Content development: qualification of employees - Quality Assurance - page 207

to perform a task in the direct manufacturing of a regulated
product.
■ The procedure addresses employee safety, or may result in
a business compliance risk to the company if not properly
performed.

These criteria clearly refl ect aspects of criticality and
complexity that go into risk assessment.
Whether or not a procedure is deemed to be critical should
be guided by three basic questions. What might go wrong
with the associated process? What is the likelihood that this
will happen? What and how severe are the consequences if
this goes wrong? 21

8.6 Disqualifi cation and
requalifi cation

Qualifi ed employees can be disqualifi ed for multiple reasons.
These include time-based expiration of training, extended
absences, job changes, and other understandable reasons.
Disqualifi cation can also occur should performance on the
job fail to meet qualifi cation standards. This disqualifi cation
process can be the result of a management or quality
assurance (QA) department observation of non-compliant
performance.
Disqualifi cation can also be the result of a pattern of
exceptions that can be attributed to the employee, such as
the following:

￿ ￿ ￿ ￿ ￿

■ serious deviations;
■ retraining history;
■ repeated deviation;