Process Approach

The Process Approach is a foundational principle of modern Quality Management Systems (QMS), particularly those based on the ISO 9000 family of standards. It is a strategic way of managing an organization by viewing its activities as a system of inter-related processes, rather than as separate departments or functions.

The Process Approach is one of the seven core quality management principles (QMPs) guiding the ISO 9000 family of standards. It asserts that a desired result is achieved more efficiently when activities and related resources are managed as a process. This view encourages understanding and managing inter-related processes as a system to contribute to the organization's effectiveness and efficiency, thereby enhancing the overall performance of the system.

The adoption of the process approach is a strategic decision for an organization that helps improve its overall performance and provides a sound basis for sustainable development initiatives.

Fundamental Principle of ISO Standards

The Process Approach is a key principle underlying internationally recognized QMS standards, including:

ISO 9001:2015: This standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. This approach helps streamline processes, enhance communication, and ensure that every aspect of the organization's operations aligns with best practices.

Historical Context: The ISO 9001:2000 version made a radical change in thinking by placing the concept of process management front and center, moving away from just inspection of the final product.

Automotive Industry: The ISO/TS 16949 (now IATF 16949) standard emphasizes a process approach that is stronger than what was required in ISO 9001:2008.

Implementation and Core Activities

Applying the process approach involves the systematic definition and management of processes, their interactions, and their direction to achieve the organization's intended results in accordance with the quality policy and strategic direction.

The organization shall establish, implement, maintain, and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of the international standard.

Implementing the process approach in a QMS enables:

• Understanding and Consistency: It provides understanding and consistency in meeting requirements.
• Added Value: It allows for the consideration of processes in terms of added value.
• Performance Achievement: It facilitates the achievement of effective process performance.
• Improvement: It supports the improvement of processes based on the evaluation of data and information.

For each process required for the quality management system, the organization shall determine:

• The inputs required and the outputs expected.
• The sequence and interaction of these processes.
• The criteria and methods (including monitoring, measurements, and related performance indicators) needed to ensure the effective operation and control of these processes.
• The resources needed to ensure their availability.
• The responsibilities and authorities for these processes.
• How to address the risks and opportunities associated with the processes.
• How to evaluate and implement any changes needed to ensure the processes achieve their intended results.
• How to improve the processes and the quality management system.

A schematic representation of a single process shows the flow from inputs (material, information, or resources) through activities, resulting in outputs (products, services, or decisions), and illustrates the interaction with the receivers of outputs and sources of inputs.

Connection to the PDCA Cycle

The process approach is fundamentally linked to the Plan-Do-Check-Act (PDCA) cycle. The PDCA cycle can be applied to all processes and to the quality management system as a whole.

Plan: Establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customer requirements and the organization's policies.

Do: Implement what was planned.

Check: Monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, and requirements, and report the results.

Act: Take actions to improve performance, as necessary.

This iterative approach ensures continuous improvement within the QMS.

Process Approach in Documentation

The QMS documentation structure is inherently tied to the processes within the organization. Quality procedures are documented instructions that outline the steps and activities to be followed in the performance of specific processes within a QMS. The documentation hierarchy, which starts with the Quality Policy and includes procedures, work instructions, and records, provides a clear framework of the operations in an organization and allows for the consistency of processes.

Analogy for Understanding the Process Approach

Viewing an organization through the Process Approach is like treating a professional kitchen not as a collection of separate stations (butcher, baker, server), but as a single integrated meal preparation process.

If a customer complains about the meal (nonconformity), the traditional department view might blame the baker for the soggy bread. The Process Approach investigates the entire interconnected system: Did the purchasing process order low-quality flour (input)? Did the storage process (activity) expose the ingredients to humidity? Did the serving process (output) delay delivery, making the hot food cold? By managing meal production as a continuous, flowing process with defined inputs, activities, and measurable outputs, the kitchen can efficiently identify exactly where systemic errors occur and apply controls to ensure every future meal is consistently high quality.

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