This document summarizes the risks identified in complying with ISO/IEC 17025 requirements and the actions taken by the laboratory to mitigate those risks. It identifies 14 main risk areas related to impartiality, confidentiality, personnel, facilities, equipment, purchasing, methods, sampling, test items, measurement uncertainty, validity of results, reporting, complaints, and management system documentation. For each risk, it evaluates the impact and likelihood, identifies mitigation actions taken through procedures, policies, and controls, and reduces the residual risk. The overall goal is to ensure the validity of test results, protect confidentiality, maintain impartiality, and improve customer satisfaction and confidence in the laboratory's operations.

1. Date of Risk Assessment:
SR.NO
17025
REQUIREMENT
LAB SITUATIONs RISK I P RR LAB ACTION and Nature
RR
After
MITIGATION
Opportunity if any
1
4.1 Impartiality
Organizationalsodoes
ConsultancyServices
and testsinhouse
samples
Undue Pressure
influencelab results
M M M
Procedure onImpartiality,sample
coding,Organizationstructure
separatingtwoactivities,Quality
Policy - Mitigation
Low
Safeguarding
impartiality will
protect the interests
of laboratory as well
as customer and
save legal hassles
Personnel Interests,
relationshipof staff
Influence onroutine
basis
M M M
Procedure onImpartiality /HR
Polices- Mitigation Low
Improve lab
confidence
4.2
Confidentiality
Customer's Information
/ Informationabout
customerfromothers
SharingConfidential
informationtothird
party - Legal Issues
H L M
ConfidentialityPolicyinformedin
advance - Elimination
Nil
Save Legal Hassel,
Improve
confidence in lab
operations
Lab Visitors /External
service providers
Sharinginformation
to external
interestedparties.
H L M
Confidentiality Formatisfilled -
Elimination
Nil
2 6.2 Personnel
Employmentof External
personnel
As onDate None
Contractual Agreement.
Zero
Competent staff
with clear
responsibilities will
ensure validity of
results, customer
confidence
Internal personnel Legal Issues H L M
EmploymentAgreement..Procedure
on impartiality- Mitigation
Low
Recruitmentof
personnel- Competence
etc.
Lack of qualification,
knowledge,
experience-Doubt
on validityof results
H M H
Procedure forrecruitmentof
personnel andcompetence
establishedasperNABL165 /
Ensuringvalidityof results
Low
Training
Influence onroutine
basis
L M M
Conducttrainingonbasisof need,
JobDescription - Mitigation
Low
Authorizationand
responsibilitiesof key
personnel
Influence onroutine
basis
M L M
Interoffice Communication/Notice -
Mitigation
Low

2. SR.NO
17025
REQUIREMENT
LAB SITUATIONs RISK I P RR LAB ACTION and Nature
RR
After
MITIGATION
Opportunity
if any
3
6.3 Facilities&
environmental
condition
Inappropriate storage
conditions,cross
contamination
RiskingSample
integrity
H H H
Providedseparate storage areas or
separate glassware orseparate work
benchor partitions- Mitigation
Low
Safe Work
place
reduces lost
work days,
save legal
hassles,
claim
settlements
Housekeeping
Influence onresults
and Safety and
health
L L L
Good Lab practicesFollowedasregular
cleaningandmaintenance - Mitigation
Low
Emergencies- Man
made
Chemical Spillage,Fire,
hazardousmaterial,
accidents
Influence on Safety H M H
MSDS provided,Fire Extinguisher, Use
of PPE, Fume Hood,Eye Shower,Fire
Extinguisher&Trainings- Mitigation
Low
Emergencies natural-
Flood,earthquake
Disruptionof Work L L L Acceptedandcarriedalong. Low
Powercut
Influence onlab
activities,Records,
Instrument
breakdownand
maintenance voiding
itsoperatingstatus
M M M
D.G Set provided,InvertorsandUPS
used- Eliminated
Low
Equipments
long life is
ensured.
Customer
Confidence
is built
Environmental
Conditions
Influence onresult M M M
Environmental conditionscontrolled
and maintained,intermediate checks
done- Mitigation
Low

