SQP审核清单(中英文对照)

发布时间:2020-09-23 来源: 工作计划 点击:

 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,effective communication,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 company"s 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 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 from 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 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 staff? 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 company"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 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,transport…etc)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 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 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.

 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 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 legislation,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 of 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,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 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 & Improve,Acceptable)

 Moderate 2.2.5 Does the company 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 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 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 & canteen,pest control)

 2.2.6.8 personal protective equipment(including 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 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 Points 2.2.7.6 Records of monitoring & 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 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 regularly 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 assessment? 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 Statement 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 involved 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 review 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 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 use? Minor 3.2.1.3 Are document legible,unambiguous,in appropriate languages and sufficiently detailed to enable their correct application by staff? Minor 3.2.1.4 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 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,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 specified 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 finished 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 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 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 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 current 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 package 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 test 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 requirements(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 reviewed 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 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 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 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 (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 year, 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 conformity and non conformity with requirements documented? Minor 3.5 Purchasing ,Supplier & 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 context suppliers shall include sub contractors and home workers. 3.5.1 Does the company have a "List of Approved Suppliers & Sub-contractors"? Minor 3.5.2 Is the "List of Approved Suppliers & Sub-contractors" up-to-date to cover the components,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 & sub-contractor selection and approval process? Minor 3.5.5 Does the company conduct an ongoing supplier & sub-contractor performance assessment? Minor 3.5.6 Does the company review the performance of new suppliers & 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 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 (including intellectual property)

 while it is under the company?s 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,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 standards,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 & 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 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 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 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 incoming 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-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 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 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 that 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 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/threats to a business. 3.10.1 Does the company 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? 3.10.2.1 A senior management responsibility for decision making,oversight and initiating actions arising from a crisis management incident; 3.10.2.2 A current list of key contacts; 3.10.2.3 Sources of legal and expert advice; and 3.10.2.4 The responsibility for internal communications and communications with authorities,external organizations and media. Minor 3.11 Customer Focus The company"s senior management shall ensure that processes are in place to determine any customer requirements and expectations with regard to product safety and quality,and ensure these are fulfilled. 3.11.1 Does the company have processes in place to ensure customer specifications,needs and requirements are understood and met? Moderate 3.11.2 Does the company have documentary evidence of customer requirements (including performance indicators,where applicable)

 relating to the development of specification,manufacture and distribution of product? Minor 3.11.3 Are customer requirements (e.g.,production capability,capacity…etc)

 reviewed on a suitable planned interval? Minor 3.11.4 Are any resulting changes to existing agreements or contracts documented and communicated to relevant parties? Moderate 3.11.5 Does the company establish performance indicators relating to customer satisfaction?

  Minor 3.12 Complaint Handling The company shall operate an effective system for handling and investigating the cause and resolution of product complaints. 3.12.1 Does the company operate an effective system for handling and investigating the cause and resolution of product complaints? Moderate 3.12.2 Does the company carry out prompt and effective actions in accordance with the seriousness and frequency of the problems identified? Minor 3.12.3 Does the company analyse and use complaint data to implement ongoing improvements? Minor 4. Site and Facilities Management 4.1 Location and Perimeter The site shall be of suitable size,location,construction and design to facilitate maintenance,prevent contamination and enable the production of safe and legal finished products. 4.1.1 Is the factory site location and perimeter allow the production of safe and legal products? Minor 4.1.2 Where necessary,are measures taken to prevent contamination from local activities and the site environment which may have an adverse impact on the integrity of finished products? Moderate 4.1.3 Is there any evidence of damage due to inadequate drainage or flooding? Minor 4.2 Internal Site :

 Factory Layout ,Product Flow and Segregation

 FUNDAMENTAL Premises and plant shall be designed,constructed and maintained so as to control the risk of product contamination and to comply with all relevant legislation. 4.2.1 Are site buildings and facilities suitable for the intended purpose and properly maintained? Moderate 4.2.2 Is process flow diagram available? Minor 4.2.3 Is the process flow and location of machinery and equipment from intake to dispatch,logical to minimise product contamination risks? Moderate 4.2.4 Is working space and storage capacity sufficient? Minor 4.2.5 Are floors well designed to meet the following criteria?

