Environmental monitoring

data management systems

Records of monitoring shall
include
 Dateand time of  Required analysis
sampling  date(s)
analyses
 Sampling location were performed
 Site description  Analyst’s name
 Sample type  Analytical
 Sampler(s) name techniques or
methods used
 Analytical results
 Data Management
 Data are like letters of the alphabet:
 taken individually, they reveal very little.
 Put together with a little thought and organization, however,
those same letters can tell a complete story.
 Organised data should tell a story!

 Statistics
and graphics can be tremendously helpful in
perceiving relationships among different variables
contained in the data.
 Data Management
Detailed plan for collection, recording, and maintenance of data.
 Specifies what data will be collected with observations
 Specifies what the data will be used for (WHY data?)
 Specifies how the data will be processed
 Specifies when it will be processed and reported,
 and who will be responsible for each task.
 Specifies how and where data will be kept
 Laboratory notebooks
 Equipment/procedure logs
 Laboratory Information Management systems (LIMS)
 Specifies Data Retention and Storage
 Frequently 3-5 years on-site; up to 10 in off-site or archived storage
 Keeping a Good Lab Notebook
 Generally:

 Be organized
 Date (and sign) each new entry
 Write everything down, no matter how trivial it may
seem.
 Do not erase; rather strike through and initial corrections.
 Permanently affix additions to lab notebook
 Have supervisor review and sign-off on data at least
Transferring Data from Lab Notebook to
Electronic Database
 Best to use LIMS with date stamping.
 Location of original data should be recorded.
 Once input, data entry should be validated
(ideally by another person; unrealistic)
 Dataanalysis procedures should be
annotated where possible
 Data Management
 Nowadays, computerized data management systems provides
a great deal of advantages, especially if the data collection
effort is conducted at many sites and/or over a long time
period
 Computer software includes a variety of spreadsheet and
database packages that allow you to organize the data and
perform statistical analyses.
 Examples of common spreadsheet software packages?
 Examples of common database software packages include
dBase, Access, SMIS at MUBAS, etc.
Choosing spreadsheet software
packages
Almost every option you’ll encounter should have
the same basic functionalities, which include:
 Data input (entering data into cells)
 Cell
formatting (adjusting font, color, size, and
other features of individual cells or cell groupings)
 Basicformulas (addition, subtraction,
multiplication, and division)
 Sorting (in ascending or descending order)
 Filtering (narrowing down data based on specified
criteria)
 Choosing spreadsheet software
At packages
a minimum, look for the following advanced features
that make it easier to sort, parse, and understand datasets:
 Pivottables (summarizing, analyzing, and presenting data
interactively)
 Advanced formulas and functions (performing complex
calculations)
 Datavisualization (converting data into charts, graphs,
and other infographics)
 Collaboration
tools (real-time collaborative editing,
comments, and shared access)
Designing a Data
Management System
 Many people are capable of writing their own
programmes to manipulate and display data.

 Greater efforts are being made to develop

data storage systems that facilitate data
exchange among different users.
 Designing a Data Management
System
Design the database or spreadsheet before you start
collecting the data.
 The design should be in such a way that it is readily apparent
where data should be entered.
E.g., highlighting data cells with a special color.
 Itis always a good idea to make backups of any
electronic database or spreadsheet.

 Graphics (graphs, maps, photos) are nice but should not

distort the meaning of the data and should not be presented
as a duplicate to the data.
 Benefits of environmental monitoring data
management systems
The benefit can best be seen from analyzing the impact of the
data management system on the whole site investigation and
remediation process.
1. During remediation you might be able, by more careful tracking
and modeling of the contamination, to decrease the amount of
waste to be removed or water to be processed.

2. You may also be able to decrease the time required to complete the
project and save many person-years of cost by making quality data
available in a standardized format and in a timely fashion.
 Benefits of environmental monitoring
data management systems
 For
smaller sites, automating the data management process
can provide savings by repetition.

 Once the system has been set up for one site and people
trained to use it, that effort can be re-used on the next site.

A higher quality work product, and better decision making.

EMS Vs. EMIS Vs. EDMS
 AnEMS is a set of policies and procedures for managing
environmental issues for an organization or a facility.

 An
EMIS is a software system implemented to support the
administration of the EMS.

