NABL

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