See discussions, stats, and author profiles for this publication at: https://www.researchgate.

net/publication/337951559

ISO 17025 risk management example

Presentation · December 2019

DOI: 10.13140/RG.2.2.31682.94409

CITATIONS READS

0 629

1 author:

Shodlik Masharipovich Masharipov

Tashkent State Technical University
70 PUBLICATIONS   5 CITATIONS   

SEE PROFILE

Some of the authors of this publication are also working on these related projects:

Metrology and measurement uncertainty View project

метрология и стандартизация View project

All content following this page was uploaded by Shodlik Masharipovich Masharipov on 16 December 2019.

The user has requested enhancement of the downloaded file.

 Doc. QCL/FRM 10.01
Lab Risk Assessment based on ISO 17025:2017 for Chemical Labs

Initial Risk Assessment Residual Risk Assessment

(without any controls in place)
Risk Further
Sr Severity Severity Likelihoo Risk
Area Activities / Process Quality Concerns / Risks Likelihood Ratin Existing Controls in Place Controls
# Rating Rating d Rating
g Required
Sample receiving person from lab
verify name & identification Criteria.
Furthermore, as sample received in
Lab Misidentification of
1 Sample collection 3 3 9 lab it is entered in Sample Log and 3 1 3
Activities sample/specimen
batch number/code is also alotted
otherwise he will return sample to
customer for proper identification

All sample are stored in designated

location of lab and environment
Lab Samples received in lab is not
2 Sample collection 4 2 8 conditions of lab is recorded on daily 4 1 4
Activities placed in controlled environment
basis. Lab Incharge also verified
environment record.

Weighing balance are calibrated and

Inaccurate process parameters
Lab (e.g. Temp. Pressure, weighing
3 Sample preparation
Activities error), expire reagents used in
preparation
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.
4 2 8 4 1 4
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
 Lab STMs are developed and
available at the place of use. Active
testing parameters are saved in
Lab Inaccurate test parameters HPLC. Chemist just select the test
4 Performing Test 4 2 8 4 1 4
Activities wABC e performing test parameter from equipment for
testing.
To ensure accuracy of test results lab
run standard with sample
Lab environment is controlled and its
Lab person perform test in lab
Lab conditions is recorded on daily basis.
5 Performing Test without considering environment 4 2 8 4 1 4
Activities Lab Incharge also verify evironment
conditions
record.
Lab Instruments are calibrated from
Lab
6 Performing Test Inaccurate measurements 4 1 4 accredited lab for accurate 4 1 4
Activities
measurements
Lab QC Lab Staff health & work risk, Lab has chemical spill kit available
Activities Lab environment condtion and and Emergency eye wash is placed
7 Chemical Spillage 3 4 12 3 1 3
result error may occur to avoid serious injury.

Equipment log books are available in

which all data of equipment are
recorded on daily basis.
Lab Person prepare test report
Lab Chromatrograph results of actives
8 Preparing Test Results without performing test on 5 2 10 4 1 4
Activities are attached with final report to
specimen
ensure the integrity and these
chromatrographs have date and time
mention on it

Final report is approved by GM

Technical/Manager QC after
verification of test evidence and
Miscalculation Data entry reviewed by Chemist. If evidence is
Lab
9 Preparing Test Results mistakes wABC e preparing 5 2 10 not appropriate report will not be 5 1 5
Activities
results 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
 Lab Staff has implemented
Staff of QC lab leaks
Confidenti Confidentiality Policy
10 Lab Information Leakage confidential information of test 4 2 8 4 1 4
ality Furthermore all confidential
results and equipment’s
information is under control condition
Lab has signed NDC agreement from
Personnel other than lab having
Confidenti all authorized person. In case of any
11 Lab Information Leakage authorization of lab data (IT etc.) 2 5 10 2 2 4
ality violation legal action can be taken
leak confidential data
against person
PCs are password protected and
hard form documents are under lock
Confidenti Lab confidential data theft in
12 Lab Information Leakage 2 5 10 & key. Authorized person have 2 2 4
ality electronic or hard form
signed Non-Disclosure (NDC)
agreement
Staff of QC Lab should be
independent from the Lab Staff has implemented
production. Impartiality Policy.
13 Impartiality Impartiality 4 2 8 4 1 4
Lab is independent of external or
internal pressure and conflicts

Test report adultration is not possible

Lab Person adulterate the report in case of active because its result is
14 Impartiality Performing Test due to good relation with 4 2 8 automatically generate from system. 4 1 4
customer In case of weighing, volume, pH log
books are maintained. Furthermore

Lab Authorized persons and

Due to per pressure from
company owner; top
15 Impartiality Ownership
management interfere to change
test results
management have signed non-
disclosure agreement with company
in case of violation legal action can
2 5 10 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

16 Impartiality Shared Equipment
17 Impartiality Shared facility
Due to un-availability of some
desire equipment; Lab use
production or store department
equipment for its activities
Lab facility is used by production
or store department for its
activties
ABC lab has dedicated equipment in
labs that is not available in other
3 5 15 department. Other than this 1 2 2
supporting equipments like monitors
etc. back up are available in lab
Lab facility is dedicated for testing
activities only and persons are
4 5 20 2 2 4
authorized for this. Unauthorized
persons are not allowed in lab
 RISK MATRIX

Risk Assessment Matrix Value Probability Definition

Level of Risk 5 Very High At least once in a Day
IMPACT 4 High At least once in week
Very
PROBABILITY Very Low Low Medium High 3 Medium At least once in a month
High
1 2 3 4 5 2 Low At least once in 6 months
Very High (5) 5 10 15 20 25 1 Very Low At least once in a year or Rarely Occurs
High (4) 4 8 12 16 20
Medium (3) 3 6 9 12 15 Value Impact Description
Little/No impact on testing activities or the
Low (2) 2 4 6 8 10 1 Very Low
personnel performing the activity
Low Impact due to changes in work
Very Low (1) 1 2 3 4 5 2 Low environment which may create delays in
testing activity
Medium Impact due to changes in work
3 Medium environment (or equipment) which may
lead to ambiguous testing results
High Impact due to personal grievances or
pressure on the personnel performing the
4 High 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 /
5 Very High Bribery case / compromise/change in
report for personal gains

View publication stats