RISK-BASED CHANGE CONTROL - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 362

START: Change
initiator submits
change request

Initial review
by change
leader

First risk
assessment (initial
screening)

N

In scope?

CR not required

Y

Y

Return to
change initiator
for more
information

More
information
req'd?

Second risk
assessment
(review impact to
existing product
risk assessment
document or
prepare a new
one)

N

Detailed review
by change
review team

Y

More
information
req'd?

N

Change
approved-OK
to implement

Implement
according to
plan

Change
review team
identifies
actions needed
to rectify
issues

N

Y

Deviations from
plan?

Close out-
done

Figure 13.1 The change control process. ( See insert for color representation of the
figure .)