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Effective Quality Management System Guide

This document describes what a quality management system (QMS) is, its historical evolution, its key principles, and its relevance for companies. A QMS defines the processes and activities necessary to achieve an organization's quality objectives and satisfy customers.

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© All Rights Reserved
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0% found this document useful (0 votes)
26 views20 pages

Effective Quality Management System Guide

This document describes what a quality management system (QMS) is, its historical evolution, its key principles, and its relevance for companies. A QMS defines the processes and activities necessary to achieve an organization's quality objectives and satisfy customers.

Translated by

ScribdTranslations
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

The ultimate guide to

set up a
MANAGEMENT SYSTEM
Effective quality (SMQ)
SUMMARY

Towards a digitized Quality Management System 5

What is a Quality Management System (QMS)? 6


Building one's documentation system within the framework of the QMS 9

The QMS, an approach based on the PDCA 13


The interest of optimizing your management review 16
CITAL Testimony: "The auditor mentioned as a strong point the possibility of
telecommute thanks to the digitalization of our QMS 19

SMQ Guide - All rights reserved) BlueKanGo 2020 2/20


PREFACE

Towards a Management System


Digital quality

A quality approach creates value for both the clients (or the
consumers), than the collaborators and the decision-makers. The objectives of a
The direction that engages in this type of approach varies according to the activity and
the type of products manufactured. However, satisfaction and more broadly
Customer experience is indeed at the heart of all concerns.

The implementation of a Quality Management System (QMS) is


essential to support this approach. If the pilot is the responsible
QHSE must be supported by its management. For this system to function,
management must be established according to a methodology understandable by all
the stakeholders involved (employees, clients, suppliers, auditors...).

To do this, the company has every interest in digitizing its QMS, a guarantee of
performance and security for the QHSE service and all stakeholders of the
approach. This new guide provides the basics for understanding the stakes of a
SMQ and tips for implementing it effectively.

Enjoy your reading

Jean-Marc BRIAND
CEO of BlueKanGo

SMQ Guide - All rights reserved) BlueKanGo 2020 3/20


What is a System of
Quality Management System (QMS)?

The Quality Management System is necessary for good


operation of the various processes of an organization. This is an activity
support that has a full role to play in the strategy of each
company.

How has the concept evolved to prevent non-compliances


of the quality of the 1950s (staff training, process
defines...) and we aim more at
to today?
search the cause of ces
malfunctions for avoid
Until the 1950s, the
any recidivism.
quality was associated with the notion of
control: it is the quality service that
The first certifications of type
perform the post-controls.
ISO 9001 appears in the
the method nevertheless has its limits:
1990s, at the same time as the
post-control leads to
notion of quality assurance: indeed,
significant labor costs
the company (but also its
of work and time spent, without
suppliers/service providers must
note the fact that the production of
to present à this clients of
non-compliant products continue
documents manual quality
during the time of the control.
procedures, records,
audit reports...) proving the
It was only from the 1960s onwards
respect for quality standards all the way
what first appeared
length of the production chain.
controls during production, and this
throughout the chain of
Quality control allowed
product manufacturing.
until then to determine if a
product/service was responding help
The first concepts of prevention
different requirements (from the client, from
and continuous improvement have seen the
market, legislation or even
day in the 1970s to 1980.
of the certification). The insurance
An organization is set up
quality arrives as a complement in the

Guide SMQ - All rights reserved) BlueKanGo 2020 4/20


but to ensure overall control of
the quality. The QMS ensures a
mastery of processes, based on
In the 2000s, the principle principles of continuous improvement
quality assurance shifts small to results and performances.
small towards management Quality management is a
quality. It is no longer guaranteed. transversal function that relates to
mastery of a process all the services of the company:
starting from the simple implementation communication marketing
of a procedure: it is about proving production purchases/sales
that the objectives defined beforehand human resources, logistics
in quality policy have been maintenance.
reached and that action plans have
have been deployed. Pilots of The QMS complies with ISO standards.
processes are designated in order to 9000 regarding the systems of
ensure the achievement of these objectives quality management.
in the context of this news
process-based approach.
What is the point of putting in
Today, the organization you place a QMS ?
quality management is
refocused on needs and expectations The goals of leaders/chiefs
of the client, as well as on the measurement of
of companies that are committed to
his satisfaction. The companies and a quality approach is diverse and
organizations are betting more on varied. Customer satisfaction seems
prevention to prevent the to be the main motivation for the implementation
potential malfunctions. instead of a QMS: it is about
satisfy and above all retain the
clients in order to ensure a level of
optimal competitiveness.
The QMS in brief
Also, it is very interesting for the
A Management System of the companies to master quality
Quality (QMS) defines the entire set of products and services while
activities that must be implemented reducing production costs.
an organization to achieve its
quality objectives, while respecting
the quality policy established upstream.

Guide SMQ - All rights reserved ) BlueKanGo 2020 5/20


The 7 principles of the Quality Management System (QMS)

Principle 1 Client orientation The main objective of the QMS is to satisfy


to the requirements of the clients and to strive
to meet their expectations.

Principle 2 Responsibility of the At all levels, leaders establish


Direction the purpose and orientations and create
conditions under which the staff is
involved in achieving quality objectives
of the organism.

Principle 3 Implication of It is essential that all staff


staff be competent, authorized, and involved to
provide value.

Principle 4 Process approach Consistent and predictable results are


obtained in a more efficient and effective manner
when the activities are understood and managed
like correlated processes functioning
as a coherent system.

Principle 5 Improvement The improvement, based on a type system


PDCA is essential for an organization
maintains its performance levels all
by creating new opportunities.

Principle 6 Decision making Decisions based on analysis and


based on some the evaluation of data and information is
evidence more likely to produce the results
expected.

Principle 7 Relationship management To achieve sustainable performance, the


with the parts organisms manage their relationships with
interested interested parties (suppliers, service providers).

SMQ Guide - All rights reserved) BlueKanGo 2020 June 20


Build your system
documented within the framework of the QMS

Every organization must have a well-established documentation system in the


framework of the quality approach. The objective is to formalize practices to
improve the performance of the company.

Insurance quality is a company. Often implemented


set of documents that have to meet a requirement of the
to clarify ISO 9001 standards, this document is a
the internal organization and the genuine tool usable internally.
practices implemented in From now on, the latest version of
the establishment. Each structure ISO 9001 (version 2015) no longer imposes the
built its documentary system implementation of a quality manual.
taking into account its size, its Nevertheless the establishments
local and its activities. This can, if they wish, the
system is most of the time preserve within their framework
imagined in the form of a pyramid, document management.
representative from top to bottom (of Its regular update forces the
the most general document to the most direction to renew its objectives
detailed) : the quality manual ; the and to confront the different points
process sheets; the procedures; from their perspective. The quality manual
the modes operational ; the constitutes a true common foundation
records. of knowledge of quality in
company.

THE QUALITY MANUAL Externally, it allows to give


trust in customers and suppliers
What is it for? on the quality policy and its
organization.
The quality manual aims to
What does it contain?
describe the organization and the
engagements specific to each

Guide SMQ - All rights reserved ) BlueKanGo 2020 7/20


He does not existnone obligation What are they for?
regarding the formatting of
quality manual. The document must The procedures allow for
make sure to gather the information describe and formalize the way in which
following: must be completed one or
several activities in the company.
● A very concise description This reference document allows
of the company and its activities of do to know à all
; the organization the key processes.
● A text from the management
presenting its commitments Some examples of procedures
as well as the quality policy of :
the company
● The arrangements made for ● management procedure of
maintain the quality of non-conformities;
products/processes and ensure the ● quality audit procedure
customer satisfaction internal/external
● The commitments of the company ● processing procedure for
in terms of training and customer complaints...
support of
collaborators.
What do they contain?

