1. Management commitment and continual improvement
CL-SQP Questions Question
Risk Weighting
1.1Does the company's management define product safety and quality objectives?Major 1.2Is the review of the management systems carried out least annually?Minor 1.3Does the review of the management systems include evaluation of the following items?
1.3.1 Results of audits (internal, cond 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.
Major
1.4Are the decisions taken and actions agreed during the review communicated
effectively to appropriate staff?
Minor 1.5Are the actions implemented within the agreed timescales?Minor
1.6Does 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 environment
1.6.4 financial support
Major 2 Risk Management Systems
2.1Legislative and Safety Requirements
CL-SQP Questions Question
Risk Weighting
2.1.1Is the company aware of relevant legislation, mandatory standards and
industry/customer codes of practice applicable to the product in the countries of
intended sale?
Major
2.1.2Does 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
FUNDAMENTAL: The company's nior 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.
FUNDAMENTAL: The company shall have a product risk management plan, bad on a risk asssment 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 the exist in the countries of intended sale.
2.1.3Does the company have a process in place for ensuring it is kept informed of changes
to relevant legislation, standards etc?
Major
2.3Verification of Risk Asssment
CL-SQP Questions Question
Risk Weighting
2.3.1Is the verification of risk asssment carried out prior to production?Major 2.3.2Is the risk asssment carried out by competent personnel (internal or external)?Major 2.3.3Is the risk asssment regularly reviewed, at least annually or when changes made to
product design and materials and/or key manufacturing process?
Major
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 asssment?
Critical
2.3.5
Where required by legislation or when it is necessary to confirm its safety or legality, does the risk asssment include the testing results of a reprentative product?
Critical
3 Quality Management System 3.1Policy Statement
CL-SQP Questions
Question Risk Weighting 3.1.1
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?
Major
3.1.2Does the policy include the following?
- The company's intention to produce safe and legal products to defined quality, and to meet its resp
onsibility to its customers; and
- A commitment to comply with quality management system requirements and continual improvement
Minor
3.1.3Does the company periodically review the quality policy for continuing suitability?
Minor
3.2General Documentation Requirements 3.2.1Control of Document
CL-SQP Questions
Question Risk Weighting 3.2.1.1Does the company effectively control all documents (internal and external) impacting product safety, legality and quality?
Major 3.2.1.2Are current versions of documents available at points of u?
Minor 3.2.1.3Are document legible, unambiguous, in appropriate languages and sufficiently detailed
to enable their correct application by staff?
Minor 3.2.1.4Are obsolete documents identified and removed from u?
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
3.2.2Control of Record
CL-SQP Questions Question
Risk
Weighting
3.2.2.1Does the company establish procedures for the collation, review, maintenance, storage and retrieval of all records impacting product safety, legality and quality?
Minor
3.2.2.2Are records legible, genuine and authorid?Minor 3.2.2.3Are records readily accessible, curely stored to prevent damage deterioration?Minor 3.2.2.4Are records retained in accordance with periods specified by a customer or legislation?Major 3.2.2.5
Are any alterations to records justified and authorid?
Major
The company's nior management shall develop, document and implement a policy statement which is authorid, regularly reviewed, signed and dated by an appropriate nior manager.
The company's nior management shall ensure that all documents, records and data impacting the management of product safety, legality and quality are in place and effectively controlled
The company shall maintain records to demonstrate the effective control and achievement of product safety, legality and quality.
3.2.3Specifications
CL-SQP Questions Question
Risk Weighting
3.2.3.1Does the company establish specifications for raw materials, components, and bought-
in-parts including packaging, intermediate/mi-procesd and any product or rvice
which could impact the integrity of the finished product?
Major
3.2.3.2Is a specification of each final product documented and dated? Major 3.2.3.3Does the specification include the following information, where applicable?
- composition, size, colour
- bill of materials
- asmbly diagrams
- primary packaging
- intended shelf life
- warnings or instructions for u
- u, misu, usage patterns
- production volumes
Major
3.2.3.4Are specifications accurate and complying with relevant safety, legislative and
customer requirements?
Critical 3.2.3.5Are current specifications available at points of u?Minor 3.2.3.6Does 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?
Minor
3.2.3.7Does the technica dossier include the following information:
- a detailed product specification
- safety data sheets on chemicals ud where relevant to the safety, legality or quality
of the product
- the risk asssment(s)
- a description of the conformity asssment 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)
Major
3.2.3.8Are 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 ek formal agreement.
Minor
3.2.3.9Are specifications regulary reviewed at least annually to ensure its adequacy and
status?
Minor 3.3Responsibility and Authority
CL-SQP Questions Question
Risk Weighting
3.3.1Is the organisational chart available and up to date?Minor
3.3.2Are responsibilities, accountability and authorities clearly defined and commmunicated
for key staff involved with activities impacting product safety, legality and quality? Major
The company shall ensure that specifications exist for raw materials, components and bought in parts including packaging, intermediate/mi-procesd and finished products and any product or rvice which could affect the integrity of the finished product. A technical file shall be established for each product.
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
3.3.3Does the company have appropriate arrangements in place, to cover for the abnce
of key staff?
Minor 3.4Internal Audit
3.5Purchasing, Supplier & Sub-contractor Approval and Performance Monitoring
CL-SQP Questions Question
Risk Weighting
3.5.1Does the company have a 'List of Approved Suppliers & Sub-contractors'?Minor 3.5.2Is the 'List of Approved Suppliers & Sub-contractors' up-to-date to cover the
components, materials and rvice impacting safety, legality and quality?
Major 3.5.4Are specifications/requirements communicated to and agreed with the suppliers or sub-
contractors?
Minor 3.5.5Does the company establish supplier & sub-contractor lection and approval
process?
Minor 3.5.6Does the company conduct an ongoing supplier & sub-contractor performance
asssment?
Minor 3.5.7Does 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
3.5.8Does the company determine how exceptions are handled, where the u of products
or rvices of unapproved suppliers are acceptable under emergency or unusual
circumstances?
Minor 3.6Customer Property
CL-SQP Questions Question
Risk Weighting
3.6.1Is the customer property (e.g. software, intellectual property and products) identified,
verified, protected and safeguard?
Minor
3.6.2Does the company have means of reporting property that is lost, damaged or
otherwi found to be unsuitable for u to the customer?Minor
The company shall audit the management system to ensure that it is complied with and appropriate.
The company shall control all purchasing process which are impacting product safety, legality and quality to ensure that products and rvices procured conform to defined requirements. In this context suppliers shall include sub contractors and home workers
The company shall exerci care with customer property (including intellectual property) while it is under the company’s control or is being ud by the company.
