Risk Based Thinking

ISO 9001:2015 & ISO 14001:2015
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

ISO 9001 REQUIREMENT
Clause No Requirement
Quality management system and its processes shall Address the risks and opportunities as determined in
4.4.1 (f) accordance with the requirements of 6.1.
5.1.1 (d) Leadership shall Promote the use of the process approach and risk-based thinking
Customer Focus -Ensure the risks and opportunities that can affect conformity of products and services and
5.1.2 the ability to enhance customer satisfaction are determined and addressed
While planning determine the risks and opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
6.1.1 d) achieve improvement.
The organization shall plan:

a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality management system processes (see 4.4);
6.1.2 2) evaluate the effectiveness of these actions.
9.1.3 Analysis and evaluate the effectiveness of actions taken to address risks and opportunities;
9.3.2 Discuss the effectiveness of actions taken to address risks and opportunities in MRM.
10.2.1 e) update risks and opportunities determined during planning, whenever NC arises

The organization shall determine the risks and opportunities, related to its environmental aspects (see
6.1.2), compliance obligations (see 6.1.3) and other issues and requirements, identified in 4.1 and 4.2, that
need to be addressed to:
- give assurance that the environmental management system can achieve its intended outcomes;
-prevent or reduce undesired effects, including the potential for external environmental conditions to affect
the organization;
6.1.1 -achieve continual improvement.
The organization shall maintain documented information of its risks and opportunities that need to be
addressed and process(es) needed in 6.1.1 to 6.1.4, to the extent necessary to have confidence they are
6.1.1 carried out as planned
The organization shall establish environmental objectives at relevant functions and levels, taking into
account the organization’s significant environmental aspects and associated compliance obligations, and
considering its risks and opportunities.
6.2.1 Review changes in risks and opportunities in MRM
Significant environmental aspects can result in risks and opportunities associated with either adverse
Note: 6.1.2 environmental impacts (threats) or beneficial environmental impacts (opportunities).
Note: 6.1.3 Compliance obligations can result in risks and opportunities to the organization.

What is Risk?
 effect of uncertainty on an expected result.

 deviation from the expected, either positive or
negative.

How to Identify Risk & Opportunities?
 SWOT Analysis
 PESTLE Analysis
 Brainstorming
 Surveys
 Interviews
 Historical data on Failures
 Organization's Records
 Professional Expertise
 On-Site Investigations

SWOT ANALYSIS

PESTLE ANALYSIS

PESTLE ANALYSIS

SWOT ANALYSIS-ORGANIZATION
Strengths Weaknesses
Monopoly in market Attrition
Wide market presence High Rejection
Opportunities Threats
New product introduction
Arrival of competitors
Change in design
Change in technology

SWOT ANALYSIS-QC/QA PROCESS
time saving in production More paper work and high consumption of paper
Less chances of defects Spend More time searching documents
clarity for Quality control process No succession planning
improving productivity Shortage of multi skilled QC engineers
Manual communication -release of test
Inter departmental Communication
result/Material acceptance
Hand injuries while cable cutting
On time delivery Delay in delivery
customer satisfaction customer dissatisfaction
Energy saving E&OSH incidents
Conservation of resources More Resource Consumption
Zero incidentents

SWOT ANALYSIS-PRODUCT
New and innovative product High start up and R & D Cost
Customized product line
Color fades in extreme conditions
Increase Lift Height
Reduce total weight Hydraulic cylinder failure
Ramasubramanian.s Management system

consultant/Trainer/Auditor+919952229598
RISK ASSESMENT

Impact
RISK ASSESMENT 5
4
Catastrophic
Significant
3 Moderate
2 Minor
1 Insignificance
Likelihood
5 Probable
4 Possible
3 Unlikely
2 Rare
1 Negligible
Risk Rating
>11 High
6 to 10 Medium
<6 Low
RISK=IMPACT * LIKELIHOOD
RISK ASSESMENT
Reference
No Category Description Risk Owner Impact likelihood Risk Score
More paper work and high

consumption of paper
1 Quality Manager-QC 4 5 20
Spend More time searching
2 Quality documents Manager-QC 3 5 15
No succession planning,Shortage of
multiskilled QC engineers
Manual communication -release of

test result/Material acceptance
Hand injuries while cable cutting

RISK MANAGEMENT
Actions to address risks/opportunities can include
• Avoiding Risk
• Taking Risk in order to pursue an opportunity
• Eliminating the Risk source
• Changing the likelihood or consequences
• Sharing the Risk
• Retaining Risk by informed decision
RISK MANAGEMENT

RISK MANAGEMENT
Reference Risk Impac likelihoo Risk
Mitigation 1 Mitigation 2 Mitigation 3
No Category Description Owner t d Score
Monitor the Implement
More paper work and consumption of paper, ERP/SAP for
high consumption of set bench marking for Reduce, reuse eliminate paper
Manager-
paper paper consumption, and recycle paper usage
1 Quality QC 4 5 20
start Implement
Spend More time implementing 2S ERP/SAP for
Manager-
searching documents Identify and Organize of 5S automation of
2 Quality QC 3 5 15
relevant documents. immediately documentation
No succession
planning,Shortage of Organize
multiskilled QC Manager- trainings to Reward and
3 Quality engineers QC 4 3 12 develop multi recognize for multi
Develop second line skilled skilled / top
Manual communication -
person for all designees employees performers
release of test
result/Material Manager- Implement
4 Quality acceptance QC 4 3 12 Effective use of ERP/SAP for
mail/mobile automation of
communication documentation
Hand injuries while Provide display
cable cutting of Pictorial
Manager-
5 Quality QC 2 3 6 representation/s Train the operators
Provide Hand gloves and afe working on safe working
enforce workers procedures practices

Where to Start?
4.1 & 4.2 Needs & Expectation of Interested parties
 List down all interested parties(Internal, external,
Legal & regulatory bodies)
 Find all need and expectations of all interested parties
 Assess Risk and opportunities in meeting them.

