process auditing irca.ppt

8/20/2019 Process Auditing IRCA.ppt

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Purpose of the QMS

•To achieve quality

•To ensure that the organisation can

produce conforming product•To help ensure that customers are

satisfied

•To assist the organisation in running itsbusiness successfully


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Audit Objectives

•To verify that the QMS conforms to

SO !""#

•To verify that the organisation conformto the QMS

•To ensure that the QMS is effective in

helping the organisation to satisfycustomers


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Process Auditing

•$hat is a process%

•$hy audit processes%

•$hat about clauses%

•$hat about procedures%


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$hat is a Process%

&A set of interrelated or interacting activities

'hich transforms inputs into outputs(

SO !""")*"""

INPUT ACTIVITY OUTPUT


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$hat is a Process%

• A department e+g+ design, sales, etc+• A production-assembly line

• A project


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CC

UU

SSTT

OO

MM

EE

RR

..

ee

qquu

ii

r r

ee

mm

ee

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ttProduct Product

(and/or Service)(and/or Service)

RealisationRealisation

ManagementManagement

Responsibility Responsibility

ResourceResourceManagement Management

Measurement Measurement Analysis Analysis

Improvement Improvement

CC

UU

SS

TT

OO

MM

EE

RR

SS

aa

tt

ii

ss

f f

aa

cc

tt

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Product / Product /

ServiceService

Input Output

Quality Management SystemQuality Management System

Continual Improvement Continual Improvement

Quality Management Process Model


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Plan/0o/1hec2/Act

Plan / establish 'hat needsto be achieved andorganise resources

0o / implement the

processes1hec2 / monitor and

measure theprocesses and theiroutputs

Act / respond to findingsfrom the chec2ing activitiesin order to improve

A

C D

Plan

Check

Act

Do

P

C


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Processes

.ealisation Processes

Supporting

Processes

Organisational

Processes


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Processes

0esign

Sales

Planning

3uying

Manuf+

Test 4

0espatch

0oc 1ont

.ecords

Audits

Man .ev

5onconf+

1orr-Prev

action

6.

T

7inance

Mar2eting

3us 0ev

7acilities

Man

Supportin

g.ealisatio

n

Organisational


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Process Audit Planning

nput Output

Management controls

.esources

Process-Activity


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Typical nputs-Outputs

•Sales enquiries 8 sales orders

•0esign requirements 8 designspecification

•Purchase requirements 8 deliveredgoods

•Shop floor orders 8 finished product

•.equest for maintenance 8 repairedequipment


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Management 1ontrols

•Procedures

•1odes of practice

•Statutory and regulatory requirements

•Objectives and targets

•nternal audits

•Monitoring and measuring activities


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.esources

•1ompetent people

•nfrastructure and 'or2 environment

•Materials

•nformation

•9tilities

•Support services


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$hat About 1lauses%

•Must be addressed for certification

•Should not be the primary focus of theaudit / can be chec2ed later

•:eneric clauses chec2ed every'here

•Specific clauses as required


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Typical :eneric 1lauses

• ;+# :eneral requirements

• ;+*+< 1ontrol of documents

• ;+*+; 1ontrol of records

• =+# Management commitment

• =+* 1ustomer focus

• =+; Planning


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Typical :eneric 1lauses

• =+= .esponsibility> authority 4

communication

• ? .esources• @+# :eneral

• @+* Monitoring and measurement

• @+; Analysis of data• @+= mprovement


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Typical Specific 1lauses

• +* Sales

• +< 0esign

• +; Purchasing

• +? 1alibration

• @+*+* nternal audit

• @+< 5onconforming product


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Specific Area e+g+ stores

• +=+# 1ontrol of production provision

• +=+< dentification and traceability

• +=+= Preservation of product• @+*+; Monitoring 4 measurement of

product

• @+< 5onconforming product• @+=+* 1orrective action


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$hat About Procedures%

•Only ? required 8 there may not be one

for the process being audited

•The process may consist of more than

# procedure

•The auditor must establish 'hat the

process is and ho' it is controlled


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1ontrol of a Process

Methods of control may include)

•0ocumented procedure

•Training> education> eBperience /

competence

•Supervision

•7lo'chart-process map

•0iagrams-pictures-forms

•Soft'are


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Cerifying Dffectiveness

•0oes the system 'or2%

•0oes the output provide a suitable

input for the neBt process%•$hat objectives eBist%

•6o' do they monitor the effectiveness

of the system% Esee @+*+


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Cerifying Dffectiveness e+g+

Purchasing)

•Stoc2 shortages

•.ejected goods at goods received

•5onconformance in production due tofaulty ra' materials

•1ustomer complaints

•0elayed orders due to late delivery of ra'materials


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Audit Planning

• Goo2 for the sequence of activities

• HTrace for'ardI or Htrace bac2I

• 3ased on departments-processes /

not clauses


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.eporting 7indings

Processnputs Outputs

MaterialsDquipment

People

S2ills

1ompetence

MeasuresMethods

Procedures

process auditing irca.ppt

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