ISO 9000:2000 ISO 9000:2000 Internal AuditsInternal Audits

Rene’ JonesRene’ Jones

October 7, 2003October 7, 2003

Overview: Overview: ISO 9000:2000 Internal AuditISO 9000:2000 Internal Audit

• ISO Audit RequirementsISO Audit Requirements• Getting StartedGetting Started• Steps to an effective auditSteps to an effective audit

– PlanningPlanning– ExecutionExecution– Follow upFollow up

• Cessna’s ApproachCessna’s Approach

ISO 9000 Audit ISO 9000 Audit RequirementsRequirements

Internal audits are required (4.17)Internal audits are required (4.17)• Must be conducted by personnel Must be conducted by personnel

independent of responsibility for process independent of responsibility for process being auditedbeing audited

• Results must be recordedResults must be recorded• Must follow organizational objectivesMust follow organizational objectives• Frequency should be determined by the Frequency should be determined by the

organizational needorganizational need

Defined:Defined:

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

Benefits and Uses:Benefits and Uses:

• Can facilitate continuous improvementCan facilitate continuous improvement• Can Identify System FailuresCan Identify System Failures• Provide feedback to Management Provide feedback to Management

regarding efficiency of the Quality regarding efficiency of the Quality SystemSystem

How does this apply to my How does this apply to my organization?organization?

• Decide the scope of the auditDecide the scope of the audit– FullFull– PartialPartial

• How will it be conductedHow will it be conducted– UpstreamUpstream– DownstreamDownstream– Across ProcessesAcross Processes

Steps to a Successful Steps to a Successful Internal AuditInternal Audit

Scope of the AuditScope of the Audit

• Full audit of the entire Quality SystemFull audit of the entire Quality System– How many auditors will be neededHow many auditors will be needed– How will responsibilities be dividedHow will responsibilities be divided– Appoint a lead auditor to keep the audit Appoint a lead auditor to keep the audit

focusedfocused

• PartialPartial– Which departments or processesWhich departments or processes– Which clause of the standardWhich clause of the standard

How Will the Audit Be How Will the Audit Be ConductedConducted

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

• Downstream-starting with the first Downstream-starting with the first process and flowing forwardprocess and flowing forward

• Horizontal-across similar processesHorizontal-across similar processes

Steps to a Successful Steps to a Successful Internal Audit cont.Internal Audit cont.

• Develop a checklistDevelop a checklist• Perform the auditPerform the audit• Record findingsRecord findings• Follow-upFollow-up

Develop a ChecklistDevelop a Checklist

• Become familiar with the processess and Become familiar with the processess and the associated documentation to be the associated documentation to be auditedaudited

• 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 Note paragraph of the standard being

checked next to the item being auditedchecked 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 checklistSample checklist

Wavesolder Process 3/3.0Wavesolder Process 3/3.0

Component and Board Handling 3/3.2Component and Board Handling 3/3.2

Are components labeled and stored properly? ________Are components labeled and stored properly? ________

Are operators following proper board handling procedures? ______Are operators following proper board handling procedures? ______

Safety Procedures 3/3.6Safety Procedures 3/3.6

Are operators wearing appropriate safety equipment? ________Are operators wearing appropriate safety equipment? ________

Is the area clean and obstacle free?Is the area clean and obstacle free? ________________________

Interview two operatorsInterview two operators

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

How far apart should the boards be in the machineHow far apart should the boards be in the machine

When is it necessary to wear safety glasses?When is it necessary to wear safety glasses?

The Internal AuditThe 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 InterviewsAudit Interviews

• Ask open-ended questionsAsk open-ended questions• Use hypothetical questionsUse hypothetical questions• Encourage free speakingEncourage free speaking• Observe body language of the Observe body language of the

interviewee and adapt question if interviewee and adapt question if neededneeded

• Maintain eye contactMaintain eye contact

Audit Interviews cont.Audit Interviews cont.

• Minimize note taking during Minimize note taking during interviewinterview

• Restate your understanding of their Restate your understanding of their responseresponse

Recording ObservationsRecording Observations

• Record location of observationRecord location of observation• List the names of interviewees and List the names of interviewees and

their positiontheir position• Notes on non-conformances should Notes on non-conformances should

be short and to the point but be short and to the point but thoroughthorough

Non-conformancesNon-conformances

• Issue Corrective Action Requests Issue Corrective Action Requests (CAR)(CAR)– Make sure it is thoroughMake sure it is thorough– Note ownershipNote ownership– Note the paragraph of the standard Note the paragraph of the standard

that has been violatedthat has been violated– State requirements of resolutionsState requirements of resolutions

CAR ResponseCAR Response

• Must have specific details of Must have specific details of implementationimplementation

• Must have timeline for completionMust have timeline for completion

Report to ManagementReport to Management

• Reports should be thorough and Reports should be thorough and specificspecific

• Must be reviewed by management Must be reviewed by management to be effectiveto be effective

The External AuditThe External Audit

• Prior to the audit by the registrarPrior to the audit by the registrar– Let employees know what to expect Let employees know what to expect

from the external auditfrom the external audit– Let employees know what is expected Let employees know what is expected

of themof them

Cessna’s ApproachCessna’s Approach

• Previous Audit SystemPrevious Audit System– Viewed as disruptionViewed as disruption– Viewed as a policing processViewed as a policing process– Viewed as non-beneficialViewed as non-beneficial– Program was suspendedProgram was suspended

Cessna’s ApproachCessna’s Approach

• New Audit SystemNew Audit System– Thorough Phased Procedure Thorough Phased Procedure

DevelopedDeveloped– Teams with representatives from each Teams with representatives from each

quality departmentquality department– Monthly rolling auditsMonthly rolling audits– Fosters continuous improvement of Fosters continuous improvement of

their quality systemtheir quality system

QuizQuiz

• How does auditing facilitate quality How does auditing facilitate quality improvement?improvement?

• What does ISO require in regards to What does ISO require in regards to audits? audits?

Summary:Summary:

• Internal audits can be a tool for Internal audits can be a tool for retaining certificationretaining certification

• Can also be a tool for process Can also be a tool for process improvementimprovement

• Improves organizational awarenessImproves organizational awareness• Improves communicationImproves communication

Bibliography:Bibliography:

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

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

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

Bibliography cont.Bibliography cont.

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

Eaton, Brian D.J.; Eaton, Brian D.J.; Cessna’s Approach to Cessna’s Approach to Internal Quality Audits.Internal Quality Audits. IIE SolutionsIIE Solutions, , 10851259, Volume 27, No. 6, June 1995.10851259, Volume 27, No. 6, June 1995.

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

Bibliography cont.Bibliography cont.

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