 a)the demands of the process;

 b)withstand cleaning materials and methods;and

  c)impervious and maintained in good repair. Minor 4.2.7 Are buildings fabric and overhead walkways/structures (where foreign bodies could fall through)

 controlled through regular inspections,where necessary? Minor 4.2.8 Are walls,floors,ceilings,pipe-work and overhead structures designed,constructed,finished and maintained to prevent condensation and mould growth,especially in the storage areas? Minor 4.2.9 Does all water supplies used as ingredient of the products or preparation of the products where it may come into direct contact with the product meet the applicable requirements/standards for potability in the country of sale? Moderate 4.3 Staff Facilities Staff facilities shall be sufficient to accommodate the required number of personnel,and shall be designed and operated to minimise the risk of product contamination. Such facilities shall be maintained in good and clean condition. 4.3.1 Are staff facilities (e.g. toilet rooms,cleaning facilities,canteens, etc)

 well-designed and constructed so that they can be easily cleaned and maintained in order to prevent any potential contamination (e.g. bacterial contamination)

 that could compromise product quality,safety and legality? Moderate 4.3.2 Are the location of staff facilities NOT jeopardising the integrity of products? Moderate 4.3.3 Where smoking is allowed under national law,is there a designated controlled smoking areas which must be isolated from production areas? Moderate 4.3.4 Where necessary,does the company provide suitable and sufficient storage facilities to accommodate all reasonable personal items? Minor 4.3.5 Where specific work-wear is required,does the company provide designated changing facilities for all personnel,whether staff,visitor or contractor? Minor 4.3.6 Are outdoor clothing and other personal items stored separately from work-wear within the changing facilities? Minor 4.3.7 Does the company provide suitable and sufficient hand-cleaning facilities at access to,and at other appropriate points within,production areas? Minor 4.4 Cleaning and Hygiene Practices FUNDAMENTAL Housekeeping and cleaning systems shall be in place which ensure that adequate standards of cleanliness and tidiness are maintained at all times and the risk of contamination is minimized. 4.4.1 Are cleaning procedures established for the building,utilities,plant and equipment? Minor 4.4.2 Are cleaning procedures include the following as a minimum? 4.4.2.1 responsibility for cleaning 4.4.2.2 item/area to be cleaned 4.4.2.3 frequency of cleaning 4.4.2.4 method of cleaning 4.4.2.5 cleaning materials to be used 4.4.2.6 cleaning responsibility for verification,where appropriate Minor 4.4.3 Are cleaning schedules established and maintained? Minor 4.4.4 Are cleaning practices completed effectively so as to minimise risk of contamination? Moderate 4.4.5 When there is building or maintenance work,changes to equipment or introduction of new product types,are cleaning and disinfection procedures re-validated where necessary? Minor 4.4.6 Where external cleaning service contractors are employed,is the service contract clearly defined the scope and frequency of the work ? Minor 4.4.7 Is the cleaning program monitored for its effectiveness and periodically verified (e.g. such as a visual pre-operational inspection by a designated employee of equipment and facilities prior to the start of operations)? Minor 4.4.8 Are cleaning chemicals clearly labelled (Note:

 no chemicals are decanted unless into properly labelled and Minor

 identified containers)? 4.4.9 Is hand cleaning performed at a suitable frequency to maintain hygienic conditions and prevent product contamination? Moderate 4.4.9 Where there are product contamination risks (e.g.,in the final packing area),are necessary measures below taken as appropriate? 4.4.9.1 wear suitable gloves or footwear; 4.4.9.2 wear protective clothing; 4.4.9.3 control the wearing of jewellery; 4.4.9.4 prohibit eating,drinking and smoking in production/packaging area; 4.4.9.5 head and facial hair is fully contained; and 4.4.9.6 prohibit the false fingernails. Moderate 4.5 Waste/Waste Disposal There shall be adequate systems for the collection,collation and disposal of waste material. 4.5.1 Are measures established to prevent the accumulation of waste materials in production areas? Moderate 4.5.2 Where applicable,are waste materials categorised according to legislative requirements? Moderate 4.5.3 Are waste materials collected in suitably designed waste containers with clear label? Minor 4.5.4 Products which are to be disposed of on safety grounds,as the result of a recall or withdrawal,or as substandard trademarked materials,are they disposed of securely or delegated to a specialist in secure waste disposal? Minor 4.5.5 Are waste materials suitably quarantined and routed to ensure that they are not re-introduced into non-waste production flows? Moderate 4.5.6 Are external waste collection containers and compactors managed in such a manner as to minimise risk to the product? Minor 4.6 Pest Control The company shall be responsible for minimising the risk of pest infestation on the site. 4.6.1 Is pest control necessary for the audited site? Non-score 4.6.2 Where no pest control is conducted,does the site have a suitable justification for its absence and review at least annually? Minor 4.6.3 Are suitable pest control measures established for minimising the risk of pest infestation on the site? Moderate 4.6.4 Does the site either contract the services of a competent pest control contractor,or have trained personnel,for the regular inspection and treatment of premises? Minor 4.6.5 Where external contractors are employed,is the service contract clearly defined and reflect the activities of the site? Minor 4.6.6 Are procedures and inspection documentation (e.g.,log book of completed job/activity)

