WI-822-001 Internal Auditor Training

Florida MEP: Solutions for Manufacturers
Internal Auditor Training
ISO 9001 / AS9100

Quality Management System
WI-822-001 Rev. Basic CLI

Internal Auditor
Training Agenda
Today’s topics:
 How the Audit fits

 Quality System Audits vs. Other
Audits
 Parts of the Audit System
 How to Plan an Audit

Internal Auditor
Training Agenda
Today’s topics:
 How to Conduct an Audit

 How to Write the Final Report
 How to Follow up the Audit
 Review of the ISO Requirements

Internal Auditor
Training Agenda
Questions & Answers -

Ask the questions when
they come to mind,
DON’T WAIT.
How the Audit Fits

What is a Quality System?
Documentation of the System
What is an Audit?
Why do we Audit?
Management’s Role

How the Audit Fits

What is a Quality System?
 Quality Policy
 System Requirements
 Best Practices
 Types of Standards

How the Audit Fits

Quality Policy
A documented COMMITMENT to
have a QUALITY SYSTEM that
will provide CUSTOMERS with
PRODUCTS & SERVICES that
MEET ALL REQUIREMENTS &
ENSURE CUSTOMER
SATISFACTION.
How the Audit Fits

System Requirements
Installation Disposal Marketing

Design &
Sales Development
Company
Technical Quality Policy
Assistance Process
Planning
Inspection Storage Production

Continuous improvement of the QMS
A P
Act Plan
Information Management C D
Flow
Responsibility Check Do
Customers
Customers
Requirements
Satisfaction
Measurement,
Resource Info.
analysis & Flow
Management
improvement
Value added
activity
Input Product
Realization
Output Product

How the Audit Fits

Best Practices
Quality Manual
Workers
Procedures
Work Instructions
Auditor
Verification

How the Audit Fits

Types of Standards:
Contractual Standards
 OSHA
 EPA
 Customer Required Standards
Voluntary Standards
 National Particle Board Association
 NEMA
 ISO 9001

How the Audit Fits
Documentation - Why we have it

 Guidance
 Consistency
 Compliance
 Basis for Auditing

How the Audit Fits

Typical ISO Documentation Structuring
Company Policy
Statements Quality
Manual Who does What,
Where & When
The HOW to do it Procedures
instructions (Implementation of Policy)
Work Instructions
FORMS (The “how to do it” documents)
Blank Forms RECORDS

Records
Completed Forms
How the Audit Fits

What is an Audit?
 Planned Event
 Independent
 Shows Intent
 Shows Implementation
 Shows Effectiveness
 Management Driven
 Required by the Standard

How the Audit Fits

Why do we Audit?
 To Identify Opportunities for
Improvement
 To Verify Implementation
 To determine Effectiveness
 To Meet the Requirements of
ISO
How the Audit Fits

Management’s Role
 Initiate Audit Program
 Provide Audit Leadership
 Assure Auditor Independence
 Provide Resources
 Corrective Action Follow Up

Questions

Quality System Audits

vs. Other Audits
 Quality System Audits
 Other Audits
 Types of Audits


vs. Other Audits
 Whatever Affects Quality
 Relates to the ISO Elements
 Intent
 Implementation
 Effectiveness
 Supplier Quality


vs. Other Audits
Other Audits
 Product Audits
 Process Audits
 Problem or Spot Audits
 Self Audits


vs. Other Audits
ISO 9001 - Types of Audits
First Party YOU AUDIT YOURSELF
Second Party YOU AUDIT YOUR SUPPLIER OR

YOUR CUSTOMER AUDITS YOU
Third Party YOUR REGISTRAR AUDITS YOU

Questions

Parts of the Audit System

 People
 Procedures
 Goals
 Results
 Follow up


People
Top Management
Management Rep.
Audit Team
Engineering Sales
Dept. Manufacturing Dept.
Dept.

