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 Cessnas 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

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.

Benefits and Uses:

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?

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

How Will the Audit Be Conducted

Upstream-starting with the final Upstreamprocess and working backwards to the beginning Downstream-starting with the Downstreamfirst process and flowing forward Horizontal-across similar Horizontalprocesses

Steps to a Successful Internal Audit cont.

Develop a checklist Perform the audit Record findings Follow-up Follow-

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

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?

The Internal Audit

Maintain control of the audit Be professional Remain objective-look at the objectivefacts Observe everything

Audit Interviews
Ask open-ended questions openUse 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

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

NonNon-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

CAR Response
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

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

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

Cessnas 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

Quiz
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

Bibliography:
Mills,Charles A.; The Quality Audit, A Management Evaluation Tool. USA: McGrawMcGraw-Hill, 1989. Goetsch, David L., and Davis, Stanley B.; ISO 9000 and ISO Standards. Upper Saddle River, NJ: PrenticePrenticeHall, 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. Audit.Quality Progress, 30, No. 4, April 1997. Eaton, Brian D.J.; Cessnas Approach to Internal Quality Audits. IIE Solutions, Solutions, 10851259, Volume 27, No. 6, June 1995. Beeler, Dewitt L.; Internal Auditing: The Big Lies. Quality Progress, May Lies. Progress, 1999.

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