Clause 8.1 of ISO 9001: Operational Planning and Control

What Is Operational Planning And Control In The ISO Management Standards 9001?

Operational planning and control are the activities that an organisation undertakes to ensure that its resources are used effectively and efficiently to achieve its objectives.

Operational planning and control are a key part of the ISO 9001 quality management standard. They are concerned with the day-to-day running of the organization and ensuring that its resources are used effectively and efficiently to achieve its objectives.

Operational planning and control involve the following activities:

• Setting objectives and targets.

• Planning and implementing activities.

• Monitoring and controlling activities.

• Continuous improvement.

At its core, operational planning and control are about ensuring that an organisation's resources are best used to achieve its objectives.
To do this, an organisation needs to have a clear understanding of its processes, products, and services.

It also needs to have a clear understanding of the market and the customer needs. With this information, an organisation can create a plan for how to best use its resources to achieve its objectives.

Once the plan is in place, the organisation needs to monitor and control its operations to ensure that it is achieving its objectives. The operational planning and control process is an ongoing cycle that helps organisations to continuously improve their performance.

Why Is Operational Planning And Control Important?

OPC is a dynamic process that is constantly evolving in response to changes in the external environment and the needs of the organisation. It is an essential part of any organisation's overall strategy and helps to ensure that the organisation can respond effectively to opportunities and challenges.

Operational Planning and Control is important because it provides a framework for making decisions about the allocation of resources and the implementation of activities. It helps managers to ensure that an organisation can achieve its objectives by identifying and responding to opportunities and threats in the environment.

OPC also helps managers to monitor progress towards objectives and take corrective action if necessary. This can help to avoid or minimise disruptions to operations and keep projects on track.

In addition, OPC helps to improve communication between different departments and levels within an organisation. It can also help to create a sense of ownership and responsibility among employees for the achievement of organisational goals.

Comparison Of Operational Planning And Control Requirements 

Operational planning and control are two important aspects of quality management systems (QMS). Operational planning deals with the overall planning of activities and resources within an organization, while control focuses on the ongoing monitoring and execution of these plans.

There are several similarities between operational planning and control, as well as some important differences. Both involve the identification and assessment of risks, the establishment of objectives and targets, and the development of plans to achieve these goals.

Operational planning is typically more static and long-term in nature, while control is more dynamic and short-term. Additionally, operational planning generally focuses on organisational resources and processes, while control pays more attention to the actual outputs of these processes.

Operational planning is the process of planning the overall activities and resources of an organisation. It includes the identification and assessment of risks, the establishment of objectives and targets, and the development of plans to achieve these goals. Operational planning is typically more static and long-term in nature.

Control is the process of monitoring and executing the plans developed through operational planning. Control is more dynamic and short-term in nature, focusing on the actual outputs of organisational processes rather than just the resources and processes themselves.

The key differences between operational planning and control are:

• Operational planning focuses on the future and control focuses on the present.

• Operational planning is about setting goals and control is about tracking progress.

• Operational planning is top-down, and control is bottom-up.

• Operational planning is done by management and control is done by employees.

• Operational planning is proactive, and control is reactive.

 

 

Determining the Requirements for Products & Services

The requirements for products and services provided by an organisation shall be determined and managed. Determination of the requirements for products and services is a key activity of the organisation that needs to be understood, controlled, and improved.

The requirements for products and services are determined by many factors including:

•The needs and expectations of customers, clients, users, patients, etc.

•The regulatory and statutory requirements applicable to the products and services

•The market requirements for the products and services

•The organisational objectives for the products and services

•The organisational size, structure, processes, etc.

Organisations shall establish and maintain a process for the determination of the requirements for products and services. The process shall ensure that the requirements are determined and documented. The process shall be planned and carried out in a controlled manner.

The outputs of the process shall include:

•The requirements for products and services

•The documentation of the requirements

•The approved change requests for the requirements.

Implement Your Controls

The quality management system (QMS) is a set of policies, procedures and processes used by an organisation to ensure that its products and services meet the needs of its customers. QMS is also a way to monitor and improve the quality of an organisation's products and services.

One of the main requirements of the QMS is the implementation of controls. Controls help an organisation to plan and control its operations in a way that ensures the quality of its products and services.

There are two types of controls that an organisation can implement:

• Preventive controls – these controls help to prevent problems from occurring.

• Corrective controls – these controls help to fix problems that have already occurred.

What Are Preventive Controls?

Preventive controls are actions that are taken to prevent problems from occurring. They are proactive measures that are taken to avoid defects or nonconformities in products and services.

Preventive controls can be used in all stages of the product life cycle, from design to delivery. And they can be applied to all aspects of an organisation's operations, from manufacturing to marketing.

Preventive controls help organisations to avoid problems by:

• Identifying potential problems before they occur.

• Implementing measures to prevent problems from occurring.

• Monitoring the effectiveness of preventive controls.

There are many different types of preventive controls that an organisation can implement. Some common examples include:

1. Quality planning – this involves creating plans that detail how quality will be achieved throughout the product life cycle.

2. Process control – this involves implementing procedures and methods that ensure processes are carried out correctly. This may include using inspections, testing and audits.

3. Use of technology – this involves using automation and other technological tools to help prevent errors and improve quality.

4. Employee training – this ensures that employees are aware of the importance of quality and how to achieve it.

Corrective controls are implemented to detect, identify, and correct any non-conformities that may occur during the operation of a process. They are an essential part of an organisation's quality management system (QMS) and are used to prevent, reduce, or eliminate the occurrence of non-conformities in products or services.

The design and implementation of corrective controls should consider the following factors:

• The type of product or service being produced.

• The nature of the process.

• The materials, equipment and human resources involved.

• The environment in which the process is carried out.

• The customer's requirements.