Implementing Design Procedures - Medical Device Design: Innovation from Concept to Market - page 58

auditing procedure to ensure that what is supposed to happen does happen; that any
misgivings or failures are not “swept under the carpet” but are fully investigated to find the
root cause; and that the systems and procedures meet the current requirements. No rules state
how often this has to be done but it should be at least annually and the results have to be
reported, formally, to a management meeting (normally to a Quality Management Board ). It
is probably sensible to audit procedures more regularly otherwise things can easily start to go
wrong before anyone notices. Hence it is a good idea to have informal design reviews on a
regular basis, say, bimonthly. Figure 4.2 attempts to show how this could work.

The main item Figure 4.2 demonstrates is that the review/audit procedure is continual. It is a
part of the continuous quality improvement cycle. It attempts to show that you should plan a
number of design reviews in your annual calendar, and that this calendar should culminate in
an overall annual audit of your design procedures. These reviews do not replace your regular
design meetings that go with each project; they stand above these and have a view over all of
the projects and look at how they are functioning. The reviews are targeted at detecting any
areas of concern and, equally as important, any areas of good practice.

Report to
QM Review

Annual
Audit

yes

Design
Review

Confirm/
approve

Report

Design
Review

Correct

Identify root
cause

no

Design
Review

yes

Design
Review

Non-
conformity?

Design
Review

Design
Review

Figure 4.2
A suggested design review and audit program.