Risk based methodology in Laboratory Management System

Risk Based Methodology in Laboratory
Management System: Integrating ISO 17025
& 31000
Dotun Bolade
19 January 2016

Dotun Bolade
Bio
Dotun , an Analytical Chemist/Laboratory Scientist by training and practice has spent the past four years working in
Nigeria’s Oil and Gas industry. For him, ISO management systems have become second nature having worked in
environments where ISO 9001, 14001, 18001 and 17025 have been fully implemented/accredited. He is a Certified
PECB ISO/IEC 17025 Lead Assessor, ISO 14001 & 9001 Lead Implementer and Certified Trainer.
2348066884793
dotbee04@yahoo.com
linkedin.com/Dotun Bolade
twitter.com/dotunBolade
oladotunbolade@gmail.com

Objectives:
 Review key aspects of risk management
 Recognize common sources of error in
the Laboratory
 Develop a Quality Control Plan
 Introduce Laboratory Risk Assessment
Methodology

Content:
PECB Webinar|January 2016 ISO/IEC 17025:2005
 Overview of Laboratory
Management Systems
 Introduction to risk and
risk management
 Understanding Laboratory
Errors and Quality Control
 Quality control plan and
other control processes
 Risk management
processes/framework in the
Laboratory (based on ISO
31000); Risk Identification,
Analysis, Evaluation and
Treatment
 Risk Management Policy
 Implementing risk management
(PDCA Cycle)

Why do accidents happen?
Carelessness
Over crowding
Inadequate FacilitiesOutmoded Equipment
Poor Lighting
Inadequate
Safety Training
Unsafe
Experiments
Inadequate
Preparation
Poor Laboratory
Management
Ergonomic
Factors
Inadequate
Instructions
Ignorance
Fatigue

Managing Risk:
We all manage risk consciously or unconsciously
- but rarely systematically
 Managing risk means forward thinking
 Managing risk means responsible thinking
 Managing risk means balanced thinking
 Managing risk is all about maximising opportunity and minimising
threats
 The risk management process provides a framework to facilitate
more effective decision making

Risk Management:
Risk Management is the systematic
application of management policies,
procedures, and practices to the tasks
of analyzing, evaluating, controlling
and monitoring risk (the effect of
uncertainty on objectives).

Risk Management Process:
The risk management process
involves four key stages:
Analyze the process
Understand it (typically through
process
mapping) and identify risk points.
Evaluate risk points
Assess each issue based on
probability and
severity/impact. Typically this takes
the form of a matrix, in which a
value is assigned to the risk.
Control risks
Pick the highest risks, and
decide how to mitigate them
by modifying the process.
Document the results of this
stage.
Monitor risks
Every process has inherent
risk. One of the risks is the
uncertainty of the
measurement itself.

What is Risk?
 The effect of uncertainty on
objectives, whether positive
or negative – ISO 31000
 The potential for an error to
occur that could lead to
patient/staff harm.
 The likelihood that a hazard
will cause a specific bodily
injury to any person.
Risk means the chance
that someone will be
harmed by the hazard.
Risk = Hazard effect x
Probability (likelihood of
Occurrence)

AS/NZS ISO 31000:2009:

ISO 31000:2009 Process Overview:

ISO 31000:2009 Risk Management:

Laboratory Errors:

Sources of Errors:
Environmental:
– Temperature
– Humidity
– Light intensity
– Altitude
Operator:
– Improper specimen
preparation, handling
– Incorrect test interpretation
– Failure to follow test system
instructions
Specimen:
– Bubbles
– Clots
– Incorrect tube additive
Analysis:
– Calibration factor
incorrect
– Mechanical failure
• Measuring system:
- Optics, contamination,
- Mechanical failure

Types of Errors:
Systematic errors:
Errors that affect every test in a
constant and predictable manner.
Errors can occur from one point forward,
or a limited period of time.
– Reagent deterioration or preparation
– Improper storage or shipment
conditions
– Incorrect operator technique (e.g,
dilution, pipette
setting)
– Calibration errors (e.g, wrong setpoint,
factors)
QC samples do a good job at detecting
systematic errors:
Random Errors:
Errors that affect individual
samples in a random and
unpredictable fashion:
– Clots
– Bubbles
– Interfering substances
QC samples do a poor job at
detecting random errors
unless the error specifically
occurred with the QC
sample.

