ISO 9001:2015 & ISO 14001:2015
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
ISO 9001 REQUIREMENT
Clause No Requirement
4.4.1 (f) Quality management system and its processes shall Address the risks and opportunities as determined in accordance with the requirements of 6.1.
5.1.1 (d) Leadership shall Promote the use of the process approach and risk-based thinking
5.1.2 Customer Focus -Ensure the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed
6.1.1
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; d) achieve improvement.
6.1.2
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); 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
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
ISO 14001 REQUIREMENT
Clause No Requirement
6.1.1
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; -achieve continual improvement.
6.1.1
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 carried out as planned
6.2.1
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. Review changes in risks and opportunities in MRM
Note: 6.1.2 Significant environmental aspects can result in risks and opportunities associated with either adverse environmental impacts (threats) or beneficial environmental impacts (opportunities).
Note: 6.1.3 Compliance obligations can result in risks and opportunities to the organization.
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
What is Risk?
effect of uncertainty on an expected result.
deviation from the expected, either positive or negative.
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
How to Identify Risk & Opportunities?
SWOT Analysis
PESTLE Analysis
Brainstorming
Surveys
Interviews
Historical data on Failures
Organization's Records
Professional Expertise
On-Site Investigations
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
SWOT ANALYSIS
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
PESTLE ANALYSIS
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
PESTLE ANALYSIS
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
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
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
SWOT ANALYSIS-QC/QA PROCESS Strengths Weaknesses
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
Inter departmental Communication Manual communication -release of test result/Material acceptance
Hand injuries while cable cutting
Opportunities Threats On time delivery Delay in delivery
customer satisfaction customer dissatisfaction
Energy saving E&OSH incidents
Conservation of resources More Resource Consumption
Zero incidentents
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
SWOT ANALYSIS-PRODUCT
Strengths Weaknesses
New and innovative product High start up and R & D Cost
Customized product line
Opportunities Threats
Increase Lift Height Color fades in extreme conditions
Reduce total weight
Hydraulic cylinder failure
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
RISK ASSESMENT
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
RISK=IMPACT * LIKELIHOOD
Impact 5 Catastrophic
4 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 ASSESMENT
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
RISK ASSESMENT Reference
No Category Description Risk Owner Impact likelihood Risk Score
1 Quality
More paper work and high consumption of paper
Manager-QC 4 5 20
2 Quality
Spend More time searching documents Manager-QC 3 5 15
3 Quality
No succession planning,Shortage of multiskilled QC engineers
Manager-QC 4 3 12
4 Quality
Manual communication -release of test result/Material acceptance
Manager-QC 4 3 12
5 Quality
Hand injuries while cable cutting
Manager-QC 2 3 6
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
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
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
RISK MANAGEMENT
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
RISK MANAGEMENT Mitigation 1 Mitigation 2 Mitigation 3
Monitor the consumption of paper, set bench marking for paper consumption,
Reduce, reuse and recycle paper
Implement ERP/SAP for eliminate paper usage
Identify and Organize relevant documents.
start implementing 2S of 5S immediately
Implement ERP/SAP for automation of documentation
Develop second line person for all designees
Organize trainings to develop multi skilled employees
Reward and recognize for multi skilled / top performers
Effective use of mail/mobile communication
Implement ERP/SAP for automation of documentation
Provide Hand gloves and enforce workers
Provide display of Pictorial representation/safe working procedures
Train the operators on safe working practices
Reference No Category Description
Risk Owner
Impact
likelihood
Risk Score
1 Quality
More paper work and high consumption of paper
Manager-QC 4 5 20
2 Quality
Spend More time searching documents
Manager-QC 3 5 15
3 Quality
No succession planning,Shortage of multiskilled QC engineers
Manager-QC 4 3 12
4 Quality
Manual communication -release of test result/Material acceptance
Manager-QC 4 3 12
5 Quality
Hand injuries while cable cutting
Manager-QC 2 3 6
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
Where to Start?
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
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?
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
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?
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
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?
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
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?
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
9.3.2 Management Review
Discuss the effectiveness of the mitigation plan put in place.
What is Next?
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
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?
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
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?
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
Ensure your Risk Management plan is a dynamic one.
So you can achieve Continual Improvement….
ISO 9001 REQUIREMENT
Clause No Requirement
4.4.1 (f) Quality management system and its processes shall Address the risks and opportunities as determined in accordance with the requirements of 6.1.
5.1.1 (d) Leadership shall Promote the use of the process approach and risk-based thinking
5.1.2 Customer Focus -Ensure the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed
6.1.1
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; d) achieve improvement.
6.1.2
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); 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
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
ISO 14001 REQUIREMENT
Clause No Requirement
6.1.1
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; -achieve continual improvement.
6.1.1
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 carried out as planned
6.2.1
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. Review changes in risks and opportunities in MRM
Note: 6.1.2 Significant environmental aspects can result in risks and opportunities associated with either adverse environmental impacts (threats) or beneficial environmental impacts (opportunities).
Note: 6.1.3 Compliance obligations can result in risks and opportunities to the organization.
Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
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Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
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Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
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Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598
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Ramasubramanian.s Management system consultant/Trainer/Auditor+919952229598