Where to Start?
5.1.2 Customer Focus
 Find all requirement for the products &
services(customer, Legal & your own)
 List down all the processes for Meeting the
requirements
 Assess Risk and opportunities in converting the inputs
in to outputs

What is Next?
6.1 Action to address Risk & Opportunity
 Incorporate Mitigation action in to your
process/procedure wherever required.
 Consider Risk mitigation as objectives wherever
required.
 Monitor the Risk on regular basis.

What is Next?
9.1.3 Analysis and evaluation
 Monitor the Risk on regular basis.

 Analyze the effectiveness of the mitigation plan put in
place.

What is Next?
9.3.2 Management Review
 Discuss the effectiveness of the mitigation plan put in

place.

What is Next?
10.2 Non conformity & Corrective action
 Whenever Non conformity arises, check whether the

particular NC addressed in Risk Register?
 If yes, investigate what went wrong with the mitigation
plan ?
 If not include it with mitigation plan.

What is Next?
6.3 & 8.5.6 Changes in Risk & Opportunity
Asses Risk & Opportunities Whenever changes
happening in
 Need & expectation of interested parties (4.0)
 Leadership, policy, roles & responsibilities (5.0)
 Objectives (6.0)
 Resources(7.0)
 Process /Operations(8.0)
& Update Risk mitigation plan.

What is Next?
Ensure your Risk Management plan is a dynamic one.
So you can achieve Continual Improvement….

Quality management system and its processes shall Address the risks and opportunities as determined in
4.4.1 (f) accordance with the requirements of 6.1.
5.1.1 (d) Leadership shall Promote the use of the process approach and risk-based thinking
Customer Focus -Ensure the risks and opportunities that can affect conformity of products and services and
5.1.2 the ability to enhance customer satisfaction are determined and addressed
While planning determine the risks and opportunities that need to be addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
6.1.1 d) achieve improvement.
The organization shall plan:

a) actions to address these risks and opportunities;
b) how to:
1) integrate and implement the actions into its quality management system processes (see 4.4);
6.1.2 2) evaluate the effectiveness of these actions.
9.1.3 Analysis and evaluate the effectiveness of actions taken to address risks and opportunities;
9.3.2 Discuss the effectiveness of actions taken to address risks and opportunities in MRM.
10.2.1 e) update risks and opportunities determined during planning, whenever NC arises
The organization shall determine the risks and opportunities, related to its environmental aspects (see
6.1.2), compliance obligations (see 6.1.3) and other issues and requirements, identified in 4.1 and 4.2, that
need to be addressed to:
- give assurance that the environmental management system can achieve its intended outcomes;
-prevent or reduce undesired effects, including the potential for external environmental conditions to affect
the organization;
6.1.1 -achieve continual improvement.
The organization shall maintain documented information of its risks and opportunities that need to be
addressed and process(es) needed in 6.1.1 to 6.1.4, to the extent necessary to have confidence they are
6.1.1 carried out as planned
The organization shall establish environmental objectives at relevant functions and levels, taking into
account the organization’s significant environmental aspects and associated compliance obligations, and
considering its risks and opportunities.
6.2.1 Review changes in risks and opportunities in MRM
Significant environmental aspects can result in risks and opportunities associated with either adverse
Note: 6.1.2 environmental impacts (threats) or beneficial environmental impacts (opportunities).
Note: 6.1.3 Compliance obligations can result in risks and opportunities to the organization.

? Questions
! Suggestions

To know more:
Contact:
 Ramasubramanian.s
 E.Mail id:ramasubramanian.s@outlook.in
 Mobile No:+919952229598/+919042006101

Contact For
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management like SEDEX,WRAP,SA8000,Sustainability
management,Legal complaince management Projects and
Certifications.
 Training on various topics included ISO
9001,22000,14001,18001,BRC Food ,BRC IOP,TS 16949 awareness
training, Internal auditor training,HACCP,HIRA,Aspect &
Impact,ccGMP,USFDA Compliance
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THANK YOU

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ISO 9001:2015 & ISO 14001:2015

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

The organization shall plan:

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

 effect of uncertainty on an expected result.

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Wide market presence High Rejection

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Customized product line

Ramasubramanian.s Management system

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

More paper work and high

Manual communication -release of

Hand injuries while cable cutting

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

 Monitor the Risk on regular basis.

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

 Discuss the effectiveness of the mitigation plan put in

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

 Whenever Non conformity arises, check whether the

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

& Update Risk mitigation plan.

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

So you can achieve Continual Improvement….

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

The organization shall plan:

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

Ramasubramanian.s Management system

Ramasubramanian.s Management system

Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598

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