Lessons learned from the medical device manufacturing industry
As I write this, the COVID-19 pandemic continues to have a significant impact on the world. Terminology we were not familiar with before has entered our vocabulary: social distancing, shelter-in-place, and furlough are now part of our daily lexicon. These are all measures, among others, instituted to protect us. Yet they have disadvantages too and business interruption is one of them. However, there is opportunity in every situation. For businesses today, COVID-19 is accelerating the reliance on technology and honing the focus on technological advancements to support ongoing business success.
Just like individuals, each business will have its unique challenges, and some commonalities as well. For manufacturers, the need to maintain customer approvals, industry accreditations, equipment calibration and efficiency are vital to the current and future ability to provide their services. Yet these are not easy to achieve in optimal conditions, and today’s world is indisputably suboptimal.
If your organization, like so many at this time, is trying to balance many competing demands, the following tips compiled by the MedAccred® team may be helpful. MedAccred is an industry-managed, consensus-driven approach to ensuring critical manufacturing process quality throughout the medical device supply chain. With a goal of reducing risk to patient safety, MedAccred addresses industry challenges such as number of recalls, flow down to sub-tier suppliers, and purchasing controls through a shared, industry-wide approach. Medical device companies who are leading this initiative as subscribers include Johnson & Johnson, Medtronic, Philips, Stryker, Boston Scientific, Baxter, Roche Diagnostics, Bausch Health, Edwards Lifesciences and BD.
Maintain your self-audit activity
Even if it is limited to a desktop review at this point, ensuring a continued focus on your procedures and records means that they remain front of mind and may help to avoid silly mistakes once normal operations resume. This could be an opportunity for manufacturers to ensure that the following records are current:
• List of equipment
• List of purchased services
• List of quality personnel and approved manufacturing personnel on each shift
• List of customers and specifications
• Copy of internal general procedures
• Organization chart
• Personnel Training
Communicate openly and often
Your customers, notified bodies, regulator, suppliers, and other stakeholders want to know how you are doing. The performance of your business affects more than your business. We are all experiencing many of the same challenges so you may be able to obtain temporary extensions, waivers etc. to cover you for this period.
Update your process controls
You must be able to demonstrate that you have reviewed and are meeting the process control requirements for each of your customers and that you have an internal procedure and “system” that documents compliance, including to other testing and controls required by specifications. Make sure that you have updated your internal documents to reflect any contingencies you have in place for the current situation.
Adapt where possible
When “business as usual” is just not an option, work with your customers and regulators to identify what adaptations you can make that enable you to continue to provide the service they need at the level they expect. While you maintain control of any activity granted a temporary deviation from a requirement, avoiding the disaster of not returning to compliance once this situation has passed will be critical for ongoing conformity.
Explore different technological options to support your business. The MedAccred Subscribers recently authorized temporary virtual accreditation extension audits to enable companies whose accreditations were due to lapse a safe way to maintain their status. This type of audit can be used only when a physical on-site audit cannot be conducted. While not as desirable as an on-site in-person audit, it is bridging the gap for now. MedAccred virtual accreditation extension audits are limited scope audits conducted via videoconference technology that extend a current MedAccred Accredited auditee’s certificate for 3 months if they meet all requirements and properly close out their findings. The auditor conducts the audit with a representative from the factory, operating a live-stream video device pointed at areas on the factory floor that the auditor requests to see. In addition to live streaming from the factory floor while production lines are running, documents are shared and reviewed through normal videoconference application, such as Microsoft Teams or Zoom.
“Jabil Circuit (Shanghai) Ltd. gained MedAccred printed circuit board assemblies accreditation in April 2019. This was a very proud moment for our team, and the result of a lot of hard work. The MedAccred audit is not a simple checkbox exercise; the auditor really looks in detail into the procedures and records, as well as observing parts processing in real time.
“Accreditation is initially awarded for one year. Due to the COVID-19 pandemic, there was a risk of accreditation lapse. Measures such as travel restrictions and social distancing, as well as concern for the safety and welfare of all involved in the audit, made it difficult to conduct an onsite audit. We partnered with the MedAccred team and were able to successfully host a virtual accreditation extension audit online.
“This meant the MedAccred auditor conducted our audit at a distance, covering the key requirements and permitting Jabil Circuit (Shanghai) Ltd. a three-month extension on our accreditation. It is not the same as conducting the audit in person but it is a great example of how technology can be leveraged in these challenging times to demonstrate our unwavering dedication to quality and ability to satisfy our customers’ requirements. The intent is that this will help us evidence our compliance until we can welcome the MedAccred auditor back onsite again.”
Alice Wang, Manager of Quality System at Jabil Circuit (Shanghai) Ltd.