REGULATORY CHANGE MANAGEMENT (RCM) In Environmental Health and Safety

Regulatory Change Management Page 1

REGULATORY CHANGE MANAGEMENT (RCM)

In Environmental Health and Safety

Regulatory Change Management Page 2Page 2

Speaker: Ed SattarEd Sattar is the CEO of 360factors For more than a decade, Ed has made significant professional contributions to the regulatory compliance space across multiple industries. His experiences include extensive research and consulting to regulatory compliance consulting firms, training providers as well as state and federal regulatory agencies. During his tenure in the regulatory compliance workflow automation and eTraining space, he has identified key criteria and compliance standards that are currently being published and implemented.

Ed Sattar has been nominated for the Ernst & Young Entrepreneur of the Year award three times and was among the top seven finalists in 2009. 360training.com, the parent company of 360factors, has appeared on the Deloitte Fast 50 as the 6th fastest growing company in Texas. It has also been listed in Inc 5000 several times as one of the fastest growing companies. Ed studied Electrical Engineering and Finance at the University of Texas at Austin.


Rising Regulations and Cost


1. Understanding Regulations- Either Over Complying or Under Complying-

2. Regulatory Applicability and Managing Regulatory Changes.

3. Automating And Streamlining Day To Day Compliance, Event And Incident Management With Respect To Regulatory Change Management

4. Cost Efficiency By Automating Tracking and Monitoring a Non Compliance Items Such as Events, Incidents, Audits & Investigations

Four Reasons Why Implement Regulatory Change Management


Four Reasons Why Implement Regulatory Change Management

Understanding Regulations Regulatory Change

Management Regulatory Applicability Day to Day Compliance Tasking Event-Driven Compliance

Tasking Incident Management and Root

Cause Analysis

Predictive Risk Analysis Corrective and Preventive Actions Policy and Procedure

Management Audit Management Sustainability Training Management Multiple Tools to address Reg

Compliance

Other Industry Pain Points


REGULATORY CHANGE MANAGEMENT METHODOLOGY

Requirements

Regulations

Standards

Business Requirements

Business Process

Risks & Controls

Organization

Location/

Assets

HOW

WHY

WHAT

WHO

WHERE


1. Regulatory Knowledge Base & Taxonomy

2. Risk and Internal Controls

3. Business Process -> Regulatory Workflow

4. Location / Assets

5. Roles and Responsibilities of Key Management Functions

Five Steps to Manage RegulatoryCompliance


Requirements Knowledge Based &

Taxonomy

Business Process

Risk and Internal Controls

Roles and Responsibilities

Locations and Assets

COMPONENTS OF REQUIREMENTS KNOWLEDGE BASE

1. Regulatory, Standards, Requirements and Objectives library management

2. Translate regulatory requirements into action, evidence, subject, frequency

3. Monitor regulatory change

4. Regulations in effect to proposed

5. Mapping- regulatory requirements mapped to CAPA , policy procedures and evidence

6. Regulation Applicability

Step 1- Requirements Knowledge Base & Taxonomy


1. What is impacted

2. Define internal controls?

3. Define risk

Step 2- Risk & Internal Controls


Taxonomy

Roles and Responsibility


Reporting

Regulatory Compliance

Software


Step 2- Risk & Internal Controls


Taxonomy

Roles and Responsibility


Reporting


Software

Small Workforce Large Workforce

Hig

h R

isk

Low

Ris

k

Simple

to

complex


1. How

2. Compliance process around sites, assets, events

3. Process automation and cost

4. Manual VS automation

Step 3- Business Process


Taxonomy

Business Process


Reporting


Software


Automate Corrective Action to Increase Speed, Eliminate Waste and Cut Costs

Automate Scheduling, Tasking and Tracking

Embed Transparency and Accountability

Automate Management of Change

PROCESSESS THAT CAN BE AUTOMATED

PROCESSESS THAT CAN’T BE AUTOMATED

Translation of Requirements

Subject Matter Expertise

Step 3- Business Process


Taxonomy

Business Process


Reporting


Software


1. Where is compliance done.

2.Compliance done at the site and asset level

Step 4. Location & Assets


Taxonomy

Business Process


Roles & Responsibility

Location / Assets


1. It is important to define the roles and responsibilities before you create an EHS Regulatory Compliance Framework?

2. So what are the barriers to creating a Regulatory Compliance Framework?

3. Is there a specific role and responsibility structure or can it vary from organization and industries?

Step 5. Roles & Responsibility


Taxonomy

Business Process



Location / Assets


1. Key Roles and Structure

2. Key Functions

3. Key Actions

4. Outcome / Results

COMPONENTS OF ROLES AND RESPONSIBILITES

Step 5. Roles & Responsibility


Taxonomy

Business Process



Location / Assets


1. Is Technology perceived as a catalyst for growth and performance?

2. Are people or technology barriers to Regulatory Compliance Automation?

Automate Regulatory Compliance Through Software

Requirements

Regulations

Standards

Business Requirements

Business Process

Risks & Controls

Organization

Location/

Assets


Source: Global survey by KPMG, Inc

BENEFITS OF AN INTEGRATED MANAGEMENT SYSTEM

Automate Regulatory Compliance Through Software


Predict360 REGULATORY COMPLIANCE

ARCHITECTURE


Presentations & Public Speaking

REGULATORY CHANGE MANAGEMENT (RCM) In Environmental Health and Safety