SQP審核清單(中英文對照).doc

1、SQP審核清單(中英文對照)1.Management mitment and continual improvement FUNDAMENTAL：The pany"s senior management shall demonstrate they are fully mitted to the implementation of the requirements of the Supplier Qualification Program.This shall include provision of adequate resources，effective munication，s

2、ystems of review and actions taken to identify and effect opportunities for improvement.該公司的高級管理層應(yīng)當證明他們會全力的供給商資格認證方案的要求執(zhí)行。這應(yīng)包括提供足夠的資，有效的溝通，審查和改良系統(tǒng)和采取確定的行動效果的時機。1.1 Does the pany"s management define product safety and quality objectives? 貴公司管理層確定產(chǎn)品的平安和質(zhì)量目的？ Moderate 1.2 Is the review of the mana

3、gement systems carried out at least annually? 是管理制度的檢討進展每年至少一次？ Minor 1.3 Does the review of the management systems include evaluation of the following items? 是否該管理系統(tǒng)的審查包括以下工程的評價？ 1.3.1 Results of auditsinternal，second and third party audits；審計結(jié)果內(nèi)部，第二和第三方審計1.3.2 Follow up actions from previous manag

4、ement reviews；按照以往管理評審的跟蹤措施 1.3.3 Customer plaints and feedback；客戶投訴和反應(yīng) 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；過程績效和產(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 Product safety and quality object

5、ives；產(chǎn)品平安和質(zhì)量目的 1.3.8 Risk management；風險管理 1.3.9 Statutory and regulatory requirements；法律法規(guī)要求 1.3.10 Resource needs；and資需求，以及 1.3.11 Remendations for improvement.改善建議 Moderate1.4 Are the decisions and actions agreed during the review municated effectively to appropriate staff? 被審查有效適當?shù)墓ぷ魅藛T溝通過程中的決策和行動

6、一致？ Minor 1.5 Are the actions implemented within the agreed timescales? 是在商定的時間表落實的行動？ Minor 1.6 Does the pany"s management provide the following overall resources required to implement and improve the quality management system and risk assessment plan，and to address legal，product safety，and pr

7、oduct quality matters? 請問公司的管理提供了實現(xiàn)和完善的質(zhì)量管理體系和風險評估方案所需的以下整體資，以解決法律，產(chǎn)品的平安性和產(chǎn)品質(zhì)量問題？1.6.1 personnel 人員1.6.2 infrastructuree.g.，building，equipment，transport.etc根底設(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 財政支持 Moderate 1.7 Does the pany have a process in place to identify opportu

8、nities for improvements? 公司是否制定一個過程，識別改良時機？ Minor 2 Risk Management FUNDAMENTAL：The pany shall have a product risk management plan，based on a risk assessment system which shall be systematic，prehensive，thorough，fully implemented and maintained.panies must be aware of and make reference to up-to-date

9、 legislation，product standards，codes of practice and developments in science or technology that may impact the risk concerning their products and packaging where these e_ist in the countries of intended sale.該公司須有產(chǎn)品的風險管理方案，根據(jù)風險評估制度，應(yīng)是系統(tǒng)的，全面的，徹底的，全面施行和保持。企業(yè)必須理解并參考了最新的法規(guī)，產(chǎn)品標準，理論的科學或技術(shù)標準和開展，可能會影響到有關(guān)他們的

10、產(chǎn)品和包裝，其中這些存在于擬出售的國家的風險。2.1 Legislative and Safety Requirements2.1.1 Is the pany 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 Does the pany have a mean of validating information im

11、pacting product safety，quality and legality，where such information is provided by the customer or related party? Minor 2.1.3 Does the pany have a process in place for ensuring it is kept informed of changes to relevant legislation，standards etc? Moderate 2.2 Risk Assessment2.2.1 Does the pany establ

12、ish a product risk assessment for each product or a group of similar products，e.g.，F(xiàn)MEA? Moderate 2.2.2 Where manufacturing sites have no responsibility for product design，is the pany provided with a validated copy of the product risk assessment? Moderate 2.2.3 Does the product risk assessment addre

13、ss the following aspects which have an effect on product safety and legality? 2.2.2.1 User typese.g.，new born，young children，vulnerable people i.e.，elderly，disabilities2.2.2.2 Product usee.g.，behaviour，durability，user awareness，information and adviceModerate 2.2.4 Does the product risk assessment de

