ISO 9000:2000 Internal Audits Rene’ Jones October 7, 2003

Overview: ISO 9000:2000 Internal Audit ISO Audit Requirements Getting Started Steps to an effective audit Planning Execution Follow up Cessna’s Approach

ISO Audit Requirements

Getting Started

Steps to an effective audit

Planning

Execution

Follow up

Cessna’s Approach

ISO 9000 Audit Requirements Internal audits are required (4.17) Must be conducted by personnel independent of responsibility for process being audited Results must be recorded Must follow organizational objectives Frequency should be determined by the organizational need

Internal audits are required (4.17)

Must be conducted by personnel independent of responsibility for process being audited

Results must be recorded

Must follow organizational objectives

Frequency should be determined by the organizational need

Defined: An ISO 9000:2000 internal audit is a method for verifying the efficiency and performance of an organizations quality system. It ensures that the quality system meets or exceeds the required standard for certification by the chosen registrar.

An ISO 9000:2000 internal audit is a method for verifying the efficiency and performance of an organizations quality system. It ensures that the quality system meets or exceeds the required standard for certification by the chosen registrar.

Benefits and Uses: Can facilitate continuous improvement Can Identify System Failures Provide feedback to Management regarding efficiency of the Quality System

Can facilitate continuous improvement

Can Identify System Failures

Provide feedback to Management regarding efficiency of the Quality System

How does this apply to my organization?

How does this apply to my organization?

Decide the scope of the audit Full Partial How will it be conducted Upstream Downstream Across Processes Steps to a Successful Internal Audit

Decide the scope of the audit

Full

Partial

How will it be conducted

Upstream

Downstream

Across Processes

Scope of the Audit Full audit of the entire Quality System How many auditors will be needed How will responsibilities be divided Appoint a lead auditor to keep the audit focused Partial Which departments or processes Which clause of the standard

Full audit of the entire Quality System

How many auditors will be needed

How will responsibilities be divided

Appoint a lead auditor to keep the audit focused

Partial

Which departments or processes

Which clause of the standard

How Will the Audit Be Conducted Upstream-starting with the final process and working backwards to the beginning Downstream-starting with the first process and flowing forward Horizontal-across similar processes

Upstream-starting with the final process and working backwards to the beginning

Downstream-starting with the first process and flowing forward

Horizontal-across similar processes

Steps to a Successful Internal Audit cont. Develop a checklist Perform the audit Record findings Follow-up

Develop a checklist

Perform the audit

Record findings

Follow-up

Develop a Checklist Become familiar with the processess and the associated documentation to be audited Make notes on possible questions List items to look for and observe Note paragraph of the standard being checked next to the item being audited Leave space to record observations Use only one sheet per process or area

Become familiar with the processess and the associated documentation to be audited

Make notes on possible questions

List items to look for and observe

Note paragraph of the standard being checked next to the item being audited

Leave space to record observations

Use only one sheet per process or area

Sample checklist Wavesolder Process 3/3.0 Component and Board Handling 3/3.2 Are components labeled and stored properly? ________ Are operators following proper board handling procedures? ______ Safety Procedures 3/3.6 Are operators wearing appropriate safety equipment? ________ Is the area clean and obstacle free? ____________ Interview two operators What is the procedure for loading a board into the machine? How far apart should the boards be in the machine When is it necessary to wear safety glasses?

Wavesolder Process 3/3.0

Component and Board Handling 3/3.2

Are components labeled and stored properly? ________

Are operators following proper board handling procedures? ______

Safety Procedures 3/3.6

Are operators wearing appropriate safety equipment? ________

Is the area clean and obstacle free? ____________

Interview two operators

What is the procedure for loading a board into the machine?

How far apart should the boards be in the machine

When is it necessary to wear safety glasses?

