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

L

Lincole

#1
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!
 
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T

TigerLilie

#2
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.


 
#3
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

Staff member
Admin
#4
Refer http://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

Quite Involved in Discussions
#5
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
 

Attachments

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J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
T ISO 9001 8.5.2. - Identification and traceability to Identify Outputs - Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
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M Informational EU – Unique Device Identification (UDI) System – FAQs Medical Device and FDA Regulations and Standards News 0
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M MDR Annex IX Chapter I, 2.2 (c) - Device identification procedures during manufacture. EU Medical Device Regulations 1
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S Looking for procedure on UDI (Unique Device Identification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S UDI (Unique Device Identification) Requirements for Remanufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Quality Management System documentation identification Document Control Systems, Procedures, Forms and Templates 11
K Document Numbering (Identification) System Document Control Systems, Procedures, Forms and Templates 10
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Q ISO 9001 Cl. 8.5.2 and 8.5.4 - Identification in Products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Measurement Equipment - Identification of Calibration Status General Measurement Device and Calibration Topics 25
J Customer Identification and Traceability in Manufacturing Plans Manufacturing and Related Processes 5
M Risk Identification and Risk Assessment for any Process - Is it necessary? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
Edward Reesor UDI (Unique Device Identification): HIBCC or GS1? ISO 13485:2016 - Medical Device Quality Management Systems 31
R Identification of Medical Devices in MDD 93/42 Certificate EU Medical Device Regulations 2
L Managing Finance Processes - Identification of Sub Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Informational Is Identification of Risks and Opportunities required for QMS Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 96
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H UDI (Unique Device Identification) Requirements for IVD Software EU Medical Device Regulations 2
A Receiving Goods Inwards - Identification Records and Data - Quality, Legal and Other Evidence 8
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Q RFID (radio frequency identification) registration for Medical Device Other Medical Device Regulations World-Wide 6
B Class II Medical Device UDI (Unique Device Identification) Question(s) Other US Medical Device Regulations 8
A Is Risk Identification and Treatment a Process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
M Identification of Glass Instruments and Measurement Devices General Measurement Device and Calibration Topics 2
A Identification of Customer Property: Customer-Supplied Thumb Drives & Ext Hard Drives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Z Failure Mode Identification in PFMEA according to AIAG FMEA Rev.4 FMEA and Control Plans 6
M Reagent Status Identification - 7.4.3 Verification of Purchased Product ISO 13485:2016 - Medical Device Quality Management Systems 6
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M Identification and labeling medical device replacement system components Other Medical Device and Orthopedic Related Topics 12
T Implementing a Suspect Counterfeit Identification Program Quality Manager and Management Related Issues 3

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