QSF 1 - RISK AND OPPORTUNITIES REGISTER-compilation by Clause

Form No : 1/1
Issue Date : 7 September 2018

JABATAN KIMIA MALAYSIA
QUALITY SYSTEM FORM (QSF) Authorisation : Senior Director QMRC
QSF 1: RISK AND OPPORTUNITIES REGISTER
BRANCH/ DIVISION/ SECTION : PREPARED BY :

WORK PROCESS/ AREA : APPROVE BY :
DATE : REVIEW DUE :
1. Risk & Opportunity Identification 2. Risk Assessment 3. Risk Control

Work Process Risk & Opportunity Effect Probability Severity Risk Matrix Risk level Eliminate Prevent Minimize
(P) (S) (R = P x S)
1) Impartiality Risk 1: Financial Alteration on 2 3 6 Moderate Counseling and Request
problem result consultation financial
Close monitoring expense
through
Department
Opportunity:
Consultation of financial
management
Risk 2: Social life Alteration on 2 3 6 Moderate Counseling and
result consultation
Close monitoring
Opportunity:
Consultation
Risk 3: Conflict of Inaccurate 2 2 4 Moderate Independent party Case assign

interest analysis,
injustice
Opportunity: Maintain
credibility and prevent
negative perception
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(P) (S) (R = P x S)
Risk 4: Direct Inaccurate 2 5 10 High Notify Senior

intervention from analysis, impact Officer
stakeholders alterations of
results/report
Opportunity: Maintain
credibility and integrity
Risk 5: Self review Inaccurate 2 3 6 Moderate Close

analysis monitoring
Opportunity:
Risk 6: Hearsay Inaccurate 3 2 6 Moderate Senior officer Review case

analysis, reviewed and follow
injustice test method
Opportunity:
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Work Process Risk & Opportunity Effect Probabilit Severity Risk Risk level Eliminate Prevent Minimize
y (P) (S) Matrix (R
= P x S)
2) Confidentiality Risk 1: Leak of Unsatisfactory 2 4 8 Moderate Proper filing system
Controlled document to customer and (Report).
(report, etc.) by external beneficial to Minimize or
party due to not competitor controlled hard
properly managed copy. Classification
Risk 2: Leak of Loss of 1 5 5 Moderate OSA and legal
information by in ethical confidential info action
personnel due to his/her to the
personal gain interested party
and lost
credibility and
customer trust
Opportunity: establish
OSA (Official Secret Act
1972) and legal action
Risk 3: System breach Same as Risk 2 1 5 5 Moderate upgrade more
(server, access card) secure system
(firewall, antivirus,
data encryption
etc)
Opportunity: upgrade
more secure system
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1.Risk & Opportunity Identification 2. Risk Assessment 3. Risk Control

Work Process Risk & Opportunity Effect Probability Severity Risk Risk level Eliminate Prevent Minimize
(P) (S) Matrix
(R = P x S)
3) Personnel Risk 1: Insufficient - Affecting results of 3 4 12 High
technical analysis, may Staff impact To follow
skills/competency produce wrong rotation succession plan
results too accordingly
- work delays frequent
(affecting TAT)
- Unable to provide
the required analysis
to client
Opportunity: On the job - Improve lab’s
training/ Participate PT proficiency
ILC - Produce accurate
and quality result
- Meeting TAT
- Improve laboratory’s
efficiency
- Able to meet
customer’s
requirement
Risk 2: Ineffective - May produce wrong 2 3 6 Moderate - Review
training results training
- Unable to provide module
the required analysis - Target
to client suitable
- Incompetent worker participant
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- Work delays - Choose

- Affect lab’s suitable
proficiency and trainers
capability (both theory
- Waste of resources and practical)
(cost, time) with no
output
Opportunity: External - Produce accurate
training and quality result
- Meeting TAT
efficiency
- Able to meet
customer’s
requirement
Risk 3 : Poor talent - Loss of expertise 2 4 8 Moderate - Restructure
management-(between - Not able to sustain accordingly
highly specialized and experts - Enhance
multi-tasking) - No specialized area subject
- Work demotivation matter
- Work delays expert
program
/mentoring
- Train for
backups
Opportunity: To identify - More specialized
the correct person for area
each category - Able to sustain
expertise
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Risk 4: High staff - Loss of expertise 2 4 8 Moderate - Restructure

turnover - Not able to sustain accordingly
(Transfer/moved) experts
- No specialized area
- Demotivation
- Work delays
Opportunity: Implement - Produce multi-
job rotation tasking and highly
skilled staffs
- Backups for
competent test
Risk 5 : Low motivation - Demotivation 2 4 8 Moderate - S
personnel - Loss interest to
- Education level higher perform better
than the job position) - Compromised quality
- Weekend family of work
- Financial problem
Opportunity: Provide - Improves motivation - Restructure

