IATF 16949:2016 Clause 8.5.1.1 Control plan

The standard requires the supplier to develop control plans using a multidisciplinary approach at the system, subsystem, component, and/or material level for pre-launch and production and prototype when required. The purpose of the control plan is to ensure that all process outputs will be in a state of control by providing process monitoring and control methods to control product and process characteristics. The control plan as in APQP manual consists of forms containing data for identifying process characteristics and helps to identify sources of variation in the inputs that cause product characteristics to vary. Three types of control plan are required. During the product design and development phase, a prototype control plan is required to be produced. During the process design and development phase, a pre-launch or pilot production control plan is required, and during the product and process validation phase, the production control plan is to be issued. Pre-launch occurs after prototype testing and prior to full production. Additional inspections and tests may be needed until the production processes have been validated and process capability assured. The additional checks serve to contain nonconformities until variation has been brought within acceptable limits for production.

Clause 8.5.1.1 Control plan

The organization shall develop control plans at, subsystem, component, and/or material level for the relevant manufacturing site and all product supplied, including those for processes producing bulk materials as well as parts. Family control plans are acceptable for bulk material and similar parts using a common manufacturing process. The organization shall have a control plan for pre-launch and production that shows linkage and incorporates information from the design risk analysis (if provided by the customer), process flow diagram, and manufacturing process risk analysis outputs (such as FMEA). The organization shall, if required by the customer, provide measurement and conformity data collected during execution of either the pre-launch or production control plans. Control plan shall include controls used for the manufacturing process control, including verification of job set-ups; first-off/last-off part validation, as applicable; methods for monitoring of control exercised over special characteristics defined by both the customer and the organization; the customer-required information, if any; specified reaction plan; when nonconforming product is detected, the process becomes statistically unstable or not statistically capable. The organization shall review control plans and update when the organization determines it has shipped nonconforming product to the customer; when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes, or risk analysis (FMEA) ; after a customer complaint and implementation of the associated corrective action, when applicable; and) at a set frequency based on a risk analysis. If required by the customer, the organization shall obtain customer approval after review or revision of the control plan

Annex A: Control Plan

1. Phases of the control plan

A control plan covers three distinct phases, as appropriate:

1. Prototype: a description of the dimensional measurements, material, and performance tests that will occur during building of the prototype. The organization shall have a prototype control plan, if required by the customer.
2. Pre-launch: a description of the dimensional measurements, material, and performance tests that occur after prototype and before full production. Pre- launch is defined as a production phase in the process of product realization that may be required after prototype build.
3. Production: documentation of product/process characteristics, process controls, tests, and measurement systems that occur during mass production.

 Control plans are established at a part number level; but in many cases, family control plans may cover a number of similar parts produced using a common process. Control plans are an output of the quality plan. 

NOTE 1 It is recommended that the organization require its suppliers to meet the requirements of this Annex.

 NOTE 2 For some bulk materials, the control plans do not list most of the production information. This information can be found in the corresponding batch formulation/recipe details. 

A.2  Elements of the control plan

A control plan includes, as a minimum, the following contents:

General data

1. control plan number;
2. issue date and revision date, if any;
3. customer information (see customer requirements);
4. organization’s name/site designation;
5. part number(s);part name/description;
6. engineering change level;
7. phase covered (prototype, pre-launch, production);
8. key contact;part/process step number;
9. process name/operation description;
10. functional group/area responsible.

Product control

1. product-related special characteristics;
2. other characteristics for control (number, product or process);
3. specification/tolerance;

Process control

1. process parameters (including process settings and tolerances);
2. process-related special characteristics;
3. machines, jigs, fixtures, tools for manufacturing (including identifiers, as appropriate);

Methods

1. evaluation measurement technique;
2. error-proofing;
3. sample size and frequency;
4. control method;

Reaction plan

1. reaction plan (include or reference);

Control plans are written descriptions of the systems for controlling parts and processes. Separate control plans cover three distinct phases:

