Biomedical Engineering Reference
In-Depth Information
• What is the impact of inaccurate information on product quality and
patient safety?
• Are there additional safeguards in place to catch mistakes or are the
systems to which the information is used not of direct or significant
quality impact?
The less reliable the source, the more the qualification person should mitigate
the risk or impact of inaccurate information. Mitigation might take the form of
the following:
• not using the information;
• confirming the information through audit of systems and test results; or
• providing assistance to help the source provide more reliable information
through detailed specification of information needed or training.
Sometimes the accuracy of information is based on the level of understanding
between the source and the qualification person. The meaning of nomenclature
and terminology may differ from company to company, industry to industry, or
discipline to discipline.
To illustrate the point, consider the example of a simple steam line purge.
The qualification protocol called for a purge of the steam lines. The mechanical
contractor agreed to perform this step. After it was completed, the qualification
group tested the cleanliness of the line by inspecting the effluent for clarity and
lack of visible particles. They found an unacceptable level of particles, specks,
and debris. The test failed and the project was delayed. On investigation, it was
discovered that the person writing the protocol defined purge as running steam
through the line in a sufficient quantity to blow out any debris, thus cleaning the
line of residue. The contractor did in fact perform the purge, but to him a purge
of a steam line meant replacing the air in the line with steam. To accomplish
what the protocol writer had in mind was a simple task, but it was not a purge,
it was a steam cleaning or flushing operation. The result was a test failure. This
mistake presented a risk to the execution of the project. The risk of this type of
failure could have been mitigated by a common understanding of terminology;
perhaps through training, better specifications and test protocol descriptions, or
using a contractor more experienced in GMP facility testing.
Another example illustrates a potential risk to product quality as a result
of accepting information which would not be reconfirmed later and occurred
shortly after on a different project. In this example, the commissioning effort
included verification of process line slope. The slope was needed to provide
proper drainage and allow for cleaning and reduce the possibility of pooled
material and contamination. As the mechanical contractor needed to verify line
slope at the completion of their work and possessed the expertise to do so, it was
decided to use that verification in the qualification protocol and not require an
additional qualification team measurement. The line sloops were verified by the
mechanical contractors properly as soon as the system installation was completed.
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