 EMIS usually has a focus on record keeping and reporting,

and is implemented with the hope of improving business
processes and practices.
EMS Vs. EMIS Vs. EDMS
A site EDMS is a software system for managing data
regarding the environmental impact of current or former
operations.

 EDMS overlaps partially with EMIS systems.

 For an operating facility, the EDMS is a part of the EMIS.

 For
a facility no longer in operation, there may be no formal
EMS or EMIS, but the EDMS is necessary to facilitate
monitoring and cleanup.
 PURPOSE OF DATA MANAGEMENT
The purpose of data management is to support the goals of the
organization which are:

 Improveefficiency – Environmental site investigation and

remediation projects can involve an enormous amount of
data.

 Well designed and implemented computerized methods can be

a great help in improving the flow of data throughout the
project.

 Poorly managed methods can be a great sink of time and effort.
 PURPOSE OF DATA MANAGEMENT
 Maximize quality

 Carefuldata storage, and annotation of data with quality

information, can be a great help in achieving data quality
objectives.

 Minimize cost

 Electronic
data management can help contain costs by saving
time and minimizing loss of data.
 Errors in Environmental Data
 Error is the exact result of the difference between the
true/accepted value of the measure and the measured
value.

 shows how accurate the measurement result is by showing the

actual distance to the true value.

 Errorsof environmental data can be approximately divided

into sampling error and analytical error.
 Errors in Environmental Data
In general, these errors are of two types:
 Determinate errors (systematic errors)
 canbe traced to their sources, such as improper sampling and
analytical protocols, faulty instrumentation, or mistakes by
operators.

 Indeterminate errors (random errors)

 random fluctuations and cannot be identified or corrected for.
 Random errors are dealt with by applying statistics to the data.
 Minimisation of errors through DQP

 Twomain parts of a data quality programme (DQP) are

quality control (QC) and quality assurance (QA).

 QCis generally a system of technical activities aimed at

controlling the quality of data so that it meets the need of
data users.
 QCprocedures should be specified to measure the precisions
and bias of the data.
Minimisation of errors through DQP

A QA programme is a management system that ensures

the QC is working as intended.

 QA/QCprogrammes are implemented not only to

minimize errors from both sampling and analysis, but
many are designed to quantify the errors in the
measurement.
Quality Assurance (QA)
of chemical
measurements
 Quality Assurance (QA)
 Quality assurance is a definite plan for laboratory operation
that specifies standard procedures that help to produce data
with defensible quality and reported results with a high level
of confidence.
 It is a necessary part of data production, and it serves as a
guide for the operation of the laboratory for production data
quality.
 Quality Assurance (QA)
 Basic requirements of a quality assurance programme
 recognize possible errors,
 understand the measurement system used, and
 develop techniques and plans to minimize errors.
 Italso includes evaluating what was done, and reporting
evaluated data which are technically sound and legally
defensible.
 Quality control in data processing, including expression of
the analytical results, rounding, normalization and
interpretation.
 Quality assurance is the statistical control of quality.
 The elements of the quality assurance are quality control
 Activities related to Quality Assessment
and Quality Control
Quality Assessment Quality Control
• Certified reference • GLP, GMP, SOP
material • Calibration
• Replicates • Standardization
• Splits • Instrument maintenance
• Spikes • Facilities maintenance
• Surrogates • Education and training
• Collaborative tests • Inspection and validation
• Statistical analysis

https://doi.org/10.1016/j.scitotenv.2015.08.056 https://doi.org/10.1080/00022470.1979.10470849

https://doi.org/10.1016/0160-4120(80)90059-8
 Quality Control (QC)
 Quality control is a mechanism established to control
errors.

 It is a set of measures within a sample analysis
methodology to assure that the process is in control.

 It helps to provide quality that is satisfactory,

adequate, dependable, and economical.

 It consists of the use of a series of procedures that

must be rigorously followed.
 Quality Control (QC)
 Goodquality control systems should include provisions for
inspection, both periodical and unannounced, to ascertain
how well the procedures are functioning.
 Largelaboratories have a quality control officer or group,
independent of the laboratory management, that oversees
the operation of the system.
 Quality Control (QC)
The elements of quality control are
 Competentpersonnel with adequate educational
background with specific training and experience.

 Suitableand properly maintained laboratory equipment

and facilities.

 Modern equipment increases the need for QA/QC.