Counseling, Rewards - More work quality accordingly
(financial or self-esteem), - Improve - Fair work
Reshuffle accordingly performance distribution
- Plan work
force
efficiently
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Work Process/Source Risk & Opportunity Effect Probability Severity Risk Matrix Risk Elimin Prevent Minimise
(P) (S) (R = P x S) level ate
4) Facilities & Risk 1: - Analysis cannot 3 3 9 Moder - Rewiring
Environment Instrument breakdown be performed ate - Increase voltage
Conditions - Instrument - Audit power
Disruption of utilities require supply by TNB
Opportunity: repair/recalibrat - gen set available
(power failure, water)
- Purchase UPS for e
instrument - Sample
- Justify for recruitment deteriorate
electrical technician “J”
Risk 2: 2 3 6 Moder -
Laboratory contaminated ate alternative/pro
(action per storage
require area
)
Opportunity:
Risk 3: - Ruin JKM image 2 3 6 Moder - Training all
Report delayed - Allow ate staff
competitor to (action - Purchase of
flourish require latest
) instrument
- Request
additional
budget
-
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Form No : 1/1

Work Process Risk & Opportunity Effect Probability Severity Risk Matrix Risk Eliminate Prevent Minimize
(P) (S) (R = P x S) level
5) Equipment Risk 1: Piagam 2 4 8 Mod Scheduled PM - Spare part
Breakdown pelanggan, erate - Competent
TAT bertambah, personnel to
Kesalahan troubleshoot
laporan
Opportunity: Staff training,
Apply for equipment new method
procurement
Risk2: No information 2 3 6 Mod Proper validation Competent
Not validated on instrument erate plan personnel
performance
Opportunity: Performance on
Request training from the instrument
supplier
Risk 3: Service 3 3 9 Mod Perancangan awal Borrow from
Insufficient spare parts interrupted, erate procurement other
and consumables Delay in laboratories
reporting,
Service delivery
not efficient,
Not meet KPI
Opportunity:
Increase procurement
budget
Risk 4: Not fully utilize 2 4 8 Mod Lupus Engage technical Keep close
No service expert on budget, erate expert contact with
delay in service expert
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reporting, result
not accurate,
injustice
Opportunity:
Training oversea
Risk 5: Unreliable 2 4 8 Mod Calibration Close
No calibration result, quality erate program monitoring
and credibility
department,
client unable to
get required
result
Opportunity:
Risk 6: Inconsistence 2 3 6 Mod Lupus Perancangan

Old instrument result erate awal
procurement
Opportunity: Receive high
Purchase new end instrument,
instrument training, gain
knowledge
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(P) (S) (R = P x S)
6) Metrological Risk 1: Incompetent and Invalid result 1 4 4 Moderat Training – specific
Traceability inexperience Personnel to and decrease e modules,
carried out calibration the quality scheduled, target
equipment/apparatus level group etc
Opportunity: improve the
personnel competency
Risk2: Certified Reference High budget. 1 4 4 Moderat Use of RM
Material are too e
expensive and limited
supplier (Especially drug
substances)
Opportunity: Setup Reduce
Reference Material budget
Section to provide the
reference materials
Risk 3: Supplier had Delay the 2 4 8 Moderat
difficulty to supply on new extension of e
drugs (NPS), eg. No the new scope
License on the certain
drugs
Opportunity: upgrade
instruments software
(Library Data)
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(P) (S) Matrix
(R = P x S)
7) Externally Risk 1: Defective - Affecting results of 2 5 10 High Assigned
provided product or material analysis either work Impact competent
product delays (affecting TAT) officer during
and and produce wrong stock take and
results delivery
services
- Unable to provide
the required analysis
to client
Opportunity: can claim - Produce accurate
or get new product and quality result
- Meeting TAT
efficiency
- Able to meet
customer’s
requirement
- No compromisation
during evaluation
and put emphasize
on quality rather
than price
Risk 2 : Raw material - Affecting results of 2 2 4 Moderate Frequent
delay analysis either work follow ups and
delays (affecting TAT) proper
and produce wrong management
results of
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- Unable to provide inventory/stock

