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.
Question Risk WeightingMajorMinorMajor
CL-SQP1.11.21.3
Questions
Does the company's management define product safety and quality objectives?Is the review of the management systems carried out least annually?
Does the review of the management systems include evaluation of the following items? 1.3.1 Results of audits (internal, second and third party audits); 1.3.2 Follow up actions from previous management reviews; 1.3.3 Customer Complaints and feedback;
1.3.4 Status of preventive and corrective actions; 1.3.5 Process performance and product conformity;
1.3.6 Changes that could affect the Management Systems 1.3.7 roduct safety and quality objectives; 1.3.8 Risk management;
1.3.9 Statutory and regulatory requirements; 1.3.10 Resource needs; and
1.3.11 Recommendations for improvement.
Are the decisions taken and actions agreed during the review communicated effectively to appropriate staff?
Are the actions implemented within the agreed timescales?
Does the company's management provide the following overall resources to ensure effective management and performance of work?1.6.1 personnel
1.6.2 infrastructure (e.g., building, equipment, transport…etc)1.6.3 work environment1.6.4 financial support
1.41.51.6
MinorMinorMajor
2 Risk Management Systems
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.
2.1CL-SQP2.1.1
Legislative and Safety Requirements
Questions
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?
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?
第 1 页，共 21 页
Question Risk WeightingMajor
2.1.2Minor
2.1.3
Does the company have a process in place for ensuring it is kept informed of changes to relevant legislation, standards etc?Risk Assessment (Documentation)QuestionsDoes the company establish a product risk assessment for each product or a group of similar products, e.g., FMEA?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)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); 2.2.3.3 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)Where manufacturing sites have no responsibility for product design, is the company provided with a validated copy of the product risk assessment?Does the company conduct a process risk assessment of hazards potentially introduced during the production, packaging or storage processes?Does the process risk assessment take the following into account?2.2.6.1 manufacturing parameters such as pressure, time, temperature2.2.6.3 conditions of equipment, moulds, dies, machinery2.2.6.4 chemicals / materials used for equipment (e.g. lubricating oils and paints)2.2.6.5 calibration of equipment2.2.6.6 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)Does the process risk assessment identify the following?2.2.7.1 A list of potential risk or hazards in the production process2.2.7.2 Control points to manage the identified risk to acceptable level2.2.7.3 Accept / reject limits defined for each control point2.2.7.4 Corrective action to be taken where a CCP is out of control2.2.7.5 Responsibility of Control Points2.2.7.6 Records of monitoring & reviewsIf the assessment resulted in unacceptable risk, does the company go back to product design process or customer for modification to achieve acceptable risk?Verification of Risk Assessment
Questions
Is the verification of risk assessment carried out prior to production?
Is the risk assessment carried out by competent personnel (internal or external)?Is the risk assessment regularly reviewed, at least annually or when changes made to product design and materials and/or key manufacturing processes?
Major
2.2CL-SQP2.2.12.2.2Question Risk WeightingMajorMajor2.2.3Major2.2.42.2.52.2.6MajorMajorMajor2.2.7Major2.2.8Major2.3CL-SQP2.3.12.3.22.3.3
Question Risk WeightingMajorMajorMajor
第 2 页，共 21 页
2.3.4
2.3.5
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?
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?
Critical
Critical
3 Quality Management System3.1Policy 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.
Question Risk WeightingMajor
CL-SQP3.1.1
Questions
Does the company establish a quality policy which has been communicated and understood by all staff involved with activities impacting product safety, legality and quality?
Does the policy include the following?
- The company's intention to produce safe and legal products to defined quality, and to meet its responsibility to its customers; and
- A commitment to comply with quality management system requirements and continual improvement
Does the company periodically review the quality policy for continuing suitability?
3.1.2Minor
3.1.3Minor
3.2General Documentation Requirements3.2.1Control 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
Question Risk WeightingMajorMinorMinorMinorMinor
CL-SQP3.2.1.13.2.1.23.2.1.33.2.1.43.2.1.5
Questions
Does the company effectively control all documents (internal and external) impacting product safety, legality and quality?
Are current versions of documents available at points of use?
Are document legible, unambiguous, in appropriate languages and sufficiently detailed to enable their correct application by staff?
Are obsolete documents identified and removed from use?
Does the company record the date and reason for any change/amendment to documents impacting product safety, legality or quality?
3.2.2Control of Record
The company shall maintain records to demonstrate the effective control and achievement of product safety, legality and quality.
Question
CL-SQPQuestionsRisk
Weighting
3.2.2.1Does the company establish procedures for the collation, review, maintenance, storage Minor
and retrieval of all records impacting product safety, legality and quality?
3.2.2.2Are records legible, genuine and authorised?Minor3.2.2.3Are records readily accessible, securely stored to prevent damage deterioration?Minor3.2.2.4Are records retained in accordance with periods specified by a customer or legislation?Major3.2.2.5
Are any alterations to records justified and authorised?
Major
第 3 页，共 21 页
3.2.3Specifications
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. A technical file shall be established for each product.CL-SQP3.2.3.1
Questions
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?
Is a specification of each final product documented and dated? Does the specification include the following information, where applicable?- composition, size, colour- bill of materials- assembly diagrams- primary packaging- intended shelf life
- warnings or instructions for use- use, misuse, usage patterns- production volumes
Are specifications accurate and complying with relevant safety, legislative and customer requirements?
Are current specifications available at points of use?
Does the company maintain technical dossier containing all relevant data (or detail of where such data is located) to ensure that products meet the applicable requirements?Does the technica dossier include the following information:- a detailed product specification
- safety data sheets on chemicals used where relevant to the safety, legality or quality of the product
- the risk assessment(s)
- a description of the conformity assessment procedure;- test reports, inspection reports
- a list of the legislation, product standards with which the products are manufactured to comply
- production control procedures and charts
- approvals by any government body (if applicable)
- declarations of conformity to legal requirements (if applicable)
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.
Are specifications regulary reviewed at least annually to ensure its adequacy and status?
Question Risk WeightingMajor
3.2.3.23.2.3.3MajorMajor
3.2.3.43.2.3.53.2.3.6
CriticalMinorMinor
3.2.3.7Major
3.2.3.8Minor
3.2.3.9Minor
3.3Responsibility 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 staffCL-SQP3.3.13.3.2
Questions
Is the organisational chart available and up to date?
Are responsibilities, accountability and authorities clearly defined and commmunicated for key staff involved with activities impacting product safety, legality and quality?
Question Risk WeightingMinorMajor
第 4 页，共 21 页
3.3.3
Does the company have appropriate arrangements in place, to cover for the absence of key staff?
Minor
3.4Internal Audit
The company shall audit the management system to ensure that it is complied with and appropriate.CL-SQP3.4.13.4.23.4.33.4.43.4.53.4.6QuestionsDoes the company conduct internal audits at planned intervals?Does the company define an audit schedule detailing audit criteria (requirements based on), scope (including areas, departments or processes) and frequency?Is the frequency of internal audits based on importance of activities, as well as the results of previous audits?If there are any exceptional aspects to be audited more than one year, are they justified and documented in risk assessment?Are internal audits carried out by competent personnel, who shall be independent of the area of operation being assessed?Are records of internal audits and associated corrective actions maintained with both conformity and non conformity with requirements documented?Question Risk WeightingMajorMinorMinorMinorMajorMinor3.5Purchasing, Supplier & Sub-contractor Approval and Performance MonitoringThe 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
Question Risk WeightingMinorMajorMinorMinorMinorMinor
CL-SQP3.5.13.5.23.5.43.5.53.5.63.5.7
Questions
Does the company have a 'List of Approved Suppliers & Sub-contractors'?Is the 'List of Approved Suppliers & Sub-contractors' up-to-date to cover the components, materials and service impacting safety, legality and quality?
Are specifications/requirements communicated to and agreed with the suppliers or sub-contractors?
Does the company establish supplier & sub-contractor selection and approval process?
Does the company conduct an ongoing supplier & sub-contractor performance assessment?
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?
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?
3.5.8Minor
3.6Customer 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.CL-SQP3.6.13.6.2
Questions
Is the customer property (e.g. software, intellectual property and products) identified, verified, protected and safeguard?
Does the company have means of reporting property that is lost, damaged or otherwise found to be unsuitable for use to the customer?
Question Risk WeightingMinorMinor
第 5 页，共 21 页
3.7Corrective 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
Question Risk WeightingMajorCL-SQP3.7.1QuestionsDoes the company establish a procedure to capture and investigate the cause of non-conformity and potential non-conformity impacting product safety, legality and quality?Does the documented 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; and 3.7.2.4 recording the results of action taken 3.7.2.5 evaluating the effctiveness of the action takenAre appropriate staff member identified and assigned the responsibilty and accountability for each corrective and preventive action?Are corrective / preventive actions effectively taken to eliminate the causes of non-conformities in order to prevent recurrence / occurence?Are corrective and preventive actions undertaken in an agreed timeframe?Identification & Traceability
3.7.2Major3.7.33.7.43.7.53.8
MinorMajorMinorFUNDAMENTAL: 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.CL-SQP3.8.1
Questions
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 stages of receipt, production, storage and dispatch?
Are finished products labelled according to the customer specification and/or legislative requirements?
Do finished products (including re-work) have a full traceability to raw materials source, and vice versa?
Is the effectiveness of the traceability system regularly tested, at least annually?
Question Risk WeightingMajor
3.8.23.8.33.8.4
CriticalMajorMinor
3.9Incident, Product Withdrawal and Product Recall
The company shall have a plan and system in place to effectively manage product withdrawal and product recall procedures.CL-SQP3.9.1
Questions
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?
Does the company have a written agreements/consensus in place with relevant parties in the supply chain regarding the product withdrawal/recall?
Question Risk WeightingMajor
3.9.2Minor
第 6 页，共 21 页
3.9.3
3.9.4
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?
Is the product withdrawal and recall procedure regularly tested, at least annually?
Major
Minor
3.10Business 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.CL-SQP3.10.1
Questions
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?
Does the business continuity plan include the following, as a minimum?
- A senior management responsibility for decision making, oversight and initiating actions arising from a crisis management incident; - A current list of key contacts;
- Sources of legal and expert advice; and
- The responsibility for internal communications and communications with authorities, external organizations and media.
Question Risk WeightingMinor
3.10.2Minor
3.11Customer 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.CL-SQP3.11.13.11.2
Questions
Does the company have processes in place to ensure customer specifications, needs and requirements are understood and met?
