wi-822-001 internal auditor training

8/8/2019 WI-822-001 Internal Auditor Training

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Florida MEP: Solutions for Manufacturers

WI-822-001 Rev. Basic CLI

Internal Auditor Training

ISO 9001 / AS9100

Quality Management System


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Internal Auditor

Training Agenda

Todays topics:

How the Audit fits

Quality System Audits vs. Other

Audits

Parts of the Audit System

How to Plan an Audit


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Internal Auditor

Training Agenda

Todays topics:

How to Conduct an Audit

How to Write the Final Report

How to Follow up the Audit

Review of the ISO Requirements


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Internal Auditor

Training Agenda

Questions & Answers -

Ask the questions when

they come to mind,

DONT WAIT.


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How the Audit Fits

What is a Quality System?

Documentation of the System

What is an Audit?Why do we Audit?

Managements Role


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What is a Quality System?

Quality Policy

System Requirements

Best Practices

Types of Standards

How the Audit Fits


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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


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How the Audit Fits

Company

Quality PolicyTechnical

Assistance

Marketing

Design &

Development

Process

Planning

ProductionInspection Storage

Installation

Sales

Disposal

System Requirements


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C

ustomers

R

equirements

Management

Responsibility

Measurement,analysis &

improvement

Resource

Management

ProductRealization C

ustomers

Satisfaction

Value added

activityInput Output Product

Continuous improvement of the QMS

P

Plan

D

Do

C

Check

AAct

Information

Flow

Info.

Flow


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How the Audit Fits

Best Practices

Quality ManualProcedures

Work Instructions

Workers

Auditor

Verification


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How the Audit Fits

Types of Standards:

Contractual Standards

OSH

A EPA Customer Required Standards

Voluntary Standards

National Particle Board Association NEMA ISO 9001


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How the Audit Fits

Documentation - Why we have it

Guidance

Consistency

Compliance

Basis for Auditing


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Typical ISO Documentation Structuring

QualityManual

Procedures

(Implementation ofPolicy)

Work Instructions

(The how to do it documents)

Blank FormsRecords

Completed Forms

FORMS

RECORDS

Company PolicyStatements

Who does What,

Where & WhenThe HOW to do it

instructions

How the Audit Fits


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How the Audit Fits

What is an Audit? Planned Event

Independent Shows Intent

Shows Implementation

Shows Effectiveness

Management Driven

Required by the Standard


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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


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Managements Role

Initiate Audit Program

Provide Audit Leadership

Assure Auditor Independence

Provide Resources

Corrective Action Follow Up

How the Audit Fits


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Questions


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Quality System Audits

vs. Other Audits


Other Audits Types of Audits


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vs. Other Audits


Whatever Affects Quality Relates to the ISO Elements

Intent

Implementation

Effectiveness

Supplier Quality


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vs. Other Audits

Other Audits

Product Audits

Process Audits

Problem or Spot Audits

Self Audits


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vs. Other Audits

ISO 9001 - Types of Audits

YOU AUDIT YOURSELF

YOU AUDIT YOUR SUPPLIER OR

YOUR CUSTOMER AUDITS YOU

First Party

Third Party YOUR REGISTRAR AUDITS YOU

Second Party


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Questions


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People

Procedures

Goals

Results

Follow up


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People

Top ManagementManagement Rep.

Audit Team

Engineering

Dept. Manufacturing

Dept.

Sales

Dept.


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Procedures

Audit Tools

Audit Appeals

Auditor Qualifications

Auditor Behavior


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Audit Tools

Audit Procedures

Check List

Record of Non Conformity

Audit Plan

Corrective Action Schedule


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Audit Appeals

What is the Avenue?

Concentrate on the Facts.


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Auditor Qualifications / Attributes:

Open Minded / Mature

Sound Judgement, Analytical Skills and Tenacity

Realistic Perceptions and

Broad Perspective


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Auditor QualificationsAuditor Actions:

Fair Evaluate Effects SensitivityAvoid DistractionsG

ive Full Attention & Support Effective Under StressArrive at Valid Conclusions


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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 PhoneNumbers

Deal Only in Facts

Insist on a Knowledgeable Counterpart


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Auditor Behavior

Solutions to Stalling & Diversions

Note any Attempts at Intimidation orGratuitous Conduct

Contact the Lead Auditor when

Needed (Thats why they get paid the BIG BUCKS)


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Adhere to Auditor Rules

Safety & Smoking

Lunch / Break Times

Control of Proprietary Data

/ InformationManagement Discussions

Off Shift Auditing

Unsolicited Negative Information

Auditor Behavior


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Goals of Auditing

Ensure compliance to Quality System

Requirements

Ensure Quality system is Effective

Help Make Our Company Better


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Results

Non Conformities

Final Report


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Follow Up Results

Corrective Actions

Effective Implementation


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Questions


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How to Plan The Audit

How to Plan the Audit

Pre audit Visit

People Plan

Check List

Methods


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Pre Audit Visit

Scope

Location Departments

Expertise for Processes

Who, What & How Many


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People = Who ?