the required analysis control prior to
to client procurement of
raw material
Opportunity: use - Produce accurate
alternatives to find raw and quality result
material/ method - Meeting TAT
Outsource service - Improve laboratory’s
within internal lab efficiency
- Able to meet
customer’s
requirement
- No compromisation
during evaluation
and put emphasize
on quality rather
than price
Risk 3 :No support 2 4 8 Moderate Review supplier
service (after sales on next
service) procurement,
service according
to schedule,
follow instruction
manual.
Opportunity: gain
knowledge when trying
to troubleshoot
/opportunities for
training
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and minimize service

cost
Risk 4: Supplier non- 2 5 10 High Close review of

conformance Impact non-conformance
supplier on next
procurement of
product and
services
Opportunity: able to
procure new instrument
and chance to get new
supplier
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Work Process/Source Risk & Opportunity Effect Probabilit Severity Risk Risk level Elim Prevent Minimise
y (P) (S) Matrix inat
(R = P x e
S)
8) Review of Risk 1: Unable to meet customer - Ruin JKM 2 3 6 Moderat - Training all staff
Request, tenders expectation and satisfaction image e - Purchase of latest
and contracts - Allow instrument
competitor to - Request additional
-Customer flourish budget
request/dialogue Opportunity:
- To enhance JKM image
- procurement of instrument
and chemical
- Build confidence of JKM
- Build up networking
- Recognition of JKM expertise
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Form No : 1/1


Work Process Risk & Opportunity Effect Probabilit Severity Risk Risk Eliminate Prevent Minimize
y (P) (S) Matrix (R level
= P x S)
9) Verification Risk 1: Unreliable result 2 3 6 Mode Validation of test Validation
and Suitability of the test rate method plan
validation method
method Opportunity: Enhance
Feasibility study in individual
training knowledge
Risk 2: Quality and 2 4 8 Mode Performance check, Close
Unreliable result credibility of rate Follow instruction monitoring
department, manual
service delivery
and
performance to
the client
Opportunity: Continuous
Analyst training improvement
Risk 3: Quality and 2 3 6 Mode Dialogue with client Close
Unable to meet client credibility of rate monitoring,
requirement department adhere with
SOP
Opportunity: Increase
Collaboration/dialogue stakeholder
with client relationship
Risk 4: Inaccurate 2 4 8 Mode Stop case Training program, Close
Incompetence result, rate receiving, exit hand-on training monitoring by
personnel unplanned task policy due to from competent supervisor
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Work Process Risk & Opportunity Effect Probabilit Severity Risk Risk Eliminate Prevent Minimize
y (P) (S) Matrix (R level
= P x S)
negative personnel/supervis
behavior or
Opportunity:
Staff training
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10) Handling of Risk 1: compromise Invalid result/ 2 4 8 Mode Ensure the
Test Items Integrity/security/ dispute by Court rate requirements
-Storage of holding time of the test related to facilities
samples item and environmental
conditions are met
and follow
Opportunity:
Risk2: wrong 2 4 8 Mode Follow SOP
-Receiving and registration/labeling of Incorrect result rate properly
registration of test items. reported
samples
Opportunity:
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Work Process Risk & Opportunity Effect Probabilit Severity Risk Risk level Eliminate Prevent Minimize
y (P) (S) Matrix
(R = P x
S)
11) Handling Risk 1: Incorrect report Misjudgment by 2 5 10 High Technical data
of due to mistakes during customer such as Impact need to be verified
technical data transfer police, MOH before issuance to
records customer
Opportunity: To provide
reliable report
Risk 2: Loss of data due Incompliance to 2 3 6 Moderate - Provide
to: Department’s TAT instrument
i. Instrumentation maintenance
system failure schedule
(Software and - Provide regular
hardware problem) data backup
ii. Incompetence system
personnel - Only competent
personnel are
allowed to
handle data
system
- Provide
continuous
training
Opportunity: Able to
get updated system and
good training for
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personnel
Risk 3: Physical damage Unable to provide 2 3 6 Moderate - To have proper