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?
Are customer requirements (e.g., production capability, capacity…etc) reviewed on a suitable planned interval?
Are any resulting changes to existing agreements or contracts documented and communicated to relevant parties?
Does the company establish performance indicators relating to customer satisfaction?
Question Risk WeightingMajorMinor
3.11.33.11.43.11.5
MinorMajorMinor
3.12Complaint Handling
The company shall operate an effective system for handling and investigating the cause and resolution of product complaints.
Question Risk WeightingMajorMinorMinor
CL-SQP3.12.13.12.23.12.3
Questions
Does the company operate an effective system for handling and investigating the cause and resolution of product complaints?
Does the company carry out prompt and effective actions in accordance with the seriousness and frequency of the problems identified?
Does the company analyse and use complaint data to implement ongoing improvements?
第 7 页，共 21 页
4. Site and Facilities Management4.1 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
Question Risk WeightingMinorMajor
CL-SQPQuestions
Is the factory site location and perimeter allow the production of safe and legal products?
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?
Is there any evidence of damage due to inadequate drainage or flooding?
4.1.1
4.1.24.1.3
Minor
4.2 Internal Site: Factory Layout, Product Flow and SegregationFUNDAMENTAL
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
Question Risk WeightingMajorMinorMajorMinorMinor
CL-SQPQuestions
Are site buildings and facilities suitable for the intended purpose and properly maintained?
Is process flow diagram available?
Is the process flow and the location of machinery and equipment from intake to dispatch, well arranged to minimise product contamination risks?Is working space and storage capacity sufficient?
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.
Are buildings fabric and overhead walkways/structures (where foreign bodies could fall through) controlled through regular inspections, where necessary?
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?
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?
4.2.14.2.24.2.34.2.4
4.2.54.2.7
MinorMinor
4.2.8
Major
4.2.9
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.
Question Risk WeightingMajor
CL-SQP4.3.1
Questions
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?
Are the location of staff facilities jeopardising the integrity of products?4.3.2Major
第 8 页，共 21 页
4.3.3Where smoking is allowed under national law, is there a designated controlled smoking areas which must be isolated from production areas?Where necessary, does the company provide suitable and sufficient storage facilities to accommodate all reasonable personal items?Where specific work-wear is required, does the company provide designated changing facilities for all personnel, whether staff, visitor or contractor?Are outdoor clothing and other personal items stored separately from work-wear within the changing facilities?Does the company provide suitable and sufficient hand-cleaning facilities at access to, and at other appropriate points within, production areas?MajorMinorMinorMinorMinor4.3.44.3.54.3.64.3.74.4Cleaning and Hygiene PracticesFUNDAMENTAL
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 minimised
Question Risk WeightingMinorMinorCL-SQP4.4.14.4.2QuestionsAre cleaning procedures established for the building, utilities, plant and equipment?Are cleaning procedures include the following as a minimum? a) responsibility for cleaning b) item/area to be cleaned c) frequency of cleaning d) method of cleaning e) cleaning materials to be used f) cleaning responsibility for verification, where appropriateAre cleaning schedules established and maintained?Are cleaning practices completed effectively so as to minimise risk of contamination?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?Where external cleaning service contractors are employed, is the service contract clearly defined the scope and frequency of the work ?Are cleaning chemicals clearly labelled (Note: no chemicals are decanted unless into properly labelled and identified containers)?Is hand cleaning performed at a suitable frequency to maintain hygienic conditions and prevent product contamination?Where there are product contamination risks (e.g., in the final packing area), are necessary measures below taken as appropriate?- wear suitable gloves or footwear;- wear protective clothing;- control the wearing of jewellery;- prohibit eating, drinking and smoking in production/packaging area;- head and facial hair is fully contained; and- prohibit the false fingernails.4.4.34.4.44.4.5MinorMajorMinor4.4.64.4.74.4.84.4.9MinorMinorMajorMajor4.5Waste/Waste Disposal
There shall be adequate systems for the collection, collation and disposal of waste material.
Question
CL-SQPQuestionsRisk
Weighting
4.5.1Are measures established to prevent the accumulation of waste materials in production Major
areas?
第 9 页，共 21 页
4.5.24.5.34.5.4Where applicable, are waste materials categorised according to legislative requirements?Are waste materials collected in suitably designed waste containers with clear label?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?Are waste materials suitably quarantined and routed to ensure that they are not re-introduced into non-waste production flows?Are external waste collection containers and compactors managed in such a manner as to minimise risk to the product?MajorMinorMinor4.5.54.5.6MajorMinor4.6Pest Control
The company shall be responsible for minimising the risk of pest infestation on the site.CL-SQP4.6.14.6.24.6.34.6.44.6.54.6.64.6.74.6.84.6.94.6.104.6.114.6.124.6.134.6.14
Questions
Is pest control necessary for the audited site?
Where no pest control is conducted, does the site have a suitable justification for its absence and review at least annually?
Are suitable pest control measures established for minimising the risk of pest infestation on the site?
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?
Where external contractors are employed, is the service contract clearly defined and reflect the activities of the site?
Are procedures and inspection documentation (e.g., log book of completed job/activity) for pest control maintained?
In the event of infestation, does the company take immediate action to eliminate the hazard?
