IATF 16949 Control Plan

What is a Control Plan?

A control plan is a document that describes a system, subsystem, component, or material level for products supplied. A control plan is a live document that needs regularly scheduled reviews to confirm its effectiveness. This document should describe the actions required at each phase of a process to ensure the process outputs will meet the requirements. The control plan should also take into account the design FMEA and manufacturing process FMEA outputs.

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16949 control plans must describe the actions required at each phase of the process. During production runs, the control plan provides process monitoring and control methods to control characteristics. As the standard requires continuous improvements, the control plan must reflect a strategy that is responsive to these changing process conditions. By having a control plan in place, this will allow for your organization to be able to move forward in the event of staff turnover.

What does the standard require?

The control plan must list the controls used for the manufacturing process control, including methods for monitoring of control exercised over special characteristics defined by both the customer and the organization; the customer-required information, if any; and initiate the specified reaction plan when the process becomes unstable or not statistically capable. Control plans shall be reviewed and updated when any change occurs affecting the product, manufacturing process, measurement, logistics, and supply sources of FMEA.

The standard requires the Control Plan to include:

• A list of the controls used for the manufacturing process control.
• Methods for monitoring of controls for special characteristics as defined by customers and the organization.
• Include the customer-required information.
• If the process becomes unstable or not possible, have a specified plan.
• Control plans need to be reviewed and revised when changes occur affecting the product, manufacturing process, measurement, logistics, and supply sources of FMEA.

In addition, Annex A further addresses and defines the requirements for the Control Plan. This includes three distinct phases:

Prototype: When you build a prototype you must document the measurements, materials, and performance tests. If the customer requires, the organization may develop a Control Plan for the prototype.

Pre-launch– This stage is between the prototype and before the full production, organizations should document the measurements, materials, and performance tests that will occur during pre-launch. This stage is defined as the process of production realization.

Production – The third stage is production- organizations are required to document the product and process characteristics, process controls, tests, and measurement systems.

After production, organizations are required to go through the last and final stage-review and continual improvement. This stage must happen when:

• the organization shipped nonconforming product to the customer
• change occurs affecting the product or process
• a customer complains organizations must implement of associated corrective actions
• at a set frequency based on risk analysis

In some cases, the organization needs to get approval from the customer after review or revision of the Control Plan.

When to use the control plan?

The 16949 Control Plan should be used on an ongoing basis at an organization. It will be used throughout the entire product life cycle. To begin, it will be used in product development to document the initial plan for process control. After the initial stage, it will help guide the organization to control the process and to ensure quality. A single Control Plan can apply to a group of products that are being produced by the same process at the same time.

The Control Plan should be a dynamic document- reflecting the current methods of control and the measurement system that is being used. This document should be updated to reflect the changes in the measurement system and control methods as they are evaluated and improved.

Developing a Control Plan

Development of the Control Plan requires a multidisciplinary team and employing all available information in order to get a better understanding of the process, including:

• Process flow diagrams
• FMEA
• Lessons learned from similar parts
• Employees knowledge of the process
• Design reviews
• Optimization methods

Additionally, Annex A of the standard defines the minimum content of the Control Plan and the information required is divided into the following groups:

• General data
• Product control
• Process control
• Methods
• Reaction plan

Benefits of the Control Plan

There are several benefits of the Control Plan they include quality, customer satisfaction, and communication.

• Quality- The Control Plan provides a structured plan for organizations. This has many benefits including reducing waste, improving the quality of products during several stages: design, manufacturing, and assembly; and provides a thorough evaluation of the product and process. Additionally, control plans identify process characteristics and allow you to see the sources of variation. In other words, input variables that cause output variables.
• Communication because the Control Plan is a dynamic document, it identifies and communicates changes within the processes and product characteristics, the control methods, and measurements.
• Customer Satisfaction – The Control Plan reflects characteristics that are important to the customer. When resources are allocated correctly, it can help reduce costs without undermining quality.
• Training Employees – The control plan is also a great document for training new employees as it is easy to understand and allows individuals to grasp the process flow, inspection points, specifications, and process documentation all from one document.
• Reduces Waste – The document reduces waste and improves the quality of products during design, manufacture, and assembly. The control plans focus resources on processes and products related to characteristics that are important to the customer. The proper allocation of resources on major items helps reduce costs without sacrificing quality.
• Internal Audits – The document is also great for internal audits. The auditor can take the control plan and use this as the starting point of a process audit.
  • Learn more about internal audits and receive Internal Auditor Training Materials.

Control Plan 1st Edition

The Control Plan 1st edition manual clarifies various requirements, further explains APQP processes, provides detailed guidance on how to develop control plans, and includes the industry best practices for effectively using these plans.

Control Plan 1st Edition                      Publication Date: March 2024