Developing a Business Process Approach to ISO 9000
by Rod Southard
Registration should not be the only goal when
becoming ISO 9000 compliant; it should be a
secondary benefit to developing an effective quality system.
Developing a quality system, such as ISO 9000, is one of the most important
processes an organization will undertake. This effort should produce the
framework to manage the various processes within the company for many years.
The processes must control the activities within the organization. This
control cannot be left up to the individuals within the organization to
manage as they deem necessary. Absent or inadequate business processes will
account for most nonconformances, therefore the quality system should be
developed to eliminate the opportunities for nonconformances and not rely
on personnel to catch problems and manage processes.
Some companies are forced into developing or restructuring their quality
system by their customer. In these cases, the company may focus more on
achieving registration by the required date rather than build an effective
quality system. The customer may require registration, but will this effort
also meet the company's business needs?
Registration should be a secondary benefit to developing an effective quality
system. The companies that are forced into pursuing ISO 9000 registration
may neglect the business process approach and take one of two approaches.
They may either Band-Aid their present quality system trying to meet the
ISO 9000 requirements (this is the normal approach taken by companies forced
into implementation and given an unrealistic completion date) or try to
develop a system based on the standard's 20 elements (standard approach).
The Band-Aid approach
The Band-Aid approach is very apparent among automotive suppliers. This
is due to the large quantity of audits conducted over the years at the suppliers'
sites by customers with different expectations for an acceptable quality
system. With the recent release of QS-9000, some of the expectations should
be more consistent. The auditee wants to appease the customer as quickly
as possible to maintain the business. Each time a customer auditor finds
a problem (this may or may not be a nonconformance, but if the auditor identifies
it as a deficiency, it must be a nonconformance), the system may be changed
or additions made to correct the immediate problem.
This type of knee-jerk response just to appease the auditor leaves the supplier
with a quality system that is so disjointed that over time it becomes very
difficult to audit because the system has no flow. The goal is to respond
to the customer in a timely manner. In most cases, the supplier doesn't
review the impact these changes will have on their quality system or if
the change will be beneficial to their overall goals and the customer's
goals.
The standard approach
Many companies whose main objective is to get registered use the standard
approach. They do not look upon this endeavor as an opportunity to develop
a quality system to manage the company. Rather, they see it as an exercise
in documentation forced on them by an overbearing and unsympathetic customer
who has unrealistic expectations of what type of system their company needs
in order to supply consistent quality on time, every time.
In their haste to get registered, some companies choose to buy a generic
quality manual and procedures or hire a consultant whose primary duty is
to get them registered. The generic quality system isn't developed around
their processes, but around the standards. It doesn't cover what they do
or how they perform their processes but forces them to comply in a way that
may be unrealistic and useless. The purchase of these generic manuals to
use as a guide for developing a quality system is the intent of most of
the people selling these products. The end users try to cut corners and
disregard the most important step in the registration process: developing
the quality system.
These approaches may eventually lead to registration, but they may do
little to help the company organize and run its business. These systems
will not grow and change with their business but will drag them down in
a paperwork pyramid. These two approaches lead to a great deal of the negative
press around the ISO 9000 and QS-9000 quality systems, and cause people
to see them as a paperwork exercise that does little for the organization.
The objective
Developing a quality system to run the company in an efficient manner should
be the goal; registration is a secondary benefit of this goal. If this is
not the objective within your organization, then you should take a step
back and determine why you are pursuing registration and how to benefit
from this exercise. When the customer requires compliance to ISO 9000, it
may be difficult to focus on developing the overall quality system as compared
to just meeting the requirements and getting the "sheepskin" to
put on the wall. Many automotive suppliers already meet many QS-9000 requirements.
The system may be documented in a disjointed manner due to Band-Aiding,
but the processes are in place. The existence of the processes will allow
the framework to be developed in a simple step-by-step process that isn't
too painful.
The first step is to determine where your system is compared to ISO 9000
requirements. A thorough self-assessment (gap analysis) by a qualified individual
or a second- or third-party assessment will show your company's place on
the journey to registration. Once this gap analysis is complete, you should
develop a detailed implementation plan with specific dates and assignment
of responsibilities. The specifics of the documentation development will
have to wait until the next step.
The business process approach
Documenting the organization's business processes (core and supporting)
that outline what they do to make money is an excellent place to start when
developing a quality system (see Figure 1). After determining which processes
exist, the next step is to put this down on paper. A flowchart is a good
format for documenting process flow.
Four to five key top-level people within the organization should develop
the business process. Each business process should be comparable in complexity,
and the flowchart should contain less than 25 boxes, if possible. When there
are more than 25 boxes for the core and supporting processes, the flowchart
may be at too low of a level. Once the team has documented the business
processes and top management has approved the document, a process owner
should be designated for each step of the business process.
Process owners are responsible for ensuring that the business process meets
its objective. Has a flowchart and procedure been developed that thoroughly
describes the process in an efficient manner? In larger companies, team
leaders may be appointed for the various procedures that form a part of
the business process element. In smaller companies, the process owner will
act as the team leader for all processes. The process owner will also resolve
any conflicts that may arise within the scope of the business processes.
