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Jen, the VP of Quality Assurance at one of the world’s largest medical device manufacturing companies based in Minneapolis, MN, was preparing for her bi-monthly Management Review Meeting (MRM). It was a freezing day in December, with the city completely buried in snow. The quality leader got off a quick call with the CEO’s executive assistant and they decided to do the meeting virtually.

The VP of Quality logged in to the company’s EQMS system and downloaded various reports and data charts. She was all set, thanks to having access to a modern, cloud-based EQMS solution.

Overall, the company was doing very well in terms of quality except in the case of one new product. After some quick number crunching, Jen realized that the biggest reason for quality issues in this problematic business unit was repeated internal failure. There were issues in both the lab and the shop floor. And, unfortunately, these issues weren’t caught before they went out the door and resulted in customer complaints.

Non-conformity

Here’s a replay of the conversation between Jen and the CEO during the MRM.

CEO: I am glad we’re doing very well across most of our business units. The quality metrics in our cardiovascular portfolio are top-notch. Can we get to the same level in our neuromodulation products?

Jen: Thanks, Bob. (Getting straight to the point) I knew this would come up and I’ve done an RCA of why we’re seeing so many customer complaints in the neuro product. The biggest problem is internal. We should actually catch most of these issues even before it leaves our facilities.

CEO: What do we need to make it happen?

Jen: I am working on a more robust nonconformance management system. A few processes are completely new in this business unit, and our QMS needs a little tweak. We need a slightly modified, customized workflow that includes a deeper understanding of internal failure.

CEO: Go on…

Jen: I am setting up a “mock customer” within our facilities, one who would test out our neuromodulation batches for key quality metrics. We conducted a 5 Why and there are three major reasons for failure: a) equipment issues in the lab. We need to upgrade and maintain this better, so our calibration is as good as our customers’. b) better training for our people. c) spot process variations ahead of time.

CEO: The last one is critical. We cannot afford to have any process variations. Equipment and training-related aspects seem like low-hanging issues that can be tackled. Right?

Jen: Absolutely. I am automating the entire nonconformance management process. I will keep you in the loop.

Over the next three months, Jen was completely focused on driving a complete digital transformation of the nonconformance workflow. Here’s what she had to do.

#1 – Automate Retesting Workflow

At the core of catching nonconformance issues is having access to data. It requires a deep understanding of what the customer is looking for and retooling the QMS to ensure these quality requirements are met before it leaves the proverbial four walls of the company.

When the lab or shopfloor team spots issues, they take corrective action (and preventive action) as needed. But, often, the process of retesting after the change is not robust enough. Tweaking the nonconformance management process to do this will be a game-changer.

With a modern, next-generation nonconformance management system, one can automate the workflow to ensure that adequate notifications and prompts are sent out so that the following actions are taken by the team as part of the change process :

  • Retesting products after rework
  • Scrapping defective products before it leaves the door
  • Double up on CAPA efforts post internal failure issues
  • Collaboratively tackle process variance
  • Robust equipment management, including calibration of lab equipment
  • Periodic training delivered to lab technicians and shopfloor workers

#2 – Automate the Process of Spotting Nonconformance Trends

At the medical device company we described above, it was difficult to spot trends and patterns from past nonconformance data. They didn’t have the right platform to look for past data as a whole, run analytics and draw insights.

With a solution like ComplianceQuest Nonconformance Management Software, it is easy to:

  • Use Einstein Predictive Analytics to capture nonconformance trends and draw insights from data
  • Streamline the process of identifying risks and rank by risk level/priority
  • Streamline next steps including escalating to CAPA
  • Trigger notifications right at the point of failure
  • Identify recurring errors and perform a 5 Why to get to the root cause

#3 – Automation Support for ISO, FDA and Other Regulatory Compliance Related to Nonconformance

FDA’s 21 CFR 820.90(a) defines nonconformity as any nonfulfillment of specifications that applies to both products and processes. The regulations vary depending on the industry and it is critical to stay abreast of the latest compliance requirements. Regulators also demand that robust documentation has to be maintained to capture nonconformance issues across the product lifecycle.

CQ’s EQMS helps with digitalizing and automating the following steps:

  • Compliance with ISO and FDA nonconformance requirements
  • The process of initiating corrective actions
  • It is available out-of-the-box, making it easy to set up and integrate with other processes
  • Integrated risk management solution
  • Streamline training management, especially when new training is needed or when people haven’t completed the required certifications

If you’re a quality leader in manufacturing, life sciences, automotive, aerospace, CPG, hi-tech, and other industries, reducing the Cost of Quality (CoQ) is a key requirement. Use ComplianceQuest Nonconformance Management Software to make your life easier and more efficient.

For more information, visit: https://www.compliancequest.com/nonconformance-and-cost-of-conformance/
Or simply sign up for a complimentary demo here: https://www.compliancequest.com/online-demo/

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