Biomedical Engineering Reference
In-Depth Information
The team members received training in the HACCP process to ensure that
they first understood what HACCP is and to learn the skills necessary to make
it function properly.
They met for 2-3 h at least once a week. The length of time to complete the
HACCP analysis depends on a number of variables including the complexity of
the subject matter and the dedication of resources. In this case, it took the team
about three months to complete the HACCP analysis.
It is important in undertaking the project that the team does due diligence
in working through the steps of the HACCP process, taking the responsibility
seriously, and not using the process as an exercise to justify a predetermined
decision.
11.3.4.2 Describe the Product and Raw Materials
Part of the analysis was to
describe the product and raw materials. The team started by defining such product
attributes as follows:
• route of administration;
• type of packaging;
• intrinsic factors (e.g., pH and water activity [A
w
]);
• regulatory or compendia requirements;
• storage conditions; and
• list of raw materials.
11.3.4.3 Construct a Process Flow Diagram
Another part of the analysis was
for the team to construct a process flow of the operations. The process flow dia-
gram provides a clear, simple outline of the steps involved in the process within
the scope of the assessment. The HACCP team members walked the process in
constructing the diagram to understand firsthand and in detail the personnel and
material flow, interconnections, and potential hazards in the processes. The team
constructed a process flow diagram as shown in Figure 11.2.
The types of data that the HACCP team considered and included in the process
flow diagram were as follows:
• all raw materials;
• packaging components;
• storage conditions;
• microbiological data;
• sequence of all process operations (including raw material addition;
• holding times and temperature;
• equipment design features, cleaning, and storage; and
• details of any product rework or recycling.
Site information was integrated into the process flow diagram and included
the following:
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