Risk Based Thinking:ISO 9001:2015

Senko Ramadurai & John Lazarchic

Becton Dickinson, Columbus NE

American Society for Quality Nebraska Section 1302

QUICKLY!!!Think of one thing about yourself to share with the group that no one else here is likely to know about you.

How well we understand Risk??

Can you name the creature in the African sub-continent most dreaded by humans?

Arrange in order as seen below all items that have a likely chance of causing health problems (highest to lowest):

a.Deodorant b. Wine c. Mouth Wash

d. medical X-rays f. Facebook

Answer: Facebook, Wine, Mouth wash, Deodorant and medical X-rays

Agenda for Today

Know your book definitions

Features & benefits of Risk based thinking

Swiss cheese model

Systematic approach to Risk based thinking used organizations

FMEA Analysis – risk based tool

Book Definitions Risk (defined by ISO 9001: 2015): Risk defined as effect of

uncertainty on an expected result resulting in a deviation from the plan

Uncertainty is defined by 2 parameters: Severity and Probability

Risk is often seen only in the negative sense. With the advent of systematic risk based thinking it has opened doors to identify opportunities

Situation #1: Sam needs to get to the other side of the a very busy street to buy medicines for his ailing mom. The quick and fastest way is crossing the road, but if he decides to do that there is an increased risk of injury from moving cars. Sam has to have a plan to reduce either the likelihood or impact of Injury.

Ask these questions to yourself

WHAT, WHERE, HOW and WHICH

Risk based Thinking - Features

Controllable and uncontrollable factors

Done automatically and subconsciously by human brain - Sam waits for road to stay clear of vehicles, looks for traffic light, crossing bridge

Risk management start and end

Usually done from beginning and throughout entire activity performed – Sam has to ensure his safety until he gets back the medicines to his mom

Prepare for future

Creates a sense of awareness that is spread across to everybody –share learnings and teachings to ensure it’s safe for people to cross the road

Alternatives

Makes preventive action steps to be taken as a part of Routine- move to different pharmacy, get medicines home delivered, understand the frequency of car through out the day and look for new affordable opportunities.

Swiss Cheese Model

Uses

Aviation

Engineering

Healthcare

Civil

A combination of latent failures during various processes and methods results in risk to the end user.

Why and how do we need RBT?Organization shall determine risks & opportunities

- in accordance with requirements

- can affect conformity of products & services & customer sat.

Give assurance that QMS can achieve its intended result

Prevent, or reduce, undesired effects

Achieve continual improvement

integrate and implement the actions into its QMS process

Evaluate the effectiveness of these actions

Post-delivery associated with products and services

Effectiveness of actions management review

5 step Planning Approach

Step 1: Know your Hazard

Step 2: Determine consequence severity

Step 3: Evaluate event likelihood

Step 4: Take Risk-Based Approach

Step 5: Monitor and Evaluate

5 Step Approach - Risk

Know Your Hazard Tasks

Analysis Tasks Communication Tasks

Scope of the issue 1. Establish problem/decisionparameters

2. Identify the resource needs

3. Identify the hazard information gaps

4. Gather background information

5. Agree an information management system

Engagementapproach

Identify the team professionals

Begin internal communication

Cover the important base elements

Begin external communication

Identify useful information for sharing with stakeholders, clarify areas of uncertainty

Update engagement approach

Step 2: Severity of ConsequencesDetermine severity of consequences

Risk Analysis Tasks

Risk Communication tasks

Build a picture of possible consequences and impact of natural hazard event

Cascading hazards and consequence table

Validate hazard information

Proposed development of the hazard event

Determine severityof consequences for the hazard event will set the consequence level

Update stakeholders analysis

Assess engagement approach

Record decisions and assumptions

Step 3: Evaluate Event Likelihood

Event Likelihood Risk Analysis CommunicationPlan

Assessmentlikelihood of any event that will result in consequences outlined in step 2

1. Take a cumulative hazard events (cascading hazards areaddressed against the trigger hazard)

Record Decisions and assumptions

2. Cumulative hazards may result in increase in likelihood

3. Likelihood will be required for modelling and assessing the hazard (Step 1).

Step 4: Take a Risk based approach Risk based approach

Risk Analysis Tasks Communication tasks

Stakeholder acceptance of the calculated levels of risk

1. Determine levels of risk for Policy

Validate levels of risk for policy and consent categories with stakeholders

Associated consent categories

2. Determine resource consent activity status based on levels of risk

Engage stakeholders in identifying and reviewing risk mitigation options

3. Assess against assessment criteria and anticipated environmental outcomes

Update stakeholder analysis and engagement approach

4. Assess resource consent applications based on levels of risk

Forums/meetings/public events per engagement strategy

5. Identify and consider risk mitigation options

Step 5 – Monitor & EvaluateMonitor & Evaluate Risk Analysis

TasksRisk CommunicationTasks

Evaluation and monitoring has taken place throughout at his final stage the outcomes of the process

1. Evaluate risk-reduction effectiveness

1. Evaluate acceptance of mitigation options

2. Evaluate acceptance of residual risks

3. Evaluatecommunication and engagement strategy

4. Communicate risk outcomes with stakeholders and community and review if required

2. Plan change/revisitstrategy

Risk-Based Thinking: ISO 9001:2015

Questions?

Thank You for Your Attention!