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ISO 17025 Lab Risk Assessment
Method · September 2019
DOI: 10.13140/RG.2.2.17939.02087
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Doc. QCL/FRM 10.01
Lab Risk Assessment based on ISO 17025:2017 for Chemical Labs
Sr
#
1
2
3
Area
Activities / Process
Lab
Sample collection
Activities
Lab
Sample collection
Activities
Lab
Sample preparation
Activities
Initial Risk Assessment
(without any controls in place)
Risk
Severity
Likelihood Ratin
Rating
g
Quality Concerns / Risks
Misidentification
sample/specimen
of
Samples received in lab is not
placed in controlled environment
Inaccurate process parameters
(e.g. Temp. Pressure, weighing
error), expire reagents used in
preparation
3
4
4
3
2
2
Residual Risk Assessment
Existing Controls in Place
Severity Likelihoo Risk
Rating
d
Rating
9
Sample receiving person from lab
verify name & identification Criteria.
Furthermore, as sample received in
lab it is entered in Sample Log and
batch number/code is also alotted
otherwise he will return sample to
customer for proper identification
3
1
3
8
All sample are stored in designated
location of lab and environment
conditions of lab is recorded on daily
basis. Lab Incharge also verified
environment record.
4
1
4
4
1
4
8
Weighing balance are calibrated and
placed on flat surface. Furthermore
rubber pad under weighing balance
to reduce vibrations and it is place in
designated position.
Volume measurement is done
through calibrated flask.
Chemist are properly trained on
testing activities.
Reagents lists are available used in
testing activities, expiry of reagents
are recorded in this list. Before using
reagents Chemist verify its expiry
Further
Controls
Required
4
Lab
Performing Test
Activities
Inaccurate
test
parameters
wABC e performing test
4
2
8
5
Lab
Performing Test
Activities
Lab person perform test in lab
without considering environment
conditions
4
2
8
6
Lab
Performing Test
Activities
Inaccurate measurements
4
1
4
3
4
12
7
8
9
Lab
Activities
Chemical Spillage
Lab
Preparing Test Results
Activities
Lab
Preparing Test Results
Activities
QC Lab Staff health & work risk,
Lab environment condtion and
result error may occur
Lab Person prepare test report
without performing test on
specimen
Miscalculation Data entry
mistakes wABC e preparing
results
5
5
2
2
Lab STMs are developed and
available at the place of use. Active
testing parameters are saved in
HPLC. Chemist just select the test
parameter from equipment for
testing.
To ensure accuracy of test results lab
run standard with sample
Lab environment is controlled and its
conditions is recorded on daily basis.
Lab Incharge also verify evironment
record.
Lab Instruments are calibrated from
accredited lab for accurate
measurements
Lab has chemical spill kit available
and Emergency eye wash is placed
to avoid serious injury.
4
1
4
4
1
4
4
1
4
3
1
3
10
Equipment log books are available in
which all data of equipment are
recorded on daily basis.
Chromatrograph results of actives
are attached with final report to
ensure the integrity and these
chromatrographs have date and time
mention on it
4
1
4
10
Final report is approved by GM
Technical/Manager
QC
after
verification of test evidence and
reviewed by Chemist. If evidence is
not appropriate report will not be
approved. All test results from raw
data and from equipment data. If it is
not match with raw or machine data
then Chemist correct typo error
5
1
5
Staff
of
QC
lab
leaks
Confidenti
10
Lab Information Leakage confidential information of test
ality
results and equipment’s
4
2
8
4
1
4
2
2
4
2
2
4
8
Lab
Staff
has
implemented
Impartiality Policy.
Lab is independent of external or
internal pressure and conflicts
4
1
4
8
Test report adultration is not possible
in case of active because its result is
automatically generate from system.
In case of weighing, volume, pH log
books are maintained. Furthermore
4
1
4
10
Lab Authorized persons and
management have signed nondisclosure agreement with company
in case of violation legal action can
be taken against person.
ABC has good repute in market so
top management/ owner can't force
to adultrate results to avoid minimal
loss as compare to company repute
Personnel other than lab having
Confidenti
11
Lab Information Leakage authorization of lab data (IT etc.)
ality
leak confidential data
2
5
10
Confidenti
Lab confidential data theft in
Lab Information Leakage
ality
electronic or hard form
2
5
10
12
13 Impartiality Impartiality
14 Impartiality Performing Test
15 Impartiality Ownership
Staff of QC Lab should be
independent from the
production.
Lab Person adulterate the report
due to good relation with
customer
Due to per pressure from
company owner; top
management interfere to change
test results
4
4
2
2
2
5
Lab
Staff
has
implemented
Confidentiality Policy
Furthermore
all
confidential
information is under control condition
Lab has signed NDC agreement from
all authorized person. In case of any
violation legal action can be taken
against person
PCs are password protected and
hard form documents are under lock
& key. Authorized person have
signed
Non-Disclosure
(NDC)
agreement
16 Impartiality Shared Equipment
Due to un-availability of some
desire equipment; Lab use
production or store department
equipment for its activities
17 Impartiality Shared facility
Lab facility is used by production
or store department for its
activties
3
4
5
5
15
ABC lab has dedicated equipment in
labs that is not available in other
department. Other than this
supporting equipments like monitors
etc. back up are available in lab
1
2
2
20
Lab facility is dedicated for testing
activities only and persons are
authorized for this. Unauthorized
persons are not allowed in lab
2
2
4
RISK MATRIX
Risk Assessment Matrix
Level of Risk
IMPACT
PROBABILITY
Value
5
4
Probability
Very High
High
Definition
At least once in a Day
At least once in week
3
Medium
At least once in a month
4
20
16
12
Very
High
5
25
20
15
2
1
Low
Very Low
At least once in 6 months
At least once in a year or Rarely Occurs
Value
Impact
6
8
10
1
Very Low
3
4
5
2
Low
3
Medium
Description
Little/No impact on testing activities or the
personnel performing the activity
Low Impact due to changes in work
environment which may create delays in
testing activity
Medium Impact due to changes in work
environment (or equipment) which may
lead to ambiguous testing results
Very Low
Low
Medium
High
Very High (5)
High (4)
Medium (3)
1
5
4
3
2
10
8
6
3
15
12
9
Low (2)
2
4
Very Low (1)
1
2
4
5
View publication stats
High
High Impact due to personal grievances or
pressure on the personnel performing the
test which may lead to compromised test
results or falsified report ultimately lead to
high financial loss > 500000
Very high Impact due to illegal activity /
Very High Bribery case / compromise/change in
report for personal gains