Biomedical Engineering Reference
In-Depth Information
that is what they specialize in. These will be relatively cheap. Other items out of the “sweet
spot” will cost more. And that is why Rule 1 is so important.
10.2.2 Initial Audit
Consider having an initial audit just to ease your mind. This need not be a rigorous procedure
but you should supply the auditors with an audit plan (a list of things you wish to examine)
and then write a brief report of this audit. You may be surprised by what you find; companies
who on paper seem to be excellent can be a letdown when you actually get to the actual
premises. Do not forget to examine the auditors' own audit trail. Examples of things you
should be looking for are:
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General cleanliness
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Paperwork following products
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Raw material quarantine procedures
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Use of animal products
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Tooling (potential cross-contamination)
As we have touched on earlier, the second to last point is of paramount importance. You
must
get a statement from the company that no animal products are used in their processes. If this
is not forthcoming then you really should question their suitability as a supplier unless they
are absolutely necessary.
10.2.3 Contractual Arrangements
Every regulatory body will expect you to have contracts detailing your subcontractors'
responsibilities. It is a truism that without these you will not survive an audit. The contracts
need not be onerous but they must stipulate certain things:
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They will only make to your specification.
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They will not substitute materials without your written approval.
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They will not modify any of your part drawings.
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They will retain relevant documents for the prescribed period, or supply them to you for
you to keep.
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They will supply a statement of conformity with each batch.
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They will not use animal by-products in any process, without your knowledge and
consent.
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They will notify you immediately of any nonconformance or hazard that they become
aware of that may impact on your devices.
In addition, of course, you will have your own performance-based criteria.
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