Internal Auditor Trainers Guide

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 can
meet 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 ISO
9001:2000 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 of
a fictitious company. Allow 1 day for this section.

It is recommended that the first audit the student is involved with, be under the leadership
of 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 one
copy 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 slides
out 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 have
a 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.

ICE BREAKERS

If you have a group of students who don"t know each other very well, you could chose
one of the following ice breakers to help with the introductions and relax the students
before starting the instruction.

I. On a piece of paper or on the back sheet of a page in their manual, have each
student 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 four
statements about yourself, and let the students guess which one if false.

When they have them written down, have them take turns reading their
statements 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 split
them 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.

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


The standard

Introduction

You can put up an overhead of the Agenda and explain what is coming, and do any
introductions 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 overheads You could show and discuss the first three slides of the
#Internal Auditing to ISO 9001$ Power Point Presentation.

Exercise
Review 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 or
false, 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 and
help 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 go
through 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 is
included on the following pages.

ISO 9001:2000 Standard

Review the standard using the Power Point presentation. If you use the speaker"s 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.


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. T
Clause:
6.2.2.c
F
Clause:
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. T
Clause:

F
Clause:
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 of
product.
Caution: 4.2.1.d still applies
T
Clause:

F
Clause:
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 be
returned to the customer.
T
Clause:

F
Clause:
7.5.4
12. Work instructions may be changed if quality assurance
approves the changes.

T
Clause:
F
Clause:
4.2.3

13. All work instructions must be the current revision. T
Clause:
4.2.3.d
F
Clause:
14. Only one copy of each work instruction may exist. T
Clause:

F
Clause:
4.2.3.d
15. 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 maintaining
traceability of product.
Note:For some companies this is a requirement
T
Clause:
F
Clause:
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 process
is 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 audited
once per year.

T
Clause:
F
Clause:
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 quality
management system.

T
Clause:

F
Clause:
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


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 of
work.
6.1

19. Do not release product until all required inspection has been
completed 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 verify
product.
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


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 Sticky
Bubble 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 option
shows 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 their
own 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 Gum"s 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 now
September 12
th
, and the class is going to perform an internal audit of Sticky Bubble
Gum"s management"s area.

Overhead Basic Steps for an Audit
This 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.

Overhead Prepare an audit plan for SBG
Discuss filling out the plan; as they are doing it you can show the example included in the
appendix.
Overhead Sample Audit plan (in appendix)

Overhead - Opening Meeting Agenda
Have 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

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 be
Sticky 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.

Overhead Prepare your checklists
Have 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. They
should 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 the
checklist.

Overheads Ask Question of Employees
When they are ready to audit SBG management, let the teams ask questions of the
Trainer 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 should
take 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 Document
Nonconformances$ 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 review
The 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 Customer &related processes
Quotes
Customer purchase orders
The Trainer could act as Mary again for this since she is the Customer Service
Manager.

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 Logs
The 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 be
out visiting a vendor, and audit Mary who fills in for him, but doesn"t have a key to
his files.

7.5 Product and service realization have been included as an option. It was not on SBG"s
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 standard
is 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, have
the 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 Actions
In this case the Trainer could be Somersby, the QA manager who is also the
corrective action coordinator.
After reviewing the nonconformances they have found, its time to write things up.

OverheadsWrite up the Nonconformance
In 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 standard
that 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 the
nonconformance.
Overhead CPAR example This can be shown while they are writing their CPAR"s


Overhead - The Audit Report
Next is the student manual is the Audit Report. Have each student complete the report
based on their assessment of Sticky Bubble Gum"s implementation of the QMS.
Overhead show example of an Audit Report.

Overhead Closing Meeting Agenda
Next 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 auditor
conducts 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.

Overhead The Audit File
Review what goes into the audit file for each audit.

Questions and answers

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
April 11, 2002

AGENDA

I. The Standard

Introduction
Exercise
ISO 9001:2000 Standard
Find the requirement (exercise)
Questions

II. The Audit

Planning the audit
Opening meeting
Audit 4.2 Documentation
Audit 5.0 Management responsibility
Audit 7.2 Customer-related processes
Audit 7.4 Purchasing
Audit 7.5 Product realization
Audit 8.5 Corrective action
Write Nonconformances
Audit Report
Closing Meeting
Audit File

April 11, 2002

EXAMPLE
F-822-001-A
Internal Audit Plan

23401
Audit Number: 5
Date: 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 will
include auditing the warehouse for the following clauses
of 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, Robbie
Roberts
Proposed Schedule
Time Process or Procedure Team 1 Team 2
8:00 Opening meeting

8:30 Auditors meeting

( doc review)

9:30 7.5 Product provision

11:00 8.2 Monitoring and
measur.