• Prototype – A description of the dimensional measurements and material and performance tests that will occur during Prototype build. Prototype control plans are a description of the dimensional measurements and material and functional tests that will occur during prototype build. The organization’s product quality planning team should ensure that a prototype control plan is prepared. The manufacture of prototype parts provides an excellent opportunity for the team and the customer to evaluate how well the product or service meets the Voice of the Customer objectives. It is the organization’s product quality planning team’s responsibility to review prototypes for the following:
  • Assure that the product or service meets specification and report data as required.
  • Ensure that particular attention has been given to special product and process characteristics.
  • Use data and experience to establish preliminary process parameters and packaging requirements.
  • Communicate any concerns, deviations, and/or cost impact to the customer.
• Pre-launch – A description of the dimensional measurements and material and performance tests that will occur after Prototype and before full Production. Pre-launch control plans are a description of the dimensional measurements and material and functional tests that will occur after prototype and before full production. The pre-launch control plan should include additional product/process controls to be implemented until the production process is validated. The purpose of the pre-launch control plan is to contain potential non-conformities during or prior to initial production runs. Examples of enhancements in the pre-launch control plan are:
  • More frequent inspection
  • More in-process and final check points
  • Robust statistical evaluations
  • Enhanced audits
  • Identification of error-proofing devices
• Production – A comprehensive documentation of product/process characteristics, process controls, tests, and measurement systems that will occur during mass production. The production control plan is a written description of the systems for controlling production parts and processes. The production control plan is a living document and should be updated to reflect the addition or deletion of controls based on experience gained by producing parts. (Approval of the authorized customer representative may be required.) The production control plan is a logical extension of the pre-launch control plan. Mass production provides the organization the opportunity to evaluate output, review the control plan and make appropriate changes.

Control Plan Methodology

The purpose of this control plan methodology is to aid in the manufacture of quality products according to customer requirements. It does this by providing a structured approach for the design, selection and implementation of value-added control methods for the total system. Control plans provide a written summary description of the systems used in minimizing process and product variation. The control plan does not replace the information contained in detailed operator instructions. This methodology is applicable to a wide range of manufacturing processes and technologies. The control plan is an integral part of an overall quality process and is to be utilized as a living document. An important phase of the process for quality planning is the development of a control plan. A control plan is a written description of the system for controlling parts and processes. A single control plan may apply to a group or family of products that are produced by the same process at the same source. Drawings and visual standards, as necessary, may be attached to the control plan for illustration purposes. In support of a control plan, operator and process monitoring instructions should be defined and used continually. In effect, the control plan describes the actions that are required at each phase of the process including receiving, in-process, out-going, and periodic requirements to assure that all process outputs will be in a state of control. During regular production runs, the control plan provides the
process monitoring and control methods that will be used to control characteristics. Since processes are expected to be continually updated and improved, the control plan reflects a strategy that is responsive to these changing process conditions. The control plan is maintained and used throughout the product life cycle. Early in the product life cycle its primary purpose is to document and communicate the initial plan for process control. Subsequently, it guides manufacturing in how to control the process and ensure product quality. Ultimately, the control plan remains a living document, reflecting the current methods of control, and measurement systems used. The control plan is updated as measurement systems and control methods are evaluated and improved. For process control and improvement to be effective, a basic understanding of the process must be obtained. A multi-disciplined team is established to develop the control plan by utilizing all the available information to gain a better understanding of the process, such as:

• Process Flow Diagram
• System/Design/Process Failure Mode and Effects Analysis
• Special Characteristics
• Lessons Learned from Similar Parts
• Team’s Knowledge of the Process
• Design Reviews
• Optimization Methods (e.g., QFD, DOE, etc.)

The benefits of developing and implementing a control plan include:

• The control plan methodology reduces waste and improves the quality of products during design, manufacturing, and assembly. This structured discipline provides a thorough evaluation of the product and process. Control plans identify process characteristics and identify the control
• methods for the sources of variation (input variables), which cause variation in product characteristics (output variables).
• Control plans focus resources on processes and products related to characteristics that are important to the customer. The proper allocation of resources on these major items helps to reduce costs without sacrificing quality.
• As a living document the control plan identifies and communicates changes in the product/process characteristics, control method, and characteristic measurement.

