Operational planning relates to what methods are used for planning, managing, implementing, and controlling processes within the quality management system. The standard also requires that these methods and practices are maintained as well as re-examined and adjusted as needed.

As stated in the ISO 9001/AS9100D/AS9120B standard, an organization will meet the requirements for operational planning and control by:

Determining the requirements for the products and services

Organizations must ensure that the requirements for the products and services to be supplied to customers are sufficiently specified, including any applicable statutory and regulatory requirements as well as those that the organization deems necessary. The organization must also verify that any items and services it offers can live up to their claims. Product requirements can be determined through contracts, project plans, customer orders, statement of work etc.

Establishing criteria for the processes

Processes in an organization are a series of actions and tasks that are tied together towards achieving product or service realization. The organization must establish criteria for ensuring that the processes are running efficiently and are achieving intended results. The outputs of operation planning can be in the form of drawings, machine setup, inspection criteria, process sheets etc. You can also utilize production specification, contracts, or quality plans to accomplish this.

Establishing criteria for the acceptance of products and services

This clause refers to the process of checking all products and services in some form. There can be a procedure in place to ensure that the product meets the stated requirements. It is up to the organization to decide how exhaustive this procedure should be. Checking and confirming each phase of production such as receiving, first article inspection, in-process, and final inspection, is a common and effective means of ensuring that the product meets requirements.

Determining resources needed for conformity

This section is requiring the organization to address the question “what resources does this operation need to function effectively? In section 7.1.1, the standard has the organization identifying resources, but on a more general scale. This section of operation and planning requires a little more specificity regarding what resources are needed to realize the product and services being offered. Organizations might consider the type of equipment, personnel, raw materials, or machines that will be needed to effectively carry out these tasks.

Maintaining and retaining documented information

According to the standard, the organization must determine, maintain, and retain documented information. It is up to the organization to decide what documents and records are necessary. Once the organization has determined what the necessary documents are, they must “maintain and retain” them. When the standard states to maintain, it refers to current and relevant documentation, which might include product specifications, operating procedures, checklists, data sheets, and so on. On the other hand, retaining refers to reports such as final inspection reports, visual inspection findings, process validations, and so on.

Controlling outsourced processes

An outsourced process is a process that directly affects the products and services of an organization but is performed by an external party. This is a common practice as it is often cost effective and efficient to have certain processes performed by another organization. Controlling the outsourced process is done in many ways, such as clearly specifying requirements on the purchase order, inspecting the outsourced work, vetting the outsourcing organization, requiring inspection reports, and making sure that the outsourcing organization is QMS certified when applicable. Overall, it is important to stay involved and monitor the progress and results of the outsourced processes.