Are pest control chemicals clearly labelled (Note: no chemicals are decanted unless into properly labelled and identified containers)?
Are all material safety data sheets (MSDS) for all chemical pest control chemicals and agents used available to relevant staff at point of use?
Are bait stations robustly constructed, tamper resistant, in good condition and effective in killing the target pests?
Are bait stations positioned to avoid potential contamination of production materials and products?
When a fumigation is necessary, are the operations carried out by competent staff with appropriate professional qualifications?
Are drains fitted with screens and traps to prevent pest entry?
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.)
Where necessary, are suitable precautions taken to prevent entry of pests if external doors are kept open?
Question Risk WeightingNon-scoreMinorMajorMinorMinorMinorMajorMinorMinorMinorMajorMajorMinorMinor
4.6.15Minor
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.
第 10 页，共 21 页
Clause5.1.15.1.25.1.35.1.45.1.5Question QuestionsRisk WeightingDoes the company have a process to identify, select and categorise reference samples Minor(pre-production and production samples)?Does the company retain the samples which have been approved by the customer? If Majorthe 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)Are the samples retained and securely stored in suitable environmental conditions to Majormaintain their original status?Are records maintained if reference samples supplied to other parties, including the Minordate supplied/returned and details of the sample?Are samples retained in accordance with periods specified by a customer or Minorlegislation? (Note: This should normally be the foreseeable lifetime of the product unless otherwise justified)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
Question Risk WeightingMajor
CL-SQPQuestions
Does company have a 'List of Approved Chemicals with Corresponding Brands / Manufacturers' including surface coatings, paints, glues, adhesives, colorants, dyes, flame retardants, biocides etc.?
If yes, does the 'List of Approved Chemicals with Corresponding Brands / Manufacturers' specify the below items?
Trade name / brand name of the chemical substances or components.Active compositions / ingredients of chemical substances or components.CAS# or other recognized chemical substance identification.The intended use of chemical substances or components.
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?
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?
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?
Is the use of any substances classified as dangerous or of very high concern, in the country of sale documented?
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)?
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?
5.2.15.2.25.2.2.15.2.2.25.2.2.35.2.2.4
Non-scoreMinorMinorMinorMinorMajor
5.2.3
Major
5.2.4
Minor
5.2.55.2.6
MinorMinor
5.2.7
Major
5.2.8
第 11 页，共 21 页
5.2.95.2.105.2.115.2.125.2.135.2.145.2.155.2.165.2.175.2.18Does 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?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?Are procedures, MSDS, description or diagram for the handling of chemicals available at the point of use?Where applicable, does the company identify and document the use of any nanomaterials?Does the factory have a clear labeling or equivalent system in place to identify the chemical substances/components and distinguish the status (pass / fail / pending) in the warehouse?Are segregation or other measures in place to avoid cross contamination or undesirable chemical reaction of chemical substances and/or preparations (e.g., acids and bases, flammables and oxidizers should not be stored together)?Does the factory adopt 'First-in and First-out'' logistic concept on its warehouse management for the chemicals with expiry date (i.e., materials with earlier expiry date should be used first)?Does the factory record the usage of chemical substances or components during production to ensure traceability?Are the production equipment and devices inspected and cleaned regularly between batches to avoid cross contamination?Does the company identify & physically segregate the nonconforming products which have defects related to contamination or change in chemical composition where tests results indicated non-conformance?CriticalMajorMinorMinorMajorMajorMinorMinorMinorCritical5.3 Product Packaging Materials
Product packaging materials shall be suitable for the intended use and stored under conditions to minimise the risk of contamination and deterioration
Question Risk WeightingMajor
CL-SQP5.3.1
Questions
Are packaging assessed for fitness for purpose and found suitable with regard to the following?
a) Protecting the product from damage; b) Maintaining the integrity of the product; c) Protecting the consumer from injury; and d) Preventing contamination
Does the product packaging conform to an agreed and documented specification and legal requirements of the country of sale with regard to composition, recyclability ?Are packaging materials effectively protected before being returned to storage?Where staples or other metal closures are used for packaging, are appropriate
precautions taken to prevent the risk of contamination, damage or injury to the product or consumer?
Where there is a risk of product contamination from transit packaging that could
compromise product safety, legality and quality, are such packaging removed outside of production areas?
5.3.2Critical
5.3.35.3.4MinorMajor
5.3.5Minor
5.4 Control of Non-conforming Materials
The company shall ensure that any non-conforming materials, components and product are clearly identified, labelled, quarantined, investigated and documented
第 12 页，共 21 页
Question CL-SQPQuestionsRisk Weighting5.4.1.1Does the company establish documented procedures for the control of non-conforming Majormaterials and products, including rejection, segregation, acceptance by concession or re-grading for an alternative use? 5.4.1.2Are the procedures understood by the authorised personnel and implemented Minoreffectively?5.4.2MajorAre all non-conforming products and their packaging handled or disposed of according to the nature of the problem and/or the specific customer or legislative requirements?5.4.3 Are the records kept for the nonconformities and subsequent actions taken?MajorWhen rework is performed, are the reworked items/products subject to 100% re-Major5.4.4inspection?5.5 Handling requirements for specific materials
Where materials or products require special handling procedures to be in place, these shall be maintained to ensure product safety, quality and legality are not compromised
Question Risk WeightingMajorCL-SQP5.5.1QuestionsWhen materials and products require segregation procedures (e.g. materials intended for different geographical regions), does the company have measures in place to ensure that product integrity is maintained?Where allergenic or sensitising materials are used, or likely to be contaminants of materials used, are such materials clearly identified on site?Where required, does the company establish a procedure for the handling of allergenic or sensitising materials which include the following? a) Physical or time segregation from other products; b) Use of identified, dedicated equipment if necessary; and c) Adequate labelling of final products.5.5.25.5.3MinorMajor5.6 Product Transport, Storage and Distribution
All facilities used for the storage and transportation of product, movement around the site, and dispatch of finished product shall be suitable for the purpose and maintained in good repair.CL-SQP5.6.1
Questions
Are preventive measures(e.g., protection or suitable packaging) taken to ensure the transport, storage and distribution across the supply chain (from raw materials
despatch to finished product delivery) minimise the risk of contamination and damage?Is transportation in good repair and in a clean/hygienic condition?
Where the product transported is susceptible to weather damage, are vehicles loaded and unloaded in covered areas/bays to prevent the risk of contamination and damage.?
Where the product needs specific environmental requirements to prevent degradation, are these conditions documented, maintained and monitored during the transportation, storage and distribution?
Are agreement established with contractors to ensure transport, storage and
distribution undertake in such a way to prevent the risk of contamination and damage?
Question Risk WeightingMajor
5.6.25.6.3MajorMinor
5.6.4Minor
5.6.5Minor
5.7 Stock Control and Product release
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The company shall ensure that finished product is not released unless all agreed procedures have been followed and the release is suitably controlled
Question Risk WeightingMinorMajor
CL-SQPQuestions
Does the company establish a procedure ensuring only products conforming to specifications/defined quality are dispatched?
Are the procedures for products dispatch include the following? a) release by authorised personnel
b) once all inspections and testing are sucessfully completed and documented to verify legistive and other defined requirements are met.
Where home-workers or subcontractors are used, are the same procedures for products dispatch (as 5.7.1 & 5.7.2) applied to the works/products done by home-workers or subcontractors?
Are controls for correct stock rotation in place to ensure materials and products used in the correct order and within the allocated shelf or usage life, where applicable?
Where necessary, are procedures established for disposal of excess stock or obsolete inventory where such situations routinely occur?
5.7.1
5.7.2
Minor
5.7.3
Major
5.7.45.7.5
Minor
6. Product Testing and Product Claims6.1 Product TestingFUNDAMENTAL
A suitable, sufficient and validated testing regime shall be in place to ensure the safe, legal production of products to the required quality. Results from the programme shall be recorded, reviewed and stored securely
Question Risk WeightingMajor
CL-SQPQuestions
6.1.16.1.2
6.1.36.1.4
6.1.56.1.66.1.7
Does the company assess the need for product testing? In case no testing is required, does the company have a documented justification and review at least annually?
Is there a documented testing procedure/programme established for each product or a group of similar products?
If yes, does the testing procedure/programme include the following:
6.1.3.1different stages (e.g., pre-production, production) at which testing is to be performed
6.1.3.2 test sampling plan 6.1.3.3 test specification6.1.3.4 pass or fail criteria
Is the testing of critical parameters undertaken by accredited laboratory (in-house or third party) or the customer‘s designated testing laboratories as agreed?
Where testing is carried our by third parties, does the company clearly defined the testing requirements including the reference to number, date and version of the test standard or method to be used?
When test results are outside the defined specification, are they evaluated and reviewed by a nominated person responsible for safety, legality and quality?Where necessary, are corrective action taken and documented?
MajorMajor
MajorMajor
MajorMajor
6.2 Product Claims
The company shall have procedures in place to validate any declared product information or claims made for the products and monitor compliance with such claims if necessary.
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CL-SQPQuestionsWhere necessary, does the company carry out quantity checks to verify the pack contents conforms to legislative requirements and / or specified customer requirement in the region where the product is available for sale?Does a quantity checking frequency and methodology comply with minimum legislative requirements, where applicable?Are quantity markings on the product or pack accurate and in compliance with legislative requirements of the country of sale?When there are claims about the product (e.g., weight, dimensions, function), does the company perform claim verification (by test, measurement or data available) to ensure that products meet the stated claim?Does the company undertake product-in-use evaluations, testing and/or reliability trials and/or shelf-life evaluations, where appropriate?Question Risk WeightingMajor6.2.16.2.26.2.3MajorMajorMinor6.2.46.2.5Minor7. Process Control
7.1 Pre-production ActivityCL-SQP
Questions
7.1.1
Is pre-production planning conducted regarding the resource allocation, critical machinery, production schedules, actual delivery dates of critical material &
components, and any out-sourced operation schedule in order to meet customers requirements and shipment date?
Are documentary evidence available to demonstrate Pre-production Meetings are conducted for each style and attended by relevant department heads/representatives prior to production?
Does the company have an approved control plan for each product or a group of similar products?
If yes, does the control plan identifies the following items:7.1.4.1 critical control points (if any), 7.1.4.2 control limits, 7.1.4.3 monitoring points,
7.1.4.4 operating parameters for production equipment and tooling,7.1.4.4 required records.
