On Thursday, June 13, BSI (British Standards Institution)
presented the webinar Corrective &
Preventive Action: Characterizing the Problem and Assembling the Right Team.
Speakers included ISO Product Manager John DiMaria and BSI Software Product
Specialist Raj Sivasankar.
The experts explained that to characterize the problem, it must
be clearly defined, including sources of data and information and a detailed
description of the problem.
According to DiMaria, all sources of information should be
documented for use during investigation and implementation of an action plan.
Internal sources of data may include supplier evaluations, internal audits,
deviation reports, design controls and test results, while common external
sources are recalls, complaints, return reports and customer test reports.
Descriptions of problems should be written, concise and
complete, presenting the information so that it is easy to understand and
translate. A description should include data without opinions or suggestions
for solutions. DiMaria suggests noting differences between operations prior to
the problem and current operations, as well as the desired state of operations.
Necessary qualities of a productive team include an
effective team leader as well as members who have a connection to the process,
varying perspectives, proper skills and a knowledge of data sources.