What is Risk Assessment?
Risk Assessment is a systematic approach to
identify hazards, evaluate risk and incorporate
appropriate measures to manage and mitigate
risk for any work process or activity.
How often must the risk assessment be reviewed ?
• At least once every 3 years;
• After an accident;
• When there is significant change in work processes,
introduction of new machinery or chemicals;
• Information on safety technology or requirement made
known

Risk Assessment Process

Risk Assessment Strategy

Risk Assessment Flowchart
Manage Risk
7. Hazard Control
8. Additional control
measures (Responsible
person, timeline)
Review, Approval,
Communicate
Record Keeping and
Document Control
Assess
5. Existing Control Measures 6. Evaluate Risk (Severity, Probability)
Identify
1. Selecting Experiments
2. Break Down into
Successive Tasks
3. Potential Hazards
4. Potential Harm (Ill health
condition)

Risk Assessment Template:
Activity or Experiment-Based Risk Assessment Form
Department:
Name of
Experiment/Activity:
Location:
Name of Person in-
charge:
Name of
PI:
Last Review
Date:
Next Review Date:
1. Hazard Identification 2. Risk Evaluation & Control
SN Task Hazards
Possible
Consequences
Existing
Risk
Control
(if any)
S L R
Addition
al / New
Risk
Control
S L R
Action
By
Deadl
ine
Conducted by: (Name,
designation)
Approved by: (Name,
designation)
Signature: Signature:
Date: Date:

Risk Analysis
Where possible confidence limits placed on
estimates and the best available information
sources are used.
Purpose:
• Separate minor risks from major.
• Provide data to assist in evaluation.
Preliminary analysis:
• Excluded Risks where possible should be listed.

Risk Evaluation:
 Identify Source of Harm
 Hazardous event or process
 Hazardous substance
 Equipment
 Identify who could be harmed
 Researcher
 Others students
 Contractor/supplier
 Visitor
 Identify how harm could occur
 Accidental fall from height
 Contact with corrosive chemicals
 Injury
 First Aid Treatment
 Visit Clinic/ hospital
 Admitted in Hospital
 Permanent damage
 Acute Vs Chronic Effects
 Lab Acquired Infection
 Property Damage
 Breakage of glassware
 Equipment
 Furniture
 Building
 Environmental Release
 Release to Air
 Water
 Waste materials - solid
Identify what are the adverse conditions may arise due the hazard
present in your experiments, laboratory or environment
IDENTIFY POTENTIAL HARM

Risk Evaluation:
 Consider existing controls
 Engineering controls (Fumehood, glovebox, chains for
cylinder, others)
 Administrative controls (Signage, training, SOPs,
others)
 Personal Protective Equipment
 Existing control will not change the severity but only
likelihood
 Severity & likelihood is based on a matrix and the respective
criteria specified
 Risk rating is the product of severity by likelihood
 Refer to acceptability criteria on the recommended
action for different risk rating
 For medium & high risk, additional controls will be
required

Risk Evaluation:
Level Human (Impact to
Physical Being)
Biological Impact Environmental
Damage
Property Damage
(S$)
(1) Minor No Injury or light injury
requiring only first aid
treatment (MC < 4 days
MC)
May not cause human disease, if does, the
disease is unlikely to spread to the community
and there is usually effective prophylaxis or
treatment available;
Reversible Up to $5,000
(2) Moderate Any injury/ill health
leading to ≥ 4 days MC
or ≥ 1 day
hospitalisation or leads
to temporary disability
Can cause severe human disease, not
ordinarily spread by casual contact from one
individual to another; it may spread to the
community, but there is usually effective
prophylaxis or treatment available
Reversible but
takes years
$5,001 to $50,000
(3) Major Fatality, permanent
Disability or life
threatening disease
Can cause lethal human disease, may be
readily transmitted from one individual to
another, or from animal to human or vice-versa
directly or indirectly, or casual contact, it may
spread to the community; usually no effective
prophylaxis or treatment available
Irreversible More than $50,000
Severity Categories & Description

Risk Evaluation:
Likelihood Categories & Description
Level Events Frequency
(1) Remote Undesired event which may occur but unlikely, once in 5
years
(2) Possible Undesired event which is probable, once in a year
(3) Frequent Undesired event which probably occur in most
circumstances, once or more in a month

