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CONTENTS UNIT
1. INTRODUCTION TO QUALITY MANAGEMENT UNIT
8.EVIDENCE BASED DECISION MAKING UNIT
9. RELATIONSHIP MANAGEMENT |
UNIT 6. PROCESS APPROACH
Part A One of the most important aspects of the
year 2000 revisions of ISO 9001 and ISO 9004 was the adoption of the process
approach to quality management systems (QMSs). A strong consensus for
adopting the process approach formed very early in the revision cycle. This approach improves on that of the
previous standard by providing a much more generic structure readily
applicable to all sectors of the economy and sizes of organization. At the
same time, it allows the requirements to be stated in language more familiar
to line managers and less encumbered by quality jargon. ISO
9001:2000 focuses on improving the effectiveness of a QMS to enhance customer
satisfaction by meeting customer requirements, while ISO 9004:2000 focuses on
improving the effectiveness and efficiency of a QMS to enhance interested
party satisfaction by meeting interested party requirements. The common
structure of the two standards is demonstrated in Figure 1. The process approach is one of the eight
quality management principles upon which the entire ISO 9000 series of
standards is based. This principle says a desired result is achieved more
efficiently when activities and related resources are managed as a process. The word «process» is defined in ISO
9000:2000 clause 3.4.1 as «a set of interrelated or interacting activities
that transforms inputs into outputs». Inputs to a process are generally
outputs of other processes. Processes in an organization are generally
planned and carried out under controlled conditions to add value. From the principle and process definition
you can see the process approach is a powerful way of organizing and managing
how work activities create value. While a more traditional structure
organizes and manages work activities vertically by function, with quality
problems frequently occurring at the boundaries of the functional departments,
the process approach organizes and manages work horizontally the way work
activities create customer value. The
process approach directly links process inputs that come from suppliers to
the outputs of the process that go to customers. This horizontal linkage
between suppliers and customers is an excellent way to manage and continually
improve both the effectiveness (the amount of value created for the
customers) and the efficiency of the process (the amount of resources
consumed). Once the processes needed for the QMS and
their sequences and interactions have been identified (see Figure 1), it is
necessary to establish management responsibilities and accountabilities for
the performance of these processes. Many methodologies are available for
managing and improving processes, but all share some simple basic elements. A
simple process management and improvement methodology organized in a series
of steps is described in the following: Step
one: Establish the responsibilities for managing the process. It is critical
to have an overall process manager or process owner with end to end
responsibility and accountability for all aspects of process performance. The
process manager needs to understand the entire process and have the authority
to effect changes in any part of it. The process manager is responsible for the
following: Forming the process management team, which includes representatives from each major part of the
process. Ensuring the process operates in a
controlled state of predictable performance. Establishing process performance measures
that adequately characterize the efficiency and effectiveness of the process
in meeting the needs of all customers and other interested parties. Ensuring all aspects of process management
and improvement are performed. This includes creating documentation, tracking
performance, and securing and allocating resources. Step two: Define the process. The process
manager and process management team need to carefully define the process so
everyone working within the process has a shared understanding of how it
operates. How much documentation is required depends on such attributes as
the stability and education of the workforce and the complexity and
criticality of the process. All process inputs and outputs are
identified, along with the suppliers and customers, who may be internal or
external. The team also identifies process steps and flows. Many quality
tools, such as block diagrams and flowcharts, are available to support these
activities. Step three: Identify customer requirements.
