C 41552: Quality Management

Part 2: LABORATORY
MANAGEMENT
Day 04

N.M.M. Jayamanne, MISM (UOC), B.Sc. (UOC)

Assistant Director, SLAB
Team Leader / Assessor ISO/IEC 17025:2017
 Wrap Up
 Last week we studied about
 Resource requirements
 Facility and environmental conditions
 Equipment
 Measurement traceability
 Externally provided services and supplies
 Process requirements
 Review of requests
 Method
Take home question last week:
 Identify two occasions in a laboratory where impartiality issues can be identified
 What are the actions you can take to minimize them?

 Lets suppose courts of Sri Lanka is requesting on test results obtained from your
laboratory for a particular product. What will you do?

 Identify three functions of a laboratory where authorizations of personnel is

mandatory?

 Identify three main requirements in maintaining laboratory facility?

Take home question this week:
 Identify two ways method validation can be performed
 Why intermediate verifications are required
 Identify two situations where subcontracting can be performed
 When selecting a suitable supplier what need to be considered
 Identify two ways review of request can be performed
 PROCESS
REQUIREMENTS
 Selection, Evaluation
Review of Handling of
verification of Ensuring
requests, test / Technical Reporting
and Sampling measureme validity of
tenders and calibration records of results
validation of nt results
contracts items
methods uncertainty

Complaints Non-conforming work Control of data and information management

SAMPLING

The action or process of

taking samples of something
for analysis.

Selection of a sub set of

elements from a set of
elements.

Sample is a subset of a
population.
 SAMPLING METHODS

Based on randomization Does not rely on randomization

Every element gets equal chance to be More reliant on the researcher’s ability to
picked up and to be part of sample for study. select elements for a sample.
PROBABILITY SAMPLING METHODS
Simple Random Sampling
Every element has an equal
chance of getting selected to
be the part sample.
Stratified Sampling
• Divide elements of the population into small
subgroups (strata) based on the similarity
(homogeneous among the group &
heterogeneous with other subgroups).
• Elements are randomly selected from each of
these strata.
 PROBABILITY SAMPLING METHODS
Cluster Sampling
Our entire population is divided into clusters or sections and then the
clusters are randomly selected. All the elements of the cluster are used
for sampling. Clusters are identified using details such as age, sex,
location etc.

Two Stage Cluster Sampling

Single Stage Cluster Sampling Here first we randomly select clusters and then from those
Entire cluster is selected randomly for sampling. selected clusters we randomly select elements for sampling
PROBABILITY SAMPLING METHODS

Systematic Clustering
• Selection of elements is systematic and not random except the first element.
• Elements of a sample are chosen at regular intervals of population.

Multi-Stage Sampling
It is the combination of one or more methods described above.
• Population - multiple clusters - sub groups (strata) based on similarity.
• One or more clusters can be randomly selected from each stratum.

Eg: Country can be divided into states, cities, urban and rural and all the
areas with similar characteristics can be merged together to form a strata.
 NON PROBABILITY SAMPLING METHODS
Convenience Sampling
Samples are selected based on the availability.
Eg: People with a specific genetic condition
Referral /Snowball Sampling
Used when the population is completely unknown
Purposive Sampling and rare.
Based on the intention or the purpose of study. Only those Referral from the elements expand the population
elements will be selected from the population which suits the size with time.
best for the purpose of our study. Eg: Drug addicts
Eg: People interested on reading e-books

Quota Sampling
Selects the representative sample from the population.
Proportion of characteristics/ trait in sample should be same as
population
Eg: If our population has 45% females and 55% males then our
sample should reflect the same percentage of males and
females.
 SAMPLING

SAMPLING PLAN
SAMPLING METHOD
The sampling plan and method shall be available at the site
where sampling is undertaken.

Sampling method shall describe:

• the selection of samples or sites;
• the sampling plan;
• the preparation and treatment of sample(s) from a substance,
material or product to yield the required item for subsequent
testing or calibration.
• factors to be controlled
 SAMPLING
Retain records of sampling data
• reference to the sampling method used;
• date and time of sampling;
• data to identify and describe the sample (e.g. number, amount, name);
• identification of the personnel performing sampling;
• identification of the equipment used;
• environmental or transport conditions;
• diagrams or other equivalent means
 HANDLING OF TEST OR CALIBRATION ITEMS
Procedure:
• Transportation
• Receipt
• Handling
• Protection
• Storage
• Retention
• Disposal or return of test or calibration items

Disposal or
Transportation Receipt Handling Protection Storage Retention
return
 HANDLING OF TEST OR CALIBRATION ITEMS

Receipt Protection Retention

• Conditions • Requirements • Safety • Prior
• Safety • Acceptance • Training / • Confidentiality • Access • Specified time agreement
• Confidentiality criteria Instructions • Safety • Conditions with customer
• Deviations • Deterioration
Disposal or
Transportation Handling Storage
Return
HANDLING OF TEST OR CALIBRATION ITEMS
Precautions shall be taken to avoid
• deterioration, contamination, loss or damage to the
item
• during handling, transporting, storing/waiting, and
preparation for testing or calibration.

Handling instructions of the sample to be followed

 HANDLING OF TEST OR CALIBRATION ITEMS
Unambiguous identification
• Single items
• Sub groups
• 03 water samples from each location
• Blood samples for different test form same person

Proceed with deviations

Specified conditions If, Disclaimer on the report
of the test item to be • Requirements not Consult
recorded at receipt. fulfilled Stop proceeding
Eg: Temperature of Meat / • Any doubt on customer Sample re-submission
Water suitability
Fulfill deficiency
Submission of inadequacies
HANDLING OF TEST OR CALIBRATION ITEMS

When items need to be stored or conditioned under

specified environmental conditions, these conditions shall be
maintained, monitored and recorded.

