Abordagem de processos

 Pretesh Biswas  Uncategorized  9 de maio de 2019 14 minutos

por Pretesh Biswas

Introdução
Todas as organizações utilizam processos para alcançar seus
objetivos. De acordo com a definição
iso "Um processo: o conjunto de atividades
interrelacionadas ou interativas que usam entradas para
entregar um resultado
pretendido NOTA: Entradas e saídas podem ser tangíveis
(por exemplo, materiais, componentes ou
equipamentos) ou intangíveis (por exemplo, dados,
informações ou conhecimentos)."
A abordagem do processo é a base sobre a qual seu QMS deve ser
desenvolvido. A Norma ISO 9001 promove a adoção de uma
abordagem de processo no desenvolvimento, implementação e
melhoria da eficácia de um sistema de gestão da qualidade, para
aumentar a satisfação do cliente, atendendo às necessidades dos
clientes. A ISO 9001:2008 promoveu a adoção de uma abordagem
de processo no desenvolvimento, implementação e melhoria da
eficácia de um sistema de gestão da qualidade. A ISO 900:2015
torna isso mais explícito (em 4.4) ampliando os requisitos em
torno dos Processos QMS – especificando requisitos considerados
essenciais para a adoção de uma abordagem de processo. Por
exemplo, determinar os insumos necessários e as saídas esperadas
a partir desses processos , depois de determinar os riscos e
oportunidades e planos para enfrentá-los em 6.1 - integrá-los em
seus processos QMS (4.1.f – planejar e implementar ações),
indicadores de desempenho relacionados (4.4.1c.), atribuição de
responsabilidades e autoridades para esses processos (4.4.1 e).
Para que uma organização funcione efetivamente, ela tem que
identificar e gerenciar inúmeras atividades vinculadas. Qualquer
atividade, utilizando recursos e gerenciada para viabilizar a
transformação de entradas em saídas, pode ser considerada um
processo. Muitas vezes a saída de um processo forma diretamente
a entrada para a próxima. A aplicação de um sistema de processos
dentro de uma organização, juntamente com a identificação e
interações desses processos, e sua gestão, pode ser referida como a
"abordagem do processo".
Uma vantagem da abordagem do processo é o controle contínuo
que ele proporciona sobre a ligação entre os processos individuais
dentro do sistema de processos, bem como sobre sua combinação
e interação.
Quando utilizada dentro de um sistema de gestão da qualidade, tal
abordagem enfatiza a importância de:
 Um entendimento dos resultados e requisitos
pretendidos
 Consideração de processos em termos de agregação de
Valor e desempenho efetivo
 Melhoria de processos com base na avaliação de dados e
informações
 Resultados consistentes e previsíveis
 Atender aos requisitos e satisfação do cliente
 Compreensão e gestão de atividades de processos
interrelacionados
O modelo de um sistema de gestão da qualidade baseado em
processos mostrado na figura ilustra as vinculações de processo
apresentadas nas cláusulas 4 a 10. Esta ilustração mostra que as
exigências, as necessidades e as expectativas das partes
interessadas relevantes, juntamente com a organização e seu
contexto, desempenham um papel significativo na definição de
requisitos como insumos. A saída do processo é resultado do QMS
que inclui produto e serviço que a organização fornece, o que deve
resultar na satisfação do Cliente. O modelo mostrado em Figura
abrange todos os requisitos desta Norma, mas não mostra
processos em um nível detalhado.

