Electronic Change Control Systems
Electronic Change control systems
Organisations in Australia and around the world are dealing with higher expectations from customers, regulators, shareholders and society in general. They need to manage their operations and governance in a responsible and ‘socially acceptable’ way. At the same time the are expected to be competitive in the global marketplace, this requires a drive for continual innovation and improvement.
“Whosoever desires constant success must change … with the times.”
― Niccolò Machiavelli
These two factors suggest that for organisations to be successful they should be implementing optimised processes for managing and controlling changes. Having an laissez-faire approach to change management, has a high risk of changes being released without the adequate consultation with staff. This leads to increased organisational churn or worse wasted effort being spent on ideas and changes that have no or very little benefit to the organisation.
On the other side, implementing a change control system that hinders innovation by being overly bureaucratic can be just as damaging. For one our ISO 9001 clients we were asked to audit the Quality Management Systems in place; the QMS was more than adequate in terms of structure and documented content but we quickly noticed talking to staff that the gaps were large in practice. No one wanted to use the Change control paper forms. They often got delayed by the involved documentation required to be completed. Quality personnel were always at capacity, they didn’t have time to sort out the minor issues or train staff appropriately. What resulted was a mess of forms not completed properly, major changes implemented without any review or consultation. One department was left stagnating and continuing with current practices rather than improving.
What is the objective of electronic change control process?
Electronic change control management systems help to ensure that the business is able to continually improve their way of working, in a standardised controlled method with efficient handling of changes. Automated change controls may minimize the potential negative impact of change-related incidents on service quality or health, safety and environmental aspects, as well as improve the day-to-day operations of the organization to enable growth.
Laying out your electronic Change Control process
Taking the lead from the IT world where small changes can have large impacts across the business, we have designed a baseline approach for change control that can easily be modified to meet the needs of small and medium enterprises.
Change Request – A user may request a change and stipulate the expected benefits and impacts on any specific items or assets.
Change Review and high level classification – An authorised reviewer, usually from the Quality department, assesses the change and provides any additional context required based on the request. They will provide a high level classification of the impact of the change based on their assessment as to whether it is a critical change, or poses minor overall impact to Quality concerns.
Impact assessment and risk assessment – Each department is provided with a scope of the change and is required to assess the potential impact on their area through a configurable proforma. Risk assessments are able to be tied in to a centralised Quality risk management system to improve consistency of approach and analysis.
Change Planning – Based on the impact assessment, system generated change actions are created and then modified by the Change management delegate, to ensure reasonable considerations are made for Quality and HS&E aspects.
Change Implementation, testing and validation – Changes should be initially made away from the controlled processes and systems. For computer systems, this can mean testing in a Sandbox environment. For equipment, process or methods, this usually means implementing the change during a period when operations has shut down or in a nearby marked off ‘safe’ area.
Training and Release – Training of operators for changes can be one of the biggest determining factors in successful implementations and good Quality and Safety outcomes, once training is completed the change is able to be released for normal controlled operation.
Change Effectiveness Review – electronic change controls are able to be flagged after a set period of time for review, to assess if the change has been successful in achieving it’s outcome this assessment can be used as part of the periodic Quality reviews.
5 Reasons to consider automated change control systems
One of the leading causes for changes to lead to adverse incidents is the lack of communication and collaboration at all stages of the change. Getting stakeholders involved early, and providing them with clear and simple reports on progress of the change enables greater accountability. This leads to a sense of greater ownership and better outcomes for all.
Electronic change controls allow for centralised reporting without any data copying or transcriptions. A single source of truth exists in the electronic repository of all actions and outcomes of the change. At any point you can view the latest status instantly without having to chase paper.
With additional tools and processes the process for managing changes is maintained is a state of control electronically, users are not required to have an in depth knowledge of the process as the system guides them along the right path and manages the administration of approval and review. Better control leads to getting the expected outcome more often.
Visibility and Tracking
Track current electronic changes without having to invest effort in to administration tasks, everyone has visibility in to the process and can see when and where roadblocks occur. Users take ownership for their tasks so as to not be the one holding back the process.
Automated change controls have built in audit trails that give instant feedback as to when and what actions were performed, improving traceability and data integrity. Audit trails enable quick review of actions to understand what happened to get to a root cause if any issues occur.
Where to next?
Is an automated Change Control process needed to maintain your systems and processes without the headache of paper. Talk to us about the Ibiqs Change Control module and how it can assist your business. We can help scope out your As-Is process and map it to an electronic change control approach.