Changes may be required to the core process to adequately portray what the
company does to make money and support the customer. The business process
will continue to adapt as the company grows and changes. The core and supporting
processes should be open to change. Finally, the process owner must coordinate
all activities with the ISO 9000 project coordinator to ensure continuity.
The coordinator and process owners should then develop a detailed timeline
for procedures showing key activities for developing each procedure. This
may include completion of the flowchart, draft procedure, procedure completion
and approval. These process owners and team leaders will then select interdepartmental
teams who will flowchart the processes as they are presently being performed,
down to the detail necessary to allow the work force to consistently follow
the process.
Flowcharting is an excellent method to visualize a process and detect nonvalue-adding
steps. The business process approach requires all departments within the
company (not just the quality department) to flowchart their processes and
then document them into procedures. This will help in the implementation
phase as ownership spreads across the entire organization. Some changes
to the processes may be required to ensure compliance to the standard, but
at the same time, changes can be made to the flowchart to optimize the processes
and eliminate nonvalue-adding steps. A representative from the process before
and after should participate on the team. This is key to ensuring that a
flow is maintained and that processes don't just abruptly begin and end.
These processes are then converted into procedures. With this approach,
the participants should be trained in flowcharting techniques and procedure
development. This will keep the procedure format and style consistent throughout
the organization. The procedure-writing process is simplified because the
flowchart has already documented the process and the procedure should follow
the chart step by step.
The business process approach easily adapts to change as the company evolves
because the system was designed around how the work is performed. During
management review, the quality system should be reviewed to determine if
it reflects how the organization still does business. This portion of the
review can simply take place by reviewing the core and supporting processes,
and determining if business should still be conducted this way.
Using the Band-Aid approach will only continue the process of repairing
the previously documented system and will not objectively look at the quality
system as a whole and determine the interrelationships that the standard
requires.
When using the standard approach, building the procedures around the standard
itself forces the company to change to conform to the standard. The standard
approach often is viewed as extra work. This is not the intent of those
spearheading the effort, but the perception of excess paperwork still remains.
When everyone is involved in documenting their own processes based on how
the company does business, they each have ownership and control. They are
also responsible for ensuring that the quality system is not just a paperwork
exercise.
Management commitment is key
The business process method requires a strong management commitment because
many existing procedures will need to be discarded and completely rewritten.
Management is responsible for developing the overall business process and
must approach it as developing how they run the business, not just how the
quality department operates. The management representative who normally
coordinates this effort will be required to have an in-depth understanding
of the requirements since he or she will review all procedures to ensure
that all requirements are addressed. This may require additional education
for the management representative.
Taking the business process approach also requires a matrix identifying
the ISO 9000 element and where the company procedure is documented. Customers
and third-party auditors will use this matrix as they review the documentation
to determine if it covers all ISO 9000 elements.
Developing the quality manual
The top-level manual may be developed following the business process or
the ISO 9000 elements. Since this document is normally used to provide customers
and the registrar with a system overview, following the 20 elements and
referencing the procedures where they are covered works well. Although the
quality manual is the company's guiding document, most people within the
company will not read or use the manual in their day-to-day operations.
The manual is more like a reference book that will be used on occasion but
still forms the basis for the overall system.
The manual will define the approach and responsibilities for the ISO 9000
elements. The manual should also identify which procedure addresses each
element. This may be covered in each element description or by relying on
the matrix to connect each element to the appropriate procedure. The people
within the company will use procedures and instruction-level documents daily.
The people who will use the manual are the customer and the registrar. The
goal of the quality manual with the business process approach is to make
it easier for the registrar and customers to review and perform audits because
they may only be familiar with the requirements that are similar to the
standard approach.
Process measurement
The business process approach flows well into process measurement as outlined
in a quality operating system and a total quality management approach. This
is because the entire business process has already been documented and these
procedures are based on how the company conducts business. Each process
can be measured because it follows what the company does to generate revenue.
For example, in purchasing, measurements of on-time delivery and delivery
of acceptable product should support the company's policy for meeting customer
expectations. These are measurable, and we can track improvement and see
a relationship to meeting the customer's demands and expectations. Measuring
the number of purchase orders generated may not directly show whether the
process is functioning properly or provide evidence of where improvements
can be made. However, to some companies striving to consolidate purchase
orders to reduce the purchase price, this may be an item that should be
measured as it may generate cost savings to the company and thus the customer.
In most companies, the processes that generate revenue are also the processes
used to meet customer requirements. Measuring the processes provides objective
evidence to support the organization's objectives for quality and customer
satisfaction. Do not measure for the sake of collecting data. Every measurement
must have a goal and should relate to meeting customer demands and expectations.
About the author . . .
Rod Southard is a lead assessor with KPMG Quality Registrar. He has served
as a quality assurance professional in a number of companies, among them
AB Dick Co., AAR Corp., Corcom and Amphenol.