Procedures
 Audit Tools
 Audit Appeals
 Auditor Qualifications
 Auditor Behavior


Audit Tools
 Audit Procedures
 Check List
 Record of Non Conformity
 Audit Plan
 Corrective Action
 Schedule


Audit Appeals
 What is the Avenue?
 Concentrate on the Facts.


Auditor Qualifications / Attributes:
 Open Minded / Mature
 Sound Judgement, Analytical
 Skills and Tenacity
 Realistic Perceptions and
 Broad Perspective


Auditor Qualifications
Auditor Actions:
 Fair
 Evaluate Effects
 Sensitivity
 Avoid Distractions
 Give Full Attention & Support
 Effective Under Stress
 Arrive at Valid Conclusions


Auditor Behavior
Solutions to Stalling & Diversions
 Schedule Briefing Prior to Audit
 Allocate Specific Time for Tour / Audit
 Offer to Meet Again if Conflict is
Apparent
 Have Contact / Alternate Phone
Numbers
 Deal Only in Facts
 Insist on a Knowledgeable Counterpart

Auditor Behavior
Solutions to Stalling & Diversions
 Note any Attempts at Intimidation or
Gratuitous Conduct
 Contact the Lead Auditor when
Needed (That’s why they get paid the BIG
BUCKS)


Auditor Behavior
Adhere to Auditor Rules
 Safety & Smoking
 Lunch / Break Times
 Control of Proprietary Data
/ Information
 Management Discussions
 Off Shift Auditing
 Unsolicited Negative Information

Goals of Auditing
 Ensure compliance to Quality System
Requirements
 Ensure Quality system is Effective
 Help Make Our Company Better


Results
 Non Conformities
 Final Report


Follow Up Results
 Corrective Actions
 Effective Implementation

Questions

How to Plan The Audit

How to Plan the Audit
 Pre audit Visit
 People
 Plan
 Check List
 Methods


Pre Audit Visit
 Scope
 Location
 Departments
 Expertise for Processes
 Who, What & How Many


People = Who ?
 Technical Expertise of Auditors

 Auditing Expertise of Auditors
 Independence From Departments
Audited
 Need For Orientation


The Plan - Do we have one?
 The Schedule (Annual Plan)
 The Check List (Who, Where, What
to Audit and What you Found)


Check List
 To Stay Focused
 To Show Serious Intent
 It Reminds You What to Look at & for
 Provides a Place to Record Findings


Making up a Check List
 Fill Out Header Information
 Review / Understand Documents
pertinent to Area to be Audited
 Use Document Paragraph Reference
numbers when Selecting Audit Point
 Write Audit Point Clearly on Check List


Methods of Auditing
 Vertical - follow records through departments
 Upstream - shipping to sales
 Downstream - sales to shipping
 Horizontal - departmental interfaces
 By ISO Requirement

Questions

How to Conduct the Audit
 Opening Meeting
 Objective Evidence
 Audit Techniques
 Non Conformities
 Closing Meeting


Opening Meeting
 If You Don’t Know the Auditee -
introduce Yourself
 May Be a Phone Call or Hallway Meeting
 Deliver / Send a Copy of the Check List
 Determine If Confidentially Issues Exist
 Special Precautions / Safety


Objective Evidence
 First Hand
 Factual
 Based on Direct Observation
 Interviews
 Records
 Results of an Activity


Objective Evidence
Information Which Can Be

Proven TRUE, Based on FACTS
Obtained Through OBSERVATION,
MEASUREMENT, TEST or Other
Means.


Audit Techniques
 Review Documentation Prior to
Audit
 Use Your Check List
 Use Different Interviewing
Techniques
 Open Ended Questions
 Closed Ended Questions
 Silence
Questions
 Open-ended questions typically begin with words such as
"Why" and "How", or phrases such as "Tell me about...".
Often they are not technically a question, but a statement
which implicitly asks for a response.
 Closed ended questions encourages a short or single-

word answer.
 Examples:
Closed-Ended Questions Open-Ended Questions
Do you get along on well with your boss? Tell me about your relationship with your boss.
Who will you vote for this election? What do you think about the candidates in this
election?
What color shirt are you wearing? That’s an interesting color shirt you’re wearing.


