All organizations use processes to achieve their objectives. As per ISO definition
“A process: the set of interrelated or interacting activities that use inputs to deliver an intended result
NOTE: Inputs and outputs may be tangible (e.g. materials, components or equipment) or intangible (e.g. data, information or knowledge).”
The process approach is the foundation upon which your QMS must be developed. The ISO 9001 Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.ISO 9001:2008 promoted the adoption of a process approach when developing, implementing and improving the effectiveness 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 essential to the adoption of a process approach. For example, determining the inputs required and outputs expected from these processes , then after determining the risks and opportunities and plans to address these in 6.1 – integrate these into its QMS processes(4.1.f – plan and implement actions), related performance indicators (4.4.1c.), assignment of responsibilities and authorities for these processes (4.4.1 e).
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 inputs into outputs, can be considered a process. Often the output from one process directly forms the input to the next. The application 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 individual 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 processes in terms of adding Value and effective performance
- Improvement of processes based on evaluation of data and information
- Consistent and predictable results
- Meeting requirements and customer satisfaction
- Activity understanding and management of interrelated processes
The model of a process-based quality management system shown in figure illustrates the process linkages presented in clauses 4 to 10. This illustration shows that customers requirements, the needs, and expectations of relevant interested parties along with the organization and its context play a significant role in defining requirements as inputs. The output of the process is the result of the QMS that includes product and service the organization provides, which should result in Customer satisfaction. The model shown in Figure covers all the requirements of this Standard but does not show processes at a detailed level.
Understanding Process :
Let’s understand some basics about processes.
- All work generally involves a process – things go in (inputs); get worked upon (conversion), and come out differently (output). The value-adding conversion activity within a process transforms inputs into outputs, e.g. takes raw materials (the input) and manufactures (the value-adding conversion activity using various resources) a product (the output).
- Process inputs and outputs can be tangible such as raw materials or finished product or intangible like INFORMATION – e.g. computerized drawing or specification.
- All processes have a supplier and a customer. These suppliers and customers may be internal processes or external to your organization. Each process must have an accountable owner, i.e., having defined responsibility and authority to operate, control and improve their process.
- All processes require the use of resources, e.g. – people, equipment, materials, technology, etc. These resources can be used as inputs (raw materials or information such as a customer specification) as well as for the value-adding conversion activity (e.g. use of machinery, equipment, computers, technology, people, etc.) to transform raw material (input) into finished product (output).
- 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.
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.
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.
Deploy and implement your QMS processes and manage and control them according to your plan as documented above.
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.
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 organization||The organization should identify its responsibilities, the relevant interested parties and their relevant requirements, needs & expectations to define the organization’s intended purpose.||Gather, analyze and determine external and internal responsibilities of the organization to satisfy the relevant requirements, needs, and expectations of the relevant interested parties. Monitor or communicate frequently with these interested parties to ensure continual understanding of their requirements, needs and expectations.|
| Define the scope, objectives, and policies of the
|Based on the analysis of the requirements, needs and expectations establish the scope, objectives, and policies that are relevant for the organization’s quality management system.||The organization shall determine the scope, boundaries, and applicability of its management system taking into consideration the internal and external context and interested party requirements. Decide which markets the organization should address. Top management should then establish objectives and policies for the desired outcomes.|
|Determine the processes in the organization|| Determine the processes needed to meet the objectives and policies and to produce the intended
|Management shall determine the processes needed for achieving the intended outputs. These processes include management, resources, operations, measurement, analysis, and improvement.|
|Determine the sequence of the processes||Determine how the processes flow in sequence and interaction.|| Define and describe the network of processes and their interaction. Consider the following:
Note: As an example, realization processes (such as those needed to provide the products or services delivered to a customer) will interact with other processes (such as the management, measurement, procurement in the provision of resources). Process sequences and their interactions may be developed using tools such as modeling, diagrams, matrices, and flowcharts.
|Define people who take process ownership and accountability||Assign responsibility and authority for each process.||Top Management should organize and define ownership, accountability, individual roles, responsibilities, working groups, remits, authority and ensure the competence needed for the effective definition, implementation, maintenance and improvement of each process and its interactions. Such individuals or remits are usually referred to as the Process Owners. To manage process interactions it may be useful to also establish a management system team that has a system overview across all the processes and may include representatives from the interacting processes and functions.|
|Define the need for documented information||Determine those processes that need to be formally defined and how they are to be documented.|| Processes exist within the organization. They may be formal or informal. There is no catalog or list of processes that have to be formally defined. The organization should determine which processes need to be documented on the basis of risk‐based thinking, including, for example:
Processes can be formally documented using a number of methods such as graphical representations, user stories, written instructions, checklists, flow charts, visual media or electronic methods including graphics and systemization. However, the method or the technology chosen are not the goals. They can be used to describe processes, which are the means to achieve the goals. Effective and organized processes can then deliver consistent and accountable operations and the desired objectives and results which can then be improved.
|Define the interfaces, risks
and activities within the process
|Determine the activities needed to achieve the intended outputs of the process and risks of unintended outputs.||Define the required outputs and inputs of the process.
Determine the risks to conformity of products, services, and customer satisfaction if unintended outputs are delivered.
Determine the activities, measures and inherent controls required to transform the inputs into the desired outputs. Determine and define the sequence and interaction of the activities within the process. Determine how each activity will be performed.
Ensure that the management system as a whole takes account of all material risks to the organization and users.
Note: In some cases the customer may specify requirements not only for the outputs but also for the realization of a process.
| Define the monitoring and
| Determine where and
how monitoring and
measuring should be
applied. This should
be both for control
and improvement of
the processes and the
outputs. Determine the need for recording results.
| Identify the validation necessary to assure effectiveness and
efficiency of the processes and system. Take into account such factors as:
|Implement|| Implement actions
necessary to achieve
planned activities and
| The organization should perform activities, monitoring, measures and controls of defined processes and procedures
(which may be automated), outsourcing and other methods necessary to achieve planned results.
| Define the resources
|Determine the resources needed for
operation of each
| Examples of resources include:
| Verify the
process against its planned
| Confirm that the process is effective
and that the
characteristics of the
consistent with the
purpose of the
| The organization should compare outputs against objectives to verify that all the requirements are satisfied. Processes are needed to gather data. Examples include
measurement, monitoring, reviews, audits and performance analysis.
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