1. Purpose

Through the development, implementation and management of the control plan, to ensure that the product manufacturing process is in a controlled state, to produce products that meet customer requirements.

2、Scope

It applies to the preparation and implementation of all product quality control plans of the company, including samples, trial production and mass production.

3、Responsibilities

3.1 Technology Department process staff for the control plan development and management of the focal point.

3.2 Quality Department, Equipment Division, Manufacturing Headquarters, Purchasing Department, the workshop for the control plan development, implementation and management of the cooperative departments.

4、Working procedure

4.1 Project planning and implementation phase according to the results of FMEA and project schedule requirements or customer requirements, by the Technology Department process staff to establish a multi-party demonstration of the group responsible for the preparation of the control plan. Control plan process inputs include process flow charts, FMEA, reliability results, design review results, product definition (drawings), material specifications, special characteristics, experience gained from similar parts, the team's understanding of the process, optimization methods (such as QFD, DOE) and so on.

4.2 If the customer does not request a control plan, a single control plan can be applied to the same series of products produced by the same process and from the same raw materials. When the customer has a requirement, a single control plan must be provided. Customers have special requirements according to customer requirements for the preparation of the control plan, no requirements for the preparation of the following provisions, version number and other related management according to the “documents and information management program,” the provisions of the implementation.

4.3 Control plan corresponding columns should be filled out and developed in accordance with the following requirements

4.3.1 Sample, trial production, production

Sample - in the prototype manufacturing, the description of dimensional measurement, material and performance testing.

Trial production - in the prototype trial manufacturing process, the description of dimensional measurements, materials and performance testing

Production - a fully documented description of the product/process characteristics, process inspection, test and measurement systems during full-scale production

If applicable to trial production or mass production, in the front of the corresponding box to mark, customer requirements need to be done when the sample quality control plan.

4.3.2 Control plan marking and numbering

Control plan number according to product differentiation, such as Santana after the reduction of “WJ04-2915JK01” for multi-page control plan is to fill in the page number (page ...... of ......) For multi-page control plans, fill in the page number (page ).

4.3.3 Part number / latest change level

Enter the number of the system, subsystem or part being controlled. If applicable, enter the most recent engineering change level and/or release date derived from the drawing specification.

4.3.4 Part Name/Description

Enter the name and description of the product/process being controlled.

4.3.5 Supplier / Factory

Fill in the name of the company preparing the control plan and the appropriate branch/plant/department.

4.3.6 Organization code (supplier code)

Fill in the identification number (e.g., Dunn's number, customer supplier code) as required by the customer.

4.3.7 Main contact person/phone number

Fill in the name and telephone number of the main contact person responsible for the control plan.

4.3.8 Core Team

Enter the name and telephone number of the person responsible for preparing the final version of the control plan.

4.3.9 Supplier/Factory Approval/Date

If necessary, obtain responsible manufacturing plant approval

4.3.10 Date (preparation)

Enter the date the control plan was first prepared

4.3.11 Date (revision)

Enter the date of the most recent revision of the control plan

4.3.12 Customer engineering approval/date (if required)

Obtain customer engineering approval, if required

4.3.13 Customer Quality Approval/Date (if required)

If necessary, obtain responsible supplier quality representative approval

4.3.14 Other approvals/dates (if required)

If necessary, obtain other consent approvals

4.3.15 Part/process number

Refer to the process flow chart for this number.

4.3.16 Process Name/Operation Description

All steps in the manufacture of a system, subsystem or component are described in the process flow diagram. Identify the process/operation in the flowchart that best describes the activity to which it belongs.

4.3.17 Production Equipment

Fill in each of the operational tools described.

Characterization (including 18-20)

4.3.18 Numbering

If necessary, fill in the sequential number of the characteristic to be controlled by the process

4.3.19 Product

A product characteristic is a feature or attribute of a part, component, or assembly that is described in a drawing or other primary engineering information. The core team shall identify special product characteristics from all sources that constitute significant product characteristics. All special characteristics must be listed in the control plan. In addition, the organization may list other product characteristics that are routinely tracked for process control in normal operations.

4.3.20 Process

A process characteristic is a process variable (input variable) that is causally related to an identified product characteristic. Process characteristics can only be measured as they occur. The core team shall identify the process characteristic and control the variation of the process characteristic to minimize product variation. Each product characteristic can have one or more process characteristics. In some processes, a process characteristic may affect multiple product characteristics.

4.3.21 Classification of special characteristics

Fill in the corresponding characteristic program identifier here. Classification is done in the following way:

S, R: A change within a reasonable range of predictability that significantly affects a product's compliance with a safety characteristic (S) or government regulation (R). Such as: flammability, occupant protection, steering control, emissions, noise, etc.; the need for special production, assembly, shipping, or control of product requirements (dimensions, specifications, testing) or process parameters, generally according to customer requirements listed in this category.

A, within a reasonable range of foreseeable variations that may significantly affect customer satisfaction, such as fit, function, installation and appearance (non-safety or regulatory aspects).

B. Changes within a reasonable range of predictability do not significantly affect product safety, compliance with government regulations, or customer satisfaction with the product, but do have a significant impact on the next step or process, such as assembly, manufacturing, and so on.

C. Changes within a predictable and reasonable range will not significantly affect the performance, installation, or appearance of the assembled product, and will not result in customer complaints.

When requested by the customer, important characteristics shall be identified by customer-specific symbols.

Methods (including 22-25)

4.3.22 Product/Process Specifications/Tolerances

Specifications/tolerances can be obtained from a variety of engineering documents such as drawings, design reviews, material standards, computer-aided design data, manufacturing or assembly requirements, etc.

4.3.23 Evaluation/Measurement Techniques

This identifies the measurement system used. The measurement system should be analyzed before it is used.

4.3.24 Sample size/frequency

When sampling is requested, list the appropriate sample size/frequency. Sample sizes may be based on industry standards.

4.3.25 Control Method

This is one of the key elements of an effective control program. This column contains a brief description of how the operation is to be controlled and, where applicable, the program number. The use of control methods should be based on an effective analysis of the process. The control method is determined by the type of process and risk identified within a quality plan such as an FMEA, and the operation may be controlled by, but is not limited to, statistical process control, inspections, count-type data, error-proofing, and sampling plans.

4.3.26 Response Plan

Preventive and corrective actions required to avoid the production of nonconforming products and uncontrolled operations shall be the responsibility of the person closest to the process (operator, shift leader, or inspector). For example, fill in “isolation and adjustment”, “equipment adjustment and reset parameters”. The measures taken should be recorded.

In all cases, suspect or nonconforming material should be clearly identified, isolated, and disposed of by the person responsible for the response plan. This column can also be used to label a specific response plan number and identify the person responsible for the response plan.

4.4 Control program implementation and management

4.4.1 The Technical Section is responsible for: the design of products, process specifications, tooling, jigs, fixtures, special inspection gauges, etc., etc.

4.4.2 Equipment Section is responsible for: assessment, improvement and management of production equipment and tooling.

4.4.3 The Quality Department is responsible for: acceptance, regular inspection, evaluation, improvement and management of general gauges; implementation of control methods for incoming and transferring inspections; and supervision of the implementation of control plans.

4.4.4 Purchasing Department is responsible for: raw materials, outsourcing parts, such as incoming; the purchase of general gauges, tools

4.4.5 Manufacturing headquarters, the workshop is responsible for: tooling, special inspection fixtures production, acceptance and implementation in strict accordance with the control plan

4.4.6 The autonomy, authority and responsibility of the project manager should be developed.

4.5 After the control plan is completed and approved, it shall be distributed to the relevant departments by the Technical Department according to the “Document and Information Management Procedures”.

4.6 For the control plan of the series of products in the event of the following circumstances, the Technology Department shall review and update the control plan, and its change method shall be implemented in accordance with the “Document and Information Management Procedures”.

4.6.1 Product changes

4.6.2 Process changes

4.6.3 Revision of test methods, frequency, etc.

4.6.4 Process instability, insufficient process capability

4.6.5 Corrective and preventive measures for customer complaints, if required.

4.6.6 For a single product control plan, in addition to the above circumstances need to review and update the control plan, when there are changes in the product also need to review and update the control plan.

4.7 Normally, the control plan shall be reviewed, revised and updated once/year.

4.8 Control plan must include incoming materials, through the entire production process until storage, shipment; control plan must include annual type test.

5, document control

5.1 References

APQP “product quality advance planning and control program” Reference Manual

5.2 Records

Quality control program

Control plan checklist