Risk based thinking

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




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.


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


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 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


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


RISK ASSESMENT


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


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


Manager-QC 2 3 6


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 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


Manager-QC 2 3 6


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….



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




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.


? Questions

! Suggestions


To know more: Contact:

Ramasubramanian.s

E.Mail id:[email protected]

Mobile No:+919952229598/+919042006101


Contact For Implementation of Management systems like ISO

9001,14001,22000,22716,OSHAS 18001,BRC Food,BRC IOP,USFDA/CGMP Complaince management,Social compliance 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 management,5S,TPM,TQM,7QC tools,Industrial safety,safety audit,EHS compliance management,Industry specific Safety trainings etc.

Internal audits,supplier audits,certification audits for ISO 9001,TS16949,ISO 22000,18001,14001,SA 8000,SEDEX,BRC Food and BRC IOP,SEDEX,etc.


THANK YOU


Risk based thinking

Leadership & Management

Transcript of Risk based thinking