Examples of qualification stages from DQ to PQ.
This subsection presents examples of items that must be described in an implementation plan and an implementation report
of qualification from DQ to PQ. Two of the direct factors of the heating plate (i.e., the heating plate temperature and parallelism)
are used as examples.
An example of DQ. The devices and parts that affect the heating-plate temperature and parallelism listed in the requirements specification
must be properly documented in the manufacturing specification. The location of the confirmed items in the requirement specification
and the manufacturing specification must be recorded in the report.
At minimum, the following items must be described in the DQ implementation plan: the important product-quality factor (i.e.,
web thickness of 50 μm), the direct factors (i.e., heating-plate temperature and parallelism), and the assessment procedure.
At minimum, the following items must be described in the DQ report: the important product-quality factor, the document to
be verified or confirmed (i.e., the document number of the requirements specification, the page numbers of the relevant items,
the document number of the manufacturing specification, and the page numbers of the relevant items), the result, the date,
and the inspector.
An example of IQ.
The devices and parts that affect the heating-plate temperature must be installed according to the manufacturing specification,
and the heating-plate parallelism must conform to the criteria in the IQ implementation plan. The results must be recorded
in the IQ report.
At minimum, the following items must be described in the IQ implementation plan: the important product-quality factor, the
direct factors, the criteria (i.e., installation of the heating device according to the manufacturing specification and within
acceptable margin of parallelism), and the assessment procedure.
At minimum, the following items must be described in the IQ report: the direct factors, the criteria, the results, the judgment,
the date, and the inspector.
An example of OQ. The heating-plate temperature must conform to the criteria in the OQ implementation plan. The results must be recorded in
the OQ report.
At the OQ stage, the temperature of a versatile heating plate that can be used for different products is usually examined.
However, if the plastic film used for these products is the same and the required web thickness is also the same, then OQ
and PQ can be combined.
At minimum, the following items must be described in the OQ implementation plan: the important product-quality factor, the
direct factors, the criteria (i.e., preset temperature and permissible fluctuation), and the assessment procedure.
At minimum, the following items must be described in the OQ report: the direct factors, the criteria, the results, the judgment,
the date, and the inspector.
An example of PQ. The heating-plate temperature specified in the product master formula must conform to the criteria in the PQ implementation
plan. The results must be recorded in the PQ report.
At minimum, the following items must be described in the PQ implementation plan: the important product-quality factor, the
direct factors, the criteria (i.e., preset temperature and permissible fluctuation), and the assessment procedure.
At minimum, the following items must be described in the PQ report: the direct factors, the criteria, the results, the judgment,
the date, and the inspector.
Conclusion
The authors propose a new approach to target selection and implementation of qualification that can be summarized by the following
points:
- Product quality and the factors that influence it (i.e., the important factors) must be defined.
- The critical functions of the devices and parts that directly affect the important factors must be specified.
- The factors (e.g., pressure and heat) that the critical functions assign to the objects of the manufacturing process must
be defined.
- The above factors are direct factors and should be taken as the sole targets of qualification.
- Direct factors should be classified as either dynamic or static factors. Dynamic factors should be further classified as either
subject to the process control or not.
- Required stages of qualification should be determined according to the above classifications.
- Indirect factors must follow GEP, but do not require qualification.
This proposal should aid the practical implementation of qualification. The authors welcome readers' comments.
|
