1. Managing Regulatory
Compliance:
Responsibility and Accountability
for All Levels and Positions
Mitchell W. Manning Sr.
manningmitch@aol.com
www.linkedin.com/in/mitchmanningsr

2. Managing Regulatory Compliance
Compliance is a Performance Requirement
Leadership/Management is Responsible and Accountable for Compliance Performance
Chain of Command is Functionally Responsible for Compliance Management
Compliance Performance Management is Good Management Practice
Compliance Responsibilities and Accountabilities are Job Performance Measures
Demonstrating Compliance Competence and Confidence Meets Requirement
Desire and Fear are Compliance Motivators
Performance Evaluation, Training, and Development are Compliance Enablers
Annual Compliance Performance Review Empowers Good Leadership/Management

3. Managing Regulatory Compliance
Compliance is Integral in the Functional Organization
Executive/Administration Compliance is strategic
Finance Compliance is bottom-line
Human Resources Compliance is job performance
Information Technology Compliance is systems proofing
Purchasing Compliance is long-term lowest cost
Marketing Compliance is marketable
Sales Compliance sells
Engineering Compliance can be engineered in
Quality Compliance is key to quality
Manufacturing Compliance is good manufacturing practice
Logistics Compliance is good logistics practice

4. Managing Regulatory Compliance
Compliance is the Quality Systems Approach
Compliance is ... Management Control
Compliance is ... Corrective and Preventive Actions
Compliance is ... Design Control
Compliance is ... Production and Process Controls
Compliance is ... Equipment and Facility Controls
Compliance is ... Records, Documents, and Change Controls
Compliance is ... Material Controls

5. Managing Regulatory Compliance
Compliance Responsibility and Accountability is for All Levels
Leadership/Management (Systems and Processes)
Establishment of Quality (Compliance) Objectives
Translation of Objectives into (Compliance) Methods and Procedures
Implementation of Quality (Compliance) System
Management of Quality (Compliance) System
Workers (Functions and Tasks)
Compliance Duties
Compliance Responsibilities
Compliance Assignments
Compliance Documentation

6. Managing Regulatory Compliance
Compliance Consultants Have 3 Key Job Performance
Responsibilities and Accountabilities
Simplify Compliance
Eliminate Compliance Waste
Accelerate Compliance

7. Managing Regulatory Compliance
Compliance Consultants Have 2 Key
Compliance Performance Measures
Technical and Scientific Competence and Confidence
Ethical and Moral Competence and Confidence

8. Managing Regulatory Compliance
When Selecting Compliance Consultants :
Look For Strengths and Weaknesses in 3 Key Areas
Systems Compliance
Process Compliance
Function and Task Compliance

9. Managing Regulatory Compliance
Evaluate Compliance Consultants
on Consulting Process Performance Using:
Situation Appraisal - Gap Analysis - Root Cause Analysis - Problem
Solving - Needs Assessment - Wants Prioritization - Decision Making
- Problem Prevention - Opportunity Analysis - Opportunity
Promotion - Risk Analysis - Scenario Analysis – Planning Next Steps

10. Managing Regulatory Compliance
Conclude The Annual Compliance Performance Review
With Four Closed Questions
Is leadership compromising or complementing compliance?
Is leadership modeling compliance behavior?
Is leadership reviewing compliance performance behavior?
Is leadership managing compliance performance behavior?
Areas to Consider:
Compliance Competence, Confidence, Budgets, Schedules, Goals and
Objectives, Values and Ethics, Reputation, Relationships

11. Managing Regulatory Compliance
Regulatory Compliance Is
A Performance Requirement
Mitchell W. Manning Sr.
manningmitch@aol.com
www.linkedin.com/in/mitchmanningsr