Processo de compreensão :
Vamos entender alguns fundamentos sobre processos.
 Todo o trabalho geralmente envolve um processo – as
coisas entram (entradas); ser trabalhado (conversão) e
sair de forma diferente (saída). A atividade de conversão
de valor agregado dentro de um processo transforma
entradas em saídas, por exemplo, pega matérias-primas
(a entrada) e fabrica (a atividade de conversão de valor
agregado usando vários recursos) um produto (a saída).
 As entradas e saídas do processo podem ser tangíveis,
como matérias-primas ou produtos acabados ou
intangíveis como INFORMAÇÕES – por exemplo,
desenho ou especificação computadorizadas.
 Todos os processos possuem um fornecedor e um
cliente. Esses fornecedores e clientes podem ser
processos internos ou externos à sua organização. Cada
processo deve ter um titular responsável, ou seja, tendo
definido responsabilidade e autoridade para operar,
controlar e melhorar seu processo.
 Todos os processos exigem o uso de recursos, por
exemplo – pessoas, equipamentos, materiais, tecnologia,
etc. Esses recursos podem ser usados como insumos
(matérias-primas ou informações como uma
especificação do cliente) bem como para a atividade de
conversão de valor agregado (por exemplo, uso de
máquinas, equipamentos, computadores, tecnologia,
pessoas, etc.) para transformar matéria-prima (entrada)
em produto acabado (saída).
 All processes must meet customer, organizational and
applicable regulatory requirements. The performance of
all processes can be monitored and measured. Gather
performance data that can be analyzed to determine
process effectiveness and whether any corrective action
or improvement is needed.

As an example, the below process contains a set of activities that

are interrelated (showing links from/to), interacting (showing
inputs/ outputs), and the transformation of process inputs into
process outputs.
Schematic Representation of the elements of single
process
Procedures are typically used to control deviation where
risk/hazards are present. It is defined as a specified way to carry
out an activity or a process’, which may be a documented set of
instructions, or simply an established way of doing a specific task
that itself forms part of a larger process. In ISO 9001:2015 this
might be considered captured, in the main, by’the availability of
documented information that defines: the characteristics of the
products to be produced, the services to be provided, or the
activities to be performed. An organization’s QMS processes may
be grouped or categorized in many ways. One logical way would
include the following:
Customer Oriented Processes (COP’s):

These are product realization processes that determine customer

requirements (inputs), design, make, deliver and service product
(outputs) to customers and determine customer satisfaction.
These processes generally have the greatest degree of interaction
with external customers. COP’s includes marketing and sales,
design and development, production, shipping, packaging,
servicing/ warranty, customer satisfaction, etc., whether
performed onsite or off-site.

Support Oriented Processes (SOP’s) :

These processes provide the necessary resources to COP’s to

facilitate product realization. These processes generally have the
greatest degree of interaction at an operational level with COP’s
and to a lesser degree with other internal QMS processes. SOP’s
includes human resources, information technology, purchasing
and receiving, laboratory, maintenance, tooling, facility
management, etc, whether performed onsite or off-site.

Management Oriented Processes (MOP’s)

These processes provide the commitment, leadership, resources,

review, and decision-making by top management.  These
processes generally interact with all QMS processes at the QMS
planning and review level. MOP’s includes business planning,
management review, quality planning, resource planning,
communication, etc., whether performed offsite or on-site.

Quality Management Processes (QMP’s):

It includes all process which is used to document, measure,

analyze and improve all processes. These processes provide
quality management support to and interact with all QMS
processes. QMP’s includes document control, records control,
monitoring and measurement of processes and product, internal
audits, control of the nonconforming product, corrective and
preventive action, continual improvement, etc whether performed
onsite or off-site.

Outsourced Processes (OP’s):

An “outsourced process” is a process that the organization has
identified as being needed for its quality management system
(QMS), but one which it has chosen to be carried out by an
external party outside the managerial control of your facility and
not subject to your QMS. These could include MOP’s, COP’s or
SOP’s. They may be performed onsite or off-site. These processes
may include – strategic planning is done at head office;
purchasing or design done at head office or another location; heat
treating; painting; welding, calibration; testing; sort; HR; etc.,
done by an outside organization.