Carefully gather, analyze and document customer needs, including how
customers use the outputs of the process. Communicate frequently with
customers to understand needs from their viewpoint. To the extent possible, define measurable
customer needs and rank them in order of importance. Directly validate needs
and requirements with customers. Step four: Establish measures of process
performance. Translate customer needs and requirements into measures of
process performance. This is one of the most important and difficult steps in
process management. Include customer satisfaction, in-process
measures and measures of supplier performance in process measures. Relate all
important customer needs, such as on time performance, defect or error rates,
tolerance intervals, product reusability, and worker health and safety, to
performance measures. The process approach is therefore one of the
strongest approaches for integrating management system standards because each
process must be managed and improved simultaneously for all process
performance measures. Directly linking process performance measures with
customer needs is one of the most powerful aspects of process management. Step five: Compare process performance with
customer requirements. Use the process performance measures to ensure your
process is operating in a stable and predictable manner. Compare the process performance measures
with the needs and requirements of the customers. Use a variety of
statistical tools for analyzing process measurement data to help quantify
process performance. Identify critical process improvement opportunities
through gaps in process performance. These first five steps provide a basic
methodology for process management. But the responsibilities of the process
manager and process management team do not end there. A significant benefit
of process management is its natural fit with process improvement. Once
process performance has been compared with customer requirements, process
improvement is the natural next step. Step six: Identify process improvement
opportunities. Use gaps in process performance vs. customer needs to
determine critical process improvement opportunities. Analyze process
performance measures for improvement opportunities related to sources of such
attributes as errors and defects, process simplification opportunities,
process bottlenecks and lack of adequate process controls. Both process effectiveness and efficiency
can improve as a result of process improvement activities. Many tools exist
to identify process improvement opportunities. Once process improvement opportunities are
identified, any of the many quality improvement methods can be used to
improve process performance. These quality improvement methods fit naturally
into step seven of the process management and improvement methodology. One quality improvement method that can be
used at this step is the plan, do, check, act (PDCA) cycle. Step
seven: Improve process performance. Select the process improvement
opportunity to pursue. This selection should take into account such
attributes as the criticality of certain improvement needs, difficulty of
improvement opportunities, and resources and expertise available. Establish quality improvement teams to
pursue specific improvement opportunities. These teams are established by the
process manager and process management team. The quality improvement teams
report to the process manager or the process management team and are
typically disbanded once their improvement project is completed. The quality improvement teams complete the
following activities: Clarify the improvement opportunity problem
statement, schedule and budget. Determine the root causes of problems. Develop and implement countermeasures to
reduce or eliminate the occurrence of root causes. Stabilize the process at the new level of
performance. Return to step six or seven. The process approach is an important part of
the system approach to management. The process approach assumes understanding
and managing interrelated processes as a system can contribute to an
organization's effectiveness and efficiency in achieving objectives. Using the process approach, a QMS is
comprised of the following four categories of interrelated processes: ·
management
responsibility; ·
resource
management; ·
product
realization; ·
measurement,
analysis and improvement. Each process can be managed and improved
using process management and improvement methodology, but managing the
interrelated processes as a system introduces additional improvement
opportunities. First, processes can be analyzed and
improved together as mega-processes, increasing the opportunities for
improvement. But you can also directly pursue improvement of the entire QMS
using audit and self-assessment (using 9004:2000 or quality award criteria)
results and the PDCA cycle. The multiple levels at which continual
improvement occurs make QMSs based on the process
approach a powerful way to manage organizations toward achieving performance
excellence. EXERCISES 1. Sum up the main ides of the text and retell
it in Russian. 2. Read and translate the following word
combinations from English into Russian.
