Production and Service Provision Control Specifications

Purpose To effectively control the steps and factors related to the production and service provision processes, ensuring that products meet customer needs and expectations.

Scope Applicable to the effective control of planning, confirmation, control, identification and traceability, customer property, and product protection in the production and service provision processes.

Definitions Special process: When the output of the production and service provision processes cannot be validated by subsequent monitoring and measurement, the ability to achieve the planned results for these processes is confirmed and periodically reconfirmed.

Responsibilities 4.1 Production Department: Responsible for controlling the production and service provision processes and controlling the working environment necessary for product conformity; responsible for product identification and traceability. Based on the minimum inventory level and production tasks issued by the Sales Department. 4.2 Technical Department: Responsible for developing corresponding process specifications or work instructions. 4.3 Sales Department: Responsible for product delivery and customer service, responsible for technical support services for product delivery and after-sales. 4.4 Quality Department: Responsible for product validation and management.

Operational Procedures 5.1 Planning of Production and Service Provision Processes 5.1.1 Implemented by the Production Department after receiving sufficient resources from the Research and Development Department and relevant departments, to ensure that the production and service provision processes are conducted under controlled conditions. 5.1.2 Controlled conditions should include:

  • Obtaining documented information on product description, service provision, or activity characteristics, and the desired results, including technical documents, drawings, product standards, work instructions, etc.
  • Configuring and using appropriate monitoring and measuring resources.
  • Monitoring and measuring at appropriate stages to validate control criteria for processes or outputs, and acceptance criteria for products and services.
  • Using appropriate equipment and working environment.
  • Assigning competent personnel, including required qualifications.
  • Confirmation and periodic reconfirmation of special processes.
  • Implementing measures to prevent human errors (process error prevention checklist).
  • Implementing release, delivery, and post-delivery activities of products and services. 5.1.3 Production Preparation Based on customer orders and sales forecasts provided by the Sales Department, the Production Department considers inventory levels and the company's production capacity. When the factory's production capacity can meet market demands, production is carried out in-house. When the factory's production capacity cannot meet market demands, outsourcing is increased based on actual conditions. A corresponding 'Production Plan' is formulated based on the analysis and approved by the representative. Production scheduling can be changed according to changes in procurement, production, sales, etc. The production workshop arranges production according to the 'Production Plan' and tracks the production progress regularly.

5.2 Special Processes and Key Processes 5.2.1 For special processes, the Production Department should take corresponding control measures to verify their process capabilities, including:

  • Process identification, verifying whether the process methods used meet requirements and are effectively implemented.
  • Recognition of the capabilities of equipment and facilities used, and strict maintenance requirements.
  • Qualification assessments for specific personnel, ensuring relevant capabilities and certification.
  • Determination of optimal process parameters by the Technical Department, responsible for developing work instructions to ensure product quality.
  • Confirmation of quality monitoring and capability for these processes.
  • Requirements for reconfirmation of processes: When production conditions change, the above processes should be reconfirmed to promptly reflect changes that affect process capability. Reconfirmation should be done annually under normal circumstances. Complete the 'Special Process Confirmation Record' in a timely manner. 5.2.2 Key Processes
  • Processes that directly impact the performance, lifespan, reliability, and economy of the final product.
  • Processes that form the quality characteristics of the product.
  • Processes with high process difficulty, prone to quality fluctuations, or frequent problems. Based on the actual situation of the company, as there are no special processes, the parameter debugging process is set as a key process.

Implementation of Production and Service Provision Processes The Production Department, based on customer orders and sales forecasts provided by the Sales Department, ensures inventory levels and issues a 'Production Plan' to the production workshop. Production is arranged according to the 'Production Plan' and a 'Material Requisition' is filled out. The material requisition is then used by the material requisition personnel to obtain the required materials from the warehouse, and the production team leader is responsible for reviewing it. 5.3.1 The machine operator monitors and sets parameters according to the equipment operation instructions and production process parameter monitoring records, using appropriate production tools for machine debugging and setup. The production team leader conducts pre-operation inspections based on the 'Operation Preparation Verification Record' and production personnel conduct initial inspections before starting production if qualified. Self-checks are performed during the production process and relevant forms are filled out. The products are then packed and the quantity is verified before being moved to the inspection area. Relevant personnel conduct regular checks on the compliance of operators with operating procedures during the production process and promptly correct any violations. 5.3.2 During the product processing process, operators perform self-inspections according to the process documents. Non-conforming products found during inspection are handled in accordance with the 'Non-Conforming Control Specifications'. 5.3.3 Use appropriate production equipment and arrange suitable working environments, and maintain and upkeep the equipment and related processing equipment. The Production Department is responsible for inspecting the equipment status and addressing any issues promptly. Equipment preventive maintenance should be carried out according to the operating vendor/service manual. To prevent any unforeseen accidents, priority should be given to preventive maintenance based on the 'Equipment Maintenance Schedule'. After maintenance, sign the 'Equipment Maintenance Schedule'. 5.3.4 Monitor the implementation of production and service operations, allocate suitable measurement and monitoring resources, and implement the 'Monitoring Resource Control Specifications'. Self-checks should be performed diligently during production and corresponding records should be made. The release of products should comply with the relevant provisions of the 'Product and Service Release Control Specifications'.

5.4 Identification and Traceability Control 5.4.1 The Production Department establishes methods for labeling the status of all materials as required and monitors their effectiveness. When significant problems occur with products, traceability is organized. 5.4.2 When traceability is required, products are uniquely identified using QR codes for traceability purposes.


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