Product Design Audit Points
Are there production design phases and its activities are identified?
Whether product design is reviewed? Is there verification process & validation activities are identified?
Are there identified production design’s verification & validation process is criteria defined for acceptance? How it’s measured?
Are there all the concern people who working on the product design are responsibilities and authorities for each phase and its activities are assigned? They are aware its responsibility & authorities.
Whether project department had taken the product design as schedule? Or is there any design project schedule is available?
Is there project department had targeted the time frame? They are on track of project schedule? How the schedule is defined? Are the each activities and its completion date phase wise defined?
Is there project design department had covered verification and validation process activities? How that are sound it?
Project design inputs are cleared noted & documented? How is design inputs documented?
Project design inputs is base part that, separately responsibility & authority defined? Who is responsible for reviewing & approval authority for the inputs?
Each documents created in project design are documented & recorded? What is the process of the approval?
Design change and its additional requirements for inputs are properly handled?
Design is projected in the flow? What is the output of the design project? Its all are documented? How project design / product design is maintained?
Are the documents reviewed and approved prior to release and by whom?
What is the process, how are preliminary documents from the final released documents?
Are there designs & concern documents are verified by production? Production concern people aware of the outputs of design projects? Verification of the output is documented?
What specific actions are taken to verify that design outputs meet the design input requirements?
What is the process step of the verification of final out puts? Is there a systematic review to verify the design output met design input requirements?
Are results of reviews, verifications and validations included in design change records?
What is the process for the design changes and documentations?
How to procurement are done? What is communication and information flow to product design to procurement?
Procurement department is aware of the requirements of product design? Such as material specifications, technical parameters, technical information, Spare parts lists, material safety data sheet requirements, etc.?
Is there production department peoples clearly understand specifications? Drawing? And instructions of production? How measure?
What is the Inspection & testing criteria for acceptance?
Incoming material / procured material inspection & testing are documented? How to concern with product realization?
Are the all records are maintained?
Inputs listing to check all design input are considered or not.
List out of each members of review team
How many design reviews are planned? Documents and records listing
Records of the design project results, actions for the implementation and effectiveness verifications.
Records of prototype, testing of prototype, result of prototype of tested.
Validation of product design records.