q

Basic aMR Course

As a QMR, how can you help
Y oLnY Busimess?
(BQMR-016)

14 November 2013
Cebu City

by

Mr. Mac C. Evangelista

Consultant

Management Cons u ltants, I nc.

WffiffiWW,MWW
[Link]
 r> NOTICE ce

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Management Consultants, lnc.

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The materials in this document were conceptualized, researched, designed,

developed, and written or published to provide accurate and authoritative
information in regard to the subject matter covered.

12 November2013

ROSEHALL Management Consultants, lnc.

Unit 1405 Prestige Tower, F. Ortigas Jr. Rd, Ortigas Center, Pasig City 1600
[Link]. (632)633-4733;631-2924;637-5202
Fax No. (632\ 631-2875
E-mail business@[Link]
 q

ilC$*.l1{l..r- lulanaqemenl. Con-cuilent;', L.c

Resum6
of

Mac C. Evangelista
Consultant
ROSEHALL Management Consultants, Inc.

Mr. Mac C. Evangelista is a Senior Consultant of. Rosehall Management

Consultants, Inc. He has been a Consultant for more than ten years.

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).

As Consultant, Mac had provided consultancy and training services to a number of

companies on quality management, environmental and health & safety
management. These companies have successfully obtained certification to ISO
9001, ISO 14001, OHSAS 18001 and ISO/TS 16949. The companies he had
assisted, or are currently working for their certification are in the following
industries: electronics, garments, automotive, construction, cement, steel, bank
and chemical.

Mac has attended the following training courses:

o IRCA Approved ISO 9001 Transition Auditor Training
. ISO 9001:2008 Awareness & Implementation Training
. Product Quality Planning & Control Plan Seminar
. ISO 14001 (EMS) Implementation Training
. Advanced Statistical Quality Control
. IRCA Approved Internal Quality Auditor Training
. IRCA Approved OHSAS 18001 Lead Auditor Course
. OHSAS 18001:2007 Transition Training
. Balanced Scorecard
. ConformityAssessment
. ProductivityMeasurement
. Process Management

Mac graduated with a degree on BS Electrical Engineering from St. Louis

University. He completed Diploma course on Environment & Natural Resources
Management at University of the Philippines-Open University.

niac [Link] UDdaled Dclober 1.:1, 2*13 ffi

 T

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,

[Link] concerns or
apprehensions of participants.

GOURSE PROGRAM
Registration, early snacks, reading of
materials

Msdule 1: a self-assessment against competence

requirements, duties, responsibilities, authorities and
knowledge of basic quality management

M"[Link] 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

h4pd alls 2; (continuation)

Madule 3: Workshop

l" '' n *i' \ " '";

Module4: -'1'1( "' '
/
As a QMR, lgiw can you help improve the business?
How the qMS can be improved:
. Risk Management
. Process-based and Risk-based lnternal Audit
.Aligning Quality objectives with Business Goals

course Evatuation
I "-*^;l
Self-Diaanosis as QMR

Write A if you agree and D if you disagree with the following statements:

I (1) The management representative (MR or QMR) is appointed by Top

Management.
L (2) ; ;;il;-;;;; ;"i ;",o oi"j'-,;,;:; ;;;^*-l-0., orthe
orga nization's management.
p (3) The MR/QMR position should be a full-time, dedicated job.
D (4) The complete competency requirements of an MR/eMR position
are as follows:
. Knowledge of ISO 9001:2008 requirements
. Knowledge of the organization's eMS
L (s) The MR/QMR is responsible for documenting the QMS manuals.
n (6) fte nhnlq#[Link],,"'t"p r;;;sffi;tiregarding the status of
QMS performance and any needs for improvement.
,-'t lt','i
':' 'J;' .,'n'l,1 '\ I

D (7) The MR/QMR is responsible for identifying the scope of QMS

internal audits
4 (8) The MR/QMR should be very familiar with Quality terminologies,
tools, technologies, and principles to be effective in his/her job as
MR/Qun'
A (g) The MR/eun owns some processes in the eMS.
T; (10) Qualitv Assurance has the same meaning as Qualitv Control. The
former is just a modern term for the Iatter.
i) (11) Qualitv is the degree to which a set of inherent features or
characteristics fulfills requirements of the customer/s. Therefore
Quality pertains to products only.
L (12) Customers could be internal, intermediate or external to the
organization. Buyers of products or services for further processing
are not considered customers.
 -

Self-Diaanosis qs QMR

{J (L3) A process means the same as procedure.

