According to the ISO,
“Management of change is a systematic way to handle changes within an organization to effectively deal with the change and to capitalize on possible opportunities. It involves adapting to the change, controlling the change, and effecting new change.”
There are many triggers that can cause a change to the Quality Management System, including the following:
- Customer feedback
- Customer complaint
- Product and service failure
- Feedback from employees
- Innovation and competitive strategy
- Determined risk
- Determined opportunity
- Internal or external audit results
- Management review results
- Identified nonconformity
- Identified opportunities for improvement
Each change will have its implications not only for that phase of the activity or even the specific process but also downstream and upstream. Therefore, the stakeholders need to understand its consequences and impact on the interrelated processes every time a change is proposed. Consequently, the FDA requires manufacturers to create and maintain procedures to identify, document, validate and verify, review, and approve design changes before their implementation.
Another aspect of introducing a change is its criticality. An organization has to weigh the change against questions such as:
- Is it critical?
- How will it improve the organization’s efficiency and effectiveness?
- What will be the cost-benefit ratio?
- How will it affect compliance?
- What benefits will it entail?
It is important to answer these questions before deciding to go ahead and implement the change. Introducing any change will also require all downstream and upstream process owners to evaluate the impact of this change on their specific process.
For instance, if a material is being substituted with another at the design stage, it will impact the supply chain, finance, marketing, quality processes. This may require training the employees to understand how to use it. It may even require new machinery and process changes, impacting the cost, skills required, timelines, and the like.
Like a domino effect, one change can lead to multiple changes in different functions that must be factored in. Before considering a change request, it is imperative to conduct an impact analysis to validate the business case and verify if the company benefits in the long run.
What Impact Analysis of Change Requests Involves
Impact analysis can be defined as “understanding the consequences of a proposed change by managing it responsibly”. It requires the top management to:
- Analyze the change that has been proposed
- Assess the effort and the impact (downstream and upstream)
- Identify control factors
- Empower teams with insights to help them make an informed decision of approving or rejecting the proposed change
The Need for Impact Analysis
By assessing the risk-benefit involved in a proposed change, impact analysis helps avoid any unpleasant surprises. A thorough analysis will also enable setting performance goals and measuring the success at specified milestones to course correct or reverse the change if needed to minimize the impact.
The introduction of change needs to be strategized. The cost, time, and resources needed should also be calculated before approving the change. The risk and control measures must also be identified to understand the impact and mitigation of any proposed change. Multiple changes must be prioritized based on criteria established by the management team to provide a roadmap and make it easy for the employees to align with it. In addition, the change also has an impact on records and documents.
Why Automate Change Management?
Proposing a change is probably the easiest exercise. It can be driven by a true business need, customer feedback or just to keep up with the competition. For a change to be effective, it needs to be linked to a goal and tracked to make sure it progresses as planned.
A manual approach to change management may be challenging. Knowing how a change can affect different stakeholders may be difficult to analyze, and any slip-up may prove costly. Humans also tend to introduce errors, which may have quality, safety, and regulatory implications. Collaboration and communication in real-time between different teams in remote locations are of the essence to ensure that all the stakeholders are aware of the proposed change and know how it will impact their function. Any communication gap can prove to be expensive for the organization.
Some of the other factors businesses have to keep in mind to manage changes include:
- Being compliant with applicable regulations in all processes as well as how the change is implemented
- Reduce risks for the business as well as its employees and stakeholders
- Ensure document management related to the changes
- Provide efficient and transparent change management
- Minimize errors and the associated costs
- Prioritize the implementation of different proposed changes
- Be able to assess the various possible impacts of a proposed change
Automation can provide businesses with a platform to collaborate, communicate, share findings, study impacts, have better visibility into interrelated processes that will be impacted, run analytics, and generate reports that can be shared.
Automating with ComplianceQuest Change Management Software
A cloud-based solution built on Salesforce, ComplianceQuest EQMS has a dedicated Change Management Software that is integrated with all other processes and can provide the required visibility and collaboration in one place.
Some of the key features include:
- Organizational Governance and Oversight: Ensure compliance through documented workflow tracking and monitoring the execution of all changes. Conduct impact assessments to understand how the change can affect the organization.
- Collaboration with Stakeholders: Notify all relevant stakeholders instantly whenever a change has been implemented using integrated enterprise collaboration tools such as Chatter. Assign action items, track, and update suppliers. Impacted functional heads are alerted by planned changes to review/approve changes from their own devices from anywhere, anytime.
- Establish and Follow Best Practices: Implement proper procedures and practices to roll out changes. Automate processes to minimize errors and delays. Define your own policy and track each step in the change lifecycle from initiation to business/risk assessment to approval to task assignment to change implementation to verification. Streamline the process and guarantee consistency and repeatability across the entire change process.
- Accelerate the Change Process: A structured process ensures that all associated tasks with changes are specified and tracked, documents are updated, training gets completed, and processes get updated more efficiently. An improved collaboration and communication process eliminates the need for back-and-forth emails and meetings and resultant delays. A faster change implementation process improves productivity and reduces the cost of change.
- Enhance Change Visibility: Track change actions and the related impact to assess progress. Improved visibility across the organization helps the impacted functions plan and prepare, increase effectiveness, and improve productivity. Validating changes will also help to mitigate risks.
Request a demo of the Change Management Software: https://www.compliancequest.com/online-demo/