We recently partnered with American Society for Quality (ASQ) and Datt Mediproducts (DMP) for a webinar on the topic of Quality Management on the Shop Floor. The webinar was spearheaded by Sundeep Agarwal of DMP, and he touched upon specific aspects that medical device manufacturers need to keep in mind as operations restart.
Sundeep started on a lighter note by introducing the audience to ‘Namaste’, the Indian way of greeting people with folded hands! He recommended it as the first rule to follow when shop floor operations restart with social distancing norms in place.
Inspired by the webinar, we also published a whitepaper on the subject, presenting a four-step guide to starting factory operations:
- Conducting Gap Analysis
- Understanding the Best Practices to follow with respect to workplace safety and supplier readiness
- Data-driven, Automated approach to shop floor operations (ideally, powered by a cloud-based QHSE solution)
- A process in place for Continuous Improvement (CI).
Read the full whitepaper here. In this post, we capture a summary of key points that Sundeep touched upon in the Webinar.
Quality & Safety-first approach to restarting
As a first-step to resuming operations, the speaker suggested the following guidelines:
- Begin with an e-meeting with your core team and understand the immediate next steps. While one focus is to resume operations with emphasis on quality and safety, the other aspect to consider is to also enhance and rejig your shop floor for the future.
- Prepare a Do’s and Don’ts list either based on guidelines set by CDC, OSHA, EPA, WHO and other governmental agencies
- Communicate this to employees and key stakeholders through whichever medium is feasible and available. Ideally, we’d recommend a cloud-based QHSE platform that is collaborative, data-driven and integrated.
- Initiate an online training process for your team on new safety norms including wearing PPE, maintaining social distancing rules, capacity guidelines, new workflows, etc.
- Orient your team towards the need for a new set of skills that would be required in the days to come. You could also organize sessions with subject matter experts and external trainers who can to boost the confidence levels of the workers in dealing with the new safety norms that will protect them and their colleagues
- Conduct a maintenance check of all the machineries and the cleaning room as a large percentage of accidents happen at the time of a restart
- The shop floor must be cleaned and sanitized at least two to three days prior to the reopening
- Perform a quick internal audit of the manufacturing floor. Ideally, your cloud-based QHSE or Workplace Safety App must allow for a dashboard that highlights all key safety indications, including a safety checklist and a safety scorecard
- Revision of SOPs is mandatory as per ISO 13485:2016 and other regulations and standards
- With limited resources, manual quality, health, safety and environment management will pose a challenge. If you do not already have an EQHSE management system, start planning for a cloud-based one. It is flexible, scalable, customizable and easy to deploy.
A restart is probably more difficult than starting afresh because old habits die hard and new habits are hard to cultivate. If businesses have to continue to provide quality products without compromising on quality, health, safety and environment norms, automation is the only way forward.
A cloud-based QHSE will make it easy to capture data from remote audits, manage inspection schedules, maintain a safety scorecard for all manufacturing locations, take corrective and preventive action, gauge supplier readiness, to name a few features.
Overall, the prediction is there will be a greater demand on medical device manufacturers, pharmaceutical and life sciences companies to fight deadly diseases with safe and effective products and play a larger role. The Covid-19 pandemic has shown that businesses have to be ready for any eventuality and be equipped with an efficient risk management mechanism for more such future disruptions.
The role of IoT-based connected devices
One of the key aspects of automating any shop floor is access to data. The ideal way to capture data from a factory is by using IoT-based sensors and connected devices. These IP devices can automatically feed data inputs to ERP and QHSE systems. This makes it really easy to derive insights from predictive analytics models. It also makes it easier to manage change and risk, using data at the front and centre of the process.
The factory of the future is going to truly digital. The entire operations of a shop floor will be mirrored in a digital twin – offering the plant head real-time access to all key data and information.
Broadly, we believe that a cloud-based QHSE solution is ideal to capture and process all this data from the shop floor, while simultaneously integrating with a next-generation ERP.
The transition to a cloud-based QHSE system may seem daunting at first, but it’s the best approach to derive ROI from your digital transformation investments using an op-ex model.
At ComplianceQuest, we offer a suite of next-generation solutions as part of our QHSE. This includes world-class solutions for supplier management, document management, change management, risk, CAPA, training, workplace safety and employee health.
We also built two apps for Salesforce’s Work.com initiative. One is a Workplace Safety app designed to automate the process of restarting operations. Another is a Supplier Readiness app to help companies re-qualify their suppliers and on-board new ones as needed.
If you’d like to demo any of our solutions, schedule here:
We also published a whitepaper on this topic. Check it out here: