Biomedical Engineering Reference
In-Depth Information
2. How bad is it if it does go wrong?
What is the impact of the failure on product quality?
3. What is the likelihood that it will go wrong?
What is the probability that the failure will occur to an extent where it will
adversely affect product quality?
The next sections of the chapter present some thoughts on the development of
an approach and plan for the qualification of facilities and equipment using risk
as a logical means for making qualification-related decisions.
7.2 RISK-BASED QUALIFICATION PLANNING
Commissioning, qualification, and risk-assessment-related activities should be
documented in formal procedures, policies, and directives. Evaluations, justifica-
tion, test methodology, acceptance criteria, and results should be documented in
properly prepared and approved plans, protocols, and reports.
A key element in risk-based qualification is the prioritization of tasks and
the allocation of resources commensurate with relative risk to product quality.
Poor prioritization and allocation can result in project delays and the potential to
overlook or miss activities essential to the qualification effort. A sound project
plan is an effective tool for a successful risk-based qualification project.
The starting point for risk-based qualification planning should be the develop-
ment of a plan that defines the
who, what, when, where, and how
of the project.
A typical project plan will address areas such as project description, roles and
responsibilities, project controls, schedule development strategies, information
leveraging and management, and overall integrated approach.
7.2.1 Project Description
The project description provides information on which the reader or reviewer can
rely on to ascertain if the approach will result in the qualification of the systems
and equipment. It should present an explanation of the project and may include
location, scope, facility or process function, and notable directives or policies. It
should also establish that decisions related to acceptance criteria will be based
on risk to product quality and patient safety.
Understanding the interdependence of processes related to risk to product qual-
ity is important. For example, a cooling water system used to cool a bulk product
may not be considered to have an effect on the product if there is an effective
monitoring system that indicates water and product temperature. However, for
that to be the case that monitoring system must be qualified. A less reliable
monitoring system might redirect efforts to qualifying the cooling water system.
To begin the planning process, one should assemble the key players that will be
involved in the project and outline the project description and business objectives
Search WWH ::
Custom Search