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Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
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Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
Manage Operational Risk Tracking, Evaluation, Mitigation and monitoring
Leveraging CAPA for Continuous Improvement
Ensure your laboratory is compliant with systematic and efficient laboratory investigations
Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
Conduct smart management review meetings with a tower of data to improve your quality and safety systems
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Enhance Safety and Compliance with Smarter Chemical Management
Ensuring Quality across Departments & Locations
Partner With Suppliers And Vendors To Improve Quality And Safety
Create Loyalty by Addressing Customer Complaints Smartly
Bring Consistency to Permit Practices
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Streamline Permit Management and Ensure Compliance
When Learning Propels Organizational Growth
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Assuring Quality Products and Services
ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
ComplianceQuest Medical Devices QMS Success Stories eBook
Complaint Handling Process for MedTech and Life Science Companies
Audit Management
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Unlocking the Value of Complaints
Why You Need to Digitally Transform Your QMS
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Safety Technology Trends to Watch in 2023 (Infographic)
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
American Society of Quality Lean Six Sigma Conference
23 Feb, 2025
Phoenix, AZ
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase product, quality, safety, and supplier as they bring their products from concept to customer success.
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Stronger Together: How our partnerships drive success and innovation
Change is everywhere, and can be initiated from anywhere in your organization. A quality leader may initiate a change request to modify a supplier or change the type of raw material used. A plant head may want to rejig a process, to improve risk management capabilities. A new regulation may force you to change a process.
According to 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:
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:
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.
Impact analysis can be defined as “understanding the consequences of a proposed change by managing it responsibly”. It requires the top management to:
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.
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:
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.
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:
Request a demo of CQ's Change Management Software: https://www.compliancequest.com/online-demo/
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