原创SQP审核清单(中英文对照)

1、原创sqp审核清单(中英文对照) 1. management commitment and continual improvement fundamental：the companys senior management shall demonstrate they are fully committed to the implementation of the requirements of the supplier qualification program. this shall include provision of adequate resources，effective comm

2、unication，systems of review and actions taken to identify and effect opportunities for improvement. 该公司的高级管理层应当证明他们会全力的供应商资格认证计划的要求执行。这应包括提供足够的资源，有效的沟通，审查和改进系统和采取确定的行动效果的机会。 1.1 does the companys management define product safety and quality objectives? 贵公司管理层确定产品的安全和质量目标？ moderate 1.2 is the review

3、of the management systems carried out at least annually? 是管理制度的检讨进行每年至少一次？ minor 1.3 does the review of the management systems include evaluation of the following items? 是否该管理系统的审查包括以下项目的评价？ 1.3.1 results of audits（internal，second and third party audits）；审计结果（内部，第二和第三方审计） 1.3.2 follow up actions fro

4、m previous management reviews；按照以往管理评审的跟踪措施 1.3.3 customer complaints and feedback；客户投诉和反馈 1.3.4 status of preventive and corrective actions；预防和纠正措施的状况 1.3.5 process performance and product conformity；过程绩效和产品的符合性 1.3.6 changes that could affect the management systems；可能影响管理体系的变化 1.3.7 product safety

5、 and quality objectives；产品安全和质量目标 1.3.8 risk management；风险管理 1.3.9 statutory and regulatory requirements；法律法规要求 1.3.10 resource needs；and 资源需求，以及 1.3.11 recommendations for improvement. 改善建议 moderate 1.4 are the decisions and actions agreed during the review communicated effectively to appropriate s

6、taff? 被审查有效适当的工作人员沟通过程中的决策和行动一致？ minor 1.5 are the actions implemented within the agreed timescales? 是在商定的时间表落实的行动？ minor 1.6 does the companys management provide the following overall resources required to implement and improve the quality management system and risk assessment plan，and to address l

7、egal，product safety，and product quality matters? 请问公司的管理提供了实现和完善的质量管理体系和风险评估计划所需的下列整体资源，以解决法律，产品的安全性和产品质量问题？ 1.6.1 personnel 人员 1.6.2 infrastructure（e.g.，building，equipment，transportetc）基础设施（如建筑物，设备，交通工具.等） 1.6.3 work environment 工作环境 1.6.4 financial support 财政支持 moderate 1.7 does the company have a

8、 process in place to identify opportunities for improvements? 公司是否制定一个过程，识别改进机会？ minor 2 risk management 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 mu

9、st be aware of and make reference 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. 该公司须有产品的风险管理计划，根据风险评估制度，应是系统的，全面的，彻底的，全面实施和保

10、持。企业必须了解并参考了最新的法规，产品标准，实践的科学或技术规范和发展，可能会影响到有关他们的产品和包装，其中这些存在于拟出售的国家的风险。 2.1 legislative and safety requirements 2.1.1 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? moderate 2.1.2 d

11、oes 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? minor 2.1.3 does the company have a process in place for ensuring it is kept informed of changes to relevant legislation，standards

12、etc? moderate 2.2 risk assessment 2.2.1 does the company establish a product risk assessment for each product or a group of similar products，e.g.，fmea? moderate 2.2.2 where manufacturing sites have no responsibility for product design，is the company provided with a validated copy of the product risk

13、 assessment? moderate 2.2.3 does the product risk assessment address the following aspects which have an effect on product safety and legality? 2.2.2.1 user types（e.g.，new born，young children，vulnerable people i.e.，elderly，disabilities） 2.2.2.2 product use（e.g.，behaviour，durability，user awareness，in

