Understanding ISO 9001:2015
ISO 9001 Process Approach
What is the definition of a process?
A “Process” can be defined as a “Set of interrelated or interacting activities, which transforms inputs into outputs”. These activities require allocation of resources such as people and materials.
What is the definition of the ‘process approach’?
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”.
The processes are managed as a system, by creating and understanding a network of the processes and their interactions (see figure 2). The consistent operation of this network is often referred to as the “system approach” to management.
The performance of an organization can be improved through the use of the process approach.
What are the characteristics of processes?
Processes are the foundation upon which your quality management system (QMS) must be developed. Let’s understand some basics about processes.
Figure 1 – 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 (raw materials or finished product) or intangible (information – e.g. computerized drawing or specification).
Figure 2 – All process has 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).
The purpose of the process approach is to enhance an organization’s effectiveness and efficiency in achieving its defined objectives. Process effectiveness and efficiency can be assessed through internal or external review processes.
All processes must also 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.
What are the characteristics of the process approach?
A major advantage of the process approach, when compared to other approaches, is in the management and control of the interactions between these processes and the interfaces between the functional structure of the organization.
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 (See Figure 2). 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. (See types of processes below).
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?
What benefits does the process approach provide?
The process approach:
Focuses on integrating, aligning and linking processes effectively to achieve planned goals and objectives
Allows the organization to focus on improving process effectiveness and efficiency.
Facilitates consistent performance which in turn provides assurance to customers about the organization’s quality and capability.
Promotes the smooth and transparent flow of operations within the organization.
Contributes to lower costs and shorter cycle times, through the effective use of resources.
Focus on continual improvement of processes results in improved, consistent and predictable results.
Facilitates the involvement and empowerment of people and the clarification of their responsibilities.
How is the process approach different from a departmental approach?
The process approach is an effective way to organize and manage business activities to create value for the customer and other interested parties.
Organizations are often structured into a hierarchy of functional departments.
These departments are usually managed vertically, with responsibility for the intended outputs being divided among functional units. The end customer or other interested party is not always visible to all involved. Consequently, problems that occur at the interface between departments are often given less priority than the short-term goals of the departments. This leads to little or no improvement to the customer, as actions are usually focused on the departmental functions, rather than overall benefit to the organization.
The process approach introduces horizontal management of activities, by removing the barriers between different departments and focusing their collective effort to the main goals of the organization.
How can QMS processes be grouped or categorized?
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 (see clause 7) 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 include – 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 and measurement and monitoring activities. 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 include – human resources; information technology; purchasing and receiving; laboratory; maintenance; tooling; facility management; etc, whether performed onsite or off-site. See clause 6 and 7.
· Management Oriented Processes(MOP’s) – These processes provide the strategic planning, commitment, leadership, resources, review and decision-making by top management (see clause 5). These processes generally interact with all QMS processes at the QMS planning and review level. MOP’s include – business planning; management review; quality planning; resource planning; communication, etc., whether performed offsite or on-site.
· Quality Management Processes (QMP’s) to document, measure, analyze and improve all processes – These processes provide quality management support to and interact with all QMS processes. QMP’s include – document control; records control; monitoring and measurement of processes and product; internal audits; control of nonconforming product; corrective and preventive action; continual improvement; etc whether performed onsite or off-site. See clause 4 & 8.
· Outsourced Processes (OP’s) – These are COP’s or SOP’s that are performed by a function or organization outside the ownership or managerial control of your facility. They may be performed onsite or off-site. These processes include – heat treating; painting; welding, calibration; testing; sort; HR; etc.
How Should a QMS Be Implemented Using the Process approach?
To plan your QMS using the ‘Process Approach’, you must:
Start by identifying your customers and their requirements (see clause 5.2, 7.1 and 7.2).
Identify applicable requirements of regulatory bodies (see clause 7.1, 7.2 and 7.3).
Define organizational strategic and quality goals, objectives and policies for products and management systems.
Identify the processes needed for the QMS (see listing above).
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. These include:
Identify the internal/external customer-required output.
Identify process owners and their responsibilities.
Describe the process activity that produces the output.
Identify the resources (facility; equipment; utilities; materials; labor, finances, etc.) needed for the process 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 risk of errors, omissions, or nonconformities in the process activity. These controls may come from the management system standard; customer; regulatory and your own organizational requirements (more details provided in clause 4.1).
Interaction – with sources that provide the inputs (internal process or external supplier); uses the output (internal process or external customer); or provide the resources (internal support process) to perform the process activity.
Implement your QMS according to your plan.
Use project management tools that include, but is not limited to communication; awareness; training; change management; management involvement; review activities.
Monitor and measure each QMS process and its interaction with other processes. Performance indicators to monitor and measure process performance may come from the management system standard; customer; regulatory and your own organizational requirements. Performance indicators may relate to the process output as well as the process activity.
Evaluate process data obtained from monitoring and measuring, in order to quantify process performance. Where appropriate, use statistical methods.
Compare process performance measurement results with the defined requirements of the process to confirm process effectiveness, efficiency and any need for corrective action. Identify process improvement opportunities based on process performance data. Report to top management on the performance of the process, as appropriate.
Improve QMS processes
Define the corrective action process that will be used to eliminate the root causes of problems (examples of problems include errors, defects, lack of adequate process controls). Implement the corrective action process and verify its effectiveness.
Once the planned process requirements are achieved, the organization should focus ion actions to improve process performance to higher levels, on a continual basis.
Identify areas for improvement (e.g., process simplification, enhancement of efficiency, improvement of effectiveness, reduction of process cycle time). Verify the effectiveness of the improvement.
Use risk analysis tools to identify potential problems. The root cause(s) of these potential problems should also be identified and corrected, preventing occurrence in all processes with similarly identified risks.
1. 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. See clause 5.4.2 for quality objectives.
2. 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. Review notes on clause 4.1 General Requirements in conjunction with the above notes on the process approach, for more insight on process documentation.
3. For those interested in gaining a deeper insight into understanding and implementing the process approach, study the ISO guidance document on the concept and use of the process approach for management systems – Document: ISO/TC 176/SC 2/N544R2(r), issued 13 May 2004 on the ISO website.
Keep in mind that the above notes and reference are for guidance and the manner and detail of application and documentation of the ‘process approach’ will vary from organization to organization, due to a variety of factors such as size and complexity of the organization; products, processes; customers; etc. See clause 4.1 for more details on applying the process approach.
What is the PDCA approach to process implementation?
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 – from the executive high-level strategic processes, such as business planning or management review to operational processes such as product realization or calibration.
(PLAN) – 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 needed (e.g. facility, equipment, labor, materials, time, etc).
Preventive and detective controls needed for process activity, input, output and resources used.
Process documentation (e.g. 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. We will look at QMS planning in more detail when we review clause 4.1 requirements.
(DO) – Deploy and implement your QMS processes and manage and control them according to your plan as documented above.
(CHECK) – 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.
(ACT) – 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.
As mentioned above PDCA is a dynamic cycle and so continual improvement must be an on-going process for improving your QMS and enhancing customer satisfaction.
What is the Continual Improvement Process model for QMS implementation?
SEE FIGURE 4
Figure 4 – 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.
Controls for your processes come from the ISO 9001 standard, customer requirements, your organization or applicable regulatory requirements.. The five clauses of ISO 9001 provide control requirements for PDCA – planning, implementation; monitoring and measurement; and for improvement of each QMS process. The applicable requirements of these five clauses must be applied to each process (inputs; outputs; resources used; transformation activities; interaction with other processes) for effective control. In clause 4.1 we will discuss this in further detail.
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