Process Approach and PDCA Cycle

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Process Approach and PDCA Cycle

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Process Approach

 

ISO 9001:2015 QMS standard promotes the process approach. Clause 4.4 of the standard specifically deals with specific requirements related to the quality management system and its processes.

 

Let’s begin with the understanding the process approach. A process is a set of interrelated or interacting activities, which transforms inputs into outputs.

 

Interrelated activities = Activities having a mutual connection = Activities related to or connected to one another

 

Interacting activities = Activities that talk or deal with others = Activities acting in such a way as to have an effect on each other

 

A process uses inputs to deliver an intended (planned) result. Inputs and outputs may be tangible or intangible.

 

Tangible = A thing that is perceptible (able to be seen or noticed) by touch, such as material, component, equipment

 

Intangible = Unable to be touched, not having physical presence, such as data, information, knowledge

 

The processes of a business or an organization is the totality of all of the individual activities that the business or the organization performs. Let’s take an example. The process of an organization may include determining a customer needs, creating a product or service to meet the determined needs, defining how the product or service will be produced, operational part, measurement etc. The process approach means the establishing all above processes of the organization to operate as an integrated and complete system.

 

Process approach = The systematic management of processes and their interactions to achieve the intended results.

 

To manage a number of processes, the organization develops a management system, such as quality management system, environmental management system, etc. the management system integrates processes. It also measures processes and outputs to meet objectives. There are a number of processes in each management system. Typical processes in the quality management system includes understanding the context of the organization, performing leadership roles, planning, providing support, doing operational activities, design and development, performance evaluation, audit, improvement etc.

 

A process map is a very significant tool as part of quality management system of an organization. Creating this process map is defining the links where the process starts and where it ends, and also determining the specific activities that need to be performed, process owners for each activity and customer satisfaction measures. From the process map the organization can begin to define which QMS-related processes are involved and how the organization can flowchart them in detail, improve them, update the flowchart, and document it, if required necessary, deploy and maintain the process. A flowchart is a visual representation that uses symbols to illustrate the sequence of steps, decisions, and information flow in a process.  

 

The process approach incorporated the risk-based thinking that ensures consideration of risks when establishing, implementing and maintaining a management system, each process and each activity.

 

PDCA Cycle

 

PDCA = Plan, Do, Check, Act

 

PDCA cycle is a tool that is used to manage processes and the quality management system of an organization. ISO 9001:2015 QMS standard suggests application of PDCA cycle to organization’s processes and to the quality management system as a whole.

 

PDCA stands for:

 

P = Plan = Establish the objectives (organizational goals at each relevant functions, levels and processes needed for the quality management system) to deliver intended results. Plan include: (1) What to do? And (2) How to do?

 

D = Do = Implement as planned and control implementation

 

C = Check = (1) Monitor and measure processes and outputs, and (2) Report results (conformity, any deviation, or improvement opportunity). It involves evaluating whether the planned actions are achieving the desired results and identifying any deviations or opportunity for improvement.

 

A = Act = Take actions to (1) Improve output result, and (2) Continually improve performance of the organization’s processes. Act is the process of implementing changes based on the results and how it ties into the concept of continual improvement,

 

process of implementing changes based on the results and how it ties into the concept of continuous improvement.

 

PDCA methodology operates as a cycle of continual improvement, integrated with risk-based thinking at each stage in ISO 9001:2015 QMS.

Best wishes,

Keshav Ram Singhal

 

(This write-up is a part of a forthcoming book on ISO 9001 being written by Keshav Ram Singhal)