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The manufacturing of a medical device requires process control at every step due to its criticality for human health and life. It is, therefore, more stringently regulated than most other industries. However, despite the many checks and balances, returns due to defects are not unheard of, and dealing with it satisfactorily is crucial to retain brand reputation and customer loyalty. Better still is to reduce the need for RMA to improve profit margins due to its impact on resources for assessing and repairing the product and sometimes even reworking the process to avoid the defect.

The Process of Returning Merchandise

The manufacturer of the medical device has to make sure that the product is repaired or replaced, provided certain conditions are met.

  1. The label should clearly state the conditions under which a product can be returned
  2. It should specify whether the customer needs to first contact the customer relationship team regarding this issue
  3. Explain how the product should be returned – with packaging, with all documents intact, or as appropriate
  4. Sharing the details of the person the product should be shipped back to (in the manufacturing company)

The Response to the Return

Once the product is received, the company should have a clear understanding of the roles and responsibilities for dealing with the defective product.

It has to be assessed for the nature of the defect, a decision made on whether it can be repaired, the team responsible for that, and whether it needs to be reported. In most cases, a root cause analysis process must be done, and CAPA initiated to avoid or eliminate recurrence.

In case of replacement, SOPs must be documented to dispose of the defective product.

This needs the company to have a clear Return of Merchandise Authorization (RMA) management process to enable it to respond to the complaint in a timely and appropriate manner – to maintain customer relationship as well as improve internal processes to manage such an event.

If the product being returned is from a customer abroad, then there are additional legal requirements to bring it back to the company, repair or replace and send it back to the customer.

While manual intervention to talk to the customer is essential, the logistics of receiving the product and returning it after repair or replacing it, the action taken, learning from the incident to improve processes, documenting it, and reporting to authorities where changes are needed are all essential to prevent recurrence and improve the quality processes. This can be challenging in manual or on-prem systems.

CQ Complaint Management solution helps with establishing an automated workflow for the entire complaints lifecycle and acts as the first step in dealing with an RMA request. Since ComplianceQuest’s EQMS solution is seamlessly integrated, it makes it easy to deal with the RMA request with deep collaboration among various departments and stakeholders.

It is also easy to ensure that RMA related document management, change, CAPA, training management and complaints are all managed in a single window, with easy access to “single source of truth” data.

Automating the Quality Process to Reduce RMA Costs

A medical device manufacturer specializing in optic technology automated its quality management process. The company, with several thousand products and seven locations across the globe, was growing at 15% year on year but its systems and processes weren’t geared to support long-term growth.

It did not have a standardized document control or quality management process, every department worked in silos, and data was spread across systems. Getting a unified view of the different processes and their impact was not possible.

And as a result, there were duplications of RCA and CAPA efforts. Lack of real-time information and data resulted in gaps, compelling the need for a robust solution that would tie the systems, processes, and bandwidth together.

The company automated its quality management system using the ComplianceQuest platform built on the Salesforce platform. As a result, the company experienced:

  • Improved document control and centralization
  • Unification of data across multiple locations with our EQMS acting as the single source of truth
  • Real-time accountability, compliance, data visibility, and traceability
  • 100% paperless functioning that increased productivity
  • Improved collaboration among various stakeholders and departments

But most importantly, one of the significant impacts was on reducing RMA, defects, and scrap rates, leading to increased gross margins. The company saw the customer returns dropping from 3% to 0.3%, effectively a 90% decrease in returns. Reduced scrap contributed savings of $400,000 and defect rates dropped from 8% to 1% or less.

You can read the detailed case study here on how ComplianceQuest helped the company with automating and digitally transforming the entire RMA process and the rest of the QMS workflow.

Read the Case Study

RMA Management with ComplianceQuest

The EQMS solution from ComplianceQuest is aligned to the regulatory standards and enables businesses to get a unified view of the entire supply chain from the point of supplier qualification to complaint handling.

With automation of workflows for audits, inspections, RCA, CAPA, equipment, complaints, compliance, document, change, nonconformance, and risks, the platform also enables RMA management right from assigning a number to the product to tracking and identifying trends. The RMA process is tied to a form for automating the RMA workflow and enables identification and traceability of the product being returned. Refunds, credits can be managed well to improve customer satisfaction while reporting to authorities where required can also be integrated in the system.

The ComplianceQuest EQMS allows access to product specs, documents, work instructions, and SOPs in real-time, enabling the design and manufacturing teams to reduce nonconformance. Approvals can also be speeded up, improving the speed of time-to-market, as also facilitate collaboration between remote teams. This has a huge impact on product quality.

With a periodic inspection of materials from suppliers, the production facilities, equipment calibration, and compliance with various applicable regulations, businesses can reduce the chances of any defects slipping through and thereby reduce RMA.

If you would like to know more about how ComplianceQuest’s EQMS can improve your gross margins by reducing defects, contact us now.

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