I
visited Knowledge Transfer Office (KTO), CityU for startup related meeting on
16 Jan 2017. KTO is the vital link
between the University and the community in terms of the exchange of knowledge,
which includes technology, know-how, skills and expertise, for both commercial
and non-commercial applications. I took
a photo in front of the office.
(Left:
Dr. Victor Lau, I, Mr. Clement Lam and Ms. Fanny Ho)
I
would like to share some ideas for R&D Management based on quality
perspective.
Plan:
During
the R&D Project planning stage (especially cooperation with University), it
should be considered the following items.
-
Roles (Who does what?)
-
Responsibility (For what each party will be held to account?)
-
Liabilities (What money or other assets each party owes to the group?)
-
Rights of the parties (What each party will receive from the
collaboration?)
-
Management of the undertaking and any IP involved.
-
Non-disclosure agreement (NDA) mechanism to protect both parties.
-
Assign Project-in-charge to follow the R&D schedule!
-
Written down the project deliverables (align both expectation!)
(Reference
to Drafting Partnership agreement on R&D project below)
Do:
During
R&D process, Design History File (DHF) should be kept. It should be contain or reference the records
necessary to demonstrate that the design was developed in accordance with the
approved design plan and the requirements of this part. It may include the followings:
-
Detailed design and development plan specifying design tasks and
deliverable
-
Copies of approved design input documents and design output documents.
-
Documentation of design reviews.
-
Validation documentation.
-
When applicable, copies of controlled design documents and change
control records.
(Reference
to FDA Design Control Guidance for MD Manufacturers & MD seminar)
Check:
In
each stage of the planning, the assigned project-in-charge should check the R&D
progress, review the verification and validation data, as well as, reporting to
both parties top management. Some items
should be involved:
-
Do Design Inputs match Design Outputs?
-
Do the scheduled deliverable obtained and satisfied?
-
Resource enough? (HR, time, material, technology)
-
Any problem met? Are they solved?
-
Any design change needed? Are
they recorded?
Act:
After
the R&D Project, we should identify the objectives met and any corrective
action taken, as well as, any lesson learned; so as to improve the next R&D
project in future.
My
opinion is to add Quality Management System concept into R&D process and
get the balance. Professors and R&D
student like freedom and feel free to try during R&D process. However,
industry people need to control the outcome and project schedule. We need a suitable R&D Quality Management
System that not too tight and not too loose.
There
are 8 questions should be asked to startup or SME for formulating strategy and it
related to R&D in the old seminar named “Formulating Strategy for
Sustainable Growth” in the reference below.
Reference:
