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. Copyright 2002 Vinca, LLC
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. Copyright 2002 Vinca, LLC
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 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.
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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. 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 Copyright 2002 Vinca, LLC
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
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 Copyright 2002 Vinca, LLC
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
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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 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 Copyright 2002 Vinca, LLC
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. Copyright 2002 Vinca, LLC
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
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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 Copyright 2002 Vinca, LLC
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 Copyright 2002 Vinca, LLC April 11, 2002
AGENDA
I. The Standard
Introduction Exercise ISO 9001:2000 Standard Find the requirement (exercise) Questions
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
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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.
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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. 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
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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 ).
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.
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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 )
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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 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