A (14) Quatity Planning entails setting of quality objectives, product or
service features and specifying necessary processes and resources
to fulfill those objectives.
L' (15) Quatity improvement means increasing the ability to futfill quality
requirements. This can be done without tools or techniques.
.1 (15) An effective process means planned activities are realized and
planned results are achieved. An effective process leads to customer
satisfaction.
'i-,' (L7) An efficient process means that desired results are achieved using
optimized resources. Cost should q!_ways be prioritized over
custome r satisfactio n.
{
(18) Over the years, Management of Quality has evolved from mere
inspection to TQC or self quality--control to quality management
systems.

(19) Quality Management system is the only n'ianagement system in an

organization. lts requirements can be found in lso 9001:200g
rt
standard. s/;''
i't.''i' 1 ' '"1

(20) A eMs has onry two (2)

"'il;;"r: .;[;::il;Jlil.,",
and comply with statutory and regulatory requirements.
p (21) Since the QMS requirements are standard, one can simply copy the
QMS manuals of a competitor or company in the same industry, get
certified, and be confident of improved competitiveness.
A (22) ISO 9001:2008 has five (5) auditable clauses.

A (23) lmprovement of a QMS is done thru process management and

improvement using the PDCA approach.
;z
r.r'i"
':! {.,.,
",.
i, i ''' '
(2a) Support service processes are managed under clause 4: quality
management system.
p (25) The QMS under ISO 9001:2008 has six (5)
mandatory procedures.
These procedures may or may not be documented.
Self-Diaanosis os QMR

0 (26) euariilv
"ui".tilA;;';;;t',i;fUt,sraaiol-,
r;iL,T.,rriance to regar
requirements need to be monitored. These are enough to evaluate
aM: effectiveness .,, :r r.,:,.i."",,:

C (27) Certification of the established QMS means that the product is

conforming to customer, legal, and internal requirements.
(28) Considering business risks will influence our eMS, risk assessment is
not required by ISO 9001:2008 but we can use it to improve our
preventive action planning.
,, a{&1t 'l "'

(29) Preventive actions are formulated to prevent /ecurrence of

problems or non-conformities in the prganizatibn.
i '. : r'\ {"rl
l[r
$.:., : ,
(30 By studying'procedures and knowing how wel! they are
implemented, and how well records are kept, auditors will be able
to know how effective the QMS is. This is known as the process
appfqa,C-h. =l u,rrii.1{ d.,r u,':,1 r.1"., ,,,'-,,,!{ ,
e.r}.,,i
';,;- #;'t "'.''j
"ri',,:i.*,
,
(31) Regardless of criticality or relevance to Quality and business r:, l. i,

objectives, all documented processes must be audited as required

by the standard. i, ,

5) (32) The QMS objectives should be treated separately from business

goals. lt is dangerous to mix the two as they have different interests
which could be in conflict with each other.
(33) Risks in attaining quality objectives and process goals should be
identified, analyzed and evaluated. significant risks shoutd be
provided treatment plans and included in the eMS.
(34) Process controls and process standards should be reviewed at least
once a year and also when quality incidents occur.
r-? " * ' ,;
(35) Risk-bqsgr_d aLditirrg is meant to prioritize the audit of processes that
pose greater risks to product conformity, to customer satisfaction
and to meeting of quality objectives. This will make auditing more
relevant to the business.
(36) lt is possible to have ISO 9001:2008 Certification and yet have
products which are not meeting customer requirements.
 -