The key points of his writing The procedures must provide the
following information:
It is necessary to ensure that the manual Who? : which actors are involved,
quality is as synthetic as possible Who are the responsible parties?
possible, and especially that the jargon What?: What are the tasks to
used to be understandable by everyone. achieve?
Indeed, this document is not When?: what is the duration of the
intended only for listeners, it is therefore necessary task? what deadline is set?
make sure to customize it as much as How?: What are the means
possible for the whole of implemented for the realization?
collaborators and clients and/or
suppliers also adhere to it. It is essential that the procedure be
tested in the field and to be known by
the entire operational team for
validation. The latter must
THE PROCEDURES must be involved in
in its writing, at the same time as
process drivers.

Guide SMQ - All rights reserved) BlueKanGo 2020 8/20


describe several operating procedures:
one for the reception of the
The key points of their writing non-compliance, a for the
dealing with non-compliance, and
Most of the time, activities and and so on.
the tasks are represented under the
form of a flowchart which is a What do they contain?
very visual tool.
Certain steps of the flowchart The operating procedures contain
may refer to modes all the operations to be carried out in
operational or other procedures. a chronological order, as well as
all the technical information
One should not hesitate to modify the associated (material à use
procedures as soon as it proves necessary scales of temperature à
necessary integration of a apply, etc).
new machine, implementation
of a new production line, The key points of their writing
new ingredient, etc).
The operating procedure being
Note that the QHSE manager will mainly dedicated to newcomers
ensure compliance of the arriving, it may prove useful to it
procedure concerning the standards, integrate photos or diagrams,
but rather the validation of the content so that the document is the most
the technique must be performed by the simple possible.
process driver.
Of course, one must not look for
to describe everything according to the complexity of

the activity and the competence of


THE OPERATING MODES operational.

What are they for?


THE RECORDINGS
The operating procedures, also
called work instructions, What are they for?
come to supplement the procedures
by detailing each of the tasks The recordings allow to
described for the process in demonstrate the proper application of
question. quality system: it may involve
results of self-monitoring, of tracking
For example, for the procedure cooking scales, or also
management of non-conformities audit results.

SMQ Guide - All rights reserved) BlueKanGo 2020 9/20


product made and of the
It is very important to keep them. confidentiality of activities.
to be able to consult them if needed
(par example in case of The key points of their writing
product withdrawal/recall, during an audit
of certification or during processing It is a matter of ensuring that the
of a non-conformity). protection of your data is the
more effective possible : the
These recordings allow records must not be
to ensure the traceability from altered, consulted without authorization,
information about the entire chain of or even stolen.
fabrication.
It is wise to take stock.
Concerning the retention period regular with the drivers on the
everything depends on this data most important recordings
in order to anticipate a possible drift
of the system.

Electronic Document Management (EDM):


A must-have in the digital age.
The GED primarily serves to facilitate access to the company's data.
even more important with the development of remote work and/or mobility
employees. Users access documents through software.
regarding as well as the procedures shared via distribution groups. The cycle
the life of the documents (writer/reviewer/approver) is respected. It is
Possible to access all consultation/modification histories.

The GED ensures a high level of safety of internal data within the company.
Each user has tailored access, depending on their activity and their
hierarchical situation. For this, the use of a dedicated solution such as
BlueKanGo with Intranet portal is required. The possibilities for accessing documents.
from the GED since a mobile version (accessible on smartphone or tablet) is
also to be taken into account to simplify access in all situations.
Listeners will be impressed to be able to access the four with a single click.
versions of the procedure studied and the changes made since the last one
visit!

SMQ Guide - All rights reserved ) BlueKanGo 2020 10/20


Mélanie CASCELLI
QHSE Digitalization Specialist
BlueKanGo

The QMS, an approach based


on the PDCA

Considered as a true foundation of continuous improvement, the PDCA


(Plan-Do-Check-Act) is applied in many organizations. The method,
through its four stages, aims for performance and operational excellence.

