Product Safety and Risk Control
Program
1. Purpose
Strengthen the control of product safety and risk to avoid product and personnel injury,
financial loss, etc. caused by improper development and processing, or in the process of
product development and realization.
2. Scope of application
It is applicable to the whole process of product process development, product realization
and service.
3. Responsibilities
3.1 Responsibilities of the Technical Department
3.1.1 Responsible for product safety and risk analysis during process design.
3.1.2 Responsible for process risk analysis and control.
3.2 The production department is responsible for the process control of product safety
production.
3.3 The Quality Department is responsible for the inspection process control of product
safety, and conducts quality capability review of suppliers involved in product safety.
3.4 The General Department is responsible for organizing the training on product safety
responsibilities for employees who are responsible for product safety operations.
3.5 Relevant responsible units are responsible for implementing corrective and preventive
measures involving product safety and risks.
4. Working procedure
4.1 Product Safety Identification
4.1.1 The technical department organizes and sets up a multi-party demonstration team.
During the early quality planning process of the product, the safety characteristics of the
product are determined according to the characteristics of the product and its impact on the
function and safety of the product and the relevant regulations of the customer. Listed on the
Bill of Materials (BOM).
4.1.2 The technical department stipulates the identification and control activities ofproduct safety and risk in the process APQP (Process Quality Advance Planning and Control
Plan).
4.2 Product Safety Responsibilities
4.2.1 In the process of product design, production and inspection, the multi-party
demonstration team must not only consider meeting product standards, but must also adopt
advanced and effective error-proofing technology to ensure product safety.
4.2.2 The technical department must consider effective safety protection during the
quality planning process.
4.2.3 The Production Department is responsible for production safety and implements
the "Three Simultaneities" of production safety, which are specifically implemented in
accordance with the "Responsibilities for Production Safety" and the "Regulations on
Supervision and Administration of Production Safety".
4.2.4 The quality department inspects the product characteristics related to safety and
archives the records.
4.2.5 The General Department is responsible for training all operators engaged in
product safety characteristics, confirming that they meet the qualification requirements, and
carrying out necessary product safety responsibilities publicity, in order to achieve
well-known knowledge of product safety responsibilities.
4.2.6 Management personnel at all levels and employees responsible for product safety
operations shall clarify safety responsibilities.
4.3 Product safety and risk control
4.3.1 The technical department uses PFMEA technology to analyze and improve product
safety and risk in the APQP planning process.
4.3.2 When the quality department reviews the quality capability of the supplier, it must
review the safety of the products involved to determine its capability to guarantee product
safety.
4.3.3 When supplying each batch of products, suppliers involved in product safety
features must provide our factory with inspection reports and related materials of materials or
products to ensure their traceability.
4.3.4 The technical department shall mark documents related to product safety
characteristics (such as process, PFMEA, control plan, etc.).
4.3.5 In the process confirmation stage, the technical department evaluates and verifies
the risk of the product, and the results are kept as safety records.
4.3.6 The use and operation methods involving safety shall be clearly described in the
product description.
4.4 Nonconforming product response plan involving safety4.4.1 The product shall be marked for safety during transportation and storage.
4.4.2 For products involving safety, the use period and conditions of use shall be
indicated on the manual.
4.4.3 When the safety-related products are found to be unqualified, measures such as
storage and recovery shall be adopted.
5. Related file directory
5.1 "Quality Advance Planning and Control Plan Procedure"
5.2 "Safety Production Supervision and Administration Regulations"
5.3 "Safety Production Hierarchical Management Responsibilities"
6. Relevant records and retention period
