Design Transfer & use of "prototype" components in production devices.

ThatSinc

Involved In Discussions
#1
Hi All,

I have a query regarding Design Transfer, particularly with regards to 7.3.2.c. during the planning of design and development and transfer activities at "each stage" of development , and 7.3.8 for the overall process of final-design transfer to production.

As a part of the development process, prototyping, and ensuring production capability, during the design process "Company A" will manufacture components to the drawn specifications at any given time. These will be issued a batch number, and the technical drawings will have a release issue.
Rather than manufacture 5 or 6 of the prototype parts, a small production size run (~250) will be machined.

My experience of the development process has largely been at huge companies where prototype runs and production validation runs are often considered scrap of the design process and discarded.

would it be acceptable / in conformance with the design and development requirements of 13485 to use these production run sized batches, manufactured prior to final device verification, validation, and design transfer processes taking place - so long as the specification of the part manufactured at that time is the same as the specification at the time of final transfer, assuming all V&V work has been successful?

Where 7.3.2.c talks about transfer activities at each stage of development - would it be considered a design transfer activity to manufacture these prototypes if they were intended to be used as production if they meet the requirements, which would then subject them to the requirements of 7.3.9 on control of design and development changes?

Assuming all purchasing requirements are met for any raw materials, and all traceability is maintained - what additional concerns need to be contended with?

I really hope I'm over thinking this and there's a far more simple solution right in front of my face that I can't see.

Any and all guidance would be sincerely appreciated.

TS.
 
Elsmar Forum Sponsor
#2
If the lot of components meets all requirements of the currently approved specification, it is okay to use that lot for production. However, this isn't so simple, and your individual quality system processes will come into play. Is the supplier manufacturing process the same now as it was when the components were machined? Is there a first article inspection process that was not done before that now needs to be completed? What is the status label on the components? If it says R&D use only, you will need to go through a relabeling exercise. Is the supplier approved? Is the supplier process required to be validated? Are the raw materials supplied from the same place?

Sometimes this status change activity it performed by re-receiving the components to the current specification. Hope that helps.
 

ThatSinc

Involved In Discussions
#3
Fortunately, everything manufactured for R&D/Development use is treated as if it's already a production part - so the machining processes would be the same, the inspections would be the same, suppliers would all have been qualified in accordance with local procedures required for production etc.

Items are labelled with a part number and batch number, no other status markings as they're physically segregated away from the manufacturing areas.

Would it be within the realms of acceptable practise to simply include as a part of the final design transfer process a check of all "prototype batches" manufactured against current specs and review whether they are suitable for production use and transfer them through as a part of the design transfer record?
 

Hi_Its_Matt

Involved In Discussions
#4
@indubioush hit on several important factors to consider. It's not just whether the final part meets spec, but was the overall production and handling process the same (or justifiably similar enough)?

...they're physically segregated away from the manufacturing areas.
I'm not sure if the end device is sterile, but sterilization validation is based on a particular bioburden level, which is a function of the manufacturing process and controls in place. If the area you're segregating these parts off to is significantly different from a cleanliness/bioburden perspective than the regular manufacturing area, then that would call into question whether your sterilization process could adequately sterilize the previously-segregated-to-a-dirtier-area parts.

I have to assume cost is a factor driving this question, yea? It would obviously be cheaper from a materials standpoint to use the stuff you already have, but are you going to eat away at that savings simply by having people work on an investigation and justification to use the parts?
 

ThatSinc

Involved In Discussions
#5
I'm not sure if the end device is sterile,
Fortunately not sterile, and the environment in which they are segregated is the same (or cleaner, actually) as the manufacturing environment so the requirement on maintaining the level of cleanliness necessary for the device (I can't remember what ER/GSPR that is off the top of my head) is met.

Cost and "we've been doing it like this for 20 years and we're not changing, so figure out the process so that we can still do it"

It's a really small outfit and the owner/designer/tea maker says "once a component is drawn, it's considered done and if I want to make a full production run, I will".

For all intents and purposes EVERY prototype part is manufactured identically to how it is manufactured as a production part, so for near enough every part the investigation and justification will be a very quick exercise.
 
#6
Would it be within the realms of acceptable practise to simply include as a part of the final design transfer process a check of all "prototype batches" manufactured against current specs and review whether they are suitable for production use and transfer them through as a part of the design transfer record?
Yes, this is okay.
 

Hi_Its_Matt

Involved In Discussions
#7
It sounds to me like you have a pretty clear reason to use the parts.

Design validation shall be conducted on representative product. Representative product includes initial production units, batches or their equivalents. The rationale for the choice of product used for validation shall be recorded
In fact, it sounds to me like you could think about this completely the other way around...
Basically you (for some bizarre reason) defined and put in place first all the production controls, and you even built a production batch of parts. Then you used a small number of those parts to verify and validate the design, validate your manufacturing process and test methods, etc.

You're not trying to reclassify prototype parts as OK for final use... you just built a batch of "production parts," quarantined 95% of them, and used the other 5% to do all the design and manufacturing verification/validation activities necessary to make it OK to use the 95%.
 

