Saturday, November 24, 2012

Change Management

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