Interpreting and Applying 7.3.2 Design and Development Inputs

kensonic_qmr

Starting to get Involved
#1
Hello guys. I need your help again. I'm having a hard time to interpret and apply the clause 7.3.2 Design and Development inputs in our Product development team.

I would describe briefly our Product development process (Our products are mainly electronic appliances):

We will select a product from supplier using their catalog. The supplier will then send the product to us. We will evaluate the product and check if we can improve its design and specification. After improving the product, we will then give our supplier the product information requirements. The supplier will then mass produce the item based on our product information requirements.

7.3.2 Design and development inputs says that

Inputs related to product development shall be determined and records maintained. These inputs shall include

a) functional and performance requirements:

My question here is, what is our input here base on my description of our product development process.

Can you give me a sample form?

Thanks a lot guys! :thanx: This is really the best forum to learn about international standards especially from newbies like me. :yes:
 
Last edited by a moderator:
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#4
No Sir, our supplier and our company (especifically our Product development team)are the entities in our situation.
As you are the design responsible and you say :
We will select a product from supplier using there catalog.
What functional and performance requirements you seek in that product is your functional and performance design input + what ever functional and performance you want to improve for which you check and suggest design and specification changes.
Please note that you may not be the inventor of that product, but so long as you use a design input (borrow) and modify, you stand responsible for the total product design and development. A major part of this responsibility you delegate to your supplier actually, and exercise control. (By control it can be that you ask your supplier to keep you informed of any changes he does to his design, so that you will review your design to see if you need to make any changes or otherwise)
Is it now simple ~~~
 
Last edited:

Chennaiite

Never-say-die
Trusted Information Resource
#5
We will select a product from supplier using there catalog. The supplier will then send the product to us. We will evaluate the product and check if we can improve it's design and specification. After improving the product, we will then give our supplier the product information requirements. The supplier will then mass produce the item based on our product information requirements.
The basis on which you are selecting the product from the Supplier Catalogue are the Input requirements indeed. The design changes you are suggesting are perhaps intended to meet these input requirements.
 
Thread starter Similar threads Forum Replies Date
Q Interpreting Tensile Charts General Measurement Device and Calibration Topics 0
Q Interpreting China Medical Device regulations/standards China Medical Device Regulations 1
P ISO 80369-7 standard - Interpreting which Parts should be in scope Other Medical Device Related Standards 7
K PACS - interpreting MDD and Borderline Guidance CE Marking (Conformité Européene) / CB Scheme 5
M List of Packaging Contents - Medical Devices - Interpreting EU Directive 93/42/EEC CE Marking (Conformité Européene) / CB Scheme 3
D Interpreting Normal vs Weibull Capabilities Capability, Accuracy and Stability - Processes, Machines, etc. 4
P Interpreting Span Measurement - P95-P5 Six Sigma 1
B Interpreting Deviations 5 & 6 in Annex ZA in ISO 14971:2012 ISO 14971 - Medical Device Risk Management 1
B Interpreting "misuse" when assessing Hazardous Situations ISO 14971 - Medical Device Risk Management 2
S Interpreting clause 4.1.5 in ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 9
M Interpreting Process Controls - 21 CFR Part 820.70(a) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Help interpreting 21 CFR Part 806 (corrections and removals) Other US Medical Device Regulations 1
G Interpreting Type 1 MSA (Measurement Systems Analysis) Results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
M Help interpreting MIL-STD-105E Single Sampling Plans Tables Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
M Biocompatibility in Respiratory Products - Help interpreting whitepaper IEC 60601 - Medical Electrical Equipment Safety Standards Series 22
I Interpreting Product Realization (Clause 7) in ISO 9001:2008 for Service Industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V GD&T Interpreting Datums in Two Single Segmented Position Tolerances Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
M Interpreting X bar and R Control Charts Statistical Analysis Tools, Techniques and SPC 2
B Help with interpreting stock market terminologies Coffee Break and Water Cooler Discussions 4
V Interpreting Zinc Plating Specification GMW 3044 - 6K96/48 APQP and PPAP 2
S Interpreting the Calibration Report for my Dial Indicator General Measurement Device and Calibration Topics 3
J Interpreting Process Capability results and ratios Capability, Accuracy and Stability - Processes, Machines, etc. 1
B Length Measure - Interpreting Calibration Results and Measurement Uncertainty (MU) Measurement Uncertainty (MU) 3
S Interpreting Level of Confidence - Round Robin for Tensile Testing - Help needed Statistical Analysis Tools, Techniques and SPC 4
M Interpreting AS9100 Clause 8.2.2 Internal Audit Requirements Internal Auditing 28
T Interpreting my t test in Minitab Using Minitab Software 2
S Interpreting Linear Regression Results from Minitab Using Minitab Software 15
optomist1 Interpreting LMC for Pattern of Slots (GD&T) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
optomist1 Interpreting Minitab Test For Equal Variances Using Minitab Software 3
V Interpreting Minitab Gauge R&R Results Using Minitab Software 6
A ISO 2081 - Interpreting Coating Thickness Other ISO and International Standards and European Regulations 3
L Interpreting Injection Molding Tooling Documents - Cavities Manufacturing and Related Processes 3
C Interpreting Gage R&R Results - 3 operators, 3 iterations and 10 parts Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
M Interpreting Measurement Uncertainty for Temperature PRT probes Measurement Uncertainty (MU) 2
N Interpreting Hygrometer Calibration Uncertainty - Temperature Coefficient Measurement Uncertainty (MU) 1
mr500 Interpreting Decimals in the mm state - Off Wall Question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 14
J Interpreting clause 7.5.2.1 (validation of software used in production & service) ISO 13485:2016 - Medical Device Quality Management Systems 2
E Interpreting Partial Least Square Results Using Minitab Software 1
C Interpreting Outside Laboratory Calibration Certificate Measurement Uncertainty (MU) 3
M Interpreting MIL-PRF-19500 (Performance Spec, Semicon Dev) - What is LTPD of 20 - ??? Manufacturing and Related Processes 4
T Rules for interpreting control charts Statistical Analysis Tools, Techniques and SPC 2
Q Interpreting Responsibility and Authority Clause 5.5.1 ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 18
H Interpreting 'Evaluation of compliance' in ISO 14001 Internal Auditing 4
P Micrometer Gage R&R study - Interpreting the data and suggestions Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
W Interpreting a Normal Probability Plot Statistical Analysis Tools, Techniques and SPC 4
Wes Bucey "Downsizing" ramifications - Evaluating and Interpreting the News World News 0
Q Interpreting calibration result of Air Particle Counter on Counting efficiency General Measurement Device and Calibration Topics 1
A Particle Counter Results - Interpreting Data for a Class 100,000 Cleanroom Other Medical Device Related Standards 12
M GD&T Q&A session - Interpreting FCF (Feature Control Frame) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 43
N TL 9000 - Help Interpreting Normalization Unit for Measurements TL 9000 Telecommunications Standard and QuEST 2

Similar threads

Top Bottom