 Properly selected methodology.
 Quality Control (QC)
 Good laboratory practices (GLP).

 Good measurement practices (GMP).

 Standard operation procedures (SOP).

 Documentation.

 Inspection and validation.

 Quality Control (QC)-Good laboratory practices
(GLP)
 Is it dangerous to work in a laboratory
 No !
 Ifyou follow Laboratory Commandments for Good
laboratory practice which are aimed at knowing the
potential dangers and taking the necessary
precautions to protect yourself and others
Quality Control (QC)-Good laboratory practices (GLP)

Laboratory safety
 Cleaning,
housekeeping, temperature, humidity control,
glassware cleaning
 Storage,
handling, labeling, shelf-life, and disposal of
chemicals
 Samplecustody (documentation, routing, storage,
preparation, retention)
Quality Control (QC)-Good laborator
practices (GLP)

General laboratory operations

Use, maintenance, and calibration of
equipment
Statistical procedures.
Data reporting, format, documentation.
Quality Control (QC)-Good laboratory practices (GLP)

 The aim of GLP is to “ Promote mutual acceptance of

study data and results across international boundaries”.
 Good Laboratory Practices:
 Ensure high quality of results
 Ensure comparability of results
 Limit the waste of resources
 Minimise risks and hazards
 Promote mutual recognition of results
 Quality Control (QC)-Good laboratory practices
(GLP)
GLP aims to make the incidence of False Negatives
more obvious
 E.g.,
Results demonstrate non-toxicity of a well known toxic
substance

 GLP
aims to make the incidence of False Positives
more obvious
 Results
demonstrate toxicity of a well known non-toxic
substance
Quality Control (QC)-Good laboratory practices
(GLP)
 The main goal of GLP is to help laboratory personnel obtain
data which are:
 Repeatable
 Reliable ( quality and validity of test data)
 Auditable
 Recognized by scientists worldwide
 The purpose is not to assess the intrinsic scientific value of
a study
 It is just a set of organisational requirements
 Quality Assessment
 Qualityassessment is the mechanism to verify that the
system is operating within acceptable limits.
 Itis the overall system of activities whose purpose is to
provide assurance that the overall quality control job is
being done effectively.
 Quality assessment is a process to determine the quality
of the laboratory measurements through internal and
external quality control evaluations,
 includes performance evaluation samples, laboratory
comparison samples, and performance audits.
Quality Control checks
Equipment blanks
 Equipmentblanks are used to detect any contamination
from sampling equipment.
 They are prepared in the field before sampling begins, by
rinsing the equipment with analyte-free water, filling the
appropriate sample bottle with analyte free water, and
preserving with appropriate preservative.
Quality Control checks
Field blanks
 Fieldblanks are collected at the end of the sampling
event by filling the appropriate sample bottle with
analyte-free water and preserving the same manner
as the samples.
 Quality Control checks
Trip blanks
 Theseare used to verify contaminations that may occur
during sample collection and transportation.
 areblanks of analyte-free water that are prepared by the
laboratory; the blank is transported to the field and
remains unopened during the sampling event and is
transported back to the laboratory with the samples.
 Quality Control checks
Duplicate samples
 Thesesamples are collected for checking the preciseness of the
sampling process.
 Duplicate
samples are collected at the same time and from the
same source as the study samples.

Split samples
 These samples are taken to check analytical performance.
 The sample is taken in one container, mixed thoroughly, and
split into another container.
 Bothhalves are now samples that represent the same sampling
point.
Chain of Custody

 Legal
term for an unbroken sequence of
possession from sampling through analysis.
 Sample custody
 Sample custody is the process of protecting the samples
collected and analyzed.
 Ifa sample decomposes or is contaminated prior to the actual
analysis, the results are unre­liable.

 Proper sample handling is essential.

 Allthe paperwork involved in the sample custody process

defends and secures the quality of the reported data.
Sample custody
 It shows how samples are collected, preserved, stored,
transported to the laboratory, treated, numbered, and
tracked during the analytical process.

 All records have to be maintained so that they are easy

to find and ready at all times for immediate inspection.

 All documentation must be signed or initialed by the

responsible person and recorded with waterproof ink,
without any erasures or marking.
Documentation and Maintenance of
Records
 Maintenance of all records provide documentation which may
be required in the event of legal challenges due to
repercussions of decisions based on the original analytical
results.

