Quality Audit Planning

ByIshamuddin

Mustapha

Planning

Follow - up

ReportingAudit Execution

REPORT TO MGMNT REVIEW

Audit program will be influenced by the following criteria : The scope, objective and duration of each audit

to be conducted The number, importance, complexity, similarity,

and location of the activities to be audited Standards, statutory, regulatory and

contractual requirements and other audit criteria

Results of previous audit Significant changes to an organization or its

operation

Audit Flow Chart Activities Define the audit scope, area

Appoint lead auditor, auditors, auditees

Call a meeting / notice with related team (coomunications)

Firm date, time & place of audit Opening meeting

Clarify audit scope

Auditors versus auditees availability

Confirmation on any findings / NC / observations / improvement

To be confirm by auditee

Auditors to verify / follow-up the corrective action

Lead auditor to publish the audit results after compile all information’s

Re-verify the corrective actions after its implementation date.

Planning the audit

Initiating the audit

Implementing the audit

Analysis of the Audit

Corrective Action and Follow-up

Reporting the Audit

Closing the Loop on the Audit Process

Initial activities in this steps involved :1. The decision to conduct an audit2. The type 3. Scope4. Client5. Objectives6. Requirements7. Lead auditor8. The audit team assign

The early planning activities of the lead auditor include :1. Document review of the organization

The vision and mission statement The quality policy The quality manual System and operation procedures Work instruction An organization chart Specific functional responsibilities of the quality assurance program The contract existing between the client and purchaser Any internal and /or external regulatory requirements

2. The intended audit scope** this is important as to developing a detailed checklist

Upon selection of audit teams:1. The audits team will conduct a planning

meeting to : Select and assign audit activities Further developed and evaluates the checklist Review documentation Schedule the actual assessment audit

2. Communication with client Lead auditor will contact client to obtained agreement on

schedule and audit planned and inform the audit team members

Re-confirm of below :1. Establish correct audit type and scope2. Establish correct audit basis – it is the

standard, manual, procedures or combination thereof?

3. Suitable audit personnel – size is dependent on the type, purpose and scope of audit. Audit team may include specialists, trainee auditors, observers acceptable to auditee and audit team.

Re-confirm of below :4. Readiness –

Read basis documentation as well as previous audit reports and determine what records shall be pulled in advance

Prepare process model – identifying the expected results of the process to be audited

5. The auditee has been informed in advance of: time, date, the scope, the basis, timetable of the audit

6. The preparation of audit checklists – use open ended questions what? Why? Who? How? Which?

Audit plan contents :1. Objective of audit and scope2. Identification of key individuals3. Identification of reference documents4. Audit team members5. Language of the audits6. Data and place of audit7. Units to be audited8. Time and duration9. Schedule of meetings10.Confidentiality requirements11.Report distribution and issue date

Audit reference No : File No :Purpose of audit :Scope of audit :Lead auditor assigned :Location (s) of audits :Unit or area to be audited :Reference documents :Team members :Date of audits ; Anticipated duration of

audit :Time of opening meeting : Anticipated time of closing

meeting :Facilities requested

UniKL MITECInternal Audit Plan

Audit plan advantages are :1. Clarifies purpose of audit2. Use time more effectively3. Ensures everything covered4. Shows open approach5. Gives structure to audit6. Gives professional impression7. Provides record of scope

Purpose of check-list :1. To provide a framework for the audits2. To ensure all aspect are addresses3. To act as a prompt for the auditor

Sources for check-list items1. Reference standard e.g. ISO9001;20082. Company DQS3. Known or classic problems4. Ideas from others5. Knowledge of industry6. Previous check-lists

Tips on check-list :1. Keep it simple – one page per

check-list2. Follow a logical sequence3. Use bullet points, if relevant4. Remember the 5W & 1H question5. Try to avoid making assumptions

Audit check-list

Function / Process Audited : ________________Document references : _________________

Audit No :________________Audit date : __________________

Item No : Audit questions

Reference Results Notes / Observation

Prepared by : _________________________

Page of :

Date prepared : _____________________

UniKL MITECAudit Checklist

1. You are a quality manager in company ABC. You found out that there are a significant problems in production department where they produce a lot of reject parts. You think it is important for you to understand the real problems in production department. What will you do than.

2. In group : Identify any function in a manufacturing company Identify suitable reference standard, audit scope

and suitable clauses / section ( at least 3 clause) Prepare suitable audit questions for each

section/clauses