Identification of Inputs vs. Outputs in Design and Development (Section 7.3)

[Lincole]

Hi all, as I am trying to write an easy to read procedure for the company, I came across this stage where I need to identify between input and output during the design and development.

I am not an Engineer, so I am having a difficulty to distinguish the difference between the two except the fact that input is to put something in and output is the finished drawing.

Is there anything specific that I should address about these two terms?

Thanks a million times!

 

[TigerLilie]

Re: Input Vs Out (Section 7.3)

We are also an engineering company and we define design input requirements are the customer specifications, presented in the form of a Request for Quotation or Proposal (RFQ or RFP), a customer purchase order or a contract. Design outputs are specifications, purchase orders, test plans and procedures.

 

[mdoremus]

We also include the following items as inputs: Applicable statutory & regulatory requirements; company standards and quidelines, information from previous designs
Although not listed on an RFQ, they are still part of the process.

 

[Ajit Basrur]

Refer https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170251.htm

Inputs are the requirements of a device. They must be documented. Review the sources used to develop inputs. Determine that relevant aspects were covered. Examples of relevant aspects include: intended use, performance characteristics, risk, biocompatibility, compatibility with the environment of intended use including electromagnetic compatibility, human factors, voluntary standards, and sterility.

Design outputs are the work products or deliverables of a design stage. Examples include, diagrams, drawings, specifications and procedures. The outputs from one stage may become inputs to the next stage. The total finished design output consists of the device, its packaging and labeling, and the device master record.

 

[dsanabria]

Hi all, as I am trying to write an easy to read procedure for the company, I came across this stage where I need to identify between input and output during the design and development.

I am not an Engineer, so I am having a difficulty to distinguish the difference between the two except the fact that input is to put something in and output is the finished drawing.

Is there anything specific that I should address about these two terms?

Thanks a million times!

IAQG (International Aerospace Quality Group) came out with a nice documents for auditors - see attachments

Hope it helps