SQP验厂-质量管理体系

Quality Management System 质量管理体系

1、 Policy Statement 政策声明
    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.

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?
1.2  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
1.3  Does the company periodically review the quality policy for continuing suitability?


2、 General Documentation Requirements 一般文件要求
2.1   Control of Document 控制文件
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
公司的高层管理者应确保所有的文件，记录和数据，影响产品的安全管理，合法性和质量进行有效的控制
  (1).  Does the company effectively control all documents (internal and external) impacting product safety, legality and quality?
  (2).  Are current versions of documents available at points of use?
  (3).  Are document legible, unambiguous, in appropriate languages and sufficiently detailed to enable their correct application by staff?
  (4).  Are obsolete documents identified and removed from use?
  (5).  Does the company record the date and reason for any change/amendment to documents impacting product safety, legality or quality?

2.2   Control of Record SQP验厂记录的控制
The company shall maintain records to demonstrate the effective control and achievement of product safety, legality and quality.
公司应保存记录以证明有效的控制产品质量。

  (1).  Does the company establish procedures for the collation, review, maintenance, storage and retrieval of all records impacting product safety, legality and quality?
  (2).  Are records legible, genuine and authorised?
  (3).  Are records readily accessible, securely stored to prevent damage deterioration?
  (4).  Are records retained in accordance with periods specified by a customer or legislation?
  (5).  Are any alterations to records justified and authorised?

2.3   Specifications 规格
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.
公司应保存原材料存在的规格，包括购买的包装组件和部分，中间/半成品和成品和任何产品或服务，这可能会影响最终产品的完整性。应为各产品建立技术文件。

  (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?
  (2).  Is a specification of each final product documented and dated?
  (3).  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
  (4).  Are specifications accurate and complying with relevant safety, legislative and customer requirements?
  (5).  Are current specifications available at points of use?
  (6).  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?
  (7).  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)
  (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.
  (9)  Are specifications regulary reviewed at least annually to ensure its adequacy and status?


3、 Responsibility and Authority 职责和权限
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.
公司应当有明确的组织结构和记载，以确保工作职责和主要工作人员的关系。

3.1   Is the organisational chart available and up to date?
3.2   Are responsibilities, accountability and authorities clearly defined and commmunicated for key staff involved with activities impacting product safety, legality and quality?
3.3   Does the company have appropriate arrangements in place, to cover for the absence of key staff?


4、 Internal Audit SQP验厂内部审计
The company shall audit the management system to ensure that it is complied with and appropriate.

4.1  Does the company conduct internal audits at planned intervals?
4.2  Does the company define an audit schedule detailing audit criteria (requirements based on), scope (including areas, departments or processes) and frequency?
4.3  Is the frequency of internal audits based on importance of activities, as well as the results of previous audits?
4.4  If there are any exceptional aspects to be audited more than one year,  are they justified and documented in risk assessment?
4.5  Are internal audits carried out by competent personnel, who shall be independent of the area of operation being assessed?
4.6  Are records of internal audits and associated corrective actions maintained with both conformity and non conformity with requirements documented?


5、 Purchasing, Supplier & Sub-contractor Approval and Performance Monitoring 采购，供应商和承包商验收和性能监测
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
应控制所有采购过程是否影响产品的安全性，合法性和质量，确保采购的产品和服务符合规定的要求。在这种情况下，供应商应包括分包商和工人

5.1  Does the company have a 'List of Approved Suppliers & Sub-contractors'?
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?
5.3  Are specifications/requirements communicated to and agreed with the suppliers or sub-contractors?
5.4  Does the company establish supplier & sub-contractor selection and approval process?
5.5  Does the company conduct an ongoing supplier & sub-contractor performance assessment?
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?
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?


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.

6.1  Is the customer property (e.g. software, intellectual property and products) identified,verified, protected and safeguard?
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?


7、 Corrective and Preventive Action SQP验厂纠正和预防措施
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
基础：公司高级管理层应确保程序存在的记录，调查，分析和纠正不合格的产品影响产品安全规范程序，合法性和质量的原因。

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?
7.2  Does the documented procedure include the following?
  (1) reviewing non-conformities (including customer complaint);
  (2) investigating the root cause of non-conformities;
  (3) determing and implementing corrective/ preventive actions needed; and
  (4) recording the results of action taken
  (5) evaluating the effctiveness of the action taken
7.3  Are appropriate staff member identified and assigned the responsibilty and accountability for each corrective and preventive action?
7.4  Are corrective / preventive actions effectively taken to eliminate the causes of non-conformities in order to prevent recurrence / occurence?
7.5  Are corrective and preventive actions undertaken in an agreed timeframe?


8、 Identification & Traceability 标识和可追溯性
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.

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 stages of receipt, production, storage and dispatch?
8.2  Are finished products labelled according to the customer specification and/or legislative requirements?
8.3  Do finished products (including re-work) have a full traceability to raw materials source,and vice versa?
8.4  Is the effectiveness of the traceability system regularly tested, at least annually?


9、 Incident, Product Withdrawal and Product Recall SQP验厂产品撤回和产品召回事件
The company shall have a plan and system in place to effectively manage product withdrawal and product recall procedures.

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?
9.2  Does the company have a written agreements/consensus in place with relevant parties in the supply chain regarding the product withdrawal/recall?
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?
9.4  Is the product withdrawal and recall procedure regularly tested, at least annually?


10、 Business Continuity Planning 业务连续性计划
The company shall have procedures in place to identify methods of ensuring business continuity in the case of major incidents/threats to a business.

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?
10.2  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.


11、 Customer Focus 客户至上
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.

11.1  Does the company have processes in place to ensure customer specifications, needs and requirements are understood and met?
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?
11.3  Are customer requirements (e.g., production capability, capacity…etc) reviewed on a suitable planned interval?
11.4  Are any resulting changes to existing agreements or contracts documented and communicated to relevant parties?
11.5  Does the company establish performance indicators relating to customer satisfaction?


12、 Complaint Handling SQP验厂-投诉处理
The company shall operate an effective system for handling and investigating the cause and resolution of product complaints.

12.1  Does the company operate an effective system for handling and investigating the cause and resolution of product complaints?
12.2  Does the company carry out prompt and effective actions in accordance with the seriousness and frequency of the problems identified?
12.3  Does the company analyse and use complaint data to implement ongoing improvements?