Implementing QMS using Process Approach

Your QMS is made up of a network of these value-adding
processes that link, combine and interact with one another to
collectively provide product or service. These processes are inter-
dependent and can be defined by complex interactions. For
example, any of the COP processes could interact with some or all
of the MOP’s, SOP’s, QMP’s. Also, note that resources (SOP’s) and
QMP’s may also be applied to all other processes.
Interactions between QMS processes may occur at any of the three
process stages (input, output or conversion activity). The
interaction may occur in many different ways – physical,
documentary, verbal, electronic, etc. For each process, we must
identify these interactions, assess the risks of problems that may
occur and implement appropriate controls to prevent them, e.g., if
orders are communicated verbally by sales personnel to
production, what is the risk that production errors will occur?
Therefore, in general, in order to plan and implement your QMS
using the ‘Process Approach’, you must:
 Identify the processes needed for the QMS.
 Determine their sequence and interaction(show the
sequence and interaction of your COP’s). There are many
ways to document this, e.g., a high-level flowchart or a
process map.
 Determine the application of QMS processes throughout
the organization (show how MOP’s; SOP’s and QMP’s
are applied to each COP and to each other). There are
many ways of documenting this. A popular way is
through graphical representation, e.g. process maps.
  Determine (plan) the criteria, methods, information,
controls, and resources needed for each QMS process.
 Identify the internal/external customer-required output.
 Describe the processing activity that produces the
output.
 Identify the resources needed for the processing activity.
 Identify the inputs for the process – information,
materials, supplies, etc.
 Define the process methods, procedures, forms, etc., that
may be needed to produce the output.
 Define the controls to prevent or eliminate the risk of
errors, omissions, or nonconformities in process activity.
controls may come from the IS standards; customer;
regulatory and your own organizational requirements
 Interaction with sources that provide the inputs (internal
processes or external supplier), uses the output (internal
processes or external customer), or provide the
resources (internal support process) to perform the
process activity.
 Implement your QMS according to your plan.
 Monitor, measure and improve each QMS process and
its interaction with other processes. Performance
indicators to monitor and measure process performance
may come from the IS standard, customer, regulatory
and your own organizational requirements. Performance
indicators may relate to the process output as well as the
process activity.
 Performance indicators for process output must focus on
meeting customer and regulatory requirements.
Performance indicators for process activity should focus
on measuring process effectiveness and efficiency.

It is useful to point out that while we do need to identify all QMS

processes and describe their interaction, not all identified QMS
processes need to be documented or documented in the detail
described above.

PLAN-DO-CHECK-ACT (PDCA)
In addition, the methodology known as “Plan-Do-Check-Act”
(PDCA) can be applied to all processes. PDCA can be briefly
described as follows.
Plan: Establish the objectives and processes necessary to deliver
results in accordance with customer requirements and the
organization’s policies.
Do: Implement the processes
Check: Monitor and check processes and product against
policies, objectives, and requirements for the product and report
the results
Act: Take actions to continually improve process performance

PLAN-DO-CHECK-ACT (PDCA) is a very effective tool for

business management and the ISO 9001 standard strongly
recommends its use.  PDCA is a dynamic cycle that can be applied
to each of the organization’s processes, and also to the system of
processes as a whole. It may be used to plan, implement, control
and continually improve both product realization and other QMS
processes.
Maintenance and continual improvement of QMS processes can
be achieved by applying PDCA to processes at all levels within the
organization right from the executive high-level strategic
processes, such as business planning or management review to
operational processes such as product realization or calibration.
PLAN :

For each QMS process you must establish:

 Process owner and his/her accountability.
 Process inputs, outputs, value adding or conversion
activities and sequence/interaction of these activities
(sub-processes) within the process. Many of the COP’s
and SOP’s may have sub-processes.
 Process policies, responsibilities and accountability.
 Process objectives and performance indicators and
methods to monitor and measure process performance
to these objectives and indicators.
 Resources such as facility, equipment, labor, materials,
time, etc needed.
 Preventive and detective controls needed for process
activity, input, output, and resources used.
  Process documentation such as procedures, forms, work
instructions, specification, etc.
 The nature, method, frequency, and timing of interaction
with other processes and where this interaction will
occur – input, output, use of resources, conversion
activity, etc.
 You must pay a lot of attention to this stage of your QMS
development. Planning must also consider how you will
meet customer, applicable regulatory, and your own
organizational requirements, in addition to ISO 9001
requirements.

