Internal Auditor Trainers Guide

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Copyright 2002 Vinca, LLC

Internal Auditing to ISO 9001:2000

Overview

This course is to train people to be able to conduct your internal quality audits so you canmeet the internal audit requirements of the standard. The course is divided into two

sections. The first section will familiarize the students with the requirements of the ISO9001:2000 quality management system. This normally is day. The second section is

devoted to the auditing process. The students will go through all the steps required for an

audit, with hands on involvement in performing each step by conducting a mock audit ofa fictitious company. Allow 1 day for this section.

It is recommended that the first audit the student is involved with, be under the leadershipof a lead auditor that has audit experience.

What you will need to conduct this course

The supplies you will need are:

Copies of the Student Manual (included). Print one copy for each student.

Copies of the Sticky Bubble Gum Documents and Records (included). Print onecopy for each team of two or three students.

Copies of the ISO 9001:2000 Standard (one copy for each two or three students)Standards are available electronically from http://www.asq.org

Introduction to ISO 9000 Power Point Presentation by Vinca, LLC (included).This can be done by showing the presentation from a PC, or by printing the slidesout as overhead transparencies and using an overhead projector.

Internal Auditing to ISO 9000 Power Point Presentation by Vince, LLC(included). These can be used as overheads to supplement your training

activities.

The method of setting up the classroom will depend on the facility you have available.

The class can be delivered with everyone sitting around a conference table, or if you havea larger room with tables that can be arranged, some suggested configurations are

included on the next page. You will need a screen or suitable wall to show the power

point presentations or the overheads on.

An explanation of the room set-up and how to use it will be explained later as the

situations arise.
http://www.asq.org/http://www.asq.org/


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ICE BREAKERS

If you have a group of students who dont know each other very well, you could chose

one of the following ice breakers to help with the introductions and relax the studentsbefore starting the instruction.

I. On a piece of paper or on the back sheet of a page in their manual, have eachstudent write down four statements about themselves. Have three of them be

true, and one false. You could give them examples by starting it off with fourstatements about yourself, and let the students guess which one if false.

When they have them written down, have them take turns reading theirstatements and let each of the other students guess which is false. If you want,

you could have them keep score and see who gets the most correct, or who

can fool the most with their false statement. If the class is large, you can splitthem into groups for this exercise to save time.

II Divide the class into pairs. Have each pair take about three minutes to

interview each other. Then have each student introduce their partner to the

rest of the class.


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Some suggested room configurations.

If you have a conference table:

1 1 1 3 3 3

T

2 2 2 4 4 4

If you have a room with movable tables:

1 2 5

1 2 5

S

T

3 4 6

3 4 6


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The standard

Introduction

You can put up an overhead of the Agenda and explain what is coming, and do anyintroductions or icebreakers. At this point each student should have a student manual,

and each team of 2 or 3 should have a copy of the standard.

Introduction overheadsYou could show and discuss the first three slides of the

Internal Auditing to ISO 9001 Power Point Presentation.

ExerciseReview the organization of the ISO standard with them so they have an idea where to

find things in the standard.Have the students open to Is it a requirement in the front of the student manual.

Working in groups of 2 or 3, have them determine whether or not the statement is true orfalse, and write down the clause of the standard where they found it. This is not a test,

but an exercise to get them familiar with the standard, so the trainer can go around andhelp the teams, particularly the slower teams that get behind the rest.

After one or two teams finish, or after a maximum of about 45 minutes, you can gothrough the statements and discuss the answers. Remind the students that there are some

things that are mentioned in more that one place in the standard, so there could be more

than one correct answer in some cases. A copy of the exercises with the answers isincluded on the following pages.

ISO 9001:2000 Standard

Review the standard using the Power Point presentation. If you use the speakers notes

this review could take about 2 hours. Encourage questions as you go. The student

manual has note pages so students can follow along in their manual and take notes.

Find the requirement

Next in the Student Manual is another exercise Find the Requirement. Have students

find the clause in the standard that applies. Have them work in groups as in the previous

exercise. Again, discuss the answers together.

To conclude this first section of the course, open it up to questions and answers on the

standard.


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Is it a Requirement?

The standard requires that:

If the requirement is true, circle True and list the clause.If it is false, circle False and list the clause used.

True(clause)

False

1. Verbal orders may not be accepted. T

Clause:

F

Clause:

7.2.2

2. Management must review the quality system every

quarter.

T

Clause:

F

Clause:

5.6.1

3. A procedure must be written for contract review

(receiving and processing of customer orders).

