Biomedical Engineering Reference
In-Depth Information
For example, a design review highlights that one person keeps forgetting to update revision
numbers on part drawings (hence no one knows which drawing is the most recent). This is
clearly an issue, and one that cannot wait for the end of the year to be resolved. The issue is
raised as a nonconformity (this means it does not conform to the procedures) and a plan to
rectify it is developed. The plan is implemented and then the outcome evaluated. Hopefully
the person now updates the revision numbers and this is checked out. When confirmed that
revision numbers are now updated the NC (nonconformity) is closed. A report is written,
signed off, and submitted for the annual audit.
You can see that this review process makes sure that any issues are detected early and
sorted out using planning, implementation, and final checks working as it should. But more
importantly, it involves learning from a mistake and improving your design procedures to
ensure it doesn't happen again.
The annual audit, however, has a more strategic quality role and looks at the design
procedures as a whole: Are they working? Are there recurrent issues? Are there areas for
improvement? By looking at the year as a whole, a bigger picture is formed. Also this annual
audit provides evidence to the Quality Management team (and any external auditors) that the
design control, as stipulated in the FDA guidelines and ISO 13485, is being implemented. It
also provides the overall evidence required by the annual external auditors who will come to
check that you can keep your medical device manufacturer status.
This can seem very onerous, and indeed some people do take the audit trail to the extreme! It
need not be so if you remember what the audit and review processes are for:
1.
To provide evidence that your design team(s) is following the procedures that you have
set in order for your devices to be designed to meet FDA and EC regulations; and to
ensure the necessary documentary evidence exists.
2.
To enable your design management team to continually improve your design quality.
3.
To identify any nonconformity issues and correct these as soon as possible, and before
they have the chance to do any long-term damage.
4.
It does not mean filling out multiple forms in triplicate!
It is not necessary to have graphical procedures. Personally I like them as I think they provide
a flow of actions. Some people prefer to write documents - it is perfectly acceptable to write a
procedure. We can reformulate Figure 4.1 into a document: Table 4.2 for example.
Table 4.2 suggests that each team gets a formal audit every year, but not all at once. You could
chose to audit everyone at once, but this has one major failing - you need lots of internal
auditors! One person cannot audit all 10 teams at the same time. Also, this enables the team
leader from another team to act as the internal auditor ; this gives the required “fresh pair of
independent eyes” that enables the audit to spot what can easily be overlooked. Note, though,
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