Implementing Design Procedures - Medical Device Design: Innovation from Concept to Market - page 61

that it is still important for the team leaders to keep things in control throughout the whole
year and not just at audit time. The audits are not onerous; they may take two days and may
be intense - but these are two very important days. The important thing to remember is that if
they are planned well, are well structured, and are treated as constructive then the experience
is pleasurable. If they are not planned well, are not well structured, and are initiated as
combative (like gladiators in a coliseum) then they will fail and everyone will grow to hate
them.
It does not matter whether your company is a “one-man band” or a multinational
organization, the audit trail must be complied with. The only problem with a one-man
company is who will be the auditor? Who will be the independent eyes? The obvious answer
is to get someone else to do it, but remember that they have to know what they are doing -
they cannot be an acquaintance from the tennis club.
Another important consideration is the individual audits/reviews themselves. You will need
to develop an audit plan ; this plan is best set by the annual design audit for the following
year. The audit plan is, literally, a list of all of the procedural points the auditor must look at
in order to confirm that there is evidence that the correct procedure has been followed. The
auditor is not required to look at everything but selects randomly from the whole. Not every
audit needs to cover every procedure, but by the end of the year all procedures must have
been covered.
It is, therefore, obvious that the auditor requires training to perform his or her role correctly
and diligently. Hence it is wholly appropriate for all internal auditors to go through an internal
auditing training program.
Despite the above it should be noted that the auditing of your design procedures will, in the
main, be controlled by Quality Management. However, the audit process has to work so it
should be “designed” to suit your particular needs and not just copied from somewhere else
(or even worse imposed by someone on the outside who does not understand design).
4.5 The Design Process
At last we come to the nub of the problem. We need to develop a procedure that describes
how, as a company, we undertake our design activity. Unlike most procedures this is one
that is hard to write down; it is more suited to a graphical flowchart approach. However,
it is worth recalling that in Chapter 3 we described the design process in theory; all we
need to do is put this theory into practice. The first phase was all about understanding
the actual problem ( (clarification phase ) and ultimately ending in a product specification. .
Hence it is worth building an overall model that starts here and then looks at each in turn.
Remember, from Section 4.3 we will have two overall design processes: “New Product”
and “Design Change.”