All 1)_________ use
processes to achieve their objectives. «A process: set of interrelated or
interacting activities that use inputs to 2)_________ an intended result NOTE: Inputs and outputs may be tangible
(e.g. materials, components or equipment) or 3)_________
(e.g. data, information or knowledge)». The process approach is the foundation upon
which your QMS must be developed.The ISO 9001
Standard 4)_________ the adoption of a process
approach when developing, implementing and improving the effectiveness of a
quality management system, to 5)_________ customer satisfaction by meeting
customer requirements.ISO 9001:2008 promoted the adoption of a process
approach when developing, implementing and improving the 6)_________ of a
quality management system. ISO 900:2015 makes this more explicit (in 4.4) by
expanding the requirements around QMS Processes – specifying requirements
considered 7)_________ to the adoption of a process
approach. For example, determining the inputs required and outputs 8)_________ from these processes , then after determining
the-risks and opportunities and plans to address these in 6.1 – integrate
these into its QMS processes, related performance indicators, assignment of
responsibilities and authorities for these processes . For
an organization to function effectively, it has to identify and manage
numerous linked activities. Any activity, using resources and managed in
order to enable the transformation of 9)_________
into outputs, can be considered a 10)_________. Often the output from one
process directly forms the input to the next. The 11)_________
of a system of processes within an organization, together with the
identification and interactions of these processes, and their management, can
be referred to as the «process approach». An advantage of the process approach is the
ongoing control that it provides over the linkage between the 12)_________ processes within the system of processes, as
well as over their combination and interaction. When
used within a quality management system, such an approach emphasizes the
importance of: ·
An
understanding of the intended results and requirements ·
Consideration
of 13)_________ in terms of adding Value and effective performance ·
Improvement
of processes based on evaluation of data and 14)_________ ·
Consistent
and predictable results ·
Meeting
requirements and customer satisfaction ·
Activity
understanding and 15)_________ of interrelated processes 3. Read the following article and make a rendering
of it in English. Описание алгоритма работы Клиент оставляет на сайте заявку, которая появляется на портале в виде
нового вида. О появившемся лиде сразу сообщается
сотруднику, который принимает решение о назначении ответственного за его
обслуживание . Он должен зайти на сайт и назначить
того, кто будет работать с данным лидом в
дальнейшем, а так же поставить соответствующую задачу, содержащую крайние
сроки и комментарии. Ответственный пользователь (далее ОП по тексту) получает уведомление о
том, что нужно связаться с клиентом и получить у него дополнительные сведения
относительно его заявки. Обязательным условием продолжения работы является
назначение даты повторного звонка, чтобы уточнить, готов ли клиент заключить
сделку. По повторному звонку принимается решение о дальнейшем обслуживании лида: •Если клиент готов сделать заказ, то создается новая сделка, в которую
заносятся данные из лида. •Если клиент еще не принял решения о продолжении сотрудничества, то ОП
должен договориться о дате следующего звонка. •Если клиент отказывается заключать сделку, то ОП должен выяснить
почему. Возможны следующие причины отказа: ◾Сделка физически невозможна – ОП
указывает причину. Процесс заканчивается. Клиент хочет закупаться у поставщиков – ОП уведомляет
сотрудника-оптовика о том, что тому нужно связаться с клиентом и договориться
о поставках. Сам оптовик теперь становится ответственным. Важным является то,
что сотрудник-оптовик после звонка должен сразу выяснить: будет клиент
осуществлять закупку или нет. Клиента не устраивает цена – ОП уведомляет главу отдела продаж об этом.
Глава отдела продаж принимает решение о том, какие скидки и бонусы можно
предоставить клиенту. В зависимости от этого отсылается один из пяти
содержащих скидки прайс-листов, назначается дата нового звонка. Если не один
из прайсов не подошел клиенту, то с ним должен
связаться сотрудник-оптовик. Клиент не идет на контакт – необъяснимая невозможность договориться
(личная несовместимость, конфликтная ситуация) или связаться с клиентом. В
данном случае ОП уведомляет назначающего сотрудника о том, что нужно сменить
ответственного. Другое – причина указывается в комментарии. Данную задачу будет удобно разделить на несколько основных этапов,
каждый из которых будет рассмотрен отдельно. Part B Quality and performance are the aims of
process management. In this lesson, you'll learn about process management and
some of its key concepts. You'll also have a chance to take a short quiz
after the lesson. Process management is an approach to
management that views the activities of an organization as a set of processes
undertaken to advance organizational goals. A manager using this technique
attempts to design organizational processes – activities – that emphasize
quality and performance. Let» start with defining what a process is.