14、formation and advice） moderate 2.2.4 does the product risk assessment determine the following? 2.2.3.1 possible hazard/risk identification（e.g.，chemical，physical，regulatory）； 2.2.3.2 risk level for each identified hazard/risk（e.g.，severe，high，moderate，slight）； 2.3.3 whether the risk is acceptable co

15、nsidering the probability or likelihood and the severity and potential consequences of the effects on consumer safety（e.g.，not acceptable，review amp; improve，acceptable） moderate 2.2.5 does the company conduct a process risk assessment of hazards potentially introduced during the production，packagin

16、g or storage processes? moderate 2.2.6 does the process risk assessment take the following into account? 2.2.6.1 manufacturing parameters such as pressure，time，temperature 2.2.6.3 conditions of equipment，moulds，dies，machinery 2.2.6.4 chemicals / materials used for equipment（e.g. lubricating oils and

17、 paints） 2.2.6.5 calibration of equipment 2.2.6.6 policies on foreign body contamination（e.g. needles，metal，glass and brittle plastics） 2.2.6.7 policies on microbiological contamination（e.g. hygiene of toilet amp; canteen，pest control） 2.2.6.8 personal protective equipment（including specific clothin

18、g and footwear） moderate 2.2.7 does the process risk assessment identify the following? 2.2.7.1 a list of potential risk or hazards in the production process 2.2.7.2 control points to manage the identified risk to acceptable level 2.2.7.3 accept / reject limits defined for each control point 2.2.7.4

19、 corrective action to be taken where a ccp is out of control 2.2.7.5 responsibility of control points 2.2.7.6 records of monitoring amp; reviews moderate 2.2.8 if the assessment resulted in unacceptable risk，does the company go back to product design process or customer for modification to achieve a

20、cceptable risk? moderate 2.3 verification of risk assessment 2.3.1 is the verification of risk assessment carried out prior to production? moderate 2.3.2 is the risk assessment carried out by competent personnel （internal or external）? moderate 2.3.3 is the risk assessment regularly reviewed，at leas

21、t annually or when changes made to product design and materials and/or key manufacturing processes? moderate 2.3.4 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? major 2.3.5 w

22、here required by legislation or when it is necessary to confirm its safety or legality，does the risk assessment include the testing results（from a qualified and accredited external/internal laboratory）of a representative product? major 3 quality management system 3.1 policy statement the companys se

23、nior management shall develop，document and implement a policy statement which is authorised，regularly reviewed，signed and dated by an appropriate senior manager. 3.1.1 does the company establish a policy statement which has been communicated and understood by all staff involved with activities impac

24、ting product safety，legality and quality? moderate 3.1.2 does the policy statement include the following? 3.1.2.1 the companys intention to produce safe and legal products to defined quality，and to meet its responsibility to its customers；and 3.1.2.2 a commitment for review and continual improvement

25、 minor 3.1.3 does the company periodically review the policy statement for continuing suitability? minor 3.2 general documentation requirements 3.2.1 control of document the companys senior management shall ensure that all documents，records and data impacting the management of product safety，legalit

26、y and quality are in place and effectively controlled. 3.2.1.1 does the company effectively control all documents （internal and external） impacting product safety，legality moderate and quality? 3.2.1.2 are up-to-date versions of documents available at points of use? minor 3.2.1.3 are document legibl

27、e，unambiguous，in appropriate languages and sufficiently detailed to enable their correct application by staff? minor 3.2.1.4 are obsolete documents identified and removed from use? minor 3.2.1.5 does the company record the date and reason for any change/amendment to documents impacting product safet

28、y，legality or quality? minor 3.2.2 control of record the company shall maintain records to demonstrate the effective control and achievement of product safety，legality and quality. 3.2.2.1 does the company establish procedures for the collation，review，maintenance，storage and retrieval of all records

29、 impacting product safety，legality and quality? minor 3.2.2.2 are records legible，genuine and authorised? minor 3.2.2.3 are records readily accessible，securely stored to prevent damage deterioration? minor 3.2.2.4 are records retained in accordance with periods specified by a customer or legislation

