RISK Assessment Of Quality Management System ISO 9001:2015

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A
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Co
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Consequence
(C)
Likelihood
(L)
Risk Score
(L X C)
Risk Rating
INFORMATION/
TECHNOLOGY
Male ware/Spam
Computer Breakdown
Data Security
Software /Human Error
HR &
PERSONNEL
Employ dissatisfaction/dispute
Insufficient technical skills
Inadequate training
Absence of a constructive
company climate
Poor talent management
High staff turnover
Psychosocial risks, like stress,
bullying and harassment
DISASTERS
WHICH EFFECT
SENIOR AND
KEY STAFF
Accidents while Traveling
Key individual losses

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OPERATIONAL
Rejected product
Contaminated / unsafe
/defected products (Rework)
Unexperienced Staff
Planning and scheduling
conflicts
Late Deliveries/Poor Time &
Efficiency Management
Improper scheduling for
maintained equipment and/or
infrastructure
Contaminated/damage raw
materials
Equipment
– breakdown
– unavailability of parts
– no preventive maintenance
– no calibration
Superseded equipment
Raw Material delays/Supplier
Non conformance
CONTRACTUAL/
LEGAL
Breach of contract (either site)
Product liability
Statutory breaches
Changes in Government
Legislative changes

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MARKETING/
CUSTOMER
Defective products/loss of
orders
Export competition
Limited range of products
(Contractors)
Over-reliance on a small
Customers/ Dependence on
few ordering parties
Loss of marketing channels
/buying house
Undetected changes in
market/customer
NATURAL AND
MAN-MADE
DISASTER
Arson
Electrical
Fire
Flooding
Industrial accidents
Power breakdown
Sabotage
Malicious
damage/vandalism/terrorism
Staff exposure to long-term
hazards and pollution
Water cuts

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FINANCIAL
Industrial strikes
Interruption of supply
Loss of records
Exchange rates
Fines/judgment orders
Fraud
Inaccurate accounting and/or
reporting systems
Inadequate costing systems
(leading to unsustainable
pricing)
Inadequate insurance
Inventory risk
– Old/uselessness stock
- Stock losses
Negligence of staff
Poor cash flow
Asset/liability management
Credit rating

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MANAGEMENT
SYSTEM
Ineffective training about QMS
and Its requirements
Lack of Continuous
Improvement Process
Lack of documented
information control
Poor communication
(internal/external)
Lack of customer satisfaction
Supplier Performance not
monitoring/
Ineffective internal /external
audit
Ineffective corrective action on
 Internal audit
 MRM
 Customer Complaint
 Product Non Conformity
 Analysis of Data
MRM not scheduled timely
Resources not provided
Objectives not SMART
Risk with Product not
monitored regularly
QMS not formalized effectively

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1.0 Risk Analysis
1.1 Likelihood (L) score
Score
Frequency
Description
1
Rare
This will probably never happen or recur
2
Unlikely
Do not expect it to happen or recur but it is possible it may do so
3
Possible
Might happen or recur occasionally
4
Likely
Will probably happen or recur, but it is not a persisting issue / circumstance
5
Almost Certain
Will undoubtedly happen or recur, possibly frequently.
1.2 Consequence(C) score
Consequence
Catastrophic
5
Major
4
Moderate
3
Minor
2
Negligible
1
1.3 Risk Scoring = Likelihood score (L) x Consequence score (C)
Risk Assessment Matrix Risk Category
<----CONSEQUENCE-->
5
5
10
15
20
25
17-25
Unacceptable/High Risk
Stop Activity & Make Immediate Improvements
4
4
8
12
16
20
10-16
Tolerable/Moderate
Look to Improve within specified time scale
3
3
6
9
12
15
5-9
Adequate/Low Risk
Look to Improve at next review
2
2
4
6
8
10
1-4
Acceptable/Very Low Risk
No Further Action Required but ensure controls are maintained
1
1
2
3
4
5
1
2
3
4
5
<--------- LIKELIHOOD------>