A process is basically a set of actions that you take in a set order to
accomplish a goal. All business activities can be viewed as a process under
this definition. For example, let's say you operate a bakery. Baking a cake
is a process. You should also note that while there are
many different ways to do something, some ways are better than others. If
we're baking a cake, it's often better to add all the dry ingredients
together in one mixing bowl, and then mix all the wet ingredients in another
bowl. You then combine the mixed dry ingredients and mixed wet ingredients
together in one bowl and mix them all together to make the batter. This is
the optimal process for making cake batter. However, you can certainly mix
all the ingredients in one bowl and the process will still work and you will
have a cake. On the other hand, sometimes a process is too flawed to work,
such as baking the wet and dry ingredients of our cake in different pans. Processes are typically documented so that
there is consistency in application. Documenting a process is simply
explaining the process in writing or some other medium, such as a video
demonstrating the process. A simple example of process documentation is a
recipe in a recipe book. Managers continually monitor the process and
its outputs. They will then measure the process and outputs against a
predetermined standard called a benchmark. You want to make sure that the
process is producing up to the organizational standards. For example, a box
of cereal produced by a company should contain 12.5 ounces of product, which
is the baseline established by the company. Every box of cereal that comes
off the production line should contain 12.5 ounces of product if the process
is working correctly. Process management seeks to continuously
improve organizational processes through process analysis, which is where you
break down a process into its distinct steps and the related inputs and outs
of each step to see if any changes in the steps can lead to improvements in
the process. Turning to our bakery example, we need to
analyze our cake batter process to see if it is truly optimal, and if it is
not, what we can do to improve it. We first take a look at the recipe to
break the process down into component steps. We then can use different tools
to measure the process and its output. We may check the consistency of the
batter, the temperature of the batter, the mixing and baking time required
and the moistness of the cake produced by the batter. If we can improve the process, we modify it
to enhance performance and quality. This process may be undertaken in a
scientific manner with precise measurements, tests, and computer models to
test efficiencies. On the other hand, we may just use trial and error. Returning to our cake example, perhaps we
should melt our butter before mixing it with the other ingredients, and sift
our flour and other dry ingredients before mixing them with the wet
ingredients. We may also test to see if hand mixing or electric mixing
produces a better batter. We may also experiment with ingredients of
different quality and costs to make the batter. We will bake cakes with these
alternative processes and compare them against our original cake, which is
our current baseline. The goal is to improve the process. If we have done our
work right, we may have improved the performance of our cake production as
well as the quality of our cakes. Now, let's take this a step further and get
a bit more technical. An organization can be viewed as a group of processes
working within a hierarchy that produces goods and services. You can think of
all organizational functions, such as engineering design, production,
marketing, sales, and distribution, as processes that are undertaken to serve
the organization's goals, such as serving the needs and requirements of its
clients or customers. In other words, a process from an organizational
standpoint is the steps an organization and its
members take that transforms inputs such as the work of employees and the use
of materials and machines into outputs such as products and services. EXERCISES 1.
Sum up the main ides of the text
and retell it in Russian. 2. Read and translate the following word
combinations from English into Russian.
