audit methodology iso 90002000

8/10/2019 Audit Methodology ISO 90002000

1/45

1

Aud it Methodo logy as per ISO

9000:2000


2/45

2

Course Contents

1) Objectives2) What is Quality?

3) Criteria for Selection of the Suppliers

4) Quality audits5) Audit methodology

6) Assessment of audit findings Corrective Action

7) Common findings against ISO Clauses


3/45

3

Course Objectives

1. To provide participants with an overview of aSupplier Audit.

2. To provide participants with the basic knowledgeand awareness of the tasks required of a

Supplier Audit.3. To provide practical guidance on the proper

conduct of a Supplier Audit.


4/45

4

What is Quality?

What does quality mean to you?

Conformance to specifications

Fitness for purpose

Meeting needs and expectations

Free from defects Value for money

On-time delivery

Consistency

Safe and reliable Customer satisfaction

Delighting customers


5/45

5

Selection of Suppliers

Criteria for selection of the Supplier Key Suppliers

Poor Quality Performance

Safety Critical Items

Reliability Critical Items

Special Processes


6/45

6

Quality Audits (ISO 9000:2000 definition)

1. Audit - systematic, independent and documentedprocess for obtaining audit evidence andevaluating it objectively to determine the extentto which audit criteria are fulfilled.

2. Audit evidence - records, statements of fact orother information which are relevant to the auditcriteria and verifiable.

Note: Audit Recording Sheet


7/45

7

Quality Audits

Types of audits:

1. First Party audit (Internal Quality Audit)

For organisations to evaluate the conformance ofthe various activities to the quality programme

and effectiveness of the quality system. Internalquality audits are carried out to:

a) maintain or improve the efficiency of theorganisations operations;

b) determine how disciplined and effective theorganisations operations are;

c) conform to ISO 9001 standards requirement(clause 8.2.2).


8/45

8

Quality Audits

Types of audits:2. Second Party audit (Supplier Audit)

Carried out by an organisations auditors toevaluate the ability of a supplier or potential

supplier to provide a particular product, serviceor process.

Generally, supplier audits are based on nationalor international standards, depending on theorganisations needs or contract requirements.


9/45

9

Quality Audits

Types of audits:3. Third Party audit (Certification Audit)

Carried out by independent certification bodies(e.g. PSB, DNV, ABS, Lloyds, BVI, SGS .) to

evaluate an organisations quality system withrespect to national or international standards soas to provide registration or certification ofacceptable programme.


10/45


11/45

11

Audit Methodology

2. Document review review the relevant quality system

documents and records and determine theiradequacy

3. Preparing for the on-site audit activities

planning the on-site activities

audit team work assignment

preparation of work documents


12/45

12

Audit Methodology

4. On-site audit activities conduct opening meeting

collecting and verifying information

identifying audit findings

communication during the audit

preparation for the closing meeting

conduct closing meeting


13/45

13

Audit Methodology

5. Reporting on the audit audit report preparation

report approval and distribution

retention of documents

raise corrective action form

Note: Audit Summary Report

Supplier Corrective Action Request


14/45

14

Audit Methodology

6. Follow-up activities verify adequacy and effectiveness of

corrective/preventive actions

close CAR if corrective action is satisfactory


15/45

15

Audit Methodology

Audit Strategies and Techniques

STRATEGIES TECHNIQUES

Trace Forward

Trace Backward

Task-based

ISO 9000 elements

Process flow

Clarifying

Interviewing

Observing

Verifying

Collecting ObjectiveEvidence


16/45

16

Audit Methodology

1) Horizontal auditHorizontal audit follows a process from startto end. This method requires the auditors toexamine many small samples of activities,

processes, products over a large area.Because of the small samples used, theactivities and articles examined are not ingreat detail, and the audit results will onlygive a general overall condition of the quality

system.


17/45

17

Audit Methodology

2) Vertical auditVertical audit look, in depth, at a particularfunction or department. This method requirethe auditors to focus on an activity or a

process and to examine in great detail alldocuments and records pertaining to the areaof focus. The advantage of the vertical auditis that it may uncover discrepancies which arehidden and are unnoticeable in daily activities.

This is very useful, especially if there is aneed to get to the root of a quality problem.


