TS169492002版英文检查表(1).docx

Quality System Assessment Check-List

Checklist to ISO/TS 16949:2002

Last revision 09/10/ 2001

Second Edition, Issued October, 2001
Copyright © 2001

© DaimlerChrysler, Ford Motor Company, General Motors Corp., © ANFIA, © CCFA/FIEV, © VDA, © SMMT

FOREWORD

The Quality System Assessment Check-List to ISO/TS 16949 Second Edition is based on the content of ISO/TS 16949 and it is effective for the life of ISO/TS 16949, Second Edition.

The Quality System Assessment Check-List is to be used as a guide in auditing the requirements of ISO/TS 16949, Second Edition. The requirements column references the clauses in ISO/TS 16949. All italics are ISO 9001: 2000. The "What to look for" column is not mandatory but it is a good guide. It is expected that auditors will supplement this column with their educated and experienced enhancements.

Acknowledgements for this effort are due to the IATF membership.
ELEMENT 4 – Quality management system

Requirements
What to look for
Assessor notes / Objective evidence
4.1 General Requirements
4.1.1

Has the organization established and documented a quality management system in accordance with the requirements of ISO/TS 16949:2002(E)?
(4.1)
· Quality manual according to TS 16949 or one with a conversion matrix.

4.1.2

Has the organization implemented and maintained its established quality management system in accordance with the requirements of ISO/TS 16949:2002(E)?
(4.1)
· Key personnel interview.
· Examples of effective implementation.

4.1.3

Is the organization continually improving the effectiveness of its quality management system in accordance with the requirements of ISO/TS 16949:2002(E)?
(4.1.1.1)
· Examples and status of quality management system continuous improvement projects , not corrective actions.
· Management review results.
·
4.1.4

Does the organization’s quality management system :
a) identify the processes needed for the quality management system and their application throughout the organization?
b) determine the sequence and interaction of these processes?
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective?
(4.1.a, b, c)
· Quality manual according to TS 16949 or one with a conversion matrix.
·

4.1.7

Does the organization’s quality management system :
a) ensure the availability of resources and information necessary to support the operation and monitoring of the processes needed for its quality management system?
b) monitor, measure and analyze the processes needed for its quality management system?
c) implement actions necessary to achieve planned results and continual improvement of the processes needed for its quality management system?
(4.1.d, e, f)
· Review of all the elements of the quality management system to insure its continuing suitability and effectiveness.
· Review of quality cost indicators
· Management review meeting minutes, attendance and adequate frequency.
· Action plans and follow-up.

4.1.10

Does the organization manage the processes needed for its quality management system in accordance with the requirement of ISO/TS 16949:2002(E)?
(4.1)
·

4.1.11
Does the organization ensure control over outsourced processes that affects product conformity with requirements?
(4.1)
·

4.1.12

Is the control of the organization’s outsourced processes that affects product conformity with requirements identified within the quality management system?
(4.1)
· Quality manual according to TS 16949 or one with a conversion matrix.
·

ELEMENT 4.2 Documentation requirements

4.2.1 General
4.2.1

Does the quality management system documentation include the following:
a) documented statements of a quality policy and quality objectives?
b) a quality manual?
c) documented procedures required by ISO/TS 16949:2002(E)?
d) documents needed by the organization to ensure the effective planning, operation and control of its processes?
e) records required by ISO/TS 16949:2002(E) (see element 4.2.4)?
(4.2.1)
· Quality manual according to TS 16949 or one with a conversion matrix.
· Adequacy of the procedures to the complexity of the organization.
· Quality management system procedures.
· Quality records.

4.2.2 Quality Manual
4.2.2

Has the organization established and maintained a quality manual that includes :
a) the scope of the quality management system, including details of and justification for any exclusions (see section 1.2 of ISO/TS 16949:2002(E))?
b) the documented procedures established for the quality management system, or reference to them?
c) a description of the interaction between the processes of the quality management system?
(4.2.2)
· Quality manual according to TS 16949 or one with a conversion matrix.

4.2.3 Control of documents
4.2.3
Does the organization control the documents required by the quality management system?
(4.2.3)
· Quality manual according to TS 16949 or one with a conversion matrix.
· Document control master list or equivalent.

4.2.3

Has the organization established a documented procedure to define controls needed:
a) to approve documents for adequacy prior to issue?
a) to review and update as necessary and re-approve documents?
b) to ensure that changes and the current revision status of documents are identified?
c) to ensure that relevant versions of applicable documents are available at points of use?
d) to ensure that documents remain legible and readily identifiable?
e) to ensure that documents of external origin are identified and their distribution controlled?
f) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?
(4.2.3)
· Document approval authority.
· Document approval records.
· Availability of documents in various locations.
· Knowledge of documents location.
· Document accessibility.
· Storage and disposal of obsolete documents.
· Process for notification/distribution of documents from internal and external origins.
· Review and approval of revised documents.

4.2.3.1 Engineering specifications
4.2.4

Does the organization have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes (including the updating of appropriate documents) based on customer required schedule?
(4.2.3.1)
· Process for notification/distribution of customer engineering standards changes.
· Process for implementation of customer initiated changes.
· Document changes triggered by engineering changes.

4.2.5

Does the organization maintain a record of the date on which each change is implemented in production?

(4.2.3.1)
· Records of engineering changes implemented.

4.2.4 Control of records
4.2.6

Has the organization established and maintained records to provide evidence of conformity to requirements and of the effective operation of the quality management system?
(4.2.4)
· Quality management system records.
· Records maintenance system, including disposal of records..