T

Clause:

F

Clause:

7.2

4. The effectiveness of employee training must be assessed. TClause:

6.2.2.c

FClause:

5. Statistics must be used to monitor processes.

Note:the intent of the new standard is to clarify the

standard to the extent that the use of statistical

techniques is a stated requirement.

T

Clause:

8.1

F

Clause:

6. Customer complaints are handled by management. TClause:

FClause:

8.5.2.a

7. The results of corrective actions taken must be

documented.

T

Clause:8.5.2.e

F

Clause:

8. Release of product for delivery must be authorized. T

Clause:

8.2.4

F

Clause:

9. There must be a documented procedure for purchasing ofproduct.

Caution: 4.2.1.d still applies

TClause:

FClause:

7.4

10. A list of approved suppliers must be maintained. T

Clause:

F

Clause:

7.4.1

11. All non-usable customer supplied product must bereturned to the customer.

TClause:

FClause:

7.5.4

12. Work instructions may be changed if quality assurance

approves the changes.

T

Clause:

F

Clause:

4.2.3


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13. All work instructions must be the current revision. TClause:

4.2.3.d

FClause:

14. Only one copy of each work instruction may exist. T

Clause:

F

Clause:

4.2.3.d15. Purchasing may order from any vendor as long as the

president of the company approves the order.

T

Clause:

F

Clause:

7.4.1

16. Documented procedures are required for maintainingtraceability of product.

Note:For some companies this is a requirement

TClause:

FClause:

7.5.3

17. Know where each copy of a controlled document is T

Clause:

4.2.3.d (g)

F

Clause:

18. Release of nonconforming product to customers must be

documented.

T

Clause:8.3

F

Clause:

19. When a process is outsourced, the control of the processis the responsibility of the organization

T

Clause:

4.1

F

Clause:

20. Management review must include preventive actions

taken.

T

Clause:

5.6.2

F

Clause:

21. Conduct internal audits using personnel that have no

Knowledge of the area being audited.

T

Clause:

F

Clause:

8.2.2

22. Schedule you internal audits so that each area is auditedonce per year.

TClause:

FClause:

8.2.2

23.The effectiveness of the quality management system

is determined by the internal auditors during the audit.

T

Clause:

F

Clause:

8.2.2b

24. Building space must be provided as part of the qualitymanagement system.

TClause:

FClause:

6.3

25. There is no need for employees to be aware of customer

requirements, except for the quality department.

T

Clause:

F

Clause:

5.5.2.c


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Find the Requirement

Clause:

1.Establish a quality policy. 5.1.b

(4.2.1.a)

2. Determine customer requirements. 5.2

(7.2.1)

3. Check to see if a corrective action was effective. 8.5.2

4. Provide controlled conditions for servicing. 7.5.2

5. Identify any quality requirements your supplier must meet on your

purchasing documents.

7.4.2

6. Ensure that purchased product meets specified requirements. 7.4.3

7. Ensure communication between different groups involved in the

design and development of products.

7.3.1

8. Determine what training is required for staff. 6.6.2

9. Changes to documents should be identified. 4.2.3.c

10. Determine how changes to customer orders will be communicated

to the appropriate people in you facility.

7.2.2

11. Planning processes needed for product realization. 7.1

12. Select your suppliers on their ability to meet requirements. 7.4.1

13. Management must communicate the importance of meeting

customer requirements.

5.1.a

14. If your customer intends to perform verification at your suppliers

site, the arrangements need to be in the purchasing documents.

7.4.3

15. Document how planning will be done. 4.2.1.d

16. Obsolete documents must be protected against unintended use. 4.2.3.g

17. Have a maintenance program for your equipment. 6.3

18. Have adequate amounts of trained personnel for performance ofwork.

6.1


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19. Do not release product until all required inspection has beencompleted and approved.

8.2.4

20. Prepare documented procedures 4.2.1.c

21. Identify where statistics are required to verify product

characteristics.

8.1

22. Design outputs must enable verification against design inputs. 7.3.3.a

23. Record the unique identification of product, where required. 7.5.3

24. Assign a member of management to ensure that the quality system

is established and maintained.

5.5.2.a

25. Identify inspection and test status of product. 7.5.3

26. Review the quality system at planned intervals. 5.6.1

27. Identify the monitoring and measurement devices needed to verifyproduct.

7.1.c

28. Release of product must be approved by the relevant authority. 8.2.4

29.Ensure that purchased product conforms to specified requirements. 7.4.3

30. Before accepting an order from a customer, review the order to

ensure that requirements are defined

7.2.2

31. Conformity of product must be maintained during storage. 7.5.5

32. Document the responsibility for dealing with nonconforming

product.