18/45

18

Audit Methodology

Selection of sample PO

We should select SCI or RCI PO

Condition of the PO (heat treatment, chemicalcoating, material supplied, etc)

Verify the revision of the PO drawings


19/45

19

Audit Methodology

Quality section

Verify inspection record (sampling size, GD&T,missing dimension, measuring mean, correctspecification, etc)

The inspection records including the following:- In-coming inspection report- First off inspection report

- In-process inspection report- Out-going inspection report


20/45

20

Audit Methodology

Control of measuring and monitoring devices

Calibration master list

Identify the item and serial number, due date forcalibration

Verify the frequency of the calibration

Verify the evidence of review on the calibrationreport


21/45

21

Audit Methodology

Production section Verify the process documents (route/travel card,

revision of drawing, etc)

Verify the inspection key point during themanufacturing processes (first off, in-process,etc)


22/45

22

Audit Methodology

Production section

Verify the parts/material adequatelyidentified/controlled at all time throughout themanufacturing process

Ask the machinist to demonstrate the inspectiontechnique to check their competency


23/45

23

Audit Methodology

Special process

Verify the training record

Verify WPS, WQP for the welding

Verify the painter qualification

Verify the heat treatment parameter

Verify the analysis of chemical bath

NDT inspector records


24/45

24

Audit Methodology

Control of non-conformance materials

Who is responsible to review and disposition ofnonconforming material

Nonconforming material segregate at all time

Verify the record of action taken (repair, scrap,concession, etc)


25/45

25

Audit Methodology

Purchased product

Verify the evidence of reviewing on COC, millcertificate, test report, etc

Verify the chemical composition: yield strengthand hardness

Verify the adequate of identification of the rawmaterial


26/45

26

Classification of audit findings

1. Non-conformance

The non-fulfilment of specified requirements

In an audit, non-conformance may be due to:

system document did not adequately address

the requirements of the applicable qualitysystem standard or reflect actual systempractices

Practices or implementations did not comply

with established system documents orrequirement(s) of applicable system standard


27/45


28/45

28

Classification of audit findings

2. Observation

An observation is not a non-conformance. It isan area where the auditor or audit teamhighlights, so that further investigation can belooked into to improve the overall effectiveness

of the quality system

3. Area of Improvement

The audit evidence is not sufficient for non-conformance report, but it is an area of concernto avoid and for improvement


29/45


30/45

30

Corrective Action

2. Process for Corrective Action

The corrective action process usually requiresthe audittee and other responsible persons to:

Investigate and determine the root cause(s)of non-conformance

Analyse the causes (such as man, machine,material, method and environment)


31/45

31

Corrective Action

2. Process for Corrective Action (continue)

Select and implement appropriate correctiveaction to prevent recurrence of non-conformance

Apply control to ensure effectiveness ofcorrective action taken

Record corrective action taken and updateaffected documents


32/45

32

Corrective Action

3. Follow-up verification

This is a post audit activity which is part of thecorrective action process. The follow-upverification usually involves the auditor/audit teamverifying the appropriateness and effectiveness of

corrective action(s) taken.


33/45


34/45

34

Quality requirements of ISO 9001:2000 standard

4.2.3 Control of Documents

Documented Procedure shall be established todefine the controls needed:

To approve for adequacy prior to use

To review, Update and Re-Approve To identify Current and Current Revision

Status

To ensure availability at Point of Use


35/45

35


4.2.3 Control of Documents (Continue)

To ensure documents are Legible and ReadilyIdentifiable

To ensure documents of external origin (e.g.

customer) are identified and controlledTo ensure obsolete documents are

Prevented from unintended use

Identified if retained


36/45


37/45

37


7.5.1 Control of Production and Service Provision

Control conditions include:

Product Characteristics

Work InstructionsEquipment

Monitoring & Measuring Devices

Monitoring & Measurement

Product Release, Delivery and PostDelivery


38/45

38

Common findings against ISO Clauses

Production and service provision (7.5.1)

Wrong specifications stated in the processdocuments

Use of non-approved process documents


39/45

39


8.3 Control of Non-conforming productRecord the nature of non-conformities

Record the subsequent actions taken

Re-evaluate the corrected non-conformingproduct

Non-conforming product detected afterdelivery


40/45

40


Control of non-conforming product (8.3)

Rejected parts are not properly identified and notsegregated from the acceptable parts


41/45


42/45

42


7.6 Control of Monitoring and Measuring Devices

(continue)

Ensuring device give valid results:

Calibrated or Verified at specific intervals

Adjusted or re-adjusted as necessary

Identified to enable the calibration status

Safeguard from adjustments

Protected from damage and deteriorationduring handling, maintenance and storage


43/45

43


Control of monitoring and measuring devices (7.6)

Use of un-calibrated or expired gauges andmeasuring instruments

Use of inappropriate measuring instruments orgauges

Use of non-approved work instructions for in-house calibration

Measuring instruments are not calibrated to theirfull range


44/45

44


8.2.4 Monitoring and Measurement of Product

Monitor the product characteristics

Record the evidence of conformity &authority for product (4.2.4)

Release product and deliver service onlywhen the monitoring requirements aresatisfactory completed

Waiver with relevant authority approval (and/ or customer approval where applicable)


45/45

45


Monitoring and measurement of product (8.2.4)

Inspection samples are not taken according to thesampling plans

Measuring instruments used are not reflected inthe inspection record

The GD&T dimensions are not reflected in theinspection report

The tolerances are not reflected in the inspectionreport