What is PDCA? The slope represents progress, and


to avoid any backward movement, we
The PDCA is a theoretical concept, represents the wheel with a wedge that
based on the notion of cycle, which has prevents him from coming back down. The bet

was developed by William Edwards instead of a PDCA requires


Deming (1900-1993). This tool has seen the a lot of rigor, with
day in the 1950s, then was data in figures, as well as a plan
renewed in the framework of the robust action and follow-up in the
ISO 9001 certification v2008. weather.

Thus, the Deming wheel is based


on a four-stroke cycle: Plan
Plan
("Check"), and Act ("Improve").

The Deming cycle applying to


repeatedly, this one allows
to ensure one approach
for improvement continue of
quality management systems.

Guide SMQ - All rights reserved) BlueKanGo 2020 November 20


To do, to carry out the actions

The objectives set and the action plan


established, it is a matter of implementing
the actions planned in the plan.

Check, to control and verify

At this stage, it is about verifying


that the action plan was effective and
that the results obtained are
coherent with regard to the objectives
fixed. To do this, different tools are
The 4 steps of PDCA used such as tables of
boards, internal audits or even
Plan, to foresee and plan product controls.

This is the first step of "Act", to act and adjust


formulation of the objectives to be achieved
in accordance with the policy This step depends of the
quality. For this, management must previous: if the results are
of to take note of the in line with the established objectives, it is about

company results. This simply to generalize the


strategic analysis carried out in best practices. In the case
amount can be carried out using on the contrary, a phase of adjustment
of a SWOT or a type analysis will be implemented by the application
PESTEL. corrective actions.

Once this work is completed, it is about


to undertake actions aimed at Focus on the Action Plan
achieving set goals: it is the
birth of the action plan. The What is the purpose of the Action Plan?
validation of the action plan can be
to be done during a management review The action plan is a tool for
in order to validate the objectives and obtain planning of key actions to
the commitment of the management in this set up in the company
concerning the allocated resources to achieve the set objectives in
(budgets purchases possibilities link with management.
human resources...)
This plan is classically established
for a year, the goal being to

Guide SMQ - All rights reserved ) BlueKanGo 2020 December 20


define objectives upstream to engage fully on the
achievable and priorities. realization and updating of this
document.
How to build a plan
Action? To complete the action plan, it
it may be wise to write
The plan action list an action sheet: this sheet
the set of actions to be taken, detail what needs to be done, as well as
but must also specify for the necessary means to achieve
each of them : the each of the actions. It is
responsible(s) ; them built with the manager
necessary means/resources; the designated from the action, which allows
deadlines (scheduled/actual start date, to engage the leaders on the
expected/actual end date. long term.

The important thing is to build the plan Thus, the PDCA is a method
of action with the ensemble of the based on continuous improvement
collaborators. The QHSE manager which is widely used. For
can serve as support to facilitate its management, it may be useful
methodological by playing the role of to use dedicated tools and
project manager, but it is the notably digital.
process drivers that must

Action plan:
A single action plan to manage everything

The Global Action Plan is a tool that must live within the company and be implemented
as regularly as possible. Thanks to a dedicated tool like BlueKanGo, it
it will be possible to correlate your audit reports, your Unique Document (DU) or
still the management of your non-conformities, directly to your action plan. By
example during a field audit, when a non-compliance is identified with a
associated action, the latter will be implemented automatically in the
Global Action Plan. The relevant pilot/service will also be notified.
automatically by email of this new action.

Guide SMQ - All rights reserved ) BlueKanGo 2020 13/20


Thus, thanks to digital technology, QHSE managers and process leaders gain in
Efficiency by avoiding multiple transcriptions from one Excel file to another.

Thibaut GILLES
QHSE digitalization specialist
BlueKanGo

The interest in optimizing the review


of direction

The management review is a planned event that allows for an assessment.


of the management system of each organization. This is an opportunity to
reaffirm the management's commitment and obtain the means/resources
necessary for the evolution of the company.

