Biomedical Engineering Reference
In-Depth Information
8.3.3 Design Meetings/Design Reviews
Whatever you do, do not forget that all of your activities must be auditable. If you recall
Figure 4.2, in Chapter 4, you will remember that the year must contain a series of design
reviews. To ensure that your team produces zero nonconformities you, as lead designer, must
ensure that they are following procedures. Hence one good part of any design meeting is
to have a standing item related to quality management. As the lead designer you are able to
perform small audits on your team to make sure that procedures are followed. As a part of a
bigger quality management process you need to be prepared to be audited too.
You need to ensure that your design meetings have a set agenda. Have standing items that tie
in with the company's quality management process. A seamless transition is always beneficial.
Apart from the obvious QM role, the design meetings are essential to maintain communication
between the whole of your design workforce. Do not worry about too much communication; it is
when someone goes quiet that you need to worry! The lead designer must take on this “paternal”
role for the project because, as described in Chapter 1, we are delivering the baby. The obvious
aim of the design meeting is to ensure the project is on track and that everyone is keeping to
timescales; the obvious connection with QM is to make sure no one is “cutting corners.”
8.4 Design Calculations
It is hard to envisage any design that does not contain at least one design calculation. The
calculation may be very simple or it may be very complex. The complexity matters not, it is
the process and the documentation that matters.
All design calculations should follow these steps:
l
State what you trying to solve.
l
State all assumptions made, giving reasons and references.
l
State the equation(s) used, giving reasons and references.
l
Perform the calculations, writing down every step.
l
State the answer to the calculations.
l
Sign off by the person “calculating.”
l
If necessary sign off by a qualified person (e.g., chartered/licensed engineer).
As with most things of this nature, we have seen that the best method is to have an established
pro forma and make sure everyone uses it.
Figure 8.1
illustrates a typical pro forma for design
calculations; feel free to make your own.
Obviously the rows can be expanded to suit. Also the sections could easily cross pages so it
is important to have the “header” on all pages. Note that there is a section for “conclusions”;
you must analyze your calculations and make suggestions from them, if only to say
something as simple as “it must be a minimum of 10 mm diameter.”
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