Rubber gloves:
Condition for 48 hrs @ 21±2°C and 50 ±5 RH
TECHNICAL RECORDS

Technical records
Results, Reports, Certificates, Work sheets,
Calibration results, Verification results,
Uncertainty calculations, etc
 TECHNICAL RECORDS

Technical records shall facilitate:

• identification of factors affecting the measurement result
• identification of factors associated measurement uncertainty
• enable the repetition of the laboratory activity under conditions as close as possible to the
original.
 TECHNICAL RECORDS
Amendments to technical records can be tracked to previous versions or
to original observations.

Both the original and amended data and files shall be retained, including the
date of alteration, an indication of the altered

How can you do this?

• Correction fluids?
• Cross?
• Cut using single line - sign, initials, date
EVALUATION OF MEASUREMENT UNCERTAINTY
Measurement Uncertainty of measurement
A property of something. Doubt that exists about the result of any measurement.
Eg: Weight of a fruit, Length of a pole

Eg: Length of a pencil

Lets consider 10 consecutive measurements: 16.1, 16.2, 15.9, 15.8, 16.0, 16.0, 16.2, 15.1, 15.9, 15.9

16 cm ±0.2 cm
The statement says that we are sure that the pencil is between 15.8 – 16.2 cm long.
 ERROR VS UNCERTAINTY
Error is the difference between the measured value and the ‘true value’ of the thing
being measured.

Uncertainty is a quantification of the

doubt about the measurement result.
 MEASUREMENT UNCERTAINTY
WHY
• Calibration - where the uncertainty of measurement must be reported on the certificate
• Test - where the uncertainty of measurement is needed to determine a pass or fail

or to meet a
• Tolerance - where you need to know the uncertainty before you can decide whether the
tolerance is met
EVALUATION OF MEASUREMENT UNCERTAINTY

• Laboratories shall identify the contributions to measurement uncertainty.

• A laboratory performing calibrations, including of its own equipment, shall evaluate
the measurement uncertainty for all calibrations.
• A laboratory performing testing shall evaluate measurement uncertainty.
MEASUREMENT UNCERTAINTY
EVALUATION OF MEASUREMENT UNCERTAINTY

Contributions to measurement uncertainty shall be identified

Sources for uncertainty Sources for Uncertainty budget

• Equipment • Repeatability
• Unit Under Test • Reproducibility
• Operator • Stability
• Method • Bias
• Calibration • Drift
• Environment • Resolution
• Reference Standard
• Reference Standard Stability
 REPEATABILITY
Measurement precision under a set of repeatability conditions of measurement.

1. Repeat a measurement ‘n’ number of times

2. Record the results of each measurement.
3. Calculate the standard deviation.
 REPRODUCIBILITY
Measurement precision under reproducibility conditions of measurement

• Operator vs Operator Reproducibility

• Equipment vs Equipment Reproducibility
• Method vs Method Reproducibility
• Day vs Day Reproducibility
• Environment vs Environment Reproducibility

1. Perform a Repeatability Test

2. Calculate the mean of average
3. Change a variable and repeat the Repeatability Test
4. Calculate the mean or average.
5. Calculate the standard deviation of the test averages.
 STABILITY
Property of a measuring instrument, whereby its metrological properties remain
constant in time

1. Review your last 3 calibration reports.

2. Record the results from each calibration report.
3. Calculate the standard deviation of the calibration results.
 BIAS
Estimate of systematic measurement error
Average of replicate indication minus a reference quantity value

1. Review your latest calibration report.

2. Find the As Left value or measurement result.
3. Find the Nominal value or standard value.
4. Calculate the difference.
 DRIFT
Continuous or incremental change over time
in indication, due to changes in metrological
properties of a measuring instrument

1. Review your last 3 calibration reports.

2. Record the results from each calibration report.
3. Record the date each calibration was performed.
4. Calculate the average daily drift rate.
5. Multiply the average daily drift rate by your calibration
interval (in days).
 RESOLUTION
Smallest change in a quantity being measured that causes a perceptible change in
the corresponding indication

1. Look at your measurement system or equipment

2. Find the least significant digit
3. Observe the smallest incremental change
 REFERENCE STANDARD UNCERTAINTY
Uncertainty of a measurement standard designated for the calibration of other
measurement standards for quantities of a given kind in a given organization or at a
given location
1. Review your latest calibration report.
2. Find the reported estimate of measurement uncertainty
 REFERENCE STANDARD STABILITY
Stability of a measurement standard designated for the calibration of other
measurement standards for quantities of a given kind in a given organization or at a
given location
1. Review your last 3 calibration reports.
2. Record the uncertainty estimate from each calibration report.
3. Calculate the standard deviation.
 DISTRIBUTIONS
Normal distribution Horizontal distribution

Values are more likely to fall near the average than Measurements are quite evenly spread between the
further away. highest and the lowest values

Other distributions
• Triangular
• M-shaped (bimodal or two-peaked)
• Lop-sided (skew)
Take home question:
 Consider following repeatability measurements of a analytical balance taken for
calculate repeatability uncertainty:
5.1, 5.0, 5.3, 4.8, 4.9, 5.1, 5.2, 5.4, 4.8, 4.2, 5.0, 5.0, 4.9, 5.1, 5.0

 Calculate mean:
 Calculate mode:
 Calculate median:
 Calculate standard deviation:
 What is the repeatability uncertainty range:
Thank you …