ISO 9000:2000 Internal Audits

BY: Ahmad Bassiouny

Evelean William

Overview: ISO 9000:2000 Internal Audit

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

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?

Decide the scope of the auditFull

Partial

How will it be conductedUpstream

Downstream

Across Processes

Steps to a Successful Internal Audit

Scope of the AuditFull 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

PartialWhich 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 beginningDownstream-starting with the first process and flowing forwardHorizontal-across similar processes

Steps to a Successful Internal Audit cont.

Develop a checklist

Perform the audit

Record findings

Follow-up

Develop a ChecklistBecome familiar with the processess and the associated documentation to be auditedMake notes on possible questionsList items to look for and observeNote paragraph of the standard being checked next to the item being auditedLeave space to record observationsUse 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 AuditMaintain control of the audit

Be professional

Remain objective-look at the facts

Observe everything

Audit InterviewsAsk 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

Recording ObservationsRecord 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-conformancesIssue 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

Cessna’s ApproachPrevious Audit System

Viewed as disruption

Viewed as a policing process

Viewed as non-beneficial

Program was suspended

Cessna’s ApproachNew 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