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Internal AuditingHow Do We Make This

Thing Work?ASQ Chapter 1205

DiGiovanni’s Restaurant

February 18, 2010

Bruce Kyles

KQC – Kyles Quality Consulting

bakyles@comcast.net

815-721-9145

First OffWe are not going to talk about the

ISO standard 9001:2008 per seWe want to concentrated on a

couple of bigger issues◦What do we audit◦How do we make them more effective◦How do we get upper management to

see the benefits of internal auditing.

Contrast the internal quality audits with the financials audits.

Where do we get Audit schedule?Most will get it the standard ways

◦By element◦By Procedures◦By what are schedule was last year◦By what the auditor says he is going

to audit

Pretty Normal Schedule

Internal Audit Schedule Process Frequency Month Audit Scheduled Date

Completed Auditor Results

J F M A M J J A S O N D Product Realization

Annual S

Corrective Action

Annual C

Shop Floor Machining

Annual C

Management Review

Annual S C

Contract Review

Annual S

Strategic Planning

Annual S

Purchasing/ Supplier Cntrl

Annual S

Production Machines

Annual S

Internal Audits Annual S

Training Annual S

Calibration Annual C C

Receiving/ Shipping

Annual S

S = Scheduled C = Completed

Type of BusinessDoesn’t really make any

difference whether the business is:◦Manufacturing – Heavy/light◦Industrial nonmanufacturing◦Service◦Financial

Maybe we need to change where we look to getting the audits.The first clue on where to go in the

internal audit schedule is the standard.

An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits.

One of the things you will find is that you can be your own worst enemy when it comes to setting up the internal audit schedule.

What does your Manual, Procedure, or Work Instruction say about what you have to audit?

Standard wordingThis procedure applies to all elements of the implemented ISO

9001 quality system at _____________, including observations on suitable working environment. Internal audits will cover all production shifts at a minimum frequency of one complete system audit annually.

Look AtYour biggest lossesThe goals and objectives of:

◦Upper management◦Individual departments

Corrective ActionsComplaintsPast areas of nonconformances

One Source of 2010 Schedule

4.2; 25.6; 27.2; 5

7.4; 117.5; 22

8.2; 3PED; 1

2009 Corrective Ac-tions by ISO Section #

Audit; 5

Cus-tomer;

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In-ter-nal; 10

Supplier; 5

Source 2009 Cor-rective Action

AuditCustomerInternalSupplier

Problem Areas

7.6; 6

6.2; 5

7.5; 58.2; 4

8.3; 4

8.5; 4

7.1; 2 7.4; 2

4.2; 1 5.6; 1

Sections with NCN Written Since 1/1/06

The audit frequency (interval) may be increased when internal/external product nonconformances or customer complaints occur.

Scope

(Dept/function/area)

1Audit Frequency

Status Audits Completed 1Primary Auditors

J F M A M J J A S O N D

1 DOCUMENT & RECORD CONTROL

ANNUAL S 4.2 & 4.3

2 PURCHASING ANNUAL S 7.4

3 PURCHASING OVS ANNUAL S Control of outside supplier services

4 CUSTOMER RELATED PROCESSES

ANNUAL S 7.2

5 PRODUCT MEASUREMENT ANNUAL S 7.5 & 8.2

6 CALIBRATION ANNUAL S 7.6

7 PRODUCT ID & TRACEABILITY

ANNUAL S 7.5

8 SHIPPING AND RECEIVING ANNUAL S

9 INFRASTRUCTURE ANNUAL S 6.3

10 HUMAN RESOURCES ANNUAL S 6.2

11 CONTROL OF NONCONFORMING

ANNUAL S 8.3

12 CORRECTIVE ACTION SEMI

ANNUAL S S 8.5

13 CONTINUOUS IMPROVEMENT &

PREVENTIVE ACTION ANNUAL 8.5

14 INTERNAL AUDIT SEMI

ANNUAL S S 8.2

15 MANAGEMENT REVIEW ANNUAL S 5.6

S= Audit Scheduled; C = Audit Completed

TECHNIQUES

Scope of AuditsLimit the time you set for auditsBy limiting the time, you may

limit the scope

EXAMPLE

Snapshot of a Process

SURPRISE, SURPRISELet the auditee know you are

coming. Schedule a timeSurprise audits don’t work.

◦You may be interrupting something important

◦If you ask the right questions and look at the evidence, it will be difficult to hide anyway.

◦Think about your past history with surprise audits.

Tool #1Use existing flow charts Make up flow charts as you audit.

◦Flow charting is one of the easiest and I think under rated quality tools in our tool box. Use it.

If you observe the good 3rd party auditors, you are seeing more and more of them putting the evidence in flow chart format.

RAW DATA

•Look at the inputs and outputs.•Turtle diagrams are invaluable

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TOOL #3

What to look for when doing the audit.

Audit the intersections of the different processes.◦How to we determine these

intersections?◦Think of your own job and the

processes involved.◦Most processes will include multiple

elements of the standard and your documents.

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TOOL #4Use of ChecklistsGood

◦Promote planning◦Ensures consistent approach◦Creates Sampling plan◦Time manager◦Place to note findings

BUT◦Can cause canned approach◦Poor coverage◦Can be limiting

MINIMIZETHE RISKS

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Determine the reason for doing the audit

Is it a regular scheduled audit?Have we had a problem?

◦ Internal defects◦New requirement◦New Equipment

Major issue with new press

Has the Customer had a problem?◦Customer complaint◦Customer credit◦Customer requirement

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The reason for the doing the audit dictates many aspects of how the audit progresses◦Timing and urgency◦Resources committed◦Attention from upper management

FINAL EXAMPLE

Request for Deviation/ Samples/ Trials

1/14/10 WI83-2

Deviation/ samples/ trialRequested

Production ControlReview

Complete

# Assign & LoggedProd Ctrl.

Routed toApprop Dept

Eng MgrPlant Mgr

Sub Contractor (if need)

Quality Mgr

OK

Routed back To Originator

Rout to CustApproval

Approved

Filed By Prod Ctrl

Fill outRFD FormAny Dept

yes

no

yes

no

CustomerService

Production

Materials

Quality

Sales

Engineering

Shipping

Form QP-83-F04

Cust Approvalneeded

yesno

yes

noAlternate process

Log Results

RFD Log

Wrap UpGo after audits that will make a difference

◦ Reduce losses◦ Gain efficiency

Use the simple tools◦ Simple process diagrams◦ Input/ output diagrams

Be effective◦ Focus - Take small snapshots of a process◦ Use your time wisely◦ Listen to your leader’s needs◦ Audit the issues

Thankyou

Bruce KylesKQC

bakyles@comcast.net