14、termine the following?2.2.3.1 Possible Hazard/Risk Identificatione.g.，Chemical，Physical，Regulatory；2.2.3.2 Risk level for each identified hazard/riske.g.，Severe，High，Moderate，Slight； 2.3.3 Whether the risk is acceptable considering the probability or likelihood and the severity and potential consequ

15、ences of the effects on consumer safetye.g.，Not Acceptable，Review & Improve，AcceptableModerate 2.2.5 Does the pany conduct a process risk assessment of hazards potentially introduced during the production，packaging or storage processes? Moderate 2.2.6 Does the process risk assessment take the fo

16、llowing 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 equipmente.g.lubricating oils and paints2.2.6.5 calibration of equipment 2.2.6.6 policies on foreign body contaminatio

17、ne.g.needles，metal，glass and brittle plastics2.2.6.7 policies on microbiological contaminatione.g.hygiene of toilet & canteen，pest control2.2.6.8 personal protective equipmentincluding specific clothing and footwearModerate 2.2.7 Does the process risk assessment identify the following? 2.2.7.1 A

18、 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 Corrective action to be taken where a CCP is out of control 2.2.7.5 Responsibility of Control Po

19、ints 2.2.7.6 Records of monitoring & reviews Moderate 2.2.8 If the assessment resulted in unacceptable risk，does the pany go back to product design process or customer for modification to achieve acceptable risk? Moderate 2.3 Verification of Risk Assessment2.3.1 Is the verification of risk asses

20、sment carried out prior to production? Moderate 2.3.2 Is the risk assessment carried out by petent personnel internal or e_ternal? Moderate 2.3.3 Is the risk assessment regularly reviewed，at least annually or when changes made to product design and materials and/or key manufacturing processes? Moder

21、ate 2.3.4 Where required by legislation，does the pany document and verify the identity，qualifications and/or licence of the person providing the safety review or risk assessment? Major 2.3.5 Where required by legislation or when it is necessary to confirm its safety or legality，does the risk assessm

22、ent include the testing resultsfrom a qualified and accredited e_ternal/internal laboratoryof a representative product? Major 3 Quality Management System 3.1 Policy Statement The pany"s senior management shall develop，document and implement a policy statement which is authorised，regularly revie

23、wed，signed and dated by an appropriate senior manager.3.1.1 Does the pany establish a policy statement which has been municated and understood by all staff involved with activities impacting product safety，legality and quality? Moderate 3.1.2 Does the policy statement include the following? 3.1.2.1

24、The pany"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 mitment for review and continual improvement Minor 3.1.3 Does the pany periodically review the policy statement for continuing suitability? Minor 3.2 General

25、Documentation Requirements 3.2.1 Control of Document The pany"s senior management shall ensure that all documents，records and data impacting the management of product safety，legality and quality are in place and effectively controlled.3.2.1.1 Does the pany effectively control all documents inte

26、rnal and e_ternalimpacting 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 legible，unambiguous，in appropriate languages and sufficiently detailed to enable their correct application by staff? Minor 3.2.

27、1.4 Are obsolete documents identified and removed from use? Minor 3.2.1.5 Does the pany record the date and reason for any change/amendment to documents impacting product safety，legality or quality? Minor 3.2.2 Control of Record The pany shall maintain records to demonstrate the effective control an

28、d achievement of product safety，legality and quality.3.2.2.1 Does the pany establish procedures for the collation，review，maintenance，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

29、 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? Moderate 3.2.2.5 Are any alterations to records justified and authorised?Moderate 3.2.3 SpecificationsThe pany shall ensure that

30、specifications e_ist for raw materials ， ponents and bought in parts including packaging ，intermediate/semi-processed and finished products and any product or service which could affect the integrity of the finished product.3.2.3.1 Does the pany establish specifications for raw materials，ponents，and

31、 bought-in-parts including packaging，intermediate/semi-processed and any product or service which could impact the integrity 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 informati

32、on，where applicable? 3.2.3.3.1 position，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 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 speci

33、fications accurate and plying with relevant safety，legislative and customer requirements? Major 3.2.3.5 Are current specifications accessible to relevant staff? Minor 3.2.3.6 Does the pany maintain technical dossier or package containing all relevant data or detail of where such data is locatedto en

34、sure that products meet the applicable requirements? Moderate 3.2.3.7 Does the technical dossier or package include the following information：3.2.3.7.1 a detailed product specification3.2.3.7.2 safety data sheets on chemicals used where relevant to the safety，legality or quality of the product 3.2.3

