1.
Customer Oriented Processes
The customer oriented processes are
the processes related to product realization, from the point when the organization
receives customers’ contracts or orders to the point when the products are
shipped to the customers. These processes may include:
1)
Contract review process
When a
new customer wants to buy a product from the organization or an existing
customer wants to buy a new product from the organization, the customer usually
signs contracts with the organization to specify its requirements (such as the technical
specifications, the price, the requirements in green purchasing, etc.). The
organization shall review these requirements and take actions to conform these requirements
if necessary. The purpose of this process is to ensure that all the customer
requirements are fully understood and can be fulfilled before accepting the customer’s contract.
2)
Design and development process:
This
process transfers the customer requirements on a product (e.g. how the product looks like,
what its functions are) to the mass production of the product. The purpose of this process is to ensure that the product and
process designed can fulfill the intended requirements for the products.
3)
Order handling process
When an
actual order for the delivery of products is received from a customer, the
requirements in the order, which is a contract usually specifying the quantity,
the product and the desired delivery date, shall be reviewed, to see whether
the organization has the capability to meet the requirements:
l Is there enough stock of finished products?
l Is there enough manufacturing capacity?
l Are there enough raw materials?
Actions
should be taken to meet the order requirements if necessary (e.g. increasing
the manufacturing capacity by adding new lines).
The
purpose of this process is to ensure that the requirements of customer orders
are fully understood and that the organization has the capability to fulfill
customer orders before accepting them.
4)
Production planning process
When an
order is accepted by the organization, a production plan should be established
accordingly to fulfill the order requirements. Meanwhile, a good production
plan should also fulfill the requirements of JIT (just-in-time), to minimize
the inventory of raw materials, WIP and finished goods. The purpose of this
process is to fulfill the customer orders and meanwhile to mitigate the
inventory and stock up of materials and WIPs in the production line.
5)
Purchasing process
This is the process in which purchasing requirements are identified
based on the production planning, and purchasing orders are issued and followed
up to fulfill these requirements.
6)
Production process
This is the process in which the raw materials are transferred to
finished goods, according to the production plan and the technical
specifications.
7)
Storage process:
The raw materials, WIP and finished goods shall be stored properly
in the warehouse and the production site. For a good storage management, it
must ensure that stored items are properly identified, specified storage
conditions (e.g. temperature, humidity, ESD & stacking height) are
fulfilled, the expiration date are monitored, the quantity is right, and FIFO
is guaranteed.
8)
Packing and delivery process:
This is the process in which the finished goods are packed and
delivered to the customers.
2.
Supporting processes
The supporting processes are those
processes to ensure the effective operation of the customer oriented processes.
They include:
1)
Document control process
This is
the process to ensure that
l The documents used for quality management are adequate and suitable;
l The documents distributed to the uses are the most updated ones and
they’re available for the users who need them;
l The documents are protected from loss and damage, and safeguarded from
leaking of confidential information.
2)
Employees management process
This is
the process to equip the organization with competent and motivated employees.
The skills and experience needed for each job post must be clearly identified,
and trainings shall be provided accordingly to ensure that the people on each
post are competent to perform their duty. Also the employees shall be
motivated. Their satisfaction and loyalty to the organization shall be
monitored and actions shall be taken if necessary to promote the employees
satisfaction and loyalty.
3)
Organizational knowledge
management process
Knowledge management is a new requirement in ISO9001:2015. The purpose
of this process is to ensure that the knowledge needed for employees or the organization
to ensure the conformity of products is identified, maintained, updated if
necessary, and made available for the relevant persons. This process can be
combined with the employees management process or the document control process
if the process owners are the same.
4)
Infrastructure & equipment management
process
This
process is to ensure that
l Necessary infrastructure and equipment are provided to meet the
organization’s needs;
l The infrastructure and the equipment are maintained so that they do
not cause negative impact to the on time deliver and products’ quality.
5)
Measuring equipment management
process
This process
is to ensure that
l Necessary measuring equipment is provided to verify the conformity
of the products;
l Measuring equipment are calibrated or verified to ensure that they
meet the purpose of the measuring activities performed.
6)
Work environment management
process
This
process is to ensure that proper work environment are established and
maintained. The work environment includes
l Physical environment, such as temperature, humidity, illumination, etc.,
which should be appropriate for products preservation and for employees to
perform their duties;
l Social and mental environment, such as no discrimination, no
physical abuse, etc., which should be appropriate so that employees social
rights are protected and ensured, and they feel no mental pressure when
performing their duties.
7)
Suppliers management process
This
process is to ensure that the organization’s suppliers meet the desired
requirements, and their performance is monitored and corrective or improvement
actions are requested from suppliers when needed.
8)
Incoming inspection process
This process is
to ensure that the purchased materials meet the specified requirements in
quality, quantity and etc. It serves as a monitoring process for the
effectiveness of the supplier management process.
9)
Inspection and testing process
This process is to ensure that appropriate
inspection and testing activities are conducted so that
l The products shipped to the customers always meet the customers’
requirements
l The nonconformities or improvement opportunities in the production
process are identified so that corrective and improvement actions can be
implemented.
10)
Customer claims handling
process
This
process is to ensure that any quality issues arising from the products shipped
to the customers are properly resolved and their recurrences are well prevented.
3.
Management processes
The
management processes are those processes which need the involvement of the top
management team and they’re the reviewing, planning and action taking processes
to ensure the customer oriented processes and supporting processes are
effective. They can include:
1)
Management review process
This
process is a review process which must be conducted by the top management team.
It is to review the overall suitability, effectiveness and adequacy of the quality
management system. The resources needed, the need for changes and improvement opportunities
are identified and actions are taken accordingly.
2)
Internal audit process
Internal
audit is conducted by internal auditors. It is another review process to
monitor
l Whether the established requirements of the quality management
system conforms to the international standards and organization’s own needs;
l Whether the implementation of the quality management system conforms
to the established requirements;
l Whether the requirements are effective, suitable and adequate.
Actions shall be taken to correct the nonconformities found during
internal audit.
3)
Customer satisfaction
monitoring process
This
process is to review the effectiveness of the quality management system through
the monitoring of the customer satisfaction. Actions shall be taken accordingly
based on the monitoring result to improve customer satisfaction.
4)
Quality planning process
This is
the overall planning process for the quality management system. It should be
led by the top management team, and supported by all the senior and junior
managers in the each department of the organization. Based on the requirements
of ISO9001:2015, following things shall be done for a good quality planning:
l Understanding of the internal and external issues of the
organization;
l Understanding the needs and expectations of the interested parties;
l Establish the quality scope;
l Identify the processes in the quality management system, establish
the requirements and control of each process, and define the roles and responsibilities
of each position in the processes;
l Establish the quality policy;
l Identify the risks and opportunities in the quality management
system and propose actions to address these risks and opportunities;
l Establish the quality objectives (the objectives for the whole
organization, for each department, for each quality process, for the effectiveness
evaluation of actions taken to address the risks and opportunities, etc.).
The actions arising from review processes above may cause changes in
the quality planning. So they’re always inter-linked.
