Biomedical Engineering Reference
In-Depth Information
may be less need to perform additional efforts to obtain similar information dur-
ing qualification studies and tests if this information is accurate and in a form
suitable for the support of the qualification program.
The key to effective leveraging of information is establishing a partnership
between vendors, contractors, and the qualification team. The way to assure a
good partnership is by aligning the objectives of all parties. The objectives of
parties performing project phases may differ. The role of the vendors building
the equipment is to provide equipment as per specification. The objective of
the vendor testing the equipment is to prove to the customer that the business
transaction has been completed by proving that the equipment has been built to
specification, thus motivating the customer to complete his end of the transaction
and pay the vendor. In providing this proof, the vendor may also be proving that
the equipment works as specified and therefore is ready for qualification. Under-
standing these differences in objectives and taking steps to better align objectives
will help ensure the efficient leveraging of vendor-provided information.
People commissioning the equipment are responsible for getting the system
in good working order and getting the system to work. Their objective is to
confirm that the system is working to the expectation of the user. In doing
so, the commissioning team will obtain information that confirms the system is
working properly. This is an important element in determining that the system will
work reliably and predictably to the level of performance needed to support the
process. Those qualifying the equipment are responsible for proving or providing
assurance that the system will work in the manner needed to support the process
to the level needed to produce safe and effective products. The objectives are
proof and confidence.
To accomplish this, the qualification team may choose to rely on vendor-
provided information or commissioning data or may choose to repeat, audit, or
confirm the accuracy of this information entirely or in part. The decision may be
based on the following risk-based criteria.
1. Source reliability
• Is the source of information reliable?
• Is it free of error, credible, accurate, and useful?
• What has been your experience with the source of information on this
project and other projects?
• Do you have any experience with this source of information? Are you
certain of the reliability of their performance?
2. Source capability
• Is the source knowledgeable in qualification-related efforts?
• Does the source of information have quality systems and training in place
to assure accuracy?
• Do they have experience with providing this type of information in a
qualification setting?
3. Impact of the information
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