35、.7.3 the risk assessments3.2.3.7.4 a description of the conformity assessment procedure； 3.2.3.7.5 test reports，inspection reports 3.2.3.7.6 a list of the legislation，product standards with which the products are manufactured to ply 3.2.3.7.7 production control procedures and charts 3.2.3.7.8 approv

36、als by any government bodyif applicable3.2.3.7.9 declarations of conformity to legal requirementsif applicableModerate 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 pany must demonstrate that it has

37、taken steps to seek formal agreement.Minor 3.2.3.9 Are specifications regulary reviewed at least annually to ensure its adequacy and status? Minor 3.3 Responsibility and Authority The pany shall have a clearly defined and documented organisational structure that ensures the awareness of job function

38、，responsibilities and reporting relationships of key staff.3.3.1 Is the organisational 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 mmunicated? Moderate 3.3.3 Does the pany hav

39、e appropriate arrangements in place，to cover for the absence of key staff? Minor 3.4 Internal Audit The pany shall audit the management system to ensure that it is plied with and appropriate.3.4.1 Does the pany conduct internal audits at planned intervals? Moderate 3.4.2 Does the pany define an audi

40、t schedule detailing audit criteria relevant procedures，requirements and standards，scope including areas，departments or processesand 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 e_ceptio

41、nal aspects to be audited at a frequency e_ceeding one year， are they justified and documented in risk assessment? Minor 3.4.5 Are internal audits carried out by petent personnel，who shall be independent of the area of operation being assessed? Moderate 3.4.6 Are records of internal audits and assoc

42、iated corrective actions maintained with both conformity and non conformity with requirements documented? Minor 3.5 Purchasing ，Supplier & Sub-contractor Approval and Performance Monitoring The pany shall control all purchasing processes which are impacting product safety，legality and quality to

43、 ensure that products and services procured conform to defined requirements.In this conte_t suppliers shall include sub contractors and home workers.3.5.1 Does the pany have a "List of Approved Suppliers & Sub-contractors"? Minor 3.5.2 Is the "List of Approved Suppliers & Sub-

44、contractors" up-to-date to cover the ponents，materials and service impacting safety，legality and quality? Moderate 3.5.3 Are specifications/requirements municated to and agreed with the suppliers or sub-contractors? Minor 3.5.4 Does the pany establish supplier & sub-contractor selection and

45、 approval process? Minor 3.5.5 Does the pany conduct an ongoing supplier & sub-contractor performance assessment? Minor 3.5.6 Does the pany review the performance of new suppliers & sub-contractor against criteria within a specified "trial" period and thereafter at a specified freq

46、uency to decide the level of ongoing performance monitoring? Minor 3.5.7 Does the pany determine how e_ceptions 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 pany shall e_ercise care

47、with customer property including intellectual propertywhile it is under the panys control or is being used by the pany.3.6.1 Is the customer property e.g.software，intellectual property and productsidentified，verified，protected and safeguard? Minor 3.6.2 Does the pany have means of reporting property

48、 that is lost，damaged or otherwise found to be unsuitable for use to the customer? Minor 3.7 Corrective and Preventive Action FUNDAMENTAL：The pany"s senior management shall ensure that procedures e_ist to record，investigate，analyse and correct the cause of non-conforming products or failure to

49、meet standards，specifications and procedures which are impacting product safety，legality and quality 3.7.1 Does the pany 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 Co

50、rrective & Preventive Actions procedure include the following? 3.7.2.1 reviewing non-conformities including customer plaint； 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

51、taken；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

52、of 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 & Traceability FUNDAMENTAL：The pany shall have a system to identify and trace product lots including raw materials，pone

53、nts and packaging materials and follow this from the source of the ining material through all stages 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-

54、used materials，finished products，re-work and non-conforming materials clearly identified of lots/batches during all Moderate stages 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

55、 finished products including re-workhave 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 Produ

56、ct Recall The pany shall have a plan and system in place to effectively manage product withdrawal and product recall procedures.3.9.1 Does the pany have a procedure outlining methods and responsibilities for notifying their customers and other relevant parties where circumstances arise that require

57、product to be withdrawan or recalled from distribution? Moderate 3.9.2 Does the pany 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/e

58、vent 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 pany sha

59、ll have procedures in place to identify methods of ensuring business continuity in the case of major incidents/threats to a business.3.10.1 Does the pany have a business continuity plan in the event of major incidents/threats such as disruption to key services e.g.water，power，staff availability，key equipment failures and customer/field returns，flood，fire，natural disaster and malicious contamination or sabotage? Minor 3.10.2 Does the business continuity plan include the following，as a minimum?