Managing Regulatory Compliance


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Managing Regulatory Compliance

  1. 1. Managing Regulatory Compliance:Responsibility and Accountability for All Levels and Positions Mitchell W. Manning Sr.
  2. 2. Managing Regulatory Compliance Compliance is a Performance RequirementLeadership/Management is Responsible and Accountable for Compliance PerformanceChain of Command is Functionally Responsible for Compliance ManagementCompliance Performance Management is Good Management PracticeCompliance Responsibilities and Accountabilities are Job Performance MeasuresDemonstrating Compliance Competence and Confidence Meets RequirementDesire and Fear are Compliance MotivatorsPerformance Evaluation, Training, and Development are Compliance EnablersAnnual Compliance Performance Review Empowers Good Leadership/Management
  3. 3. Managing Regulatory ComplianceCompliance 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. 4. Managing Regulatory Compliance Compliance is the Quality Systems ApproachCompliance is ... Management ControlCompliance is ... Corrective and Preventive ActionsCompliance is ... Design ControlCompliance is ... Production and Process ControlsCompliance is ... Equipment and Facility ControlsCompliance is ... Records, Documents, and Change ControlsCompliance is ... Material Controls
  5. 5. Managing Regulatory ComplianceCompliance 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. 6. Managing Regulatory ComplianceCompliance Consultants Have 3 Key Job Performance Responsibilities and Accountabilities Simplify Compliance Eliminate Compliance Waste Accelerate Compliance
  7. 7. Managing Regulatory Compliance Compliance Consultants Have 2 Key Compliance Performance MeasuresTechnical and Scientific Competence and Confidence Ethical and Moral Competence and Confidence
  8. 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. 9. Managing Regulatory Compliance Evaluate Compliance Consultants on Consulting Process Performance Using:Situation Appraisal - Gap Analysis - Root Cause Analysis - ProblemSolving - Needs Assessment - Wants Prioritization - Decision Making- Problem Prevention - Opportunity Analysis - OpportunityPromotion - Risk Analysis - Scenario Analysis – Planning Next Steps
  10. 10. Managing Regulatory Compliance Conclude The Annual Compliance Performance Review With Four Closed QuestionsIs 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. 11. Managing Regulatory Compliance Regulatory Compliance IsA Performance Requirement Mitchell W. Manning Sr.