原創(chuàng)SQP審核清單(中英文對(duì)照)

1、原創(chuàng)sqp審核清單(中英文對(duì)照) 1. management commitment and continual improvement fundamental：the company"s 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，effectiv

2、e communication，systems of review and actions taken to identify and effect opportunities for improvement. 該公司的高級(jí)管理層應(yīng)當(dāng)證明他們會(huì)全力的供應(yīng)商資格認(rèn)證計(jì)劃的要求執(zhí)行。這應(yīng)包括提供足夠的資源，有效的溝通，審查和改進(jìn)系統(tǒng)和采取確定的行動(dòng)效果的機(jī)會(huì)。 1.1 does the company"s management define product safety and quality objectives? 貴公司管理層確定產(chǎn)品的安全和質(zhì)量目標(biāo)？ moderate 1.2 is

3、 the review of the management systems carried out at least annually? 是管理制度的檢討進(jìn)行每年至少一次？ minor 1.3 does the review of the management systems include evaluation of the following items? 是否該管理系統(tǒng)的審查包括以下項(xiàng)目的評(píng)價(jià)？ 1.3.1 results of audits（internal，second and third party audits）；審計(jì)結(jié)果（內(nèi)部，第二和第三方審計(jì)） 1.3.2 follow up

4、 actions from previous management reviews；按照以往管理評(píng)審的跟蹤措施 1.3.3 customer complaints and feedback；客戶投訴和反饋 1.3.4 status of preventive and corrective actions；預(yù)防和糾正措施的狀況 1.3.5 process performance and product conformity；過(guò)程績(jī)效和產(chǎn)品的符合性 1.3.6 changes that could affect the management systems；可能影響管理體系的變化 1.3.7 pr

5、oduct safety and quality objectives；產(chǎn)品安全和質(zhì)量目標(biāo) 1.3.8 risk management；風(fēng)險(xiǎn)管理 1.3.9 statutory and regulatory requirements；法律法規(guī)要求 1.3.10 resource needs；and 資源需求，以及 1.3.11 recommendations for improvement. 改善建議 moderate 1.4 are the decisions and actions agreed during the review communicated effectively to a

6、ppropriate staff? 被審查有效適當(dāng)?shù)墓ぷ魅藛T溝通過(guò)程中的決策和行動(dòng)一致？ minor 1.5 are the actions implemented within the agreed timescales? 是在商定的時(shí)間表落實(shí)的行動(dòng)？ minor 1.6 does the company"s management provide the following overall resources required to implement and improve the quality management system and risk assessment pla

7、n，and to address legal，product safety，and product quality matters? 請(qǐng)問(wèn)公司的管理提供了實(shí)現(xiàn)和完善的質(zhì)量管理體系和風(fēng)險(xiǎn)評(píng)估計(jì)劃所需的下列整體資源，以解決法律，產(chǎn)品的安全性和產(chǎn)品質(zhì)量問(wèn)題？ 1.6.1 personnel 人員 1.6.2 infrastructure（e.g.，building，equipment，transportetc）基礎(chǔ)設(shè)施（如建筑物，設(shè)備，交通工具.等） 1.6.3 work environment 工作環(huán)境 1.6.4 financial support 財(cái)政支持 moderate 1.7 does

8、the company have a process in place to identify opportunities for improvements? 公司是否制定一個(gè)過(guò)程，識(shí)別改進(jìn)機(jī)會(huì)？ 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 mainta

9、ined. companies must 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. 該公司須有產(chǎn)品的風(fēng)險(xiǎn)管理計(jì)劃，根據(jù)風(fēng)險(xiǎn)評(píng)估制度，應(yīng)是

10、系統(tǒng)的，全面的，徹底的，全面實(shí)施和保持。企業(yè)必須了解并參考了最新的法規(guī)，產(chǎn)品標(biāo)準(zhǔn)，實(shí)踐的科學(xué)或技術(shù)規(guī)范和發(fā)展，可能會(huì)影響到有關(guān)他們的產(chǎn)品和包裝，其中這些存在于擬出售的國(guó)家的風(fēng)險(xiǎn)。 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

11、? moderate 2.1.2 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? minor 2.1.3 does the company have a process in place for ensuring it is kept informed of changes to relevant legi

12、slation，standards 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 o

13、f the product risk 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

14、，user awareness，information 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 ris

15、k is acceptable considering 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 p

16、roduction，packaging 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. lu

17、bricating oils and 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（includin

18、g specific clothing 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 con

19、trol point 2.2.7.4 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 modific

20、ation to achieve acceptable 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 regularl

21、y reviewed，at least 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 assessm

22、ent? major 2.3.5 where required by legislation or when it is necessary to confirm its safety or legality，does the risk assessment include the testing results（from a qualified and accredited external/internal laboratory）of a representative product? major 3 quality management system 3.1 policy stateme

23、nt the company"s senior 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 involv

24、ed with activities impacting product safety，legality and quality? moderate 3.1.2 does the policy statement include the following? 3.1.2.1 the company"s 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 re

25、view and continual improvement 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 company"s senior management shall ensure that all documents，records and data impacting the

26、management of product safety，legality 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 us

27、e? minor 3.2.1.3 are document legible，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

28、to documents impacting product safety，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，

29、storage and retrieval of all records 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 sp

30、ecified by a customer or legislation? 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 fin

31、ished products and any product or service 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 int

32、egrity of the finished product? moderate 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.

33、3.4 primary packaging 3.2.3.3.5 intended 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 cur

34、rent specifications accessible to relevant 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 packa

35、ge include the following information： 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 t

36、est reports，inspection reports 3.2.3.7.6 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 requireme

37、nts（if applicable） moderate 3.2.3.8 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 review

38、ed at least annually to ensure its adequacy 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 organisat

39、ional chart available and up-to-date? 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?

40、minor 3.4 internal audit the company 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，requi

41、rements and standards），scope （including 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 ye

42、ar， are they justified and documented 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 conformi

43、ty and non conformity with requirements 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

44、to defined requirements. in this context 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 compone

45、nts，materials and service impacting safety，legality and quality? 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 c

46、ompany conduct an ongoing supplier amp; sub-contractor performance 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

47、performance monitoring? minor 3.5.7 does the company determine how exceptions 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 （includi

48、ng intellectual property） while it is under the companys control or is being 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，

49、damaged or otherwise found to be unsuitable for use to the customer? minor 3.7 corrective and preventive action fundamental：the company"s senior management shall ensure that procedures exist to record，investigate，analyse and correct the cause of non-conforming products or failure to meet standa

50、rds，specifications and procedures which are impacting product safety，legality 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

51、 amp; preventive actions procedure include the following? 3.7.2.1 reviewing non-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 tak

52、en； 3.7.2.5 evaluating the effctiveness of the action taken moderate 3.7.3 are 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

53、 non-conformities in order to prevent recurrence / occurence? moderate 3.7.5 are 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，com

54、ponents and packaging materials and follow this from the source of the incoming 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，

55、part-used materials，finished products，re-work and non-conforming materials clearly 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

56、do finished products （including re-work） have a full traceability from raw materials 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

57、product recall the company shall have a plan and system in place to effectively 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 t

58、hat require product to be withdrawan or recalled from distribution? moderate 3.9.2 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

59、type of issue/event that would constitute a significant incident or emergency 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/