 General guidelines followed in regulated laboratories is to

maintain records for at least five years.

 Length of time over which laboratory records should be

maintained will vary with the situation.
 Sample custody
 All corrections must be made with one line marked
through the error, accompanied with a signature or
initial, date, and the corrected form.
 An important rule to remember is that “it did not happen if
it is not documented.”

 Since a large number of the work done in today's

laboratories potentially could go to litigation, all aspects
of the sample must be documented.
Sample custody
 Thisstarts with the purchase of the bottles
used to collect the samples and ends in the
laboratory with the record of the individual who
mailed the data package.
Sample custody – Documentation
must be related to:
 Sample collection, field activities
 Sample receipt, sample distribution, and holding
time
 Sample preparation prior analysis
 Analytical methods
 Reagents and standards preparation
Sample custody – Documentation
must be related to:
 Calibration procedures and frequency
 Analytical data and calculations
 Detection limits
 Qualitycontrol requirements and quality control
routine checks related to the analysis
 Data validation and reduction
 Data reporting
 Reliability of data sets
 Incomplete or inaccurate data sheets are useless!
All environmental data should be scientifically
reliable.

 Scientific
reliability means that proper procedures
for sampling and analysis are followed so that the
results accurately reflect the content of the sample.
 Causes of Scientifically Unreliable
Data
 An incorrect sampling protocol (bad sampler)
 An incorrect analytical protocol (bad analyst)
 The falsification of test results.
 There are lots of “False Eurekas” in the world – some from
well-respected scientists!
 Examples of falsification:
 “Trimming”: altering one’s data
 “Cooking”: selective reporting of one’s data
“Forging”: making up the data Source: Charles Babbage (1830)
 The lack of a good laboratory practice (GLP)
The South African National Accreditation
System
 In Southern Africa, South African National Accreditation System
(SANAS) certificates and their accompanying schedules are a formal
recognition that an organisation is competent to perform specific tasks.
 SANAS is responsible for the accreditation of:
 Medical Laboratories to ISO 15189:2007,
 Certification bodies to ISO/IEC 17021:2006, ISO/IEC 17024:2003 and 65:1996, and
 laboratories (testing and calibration) to ISO/IEC 17025:2005.
 Inspection Bodies are accredited to ISO/IEC 17020:1998 standards.
 Under SANAS principles, GLP facilities are inspected for compliance to
OECD GLP principles.
 But now there is also Southern African Development Community
Accreditation Services (SADCAS) based in Botswana which is
responsible for accreditation.
 By definition: GLP embodies a set of principles that provides
a framework within which laboratory studies are planned
performed, monitored, reported and archived.

 GLP is an FDA/SANAS/ SADCAS regulation.

 GLP is sometimes confused with the standards of laboratory

safety like wearing safety goggles.

 The overall aim is to protect the integrity and quality of

laboratory data used.
 HISTORY
 GLP is a formal regulation that was created by the FDA
(United states food and drug administration) in 1978.
 AlthoughGLP originated in the United States , it had a world
wide impact.
 Non-US companies that wanted to do business with the United
states or register their pharmacies in the United States had to
comply with the United States GLP regulations.
They eventually started making GLP regulations in their home
countries.
 In 1981 an organization named OECD (organization for
economic co-operation and development) produced GLP
principles that are an international standard.
 WHY WAS GLP CREATED?
 Inthe early 70’s FDA became aware of cases of poor
laboratory practice all over the United States.
 FDA decided to do an in-depth investigation on 40
toxicology labs.
 They discovered a lot fraudulent activities and a lot of
poor lab practices.
 Examples of some of these poor lab practices found
were
1. Equipment not been calibrated to standard form , therefore
giving wrong measurements.
2. inaccurate accounts of the actual lab study
 FAMOUS EXAMPLE
 One of the labs that went under such investigation
made headline news.
 The name of the Lab was Industrial Bio Test.
 This
was a big lab that ran tests for big
companies such as Procter and Gamble.
 It was discovered that mice that they had used to
test cosmetics such as lotion and deodorants had
developed cancer and died.
 Industrial Bio Test lab threw the dead mice and
covered results deeming the products good for
human consumption.
 Those involved in production, distribution and
sales for the lab eventually served jail time.
FDA investigation findings
 Poorly trained laboratory personnel
 Poorly designed protocols
 Procedures not conducted as prescribed
 Rawdata badly collected – not correctly identified –
without traceability – not verified or approved by
responsible persons
 Lack of standardized procedures
 Inadequate resources
 Equipment not properly calibrated
 Archives inadequate
Quality Control (QC)- Good measurement practices
(GMP)
Guidelines should be written for each measurement
technique, addressing subjects such as maintenance
and records for equipment, and specified calibration
procedures.