30、? moderate 3.2.2.5 are any alterations to records justified and authorised? moderate 3.2.3 specifications the company shall ensure that specifications exist for raw materials ， components and bought in parts including packaging ，intermediate/semi-processed and finished products and any product or se

31、rvice which could affect the integrity of the finished product. 3.2.3.1 does the company establish specifications for raw materials，components，and bought-in-parts including packaging，intermediate/semi-processed and any product or service which could impact the integrity of the finished product? mode

32、rate 3.2.3.2 is a specification of each final product documented and dated? moderate 3.2.3.3 does the specification include the following information，where applicable? 3.2.3.3.1 composition，size，colour 3.2.3.3.2 bill of materials 3.2.3.3.3 assembly diagrams 3.2.3.3.4 primary packaging 3.2.3.3.5 inte

33、nded shelf life 3.2.3.3.6 warnings or instructions for use 3.2.3.3.7 use，misuse，usage patterns 3.2.3.3.8 production volumes moderate 3.2.3.4 are specifications accurate and complying with relevant safety，legislative and customer requirements? major 3.2.3.5 are current specifications accessible to re

34、levant staff? minor 3.2.3.6 does the company maintain technical dossier or package containing all relevant data （or detail of where such data is located） to ensure that products meet the applicable requirements? moderate 3.2.3.7 does the technical dossier or package include the following information

35、： 3.2.3.7.1 a detailed product specification 3.2.3.7.2 safety data sheets on chemicals used where relevant to the safety，legality or quality of the product 3.2.3.7.3 the risk assessment（s） 3.2.3.7.4 a description of the conformity assessment procedure； 3.2.3.7.5 test reports，inspection reports 3.2.3

36、.7.6 a list of the legislation，product standards with which the products are manufactured to comply 3.2.3.7.7 production control procedures and charts 3.2.3.7.8 approvals by any government body（if applicable） 3.2.3.7.9 declarations of conformity to legal requirements（if applicable） moderate 3.2.3.8

37、are specifications formally agreed with relevant parties （e.g.，signed off by the customer）? where specifications are not formally agreed，the company must demonstrate that it has taken steps to seek formal agreement. minor 3.2.3.9 are specifications regulary reviewed at least annually to ensure its a

38、dequacy and status? minor 3.3 responsibility and authority the company shall have a clearly defined and documented organisational structure that ensures the awareness of job function，responsibilities and reporting relationships of key staff. 3.3.1 is the organisational chart available and up-to-date

39、? minor 3.3.2 are responsibilities and job descriptions of key staff involved with product safety，legality and quality clearly defined and commmunicated? moderate 3.3.3 does the company have appropriate arrangements in place，to cover for the absence of key staff? minor 3.4 internal audit the company

40、 shall audit the management system to ensure that it is complied with and appropriate. 3.4.1 does the company conduct internal audits at planned intervals? moderate 3.4.2 does the company define an audit schedule detailing audit criteria （relevant procedures，requirements and standards），scope （includ

41、ing areas，departments or processes） and frequency? minor 3.4.3 is the frequency of internal audits based on risk of activities，as well as the results of previous audits? minor 3.4.4 if there are any exceptional aspects to be audited at a frequency exceeding one year， are they justified and documente

42、d in risk assessment? minor 3.4.5 are internal audits carried out by competent personnel，who shall be independent of the area of operation being assessed? moderate 3.4.6 are records of internal audits and associated corrective actions maintained with both conformity and non conformity with requireme

43、nts documented? minor 3.5 purchasing ，supplier amp; sub-contractor approval and performance monitoring the company shall control all purchasing processes which are impacting product safety，legality and quality to ensure that products and services procured conform to defined requirements. in this con