12:00 Lunch break

1:00 8.3 Control of N/C
material

2:00 8.5 Corrective action

2:30 6.2 Training

3:00 Auditors meeting

4:00 Closing meeting

Corrective Actions to be verified:
0094, 0103, 0110
Primary contact:
Pete Peters
Time and Place for closing meeting:
4:00 Conference room B
Additional information:

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


Management Responsibility Nonconformances

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

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

The quality policy and bubble panel taste test were not
reviewed at the 4/1 meeting as the procedure requires.

During the 7/6 Management Review Meeting they did not
review:
- Bubble panel taste tests
- Action items were not assigned
- No follow-up on previous action items

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


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. Form
states Sales and Marketing Manager. All are signed by
production or customer service.

Procedure does not identify how differences are resolved.

There is no !Let"s 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


Control of documents Nonconformances

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

Procedure 4.2 009, dated 7/27/01 does not match the
Master 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 required
by the procedure.

No record of approval on the Quality Manual

Does not address Documents of External Origin.


Purchasing Nonconformances

Quality related items are not always purchased from
approved subcontractors.
PO 00-07 Kool Aid
PO 00-03 Quality Flavors
PO 00-02 Critter Control ) was used 2/10/01
approved 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 not
specify !after 4:00 p.m.$

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

Subcontractor problem log Quarter #1 includes issues
that are not subcontractor problems. Corrective Actions
should have been started on these.

No purchase order exists for 3
rd
quarter pest control. No
record of what subcontractor.

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

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


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 but
not recorded on the CAR log).

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

There is no record of follow-up on the CAR to make sure
corrective action was implemented and that if was
effective. 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 the
magnitude of the problems. ( CAR # 107 dated 3/25, due
6/29).

A customer complained for the second time about the
bubble gum. There is no record of a CAR from the first
complaint.

There is no Preventive Action Procedure

There is no record of who the investigator is.
Forms did not indicate what corrective action was taken
to prevent reoccurrences, but CAR # 108 found this.

Example
F-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 and
measurement equipment will have a calibration sticker
indicating a current calibration status, or a calibration not
required tag.

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

Investigation Finding / Root Cause

The ISO 9000 Store
F-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:
EXAMPLE
F-822-002-A
Internal Audit Report
23401 Page 1 of 2
Audit Number: 5
Date: April 1, 2001
Area(s) audited: Warehouse
Closing Meeting Attendees:
Changes to Score of Audit (as defined in audit plan):
No changes in scope. Audited per plan
Auditor(s): R Richards, Ander Anderson and Robbie Roberts
Audit Record (Describe what you did, who you spoke to, what records you
examined below):
General Comments: Everyone was very helpful and open when
being audited. The documents and records requested were
promptly furnished.
List of documents reviewed:
P-7.5.5 Preservation of product P-8.5 Corrective action
Training records CARs and PARs
P-8.3 Control of N/C product
List of persons interviewed:
Warehouse supervisor HR training coordinator
Shipping clerk Corr. Action coordinator
Fork truck drivers Equipment coordinator
Summary: The quality system is being followed with some minor
exceptions as noted on the nonconformance reports.
Assessment of systems ability to meet quality objectives and extent of
compliance: The system has been adequately implemented and
maintained.
Person responsible to issue CAs: CAR coordinator
Signature of Lead Auditor: RRR Date: April 1 2001
Final Report Distributed to:

EXAMPLE
F-822-002-A
Internal Audit Report
23401 Page 2 of 2

Audit Number: 5
Date: April 1 01

Corrective Action Table
Area 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

Internal Auditor Trainers Guide

Caricato da

Informazioni sul documento

Copyright

Formati disponibili

Condividi questo documento

Condividi o incorpora il documento

Opzioni di condivisione

Hai trovato utile questo documento?

Questo contenuto è inappropriato?

Copyright:

Formati disponibili

Internal Auditor Trainers Guide

Caricato da

Copyright:

Formati disponibili

Copyright 2002 Vinca, LLC

Internal Auditing to ISO 9001:2000

Potrebbero piacerti anche