3. SR.NO
17025
REQUIREMENT
LAB SITUATIONs RISK I P RR LAB ACTION and Nature
RR
After
MITIGATION
Opportunity
if any
4 6.4. Equipment
Use of expiredCRMs,
Use of inappropriate
chemicalsand
consumables
Influence onresult H H H
ReviewandmaintainCRMlisttimely,
Checksbefore use- - Mitigation
Low
Validity of
results is
ensured/
Equipments
life is more
EquipmentCalibration-
Absence of Plan,Gapsin
calibration,Lackof
traceability
Nonconformances H L M
Supplierselections/Responsibilityfor
Plan/ Checkbefore use - - Mitigation
Low
Maintenance of
Equipments /
Intermediatechecks/
Overloadingor
mishandlingof
equipment
Influence onresults H M H
Intermediatecheckof Instrument,
Routine checkup AMC or OnCall for
critical equipment,use of trainedstaff
or undersupervision,Labels,Job
descriptions-Mitigation
Howeverdependinguponuse andif no
testingisdone the periodicitymaybe
varied- Acceptedwithinformed
decision
Low /
Accepted
5
6.6 Externally
provided
products and
services
Procurementof
Products/Services
Influence onresults
and resources
H L M
Procedure onExternallyprovided
productand services toensure use of
suitable suppliers - Mitigation
Low
Smooth
operations
of lab

4. SR.NO
17025
REQUIREMENT
LAB SITUATIONs RISK I P RR LAB ACTION and Nature
RR
After
MITIGATION
Opportunity
if any
6
7.1 Reviewof
Request,
Tendersand
contracts
Understanding
Customer's
Requirement and
matchingwithour
capabilities,Informing
decisionrule,test
methods,cooperating
withcustomer-
Misguidingcustomer
and noncooperation
Loss of customer,
brand name in
market,credibility
H M H
Procedure forreviewof requests,
tendersandcontracts isdocumented-
Mitigation
Low
Satisfied
customer
7
7.2 Selection,
verificationand
Validationof
Methods
Use of wrong methods-
Notupdated,Not
validated,deviations
not justified
Influence onResults,
Loss of accreditation
or Scope reduction
H L M
Laboratory usesstandardmethodsonly
and keepsthemupdated - Eliminated
Nil-
Ease of
Competence
establishment
8 7.3 Sampling
Lack of Plans/Formats -
Leadingto
unrepresentative
samplesbeing
withdrawnand
Technical records
incomplete/lackof
identifications
Influence onResults H L M
Formatsare inplace,Trainingsand
samplingplansare followed- Mitigation
Low
True results
9
7.4 Handling of
Test Items
Improperhandling
while takingtolabin
case of sampling/
ImproperHandlingin
the laboratoryitself
afterreceipt/Lackof
identification
Impact onvalidityof
results;Lossof
customerconfidence
H M H
Procedure forHandlingof testitemsis
documented- Mitigation
Low
Confidence
in lab
operations

5. SR.NO
17025
REQUIREMENT
LAB SITUATIONs RISK I P RR LAB ACTION and Nature
RR
After
MITIGATION
Opportunity
if any
10
7.6
Measurement
uncertainty
Contributionssignificant
to measurement
uncertaintyisnot
identified
Influence onresults,
decisionrule
H L M
Identificationandevaluationof all
factors significanttoMU- Mitigation
Low
Conformance
to Decision
Rule
11
7.7 Ensuring
the Validityof
Results
Failure toundertake
applicable methodsfor
ensuringvalidityof
resultsordoinglessin
number
RiskingSelf
Confidence,Lossof
resources
H M H
Procedure for Ensuring the Validity of
Results is documented and PT Plan-
Mitigation
Low
Confidence
in lab
operations
12
7.8 Reporting
of results
Noncompliance to
reportingrequirements
includingmisuseof
Symbol
Lab Credibilityis
lost/Accreditation
on Risk
H M H
Testreport Format/TrainingsonNABL-
133 andotherNABL policies/
InformationonDecisionRule -
Mitigation
Low
Happy
Customer
13
7.9 Complaints
8.6.2 Feedback
/
Improvements
ComplaintsIgnored &
NotReported /
feedbacksnotobtained
or not analysed
Affect Brand Value,
Unhappy customer
H L M
Tracking and recording complaints and
actions undertaken to resolve them
(Procedure) as well as obtaining and
analysing feedbacks- Mitigation
Low
Happy
Customer
14
Non
Conforming
work, CA
Internal audits,
Control of
Document and
record, MRM,
Quality Policy
lack of documentation
or its implementation
Doubtof
managements
commitment;effects
overall labs
operations
H M H
Jobdescriptionsandresponsibilitiesare
defined-Mitigation
Low
Consistency
in
operations
and self
improvement
NEXT Review of Risk Assessment:June 2019