What are his objectives? the quality policy and objectives


quality.
The management review is a
requirement of several ISO standards. It presents itself in the form of a
Here is an excerpt from the ISO 9001 standard, annual meeting, or even semiannual.
chapter 9.3 on the Management Review It all depends on the context of
: the company (size, type of
"The management must, at intervals management, organization of QHSE.
planned, review the organization's QMS For example for a small
to ensure that it remains relevant, SME-type structure, a single one
adequate and effective. This review must review per year with all of the
understand the evaluation of services of the company may suffice.
opportunities for improvement and of On the other hand, for a bigger one.

need to modify the system of group (in multisite), there can be


quality management, including several management reviews, namely

SMQ Guide - All rights reserved) BlueKanGo 2020 14/20


a review for each
unit/service. Duration: 1H30-2H00 (2H maximum!)

Also depending on the context Before the review, it will be necessary to carry out

external, like currently with a rigorous preparation and


the COVID-19 health crisis, the structured. It is about bringing together the
reviews can to be more process drivers through the
brought together in time for process reviews. These are those
face this situation
à latest that will feed the review
exceptional. of direction.
The management review aims to establish
a global assessment of the approach As a principle, one should avoid
QHSE with the management and present too many tables and/or
allows for a floor on effectiveness figures, and to use jargon
of the QHSE management system. incomprehensible. Graphs
The interest is to take if more visuals will be favored. It can
necessary the decisions who to prove judicious to try
impose themselves. to anticipate the responses of
collaborators in order to argue about
A management review is presented in positive way. Here are the different
because the existing, while mobilizing and input data that constitute the
by engaging the management committee management review and which must be
in the process. An opportunity prepared in advance:
for the managers to exchange
their different viewpoints on the ● Audit results
current structure of the organization internal/external
QHSE. ● Risks and opportunities;
● Customer satisfaction surveys;
How to organize it? ● Non-conformities and
complaints:
Upstream organization ● Performance indicators;
● Status of actions undertaken
Firstly, it is about since the last review ;
define the participants as well as the ● Analysis of changes
duration of the meeting: possibilities;
● Areas for improvement.
participants
● the host (the person in charge Attention, the goal here is not to list
QHSE or management; one by one all of the
● process drivers; customer complaints for example,
● the management committee. but to make a summary. This

SMQ Guide - All rights reserved ) BlueKanGo 2020 15/20


synthesis must imperatively be
presented to the management before the At the end of the meeting, here is the list of
meeting. Areas for improvement output data which must be
will thus be offered in their established
majority by the management that will have had ● Details about the system structure
knowledge of each synthesis QHSE ;
established. ● Possible modifications to
regard on customer expectations;
During the management review ● Possible modifications of the
quality policy and objectives
Pendant the thirty firsts fixed;
minutes, you need to take the time to ● Assignment of
present the results and exchange resources/necessary means.
on these last ones. The rest of the
the meeting will be dedicated to the work Management review report
on the ongoing files or on a
only targeted subject. This involves writing a summary "to
"hot" by taking back the decisions that
One must be concise and use were taken as well as the actions to
regularly the terms "we" or to lead. The monitoring of the action plan
"us" to let some through global is essential: it will serve as
messages : the implication of basis for the next review of
The whole group of participants is direction.
primordial. It is about enhancing the
successes, to explain failures and
of proposer of the ideas
improvement.

Optimize your management review through


automated dashboards

Thanks to digital technology, it is possible to perform statistical data analysis through the
automated dashboards. Integrated Business Intelligence (BI) tools like in
BlueKanGo generates attractive reports and charts. QHSE managers and the
direction accesses real-time data collected from the field and consolidated.

SMQ Guide - All rights reserved ) BlueKanGo 2020 16/20


the automatic alerts, these are alerted directly by email of a possible
derivative of one or more indicators.

Strategic decisions are thus made quickly, limiting meetings, and


can be done by videoconference if necessary. Beyond the management review,
These statistical tools are used in the context of daily debriefings with the
production, or even during the safety briefings on the ground.

