MFG/PRO 9.0 User Guide Volume 3: Manufacturing - QAD.com

Use inventory sampling patterns to determine which items are to be
audited. Sampling is based on expiration dates or lot intervals. You can
also use Inventory Detail Report (3.6.5) to identify inventory items based
on expiration date, site, location, assay percentage or grade.
It is not always practical to move an entire lot from inventory for testing.
As an alternative, you can test a sample and leave the remainder in
inventory. To prevent these from being issued or transferred before results
are available, change the inventory status to a code that restricts issues or
transfers.
The quantity for a quality order must reflect the quantity of an item
moved to inspection for testing. This quantity is the same as the lot size if
an entire lot is moved to inspection, and it is the lot sample size if only a
portion is tested.
First Article Inspection
First article inspections are used to qualify a machine, a tool, or the setup
of a machine or tool by determining whether it can produce items within
design limits. It is assumed that if a few items can be produced correctly,
the machine or tool is set up properly.
First article inspection differs from regular inspection in that it examines a
sample by comparing it to most, if not all, of the engineering
specifications appropriate for a specific level of processing.
First article inspection and process validation can use either quality orders
or in-process inspection. The selection depends on whether or not the
units evaluated are obtained from a supplier or from an internal
manufacturing process.
Process Validation
Process validation—an extension of first article inspection—is used to
qualify a manufacturing process. Rather than use a single sample or
unique lot, process validation requires one or more large batches, each of
them a typical manufacturing lot. Samples from the beginning, middle,
and end of production can be examined to determine the stability of a
manufacturing process and its ability to consistently produce quality
material.
QUALITY MANAGEMENT 203
Ï See “Defining
Sampling
Patterns” on
page 197 for
more details.