verification of contents through NDA measurements, and any other information
deemed desirable and attainable through non-destructive measurements such as
radiography. This initial inspection may be part of the quality program for
verifying package integrity.
2) Early failures are caused by mistakes, missteps, or other problems in the
manufacturing, stabilizing or packaging processes that result in flawed or
defective packages that are not detected during the initial inspection. To detect
these types of failures, the initial program plan should consider alternatives such
as: 1) provisions to inspect each package at least once during the first few years
of storage; 2) an inspection of each package as it is put into storage;
3) inspection of all "high risk" packages identified based on their material
contents, whether the container was among the first manufactured, whether it
was non-conforming and accepted "as-is", etc. and inspection of only a pre-
determined sample of other packages; and 4) inspections appropriate to the
"random failure" approach, but with a higher frequency or larger sample size.
During most or all of the storage period, mechanical failures, if any, are likely to
be random. Uniform changes in the storage package population, such as a
potential gradual pressure generation in oxide containers, may also occur.
Surveillance during this period may include sampling to monitor the behavior of
the population. If a "shelf-life" program is established, it may be used to
evaluate changes in the contents so that corrective action can be taken in
advance of package failure. It should also be used to assess corrosion effects
over the long term, particularly stress corrosion cracking in containers containing
chlorides. The program plan should include provisions to assess the failure rate
and to detect any changes that might signal an end to the "early failure" period,
or the onset of an "end of life" period.
4. Inspection/surveillance methods must be documented to assure consistency.
Delineation of responsibilities is needed to assure a consistent management
approach and awareness of responsibilities.
5. No further basis is provided