8.3

33. Schedule audits based on how the quality system is performing. 8.2.2


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The Audit

Normally the class size will vary from 4 to 12. Divide the class into teams of 2 or 3. It

works best to have an even number of teams for holding opening and closing meetings.

Now in addition to a copy of the standard, each team should have a copy of the StickyBubble Gum Documents and Records. This includes the SBG Quality Manual,

Procedures, Work Instruction and various records, audit schedule and org chart.

Refer to the page showing the room layout suggestions. The conference table optionshows 4 teams of 3 each. The trainer is at the head of the table and the screen for

projecting overheads.

The other configuration shows a head table for the trainer, and 6 tables, each with a team

of 2 (12 in a class). With a smaller class, 4 tables with 2 or 3 on a team will work well.This layout could hold 6 teams of 3 at a table for a class of 18.

Next is the Student Manual is a copy of a typical Internal Audit Procedure, QP-822. You

could go through this with the class, have them read it now, or have them read it on theirown late. You could insert your own Internal Audit Procedure here in the Student

Manual instead of this example.

Next in the student manual is a MEMO from Somersby (Sticky Bubble Gums Quality

Manager) to Expert Audit Assistance. The class is Expert Audit Assistance. Read

the memo in class. If you desire, you could show the memo as an overhead. It is nowSeptember 12

th, and the class is going to perform an internal audit of Sticky Bubble

Gums managements area.

OverheadBasic Steps for an AuditThis will show the class what steps they will be going through for the balance of the

class.

Have each student fill out the audit plan that is next in the student manual. Have them

use the Sticky Bubble Gum Internal Audit Schedule and audit chart in the SBG

Documents and Records, following the SBG Quality Manual, before the procedures.

OverheadPrepare an audit plan for SBG

Discuss filling out the plan; as they are doing it you can show the example included in the

appendix.OverheadSample Audit plan (in appendix)

Overhead - Opening Meeting AgendaHave each team choose a lead auditor. Now have them conduct an opening meeting. If

you are using a conference table, Team 1 can hold a meeting with Team 2 across the


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table, and team 3 with team 4 etc. If you have the individual tables, now team one can

turn around and meet with team 2, 3 with 4, and 5 with 6. Have the odd number team be

the auditors and the lead auditor will lead the meeting. The even number team will beSticky Bubble Gum management. When they have finished, have them reverse the roles,

and do it again with the even number team lead auditor can conduct the meeting.

OverheadPrepare your checklistsHave the students turn their manual to the Audit checklist for 4.2 Control of documents.

The students are now ready to audit Stick Bubble Gums Control of Documents. Theyshould make all their notes on the checklist. To audit they have the SBG Quality

Manual, P 4.2-009, the Procedure for Control of Documents, and the Master Document

List. There are also the rest of the procedures in the manual, to see if they match the

master list. Have the students write down any questions they want to ask on thechecklist.

OverheadsAsk Question of Employees

When they are ready to audit SBG management, let the teams ask questions of theTrainer who will act the part of Somersby, the document control coordinator for SBG.

Make sure students note any nonconformances they find on their checklist. This shouldtake about 45 minutes.

Now review their findings. Ask the teams what nonconformances they found. A list of

some of the things they could find is included in the appendix Control of DocumentNonconformances If you want you could show these on an overhead as you discuss

them.

Repeat the process for 5.0 Management Responsibility. They have:

The 5.0 checklist in their student manual SBG Quality Manual

Procedure P 5.0-002

SBG org chart

Minutes on management reviewThe Trainer could act the part of Mary Tyler Moore, the Management Representative

for this one. Again, some nonconformances they could find are listed in the

appendix.

Repeat for 7.2 Customer-related processes. They have:

The 7.2 checklist in their manual

Quality manual P 7.2 Customerrelated processes

Quotes

Customer purchase ordersThe Trainer could act as Mary again for this since she is the Customer Service

Manager.


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Next comes 7.4 Purchasing. They have:

Their 7.4 checklist

Quality manual

P 7.4 Purchasing procedure

Approved vendor list Purchase orders

Subcontractor Problem LogsThe Trainer could be Dilbert Delany in purchasing, or to avoid having to show the

vendor records and various things the auditors might want to audit, Delany could beout visiting a vendor, and audit Mary who fills in for him, but doesnt have a key to

his files.

7.5 Product and service realization have been included as an option. It was not on SBGs

audit schedule. It you have sufficient time and want to include it, there is a procedure, a

flow chart and some work instructions, and the checklist in the student manual. The

checklist leads the auditors to ask questions about quality objective because the standardis putting more emphasis on objective through the organization and making sure they are

communicated. The trainer could act as the auditee for this, or for a change of pace, havethe teams audit each other, one being the auditors and the other being the operators in

production.

