Regulatory Compliance 2010 One Consultant’s Perspective Mitchell W. Manning Sr. [email_address]

Regulatory Compliance 2010: One Consultant’s Perspective 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

Regulatory Compliance 2010: One Consultant’s Perspective 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

Regulatory Compliance 2010: One Consultant’s Perspective Compliance is the Quality Systems Approach 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 Compliance is ...

Regulatory Compliance 2010: One Consultant’s Perspective 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

Regulatory Compliance 2010: One Consultant’s Perspective Compliance Consultants Have Only 3 Job Performance Responsibilities and Accountabilities Simplify Compliance Eliminate Compliance Waste Accelerate Compliance

Regulatory Compliance 2010: One Consultant’s Perspective Compliance Consultants Have Only 2 Compliance Performance Measures Technical and Scientific Competence and Confidence Ethical and Moral Competence and Confidence

Regulatory Compliance 2010: One Consultant’s Perspective Compliance Consultants Have Many Strengths and Weaknesses in 3 Key Areas Systems Compliance Process Compliance Function and Task Compliance

Regulatory Compliance 2010: One Consultant’s Perspective Compliance Consultants Can be Evaluated on Consulting Process 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

Regulatory Compliance 2010: One Consultant’s Perspective Conclude The Annual Compliance Performance Review With Four Closed Questions Is leadership compromising or complementing compliance in 2010? 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

Regulatory Compliance 2010: One Consultant’s Perspective Regulatory Compliance Is A Performance Requirement Mitchell W. Manning Sr. [email_address]