QMR Knowledge, Strengths and Weoknesses Mqtrix

Points 1-3 Points 4-6 Points 7-9

Question Actual Rating
#s points Needs a lot of Satisfactory Excellent
improvement

QMR duties,
responsibilities, 1-9
authorities, and
competence requirements
Quality Management
Functions, Quality .10-18
Terminologies and
Principles

QMS requirements based

on ISO 9001:2008 !9-27

Approaches to QMS
improvements; Risk 28-36
Management, Quality and
Business Goal Alignment
MANAGEM ENT REPRESENTATIVE

A management representative should be

appointed and given authority by top
management to manage, monitor. evaluate
and coordinate the quality management
system. This appointment is to
enhance
effective and efficient operation and
improvement of the quality management
system.
 q

What will you do if

your current QlUn
does not meet these
requirements?

GENERAL RESPONSIBI LITI ES

tr To manage, monitor, evaluate

and coordinate the QMS
To enhance effective and efficient
operation and management
improvement of the QMS
Report to top management
Communicate wlth customer and
other interested parties on QMS
related matters.
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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

Quality management principles

OTHERS

lnternal Audit Process

Tools for Corrective and Preventive
Action
Process Management and
lmprovement
Problem - Solving Process
Some Au a frtj Terrnin o fog i es

[using 950 flooo;zoor|

 DEFINITION OF TERMS

i Product ------ of
ii -result - process.
-' a r' i

Process iset of interrelated activities and resources

i ,I
iwhich transforms inputs into outputs. outputs. i

lii
'ti
;**-*...-**-,,_..
ii
t- i

i Supplier i organization or person that supplies a product. i

rii
tii
:ii
I

:OSEHALLI
. v2:\l , i

DEFINITION OF TERMS
I ----*- ----
i Related to quality cont..

Quality Monagement i coordinated activities to direct .no .oniiorinl

ii
I organization. :

Quality Plonning j; part ofqualitv management focused on

quality ',
i

i setting quality objectives and specifying i

i necessary operational processes and related

, . resources to fulfill the quality objectives.
i

i
i:
jil
iil

i Quality Control i part of quality management focused on i

i
i i fulfilling quality requirements. )

i
I
i
 q

DEFINITION OF TERMS

Quality lmprovement part of quality management focused on increasing

the ability to fulfill quality requirements.

Quality Assurance part of quality management focused on providing

confidence that quality requirements will be
fulfilled.
extent to which planned activities are realized and
planned results are achieved.
I

Etf t, t" rry-- l;; rti

",
t

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
 -

SOME QUALITY PRINGIPLES

. Quality has to be built into a product

(goods or services), done thru Quality
Planning. This is more effective than
Quality Control.
100% inspection done by humans is not an
assurance that there will be no defective products.
The person who does the product or service is
responsible for its quality.
Cost of quality goes up as the product nears the
customer.

THE 8 QUALITY MANAGEMENT

PRINGIPLES
1) Customer Focus - ,.' ' ,', ,, i

2l Leadership
3) lnvolvement of People - ' ,'
4l Process Approach i.. r . r.( ' ,,.,,.,.r si

s) System Approach to Management

6) Continual lmprovement ,- :" .' 'i ;

7l Factual approach to decision making . ,,,:,

8) Mutually beneficial supplier relationships -,,.,,'

QUALITY MANAGEMENT
FUNGTIONS
 QMS ISO 9OO{:2OO8
HIGHLIGHTS
. Tips tor QMRs in
{. establishing the QMS
.f. effective QMS implementation and
monitoring
* conducting value-added audits
t doing continual process
improvement
 QMS
(Quality Management System)
What does the QMR need to know about
the QMS?
What does the QMR need to do before,
during, and after certification of their
 -

. A qMS should be
designed in such a way
that it can help realize
the Business Goals of
 -

