Implementing Design Procedures - Medical Device Design: Innovation from Concept to Market - page 68

4.5.6 Control of Documents
It is very important to have a document control . This can be written but it must cover:

1. How long documents are kept

2. Who is responsible for maintaining the design history file

3. Where the original design history file is kept

But as you have already seen, the procedures force you to control your documents.

4.5.7 Risk Assessment Procedure
Throughout this chapter the term risk assessment has been forced into your subconscious.
This is for a very good reason. Conducting a risk assessment when you make a decision
is good practice. It forces you to inspect the ramifications of your decisions. Suppose,
for example, you decide to change a single component in a large device. The change may
be innocuous, say, reducing the diameter of a pin that holds a screen in place. However
you may have overlooked that this change now makes all of the previous devices sold
different - how will you ensure that if someone asks for a replacement pin that they will get
the right size? What is the risk (or risks) if they get the wrong size? You would be amazed
to find how many devices have suffered from ignoring this simple analytical step. As it is so
important it has its own standard - ISO 14971: Application of risk management to medical
devices.

The following procedure ( Figure 4.8 ) is general. It must be adapted to meet the specific
circumstance in which it is to be used, however it is a usable procedure; we will examine how
to perform a risk analysis in more detail later.

The important part of this procedure is to have an approved pro forma to complete. Without
this the whole procedure will fail. As with previous procedures it is important to document
the analysis at key stages (and, of course, file). It is also important to check that any suggested
actions from the risk analysis are actually undertaken, reported, and filed.

4.6 Implementing a Procedure
While a flowchart or a document describes how a procedure works it is not a formal
procedure until a number of things happen. The first is that it should be presented correctly.
The procedure will need a title, it will need a version number, it will need to be signed off
and dated, and finally it will need a table recording changes to the procedure. The last thing is
that during signing off it will need to be formally included in the company's quality manual .
Figure 4.9 illustrates a typical complete procedure.