4.2.7

Are records legible, readily identifiable and retrievable?
(4.2.4)
· Quality management system records legibility.
· Identification of quality management system records.
· Environment and storage conditions must be compatible with the file storage medium (ex: hard copy, floppy disk, etc.)

4.2.8

Has the organization established a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records ?
(4.2.4)
· Quality manual according to TS 16949.
· Defined record retention time compared to customer/regulatory requirements
· Record disposal after retention period expires
· Including identification of obsolescence documents.
· Identification of invalid/obsolete documents.

4.2.9

Does the organization treats quality records as a special type of document and control them according to the requirements given in questions 4.2.7 and 4.2.8?
(4.2.3)
· Evidence of quality records being maintained and controlled per quality manual.

5 - Management responsibility

5.1 Management commitment
5.1.1

Does top management have evidence of providing commitment to the development and implementation of its quality management system?
(5.1)
· Documented policy statement with clearly defined and measurable quality objectives approved by CEO

5.1.2

Does the organization’s top management have evidence of providing commitment to continually improving its quality management system effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements?
b) establishing the quality policy?
c) ensuring that quality objectives are established?
d) conducting management reviews?
e) ensuring the availability of resources?
(5.1)
· Customer defined objectives (Customer specifications) and company goals stated in the business plan and their alignment with the quality policy statement.
· Quality manual according to TS 16949.
· Management reviews meeting minutes; attendance and adequate frequency.
· Action plans and follow-up.

5.1.1 Process Efficiency
5.1.3
Does organization’s top management monitor the product realization processes and the support processes to assure their effectiveness and efficiency?
(5.1.1)
· Review of product realization and support processes by top management.
· Indicators and records.
· Reporting process.

5.2 Customer Focus
5.2.1

Does top management ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction?
(5.2)
· Description of an objective process
· Methodology used for surveys
· Original Customer data and scope such as customer satisfaction feedback (surveys, scorecards, awards, etc)

5.3 Quality policy
5.3.1

Does top management ensure that the quality policy:
a) is appropriate to the purpose of the organization?
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system?
c) provides a framework for establishing and reviewing quality objectives?
d) is communicated and understood within the organization?
e) is reviewed for continuing suitability?

(5.3)
· Documented policy statement with clearly defined and measurable quality objectives approved by CEO
· Records of improvement.
· Quality objectives included/linked to the business plan.
· Scope of the Quality objectives.
· Direct interviews with randomly selected people of the organization.
· Evidence of periodic review of the quality policy.
· Review of all the elements of the quality system to insure its continuing suitability and effectiveness.

5.4 Quality objectives
5.4.1

Does the organization’s top management ensure that quality objectives, including those needed to meet requirements for product (see section 7.1 of the ISO/TS 16949:2002(E) technical specification) are established at relevant functions and levels within the organization?
(5.4.1)
·

5.4.2

Are the organization’s quality objectives measurable and consistent with the quality policy?
(5.4.1)
· Quality cost indicators and quality indices
· Quality objectives included/linked to the business plan.

5.4.3

Did top management define any quality objectives and measurements?
(5.4.1.1)
· Quality objectives included/linked to the business plan.
· Scope of the Quality objectives

5.4.4

Are the organization’s quality objectives and measurements included in the business plan and used by top management to deploy the organization’s quality policy?
(5.4.1.1)
· Quality objectives included/linked to the business plan.
· Management review meeting minutes, attendance and adequate frequency.

5.4.2 Quality management system planning
5.4.5

Does top management of the organization ensure that
a) the planning of the quality management system is carried out in order to meet the general quality management system requirements stated in section 4.1 of ISO/TS 16949:2002(E), as well as the quality objectives?
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented
(5.4.2)
· Internal audit results.

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority
5.5.1

Does the organization’s top management ensure that the responsibilities and authorities are defined and communicated within the organization?
(5.5.1)

· Responsibilities and authority as defined in job descriptions, responsibilities matrices, procedures, accountabilities documents.

5.5.1.1 Quality responsibility
5.5.2

Is management with responsibility and authority for corrective action promptly informed of products or processes which do not conform with requirements?
(5.5.1.1)
· Select examples of non-compliance from suitable sources such as internal or external concerns/complaints, etc.
· Communication channels and timeliness.

5.5.3

Does the organization’s personnel responsible for quality have the authority to stop production to correct quality problems?
(5.5.1.1)
· Who is responsible for quality in the production process
· How the authority is defined
· Recent examples

5.5.4

Are the organization’s production operations staffed with personnel that ensure product quality across all shifts?
(5.5.1.1)
· Quality Assurance responsible personnel in all shifts.

5.5.2 Management representative
5.5.5

Did the organization’s top management appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes
a) ensuring that processes needed for the quality management system are established, implemented and maintained?
b) reporting to top management on the performance of the quality management system and any need for improvement?
c) ensuring the promotion of awareness of customer requirements throughout the organization?
(5.5.2)
· Who is the person in charge of this responsibility
· Evidence of activities performed including empowerment for all applicable system elements including design, sales, manufacturing, delivery, etc.
· Management review minutes

5.5.2.1 Customer representative
5.5.6

Did the organization’s top management designate individual(s) to represent the needs of the customer to address quality requirements, such as selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development?
(5.5.2.1)
· Quality function representative in project teams
· Quality function participation in milestones decisi