Technical Expertise of Auditors

Auditing Expertise of Auditors

Independence From Departments

Audited Need For Orientation


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The Plan - Do we have one?

The Schedule (Annual Plan)

The Check List (Who, Where, What

to Audit and What you Found)


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Check List

To Stay Focused

To Show Serious Intent

It Reminds You What to Look at & for

Provides a Place to Record Findings


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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


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Methods of Auditing

Vertical - follow records through departments

Upstream - shipping to sales

Downstream - sales to shipping

Horizontal - departmental interfaces

By ISO Requirement


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Questions


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How to Conduct the Audit

Opening Meeting

Objective Evidence

Audit Techniques Non Conformities

Closing Meeting


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Opening Meeting

If You Dont Know the Auditee -

introduce Yourself

May Be a Phone Call orHallway Meeting

Deliver / Send a Copy of the Check List

Determine If Confidentially Issues Exist

Special Precautions / Safety


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Objective Evidence

First

H

and Factual

Based on Direct Observation

Interviews

Records Results of an Activity


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Objective Evidence

Information Which Can BeProven TRUE, Based on FACTS

Obtained Through OBSERVATION,

MEASUREMENT, TEST or Other

Means.


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Audit Techniques

Review Documentation Prior to

Audit

Use Your Check List

Use Different Interviewing

Techniques Open Ended Questions

Closed Ended Questions

Silence


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Questions

Open-ended questions typically begin with wordssuch 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

Do you get along on well with your boss?

Who will you vote for this election?

What color shirt are you wearing?

Open-Ended Questions

Tell me about your relationship with your boss.

What do you think about the candidates in this

election?

Thats an interesting color shirt youre wearing.


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Uncover / Discover Objective

Evidence

How to Find It

Cross Check Results

Avoid Spring boarding IntoNew Findings

Audit Techniques


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Non Conformities

Activity Doesnt Follow Procedures

Written

Oral (Training Records)

Procedure Is Not Effective

Procedure is Non Existent


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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


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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 Rs With Implementation

Time Limits


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AuditorsAre 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.


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Questions


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How to Write

the Final Report

Report Procedures

Report Content


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Report Procedures

Everything Remains Proprietary

No Surprises After Closing Meeting

Organize Report Logically

Meet the Promised Date

How to Write

the Final Report


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Report Procedures

Give All Team Members Responsibilities

Clarify, Dont Argue Over the Results

How to Write

the Final Report

Fl id MEP S l ti f M f t


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Reference the Audit Basis

Results Findings & Significance

Evaluation

Conclusion

How to Write

the Final Report



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Report Content

Agreements on Corrective Actions

Recommendations if requested ??????

Non Conformities & Support

Routing of Report

How to Write

the Final Report



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Questions



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How to Follow Up The audit

Auditor Actions for Corrective

Actions

Closure With Management

What the Registrar Will Look for

Elements of Success



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Auditor Actions for Corrective Actions

Verify Corrective Action

action taken

action effective

on all findings



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Identify + Address = Reduced Recurrence

Overall Process Addressed ?Any Interim Actions ?

Root Cause Found ?

Not Symptoms

Florida MEP Sol tions for Man fact rers


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When Does C/A Take Effect ?

(Effectively) Document Your Acceptance

By Signature / Date

By Letter



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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



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Questions



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What Will The

Registrar Look For ?

Audit plan

Final report

Corrective actions

required (open)

Corrective actions

followed up (closed)



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Schedules of management

reviews

Procedures to conduct

audits

Documented auditor

training

What Will The




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What Will The


Check lists

Copies of procedures

Work instructions

Training records



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Audit reports

Non conformity reports

Records of audits

Records of management

reviews

What Will The




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What Will The


Opening and closing

meeting memos

Quality policy compliance

to the referenced quality

standard



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What Will The


Customer complaint files

Proactive, preventive

action procedures



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What Will The


ANYTHINGAND

EVERY THING THATYOU THOUGHT WASWELL TAKEN CARE

OF AND YOU LEASTEXPECTED TO BEAUDITED FOR



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Questions



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Take A Break



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ISO 9001

Quality Management

System Requirements



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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)



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4.2.2 uality anual

The uality anual must include: The cope and justi ication or any

exclusions

ocumented procedures or a re erence Interrelationship o the processes



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4.2.3 Control o ocuments

ll documents must be controlled.

