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. This document should describe the actions required at each phase of a process to assure the process outputs will meet the requirements. The control plan should also take into account the design FMEA and manufacturing process FMEA outputs.
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 product, manufacturing process, measurement, logistics, supply sources or 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 product, manufacturing process, measurement, logistics, 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.
- 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
- 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
- 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.