 General instruction manuals should be available with

the requirements and precautions for each technique.
Quality Control (QC)- Standard
operation procedures (SOP)
 SOPsare written for basic operations to be done in the
laboratory.
 Written procedures for a laboratories program.
 They define how to carry out protocol-specified activities.
 Mostoften written in a chronological listing of action
steps.
 Theyare written to explain how the procedures are
supposed to work.
 SOPsshould include sampling, measurement, calibration,
and data processing in a standard format.
Quality Control (QC)- Standard operation
procedures (SOP)
 Routine inspection, cleaning, maintenance, testing and
calibration.
 Actions to be taken in response to equipment failure.
 Analytical methods
 Definition of raw data
 Keeping records, reporting, storage, mixing, and retrieval
of data
Statistical Procedures for Data Evaluation
 Statistical procedures are not simply chosen from a
text book.

 Practitioners in a particular field may adopt certain

standards which are deemed acceptable within that
field.

 Regulatory agencies often describe acceptable

statistical procedures.
Instrumentation Validation
 This is a process necessary for any analytical laboratory.

 Data produced by “faulty” instruments may give the

appearance of valid data.

 The frequency for calibration, re-validation and testing

depends on the instrument and extent of its use in the
laboratory.
 Whenever an instrument’s performance is outside the
“control limits” reports must be discontinued
Instrument Validation (cont)

Equipment records should include:

 Name of the equipment and manufacturer
 Model or type for identification
 Serial number
 Date equipment was received in the
laboratory
 Copy of manufacturers operating instruction
(s)
Reagent/Materials Certification

 Thispolicy is to assure that reagents used

are specified in the standard operating
procedure.
 Purchasing and testing should be handled by
a quality assurance program.
Reagents and Solutions
continued
Requirements:
 Reagents and solutions shall be labeled
 Deterioratedor outdated reagents and
solutions shall not be used
 Include the date when opened
 Stored under ambient temperature
 Expiration date
Analyst Certification
 Some acceptable proof of satisfactory
training and/or competence with specific
laboratory procedures must be established
for each analyst.
 Qualification
can come from education,
experience or additional trainings, but it
should be documented
 Sufficient people
 Requirements of certification vary
Laboratory Certification

 Normally done by an external agency

 Evaluation is concerned with issues such as
 Adequate space
 Ventilation
 Storage
 Hygiene
Specimen/Sample Tracking
 Vary among laboratories
 Must maintain the unmistakable connection
between a set of analytical data and the
specimen and/or samples from which they
were obtained.
 Original source of specimen/sample(s) must
be recorded and unmistakably connected
with the set of analytical data.
Important questions to be answered
for any analytical instrument
 What is the equipment being used for?
 Is the instrument within specification and is
the
documentation to prove this available?
 If the instrument is not within specifications,
how much does it deviate by?
 If the instrument is not within specifications
what action has been taken to overcome the
defect?
 Can the standards used to test and calibrate
the instrument be traced back to national
 Whathappens if a workplace does not
comply with Good Laboratory Practice
standards?
 Disqualification of a Facility
 Before a workplace can experience the
consequences of noncompliance, an
explanation of disqualification is needed
 The SANAS/SADCAS states the purpose of
disqualification as the exclusion of a testing
facility from completing laboratory studies or
starting any new studies due to not following
the standards of compliance set by principles
of Good Laboratory Practice
Possible Violations
 Falsifyinginformation for permit, registration
or any required records.
 Falsifyinginformation related to testing
protocols, ingredients, observations, data
equipment, etc.
 Failureto prepare, retain, or submit written
records required by law.
Grounds for Disqualification
 The
testing facility failed to comply with one or
more regulations implemented by the GLP manual
 Thefailure to comply led to adverse outcomes in
the data; in other words, it affected the validity of
the study
 Warnings
or rejection of previous studies have not
been adequate to improve the facility’s compliance