Since the 1)_________
of ISO 9001 in 2000, the process approach has been a very important principle
behind the way a Quality Management System (QMS) functions. Using this
approach, a company is tasked to 2)_________ the
processes within the QMS, 3)_________ how the processes function, and also
identify how these individual processes interact with each other. By properly
4)_________ the processes, and the expected results,
it is easier to monitor and control how the processes are functioning. Additionally, by focusing on the processes,
it is easier for your organization to work on 5)_________
improvement. By breaking the overall QMS down into smaller processes, it is
much easier to identify areas for improvement, assess the risk of
implementing changes, and 6)_________ that the
changes have resulted in improvements to the process. Because improvement is
also one of the quality management 7)_________, and
one of the main reasons to implement a QMS, this is an important aspect of
implementing the process 8)_________. For more information about the seven quality
management principles behind ISO 9001, see Seven Quality Management
Principles behind ISO 9001 requirements. Start by walking through your QMS process
for creating and delivering your product or service from the 9)_________ (e.g., marketing or sales) and go through until
the end (e.g., delivery or after delivery service). What are all of the
sub-processes that are 10)_________ to get from the
beginning to the end? After these sub-processes are identified, make sure you
also identify the supporting processes that allow this to happen (e.g.,
document and record control processes). Next, look at each of these smaller
processes as a standalone entity so that you can identify the inputs, what is
11)_________, who does it, how it is done, the
results expected, and the process outputs. One tool for this is the «turtle
diagram» pictured below, which is one way of thinking about how a 12)_________ is structured. This is not the only process
tool available, but it is commonly used and easily understood. It is also a
good idea to have a process owner who understands the process and is 13)_________ for the process outcomes. When you have identified the process, you
can then gain the benefits of control, 14)_________,
and improvement for each process as mentioned above. In this way, the process
owner can tell if the process is 15)_________
properly, and if any changes made have resulted in improvements. 3. Read the following article and make a rendering
of it in English. Бизнес-процесс – это регулярно повторяющаяся последовательность
взаимосвязанных мероприятий (операций, процедур, действий), при выполнении
которых используются ресурсы внешней среды, создается ценность для
потребителя и выдается ему результат. У бизнес-процесса должен быть единый
менеджер, который управляет процессом и отвечает за его результат. В
деятельности любой компании можно насчитать как минимум несколько десятков
бизнес-процессов. Чтобы их как-то структурировать и выделять конкретный
процесс из общей массы, вводят определенные классификации. Бизнес-процесс – это регулярно повторяющаяся последовательность
взаимосвязанных мероприятий (операций, процедур, действий), при выполнении
которых используются ресурсы внешней среды, создается ценность для потребителя
и выдается ему результат. Потребитель может быть как внешним, так и внутренним по отношению к
организации. Внешний потребитель – это потребитель, который не входит в
состав данной организации, а внутренний – тот потребитель, который находится
в рамках данной организации. Важно знать потребителя бизнес-процесса потому, что именно он явным или
неявным образом задает требования к процессу и может оказывать влияние даже
на сам факт существования конкретного процесса. Если мы рассматриваем в качестве примера предприятие, производящее
шины, то производство шин – это бизнес-процесс, причем основной для данного
предприятия. Почему? Производство шин (как процесс) включает в себя множество
взаимоувязанных операций, потребляет определенные ресурсы (сырье и материалы,
электроэнергию, труд персонала и т. п.) и выдает определенный результат
потребителю – готовую шину. Потребителем для этого процесса будет одна или
несколько оптовых торговых фирм, которые организуют распределение товара до
конечных потребителей. Другой пример бизнес-процесса – закупка сырья для производства тех же
шин. Такой процесс также соответствует данному выше определению, но
потребитель конечного результата процесса будет внутренним – это
производственные цеха предприятия, в которых готовят резиновую смесь, обрезинивают металлокорд и т.
д. Результат бизнес-процесса – это самая наиболее важная его составляющая.
Деятельности без результата не бывает; иначе это не деятельность, а
бесцельное времяпрепровождение. Без достижения результата (причем с требуемыми
потребителю характеристиками) деятельность бессмысленна. А от того, как
процесс выстроен, зависят в том числе и издержки
этого процесса. У бизнес-процесса должен быть единый менеджер, который управляет
процессом и отвечает за его результат. На практике часто бывает (это
характерно для крупных компаний), что у бизнес-процесса есть так называемые владелец и менеджер процесса. Обе эти фигуры
отвечают за результаты, но при этом владелец процесса обладает полномочиями
изменять сам порядок выполнения процесса, а менеджер процесса осуществляет
оперативное управление. Чтобы это было более понятно, эти различия
проиллюстрируем на примере. Part C The major point of the process approach is
that the output of one process almost always affects another. If one creates
a set of quality procedures using a limited point of view, it can result in
an incomplete quality system that does not adequately control the
interactions across an entire organization. This in turn results in
unnecessary hurdles for staff members to cope with before they can complete
their work. Yet the most destructive consequence is the
perception by staff members that the quality system works against them and
does not support the efficient completion of their project leading to a
high-quality device. Accurate perception and acceptance of your quality
system is vital to the quality of work your organization produces. Think about the process approach in terms of
added value to your organization. Added value may take the form of knowing
that methodologies and conditions in which a product or service is rendered
are controlled and consistent. Therefore the result will be predictable and
consistent. Added value may mean doing the work right the first time or doing
it more efficiently, thus resulting in cost savings. Added value may also
come from documenting the appropriate information and collecting only the
data that will affect your organization. A measurement without an
understanding of what you might do when that measurement
changes is probably not very meaningful. Justifications of quality systems based on
such statements as «the auditor likes it that way» or «ISO/FDA says to do it
this way» are strong clues that the added value is not recognized.