THE ISO 9OO{:2OOB Standard

Glause Requirements

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

4.2 Documentation Requirements

. Quality Manual
. Quality policy & objectives
. Required procedures and records
. Documents and records for planning, operation and
control
. Control of documents

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
[Link] 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

{s required by the organization to demonstrate the validation of processes where the

7.5.2 (d)
"esulting output cannot be verified by subsequent monitoring or measurement

RECORDS REQUIRED BY
ISO 9OO1:2OO8
llause Record required

u.5.3 Ihe unique identification of the product, where traceability is a requirement

7.5.4 Sustomer property that is lost, damaged or otherwise found to be unsuitable for use

3asis used for calibration or verification of measuring equipment where no

7.6 (a\
nternational or national measurement standards exist
r'alidity of the previous measuring results when the measuring equipment is found
7.6
rot to conform to requirements
7.6 lesults of calibration and verification of measuring equipment
3.2.2 nternal audit results and follow-up actions

1.2.4 ndication of the person(s) authorizing release of product

lature of the product nonconformities and any subsequent actions taken, including
3.3
:oncession obtained
).5.2 lesults of corrective action
3.5.3 Results of preventive action B!]Mti-3s
 -

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'

5.1 ManagementCommitment'trti::t *"..'

o evidenceof commitment to development,

implementation and continual improvement of
QMS and its effectiveness
Customer Focus
" determine needs, meet them and
enhance satisfaction
Quality Policy
. defined, communicated, aligned with business
goals
 -

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

6.2 Human Resources

o competence, Awareness and Training of
employees and other personnel
6.3 lnfrastructure (support services includine lT)
. determined and managed
6,4 Work Environment
" Lighting, n,oise, temperature, humiditv, weathe[
etc.
 7 PRODUGT REALIZATION

7.L Planning of product realization process

. Quality plan for product realization
. Product control plan including verification,
tests, monitoring, measuring, etc.
7.2 Customer related processes
. Contract review, post-delivery, including
disposal, etc.
7.3 Design and development
. Review, verification and validation

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

7.6 Control of Monitoring and Measuring

Equipment
. Calibration of measuring equipment, verification and
configuration ma nagement for com puter softwa re
 8 MEASUREMENT, ANALYSIS AND
TMPROVEMENT (MAr)
8.1 General, plan & implement MA! including statistical
techniques as applicable
8,2 Monitoring & Measurement, customer satisfaction,
internal audit, monitoring & measurement of processes,
monitoring & measurement of product.
8.3 Control of Non-Conforming Product
. When corrected, do re-verification
8.4 Analysis of Data -determine, collect, analyze & evaluate
where Cl of QMS can be made, do analysis when targets are
not met.
8.5 lmprovement
. Correction, Corrective & Preventive Action
o review effectiveness of CA & PA taken.

QMR role during QMS establishment

Self-Assessment
t read 4.L,4.2,5.3, 5.4, 5.5

I processes and procedures

,l <) project masterplan - a'Jil o':ri'1

<} project schedule monitor

t coordination with department

heads and top management
 QMR role during QMS
implemelltation and monitoring

. QMS Manuals ROLL-OUT

() "WaIk-ThfU" -rr'3j.i', ' ,'
I design of Monitoring Charts -,';:""ri, i
,) Review Monitoring Results _., .-*,:,0;1,,
,'1,,,
a Audit Programme, ATL,
lnternal Auditor:s (all done by APM)
a Management Review
o QM R reports,%ther Managers report *) . "
, .i. r,

a QMS suitable, adequate, effective?

