Planning of product realization checklist of ISO/TS 16949

Planning of product realization checklist of ISO/TS 16949
Clause 7.1

7.1.1 Has the organization planned and developed the process needed for product realization?

7.1.2 Is the organizations planning of product realization consistent with the requirements of the other processes of the quality management system?

7.1.3 In planning product realization, does the organization determine the following, as appropriate:

a) quality objectives and requirements for the product?
b) The need to establish processes, documents, and provide resources specific to the product?
c) Required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance?
d) Records needed to provide evidence that the realization processes and resulting product meet requirements?

7.1.4 Is the organization’s planning of product realization output in a form suitable for the organization’s method of operations?

7.1.1 PLANNING OF PRODUCT REALIZATION – SUPPLEMENTAL

7.1.5 Are the customer requirements and references to its technical specifications included in the planning of product realization as a quality plan?

7.1.2 ACCEPTANCE CRITERIA

7.1.6 Did the organization define acceptance criteria for the product being developed and where required, approved by the customer?

7.1.7 Is the organizations acceptance criteria for attribute data sampling zero defects?

7.1.3 CONFIDENTIALITY

7.1.8 Does the organization ensure the confidentiality of customer contracted products and projects under development, and related product information.

7.1.4 CHANGE CONTROL

7.1.9 Does the organization have a process to control and react to changes that impact product realization including those initiated by the supplier?

7.1.10 Does the organization assess the effects of changes?

7.1.11 Has the organization defined the verification and validation activities for changes, to ensure compliance with customer requirements?

7.1.12 Does the organization validate changes before implementation?

7.1.13 Does the organization review proprietary designs, impact on form, fit, function, (including performance, and/or durability) with the customer so that all effects can be properly evaluated

7.1.14 Does the organization meet additional verification/identification requirements such as those required for the new product introduction when required by the customer?

Related documents:

1. ISO/TS 16949 checklist

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This entry was posted on Saturday, November 21st, 2009 at 9:15 am and is filed under ISO/TS16949 checklist. You can leave a response, or trackback from your own site.

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