The final clause to be audited is 8.5 Corrective and Preventive Action. They have:

The checklist

Quality manual

P 8.5 procedure

Corrective Action Log

Corrective ActionsIn this case the Trainer could be Somersby, the QA manager who is also thecorrective action coordinator.

After reviewing the nonconformances they have found, its time to write things up.

OverheadsWrite up the NonconformanceIn the student manual there are copies of the Corrective/Preventive Action Request. Have

the students each write one nonconformance on a CPAR for each clause of the standardthat they audited, but have it be different from the ones their teammates are writing. If

they took good notes on the checklist this should not be difficult. Remind them of that

for future audits. Emphasize the importance of being specific so those following up with

the corrective actions know what they mean. What is the requirement, and what was thenonconformance.

OverheadCPAR example This can be shown while they are writing their CPARs


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Overhead - The Audit ReportNext is the student manual is the Audit Report. Have each student complete the report

based on their assessment of Sticky Bubble Gums implementation of the QMS.

Overheadshow example of an Audit Report.

Overhead

Closing Meeting AgendaNext have each team pick someone who was not the lead auditor for the opening meeting,

to be the lead auditor for the closing meeting. Have the even number teams be the

auditors and present their finding to the odd number teams (SBG). The lead auditorconducts the meeting according to the agenda. Have each auditor read the

nonconformances that they wrote up. The lead auditor can then summarize as written on

the audit report. Have the teams change rolls and repeat the meeting.

OverheadThe Audit FileReview what goes into the audit file for each audit.

Questions and answers


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APPENDIX

Agenda

Internal Audit Plan Example

Control of documents Nonconformances

Management Responsibility Nonconformances

Purchasing Nonconformances

Customer-related processes Nonconformances

Corrective and Preventive Action Nonconformances

Corrective/Preventive Action Request for audit nonconformance Example

Internal Audit Report Example

Certificate - Example


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April 11, 2002

AGENDA

I. The Standard

IntroductionExerciseISO 9001:2000 StandardFind the requirement (exercise)Questions

II. The Audit

Planning the auditOpening meeting

Audit 4.2 DocumentationAudit 5.0 Management responsibilityAudit 7.2 Customer-related processesAudit 7.4 PurchasingAudit 7.5 Product realization

Audit 8.5 Corrective actionWrite NonconformancesAudit ReportClosing Meeting

Audit File


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April 11, 2002


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EXAMPLEF-822-001-A

Internal Audit Plan

Audit Number: 5Date: April 1, 2001

Opening Meeting Attendees:

Area(s) to be audited:

Warehouse

Closing Meeting Attendees:

Scope of audit and objectives: The scope of this audit willinclude auditing the warehouse for the following clausesof the standard:6.2, 7.5, 8.2, 8.3, and 8.5

Standard:X ISO 9001(2000)

Other: __________

Auditors:Lead auditor: Richard Richards Auditors: Ander Anderson, RobbieRoberts

Proposed Schedule

Time Process or Procedure Team 1 Team 2

8:00 Opening meeting8:30 Auditors meeting

( doc review)9:30 7.5 Product provision11:00 8.2 Monitoring and

measur.12:00 Lunch break1:00 8.3 Control of N/C

material2:00 8.5 Corrective action2:30 6.2 Training3:00 Auditors meeting4:00 Closing meeting

Corrective Actions to be verified:

0094, 0103, 0110

Primary contact:

Pete PetersTime and Place for closing meeting:

4:00 Conference room B

Additional information:

Signature of Lead Auditor: Richard Richards Date: April 1, 2001


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Management Responsibility Nonconformances

The quality policy in not communicated and understood.Conflicting quality policies are documented in the QualityManual and in the 5.0 Procedure.

It is unclear who has been appointed managementrepresentative. The Manual stated the Director of Quality,the procedure says Customer Service Manager.

The quality policy and bubble panel taste test were notreviewed at the 4/1 meeting as the procedure requires.

During the 7/6 Management Review Meeting they did notreview:

- Bubble panel taste tests

- Action items were not assigned

- No follow-up on previous action items

Procedure requires 4 managers to attend. Records ofmanagement reviews do not show who attended.


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Customer-related processes Nonconformances

There is no way to identify what PO matches a particular

quote as required by the procedure.

Procedure required the president to sign quotes. Formstates Sales and Marketing Manager. All are signed byproduction or customer service.

Procedure does not identify how differences are resolved.

There is no Lets make a change form as required.Changes are written on the PO.

Codes are not documented

No dates to indicate when quote was initiated or to who.

