process auditing irca.ppt
TRANSCRIPT
-
8/20/2019 Process Auditing IRCA.ppt
1/24
nqa training
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
-
8/20/2019 Process Auditing IRCA.ppt
2/24
nqa training
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
-
8/20/2019 Process Auditing IRCA.ppt
3/24
nqa training
Process Auditing
•$hat is a process%
•$hy audit processes%
•$hat about clauses%
•$hat about procedures%
-
8/20/2019 Process Auditing IRCA.ppt
4/24
nqa training
$hat is a Process%
&A set of interrelated or interacting activities
'hich transforms inputs into outputs(
SO !""")*"""
INPUT ACTIVITY OUTPUT
-
8/20/2019 Process Auditing IRCA.ppt
5/24
nqa training
$hat is a Process%
• A department e+g+ design, sales, etc+• A production-assembly line
• A project
-
8/20/2019 Process Auditing IRCA.ppt
6/24
nqa training
CC
UU
SSTT
OO
MM
EE
RR
..
ee
qquu
ii
r r
ee
mm
ee
nn
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
ii
oo
nn
Product / Product /
ServiceService
Input Output
Quality Management SystemQuality Management System
Continual Improvement Continual Improvement
Quality Management Process Model
-
8/20/2019 Process Auditing IRCA.ppt
7/24
nqa training
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
-
8/20/2019 Process Auditing IRCA.ppt
8/24
nqa training
Processes
.ealisation Processes
Supporting
Processes
Organisational
Processes
-
8/20/2019 Process Auditing IRCA.ppt
9/24
nqa training
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
-
8/20/2019 Process Auditing IRCA.ppt
10/24
nqa training
Process Audit Planning
nput Output
Management controls
.esources
Process-Activity
-
8/20/2019 Process Auditing IRCA.ppt
11/24
nqa training
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
-
8/20/2019 Process Auditing IRCA.ppt
12/24
nqa training
Management 1ontrols
•Procedures
•1odes of practice
•Statutory and regulatory requirements
•Objectives and targets
•nternal audits
•Monitoring and measuring activities
-
8/20/2019 Process Auditing IRCA.ppt
13/24
nqa training
.esources
•1ompetent people
•nfrastructure and 'or2 environment
•Materials
•nformation
•9tilities
•Support services
-
8/20/2019 Process Auditing IRCA.ppt
14/24
nqa training
$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
-
8/20/2019 Process Auditing IRCA.ppt
15/24
nqa training
Typical :eneric 1lauses
• ;+# :eneral requirements
• ;+*+< 1ontrol of documents
• ;+*+; 1ontrol of records
• =+# Management commitment
• =+* 1ustomer focus
• =+; Planning
-
8/20/2019 Process Auditing IRCA.ppt
16/24
nqa training
Typical :eneric 1lauses
• =+= .esponsibility> authority 4
communication
• ? .esources• @+# :eneral
• @+* Monitoring and measurement
• @+; Analysis of data• @+= mprovement
-
8/20/2019 Process Auditing IRCA.ppt
17/24
nqa training
Typical Specific 1lauses
• +* Sales
• +< 0esign
• +; Purchasing
• +? 1alibration
• @+*+* nternal audit
• @+< 5onconforming product
-
8/20/2019 Process Auditing IRCA.ppt
18/24
nqa training
Specific Area e+g+ stores
• +=+# 1ontrol of production provision
• +=+< dentification and traceability
• +=+= Preservation of product• @+*+; Monitoring 4 measurement of
product
• @+< 5onconforming product• @+=+* 1orrective action
-
8/20/2019 Process Auditing IRCA.ppt
19/24
nqa training
$hat About Procedures%
•Only ? required 8 there may not be one
for the process being audited
•The process may consist of more than
# procedure
•The auditor must establish 'hat the
process is and ho' it is controlled
-
8/20/2019 Process Auditing IRCA.ppt
20/24
nqa training
1ontrol of a Process
Methods of control may include)
•0ocumented procedure
•Training> education> eBperience /
competence
•Supervision
•7lo'chart-process map
•0iagrams-pictures-forms
•Soft'are
-
8/20/2019 Process Auditing IRCA.ppt
21/24
nqa training
Cerifying Dffectiveness
•0oes the system 'or2%
•0oes the output provide a suitable
input for the neBt process%•$hat objectives eBist%
•6o' do they monitor the effectiveness
of the system% Esee @+*+
-
8/20/2019 Process Auditing IRCA.ppt
22/24
nqa training
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
-
8/20/2019 Process Auditing IRCA.ppt
23/24
nqa training
Audit Planning
• Goo2 for the sequence of activities
• HTrace for'ardI or Htrace bac2I
• 3ased on departments-processes /
not clauses
-
8/20/2019 Process Auditing IRCA.ppt
24/24
nqa training
.eporting 7indings
Processnputs Outputs
MaterialsDquipment
People
S2ills
1ompetence
MeasuresMethods
Procedures