Audit Techniques
 Uncover / Discover Objective
Evidence
 How to Find It
 Cross Check Results
 Avoid “Spring boarding” Into
New Findings


Non Conformities
 Activity Doesn’t Follow Procedures

 Written
 Oral (Training Records)
 Procedure Is Not Effective
 Procedure is Non Existent


Non Conformities
 Document Specific Facts
 What Department, Line, Activity, Etc;
 What Specifically Was Observed
 What Was Said / by Whom?
 What Does the Activity Not Meet
 Procedures / Contract
 The requirements of the Standard
 Effectiveness Criteria

Closing Meeting
Auditees / Auditors
 Discuss Findings Found During Audit
 If Finding Not Clear, Default to Auditee
 No Surprises After Closing Meeting
 Collectively Discuss Findings &
Determine Validity
 Initiate C A R’s With Implementation
Time Limits


Auditors Are Not
Auditors Do Not Have the Knowledge
Base to Become Part of the Solution
But Tend to Become Part of the
Problem When Used As the Problem
Solvers.

Questions

How to Write
the Final Report
 Report Procedures
 Report Content

How to Write
the Final Report
Report Procedures
 Everything Remains Proprietary
 No Surprises After Closing Meeting
 Organize Report Logically
 Meet the Promised Date

How to Write
the Final Report
Report Procedures
 Give All Team Members Responsibilities
 Clarify, Don’t Argue Over the Results

How to Write
the Final Report
Reference the Audit Basis
 Results
 Findings & Significance
 Evaluation
 Conclusion

How to Write
the Final Report
Report Content
 Agreements on Corrective Actions
 Recommendations if requested ??????
 Non Conformities & Support
 Routing of Report

Questions

How to Follow Up The audit

 Auditor Actions for Corrective
Actions
 Closure With Management
 What the Registrar Will Look for
 Elements of Success

Auditor Actions for Corrective Actions
Verify Corrective Action

 action taken
 action effective
 on all findings


 Identify + Address = Reduced Recurrence
 Overall Process Addressed ?
 Any Interim Actions ?
 Root Cause Found ?
 Not Symptoms


 When Does C/A Take Effect ?
(Effectively)
 Document Your Acceptance
 By Signature / Date
 By Letter

Closure with Management
 Successful Verification of C/A

 Effective Implementation of C/A
 Summarize Results and C/A's
 Inform the Auditee
 Audit is Now Closed
 Thank All That Helped

Questions

What Will The

Registrar Look For ?
 Audit plan
 Final report
 Corrective actions
required (open)
 Corrective actions
followed up (closed)

What Will The

 Schedules of management
reviews
 Procedures to conduct
audits
 Documented auditor
training

What Will The

 Check lists
 Copies of procedures
 Work instructions
 Training records

What Will The

 Audit reports
 Non conformity reports
 Records of audits
 Records of management
reviews

What Will The

 Opening and closing
meeting memos
 Quality policy compliance
to the referenced quality
standard

What Will The

 Customer complaint files
 Proactive, preventive
action procedures

What Will The

ANYTHING AND
EVERY THING THAT
YOU THOUGHT WAS
WELL TAKEN CARE
OF AND YOU LEAST
EXPECTED TO BE
AUDITED FOR
Questions

Take A Break

ISO 9001
Quality Management
System Requirements

4 Quality Management System

4.1 General
• Establish, document and maintain a QMS
• Identify the processes
• Determine their sequence
• Available resources
• Monitor, measure and analyze (continuous
improvement)
4.2.2 Quality Manual
The Quality Manual must include:

• The Scope and justification for any
exclusions
• Documented procedures or a reference
• Interrelationship of the processes