Question Risk WeightingMajor
7.1.2Major
7.1.37.1.4
MajorMajor
7.2 Control of Incoming Components and Raw MaterialsFUNDAMENTAL
The company shall have procedures to specify, validate and approve incoming materials which shall include any testing, inspection or review of certificates of analysis
Question Risk WeightingMajor
CL-SQP7.2.1
Questions
Does the company establish a documented procedure to inspect and approve the critical raw materials, components and sub-contracted works (outsourced to other facilities) impacting product safety, legality or quality against purchase order, agreed specification or other applicable requirements?
Does the company establish documented inspection procedure/protocol, which shall at least include the following,- sample size to be taken- inspection items
- acceptance / rejection criteria- defined AQL
- defect classification
- actions to be taken in the case of rejection
7.2.2Major
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7.2.37.2.47.2.5
Are the inspection conducted as per the defined inspection procedure/protocol (correct sample size, AQL…etc)?
Are there inspection records maintained for each lot/batch?
Does the company establish a documented procedure to release approved raw materials or components including home-workers (if used)?
MajorMajor
7.3 Molding (Injection molding, Blow molding, Insert molding, Roto cast molding, Diecast molding, Vacuum Forming, etc) (Please check N/A if there is no Molding and relevant process)CL-SQPQuestionsAre machine requirements and mold/tooling requirements set up according to 7.3.1
specifications?
Are trial shots from all cavities verified against approved samples and all applicable 7.3.2
requirements prior to production/intervention?
Are process parameters (shot pressure/temperature, injection/extrusion speed, holding 7.3.3
pressure/time, mold temperature, mold cooling, cycle time, etc.) established and validated according to process control plan/sheet?
Are process parameters monitored and correction taken for any deviations that could 7.3.4
compromise product safety, quality and legality?
Are plastic material/resin type, quantity and mixing formula correctly applied? 7.3.5
Are procedures and controls for utilization of regrind material in place? 7.3.6
Are die cast type, die cast mixture and die cast measurement correctly applied in the 7.3.7
die casting process? (Die casting process only)
Are procedures and controls for tumbling and ceramic polishing in place? (Die casting 7.3.8
process only)
Are mixture of plastisol, colorants, and additives correctly applied in the roto casting 7.3.9
process? (Roto casting process only)
Is the trimming/slitting method set up properly to prevent any potential physical hazards 7.3.10
and foreign matter contamination, e.g., sharp edges, small parts, etc?
Are procedures and controls for checking and monitoring finished parts (correct 7.3.11
tooling, deformation, defects, size measurement, appearance, reference marks, clarity, etc.) in place? 7.4 Die Cutting for Fabric/Rigid Plastic/PVC Sheet or Laminates (Please check N/A if there is no Die Cutting and relevant process)CL-SQPQuestions7.4.1
Are die cutting machine and tooling requirements set up according to specifications?
7.4.2Are process parameters (cycle time, no. of fabric/sheet layer, pressure, temperature 7.4.37.4.47.4.5
etc.) established and validated according to process control plan/sheet?
Are process parameters monitored and correction taken for any deviations that could compromise product safety, quality and legality?
Are procedures and controls in place to ensure there is no physical contamination from sharp tools used (e.g. knife, die cutter)?
Are procedures and controls for checking and monitoring finished parts (defects, deformation, size measurement, appearance, uniformity, etc.) in place?
Question MajorMajorMajor
MajorMajorMajorMajorMajorMajorCriticalMajor
Question MajorMajorMajorCriticalMajor
7.5 Forming and Stamping (Please check N/A if there is no Decoration and relevant process)CL-SQPQuestionsAre machine and mold/die requirements (e.g. engraved hot stamp dies) set up 7.5.1
according to specifications?
Are process parameters (pressure, stoke, temperature, cycle time, lubrication, etc) 7.5.2
established and validated according to process control plan/sheet?
Are process parameters monitored and correction taken for any deviations that could 7.5.3
compromise product safety, quality and legality?
Question MajorMajorMajor
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7.5.4Are procedures and controls in place to ensure there is no physical hazards, e.g., sharp edges, sharp point that could compromise product quality, safety and legality? Are procedures and controls for checking and monitoring finished parts (defects, deformation, appearance, uniformity etc.) in place? Critical7.5.5Major7.6 Decoration (Spray Decoration, Coating, Tampo, Hand Painting, Printing) (Please check N/A if there is no Decoration and relevant process)CL-SQPQuestionsAre machine and toolings/jigs requirements set up according to specifications? 7.6.1Are cleaning or degreasing of parts conducted effectively prior to decoration?7.6.2Are mixing process controlled to ensure correct type, quantity and ratio of 7.6.3paints/inks/solvent/additives is applied? Is working environment suitable and monitored (e.g. no excessive dirt or moisture) so 7.6.4that it does not compromise product safety, quality and legality? Are process parameters (cycle time, indexing, air pressure, solvent evaporation rate, 7.6.5drying temperature/time etc) established and validated according to process control plan/sheet?Are process parameters monitored and correction taken for any deviations that could 7.6.6compromise product safety, quality and legality? 7.6.7Are procedures and controls for checking and monitoring finished parts (clarity, cleanliness, color, position, appearance, defects, paint/metal adhesion, etc.) in place? 7.7 Sonic Welding Process (Please rate N/A if there is no Sonic Welding and relevant process)CL-SQPQuestions
Are machine and toolings/jigs requirements set up according to specifications? 7.7.1
Are mating parts and mating surface cleaned and checked prior to welding? 7.7.2
Are process parameters (frequency, holding time, welding time, pressure etc.) 7.7.3
established and validated according to process control plan/sheet?
