Скачать или смотреть How to accurately determined the design input requirements

This channel focuses on Quality from a quality engineer prospective. If you like the content then please like, subscribe and share. Thank you kindly, Sharky

   / @thinkqualityfirst  

In this presentation, I will discuss three (3) questions:
1) What is the relationship between User Needs and Design Input?
2) What is the relationship between Design Input and Design Output?
3) What is difference between a Design History File, Design Master Record and Device History Record?
The first (1st) question is “what is the relationship between User Needs and Design Input?”
• Sometimes we look at the user needs/intended use as the same as the Design Input which it is not, in practice or regulatory wise.
First things first, we should understand the meaning of the User Needs and Intended Use:
• User Needs describes how the medical device is going to be used
• Intended Use describes the clinical issue the device addresses
Here are some more details about the user needs and intended use:
• Design engineers will translated the user needs into design inputs.
• To understand the reason for translation, we have to look at the source of the user needs and intended use. The source are usually from Marketing, Sales, Physicians, research, or clinical activities and they are likely stated in a broad description. They are rarely stated comprehensively and they shouldn’t be expected to.
It is the responsibility of the design engineer to work with the originator to get detail understanding and to translate the users need into engineering terminology, so it is clearly understood and it measureable.
The Approvers of the design input document are on the hook for ensuring that the design input requirements are appropriate. This is not a rubber stamp activity.
The third (3rd) question is “What is the difference between a Design History File, a Design Master Record and a Device History Record?”
This can be confusing trying to understand especially if you are new to the design and development environment or you have not worked closely with these activities.
Let’s look at each of them.
The design history file is a:
• Compilation of records which describes the design history of a finished device.
• These records demonstrate that the device was developed in accordance with the design plan and the regulations.
• A development project creates a large amount of records but not all records are DHF. The records that are required as a deliverable in your phase reviews are considered the DHFs.
• Examples of these records would be: verification reports, validation reports, risk management report, marketing plan, regulatory strategies, etc.
The design master record is a:
• Compilation of records containing the procedures and specifications for a finished device.
• It is like the recipe for making the device. A company should be able to replicate the device in another location using the design master record (DMR).
Lastly, the device history record is a:
• A compilation of records containing the production history of a finished device.
• These will demonstrate that the device is manufactured in accordance with the device master record. The records will include the dates of manufacture, the quantity manufactured, quantity released for distribution, etc.
At this point you should be aware that the Design history file (DHF) and the design master record (DMR) are related to product development while the device history record (DHR) is related to manufacturing.