
To perform GAP analysis and verify whether your design outputs are adequate for subsequent production or service provision processes, you should:
Review the Documentation of Design Outputs
Begin by reviewing the documented design outputs to confirm that they include all necessary details for production or service provision. These outputs should clearly describe product or service characteristics, ensuring they are appropriate and sufficient for the intended purpose. Check that they contain information on monitoring, measuring, and any acceptance criteria relevant to the final product or service.
Assess Compatibility with Production/Service Processes
Evaluate whether the documented design outputs provide all the information required by your production or service teams to execute their processes effectively. Design outputs should not leave any gaps that might cause delays, errors, or inconsistencies in production or service delivery. If the outputs are unclear or insufficient, it may hinder these teams' ability to meet quality standards or customer expectations.
Check for Retained Documentation
Confirm that documented information related to design outputs is retained as required. This includes records detailing any specifications, criteria, and characteristics necessary for production or service provision. This documentation should be stored and easily accessible for reference, ensuring compliance with ISO 9001 requirements and facilitating smooth production or service transitions.
By completing these checks, you can determine if your design outputs are adequate to support the next stages of production or service provision and meet the ISO 9001 standard.