Furthermore, if team members do not understand the reasoning behind a
requirement, they may apply it inappropriately or not at all. Communicating
the reasons why quality processes add value to development and manufacturing
is essential to the daily practice of such processes. Understanding the effects of a process on
the entire organization, and not just one specific area, is a key to
successful implementation. Often a new quality process will be conceived as a
direct result of another process being put in place. Allowing processes to
interact within a quality management system is crucial to smooth
implementation. This is why the design of quality system processes must be
specific to each company's goals. For this reason, generic systems are
usually inadequate. Just as design controls require cross-functional groups
to come together to discuss the development of a product, so can the creation
and modification of your quality processes by cross-functional groups lead to
a better quality system. To better understand the impact of the
process approach, it helps to consider how it might apply to a specific
business process. Let's look at the process of handling customer feedback and
complaints. This process is common to all companies in the medical device
industry, yet, depending on the business, type of customer, and product, it
may be handled in very different ways. The first step in developing this process is
to answer the question, «What regulatory, quality, or business requirements
are involved in this process?». There are several
regulatory requirements and voluntary quality standard requirements that
directly affect complaint handling. At a minimum, a medical device company
must consider title 21, part 820.198 of the Code of Federal Regulations
(CFR), «Complaint Files», and 21 CFR 803 or 804, «Medical Device Reporting». If the company is distributing products in
the European Union, it must also consider the vigilance reporting
requirements under the Medical Devices Directive. Additional requirements may
also be placed on this process when the distribution expands to other
countries such as Canada or Japan. From a quality-requirements standpoint,
both ISO 9001 and ISO 13485 address this process. All of these requirements
help to define the basic framework of the customer feedback process. To create an effective quality process, one
must apply this framework to the company's particular business environment.
Begin by asking the question, «What other processes interact with this
process?». In other words, what processes provide
input to or receive output from this process? Who are the stakeholders in
this process? In this example, there may be a large number
of interactions. Figure 1 shows potential sources of input for a customer
feedback process. The number of inputs for an individual company will depend
on the size of the organization, the type of product or service, the customer
using the product, and the distribution of the product. Although several
processes may submit input to the process, the type of input is most likely
the same – a customer complaint. Defining input sources will identify one of
the three groups of stakeholders – in this case, customers – who should be
involved in creating the process. For the process to be effective, this group
needs to believe it will work. If they feel the method for submitting
complaints is cumbersome, complicated, or inefficient, or that it somehow
doesn't meet their needs, they won't participate in the process. The price a
company pays is high: it will not capture all of its customer complaints and
will thereby miss golden opportunities to improve its reputation. The second group of
stakeholders needed for the creation of this process are those who
receive outputs from the customer feedback process. The outputs from a customer feedback process
may differ greatly, depending on which process receives them. Outputs could
include the results of a complaint investigation, copies of all communication
with the customer concerning the situation, a design change request, changes
to customer training, trend analyses, or a letter of response from the
company to the customer. If the information received from the process
does not meet the needs of this second group of stakeholders, one of two
things may happen. They will either ignore the information, or they will
repeat work that was already completed. In this example, this means the
handling of the complaint is ineffective. It will most likely result in
additional complaints in the future, repeated investigations conducted by
each department that hears about a complaint, and an inefficient use of
company resources. The final group of stakeholders involved in
creating a process should be the individuals that actually execute the
process. For them to do their job effectively, they need to make sure the
inputs they receive are adequate. And for their outputs to be valuable, they
must also understand the needs of those who will use the information. Stakeholders from all three areas are needed
to create or modify effective methods for executing the process. In the
customer feedback process, there are many methods from which to choose.
