SBS - The Best Value in QMS software

Ownership of Design History File

JoCam

Trusted Information Resource
#1
Hi All,

When you use a sub-contractor to assist with the design of your product and to manufacture it for commercial release who should hold the Design History File?

Thank you in advance,

Jo
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Primarily the product owner, but if you have set an agreement that the sub-contractor of design to maintain the DHF, and be available to you at short notice, it should still work.....
 

JoCam

Trusted Information Resource
#3
Thank you Somashekar,

Should the owner review and approve the documents in the DHF, or can the responsibility for this also be passed to the sub-contractor via technical agreement, or something similar?

Jo
 

rob73

looking for answers
#4
If you are placing the product on the market under your own name i think it would be prudent to review the file as if you where doing a CB audit. At the end of the day it is your responsibility for the devices safety and performance, no matter who manufactures it.
Further to Somashekar's comments, attached is a "contract" for own brand labeling that could be adapted to suit sub-contract manufacture.
 

Attachments

RCW

Quite Involved in Discussions
#5
Hi All,

When you use a sub-contractor to assist with the design of your product and to manufacture it for commercial release who should hold the Design History File?

Jo
Jo,

You stated "manufacture" in your question above. That would involve the Device History Record (DHR) which is yet another item.

My company does both contract design and contract manufacturing of medical devices. We require our customer to sign-off on the design records as they technically own the design. They have copies of the DHF at their facility but they also have my company maintain the original / master at our facility.

When it comes to the DHR, again, the master is maintained at our facility with our customer asking to provide them copies of it upon request. A few customers have set up web-based portals for us to upload the DHR to upon completion of the device.
 

JoCam

Trusted Information Resource
#6
Thank you RCW,

Your company operates as I believe it should, and in previous employment this is exactly how I ensured the DHF's and DHR's were controlled. However, at my present place of employment on requesting a DHF from a sub-contractor I was pretty much told that I don't need it, and that a list of the documents it contains should suffice, which apparently is sufficient for their other clients, including pharmaceutical ones. I need to check where I stand on this before I start pushing the matter.

I know that the DHF should be held by the product owner where the FDA is concerned, even if statements to the contrary exist in signed technical agreements, but can the same be said for Europe? Is a list of the documents a DHF contains adequate for this territory?

Jo
 

RCW

Quite Involved in Discussions
#7
However, at my present place of employment on requesting a DHF from a sub-contractor I was pretty much told that I don't need it, and that a list of the documents it contains should suffice, which apparently is sufficient for their other clients, including pharmaceutical ones.
YIKES!! :mg:
This is your sub-contractor telling you this?
If so check what agreements you have in place with them. Watch them closely and consider looking for another sub-contractor.

As a sub-contractor, I will support my customer as much as I can but as previously stated here, ultimately your company is responsible in the eyes of the regulators.

Good luck with this!
 
Thread starter Similar threads Forum Replies Date
U Process Ownership - APQP shall be be led by Design & Development Dept? Design and Development of Products and Processes 2
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
Q Company Ownership Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 3
H Transfer of Document Ownership Document Control Systems, Procedures, Forms and Templates 3
T AS9100 Maintain Approval When Business Ownership Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
Sidney Vianna ANSI acquires full ownership of ANAB - December 2018 ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 0
B Register's Ownership in Iran, India, Jordan, Arab Saudi, Egypt Other Medical Device Regulations World-Wide 8
M New FDA Draft Guidance on 510(k) Ownership and Use Other US Medical Device Regulations 3
M Ownership of Pre-Clinical cGMP Stability Testing Other Medical Device and Orthopedic Related Topics 2
S 510(K) Ownership and Protection from Use by Others 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K Ownership of Platform of Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N NAFTA Document Ownership in your Organization Various Other Specifications, Standards, and related Requirements 6
S How to notify FDA of change of ownership? US Food and Drug Administration (FDA) 16
T Ownership of Procedures where Multiple Departments are involved in the Process Process Maps, Process Mapping and Turtle Diagrams 12
B Changing Company Ownership of Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C How to achieve Page Ownership with a Wiki Document Control Systems, Procedures, Forms and Templates 2
S Tracking Ownership of QMS Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
G How can change in the 510(k) ownership impact IP protection 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Transfer of 510(k) Ownership between Companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Marc Copyright - 'Ownership' of Post Content and Files Attached to Posts Elsmar Cove Forum ToS and Forum Policies 2
A 510(k) Ownership Change - Is it painful or is it a pretty easy process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
amjadrana Customer Returns Evaluation Ownership - Medical devices Customer Complaints 5
amjadrana Sections 7.3.5 and 7.3.6 Verification and validation ownership Qualification and Validation (including 21 CFR Part 11) 2
C The warning letter of ONBO - Why FDA require identification of 510(k) ownership? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Ownership of ISO 13485:2003 company changing - Anyone to update? ISO 13485:2016 - Medical Device Quality Management Systems 5
R Ownership of FDA registered establishment changing - what to do? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K Defining Document Ownership ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Metrics (Measurement) of Operator Ownership Lean in Manufacturing and Service Industries 11
B Effect of Calibration Laboratory Changing Ownership & Moving on ISO17025 registration ISO 17025 related Discussions 4
M Training programme on Total Cost of Ownership (TCO) Training - Internal, External, Online and Distance Learning 3
A Ownership of 510(k) to transfer or submit new one - Class 1 medical device ISO 13485:2016 - Medical Device Quality Management Systems 4
ScottK What are your feelings on ESOPs (Employee Stock Ownership Plans)? Career and Occupation Discussions 7
T Shared Ownership of Two Companies and TS requirements IATF 16949 - Automotive Quality Systems Standard 2
R TS16949 clause elements compared to department ownership responsibilities matrix IATF 16949 - Automotive Quality Systems Standard 7
J PPAP ownership - What can I do to protect my company's information APQP and PPAP 5
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 11
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
A Design Change/ECO Related Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
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
E Design and Development file Procedure ISO 13485:2016 - Medical Device Quality Management Systems 0
DuncanGibbons Section 8.3 relevant for design organisations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P DFMEA - Machinery Design Best Practices FMEA and Control Plans 0
R Is a FAIR required on parts that we design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3

Similar threads

Top Bottom