Product and Process Approval Systems

Product and Process Approval Systems

1. Describe how validation and qualification methods are used to approve new or updated product, processes and services

   • VERIFICATION
     • It's conducted by engineering to determine
       • Whether design specifications are being met
         • Include
           • Formal product/ service design reviews
           • Qualificaion testing
           • Burn in/ run in tests
           • Perfomance tests
           • Demostrations
           • Prototypes
           • Design comparison with similar existing designs previously proven to work
     • STAGES OF THE PRODUCT DEVELOPMENT CYCLE
   • VALIDATION AND QUALIFICATION METHODS
     • Qualification
       • Qualification Testing
         • Evaluation results, any results of nonconformity
           • Failure should be documented
       • Qualification Process
         • It's a set of steps that demonstrate the ability of an entity to fulfill specified requirements
     • Validation
       • Methods
         • First article testing
           • to demostrate process capability standars quality tooling
         • Pilot run
           • Is a trial production run
         • Alpha testing
           • inhouse- tests conducted on prototypes
         • Beta testing
           • Final test before the product is released to the comercial market

2. QUALITY FUNCTION DEPLOYMENT

   • It's a value tool for
     • Product
     • Service
     • Process design
     • It is a structured approach to
       • Defining customer needs or requirements
         • translating them into specific plans to produce products to meet those needs

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