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