4.2.3 Control of Documents
All documents must be controlled.

• Reviewed and approve by proper people
• Changes are identified
• Available at point of use
• Legible and readily identifiable
• Prevent unintended use

4.2.4 Control of Records
• Evidence of conformity • Retention time

•Established • Disposition
•Maintained • Storage
• Legible • Retrievable
•Readily identifiable • Reference to para.
• Protection 4.2.4 means a record
is mandated
Questions

5 Management Responsibility
5.1 Management Commitment
Must show commitment to the QMS by:
• Communicating requirements
• Establishing Quality Policy & Objectives
• Conduct Management Reviews
• Making resources available

5.2 Customer Focus
Customer requirements are determined and

met with the aim of enhancing customer
satisfaction.

5.3 Quality Policy
• Is appropriate to your company

• Commitment to comply with requirements and
continuous improvement
• Provides framework for establishing and
reviewing Quality Objectives
• Communicated and understood
• Reviewed for continuing suitability

5.4.1 Quality Objectives
• Established at relevant functions and levels

• Measurable and consistent with the Quality
Policy

5.4.2 Quality Management

System Planning
• Is carried out to meet requirements and

objectives
• Integrity of the QMS is maintained when
changes to the QMS are planned and
implemented

5.5.1 Responsibility and

Authority
Ensure responsibilities and authorities are

defined and communicated.

5.5.2 Management
Representative
Appoint a member of management who:

• Ensures that QMS processes are
established, implemented and maintained
• Reports on the performance of the QMS to
top management & needs for improvement
• Promotes awareness of requirements

5.5.3 Internal Communication
Appropriate communication processes are

established and takes place regarding the
effectiveness of the QMS.

5.6.1 Management Review -

General
Planned review of the QMS to ensure:

• Continuing suitability
• Adequacy and effectiveness
• Assess opportunities for improvement
• Assess needs for changes in the QMS

5.6.2 Review Input
• Audit results
• Customer Feedback
• Process performance
• Status of Corrective and Preventive Actions
• Follow-up from previous reviews
• Recommendations for improvement

5.6.3 Review Output
• Improvements of the effectiveness of the

QMS
• Improvement of product related to customer
requirements
• Resource needs

Questions

6 Resource Management
6.1 Provision of Resources
• To implement and maintain the QMS and

continually improve its effectiveness
• To enhance customer satisfaction

6.2 Human Resources
6.2.1 General
All personnel performing work affecting
product quality must be competent on the
basis of appropriate education, training,
skills and experience

6.2.2 Competence, Awareness

and Training
• Determine competence for necessary work

• Provide training or take other actions
• Evaluate this training
• Ensure personnel are aware of their
contributions to product quality
• Maintain appropriate records
6.3 Infrastructure
Provide infrastructure needed to meet

requirements.
• Buildings, workspace and utilities
• Process equipment (hardware & software)
• Support services

6.4 Work Environment
Must determine the needs of the work

environment and properly manage these.
i.e., temperature, cleanliness, safety, facilities,

heat, light, ergonomics & safety equipment

Questions

7 Product Realization
7.1 Planning and Product Realization
• Must plan and develop the processes needed
to manufacture product
• Set quality objectives
• Inspection activity criteria
• Inspection records

7.2.1 Determination of
Requirements related
to the product
Must determine:
• Customer’s requirements for manufacture,
delivery and post delivery
• Unspecified requirements but necessary
• Regulatory requirements
• Additional requirements specified by the
organization

7.2.2 Review of Requirements

Related to the Product
Prior to acceptance of an order:
• Ensure product requirements are defined
• Differences are resolved
• Organization has the ability to meet
the defined requirements
•Amendments must be communicated to
the appropriate personnel
7.2.3 Customer Communication
Must have established processes for

communicating with customers
in relation to:
• Product information
• Inquiries, contracts, order handling,
amendments, etc.
• Customer feedback, including complaints
7.3.1 Design and Development

Planning
The organization must determine:
• Design and development stages
• Reviews, verifications and validations at the
appropriate stages
• The responsibilities of those involved and
their interfaces


