Product Realization

During the planning of the product realization process, the following contents shall be determined:

Quality objectives and product requirements;

Processes and documents that need to be established, and resources provided for the products;

Activities such as verification, validation, monitoring, inspection and testing required for specific products, and criteria for product acceptance shall be provided;

Records shall be provided to demonstrate that the realization process and products can meet the customer's requirements. References to specific technologies shall be included in the product realization plan and serve as an integral part of the quality plan.

Acceptance Criteria	Lingfan defines the acceptance standards and requirements, which need to be approved by customers. Regarding the nature of data sampling, the acceptance standards should be zero-defect.
Change Control	Lingfan must establish a process to control and respond to changes that affect product realization. Changes should be effective before implementation.
Defective Products	Theoretically, this is a description of an ideal state. In reality, we often face different interferences, which greatly increase the risk of product defects.
Traceability	Control and record the identification marks for product identification, and traceability is required. HCH retains the production and manufacturing records for at least three years, except in special circumstances.
Preventive Measures	Lingfan should take measures to eliminate the potential factors of non-conformity to prevent its occurrence. Preventive measures should be applicable to potential problems.
Problem Solving	Lingfan should define a problem-solving process that fundamentally identifies and eliminates problems. These analysis records should be retained and be available whenever required.
Corrective Measures	Lingfan should take actions to eliminate the causes of non-conformity to prevent its recurrence. Corrective measures should be applicable to unanticipated non-conforming products.