Ronen E

Problem Solver
Moderator
#8
You're not trying to reclassify prototype parts as OK for final use... you just built a batch of "production parts," quarantined 95% of them, and used the other 5% to do all the design and manufacturing verification/validation activities necessary to make it OK to use the 95%.
That's all nice and well for a post-rationalization, but one thing to remember (in general; not necessarily applicable in this specific instance) is that in validated processes there are sometimes in-process controls, or pure monitoring activities, that become evidently necessary, and are put in place for production, only after the actual process validation. If "the production process if fully put in place first, then retroactively validated using a sample from the initial production run", it's possible that such necessary controls/monitoring were not in place during that run. Just sayin'.
 
Thread starter Similar threads Forum Replies Date
G Mfr. Process Validation BEFORE Design Transfer? Other Medical Device and Orthopedic Related Topics 1
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
D Design Transfer Template capturing Customer Specific Requirements Other Medical Device Related Standards 3
C Essential Design Output(s) and Design transfer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
C Design Transfer Review - Before or after PQ validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Design Transfer - How do you guys control the design transfer process? Document Control Systems, Procedures, Forms and Templates 5
Ajit Basrur Looking for a Design Transfer Checklist 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Design Transfer between two companies with different QMS CE Marking (Conformité Européene) / CB Scheme 3
P Responsibility for Design Transfer - OEM vs. CM ISO 13485:2016 - Medical Device Quality Management Systems 6
L Software Medical Device - 7.3.8 - Design and Development Transfer ISO 13485:2016 - Medical Device Quality Management Systems 4
V Design Transfer to production = New product introduction ?? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
U When does design transfer take place? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 30
E Is Design Transfer to Production be complete prior to Release of first production lot 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Design Transfer from R&D to Manufacturing for 21 CFR 820 Design and Development of Products and Processes 4
S 21 CFR Part 820.30(h) Design Transfer Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
R Design Transfer - any feedback from Medical Device Conference at MDM Minneapolis? Design and Development of Products and Processes 1
C Definition Design Transfer - New requirement of QSR 820 - What is Design Transfer? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
K CE design Certificate EU Medical Device Regulations 3
M ISO 13485 consultants and auditors with design oriented focus ISO 13485:2016 - Medical Device Quality Management Systems 5
Q What are Quality Requirements for Design? Quality Management System (QMS) Manuals 8
B Use of Statistical Techniques in Design Verification Design and Development of Products and Processes 18
X Design stage overview (Product specification) EU Medical Device Regulations 3
gohyl Fixture Setup Design Manufacturing and Related Processes 3
D IS0 13485 - Design perspective to regulatory requirement. ISO 13485:2016 - Medical Device Quality Management Systems 3
T Software item classification and Detailed Design IEC 62304 - Medical Device Software Life Cycle Processes 4
armani 7.1.5 and design and development of product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Sidney Vianna ISO 9001 News ISO 9001 Design Specification to be developed - May 2022 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Design output vs acceptance criteria ISO 13485:2016 - Medical Device Quality Management Systems 8
M Design Control Procedure Medical Device and FDA Regulations and Standards News 4
lisap Design falling outside ISO scope Misc. Quality Assurance and Business Systems Related Topics 11
S Link Between Essential Performance Requirements and Essential Design Outputs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
G Calculating Ppk for Design Verification - Variable Sampling Design and Development of Products and Processes 15
G How many Design FMEAs do you have? FMEA and Control Plans 4
G Updating FMEAs after Design Updates FMEA and Control Plans 4
Stoic Details of Operational Qualification (OQ) test design for plastic extrusion processes, effect of material property noise, and GHTF/SG3/N99-10 US Medical Device Regulations 2
H R&D and Design procedures - can one procedure cover both activities Design and Development of Products and Processes 6
J Design Verification Testing and Statistics Reliability Analysis - Predictions, Testing and Standards 3
K Can I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated ISO 13485:2016 - Medical Device Quality Management Systems 12
S Audit Finding - Design History File (DHF) Index: few (3 to 4) reports not identified ISO 13485:2016 - Medical Device Quality Management Systems 3
S Is the Design Service Provider required to be ISO 13485 certified? ISO 13485:2016 - Medical Device Quality Management Systems 13
M How to show the effect of the failure mode on the manufacturing process as a customer of product design process? FMEA and Control Plans 3
C MDR - Annex II _3. DESIGN AND MANUFACTURING INFORMATION_a EU Medical Device Regulations 3
C Items used for Design Verification Design and Development of Products and Processes 7
S Software design document NMPA guidance and consultant China Medical Device Regulations 4
L Corrective and Preventive Actions aligned to design related defects. After Work and Weekend Discussion Topics 5
E DESIGN VALIDATION, USABILITY AND CLINICAL EVALUATION request Medical Device and FDA Regulations and Standards News 0
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 4 – Design Controls Other US Medical Device Regulations 0
D Finding Optimum Design Parameters using Taguchi method? Using Minitab Software 2
S ISO13485:2016 7.3.9 design and development change ISO 13485:2016 - Medical Device Quality Management Systems 3
J Managing design verification regression testing of design changes Design and Development of Products and Processes 1

Similar threads

Top Bottom