1.PROTOTYPE, PRE-LAUNCH, PRODUCTION: Indicate the appropriate category.

• Prototype – A description of the dimensional measurements material and performance tests occurring during Prototype build.
• Pre-Launch – A description of the dimensional measurements, material and performance tests that will occur after Prototype and before normal Production.
• Production – A comprehensive documentation of product/process characteristics, process controls, tests, and measurement systems occurring during normal production.

2) CONTROL PLAN NUMBER: Enter the control plan document number used for tracking, if
applicable. For multiple control pages, enter page number (page___of___).

3) PART NUMBER/LATEST CHANGE LEVEL: Enter the number of the system, subsystem or component being controlled. When applicable, enter the latest engineering change

4) PART NAME/DESCRIPTION: Enter the name and description of the product/process being controlled.

5) ORGANIZATION/PLANT: Enter the name of the company and the appropriate division/plant/department preparing the control plan.

6) ORGANIZATION CODE (SUPPLIER CODE): Enter the identification number (For example: DUNS, Customer Supplier Code) as requested by the customer.

7) KEY CONTACT/PHONE AND OTHER CONTACT INFORMATION: Enter the name, telephone number and other contact information, e.g., email of the primary contact responsible for the control plan.

8) CORE TEAM: Enter the name(s), telephone number(s), and other contact information, e.g., email of the individual(s) responsible for preparing the control plan to the latest revision. It is recommended that all of the team members’ names, phone numbers, and locations be included on an attached distribution list.

9) ORGANIZATION/PLANT APPROVAL/DATE: Obtain the responsible manufacturing plant approval of the organization (if required – see appropriate customer-specific requirements).

10) DATE (ORIG.): Enter the date that the original control plan was compiled.

11) DATE (REV.): Enter the date of the latest control plan updates.

12) CUSTOMER ENGINEERING APPROVAL/DATE: Obtain the responsible customer engineering approval (if required – see appropriate customer-specific requirements).

13) CUSTOMER QUALITY APPROVAL/DATE: Obtain the responsible customer supplier quality representative approval (if required – see appropriate customer-specific requirements)

14) OTHER APPROVAL/DATE: Obtain any other agreed upon approval (if required).

15) PART/PROCESS NUMBER: This item number is usually referenced from the Process Flow Chart. If multiple part numbers exist (assembly), list the individual part numbers and their processes accordingly.

16) PROCESS NAME/ OPERATION DESCRIPTION: All steps in the manufacturing of a system, subsystem, or component are described in a process flow diagram. Identify the process/operation name from the flow diagram that best describes the activity being addressed.

17) MACHINE, DEVICE, JIG, TOOLS FOR MANUFACTURING: For each operation that is described, identify the processing equipment, e.g., machine, device, jig, or other tools for manufacturing, as appropriate.

CHARACTERISTICS (Includes items 18, 19 and 20): A distinguishing feature, dimension or property of a process or its output (product) on which variable or attribute data can be collected. Use visual aids where applicable

18) NUMBER: Assign a cross reference number to all applicable documents such as, but not limited to, process flow diagram, numbered blue print, FMEAs, and drawings or other visual standards, if required.

19) PRODUCT: Product Characteristics are the features or properties of a part, component or assembly that are described on drawings or other primary engineering information. The Core Team should identify the special product characteristics that are a compilation of important Product Characteristics from all sources. All special characteristics must be listed on the control
plan. In addition, the organization may list other Product Characteristics for which process controls are routinely tracked during normal operations.

20) PROCESS: Process Characteristics are the process variables (input variables) that have a cause and effect relationship with the identified Product Characteristic. A Process Characteristic can only be measured at the time it occurs. The Core Team should identify Process Characteristics for which variation must be controlled to minimize product variation. There could be one or more Process Characteristics listed for each Product Characteristic. In some processes one Process Characteristic may affect several Product Characteristics.

