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

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

ISO 9000 Audit Requirements Internal audits are required (4.17) Must be conducted by personnel independent of responsibility for process being auditedMust be conducted by personnel independent of responsibility for process being audited Results must be recordedResults must be recorded Must follow organizational objectivesMust follow organizational objectives Frequency should be determined by the organizational needFrequency 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 improvementCan facilitate continuous improvement Can Identify System FailuresCan Identify System Failures Provide feedback to Management regarding efficiency of the Quality SystemProvide feedback to Management regarding efficiency of the Quality System

How does this apply to my organization?

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

Scope of the Audit Full audit of the entire Quality SystemFull 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 PartialPartial –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 beginningUpstream-starting with the final process and working backwards to the beginning Downstream-starting with the first process and flowing forwardDownstream-starting with the first process and flowing forward Horizontal-across similar processesHorizontal-across similar processes

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

Develop a Checklist Become familiar with the processess and the associated documentation to be auditedBecome familiar with the processess and the associated documentation to be audited Make notes on possible questionsMake notes on possible questions List items to look for and observeList items to look for and observe Note paragraph of the standard being checked next to the item being auditedNote paragraph of the standard being checked next to the item being audited Leave space to record observationsLeave space to record observations Use only one sheet per process or areaUse 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 auditMaintain control of the audit Be professionalBe professional Remain objective-look at the factsRemain objective-look at the facts Observe everythingObserve everything

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

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

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

Non-conformances Issue Corrective Action Requests (CAR)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 implementationMust have specific details of implementation Must have timeline for completionMust have timeline for completion

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

The External Audit Prior to the audit by the registrarPrior 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 SystemPrevious Audit System –Viewed as disruption –Viewed as a policing process –Viewed as non-beneficial –Program was suspended

Cessna’s Approach New Audit SystemNew 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?How does auditing facilitate quality improvement? What does ISO require in regards to audits?What does ISO require in regards to audits?

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

Bibliography: Mills,Charles A.; The Quality Audit, A Management Evaluation Tool. USA: McGraw-Hill, Goetsch, David L., and Davis, Stanley B.; ISO 9000 and ISO Standards. Upper Saddle River, NJ: Prentice- Hall, 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 Eaton, Brian D.J.; Cessna’s Approach to Internal Quality Audits. IIE Solutions, , Volume 27, No. 6, June 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, , Vol. 12, No. 1, January 2001Karapetrovic, Stanislov, and Wilborn, Walter; Audit System; Concepts and Practices. Total Quality Management, , Vol. 12, No. 1, January 2001