Is design change applicable (7.3.7)?

RCW

Quite Involved in Discussions
#1
Here's a problem that has come up. The scenario is:

A component on a circuit board is no longer available to purchase. Engineering does some research, determines an alternate replacement part and passes the part number on to purchasing via an updated parts list.

The question is, does this situation fall into the design change clause (7.3.7) whereby the change is reviewed, verified and validated?

Currently there is no evidence of verification or validation but does there need to be?

I'm lookin' for some input here......
 
Elsmar Forum Sponsor

CarolX

Super Moderator
Super Moderator
#2
Hi RCW,

I am pretty ignorant with respect to electronics, but here's my take.

If the new component performance is identical to the old one, this is not a design change.

What is Engineering's take on it? They are really the one's who have the knowledge to answer this.

Hope this help's a bit.

Regards,
CarolX
 
#3
Design or no design

I think the question is whether Engineering "designed" a new component, or if they just found a different part from a vendor.
passes the part number on to purchasing via an updated parts list
This makes me think they found a suitable part from buyer.

An example: Your job is to purchase PCBs. Engineering gives you specs on what to buy, and you buy them. The make and model normally used is no longer available. If Engineering designs a new replacement PCB and either your company, or a vendor builds it to the specs, you are design responsible. If Engineering just finds another PCB, already being manufactured, then you are not design responsible.

I think the important question is not with who owns the design, but what activities you perform.
 
Thread starter Similar threads Forum Replies Date
A Design Change/ECO Related Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Significant change related to design and intended use EU Medical Device Regulations 3
U NOC - What is considered a "design change" EU Medical Device Regulations 5
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
H New 510K VS Documents about design change. Other US Medical Device Regulations 2
R Explain what "design change" is to people new to the industry ISO 13485:2016 - Medical Device Quality Management Systems 9
T Closing out CAR while waiting for design change Nonconformance and Corrective Action 12
L Managing design projects: New Medical Device Project or Change Design and Development of Products and Processes 1
T How to Document Risk Effects on Design Change(s) ISO 14971 - Medical Device Risk Management 3
I Another design change or new product? IVD device ISO 13485:2016 - Medical Device Quality Management Systems 6
S Engineering change order versus a design change request ISO 13485:2016 - Medical Device Quality Management Systems 1
Q PPAP - How to determine the "Design Record Change Level" APQP and PPAP 2
S Verification and Validation of Post Market Design Change Design and Development of Products and Processes 2
A Reporting of Design Changes (Color Change Only) EU Medical Device Regulations 5
Q 510K Checklist that considers every Design Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
A Medical Device DHF (Design History File) - One per Design Change? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
V Product Evaluation Requirements for Change in Manufacturing Facility/Change in Design 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
S Design Change vs. Intellectual Property Design and Development of Products and Processes 9
A Design/Change Control Procedure - How to cope with Changes during Development? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 26
J What should be included in the Design Change Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S External or Internal Design Change and Responsibilities Document Control Systems, Procedures, Forms and Templates 3
C Design Change needed for Changing an Angle in existing Product from 15-25 degrees? ISO 13485:2016 - Medical Device Quality Management Systems 11
S Design Change Drawing Reviews and Customer Approval Process Document Control Systems, Procedures, Forms and Templates 5
A Design Review OR Design Change - Software development company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R Procedure for "Customer Acceptance of a design or process change" Design and Development of Products and Processes 12
D Design/Change Control Form Example and Advice Design and Development of Products and Processes 13
B Severity Reduction by Product or Process Design Change? Seeking Good Example Design and Development of Products and Processes 2
S FMEA Severity Rating - Will a Process Design Change also Change the Severity Rating? FMEA and Control Plans 21
L Outsourced Design with Internal Design Change Design and Development of Products and Processes 2
T Design and Development: 7.1.4 - Change Control - What is a good change control system Design and Development of Products and Processes 7
J When does an engineering change become a design change? Design and Development of Products and Processes 7
A Engineering change validation - Companies that have no design responsibility Design and Development of Products and Processes 5
M Reducing both Detection and Occurance in a Design FMEA WITHOUT a Design Change FMEA and Control Plans 8
N What are the VDA requirements for Design change? VDA Standards - Germany's Automotive Standards 2
K FMEA - Reduce Occurance of a Failure (or its cause) by Design Change FMEA and Control Plans 6
B Drawings - Design Rules Inspection, Prints (Drawings), Testing, Sampling and Related Topics 26
R Role of QA during Design and Development of Products and Processes Design and Development of Products and Processes 4
B Design Responsibilities for Mature Acquired Product Lines ISO 13485:2016 - Medical Device Quality Management Systems 3
I RWE Studies and Design Controls US Food and Drug Administration (FDA) 1
G How to record Regulations and Standards as Design Inputs? Design and Development of Products and Processes 15
T Design Traceability - Labelling / Instructions for Use ISO 13485:2016 - Medical Device Quality Management Systems 5
B How to exclude empty rows in full factorial design analysis? Using Minitab Software 0
M Handling design changes with use-as-is inventory disposition Quality Manager and Management Related Issues 6
M Design Control - Management of Electronic CAD files Design and Development of Products and Processes 14
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
R Using R package to implement Bayesian phase I/II dose-finding design for three outcomes ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Z Software for design control ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom