| The Quality Audit |
| Did I Catch You Unaware? |
| Auditing |
| An Open Source Document |
| Partial List Of Files In This Guide |
| Guide Objectives |
| Related Stuff Well Be Covering |
| Caution |
| Caution II |
| Auditing - The Program |
| The Goal Of An Audit |
| Basic Types of Audits |
| Audit Sub-Types |
| Audit Types |
| A Typical Audit System |
| Definitions: “Who” |
| Definitions: “What” |
| Phases of Auditing |
| The Standard Four Phases |
| The Part People See |
| Quality Audit |
| Objective Evidence |
| Objective Evidence II |
| Reasons For Audits |
| More Reasons For Audits |
| The Audit Must Be |
| Validation |
| Auditors Are Not…. |
| Why A Formal Audit Program? |
| Internal Audits |
| The Internal Audit |
| IIAs Definition Of Internal Audit |
| Internal Audit System Base Requirements |
| Internal Audit System Base Requirements |
| Role of the Internal Auditor |
| Internal Quality Auditing |
| Slide 37 |
| Compliance Audits |
| Compliance Audits |
| Compliance Audit |
| Compliance Audit |
| Systems Audits |
| Systems Audit |
| Systems Audit |
| Example Training System - A Support System |
| Process Audits |
| Process Audit |
| A Typical Series Of Manufacturing Processes |
| Process White Space Issues |
| Manufacturing Processes |
| Product Audits |
| Product Audit |
| Product Audit - A Brief Review |
| What Will YOU Will Be Auditing? |
| Basic Audit Focus? |
| Internal Audits - Focus |
| Reasons To NOT Address Compliance In Internal Audits |
| Reasons To NOT Address Compliance In Internal Audits |
| Reasons To NOT Address Compliance In Internal Audits |
| Reasons To NOT Address Compliance In Internal Audits |
| The Famed Document Pyramid |
| 4.2.3 Control of Documents (4.5) |
| Another Document Control System |
| Audit Types - A Brief Review |
| A Quality Management System? |
| A Quality Management System? |
| ISO/QS-9000 Quality Management System |
| Procedures & Systems |
| Many Requirements |
| The ISO Standards |
| The QS 9000 Document Origins |
| Documentation Hierarchy |
| Slide 73 |
| Typical Operations Flowchart |
| The Bottom Line |
| The Details |
| Complex Trade Relationships |
| An Organization As A Collection of Systems |
| What is a System? |
| System vs. Process |
| Systems Responsibilities |
| Systems Responsibilities II |
| The Organization as a System, Subsystems, and Processes |
| Systems and Subsystems |
| Extending Outside the Organization |
| An Extended System |
| Measures In The Extended System |
| CAUTION! |
| What is a Process? |
| Examples of Processes |
| Quality Through Process Improvement |
| Significant and Critical Processes |
| Responsibilities |
| Clients Responsibility |
| Auditors Responsibility |
| Auditees Responsibility |
| Auditor Qualifications |
| Education, Training & Experience |
| Auditor Personal Qualities |
| Personal Attributes |
| Applying Auditor Attributes |
| Audit Preparation |
| Planning The Audit |
| Audit Scope |
| The Audit Plan |
| Audit Failure Modes |
| A Second Auditor |
| Audit Team Assignments |
| Audit Frequency |
| QS-9000 Requirements |
| ISO 9001:2000 Requirements |
| ISO 9001:2000 Requirements Summary |
| Internal Audit Schedule Example |
| Example Responsibilities Matrix |
| A Sample Compliance Audit Schedule |
| Check Lists |
| Check Lists |
| Check List Benefits |
| Check List Preparation |
| Check List Example |
| Check List Thoughts |
| Sample Size |
| Sample Size |
| Sample Size II |
| Audit Strategy |
| Audit Strategies |
| Internal Audit Strategies |
| Available Information |
| Review of Working Documents |
| Representative Samples |
| Pre-Audit Confirmation |
| Executing the Audit |
| Changes Happen |
| Opening Meeting |
| A Registrars Opening Meeting Outline I |
| A Registrars Opening Meeting Outline II |
| A Registrars Opening Meeting Outline III |
| A Registrars Opening Meeting Outline IV |
| A Typical Registrars Finding Record |
| A Registrars Opening Meeting Outline V |
| A Registrars Opening Meeting Outline VI |
| Other Interpretations |
| Other Interpretations |
| Other Interpretations |
| Other Interpretations |
| Conducting The Audit |
| Registrar Audits |
| Registrar Audits II |
| Registrar Audits III |
| Audit Hints |
| Questions To Ask? |
| Taking Notes As Reference |
| Take Copious Notes!!!! |
| Taking Notes As Evidence |
| Avoiding Trouble |
| Good Auditing Practices |
| Keep People Informed |
| Bad Auditing Behavior |
| Expect These Reactions / Emotions |
| Interview the Right People |
| Youre In The Audit Now! |
| Recording Nonconformances |
| Nonconformance Exists Because |
| Standard Nonconformance Categories |
| Establish The Facts |
| Facts About Facts |
| Things to Consider -- Is It Serious? |
| Assessing Nonconformances |
| Simple Nonconformance Report Form |
| Sample Audit Summary Sheet |
| The Closing Meeting |
| Nonconformance Reports |
| Writing Nonconformance Reports |
| Summary Content |
| Audit Reports |
| The Audit Report |
| Audit Report Example |
| Corrective Action |
| Corrective & Preventive Actions |
| Audit Follow-Up |
| Re-Audit Focus |
| Audit Records |
| Being Audited - Life on The Other Side Of The Fence |
| Being Audited |
| What is Controlled Documentation? |
| What is an Auditor? |
| What Will The Auditors Do? |
| Who Will Be Audited? |
| The Audit Team |
| Types of Audits |
| The Reason For Audits |
| What Will Happen If... |
| Things Everyone Must Know |
| Things to Do |
| Things NOT to Do |
| General Things To Know and Do |
| Some Typical Questions to Expect |
| Managers Should Think About... |
| Some Last Things to Think About |
| Good Luck! |