21) SPECIAL CHARACTERISTIC CLASSIFICATION:Use the appropriate classification as required by the customer (see the appropriate customer-specific requirements), to designate the type of special characteristic or this field can be left blank for other undesignated characteristics. Customers may use unique symbols to identify important characteristics, such as those that affect customer safety, compliance with regulations, function, fit, or appearance.

METHODS (INCLUDES ITEMS 22-25) A systematic plan using procedures and other tools to control a process.

22) PRODUCT/PROCESS SPECIFICATION/ TOLERANCE: Specifications/tolerance may be obtained from various engineering documents, such as, but not limited to, drawings, design reviews, material standard, computer-aided design data, manufacturing, and/or assembly requirements

23) EVALUATION/ MEASUREMENT TECHNIQUE: This column identifies the measurement system being used. This could include gages, fixtures, tools, and/or test equipment required to measure the part/process/manufacturing equipment. A measurement systems analysis should be done to ensure control of monitoring and measuring devices prior to relying on a measurement system. For example, an analysis of the linearity, reproducibility, repeatability, stability and accuracy of the measurement system should be performed. Improvements to the measurement systems should be made accordingly.

24) SAMPLE SIZE/ FREQUENCY: When sampling is required list the corresponding sample size and frequency.

25) CONTROL METHOD: This is one of the critical elements to an effective control plan. This column contains a brief description of how the operation will be controlled, including procedure numbers where applicable. The control method utilized should be based on effective analysis of the process. The control method is determined by the type of process and the risks identified during quality planning (e.g. FMEA). Operations may be controlled by, but are not limited to, statistical process control, inspection, attribute data, mistake-proofing, (automated/non- automated), and sampling plans. The control plan descriptions should reflect the planning and strategy being implemented in the manufacturing process. If elaborate control procedures are used, the plan will typically reference the procedure document by a specific identification name and/or number. The method of control should be continually evaluated for effectiveness of process control. For example, significant changes in the process or process capability should lead to an evaluation of the control method.

26) REACTION PLAN: The reaction plan specifies the corrective actions necessary to avoid producing nonconforming products or operating out of control. The actions should normally be the responsibility of the people closest to the process, the operator, job-setter, or supervisor, and be clearly designated in the plan. Provisions should be made for documenting actions taken. In all cases, suspect and nonconforming products must be clearly identified and quarantined, and disposition made by the responsible person designated in the reaction plan. This column may also refer to a specific reaction plan number and identify the person responsible for the reaction plan.

Control plan checklist

• Have all the controls identified in the PFMEA been included in the control plan?
• Are all special product/process characteristics included in the control plan?
• Were DFMEA and PFMEA used to prepare the control plan?
• Are material specifications required inspection identified?
• Does the control plan address incoming material/components through processing/assembly including packaging?
• Are engineering performance testing and dimensional requirements identified?
• Are gages and test equipment available as required by the control plan?
• If required, has the customer approved the control plan?
• Are the gage methodology and compatibility appropriate to meet customer requirements?
• Have measurement systems analysis been completed in accordance with customer requirement
• Are sample sizes based on industry standards, statistical sampling plan tables, or other statistical process control methods or techniques?

Special Characteristics

The Description/Rationale column includes all special process and product characteristics agreed upon by the cross functional team. A sequential number (No.) is assigned to each characteristics listed to ensure none are overlooked by the supplier when the control plan (Part Two) is completed. Develop a rationale for each special characteristic and add this information to the list for clarification. When considered necessary, a Supplemental Form will depict measurement points and coordinates, which will be considered as an extension of the control plan when used.

No.	Description/Rationale	Specification / Tolerance	Classs	Illustration/Pictorial

Different types of processes present challenges and opportunities for control and reduction of variation. The process types can be related to their most common sources of variation or the dominant factors in determining the quality of the product. There are many effective methods of performing process analysis. It is up to the organization to determine the best method to analyze the process. Examples are:

• Fault Tree Analysis
• Design of Experiments
• Cause and Effect