I’ve been over these topics more times than I care to remember. This time around, I saw something in the latest version (ISO 9001:2015) of this Standard that hadn’t connected for me before. The introduction sections have connected the dots for me when it comes to PDCA, Risk-based thinking and the Process Approach.
Risk-based thinking helps an organization determine what circumstances could cause hiccups, or worse, disaster. The idea here is to anticipate what might go wrong and create mitigation plans.
On the flip side, ‘risk’ can be positive and organizations can build a Management System that puts them in a position to make maximum use of opportunities as they come along.
Today’s environment is increasingly complex and requires a Management System that is stable but flexible – a system that can turn on a dime while being under control. Continual Improvement is not new to ISO, and becomes more valuable as each year passes and might be achieved through breakthrough change, innovation, re-organization and other responses related to an organization’s changing environment.
The ‘Process Approach’
Since the late 1940s, W. Edwards Deming’s work has expanded around the world. He became famous for the Plan-Do-Study-Act (PDSA) model that he rolled out in Japan to bring them Out of the Chaos (one of Deming’s book titles) after WWII. It’s often mis-quoted as PDCA. Three of the 4 steps are the same, but ‘Study’ is quite different from ‘Check’. (See Rick’s comment below).
Here’s a QMS formula for your consideration: PDCA + Risk based thinking = the Process Approach (see ISO 9001:2015, 0.1 General, para 4). And another one: Customer requirements = Needs + Expectations.
A ‘process’ in ISO 9000 is defined as ‘a series of activities that turn inputs into outputs’ (or results). So the process approach gives an organization the tools to manage activities, especially during changes.
The ‘process approach’ can be valuable as a concept when an organization is developing, implementing and improving a management system. By systematically defining and managing the workflow (inputs > process > outputs) an organization has a framework to learn how their system works. By studying a system (PDSA – Shewhart)and knowing how the pieces (processes) relate, we can learn how to improve the effectiveness of our system. The goal is to build and operate a Management System that helps an organization move in its’ intended strategic direction and meet customer/client/stakeholder requirements.
By clarifying organizational goals we can build a Management System that helps us move toward our purpose. We can audit by Objectives (not documentation) to make sure our system has the processes in place to get us where we want to go. Focus on system effectiveness makes it easier to clean up the roadblocks to success!