Should the system be paper-based or electronic? Should a special committee be
established to review all complaints? Who decides whether a complaint should
be investigated? The answers that result will depend on the individual needs
of the company. After looking at inputs and outputs from the
process, the next question is, «What measurements will be used to evaluate
whether this process is functioning properly?». The
key is providing information to management so they can provide appropriate
resources to the process to maintain its effectiveness and to improve it. In
this example, two measurements that may be useful include the number of days
required to complete the investigation of a complaint and the percentage of complaints
received with insufficient information. It should be noted that these metrics are
different from the outputs created by the process. They are meant to evaluate
how the process is working, not the data received by the process (e.g., the
number of complaints received for an individual product line). From these
metrics, management can determine whether additional staff
are needed to process complaints, what type of personnel are needed,
whether additional tools are needed, or whether a change in the process is
required. One pitfall many companies encounter is the
creation of metrics for the sake of metrics, i.e., recording data that will
not lead to change, regardless of what they show. These types of metrics are
time-consuming to create and review, and generally lead to frustration and
disillusionment of the staff. Ultimately, such metrics are a waste of company
resources. An example could be the number of complaints received per day. Once the process has been defined and
metrics put in place, the final question to ask is, «What do the stakeholders
think of the process?». This is a question that
needs to be asked on a periodic basis. It ultimately indicates whether the
right process was created. As a company changes, whether by adding new
product lines or services, expanding distribution, or acquiring new assets,
asking this question helps ensure that the system is still effective. When a
product does not meet user needs, consumers do not buy it or use it; in the
same way, when a process does not meet user needs, it will be unsuccessful
and unused. The concept of a process approach is not
another hurdle that is meant to impede a company's progress. Rather, it is a
change in emphasis that, if applied appropriately, can lead to added value
within an organization. Every company must create a system that
meets its needs. The processes of one company may or may not match the
processes of another. As your firm competes in a tough marketplace, ISO's new
process approach to quality management can help integrate your business
systems and procedures to work toward a common goal – ensuring business
growth and maintaining an effective quality system. EXERCISES 1. Sum up the main ides of the text and retell
it in Russian. 2. Read and translate the following word combinations
from English into Russian.
Even when change is 1)________,
most of us would rather run the other way when we see it coming. This is
simply human nature, especially when a 2)________
seems to be working satisfactorily. But the reality is that consistent
improvement in quality demands change. So it is with ISO 3)________,
which are reviewed every five years to make sure they meet the current
standards and needs of the global community. Revisions inevitably affect each
of our 4)________ quality systems, and adapting to
change and coming up to speed quickly can determine success or 5)________ in
a highly competitive environment. The 1994 edition of the ISO 9001 standard
included 20 elements, among them contract review, design 6)________,
and statistical techniques. But with the release of ISO 9001:2000, those 20 7)________ have been incorporated into a process approach.