Inputs
Inputs relating to product requirements must be
determined and records must be maintained.
This includes:
• Functional, performance and regulatory
requirements
• Knowledge from previous designs
• Must be reviewed and must not be in conflict
with other requirements


Outputs
• Output must be verifiable against and must meet
input requirements
• Output must provide the appropriate information
for purchasing, production and service
• Must contain or reference acceptance criteria
• Must specify the characteristics of the product that
are essential for its safe and proper use


Review
• Designs must be performed at appropriate stages
in accordance with the design plan
• Must determine if the output meets the input
requirements
• Must identify problems and propose solutions
• Appropriate personnel must be involved
• Records must be maintained


Verification
• Must be performed in accordance with the

design plan to ensure the design outputs
have met the design inputs


Validation
• Must be performed in accordance with the

design plan to ensure the design outputs
have met the design inputs
• Should be performed prior to delivery or
implementation

7.3.7 Control of Design and

Development Changes
• Must be identified
• Must be verified, validated and
approved prior to implementation,
when appropriate
• Changes must evaluate the effect on
parts already delivered

Questions

7.4.1 Purchasing Process

• Must ensure that purchased product conforms to
specified purchase requirements.
• Control taken must be dependent upon it’s effect
on the finished product
• Must select suppliers based upon their ability
• Suppliers must be evaluated and records
maintained

7.4.2 Purchasing Information

Purchasing information must describe the
Product to be purchased including,
where appropriate:
• Requirements for approving product,
procedures, processes and equipment
• Requirements for qualification of personnel
• QMS requirements
P.O.’s must be reviewed prior to release

7.4.3 Verification of Purchased

Product
• Organizations must have inspection
activities to insure that purchased product
meets requirements
• If the organization or it’s customer intends
to perform an inspection at the suppliers
facility, the the arrangements must be
included in the purchasing documents

7.5.1 Control of Production &

Service Provision
Must control production and servicing under

controlled conditions, including, as
applicable:
• Available instructions and requirements
• Use of suitable equipment and inspection
equipment

7.5.2 Validation of Processes for

Production and Service (1 of 2)
• Processes must be validated when the

resulting output cannot be verified by
subsequent testing
• Validation must demonstrate that processes
are able to achieve planned results

7.5.2 Validation of Processes for

Production and Service (2 of 2)
Planned arrangements for these processes
must include:
• Criteria for approval of processes
• Approval of equipment and personnel
• Using specific methods and procedures
• Documentation is required
• Revalidation
7.5.3 Identification and

Traceability
• Product must be identified throughout the

manufacturing process
• Inspection status must be identified
• Product must be uniquely identified when
traceability is a requirement

7.5.4 Customer Property

• Identify, verify, protect and safeguard
• Customer supplied property that is lost,
damaged or found unsuitable, must be
reported to the customer
• Includes material, components,
equipment, fixtures and intellectual
materials

7.5.5 Preservation of Product
Product, raw material, components, etc. must

be protected from damage throughout all
stages of receipt, manufacturing, handling,
packaging, storage and delivery.

7.6 Control of Monitoring and

Measuring Devices
• Determine instruments to be calibrated
• Determine calibration frequency
• Establish processes
• Calibrated at specified intervals
• Identified with the calibration status
• Safeguarded from unintended adjustments
• Protected from damage
Questions

8 Measurement, Analysis and

Improvement
8.1 General
Organizations must plan for inspection and
testing to:
• Demonstrate conformity of the product
• Ensure conformity to the QMS
• Continually improve the QMS

8.2.1 Customer Satisfaction
Organizations must monitor their customers

perceptions as to whether they have met
their customers requirements

8.2.2 Internal Audit

• Must conduct audits at planned intervals to
determine conformance to the QMS, ISO
9000:2000 and other requirements
• Audits must be scheduled on the basis of
importance, problems, # of processes, etc.
• Auditor must be independent
• Should be conducted annually (unwritten)