Mélanie CASCELLI
Digitalization Specialist QHSE
BlueKanGo

SMQ Guide - All rights reserved ) BlueKanGo 2020 17/20


Testimony

The auditor mentioned


as a strong point the
possibility of telecommuting
thanks to the digitalization of
our QMS

The Algerian transport company CITAL


Industrial Transport Company
Algerians have been using BlueKanGo for several years. If the solution has
Initially retained for the QHSE part, CITAL has significantly expanded.
its scope of action. An approach crowned with success
as explained by Yazid TOUDJI, Quality System Manager.

like ours which is in a


Where are you in the multi-site context.
digitalization of your processes
at CITAL? What are the fields
applications covered by
Initially, we airplanes retained BlueKanGo?
BlueKanGo for digitize the
process of our Quality service and
HSE. They are today 100% digitized
on all CITAL sites. For example, we have digitized the
part "Engineering" and notably the
Beyond QHSE, it is all the feedback, the requests
CITAL services that have joined this engineering, the follow-up of ING files, the
monitoring of obsolescence, the validation
approach. Thanks to its ease of use
and its configuration options technical exemptions. The service
pushes, the BlueKanGo platform RH uses BlueKanGo for management
meets our expectations. It facilitates expense reports, leave,
greatly the management of a company overtime.

Guide SMQ - All rights reserved ) BlueKanGo 2020 18/20


The Financial service uses it for the to carry out of the validations
supplier payment tracking. It is electronics. In this context,
also the case of the Purchasing department for the BlueKanGo has also proven to be a
validation of purchase requests and the true facilitator for managers
supplier management. The IT department in managing their teams at
I use it for equipment management distance, through the possibilities of
and the helpdesk tickets. Finally the service collaborative work.
Maintenance manages customer quotes with
BlueKanGo and the Logistics service manage Another example, we passed the audit.
notably inter-site transport. Everyone monitoring of ISO 9001 v.2015 certification to
the services are therefore involved. distance and successfully. The audit team
was in their offices at home, our
managers from their home! It's
that's how we spent two
You have been rewarded audit days. All evidence has been
for this approach in 2019? provided to the listeners via sharing
screen: GED, KPI, audit results
interns, actions, RNC, Review of
CITAL indeed participated in the competition
direction... In the audit report, the
of the Algerian quality award organized team lead of the audit
every year by the ministry of
mentioned as a strength "the
the industry. The evaluators visited the
CITAL headquarters in Annaba. According to their
possibility of teleworking thanks to the
digitalisation
feedback, the use of a solution
like BlueKanGo for digitization
from our Management System of the
Quality (SMQ) made the difference by Your relation with the
report à others companies BlueKanGo teams?
participants. A beautiful recognition
!

As the solution administrator


The digitization of your QMS BlueKanGo at CITAL, I am
is it an asset during the period accompanied by a Hotline team and
COVID? dynamic support. In case of issues with
settings, my open tickets are
dealt with in a timely manner. In
Yes, during the lockdown period. plus, every month we benefit from
due to COVID-19 and the obligation to updates of this software with
teleworking, the use of BlueKanGo news features who me
avoided us a situation of blockage or allowing them to be exploited for
of activity delays. Indeed, the circuits satisfy the needs of the users.
of purchase or HR validation were
operational. We had the opportunity

Guide SMQ - All rights reserved ) BlueKanGo 2020 19 out of 20


A PROPOS
1 only solution FOR MANAGER
ALL YOUR PROCESSES Quality, HSE

and Strategic

BlueKanGo sustainably improves your operational performance on the ground


up to management in service of its strategy. The solution transforms
digitally your Quality and HSE processes and replaces all your supports
office automation in a single tool. The only no-code web and mobile solution
fully customizable and secure with a simple and intuitive design,

More than 3500 clients worldwide in numerous sectors

SMQ Guide - All rights reserved) BlueKanGo 2020 20/20

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