Reviewed and approve by proper people

Changes are identi ied

vailable at point o use

Legible and readily identi iable

Prevent unintended use



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4.2.4 Control o Records

vidence o con ormity stablished

aintained

Legible

Readily identi iable

Protection

Retention time isposition

torage

Retrievable

Re erence to para.

4.2.4 means a record

is mandated



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Questions



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5 Management Responsibility

5.1 Management Commitment

Must sho commitment to the QMS by: Communicating requirements

Establishing Quality olicy & Ob ectives

Conduct Management Revie s Making resources available



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5.2 Customer Focus

Customer requirements are determined andmet with the aim o enhancing customer

satis action.



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5.3 uality Policy

Is appropriate to your company

Commitment to comply with requirements and

continuous improvement

Provides ramework or establishing and

reviewing uality bjectives Communicated and understood

Reviewed or continuing suitability



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5.4.1 Quality Ob ectives

Established at relevant functions and levels

Measurable and consistent ith the Quality

olicy



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5.4.2 Quality Management

System lanning

Is carried out to meet requirements andob ectives

Integrity of the QMS is maintained hen

changes to the QMS are planned andimplemented



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5.5.1 Responsibility and

Authority

Ensure responsibilities and authorities are

defined and communicated.



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5.5.2 anagementRepresentative

ppoint a member o management who: nsures that processes are

established, implemented and maintained

Reports on the per ormance o the to

top management needs or improvement

Promotes awareness o requirements



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5.5.3 Internal Communication

ppropriate communication processes are

established and takes place regarding the

e ectiveness o the .



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5.6.1 anagement Review -eneral

Planned review o the to ensure:

Continuing suitability

dequacy and e ectiveness

ssess opportunities or improvement

ssess needs or changes in the



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5.6.2 Revie Input

Audit results

Customer eedback

rocess performance

Status of Corrective and reventive Actions

ollo -up from previous revie s

Recommendations for improvement



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5.6.3 Review utput

Improvements o the e ectiveness o the

Improvement o product related to customer

requirements

Resource needs



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Questions



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6 Resource anagement

6.1 Provision o Resources

To implement and maintain the and

continually improve its e ectiveness To enhance customer satis action



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6.2 Human Resources

6.2.1 GeneralAll personnel performing ork affecting

product quality must be competent on the

basis of appropriate education, training,

skills and experience



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6.2.2 Competence, warenessand Training

etermine competence or necessary work Provide training or take other actions

valuate this training

nsure personnel are aware o theircontributions to product quality

aintain appropriate records



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6.3 In rastructure

Provide in rastructure needed to meetrequirements.

Buildings, workspace and utilities

Process equipment (hardware so tware) upport services



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6.4 Work nvironment

ust determine the needs o the workenvironment and properly manage these.

i.e., temperature, cleanliness, sa ety, acilities,heat, light, ergonomics sa ety equipment



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Questions



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7 Product Realization

7.1 Planning and Product Realization

ust plan and develop the processes neededto manu acture product

et quality objectives

Inspection activity criteria Inspection records



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7.2.1 etermination o

Requirements related

to the product

ust determine: Customers requirements or manu acture,

delivery and post delivery

Unspeci ied requirements but necessary

Regulatory requirements

dditional requirements speci ied by theorganization



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7.2.2 Review o Requirements

Related to the ProductPrior to acceptance o an order:

nsure product requirements are de ined i erences are resolved

rganization has the ability to meet

the de ined requirements mendments must be communicated to

the appropriate personnel



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7.2.3 Customer Communication

ust have established processes or

communicating with customersin relation to:

Product in ormation

Inquiries, contracts, order handling,

amendments, etc.

Customer eedback, including complaints



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7.3.1 esign and evelopmentPlanningThe organization must determine:

esign and development stages Reviews, veri ications and validations at the

appropriate stages

The responsibilities o those involved andtheir inter aces



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7.3.2 esign and evelopmentInputs

Inputs relating to product requirements must be

determined and records must be maintained.This includes:

Functional, per ormance and regulatory

requirements

Knowledge rom previous designs

ust be reviewed and must not be in con lict

with other requirements



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7.3.3 esign and evelopmentutputs

utput must be veri iable against and must meetinput requirements

utput must provide the appropriate in ormation

or purchasing, production and service

ust contain or re erence acceptance criteria ust speci y the characteristics o the product that

are essential or its sa e and proper use



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7.3.4 esign and evelopment

Review esigns must be per ormed at appropriate stages

in accordance with the design plan

ust determine i the output meets the input

requirements

ust identi y problems and propose solutions

ppropriate personnel must be involved Records must be maintained



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7.3.5 esign and evelopmentVeri ication

ust be per ormed in accordance with thedesign plan to ensure the design outputs

have met the design inputs

Records must be maintained



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7.3.6 esign and evelopment

Validation

ust be per ormed in accordance with thedesign plan to ensure the design outputs

have met the design inputs

hould be per ormed prior to delivery or

implementation




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7.3.7 Control o esign andevelopment Changes

ust be identi ied

ust be veri ied, validated andapproved prior to implementation,

when appropriate

Changes must evaluate the e ect onparts already delivered




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Questions



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7.4.1 Purchasing Process ust ensure that purchased product con orms to

speci ied purchase requirements.