The intent of this change is to move users toward process-based methods of 8)________ management. Consequently, ISO 9001:2000 and the
upcoming release of ISO 13485 (specific to medical devices) are causing
companies to reevaluate their quality systems. Is this new emphasis on process a matter of
semantics, or is there something more substantial behind it? Although the
process approach may be unsettling at first glance for some, those 9)________ with quality management will see in it such familiar
concepts as the quality management system, management responsibility,
resource management, 10)________ realization, measurement, analysis, and
improvement. Defining metrics and 11)________
of assessment specific to an organization is critical to the development of a
successful product. This ISO revision will cause companies to think through
the life 12)________ of a device in terms of
smaller, interrelated processes that contain the 20 elements of ISO 9001. But
more importantly, this 13)________ will keep the
focus on how the quality of one process affects the quality of the next. 3. Read the following article and make a rendering
of it in English. Существующая практика построения систем управления включает в себя
несколько подходов к организации систем управления. Наиболее известны из них
системы, построенные на управлении функциями и управлении бизнес-процессами
организации. Бизнес-процесс – последовательность действий (подпроцессов),
направленная на получение заданного результата, ценного для организации. Системы управления, построенные на принципах управления функциями,
представляют собой иерархическую пирамидальную структуру подразделений,
сгруппированных по выполняемым функциям. Под функциональным подразделением
можно понимать группу экспертов в данной функциональной области. В
организациях, построенных по данному принципу, управление осуществляется на
административно-командных принципах.
Другим подходом построения систем управления является управление потоками
работ или процессами, составляющими деятельность предприятия. Процессное
подразделение включает в себя координатора – владельца процесса и
исполнителей из различных функциональных областей, сгруппированных по
принципу единства результата бизнес-процесса. Подобные системы часто называют
«горизонтальные», подразумевая под «вертикальным» управлением иерархию
функциональных подразделений и руководителей в стандартной системе
управления, построенной по функциональному принципу. Понятие бизнес-процесс лежит в основе процессного подхода к анализу и
синтезу деятельности организации. Процессный подход позволяет рассматривать
деятельность организации как связанную систему бизнес-процессов, каждый из
которых протекает во взаимосвязи с другими бизнес-процессами или внешней
средой. В настоящий момент применение процессного подхода является
обязательным условием для построения Системы менеджмента качества в
соответствии с требованиями стандарта ISO 9001. Практика показывает, что
система управления, построенная на принципах процессного управления, является
более эффективной и результативной по сравнению с равной ей по масштабу
функциональной системой. Вместе с тем, разработка и внедрение такой системы –
сложный процесс. Ключевыми понятиями процессного подхода являются: Результат бизнес-процесса – то, ради чего осуществляется
бизнес-процесс, т.е. деятельность всегда рассматривается вместе с целью этой
деятельности – получение на выходе некоторого результата, удовлетворяющего
заданным требованиям. Результаты бизнес-процесса часто упоминаются как выходы
бизнес-процесса. Владелец бизнес-процесса – должностное лицо, несущее ответственность за
получение результата процесса и обладающее полномочиями для распоряжения
ресурсами, необходимыми для выполнения процесса. Часто приходится наблюдать
чисто формальные результаты внедрения процессного подхода – владелец
бизнес-процесса назначается практически произвольно, ему не дают реальных
полномочий, например, по распоряжению персоналом, необходимым для
осуществления процесса. В этом случае говорить о какой-либо ответственности
Владельца бизнес-процесса за получение результата не приходится, и само
получение необходимого результата оказывается под угрозой. Исполнители бизнес-процесса – команда специалистов из различных
функциональных областей (кросс-функциональная
команда), выполняющих действия процесса. Исполнители процесса в большей
степени ориентированы на результат, чем исполнители отдельных функций при
функциональном подходе, так как основой мотивационной схемы при процессном
управлении является распределение бонусов среди членов команды только при
получении конечного результата. При функциональном подходе исполнители
мотивируются только за исполнение функций и не заинтересованы в получении
конечного результата. Входы бизнес-процесса – ресурсы (материальные, информационные),
необходимые для выполнения и получения результата процесса, которые
потребляются или преобразовываются при выполнении процесса. Основным вопросом, который встает перед разработчиком модели является
принцип выделения бизнес-процессов. Исходя из определения, принцип выделения
процессов один – это результат. При выделении бизнес-процессов необходимо
следить, чтобы на одном уровне модели присутствовали одноуровневые результаты
деятельности, а следовательно, и процессы. |