No record of quote being sent to customer for PO 1517


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Control of documents Nonconformances

Procedure P 5.0-002 has no signature to indicate approvalas required by the procedure.

Procedure 4.2 009, dated 7/27/01 does not match theMaster List ( 6/29/01 rev.008 ).

Obsolete document distributed. Procedure 7.4 004

dated 5/15/01. Master list says 6/14/01.

Revisions have no Italics indicating changes as requiredby the procedure.

No record of approval on the Quality Manual

Does not address Documents of External Origin.


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Purchasing Nonconformances

Quality related items are not always purchased fromapproved subcontractors.

PO 00-07 Kool Aid

PO 00-03 Quality Flavors

PO 00-02 Critter Control ) was used 2/10/01approved 5/01

Approved subcontractors list does not specify what the

subcontractors are qualified to provide.

PO 01-02 does not include all information. It does notspecify after 4:00 p.m.

PO 01-03 has a date needed that is earlier than the datepromised. There is no evidence of resolving the issue.

Subcontractor problem log Quarter #1 includes issuesthat are not subcontractor problems. Corrective Actionsshould have been started on these.

No purchase order exists for 3rd quarter pest control. No

record of what subcontractor.

No record of supplier corrective action for Trinity WorldTrading ( 1st quarter). No indication that the log is copiedfor management review.

Baker Sales not written up for being late (PO 01-06 )


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Corrective and Preventive Action Nonconformances

Due dates are not being met on completions.

The due date is not indicated on the CAR.

The CAR log is not current (#105 has been closed out butnot recorded on the CAR log).

CAR # 110 noted that the CAR log is not current, but thereis no copy of the CAR in the file.

There is no record of follow-up on the CAR to make surecorrective action was implemented and that if waseffective. It should be on the form.

The response to the corrective actions, and the due dated

do not seem to be to a degree appropriate to themagnitude of the problems. ( CAR # 107 dated 3/25, due6/29).

A customer complained for the second time about thebubble gum. There is no record of a CAR from the firstcomplaint.

There is no Preventive Action Procedure

There is no record of who the investigator is.

Forms did not indicate what corrective action was takento prevent reoccurrences, but CAR # 108 found this.


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ExampleF-852-001-A

Corrective/Preventive Action Request (CPAR)

23401 Page 1 of 2

CA PA(Check appropriate box to indicate corrective or preventive action)

Corrective Action #or

Date: April 1, 2002 Preventive Action #

Date Due By/Assigned to Completed Initials & Date

Investigation

Implementation

Audit

CAR closed

Description of Issue

Procedure P 7.5 paragraph 5.2.1 says all monitoring andmeasurement equipment will have a calibration stickerindicating a current calibration status, or a calibration notrequired tag.

The scale No. 602 in the shipping department had acalibration sticker showing it was due for calibration inNovember of 2000. The file for No. 602 has no record of a

current calibration.

Investigation Finding / Root Cause


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The ISO 9000 StoreF-852-001

Corrective/Preventive Action Request (CPAR)

2371 Page 1 of 2

Corrective / Preventive Action

Agreed to by:Date:

Auditors Comments

Was action taken effective? Yes No If no new CA/PA number:


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EXAMPLEF-822-002-A

Internal Audit Report

23401 Page 1 of 2

Audit Number: 5Date: April 1, 2001Area(s) audited: Warehouse

Closing Meeting Attendees:

Changes to Score of Audit (as defined in audit plan):

No changes in scope. Audited per planAuditor(s): R Richards, Ander Anderson and Robbie RobertsAudit Record (Describe what you did, who you spoke to, what records youexamined below):

General Comments: Everyone was very helpful and open whenbeing audited. The documents and records requested werepromptly furnished.List of documents reviewed:

P-7.5.5 Preservation of product P-8.5 Corrective actionTraining records CARs and PARsP-8.3 Control of N/C productList of persons interviewed:Warehouse supervisor HR training coordinatorShipping clerk Corr. Action coordinatorFork truck drivers Equipment coordinatorSummary: The quality system is being followed with some minorexceptions as noted on the nonconformance reports.

Assessment of systems ability to meet quality objectives and extent of

compliance: The system has been adequately implemented andmaintained.Person responsible to issue CAs:CAR coordinatorSignature of Lead Auditor: RRR Date: April 1 2001Final Report Distributed to:


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EXAMPLEF-822-002-A

Internal Audit Report

Audit Number: 5

Date: April 1 01

Corrective Action TableArea Description of Issue CA number CA verified

as effective

1 shipping Overdue calibration

2 shipping Missing records

3 warehse No hold ticked on returns

4 warehse Fork truck checklist used

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