What is Operational Planning & Control | Operational Planning & Control | 8.1 Operational Control
Today, we will discuss what operational planning & control requirements are in ISO 9001 2015 standard. This clause consists of eight elements:
• Operational planning and control
• Requirements for products and services
• Design and development of products and services
• Control of externally provided processes, products, and services
• Production and service provision
• Release of products and services
• And Control of nonconforming outputs
Let’s break this extensive list into manageable pieces and start from 8.1 Operational planning and control. The organization shall plan, implement, and control the processes, see 4.4, needed to meet the requirements for providing products and services and to implement the actions determined in Clause 6. This subclause is a web of references, and we need to clarify what the standard means. Let’s start with the referenced element 4.4. As we discussed in our earlier videos, this element requires us to establish a QMS and its processes and determine the following:
a) inputs and outputs expected from these processes.
b) the sequence and interaction of the processes.
c) performance indicators to ensure the effective operation,
d) resources needed, and others
So, this clause is about management system processes. For example, whatever we plan to produce, metal fences or electric bikes, we have to establish such processes as
• Leadership
• Documentation
• Corrective actions
• Internal audits
• Management review and others.
Now, let's return to clause 8.1 and reiterate operational planning & control. The organization shall plan, implement, and control the processes needed to meet the requirements for providing products and services. Therefore, we need to define processes specific to our products for this clause. These may include:
• Supply chain
• Receiving inspection
• Production planning
• In-process and final tests
• Packaging and shipping, and others
As you can see, the difference between elements 4.4 and 8.1 is that the first one talks about the system processes, and clause 8.1 addresses the need to meet product requirements. Now that we have sorted out the requirements of 4.4 and 8.1 elements, it is an excellent time to organize all our processes. I suggest using our process interaction matrix that addresses the requirement for the interaction of the processes. The detailed description of this model is in our video 4.4 2. You can find a link to it in the description below. Plus, our website has an article on the process interaction matrix. You will also find a link to the article in the description.
Let's summarize our discussion today:
• Clause 4.4 refers to QMS processes.
• Clause 8.1 focuses on the product-specific activities.
• Use the Process Interaction Matrix to document your processes and their interactions!
In the following video, we will continue discussing element 8.1 and the meaning of the reference to subclause six risk assessment. This clarifies what is operational planning & control in ISO 9001 clause 8.1.
Understanding Process Interactions
• What is Process Interaction | ISO 9001 Cla...
Lean Management System – A Process Interaction Matrix Article
Process Interaction Matrix | Quality Management Systems | Lean ISO (leanisomanagementsystems.com)
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