Traceability and Field Service Repairs

Traceability and Field Service Repairs

The idea behind Original Equipment Manufacturers (OEMs) utilizing outsourced service providers is to offload the time and resources it would take to service equipment themselves.

It's a great strategy but requires the right partner that can ensure devices are correctly serviced to manufacturer’s specifications in a timely manner.

Before partnering with Quest, clients are often curious about how we maintain Good Documentation Practices (GDP) and data compliance when servicing their devices. All parties involved must remain HIPAA compliant and keep all documents and data secure for the client and the patient data that may be housed in the device.

Why is Traceability Important?

Traceability is one of the most critical elements for our clients in the healthcare and life sciences space. In its essence, traceability refers to:

  • Failure analysis / repair / calibration / final testing & documentation
  • Serial and / or lot number tracking
  • Device History Records (DHR)
  • All of the above with GDP Compliance

All aspects of the servicing process are to OEM specifications which prove that the parts used, corrected the reported fault.

Clients trust us to deliver repair services on their behalf, so we create clear step by step documentation in the device's history record which allows for quick and precise diagnostic assessments by the client if needed.

Documentation is one of the major components of our process at Quest. We have accreditation, certifications, and registrations to correctly implement this process for each device.

Both ISO 9001 and ISO 13485 accreditation means that we document everything we do regarding the service cycle. Services performed in the field are captured in Quest’s proprietary data portal QuestNet which allows our clients to log in and see the real time status of scheduled repairs.

This meticulous data collection and recording in our systems gives our clients the clear advantage in monitoring the repair cycle of each device, part usage and final test results. This is important for our customers as it provides them with a tool that can be used proactively to prevent issues in the future by trending failure modes and using the information for planned field improvements.

Quest has implemented digital support records to capture field service data with ease. Our trained team ensures proper documentation of each device they touch by completing our clients’ Device History Record template or checklists.

For some of our clients we are vetted by their IT Systems Administrators and given the credentials to log in to the client’s portal, where our techs add information directly into our clients systems. This allows the client to use their own reporting tools to do data analysis without having to process external data provided in a separate report form Quest.

What are the Potential Challenges of Working with Outsourced Companies?

At times, IT can be an obstacle to allowing partnerships to transition quickly, primarily due to client security concerns. Often, new clients hesitate to integrate service applications with external suppliers due to complexity and security matters.

It is common for new clients to have many questions. The way Quest expedites the onboarding process is by communicating with clients in the following manner:

  • We are equipped to use our OEM partner's service management system(s). This avoids the technical or security issues that can arise when merging two different IT systems.
  • Quest's resources will go through a rigorous process to obtain access to existing service management software systems and ensure all appropriate data has been recorded.

Our services are not limited to single repairs or upgrades. The infrastructure, experience, and resources developed for each client allows Quest to effectively partner with OEMs and support their product lines throughout their lifecycle.

We support OEMs and their devices as an extension of their organization with warranty support, preventative maintenance and repair as well as end-of-life (EOL) or legacy service. Working with our depot services is a cost-effective alternative to resource-consuming programs.

Our supply chain logistics team and processes assist the depot service by supporting each step of the process to ensure part and packaging availability so designated repair turnaround times can be met on behalf of our customers. Our supply chain efforts include:

  • Spare Parts Inventory Management
  • Minimum Stock Thresholds for Parts(DHR) completion
  • Parts Fulfillment & Reordering based on Lead Times
  • Packaging and Insert Management
  • Planning & Procurement
  • Warehousing & Logistics Activities

One of the easiest ways to help smooth out the process for our clients is by entering data directly into their systems. Many of our clients give us restricted access to their Enterprise Resource Planning (ERP) systems and Customer Relationship Management (CRM) systems to perform real-time data entry into their environment. This allows our clients to have real-time visibility of what's taking place. All of these elements that we provide as a service provider help us ensure our clients' traceability.

Utilizing our client's own service management platform also gives them the confidence they need in having full access to their data in an environment they are familiar with. Quest supplies the data to the client in the format they expect with a level of detail that satisfies the client that they made the right choice in service providers.

Our core objective has been and will continue to be providing the highest level of quality service and supporting them as a valued partner, helping to solve their daily challenges. At Quest, our solutions ensure the best quality possible while reducing costs, creating ease and efficiency for our clients.

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