Risk Evaluation:
Risk matrix to determine Risk Level
Likelihood
Severity
Remote (1) Occasional (2) Frequent (3)
Minor (1) 1 2 3
Moderate (2) 2 4 6
Major (3) 3 6 9
Likelihood
Severity
Remote Occasional Frequent
Major Medium Risk High Risk High Risk
Moderate Low Risk Medium Risk High Risk
Minor Low Risk Low Risk Medium Risk

Risk Evaluation:
Acceptability of Risk
Risk
Score
Risk
Level
Acceptability
of Risk
Recommended Actions
<3
Low
Risk
Acceptable
No additional risk control measures required. To continue to monitor to
ensure risk do not escalate to higher level.
3 – 4
Medium
Risk
Moderately
Acceptable
Acceptable to carry out the work activity; however, task need to be
reviewed to bring risk level to As Low As Reasonably Practicable.
Interim control measures such as administrative controls can be
implemented. Supervisory oversight required.
>4
High
Risk
Not
Acceptable
Job must not be carried out until risk level is brought to at least medium
risk level.
Risk controls should not be overly dependant on personal protective
equipment. Controls measures should focus on Elimination, substitution
and engineering controls.
Immediate Management intervention required to ensure risk being
brought down to at least medium level before work can be commenced.

Risk Control:
What can be done to control risks in the workplace ?
Some measures are : ( from most to least preferred )
 Elimination – eliminate the hazard from the workplace
 Substitution - substituting a hazardous substance or
process with a less hazardous one.
 Engineering controls - installing machine guarding or
enclosing a noisy machine.
 Administrative controls - applying a permit-to-work
system or lock-out and tag-out procedures.
 PPE - provision and use of these equipment, AND
 SWP – Safe Work Procedures

Quality Control:
A stabilized surrogate sample of
known concentration that is
analyzed like a patient (or
analyte) sample to determine
assay/surrogate recovery and
result stability over time
Advantages:
– QC has target values: if the
assay recovers the target, then
everything is
assumed stable (ie, instrument,
reagent, operator, sample).
– QC monitors the end product
(result) of the entire test system.
Disadvantages:
– Patients’ results can
be reported before
problem is detected.
– When problem is
detected, one must go
back and reanalyze
patients’ results since
the last “good” QC.

Types of Quality Control:
 “On-Board” or Analyzer QC – built-in device controls or
system checks
 Internal QC – laboratory-analyzed surrogate sample controls
 External QC – blind proficiency survey; samples sent a few
times a year to grade an individual laboratory’s performance
against other laboratories
 Other types of QC – control processes either engineered by
a manufacturer or enacted by a laboratory to ensure reliable
results (eg, checking the temperature in a shipping container
of new reagents)

Developing a Quality Control Plan:

Developing a Quality Control Plan:
Monitoring should include, but is
not limited to the following
components:
• Testing personnel
• Environment
• Specimens
• Reagents
• Test system
• Reevaluation of the IQCP should
be considered when
• changes occur in any of the
above components.
Documents may include:
• QC review
• PT (scores, testing failures,
trends)
• Patient results review
• Specimen rejection logs
• Turnaround time reports
• Records of preventive
measures, corrective actions,
and
follow-up
• Personnel competency
records

Controls :

Implementation & Review :
 Management staff or Principle Investigator will need to approve the
implementation of control measures.
 Monitoring of the process or activity has to be carried to ensure
that there is no residual risk or additional risk arising from the
control measures.
 Risk assessors have to check or monitor the new implementation
of control measures and to communicate with respective lab or
operational personnel.
 Review on Risk Assessment to be carried on the following basis:
- At lease once every three years base on legislative
requirements
- After an accident/incident occurrence
- Any change in process or activity

Finally…
 A QCP summarizes potential device errors and how the laboratory
intends to address those errors.
 A QCP can be high level or very detailed depending on the device,
the laboratory, and the clinical application of the test result. The
results may vary from one laboratory to next.
 The QC plan is scientifically based. It depends on the extent to
which the device’s intended features or actions achieve its intended
purpose in union with the laboratory’s expectation for ensuring
quality test results.
 Once implemented, the quality control plan is monitored for
effectiveness and modified as needed to maintain risk at a clinically
acceptable level.

Further Clarifications:
dotbee04@yahoo.com

?
QUESTIONS
THANK YOU
2348066884793
dotbee04@yahoo.com
linkedin.com/Dotun Bolade
twitter.com/dotunBolade
oladotunbolade@gmail.com

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