DO:

Deploy and implement your QMS processes and manage and

control them according to your plan as documented above.

CHECK:

Monitor and measure the effectiveness of your QMS processes

against policies and objectives that you established under PLAN.
Monitoring and measuring activity may focus on any or all of a
process’s inputs; outputs; use of resources for conversion; and
interaction with other processes.

ACT:

Collect and analyze your monitoring and measurement

information and use it to determine the effectiveness of each
process as well as your overall QMS in meeting requirements. Use
the information to correct problems and continually improve
individual processes.

 CONTINUOUS IMPROVEMENT PROCESS MODEL

The above fig shows the macro level application of the PDCA
model to an entire organization. The organization’s QMS as
depicted by the processes within the circle is used to PLAN the
controls over all inputs, resources, value-adding activities and
outputs. We DO implement our plan by using various resources to
convert customer inputs (requirements) into outputs (product)
that meet customer requirements. We CHECK – by monitoring
and measuring QMS performance and through customer
feedback. We ACT  by using this information to continually
improve QMS effectiveness. At the micro level, this same model
can be applied to each QMS process.

The process approach in ISO 9001:2015

The process approach includes establishing the organization’s
processes to operate as an integrated and complete system.
 The management system integrates processes and
measures to meet objectives
  Processes define interrelated activities and checks, to
deliver intended outputs
 Detailed planning and controls can be defined and
documented as needed, depending on the organization’s
context.

These three concepts together form an integral part of the ISO

9001:2015 standard. Risks that may impact on objectives and
results must be addressed by the management system. Risk‐based
thinking is used throughout the process approach to:
 Decide how risk (positive or negative) is addressed in
establishing the processes to improve process outputs
and prevent undesirable results
 Define the extent of process planning and controls
needed (based on risk)
 improve the effectiveness of the quality management
system
 maintain and manage a system that inherently addresses
risk and meets objectives

PDCA  can be used to manage processes and systems.

 Plan: set the objectives of the system and processes to
deliver results (“What to do” and “how to do it”)
 Do: implement and control what was planned
 Check: monitor and measure processes and results
against policies, objectives and requirements and report
results
 Act: take actions to improve the performance of
processes

PDCA operates as a cycle of continual improvement, with risk‐

based thinking at each stage.
Steps in the process approach  What to do?  Guidance

Define the context of the The organization should Gather, analyze and det
organization identify its responsibilities, external and internal respons
the relevant interested of the organization to satis
Steps in the process approach  What to do?  Guidance

relevant requirements, need

parties and their relevant expectations of the relevant int
requirements, needs & parties. Monitor or comm
expectations to define the frequently with these int
organization’s intended parties to ensure co
purpose. understanding of their require
needs and expectations.

 The organization shall determ

scope, boundaries, and appli
 Based on the analysis of the
of its management system taki
requirements, needs and
consideration the internal and e
 Define the scope, objectives, expectations establish the
context and interested
and policies of the scope, objectives, and
requirements. Decide which m
organization policies that are relevant for
the organization should addres
the organization’s quality
management should then es
management system.
objectives and policies for the
outcomes.

 Management shall determin

Determine the processes
processes needed for achievi
needed to meet the
 Determine the processes in the intended outputs. These pr
objectives and policies and
organization include management, res
to produce the intended
operations, measurement, a
outputs.
and improvement.

