Change Management
·
Management systems look for processes for
managing changes.
·
Business Changes are
inevitable in an organization.
·
Changes can be both
from external and internal influences.
·
Changes could be
both reactive and proactive
·
External changes
can be due to the following factors
o
Market conditions
o
Economic conditions
o
Technological
changes
o
Competency
requirements
o
Etc .,
·
Internal changes
can be due to
o
Leadership change
o
Infrastructure
o
Product mix
o
Diversification
o
Strategic
requirements
o
Etc.,
·
QMS looks for
managing such changes in a controlled manner, although not explicitly. A change
management procedure helps in assessing the risks.
·
A step-by-step
approach in identifying and assessing the risks involved before implementing
the same is required.
·
A few of the
changes that would call for risk assessment are given below:
o
Changes in outsourcing
criteria, processes, products, services, control methodology, degree of sharing
of controls, etc.,
o
Introduction of
ERP/configuration management, networking, etc.,
o
Major changes in
top management, organization structure
o
Changes in product
mix, diversification, marketing structure, customer profile, market conditions,
etc.,
o
Changes in skills requirement
due to product technologies, new employees not meeting job requirements, exiting
of critical employees, etc.,
o
Major changes in
infrastructure, utilities, process equipment, machinery ageing, etc.,
o
Technological changes
in products, reduction in development cycle times, etc.,
o
Changes in supplier
profiles, reevaluation results leading to changes in supplier database, abnormal
increase in defects observed during manufacture, changes in component
specifications, large scale changes in sourcing of components, etc.,
o
Introduction of new
validated processes, deviations in validation requirements, etc.,
o
Major deficiencies
identified by customers
o
Major process deficiencies
observed leading to major changes in QMS, delays in implementing corrections
and corrective actions, ineffective implementation of CAPA's
o
Major defects observed
during product verification not meeting defined acceptance criteria, product
release without completion of planned arrangements
o
Incomplete and inaccurate
maintenance of data base, not maintaining periodicity in data analysis
·
The risk analysis
and assessment procedure is required to assess the impact of those changes and
take necessary steps