The Internal Audit Maintain control of the audit Be professional Remain objective-look at the facts Observe everything

Maintain control of the audit

Be professional

Remain objective-look at the facts

Observe everything

Audit Interviews Ask open-ended questions Use hypothetical questions Encourage free speaking Observe body language of the interviewee and adapt question if needed Maintain eye contact

Ask open-ended questions

Use hypothetical questions

Encourage free speaking

Observe body language of the interviewee and adapt question if needed

Maintain eye contact

Audit Interviews cont. Minimize note taking during interview Restate your understanding of their response

Minimize note taking during interview

Restate your understanding of their response

Recording Observations Record location of observation List the names of interviewees and their position Notes on non-conformances should be short and to the point but thorough

Record location of observation

List the names of interviewees and their position

Notes on non-conformances should be short and to the point but thorough

Non-conformances Issue Corrective Action Requests (CAR) Make sure it is thorough Note ownership Note the paragraph of the standard that has been violated State requirements of resolutions

Issue Corrective Action Requests (CAR)

Make sure it is thorough

Note ownership

Note the paragraph of the standard that has been violated

State requirements of resolutions

CAR Response Must have specific details of implementation Must have timeline for completion

Must have specific details of implementation

Must have timeline for completion

Report to Management Reports should be thorough and specific Must be reviewed by management to be effective

Reports should be thorough and specific

Must be reviewed by management to be effective

The External Audit Prior to the audit by the registrar Let employees know what to expect from the external audit Let employees know what is expected of them

Prior to the audit by the registrar

Let employees know what to expect from the external audit

Let employees know what is expected of them

Cessna’s Approach Previous Audit System Viewed as disruption Viewed as a policing process Viewed as non-beneficial Program was suspended

Previous Audit System

Viewed as disruption

Viewed as a policing process

Viewed as non-beneficial

Program was suspended

Cessna’s Approach New Audit System Thorough Phased Procedure Developed Teams with representatives from each quality department Monthly rolling audits Fosters continuous improvement of their quality system

New Audit System

Thorough Phased Procedure Developed

Teams with representatives from each quality department

Monthly rolling audits

Fosters continuous improvement of their quality system

Quiz How does auditing facilitate quality improvement? What does ISO require in regards to audits?

How does auditing facilitate quality improvement?

What does ISO require in regards to audits?

Summary: Internal audits can be a tool for retaining certification Can also be a tool for process improvement Improves organizational awareness Improves communication

Internal audits can be a tool for retaining certification

Can also be a tool for process improvement

Improves organizational awareness

Improves communication

Bibliography: Mills,Charles A.; The Quality Audit, A Management Evaluation Tool. USA: McGraw-Hill, 1989. Goetsch, David L., and Davis, Stanley B.; ISO 9000 and ISO Standards. Upper Saddle River, NJ: Prentice-Hall, 2000. Craig, Robert J.; The No Nonsense Guide to Achieving ISO 9000 Registration. New York: The American Society of Mechanical Engineers, 1994.

Mills,Charles A.; The Quality Audit, A Management Evaluation Tool. USA: McGraw-Hill, 1989.

Goetsch, David L., and Davis, Stanley B.; ISO 9000 and ISO Standards. Upper Saddle River, NJ: Prentice-Hall, 2000.

Craig, Robert J.; The No Nonsense Guide to Achieving ISO 9000 Registration. New York: The American Society of Mechanical Engineers, 1994.

Bibliography cont. Burr John T.; Keys to a Successful Internal Audit. Quality Progress , Vol. 30, No. 4, April 1997. Eaton, Brian D.J.; Cessna’s Approach to Internal Quality Audits. IIE Solutions , 10851259, Volume 27, No. 6, June 1995. Beeler, Dewitt L.; Internal Auditing: The Big Lies . Quality Progress , May 1999.

Burr John T.; Keys to a Successful Internal Audit. Quality Progress , Vol. 30, No. 4, April 1997.

Eaton, Brian D.J.; Cessna’s Approach to Internal Quality Audits. IIE Solutions , 10851259, Volume 27, No. 6, June 1995.

Beeler, Dewitt L.; Internal Auditing: The Big Lies . Quality Progress , May 1999.

Bibliography cont. Karapetrovic, Stanislov, and Wilborn, Walter; Audit System; Concepts and Practices. Total Quality Management , 09544127, Vol. 12, No. 1, January 2001

Karapetrovic, Stanislov, and Wilborn, Walter; Audit System; Concepts and Practices. Total Quality Management , 09544127, Vol. 12, No. 1, January 2001