8.2.3 Monitoring and

Measurement of Processes
Monitor the measurement of the QMS

processes and apply Corrective Action
when the results do not conform with
planned results

8.2.4 Monitoring and

Measurement of Product
• Monitor the measurement of the product
characteristics to ensure product
requirements are met
• Must be carried out at appropriate stages
• Product may not be released until it has
passed inspection by authorized personnel

8.3 Control of Nonconforming

Product
• Must ensure that product which does not conform
to requirements is identified and controlled to
prevent unintended use or delivery
• NC product may be handled by reworking, release
through concession, scrapping or regrading
• Reworked product must be reinspected
• Notify customer of suspect product

8.4 Analysis of Data

• Determine, collect and analyze data to
demonstrate the suitability of the QMS and to
evaluate where continual improvement can be
made
• Data analyzed will relate to:
– Customer satisfaction
– Conformity to requirements
– Trends of processes and products
– Suppliers

8.5.1 Continual Improvement
Continually improve the effectiveness of the QMS

through use of the:
• Quality Policy and Objectives
• Audit results
• Analysis of data
• Corrective and Preventive Actions
• Management Reviews

8.5.2 Corrective Action
• Must be appropriate to the

severity of the problem
• Determine the cause of the nonconformity
• Determine the solution
• Take action to eliminate the cause of
nonconformity in order to prevent recurrence
• Maintain records
• Review the Corrective Actions taken
8.5.3 Preventive Action

• Must be appropriate to the severity of the problem
• Determine the cause of the potential
nonconformity
• Determine the solution
• Take action to eliminate the cause
• Maintain records
• Review the Preventive Actions taken

Questions

IT’S OVER

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Florida MEP: Solutions for Manufacturers

Internal Auditor Training

ISO 9001 / AS9100

WI-822-001 Rev. Basic CLI

 How the Audit fits

WI-822-001 Rev. Basic CLI

 How to Conduct an Audit

WI-822-001 Rev. Basic CLI

Questions & Answers -

How the Audit Fits

WI-822-001 Rev. Basic CLI

How the Audit Fits

WI-822-001 Rev. Basic CLI

How the Audit Fits

How the Audit Fits

Installation Disposal Marketing

Inspection Storage Production

WI-822-001 Rev. Basic CLI

Continuous improvement of the QMS

WI-822-001 Rev. Basic CLI

How the Audit Fits

WI-822-001 Rev. Basic CLI

How the Audit Fits

WI-822-001 Rev. Basic CLI

How the Audit Fits

Documentation - Why we have it

WI-822-001 Rev. Basic CLI

How the Audit Fits

Blank Forms RECORDS

How the Audit Fits

WI-822-001 Rev. Basic CLI

How the Audit Fits

How the Audit Fits

WI-822-001 Rev. Basic CLI

WI-822-001 Rev. Basic CLI

Quality System Audits

WI-822-001 Rev. Basic CLI

Quality System Audits

WI-822-001 Rev. Basic CLI

Quality System Audits

WI-822-001 Rev. Basic CLI

Quality System Audits

First Party YOU AUDIT YOURSELF

Second Party YOU AUDIT YOUR SUPPLIER OR

Third Party YOUR REGISTRAR AUDITS YOU

WI-822-001 Rev. Basic CLI

WI-822-001 Rev. Basic CLI

Parts of the Audit System

WI-822-001 Rev. Basic CLI

Parts of the Audit System

Parts of the Audit System

WI-822-001 Rev. Basic CLI

Parts of the Audit System

WI-822-001 Rev. Basic CLI

Parts of the Audit System

WI-822-001 Rev. Basic CLI

Parts of the Audit System

WI-822-001 Rev. Basic CLI

Parts of the Audit System

WI-822-001 Rev. Basic CLI

Parts of the Audit System

Parts of the Audit System

WI-822-001 Rev. Basic CLI

Parts of the Audit System