Are process parameters monitored and correction taken for any deviations that could 7.7.4
compromise product safety, quality and legality?
7.7.5Are procedures and controls for checking and monitoring finished parts (deformation,
defects, ahesion and marks, etc.). in place? 7.8 Gluing Process (Please rate N/A if there is no gluing and relevant process)CL-SQPQuestions
Are machine and toolings/jigs requirements set up according to specifications? 7.8.1
Are gluing parts and gluing surface cleaned and checked prior to gluing? 7.8.2
Where applicable, are mixing process controlled to ensure correct type, quantity and 7.8.3
ratio of glue/solvent is applied?
Is working environment suitable and monitored (e.g. temperature/humidity controlled, 7.8.4
good ventilations and no excessive dirt) so that it does not compromise product safety, quality and legality?
Are process parameter (amount of glue, application/dispensing pattern, holding 7.8.5
time/pressure, curing time, etc.) established and validated according to process control plan/sheet?
7.8.6Are process parameters monitored and correction taken for any deviations that could
compromise product safety, quality and legality?
Is the 'break open procedure' operated to verify amount of glue or solvent applied?7.8.7
7.8.8Are procedures and controls for checking and monitoring finished parts (deformation,
defects, ahesion and excess glue marks, etc.). in place? 7.9 Assembly (Manual/Automated) (Please check N/A if there is no Assembly process)CL-SQPQuestionsQuestion MajorMajorMajorMajorMajorMajorMajorQuestion MajorMajorMajorMajorMajor
Question MajorMajorMajorMajor
Major
MajorMajorMajor
Question 第 17 页，共 21 页
7.9.17.9.27.9.37.9.47.9.57.9.67.9.7Are assembling procedures and controls (e.g. work instructions provided at the point of assembly) in place? Are screwing process parameter (torsion, sequence, workmanship, size, length) monitored and correction taken for any deviations? Are procedures and controls for material handling, assembly devices (e.g. computer-integrated manufacturing (CIM), material feeding/orientation and error sensing devices in place? Is working environment suitable and monitored (e.g. temperature, humidity, electrostatic) so that it does not compromise product safety, quality and legality?Are assembly parts verified without major deviation from the specification prior to assembly? Are process parameters carried out according to specifications and correction taken for any deviations that could compromise product safety, quality and legality?Are procedures and controls in place to ensure there is no physical hazards and foreign matter contamination, e.g., sharp edges, small parts that could compromise product quality, safety and legality? Are procedures and controls for checking and monitoring the finished assembled components/parts (e.g. defects, uniformity, workmanship quality, etc.) against approved specifications in place? MajorMajorMajorMajorMajorMajorCritical7.9.8Major7.10 Fabric Cutting (Please check N/A if there is no Fabric Cutting process)CL-SQPQuestionsAre cutting machine/equipment requirements set up according to specifications? 7.10.1
Are procedures and/or control in place to monitor and control cut panel quality (e.g., 7.10.2
nap direction from pile fabric, bowing, skewing, fabric grain, pattern, marker length and width)?
Are cut panels checked against approved pattern and approved specifications?7.10.3
Are cut panels properly stored in clean and undamaged condition?7.10.4
7.10 Sewing / Hair Rooting (Please check N/A if there is no Sewing and Hair Rooting
process)CL-SQPQuestionsAre sewing methods and sewing machine requirements (e.g., thread, needle size and 7.10.1
type) operated according to specification?
Are approved reference samples or workmanship standards readily available and used 7.10.2
as reference by the operators?
Are process parameter (machine setting, tension, sewing/rooting speed, stitches per 7.10.3
inch, etc.) established and validated according to process control plan/sheet?
Are process parameters monitored and correction taken for any deviations that could 7.10.4
compromise product safety, quality and legality?
Are procedures and controls for checking and monitoring the finished sewing parts 7.10.5
(e.g. seam strength, workmanship, root pattern etc) against approved specifications in place? 7.11 Attachment (e.g., eye, noses, buttons, snaps or other metal press fastners) (Please check N/A if there is no Attachment process)CL-SQPQuestionsAre proper machine / equipment / toolings / dies in use for the corresponding type of 7.11.1
attachments (e.g., eyes, noses, buttons, snaps or other metal press fastners)?
7.11.2
Are the strength of attachments tested by pull test equipment to verify compliance to the applicable safety and legislative requirements of the countries of intended sale?
7.11.3Are procedures and controls in place to ensure there is no physical hazards, e.g.,
sharp point and sharp edges that could compromise product quality, safety and
legality?