QMR Role in conducting

Value-added Audits

a Audit Process (lSO 19011:201L)

a Audit Programme
a Select good Audit Team Leader (ATL)
a lnternal Audit Training
a Select qualified internal auditors
a Workshop : Checklist preparation
a Audit plan
o Orient auditors on making relevant calls
Ensu re process effectiveness measurem
 QMR Role in ensuring QMS
continual process improvement
. Quality goal alignment with business goals
a Changing customer and legal requirements
Changing business environment
Use of Quality lmprovement Tools &
Techniques
Root Cause Analysis (RCA)for
Nonconformities
Poka-yoke of corrective actions
Preventive Action Tools/ Risk
ldentification, Eval uation, Treatment Tools
Process measurements

before, and after

Gertification
7) Before Certification
o Guide
o Mentor
o Coordinator
2) After Certification
o Maintainer
o lnspirer
o Consistent Leader
iw$
:iffir
SB
Module 3: WORKSHOP
Based on the results of your self-assessment in Module 2, present your
concerns or apprehensions in the subjects where you think you are most
weak among your group members. Raise the issues that your group can not
agree on to the class' attention

REMAINING ISSUES ON qMRs ROLE

lssues Specific Questions
 -

Remainina lssues on QMR's Role

lssues Specific Questions

 -

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

Why satisfy the customer?

Why comply with Iegal requirements?
Gritical Success Factors?
How Quality contributes to business

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"

"ang QMS puro procedures lang"

"puro kayo lSO-magtrabaho naman

kayo !"

"Q,MS has nothing to do with

business"

ISO 9OO1:2OO8, O.{ General says

the QMS design is influenced by

a) the orga!rizational environment, chanees in that
environment, and the risks associated with that
environment."
b)
c)
d)
e)
f)
 ENVI RONMENTAL SGAN N I NG

. Looking into various environmental

factors that could affect the
business.
. Usually S,T,E,E,P (sociological,
tech nological, economic,
environmental, and political) and
competitors
Groupwork (by compony)

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.

Environmentol Factor Threat or Opoortunitv

(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

are too many things being done now in

implementation that do not add value to
it or to the business:
(5) Process owners not made accountabte for
process performance
(6) Support function processes not given as
much attention as operational processes.
l7l Undefined resources to meet quality
objectives
(8) Too much focus on document control. Too
little or no data analysis!
 -

There are too many things being done now in

QMS implementation that do not add value
it or to the business:
(9) No measures of effectiveness for corre.f
actions.
(10) Process owners don't use systematic
problem-solvi ng in corrective actions.
(11) No or little improvement of internal auditor
competence
lLzl Quality-related risks not considered in the
QMS.
(13) Poor preventive actions due to poor data
analysis.
 Risk Management ,#

Risk-Based lnternal Audi

Quality Objectives and Business
Performance

The combination of the probability of an event and

its consequences.

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
.9 rn

=
q
(t,
=
c o
o
(, !,
E
c c(!
o u0
c c
o L

(! o
.E
I c
c3 o
E
E
o
(J

RISKS ALREADY CONSIDERED IN

. lso 14001
. oHsAS 19001
. tso I Ts L6949
. tso 22000
.

ffiTffi
HACCP
. Others

How obout RrSI(S in QIWS

(ts0 9007:2008)?
 -

RISK APPLIGATION IN QMS?

. 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.

RISKS IN MEETING QUALITY

OBJEGTIVES
(1) lack of workable action plans
(21 disapproval of resource requirements
(3) metrics-setting had shallow basis
WHAT QMRS SHOULD DO:

(1) ldentification and assessment

of potentiat product and &S
process faitures &
(21 Preventive actions for high
s
ikelihood/high impact
I

product and process failures

(3) Risk assessment on
attainment of quality
obiectives and process goals.
 -

G rou pwork (by com pc, ny)

ldentify the processes in your QMS that have higher risks

of product a nd/or process failure (non-attainment of
process goals or other metrics of effectiveness).
(1)

(21

(3)

(4)

(s)

(6)

(7)

(8)

(e)

( 10)
 -

P r o cess - 6 as edan I Risfr,

hasedgnfernafnnrt*

INTERNAL AUDIT
 [Link]
INTERNAL AUDIT

Processes critical
and relevant to
meeting product
Process
lmplementation
conformity
to requirements

[Link] INTERNAL AUDITS

important processes
with higher risks of
Process
failure
lmplementation
processes that can
cause higher risks of
product failure