74 SMT007 MAGAZINE I DECEMBER 2019
measurement or metric selected for effective-
ness demonstrates improvement or correction
of the problem (Table 6).
D7: Preventive Plans
The objective of preventive plans is to pro-
actively address items identified during the
root-cause analysis stage that could possibly
be issues in the future. It is up to the team to
determine the validity of a proposed preven-
tive action plan before it is drafted in the 8D
plan (Table 7).
D8: Recognition and Lessons Learned
This section is necessary to confirm that an
8D CAPA has successfully been completed and
to conduct a "lessons learned" review to see
what went well and challenges encountered
during this corrective action. CAPAs bring a
wealth of information to the organization, and
this section of the CAPA allows for the team to
summarize accomplishments. It is important to
recognize team members during management
review meetings once CAPAs have successfully
been completed. These projects bring value to
the organizations that receive these 8D CAPA
reports, as well as the customers who receive
them. SMT007
Reference
1. U.S. Food and Drug Administration (FDA), "Corrective
and Preventative Actions (CAPA)," September 8, 2014.
Alfred Macha is the president of
AMT Partners. He can be reached at
Alfred@amt-partners.com. To read
past columns or contact Macha,
click here.
Table 6: D6 example.
Table 7: D7 example.