of records due to reports and other controlled
environmental condition technical data to environment
causing moldy ,dull customers when such as good
reports during storage, needed ventilation
natural disaster(flood, system.
fire), pest attack - Provide special
requirement for
record keeping
area (fire
resistant
cabinets,
appropriate fire
system)
- Schedule
effective pest
control
Opportunity: To provide
suitable and proper
storage area
Risk 4: Breach of - Loss of Integrity 2 5 10 High - Assign authorized

records due to lack of and reputation to Impact personnel for
safety and the department record handling
confidentiality features - Manipulation of - Increase cyber
data by third party security system-
effective Firewall
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system
Opportunity:
Tighten security measures
Risk 5: Improper - Delay in report 3 2 6 Moderate Establish effective
maintenance of records delivery to retrieval system.
for retrieval due to customers For example:
insufficient -Time consuming Indexing, bar
identification coding, automation
system
Opportunity: Able to
improve records
management system in
line with current
approach
Risk 6: Timely work Delay in record 3 3 9 Moderate Provide updated
process required due to keeping and handling and adequate
lacking of infrastructure- process facilities
computer, printer,
internet connection
Opportunity: Upgrading
infrastructure in
accordance with current
technology
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Work Process/Source Risk & Opportunity Effect Probabilit Severity Risk Risk level Elimin Prevent Minimise
y (P) (S) Matrix ate
(R = P x
S)
12)Measurement of Risk: Method not accredited Unreliable 1 3 3 Low (no Maintain
Uncertainty method action current
require) practice
Opportunity: Set up EWG for
MU
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13) Ensuring the Risk 1: Quality of the 2 2 4 Low Adhere with SOP Early
Validity of No proper monitoring result, planning,
Results plan credibility of milestones,
department, awareness
Client unable to briefing
get good result
Opportunity:
Clear procedure
Risk 2: Quality of the 2 3 6 Mode Adhere with SOP
Incorrect performance result, rate
credibility of
department,
Client unable to
get good result
Opportunity: Increase
Competency / professionalism
Proficiency Testing
Risk 3: Increase 3 3 9 Mode Early
Limited resources workload, rate planning,
pressure milestones,
Opportunity: Undue pressure
Chances to increase
resources
Risk 4: Quality of the 3 3 9 Mode Training module
Limited experience result, rate
credibility of
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department
Opportunity:
Training
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14) Reporting Risk 1: System failure Service cannot 2 4 8 Mode Monitor frequently Inform
due to internet/ server be delivered rate by IT unit customer
breakdown cause delay efficiently. earlier due to
in reporting result / Customer the
close case unsatisfactory breakdown /
and complaint. technical
problem
Opportunity: install UPS
/ backup server to
maintain the operation
(Disaster Recovery
Centre, DRC)
Risk 2: mistake made by Incorrect report, 2 2 4 Low Reviewed report
personnel such as typo lost credibility and authorized by
error, wrong and customer competent
interpretation / trust personnel
calculation.
Opportunity:
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(P) (S) Matrix
(R = P x S)
15) Complaint Risk 1: Work beyond - Report delays due 2 3 6 Moderate - Dialogue to
scope of analysis to time taken for review
method clients
development and request
validation process - Gap analysis
- Questionable results - Improve
due to incompetent strategic
staffs /lack of planning
knowledge
- Loss of client
Opportunity: Expand - Improve lab’s

scope of service proficiency and
capability
- Able to meet
customer’s
requirement
- Chances for new
training
- Chances to get new
instrument
Page 25 of 26
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Work Process/Source Risk & Opportunity Effect Probability Severity Risk Risk level Elim Prevent Minimise
(P) (S) Matrix inat
(R = P x e
S)
16) Non-conforming Risk: 1. Ruin JKM 1 3 3 low (no Maintain
work 1. Report disputed image action current
2. Increase of require) practice
lab
competitor
Opportunity:
1. Continuous learning
Severity
1 2 3 4 5
Image No effect Division Level Centre / Branch Level Department Level Ministry Level
Work Process Operation as Normal Operation as Normal Operation 51% - 90% Operation 0- 50% Terminate
Lost / cost No Lost Lost more than 10K Lost more than 100K Lost more than 500K Lost more than 1M
Piagam Comply 90-100% Comply 80-89% Comply 70-79% Comply 51-69% 50% and below
Page 26 of 26

QSF 1 - RISK AND OPPORTUNITIES REGISTER-compilation by Clause

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Form No : 1/1

Issue Date : 7 September 2018