SQP验厂-风险管理系统

Risk Management Systems  SQP验厂-风险管理系统

      FUNDAMENTAL: The company shall have a product risk management plan, based on a risk assessment system which shall be systematic, comprehensive, thorough, fully implemented and maintained. Companies must be aware of and refer to; up to date legislation, product standards, codes of practice and developments in science or technology that may impact the risk concerning their products and packaging where these exist in the countries of intended sale.

      基础：公司有一个产品的风险管理计划，根据风险评估系统，将系统，全面，深入，全面实施和保持。公司必须认识和参考目前的立法，产品标准，规范和科学技术的发展有可能影响风险有关的产品和包装这些存在于国家的预期销售。

1、Legislative and Safety Requirements sqp验厂立法和安全要求
1.1   Is the company aware of relevant legislation, mandatory standards and industry/customer codes of practice applicable to the product in the countries of intended sale?
1.2   Does the company have a mean of validating information impacting product safety,quality and legality, where such information is provided by the customer or related party?
1.3   Does the company have a process in place for ensuring it is kept informed of changes to relevant legislation, standards etc?

2、Risk Assessment (Documentation) SQP验厂风险评估（文件）
2.1   Does the company establish a product risk assessment  for each product or a group of similar products, e.g., FMEA?
2.2   Does the product risk assessment address the following aspects which have an effect on product safety and legality?
   2.2.1   User types (e.g., new born, young children, vulnerable people i.e., elderly, disabilities)
   2.2.2   Product use (e.g., behaviour, durability, user awareness, information and advice)
2.3   Does the product risk assessment determine the following?
   2.3.1   Possible Hazard/Risk Identification (e.g., Chemical, Physical, Regulatory);
   2.3.2   Risk level for each identified hazard/risk (e.g., Severe, High, Moderate, Slight);
   2.3.3   Whether the risk is acceptable considering the probability or likelihood and the severity and potential consequences of the effects on consumer safety (e.g., Not Acceptable, Review & Approve, Acceptable)
2.4   Where manufacturing sites have no responsibility for product design, is the company provided with a validated copy of the product risk assessment?
2.5   Does the company conduct a process risk assessment  of hazards potentially introduced during the production, packaging or storage processes?
2.6   Does the process risk assessment take the following into account?
   2.6.1   manufacturing parameters such as pressure, time, temperature
   2.6.3   conditions of equipment, moulds, dies, machinery
   2.6.4   chemicals / materials used for equipment (e.g. lubricating oils and paints)
   2.6.5   calibration of equipment
   2.6.6   policies on foreign body contamination (e.g. needles, metal, glass and brittle plastics)
   2.6.7   policies on microbiological contamination (e.g. hygiene of toilet & canteen, pest control)
   2.6.8   personal protective equipment (including specific clothing and footwear)
2.7   Does the process risk assessment identify the following?
   2.7.1   A list of potential risk or hazards in the production process
   2.7.2   Control points to manage the identified risk to acceptable level
   2.7.3   Accept / reject limits defined for each control point
   2.7.4   Corrective action to be taken where a CCP is out of control
   2.7.5   Responsibility of Control Points
   2.7.6   Records of monitoring &  reviews
2.8   If the assessment resulted in unacceptable risk, does the company go back to product design process or customer for modification to achieve acceptable risk?

3、Verification of Risk Assessment SQP验厂风险评估的验证
3.1   Is the verification of risk assessment carried out prior to production?
3.2   Is the risk assessment carried out by competent personnel (internal or external)?
3.3   Is the risk assessment regularly reviewed, at least annually or when changes made to product design and materials and/or key manufacturing processes?
3.4   Where required by legislation, does the company document and verify the identity,qualifications and/or licence of the person providing the safety review or risk assessment?
3.5   Where required by legislation or when it is necessary to confirm its safety or legality,does the risk assessment include the testing results of a representative product?