How can the PDCA cycle be used in the “process approach”?
The PDCA cycle is an established, logical, method that can be used to improve a process.
· § planning (what to do and how to do it),
· (D) executing the plan (do what was planned),
· © checking the results (did things happened according to plan) and
· (A) act to improve the process (how to improve next time).
The PDCA cycle can be applied within an individual process, or across a group of processes.
[FAQ 018, April 2004]
Can any organization apply the “process approach”?
Yes. Many organizations already apply a “process approach” without recognizing it. They could achieve additional benefits by understanding and controlling it.
[FAQ 019, April 2004]
Why should an organization apply the “process approach”?
By applying the “process approach” an organization should be able to obtain the following types of benefits:
· The integration and alignment of its processestoenable the achievement of its planned results.
· An ability to focus effort on process effectiveness and efficiency.
· An increase in the confidence of customers and other interested parties as to the consistent performance of the organization.
· Transparency of operations within the organization.
· Lower costs and shorter cycle times through effective and efficient use of resources.
· Improved, consistent and predictable results.
· The identification of opportunities for focused and prioritized improvement initiatives.
· The encouragement and involvement of people, and the clarification of their responsibilities.
· The elimination of barriers between different functional units and the unification of their focus to the objectives of the organization.
· Improved management of process interfaces.
[FAQ 020, April 2004]
What is meant by the “sequence” of processes and their “interactions”?
The “sequence” of processes shows how the processes follow, or link, to each other to result ina final output.
For example, one process may become the output of the next process or processes.
The “interactions” show how each process affects or influences one or more of the other processes. For example, the monitoring or controlling of a process may be established in a separate process.
[FAQ 021, April 2004]
How can the processes in an organization be determined?
· Identify the organization’s intended outputs, and the processes needed for achieving them. These will need to include processes for Management, Resources, Realization and Measurement and Improvement.
· Identify all process inputs and outputs, along with the suppliers and customers, who may be internal or external.
· Identify the sequence and interactions of the processes.
[FAQ 022, April 2004]
Should an organization define and document all its processes?
The main purpose of documentation is to enable the consistent and stable operation of an organization’s processes.
Although statutory, standards’ or customer requirements may require certain documentation, there is no defined “catalogue”, or list of processes that has to be documented in ISO 9001, apart from the 6 indicated ones.
The organization should determine which processes are to be documented on the basis of:
· The size of the organization and type of its activities,
· The complexity of its processes and their interactions,
· The criticality of the processes and
· Availability of competent personnel.
A number of different methods can be used to document processes, such as graphical representations, written instructions, checklists, flow charts, visual media, or electronic methods.
[FAQ 023, April 2004]
How much detail is required in process documentation?
The extent of detail is likely to depend upon factors such as:
· the size of an organisation and its types of activities,
· the complexity of its processes and their interactions, and
· the competence (level of education, training, skills and experience) of its personnel.
[FAQ 024, April 2004]
Is there a standard way of describing a process?
No, there is no standard way to describe a process. It depends on the culture, management style, staff literacy, personal attributes and their interactions.
A process may be described using a flow chart, block diagram, responsibility matrix, written procedures or pictures.
Process flowcharts or block diagrams can show how policies, objectives, influential factors, job functions, activities, material, equipment, resources, information, people and decision making interact and/or interrelate in a logical order.
[FAQ 025, April 2004]
What should an organization do to adopt the “process approach”?
To adopt the “process approach” an organization should apply the following steps:
· Identify the processes of the organization,
· Plan the processes,
· Implement and measure the processes,
· Analyse the processes,
· Improve the processes.
[FAQ 026, April 2004]
What is a “process owner”?
A person who is given the responsibility and authority for managing a particular process is sometimes referred to as the “process owner”.
It may be useful for an organization’s Management to appoint individual “process owners” and to define their roles and responsibilities; these should include the responsibility for ensuring the implementation, maintenance and improvement of their specific process and its interactions.
It should be noted, however, that ISO 9001:2000 does not specifically require the appointment of “process owners”.
[FAQ 027, April 2004]
How can a process be measured?
There are various methods of measuring process controls and process performance, ranging from simple monitoring systems up to sophisticated statistically based systems (e.g. Statistical process control, or SPC, systems). The selection and use of any particular method will be dependent on the nature and complexity of an organization’s processes and products. The effectiveness of an individual process may be measured by the conformity of its output or product to customer requirements. Its efficiency may be measured from its use of resources. In all cases the measurement of the process determines if its (measurable) objectives have been achieved. Sometimes it only requires monitoring to confirm process operations.
Typical factors that are useful to consider when identifying measures of process control and process performance include:
· Conformity with requirements,
· Customer satisfaction,
· Supplier performance,
· On time delivery,
· Lead times,
· Failure rates,
· Process costs.
· Incident frequency
[FAQ 028, April 2004]
What is the difference between a “process” and a “procedure”?
A “process” may be explained asa set of interacting or interrelated activities, which are employed to add value. A “procedure” is a method of describing the way in which all or part of that process is to be performed.
ISO 9000:2000 defines a procedure as a “specified way to carry out an activity or a process”, which does not necessarily have to be documented.
[FAQ 029, April 2004]
An organization has a well-established set of procedures. Can these procedures be used to help describe its processes?
Yes, if the procedures describe inputs and outputs, appropriate responsibilities, controls and resources needed to satisfy customer requirements.
[FAQ 030, April 2004]
What is meant by “continual improvement”?
ISO 9001 requires an organization to focus on continually increasing the effectiveness of its quality management system, to fulfil its policies and objectives. One way of doing this is for the organization to improve its processes. The organization may also wish to consider improving the efficiency of its processes, for which ISO 9004:2000 provides guidance. Continual improvement (where “continual” highlights that an improvement process requires progressive consolidation steps) responds to the growing needs and expectations of customers and ensures a dynamic evolution of the quality management system.
[FAQ 031, April 2004]
What documentation is required by ISO 9001?
ISO 9001:2000 refers specifically to only 6 documented procedures; however, other documentation (including more documented procedures not specifically mentioned in ISO 9001:2000) may be required by an organization, in order to manage the processes that are necessary for the effective operation of the quality management system. This will vary depending on the size of the organization, the kind of activities in which it is involved and their complexity. For further guidance, please also refer to the ISO 9000 Introduction and Support Package module “N525 - Guidance on the Documentation Requirements of ISO 9001:2000”
[FAQ 032, April 2004]
Which standard are organizations registered/certified to?
Organizations have their quality management system registered/certified to ISO 9001:2000. The scope of registration/ certification will need to reflect precisely and clearly the activities covered by the organization’s quality management system; any exclusion to non-applicable requirements of the standard (permitted through ISO 9001 clause 1.2 “Application”) will need to be documented and justified in the quality manual (see also the ISO/TC 176/SC2 ISO 9000 Introduction and Support Package module " N524 - Guidance on ISO 9001:2000 clause 1.2 ‘Application’ ").
[FAQ 033, April 2004]