 for pest control maintained? Minor 4.6.7 In the event of infestation,does the company take immediate action to eliminate the hazard? Moderate 4.6.8 Are pest control chemicals clearly labelled (Note:

 no chemicals are decanted unless into properly labelled and identified containers)? Minor 4.6.9 Are all material safety data sheets (MSDS)

 for all chemical pest control chemicals and agents used available to relevant staff at point of use? Minor 4.6.10 Are bait stations robustly constructed,tamper resistant,in good condition and effective in killing the target pests? Minor 4.6.11 Are bait stations positioned to avoid potential contamination of production materials and products? Moderate 4.6.12 When a fumigation is necessary,are the operations carried out by competent staff with appropriate professional qualifications? Moderate 4.6.13 Are drains fitted with screens and traps to prevent pest entry? Minor 4.6.14 Are fly-killing devices and/or pheromone traps correctly sited and operational? (Note:

 If there is a danger of insects being expelled from any extermination device and contaminating the product,alternative positions,systems and/or equipment must be used)

 Minor 4.6.15 Where necessary,are suitable precautions taken to prevent entry of pests if external doors are kept open?

 Minor 5. Product Control 5.1 Reference Samples (Preproudction and Production Sample )

 Documented procedures shall be in place for the selection,handling,storage,approval and use of reference samples (Preproudction and Production Sample)

 as well as for component samples and samples of subcontracted work where relevant. 5.1.1 Does the company have a documented procedure to identify,select,categorize,handle,store,approve and use the reference samples (pre-production and production samples)? Minor

 5.1.2 Does the company retain the samples which have been approved by the customer? If the customer approval is not possible,the sample representative of the agreed specification must be retained. (Note:

 Exception for those samples are physically very large or represent a very high cost,e.g.,a sofa)

 Moderate 5.1.3 Are the samples retained and securely stored in suitable environmental conditions to maintain their original status? Moderate 5.1.4 Are records maintained if reference samples supplied to other parties,including the date supplied/returned and details of the sample? Minor 5.1.5 Are samples retained in accordance with periods specified by a customer or legislation? (Note:

 This should normally be the foreseeable lifetime of the product unless otherwise justified)

 Minor 5.2 Chemical Control The chemical composition of products and chemicals used in the manufacture or processing of products shall be identified,monitored and recorded as required by legislation in the country of sale and / or manufacture.

 Where approvals for use need to be obtained,these shall be in place. 5.2.1 Does company have a "List of Approved Chemicals with Corresponding Brands / Manufacturers" including surface coatings,paints,glues,adhesives,colorants,dyes,flame retardants,biocides etc.? Moderate 5.2.2 If yes,does the "List of Approved Chemicals with Corresponding Brands / Manufacturers" specify the below items? Non-score 5.2.2.1 Trade name / brand name of the chemical substances or components. Minor 5.2.2.2 Active compositions / ingredients of chemical substances or components. Minor 5.2.2.3 CAS#

 or other recognized chemical substance identification. Minor 5.2.2.4 The intended use of chemical substances or components. Minor 5.2.3 Does the company only purchase the approved & registered chemical substances to be used in production as defined by law and regulation of the country in which the products are sold? Moderate 5.2.4 Does the company have documented procedure for managing,approving and controlling the engineering changes / product changes that may alter the chemical composition of the final product? Moderate 5.2.5 Where the company uses materials or preparations for which the supplier does not wish to divulge confidential formulations,are measures established to ensure the safety and legality of such materials will be made available to the authorities if required? Minor 5.2.6 Is the use of any substances classified as dangerous or of very high concern,in the country of sale documented? Minor 5.2.7 Does the company have mechanism for incoming inspection of chemical substances in order to check & validate they are approved (test report,certificate,match with the "List of Approved Chemicals and Corresponding Suppliers",etc)? Minor 5.2.8 Are test reports or certificates of compliance available to demonstrate any presence of hazardous substances / Substances of Very High Concern (SVHC)

 in all incoming materials and components are below the threshold value for the country of sale? Moderate 5.2.9 Does the company test final products to ensure they are free of Hazardous Substances or SVHC are below the threshold value relating to the product safety regulations of the country in which the products are sold? Major 5.2.10 Are controlled storage facilities provided for all chemicals used in the factory site (including cleaning and pest control chemicals)

 maintained as per the recommendations on the manufacturer label to ensure the stored substances do not deteriorate or degrade? Moderate 5.2.11 Are procedures,MSDS,description or diagram for the handling of chemicals available at the point of use? Minor 5.2.12 Where appli...

相关热词搜索:清单 中英文对照 审核

版权所有 蒲公英文摘 www.zhaoqt.net