Product Safety Control Specifications

Purpose: To ensure effective control of product safety-related products and manufacturing processes.

Scope: Applicable to process control related to product safety in the enterprise.

Responsibilities:

3.1 The technical department is responsible for the centralized management of this specification and is responsible for the overall identification and control of product safety-related product and manufacturing process requirements.

3.2 Each department is responsible for the identification and control management of product safety-related requirements within its scope of responsibility.

Product Safety Control Flowchart, see attachment

Workflow:

Identify legal and regulatory requirements for product safety; The technical department is responsible for collecting relevant legal and regulatory requirements for product safety, including requirements and regulations related to product safety supervision issued by government agencies, and filling out the 'Product Safety Requirement Identification and Control Evaluation Checklist'.
Notify customers of the above requirements; For identified legal and regulatory requirements related to product safety, the technical department informs the sales department personnel to notify customers in order to ensure customer understanding and timely implementation.
Special approval of Design FMEA; The technical department conducts DFMEA analysis of relevant product safety characteristics and provides special approval.
Identify product safety characteristics; The technical department organizes relevant departments such as quality, sales, procurement, and production to identify comprehensive product safety requirements and fill out the 'Product Safety Requirement Identification and Control Evaluation Checklist'.
Identify and control safety-related characteristics from the perspective of product and manufacturing; During design and development, identify and determine the safety characteristics of the product from the perspective of production and manufacturing, and incorporate them into relevant control plans, FMEAs, and work instructions for control.
Special approval of control plans and process FMEA; After the control plans, FMEAs, and work instructions are formulated and reviewed, they are implemented after obtaining relevant leadership approval according to the process.
Response plan; In the control plan, develop response plans for various possible errors or variations.
Definition and customer notification of responsibilities, escalation processes, and information flow, including top management; For product safety requirements, clarify the departments and individuals responsible for implementation to ensure that information is effectively communicated and ultimately conveyed to top management and customers. Fill out the 'Product Safety Requirement Identification and Control Evaluation Checklist'.
Training for personnel involved in product safety-related products and related manufacturing processes determined by the company or customers; The person responsible for human resources is responsible for formulating and implementing training.
Approval of changes to products or processes, including evaluation of potential impacts on product safety resulting from process and product changes; Fill out the 'Product Safety Requirement Identification and Control Evaluation Checklist' for the sources included in the product safety requirements.
Transfer of product safety requirements throughout the supply chain, including customer-specified sources; Implement according to the 'Product Safety Requirement Identification and Control Evaluation Checklist' and include it in the purchasing requirements.
Product traceability by manufacturing batch throughout the entire supply chain; Control according to the 'Identification and Control Specification for Traceability Labels'.
Lessons learned from the introduction of new products; Consider the safety requirements of old products and similar products for each new product development to improve work efficiency.

Related Documents:

6.1 QD8.1.1-2021 'Project Management and APQP Control Specification'
6.2 QD8.3.1-2021 'Design and Development Control Specification'

Related Records:

7.1 QR4.4-03 'Product Safety Requirement Identification and Control Evaluation Checklist'

Attachment: Product Safety Control Flowchart

Process | Document Information | Department/Person in Charge ---|---|--- a) Identify statutory and regulatory product safety requirements | 'Product Safety Requirement Identification and Evaluation Checklist' | Technical department b) Notify customers of the above requirements | Notify customers | Technical and sales departments c) Identify customer requirements | 'Product Safety Requirement Identification and Evaluation Checklist' | Technical and sales departments d) Special approval of DFMEA | 'DFMEA' | Technical department e) Identify product safety characteristics | 'Product Safety Requirement Identification and Evaluation Checklist' | Technical department f) Control safety-related characteristics | 'Work Instructions' | Technical and production departments g) Special approval of control plans and PFMEA | 'Production Control Plan' 'PFMEA' | Technical department h) Define response plans | 'Control Plan' | Technical department i) Define responsibilities, escalation processes, and information flow | 'Product Safety Requirement Identification and Evaluation Checklist' | Technical department Human resources department j) Product safety training | 'Training Records' | k) Evaluation of potential impacts of changes | 'Product Safety Requirement Identification and Evaluation Checklist' | Technical and quality departments l) Customer-specified sources | Evidence of customer-specified sources | Technical and sales departments m) Traceability throughout the supply chain | 'Identification and Control Specification for Traceability Labels' | Technical department n) Lessons learned from new product introductions | 'Feasibility Analysis for New Product Development' | Technical department

Related Document Information:

QD7.5.1 'Document Information Control Specification'
QD6.1.3 'Regulatory and Other Requirement Control Specification'
QD10.2.1 'Nonconformity Correction Control Specification'
QD10.1.1 'Continuous Improvement Control Specification'
QR7.4-01 'Information Communication Checklist'
QR7.4-02 'Information Exchange Communication Consultation Record'

Attachment: Information Exchange and Communication Flowchart

Flow | Process | Responsibility Department/Person | Task | Quality Measurement | Internal and External Environment | Health and Safety | Quality Department | Production Department | Administrative Department | Feedback ---|---|---|---|---|---|---|---|---|---|---| | Feedback | | Feedback Department | Feedback | | | | | | | | Root Cause Analysis | | Centralized Department | Root Cause Analysis | | | | | | | | Information Utilization | | Responsible Department | Information Utilization | | | | | | | | Information Exchange and Communication | | Related Department | Information Exchange and Communication | | | | | | | | Develop and implement corrective/preventive measures | | Responsible Department | Develop and implement corrective/preventive measures | | | | | | | | Measure verification | | Production Department, Administrative Department | Measure verification | | | | | | | | Measure effectiveness review | | Production Department, Administrative Department | Measure effectiveness review | | | | | | | | Measure standardization | | Production Department, Administrative Department | Measure standardization | | | | | | | | Collect information | | Production Department, Administrative Department | Collect information | | | | | | | | Fill out 'Information Feedback Form' 'Information Exchange Communication Consultation Record' | | Production Department, Administrative Department | Fill out 'Information Feedback Form' 'Information Exchange Communication Consultation Record' | | | | | | | | Emergency response, handling (temporary measures) | | Production Department, Administrative Department | Emergency response, handling (temporary measures) | | | | | | | | Root cause analysis | | Production Department, Administrative Department | Root cause analysis | | | | | | | | Organize review if necessary | | Production Department, Administrative Department | Organize review if necessary | | | | | | | | Information utilization | | Production Department, Administrative Department | Information utilization | | | | | | | | Manage information exchange | | Production Department, Administrative Department | Manage information exchange | | | | | | | | Employee representatives participate in quality, environmental, health, and safety management | | Production Department, Administrative Department | Employee representatives participate in quality, environmental, health, and safety management | | | | | | | | Measure development and implementation | | Production Department, Administrative Department | Measure development and implementation | | | | | | | | Measure verification, effectiveness review | | Production Department, Administrative Department | Measure verification, effectiveness review | | | | | | | | Standardize measures | | Production Department, Administrative Department | Standardize measures | | | | | | |