1st technical dinner meeting

NEW IDEAS AND FUNDAMENTALS OF

QUALITY AUDITING

Afaq Ahmed

([email protected])

Quality Specialist

Inspection Department, Saudi Aramco

December 19, 2011

© Copyright 2011, Saudi Aramco. All rights reserved. No portion of this article may be reproduced, by any process or technique,

without the express written consent of Saudi Aramco.

Saudi Arabian Quality Council

Al-Khobar, Saudi Arabia

Road Map

Definitions

Quality Audit Fundamentals

New Quality Audit Approach

Process Components

Case Study

Quality Excellence Assessments

Summary

Definitions

Audit

Systematic, independent and documented process for obtaining

audit evidence and evaluating it objectively to determine the extent

to which audit criteria are fulfilled. (*)

Assessment

An estimate or determination of the significance, importance, or

value of something. (**)

Survey

Audits conducted in support of supplier evaluation prior to a

decision to purchase, the audit objectives may include an

evaluation of the prospective supplier’s ability to meet contract or

purchase requirements.

* ISO 19011-2011

* * Performance based assessments, Wilson and Pearson


Conducting an Audit

Planning Execution Reporting

Objective, scope and

criteria

Review of Quality

Management System

documents & records

Review of previous

audit reports

Auditor’s assignment

Schedule

Working papers

Opening meeting

Collecting objective

evidence

Findings

Conclusion

Closing meeting

Prepare

Approve

Distribute


Personal Behavior Knowledge and Skills

Auditor Competence

Ethical

Courageous

Diplomatic

Tenacious

Decisive

Punctual

Observant

Education, Training and

Experience

• Quality Management System

(QMS) Standard

• Development,

implementation and continual

improvement of QMS

• Terminology (quality and

industry specific)

• Quality tools

• Relevant industry work

experience (processes and

products)

• Audit experience

Process Components Approach: A New Perspective on Quality Audits

Current Practice: ISO Check List

Are records established and maintained to provide

evidence of conformity to requirements and of the

effective operation of the quality management system?

Are personnel performing work affecting product quality

competent on the basis of appropriate education,

training, skills and experience?

Process Components Approach

Audit is focused on essential components of a process:

INPUT

CONTROL

OUTPUT

MEASURE

PROCESS

Process Components Approach How to do it in six steps?

1. Study Process

2. Identify Activities

3. Identify Process

Components (I, O, M & C) & Elements

4. Identify Audit

Items for each

Element

5. Map Audit

Items to an Audit Criteria

6.Identify Linkages

I = Input, O = Output, M = Measures and C = Control

Case Study Audit of a Pressure Vessel’s Manufacturer

Case Study Step 1: Study Pressure Vessel Manufacturing Process Flow Chart

Receiving

Inspection

Cutting

Rolling

Welding PWHT

Dimensional

Inspection

NDT

Visual

Inspection Pressure Test

Coating

Final

Inspection

PWHT: Post Weld heat Treatment

NDT: Nondestructive Testing

Case Study Step 2: Identify Activities to be Audited

Flame Cutting

Rolling

Welding


How to do it?

1. Study Process


4. Identify Audit

Items for each

Element

3. Identify Process

Components (I, O, M & C)

Elements


Step 4: Identify Audit Items for each Element

Rolling:

Rolling Measure:

1. Dimensions

2. Visual

3. Yield

4. Scrap

Output:

1. Rolled shell

2. Identification & Traceability

3. Filled work order

4. Inspection record

Input:

1. Cut sheet

2. Identification & Traceability

3. Filled work order

4. Inspection record

5. Fabricator

6. Plate rolling machine

7. Specification

Control:

1. Fabricator

2. Maintenance

3. Set-up

Case Study

Case Study Step 4: Identify Audit Items for each Element

Audit items for Rolling Input (I) and Measure (M) Elements:

I and M Elements

Audit item

Fabricator Competency records of rolling machine

operator

Rolling Machine Rolling machine capacity

Measurement Dimensional and visual inspection of rolled

shell


How to do it?

1. Study Process


4. Identify Audit

Items for each

Element

5. Map Audit


3. Identify Process


Elements


Case Study Step 5: Map Audit Items to an Audit Criteria

ISO 9001 Clauses Mapped to Plate Rolling Input (I) and

Measure (M) Audit Items

I & M Audit Items ISO 9001

Clause Description

Competency records of rolling

machine operator 6.2.2e Competency records

Use of suitable rolling machine 7.5.1c Use of suitable equipment

Dimensional and visual inspection

of rolled shell 8.2.4

Monitoring and measurement of

product


How to do it?

1. Study Process


4. Identify Audit

Items for each

Element

5. Map Audit


6. Identify linkages

3. Identify Process


Elements


Case Study Step 6: Identify Linkages to Supporting Activities, Functions

and Facilities:

Interact

-ion Audit Samples Linkage Question

ISO 9001

Clause

Activity

Flame cutting – Plate

identification (heat #, job #,

material)

Receiving

Inspection

Are records of MTR

and receiving

inspection

maintained?

4.2.4

Function Drawing (title, # and rev #) Engineering

Is drawing used by

the flame cutting

operator of latest

revision?

4.2.3

Facilities Welding consumables details

Welding

consumables

store room

Are welding

consumables

stored as per

manufacturer

recommendations?

7.5.5

MTR: Material Test Report

Overview of Audit Items

ISO 9001

Clause Description Audit Items

4.2.3a Control of documents Control of drawing and work instruction used by

the flame cutting operator

6.1 Provision of resources Adequate number of welders

6.3b Infrastructure Preventive maintenance of rolling machine

7.4.3 Verification of purchased

product Steel sheet receiving inspection

7.6 Calibration Calibration of gauges used for inspection of

rolled shell

7.5.1c Production Rolling machine capability to roll the plate of

required thickness

7.5.2c Validation WPS and PQR availability

WPS: Welding Procedure Specification

PQR: Procedure Qualification Record


Quality Excellence Assessment Quality Audit to ISO 9001 Standard

Criteria is rigid (standard)

Objective is to check conformance

Report is based on non-conformances

Only functions related to Quality Management

System (Engineering, Purchasing)

ISO 9001 standard does not require

benchmarking of results

Only Quality Management System (QMS)

ISO 9001 is not structured around business

drivers and results

Audit purpose is to measure effective

implementation of QMS

Criteria is flexible (Excellence Model)

Objective is to measure performance

Report is based on best practices and

Opportunities for improvements (OFI)

All functions (e.g. IT and security)

Heavy emphasis on achievement of consistently

good results over a long period of time and

benchmarked against best in class

All Management Systems (e.g. financial,

environmental)

Assessment is done in pairs i.e. business driver

and it’s results

Assessment is used as a tool to improve

performance to be “Best in Class”

Audit, Assessment and a Survey

Fundamental activities of an Audit

Auditor Competency

New Perspective in Auditing (Process Approach)

Provides a methodical approach to prepare for an audit

Enhances audit findings, results and the audit program

Minimizes potential risks associated with quality auditing


Summary

Thank You

Saudi Arabian Quality Council

Al-Khobar, Saudi Arabia

Afaq Ahmed

([email protected])

1st technical dinner meeting

Business