Question MajorMajor
MajorMajor
Question Major
MajorMajorMajor
Question MajorCritical
Critical
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7.12 Stuffing (Please check N/A if there is no Stuffing process)CL-SQPQuestionsAre stuffing method and requirements (e.g. weight of stuff) operated according to 7.12.1specification? Are procedures and controls for checking and monitoring finished parts (humidity, 7.12.2weight of stuffing, dirt, and hygiene, etc.) in place? 7.13 Metal Detection and Control
Where deemed necessary by the documented risk assessment, the company shall have systems for foreign body detection in place and ensure its effective operationCL-SQPQuestions7.13.17.13.27.13.37.13.47.13.57.13.67.13.7Are sharp tools (e.g., blade, knives, scissors, pins, needles…etc) used in the audited site? If yes, please answer the remaining questions in this section.Are the Snap-off-blade knives prohibited to use?Are all sharp tools (e.g., trimmers) permanently attached to benches?Are the sharp tools controlled by a listing & registration procedure?Is the Broken Needle policy in place (e.g., for sewing, embroidery lines) where all parts of broken needles have to be returned prior to new issue?Are complete broken needle records (with all broken parts of needle found) maintained? If some needle parts are missing, are follow-up actions taken recorded? Where a metal or foreign body detector is required or specified by the customer, does the company establish documented procedures specifying its use, location, critical limits for detection and recording of results?Does the company establish procedures for routine monitoring and testing of the metal and other foreign body detectors by suitable test pieces, where applicable?Does the company take immediate corrective action in the case of metal or foreign body detectors failure?If yes, does the company implement the following measures for all affected products?7.4.9.1 isolation7.4.9.2 quarantining 7.4.9.3 re-inspection 7.4.9.4 safe disposal7.14 Final Inspections
When product inspections are deemed necessary to assure delivery of safe, legal product of the required quality, they should be carried out following defined procedures that are documented, reviewed and authorised.
Question MajorMajorQuestion Risk WeightingNon-scoreCriticalCriticalMajorCriticalCriticalMajor7.13.87.13.97.13.10MajorCriticalCriticalCL-SQPQuestions
Does the company perform final inspection to verify the finished product for legality, safety and quality before release?
Does the company establish documented inspection procedure/protocol, which shall at least include the following,- sample size to be taken- inspection items
- acceptance / rejection criteria- defined AQL
- defect classification
- actions to be taken in the case of rejection
Question Risk WeightingCriticalMajor
7.14.1
7.14.2
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7.14.37.14.4
7.14.57.14.6
Are the inspection procedure/protocol approved and reviewed when changes in production methods or materials occurred?
Are the inspections conducted at an AQL level (with correct sample size) and/or frequency that is acceptable to the customer?
Does the company establish a procedure to handle the inspected goods which include the following:
- Policy/rule on returning inspected goods to production- Repacking requirements- Disposal
MajorMajorMajor
Major
Are the inspections carried out in suitable conditions, lighting and sufficient space?Are the personnel undertaking inspections suitably qualified and/or trained, and are
7.14.7competent to carry out the work required?
When inspection results are outside the defined acceptance level, are they evaluated
7.14.8.1and reviewed by a competent person?
7.14.8.2Where necessary, are corrective action taken and documented?
7.15 Final Product Packing and Control py p pg p p supplied meeting relevant safety criteria, taking account of legal requirements and customers’ specific requirements
Question Risk WeightingMajorMinorCriticalMinorMajorMajor
CL-SQPQuestions
Does the company establish a packing procedure/instruction for products according to legislative and customers' specific requirements?
Does the company verify the information shown on primary (consumer) package labels and outer cartons are correct?
Does the information meet the legislative and safety requirements of the region of intended sale?
7.15.1 7.15.27.15.3
7.16 Calibration and Control of Measuring and Monitoring Devices
Measuring equipment used to monitor product safety, quality and legality shall be identified. The identified measuring equipment shall be calibrated to a recognised national or international
standard. Where a traceable calibration is not possible, the company shall demonstrate the basis by which calibration is carried outCL-SQP
Questions
Question Risk WeightingMinor
7.16.17.16.27.16.37.16.47.16.57.16.67.16.7
Is there a list to identify equipment used to make measurements in accept or reject activity relevant to product safety, quality and legality including those in-line monitoring devices?
Is the identified equipment calibrated to appropriate accuracy and precision?Is the identified equipment calibrated before use and then at defined frequency?Is the the calibration of identified equipment traceable to a recognised national standard?
Are the records of calibration and verification maintained for a defined period?Is the identified equipment marked to show the calibration status and period of validity?Are there procedures in place for actions to be taken if equipment is found not to be operating within specified tolerances/limits?
MajorMajorMajorMajorMinorMajor
8 Personnel Training and CompetencyFUNDAMENTAL
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The company shall ensure that personnel performing work that affects product safety, legality and quality are demonstrably competent to carry out their activity, through training, work experience or qualification
Question Risk WeightingMajorMinorMajor8.4Are personnel performing work that affects product safety, legality and quality (including temporary personnel and contractors) appropriately trained and instructed prior to commencing work and adequately supervised throughout the working period? Major8.58.68.7Are the personnel, who have a direct effect on the safety, quality or legality of products, trained to ensure understanding of risk assessment procedures or outcomes as necessary for their activity?Are the effectiveness of trainings evaluated?Are up-to-date training records stored in a secure way such that privacy of personnel is protected? CL-SQP8.28.3QuestionsDoes the company determine necessary competence for personnel performing work impacting product safety, legality and quality?Does the company regularly identify training needs (including refresher training) for personnel performing work that affects product safety, legality and quality?MajorMajor第 21 页，共 21 页
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