Control taken must be dependent upon its e ect

on the inished product

ust select suppliers based upon their ability

uppliers must be evaluated and recordsmaintained



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7.4.2 Purchasing In ormationPurchasing in ormation must describe theProduct to be purchased including,

where appropriate: Requirements or approving product,

procedures, processes and equipment

Requirements or quali ication o personnel requirements

P. .s must be reviewed prior to release



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7.4.3 Veri ication o Purchased

Product rganizations must have inspection

activities to insure that purchased product

meets requirements

I the organization or its customer intends

to per orm an inspection at the suppliers

acility, the the arrangements must be

included in the purchasing documents



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7.5.1 Control o Production

ervice Provision

ust control production and servicing under

controlled conditions, including, as

applicable:

vailable instructions and requirements

Use o suitable equipment and inspection

equipment



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7.5.2 Validation o Processes or

Production and ervice (1 o 2)

Processes must be validated when theresulting output cannot be veri ied by

subsequent testing

Validation must demonstrate that processes

are able to achieve planned results



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7.5.2 Validation o Processes or

Production and ervice (2 o 2)Planned arrangements or these processes

must include:

Criteria or approval o processes

pproval o equipment and personnel

Using speci ic methods and procedures ocumentation is required

Revalidation



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7.5.3 Identi ication and

Traceability

Product must be identi ied throughout themanu acturing process

Inspection status must be identi ied

Product must be uniquely identi ied whentraceability is a requirement



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7.5.4 Customer Property Identi y, veri y, protect and sa eguard

Customer supplied property that is lost,damaged or ound unsuitable, must be

reported to the customer

Includes material, components,

equipment, ixtures and intellectual

materials



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7.5.5 Preservation o Product

Product, raw material, components, etc. must

be protected rom damage throughout all

stages o receipt, manu acturing, handling,

packaging, storage and delivery.



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7.6 Control o onitoring and

easuring evices etermine instruments to be calibrated

etermine calibration requency stablish processes

Calibrated at speci ied intervals

Identi ied with the calibration status a eguarded rom unintended adjustments

Protected rom damage



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Questions



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8 easurement, nalysis and

Improvement8.1 eneral

rganizations must plan or inspection andtesting to:

emonstrate con ormity o the product

nsure con ormity to the Continually improve the



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8.2.1 Customer atis action

rganizations must monitor their customers

perceptions as to whether they have met

their customers requirements



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8.2.2 Internal udit ust conduct audits at planned intervals to

determine con ormance to the , I

9000:2000 and other requirements udits must be scheduled on the basis o

importance, problems, # o processes, etc.

uditor must be independent


hould be conducted annually (unwritten)



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8.2.3 onitoring and

easurement o Processes

onitor the measurement o the processes and apply Corrective ction

when the results do not con orm with

planned results



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8.2.4 onitoring and

easurement o Product onitor the measurement o the product

characteristics to ensure product

requirements are met

ust be carried out at appropriate stages


Product may not be released until it has

passed inspection by authorized personnel



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8.3 Control o Noncon orming

Product ust ensure that product which does not con orm

to requirements is identi ied 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

Noti y customer o suspect product



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8.4 Analysis of Data Determine, collect and analyze data to

demonstrate the suitability of the QMS and to

evaluate here continual improvement can bemade

Data analyzed ill relate to:

Customer satisfaction

Conformity to requirements Trends of processes and products

Suppliers



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8.5.1 Continual Improvement

Continually improve the e ectiveness o the

through use o the:

uality Policy and bjectives

udit results

nalysis o data

Corrective and Preventive ctions

anagement Reviews



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8.5.2 Corrective ction

ust be appropriate to the

severity o the problem

etermine the cause o the noncon ormity

etermine the solution

Take action to eliminate the cause o

noncon ormity in order to prevent recurrence

aintain records

Review the Corrective ctions taken



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8.5.3 Preventive ction ust be appropriate to the severity o the problem

etermine the cause o the potential

noncon ormity

etermine the solution

Take action to eliminate the cause

aintain records Review the Preventive ctions taken


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ITS OVER