Professional Documents
Culture Documents
Basic QMR Course
Basic QMR Course
14 November 2013
Cebu City
by
12 November2013
Resum6
of
Mac C. Evangelista
Consultant
ROSEHALL Management Consultants, Inc.
Prior to consultancy work, Mac has worked for about 12 years with various
companies in the electronic and construction industries particularly in the areas of
quality assurance and production operations (as project engineer).
GOURSE OBJEGTIVES
1. To orient or refresh QMRs (new, potential
and current) on their responsibilities and
basic quality management terminologies
and approaches.
2. To introduce some approaches to QMRs on
helping improve the business using
ISO 9001:2008.
l-,
3. To addres
,., u,
i.ir.irl concerns or
apprehensions of participants.
GOURSE PROGRAM
Registration, early snacks, reading of
materials
M"qd.xLe 2:
QMS and lSO 9001:2008 highlights
QMR Role in;
. establishing the QMS
. effective QMS implementation & monitoring
. conducting value-added audits
. doing continual process improvement
-
GOURSE PROGRAM
Lunch
course Evatuation
I "-*^;l
Self-Diaanosis as QMR
Write A if you agree and D if you disagree with the following statements:
Self-Diaanosis qs QMR
0 (26) euariilv
"ui".tilA;;';;;t',i;fUt,sraaiol-,
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requirements need to be monitored. These are enough to evaluate
aM: effectiveness .,, :r r.,:,.i."",,:
QMR duties,
responsibilities, 1-9
authorities, and
competence requirements
Quality Management
Functions, Quality .10-18
Terminologies and
Principles
Approaches to QMS
improvements; Risk 28-36
Management, Quality and
Business Goal Alignment
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QMR COMPETENCY
REQUIREMENTS
1) Know the requirements of ISO 9001
or other QMS standard in use
zl Be very familiar with the content of
your own QMS $
:l il:kl;'ffi';ff.'
techniques
l,", H
OTHERS
i Product ------ of
ii -result - process.
-' a r' i
i ,I
iwhich transforms inputs into outputs. outputs. i
lii
'ti
;**-*...-**-,,_..
ii
t- i
rii
tii
:ii
I
:OSEHALLI
. v2:\l , i
DEFINITION OF TERMS
I ----*- ----
i Related to quality cont..
i
i:
jil
iil
i
i i fulfilling quality requirements. )
i
I
i
q
DEFINITION OF TERMS
HYOLUTTOil OF QUALTTY
! @
Quality
@ @
! !@ s
Quality Quality Tothl
Gontrol Assurance Management Quality
of lnputs (Defect Control
(Juran,
Process Prevention) (Feigenbaum
1950s)
0utputs (1950s) late 70s)
(Defect
m ffi
Detection)
(1920s)
flffi tLiSstII4Wi't
t
-
2l Leadership
3) lnvolvement of People - ' ,'
4l Process Approach i.. r . r.( ' ,,.,,.,.r si
. A qMS should be
designed in such a way
that it can help realize
the Business Goals of
-
SfuEHSHffi
4 Quality Management System
5 Management Responsibility
6 Resource Management
7 Product Realization
S Measurement, Analysis and
lmprovement
4 Quality Monagement System
4.L ldentifyprocesses,
. its sequence and interaction, its controls, its
resources, its measurement, analysis, improvement
. Control ofoutsourced processes
. Type and extent of control defined in QIVTS
6 MANDATORY PROCEDURES OF
ISO 9OO{:2OO8
. Control of Documents
. Control of Records
. lnternal Audit
. Control of Non-conforming Products
. Corrective Action
o Preventive Action
RECORDS REQUIRED BY
ISO 9OO1:2OO8
Slause Record required
,.6.1 Vlanagement Reviews
i.2.2 (e\ Education, training, skills and experience
1 (d) ividence that the realization processes and resulting product fulfil requirements
Results of the review of requirements related to the product and action arising from
7.2.2
:he review
7.3.2 )esign and development inputs relating to product requirements
7.3.4 Results design and development reviews and any necessary actions
7.3.5 Results design and development verification and any necessary actions
r.3.6 lesults of design and development validation and any necessary actions
R.esults of the review of design and development changes and any necessary
7.3.7
actions
7.4.1 Results of supplier evaluations and any necessary actions arising from evaluations
RECORDS REQUIRED BY
ISO 9OO1:2OO8
llause Record required
7.5.4 Sustomer property that is lost, damaged or otherwise found to be unsuitable for use
MANUALS TO BE PREPARED
o
Quality Manual
a Process Manual
-Procedures
-Work lnstructions
- Forms
Job Descriptions Manual
- I ncl ud ing Com petencies
5 MANAGEMENT
RESPONSIBILITY
;; \ ; r,, , ( 't'
5 MANAGEMENT
RESPONSIBILITY
Planning
Quality Objectives (corporate & functional)
QMS Planning to link with business goals
and risks of changes in business
envlronment
Responsibility,Authority,and Communication
. MR (Management Representative)to be appointed,
manageL authorized
Management Review
o check adequacy, suitability and effectiveness of
established QMS.
6 RESOURGE MANAGEMENT
ffi
6.1 Provision of Resources
o resource requirements determined and provided
7 PRODUGT REALIZATION
7.4 Purchasing
" Supplier selection, accreditation & evaluation
7.5 Production and Service Provision
o Control, validation, identification and traceability, customer
property (incl. personal data) and product preservation
Self-Assessment
t read 4.L,4.2,5.3, 5.4, 5.5
mmk*
As d QMR, how
cdn you help
,ua
improve the
business?
-
Why QMS?
Why ISO 900{:2008?
Why the 5 Clauses? .i
Why the 136 shall requirements?,/'
,NS
With better
understanding
of the QMS, QMRs
would know what
qMS improvements
can be done to
improve the
BUSINESS!
-
RIGHT ORWRONG?
"ang QIUS pang-quality lang"
Consider the STEEP and competitive factors that influence your company's
strategies. Write at least 5 threats OR opportunities that are posed by these
environmental factors on your business.
(1) ()
(2) ()
(3) o
(4) ()
(s) o
are too many things being done now in
implementation that do not add value to
it or to the businessl
(1) lnadequate measurement of process
performance
(2) Poor measurement of process
effectiveness
(3) lnadequate or no action plans for meeting
quality objectives
(4) Process improvement objectives not
Iinked with business obiectives
RISK MANAGEMENT
The identification, assessment and prioritization of
risks, followed by coordinated and economical
application of resources to minimize, monitor and
control the probability andlor impact of unfortunate
events.
- Paul Palmes
l\l
rn
tr (o
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=
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(, !,
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c3 o
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o
(J
. lso 14001
. oHsAS 19001
. tso I Ts L6949
. tso 22000
.
ffiTffi
HACCP
. Others
. and proc":::W
T:::jproduct
F Services
F Tool used is FMEA (failure m
analysis)
. Risks to Customer Satisfaction
) Capturing customer expectations and unstated
requirements
contact with incompetent personnel.
(21
(3)
(4)
(s)
(6)
(7)
(8)
(e)
( 10)
-
INTERNAL AUDIT
PROGESS.BASED
INTERNAL AUDIT
Processes critical
and relevant to
meeting product
Process
lmplementation
conformity
to requirements
important processes
with higher risks of
Process
failure
lmplementation
processes that can
cause higher risks of
product failure