ISO/TS 16949 checklist about design and development
ISO/TS 16949 checklist about design and development
Clause 7.3
7.3.1 DESIGN AND DEVELOPMENT PLANNING
7.3.1 Does the organization plan and control the design and development of product?
7.3.2 During the design and development planning, does the organization determine:
a) the design and development stages?
b) The review, verification and validation that is appropriate to each design and development stage?
c) The responsibilities and authorities for design and development?
7.3.3 Does the organization manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility?
7.3.4 Is the organization’s product design and development planning output updated, as appropriate, as the design and development progresses?
7.3.1.1 MULTIDISCIPLANRY APPROACH
7.3.5 Does the organization use a multidisciplinary approach to prepare for product realization, including
- development/finalization and monitoring of special characteristics?
- Development, and review of FMEAs including actions to reduce potential risks?
- Development, and review of control plans?
7.3.2 DESIGN AND DEVELOPMENT INPUTS
7.3.6 Does the organization determine inputs relating to product requirements and maintain the related records?
7.3.7 Does the organization’s inputs relating to product requirements include:
a) functional and performance requirements?
b) Applicable statutory and regulatory requirements?
c) Where applicable, information derived from previous similar designs?
d) Other requirements essential for design and development?
7.3.8 Does organization review its inputs relating to product requirements for adequacy?
7.3.9 Are the inputs relating to product requirements complete, unambiguous and not in conflict with each other?
7.3.2.1 PRODUCT DESIGN INPUT
7.3.10 Does the organization identify, document and review the product design inputs requirements including:
- customer requirements (contract review)?
- Use of information (the organization shall have a process to deploy information gained)?
- Targets for product quality, life, reliability, durability, maintainability, timing and cost.
7.3.2.2 MANUFACTURING PROCESS DESIGN INPUT
7.3.1.1 Does the organization identify, document and review the manufacturing process design input requirements, including:
- product design output data?
- Targets for productivity, process capability and cost?
- Customer’s requirements if any?
- Experience from previous developments?
7.3.2.3 SPECIAL CHARACTERISTICS
7.3.12 Does the organization identify special characteristics and:
- include all special characteristics in the control plan?
- Comply with customer specified definitions and symbols?
- Identify process control documents including drawings, FMEAs, control plans, and operator instructions with the customer’s special characteristic symbol or the organization’s equivalent symbol or notation to include those process steps that affect special characteristics?
7.3.3 DESIGN AND DEVELOPMENT OUTPUTS
7.3.13 Does the organization provide outputs of design and development in a form that enables verification against the design and development input and approved prior to release?
7.3.14 Do the organization’s design and development outputs:
a) meet the input requirements for design and development?
b) Provide appropriate information for purchasing, production and for service provision?
c) Contain or reference product acceptance criteria?
d) Specify the characteristics of the product that are essential for its safe and proper use?
7.3.3.1 PRODUCT DESIGN OUTPUTS – SUPPLEMENTAL
7.3.15 Is the organization’s product design output expressed in terms that can be verified and validated against product design input requirements?
7.3.16 Does the organization’s product design output include:
- design FMEA, reliability results?
- Product special characteristics, specifications?
- Product error proofing, as appropriate?
- Product definition including drawings?
- Product design reviews results?
- Diagnostic guidelines where applicable?
7.3.3.2 MANUFACTURING PROCESS DESIGN OUTPUT
7.3.17 Is the organizations manufacturing process design output expressed in terms that can be verified against manufacturing process design input requirements and validated?
7.3.18 Does the organization’s manufacturing process design output include:
- specifications and drawings?
- Manufacturing process flow chart / layout?
- Manufacturing process FMEAs?
- Control plan?
- Work instructions?
- Process approval acceptance criteria?
- Data for quality, reliability, maintainability and measurability?
- Results of error-proofing activities, as appropriate?
- Methods of rapid detection and feedback of product/manufacturing process non-conformities?
7.3.4 DESIGN AND DEVELOPMENT REVIEW
7.3.19 Does the organization perform systemic reviews of design and development at suitable stages in accordance with planned arrangements:
a) to evaluate the ability of the results of design and development to fulfill requirements?
b) To identify any problems and propose necessary actions?
7.3.20 Do the participants in the systematic reviews of design and development identify any problems and propose necessary actions?
7.3.21 Are the records of the results of the reviews and any necessary actions maintained by the organization?
7.3.4.1 MONITORING
7.3.22 Does the organization define and analyze measurements at specified stages of design and development and reported with summary results as an input to management review.
7.3.5 DESIGN AND DEVELOPMENT VERIFICATION
7.3.23 Does the organization perform design and development verification in accordance with planned arrangements to ensure that the design and development outputs have satisfied the design and development input requirements?
7.3.24 Does the organization maintain records of the results of the verification and any necessary actions?
7.3.6 DESIGN AND DEVELOPMENT VALIDATION
7.3.25 Does the organization perform design and development validation, accordance with planned arrangements (see element 7.3.1 of ISO/TS16949:2002) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known?
7.3.26 Wherever practicable, does the organization complete design and development validation prior to the delivery or implementation of the product?
7.3.27 Does the organization maintain records of the results of validation and any necessary actions?
7.3.6.1 DESIGN AND DEVELOPMENT VALIDATION – SUPPLEMENTAL
7.3.28 Does the organization perform design and development validation in accordance with customer requirements including program timing?
7.3.6.2 PROTOTYPE PROGRAM
7.3.29 When required by the customer, does the organization have a prototype program and control plan?
7.3.30 Wherever possible, does the organization use the same suppliers, tooling and manufacturing processes as it will be used in production?
7.3.31 Does the organization monitor all performance testing activities for timely completion and conformance to requirements?
7.3.32 Is the organization responsible for the subcontracted services, including technical leadership?
7.3.6.3 PRODUCT APPROVAL PROCESS
7.3.33 Does the organization conform to a product and process approval procedure recognized by the customer?
7.3.34 Does the organization apply a product and process approval procedure recognized by the customer to its suppliers?
7.3.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES
7.3.35 Does the organization identify design and development changes and maintain records relevant to those changes?
7.3.36 Does the organization review, verify and validate design and development changes, as appropriate, and approved before implementation?
7.3.37 Does the organization’s review of design and development changes include evaluation of the effect of the changes on constituent parts and already delivered product?
7.3.38 Does the organization maintain records of the results for the review of design and development changes and any necessary actions?
Related documents:
Advertisement
Sponsor sites:
1. Phrases For Performance Appraisals.
2. Interview questions and answers.
This entry was posted
on Saturday, November 21st, 2009 at 9:20 am and is filed under ISO/TS16949 checklist.
You can leave a response, or trackback from your own site.