44、text suppliers shall include sub contractors and home workers. 3.5.1 does the company have a list of approved suppliers amp; sub-contractors? minor 3.5.2 is the list of approved suppliers amp; sub-contractors up-to-date to cover the components，materials and service impacting safety，legality and qual

45、ity? moderate 3.5.3 are specifications/requirements communicated to and agreed with the suppliers or sub-contractors? minor 3.5.4 does the company establish supplier amp; sub-contractor selection and approval process? minor 3.5.5 does the company conduct an ongoing supplier amp; sub-contractor perfo

46、rmance assessment? minor 3.5.6 does the company review the performance of new suppliers amp; sub-contractor against criteria within a specified trial period and thereafter at a specified frequency to decide the level of ongoing performance monitoring? minor 3.5.7 does the company determine how excep

47、tions are handled，where the use of products or services of unapproved suppliers are acceptable under emergency or unusual circumstances? minor 3.6 customer property the company shall exercise care with customer property （including intellectual property） while it is under the companys control or is b

48、eing used by the company. 3.6.1 is the customer property （e.g. software，intellectual property and products） identified，verified，protected and safeguard? minor 3.6.2 does the company have means of reporting property that is lost，damaged or otherwise found to be unsuitable for use to the customer? min

49、or 3.7 corrective and preventive action fundamental：the companys senior management shall ensure that procedures exist to record，investigate，analyse and correct the cause of non-conforming products or failure to meet standards，specifications and procedures which are impacting product safety，legality

50、and quality 3.7.1 does the company establish a procedure to capture and investigate the cause of non-conformity and potential non-conformity impacting product safety，legality and quality? moderate 3.7.2 does the corrective amp; preventive actions procedure include the following? 3.7.2.1 reviewing no

51、n-conformities （including customer complaint）； 3.7.2.2 investigating the root cause of non-conformities； 3.7.2.3 determing and implementing corrective/ preventive actions needed； 3.7.2.4 recording the results of action taken； 3.7.2.5 evaluating the effctiveness of the action taken moderate 3.7.3 are

52、 appropriate staff member identified and assigned the responsibilty and accountability for each corrective and preventive action? minor 3.7.4 are corrective / preventive actions effectively taken to eliminate the causes of non-conformities in order to prevent recurrence / occurence? moderate 3.7.5 a

53、re corrective and preventive actions undertaken in an agreed timeframe? minor 3.8 identification amp; traceability fundamental： the company shall have a system to identify and trace product lots including raw materials，components and packaging materials and follow this from the source of the incomin

54、g material through all ses of processing to supply of the product to the primary customer and vice versa in a timely manner. 3.8.1 are raw materials including packaging，processing aids，intermediate/semi-processed products，part-used materials，finished products，re-work and non-conforming materials cle

55、arly identified of lots/batches during all moderate ses of receipt，production，storage and dispatch? 3.8.2 are finished products labelled according to the customer specification and/or legislative requirements? major 3.8.3 do finished products （including re-work） have a full traceability from raw mat

56、erials source to the customer，and from the customer to the raw material source? moderate 3.8.4 is the effectiveness of the traceability system regularly tested，at least annually? minor 3.9 incident ，product withdrawal and product recall the company shall have a plan and system in place to effectivel

57、y manage product withdrawal and product recall procedures. 3.9.1 does the company have a procedure outlining methods and responsibilities for notifying their customers and other relevant parties where circumstances arise that require product to be withdrawan or recalled from distribution? moderate 3

58、.9.2 does the company have a written agreements/consensus in place with relevant parties in the supply chain regarding the product withdrawal/recall? minor 3.9.3 is there a written guidance to relevant staff regarding the type of issue/event that would constitute a significant incident or emergency

59、situation to the customer or consumer in terms of product safety，legality and quality? moderate 3.9.4 is the product withdrawal and recall procedure regularly tested，at least annually? minor 3.10 business continuity planning the company shall have procedures in place to identify methods of ensuring business continuity in the case of major incidents/thr