.a. • Six samples sent out for each programme. • Results reported in a formal report (taking up to 6 months to prepare) • The ILPP’s were of major benefit, improving consistency amongst laboratories.
  • 31. ILPP changes • In the early 2000’s, SCL were struggling to keep the service running. • Also, one programme a year not frequent enough • Six months too long to report back • In 2003, programmes contracted out to Global Proficiency Ltd in New Zealand, an ISO accredited provider.
  • 32. ILPP changes (contd) • Each program now runs 3x a year, with four samples per round. • Results reported back within two weeks. – More use to participants to address problems • ASPAC have also introduced a Certification Programme. Good performers issued a Certificate of Proficiency, and are listed on ASPAC’s Website.
  • 33. Benefits of these changes • We have seen definite improvement in performance.
  • 34. More recent developments • In 2014, introduced a separate programme for Acid Sulphate Soils – One round p.a., of four soils – Certification is also granted • This year, introducing a soil Physical Analysis programme (texture, water holding capacity.)