 Determine the sequence of the  Determine how the  Define and describe the netwo
processes processes flow in sequence processes and their interaction.
and interaction. Consider the following:

 The inputs and out

each process (whic
be internal or extern
 Process interactio
interfaces on
processes depen
enable.
 Optimum effect
Steps in the process approach  What to do?  Guidance

and efficiency o
sequence.
 Risks to the effect
of process interactio

Note: As an example, rea

processes (such as those nee
provide the products or s
delivered to a customer) will
with other processes (such
management, measu
procurement in the provis
resources). Process sequence
their interactions may be dev
using tools such as mo
diagrams, matrices, and flowch

 Top Management should o

and define ownership, account
individual roles, responsi
working groups, remits, author
ensure the competence needed
effective definition, impleme
maintenance and improvem
 Define people who take
 Assign responsibility and each process and its interaction
process ownership and
authority for each process. individuals or remits are
accountability
referred to as the Process Own
manage process interactions it
useful to also establish a mana
system team that has a
overview across all the proces
may include representatives fr
interacting processes and funct

 Define the need for  Determine those processes
documented information that need to be formally
defined and how they are to
be documented.
 Processes exist within
organization. They may be for
informal. There is no catalogue
of processes that have to be fo
defined. The organization
determine which processes nee
documented on the basis of risk
thinking, including, for exampl
Steps in the process approach  What to do?  Guidance

 The size of
organization and i
of activities.
 The complexity
processes and
interactions.
 The criticality o
processes.
 The need for fo
accountability
performance.

Processes can be fo
documented using a numb
methods such as gr
representations, user stories, 
instructions, checklists, flow
visual media or electronic m
including graphics and system
However, the method o
technology chosen are not the
They can be used to d
processes, which are the me
achieve the goals. Effectiv
organized processes can then
consistent and accountable ope
and the desired objectives and
which can then be improved.

Define the  interfaces,  risks Determine the activities Define the required outputs and
and activities  within needed to achieve the of the p
the process intended outputs of the Determine the risks to conform
process and risks of products, services, and cu
unintended outputs. satisfaction if unintended outp
delivered.
Determine the activities, m
and inherent controls requir
transform the inputs into the
outputs. Determine and defi
sequence and interaction
the activities within the p
Steps in the process approach  What to do?  Guidance

Determine how each activity

performed.
Ensure that the management
as a whole takes account
material risks to the organizati
users.
Note: In some cases, the cu
may specify requirements not o
the outputs but also for the rea
of a process.

 Identify the validation neces

assure effectiveness and efficie
the processes and system. Ta
account such factors as:
 Monitoring and me
criteria.
 Determine where and how  Reviews of perform
monitoring and measuring
 Interested
should be applied. This
satisfaction.
 Define the monitoring should be both for control
and measurement and improvement of the  Supplier performan
requirements processes and the intended  On-time delivery a
process outputs. Determine times.
the need for recording
 Failure rates and wa
results.
 Process costs.
 Incident frequency.
 Other measures
conformity
requirements.

 The organization should p

activities, monitoring, measur
 Implement actions
controls of defined process
necessary to achieve
 Implement procedures
planned activities and
(which may be auto
results.
outsourcing and other m
necessary to achieve planned re

 Define the resources Determine the resources  Examples of resources include

 Steps in the process approach  What to do?  Guidance

 Human resources.
 Infrastructure.
 Environment.
needed for the effective  Information.
needed
operation of each process.  Natural resources
(including knowled
 Materials.
 Financial resources

A organização deve comparar

 Verifique o processo
contra seus objetivos
planejados
Confirme que o processo é
eficaz e que as
características dos processos
são consistentes com o
propósito da organização.
com objetivos para verificar s
os requisitos estão sati
Processos são necessários para
dados. Exemplos i
medição, monitoramento, re
auditorias e análise de desempe

Anterior- SETE PRINCÍPIOS DE GESTÃO DA QUALIDADE

CONFORME ISO 9001:2015

 Próximo- ANEXO SL

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