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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
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Frost Radar for Quality Management Systems Names ComplianceQuest Leader
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Automation of the Risk Management Lifecycle with AI and Analytics
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The Ultimate Guide to Next-Generation Supplier Management [e-Book]
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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
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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
It is not uncommon for quality leaders to be informed on a Friday about an inspection at one of your locations the following Monday.
What would your reaction be if that were the case? Would you panic or is it no big deal because you’re well-prepared for it?
The true hallmark of a good quality leader is preparedness. With the right automation and digital tools in place, it is extremely important for a quality leader to drive a data-centric, collaborative approach to any quality process.
Inspection readiness is no different. As a quality leader, it is not only about regulatorycompliance but also about driving an organization-wide mindset to pursue quality excellence. A QHSE that can drive continuous improvement of quality and safety best practices is always in need.
ComplianceQuest Inspection solution makes it extremely easy for quality leaders to do the following:
There are five inter-related phases for any inspection process:
These are the phases of a closed-loop process where information and actions from one phase impact the next. Define, document, and implement an inspection readiness program that proves that your quality system operates in a state of control and that you are meeting the needs of your stakeholders, including internal and external customers, notified bodies, and regulatory agencies.
Inspection Readiness should be a well-thought-out process involving every employee, giving them time to attune themselves to the needs of being prepared. Giving them sufficient time and training is critical to getting their buy-in and meaningful participation.
Though you may wish to be in a state of perpetual readiness for any audit situation, you cannot focus on everything with the same level of rigor. Therefore, it becomes important to plan and prioritize areas of focus, and a good guideline is the 80:20 rule. Define the criteria that determine which areas are critical and contribute to the highest level of safety, quality compliance, and risk mitigation.
Schedule multiple sessions for the team with the processes and procedures. The key is practice, practice, practice. For onsite inspections, a walkthrough is a normal part of the activity. Make sure everything is clean and whatever is required as part of safety, health and environment should be followed to the T.
If you put something in your procedure and don’t follow it, it now becomes an observation because it has become a law, and for the notified body, it has become part of your system. Records should be prepared as expected and be readily accessible.
Some of the key steps for IR preparedness would be:
When you are working with different quality subsystems, identify an owner, and ensure cross-functional representation. Simulations are an essential part of the readiness program, done as a dedicated activity, or as part of your internal audit program. This is an opportunity for the owners and the users of the quality systems to not only know the processes, procedures, and work instructions, but also understand the intent. This enhances your ability to work in a state of control and deliver what is required.
By understanding the intent, employees can make better decisions when an unexpected event occurs. They will understand the impact of the decisions on the processes and products, thereby reducing non-conformances and complaints due to the distribution of non-compliant products.
Clearly label the rooms, keep the required documents filed neatly and provide them with unique IDs for easy identification, especially if there are multiple inspections/audits happening at the same time.
Have a post-inspection, close-out meeting to review what worked and what did not. Update and modify your processes and incorporate them as part of your quality initiative wherever necessary.
Establish processes and procedures based on the observations and use that as an internal audit tool for inspection readiness.
Management support is essential for businesses to become inspection ready. Equally important, an enterprise-wide quality, safety, health, and environment management solution, such as the one from ComplianceQuest, can help create a culture of quality. This automatically aligns employees with the business and quality goals and keeps them prepared and ready for inspection at any time. It provides easy access to documents and CAPA, complaints, and other similar information that an inspector may ask for. It also alerts employees to any potential SHE risk situations.
As a quality leader, it is important to manage your inspections with ease using automation. It frees up time for strategic, higher-level tasks, while ensuring you’re running a robust inspection process that is data-driven and collaborative.
ComplianceQuest’s Inspection solution is part of our cloud-based QHSE solution, built from the ground up for the cloud. We believe that it is one of the best solutions in the industry for driving your QHSE process. Request a demo here: https://www.compliancequest.com/inspection-management-software/
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