By Daniel R. Matlis
Sanmina’s Medical Division manufactures a wide range of products and systems for well known medical OEMs including laboratory, biotechnology, diagnostics, therapeutic, patient monitoring and surgical equipment.
For 7 years, Sanmina’s Medical Division has embraced Cloud-MES to optimize manufacturing operations and elevate operational performance.
To gain a deeper understanding of Sanmina’s journey to Cloud-MES, I interviewed Seán Moran, VP of Operations and Plant Manager at Sanmina Ireland and Wellington Giolo, Head of Sales & Strategic Alliances at 42Q.
In this Straight from the Source webinar, we discussed:
- Trends Enabling Cloud-MES in Life-Sciences
- Sanmina Medical Division’s Cloud-MES Journey
- FDA’s Role Incentivizing SaaS, Cloud and Manufacturing Modernization
- The Value of Cloud-MES across Business, Technology & Regulatory Dimensions
- Managing Medical Device Production in The Age of Disruption
This event brief covers key points from our interview as well as audience questions.
What drove Sanmina’s decision to select a Cloud MES over on-premises?
Seán: In the early 2010s, technologies such as the Internet of Things (IoT) and Industry 4.0 were emerging. Customers were designing increasingly sophisticated products. These products required levels of quality, efficiency and advanced automation far beyond anything we had seen in production at the time. At the same time, we were under pressure to lower the cost of ownership of our manufacturing I.T. and MES systems, enable faster time to market and start up manufacturing in multiple locations around the world. Our manufacturing operations needed to:
- Implement engineering change orders faster than ever before.
- Consolidate operations, materials, engineering and quality data from ERP, PLM and other systems.
- Integrate SMT equipment, robotics, automatic optical inspection machines, in-circuit systems and other testers.
- Duplicate production and transfer it efficiently from one location to another.
- Provide high levels of flexibility for product and forecast changes.
- Comply with increased regulatory requirements for the medical, automotive and aerospace industries.
We realized that a cloud-based advanced manufacturing platform would provide a common, shared operating environment that could cover most of these requirements and provide flexibility to scale and change, as necessary. As a result, 42Q was developed as we know it today.
How does Sanmina leverage Cloud MES to support audits?
Seán: The cloud MES is a repository of the device history record and all relevant information. We often have to show full traceability and genealogy (e.g. lot code, date code, manufacturing part number, component traceability) to respond to audit questions. 42Q allows us to provide this information in a timely manner. In addition, Sanmina leverages the validation package provided by 42Q.
Have there been any disruptions or outages since Cloud-MES?
Seán: No, we have not seen any issues with Cloud based 42Q. All the appropriate back ups are in place following the initial risk assessments. Many of us remember the challenges and difficulties that we all experienced existing in the 1980’s & 90’s when on premise was the only option. Cloud-MES is very robust and avoids those on premise problems.
Is it expensive to store equipment generated data in the cloud?
Wellington: If managed correctly, storing this data in the cloud is less costly than keeping it on-premises. Actually with the appropriate data storage strategy it can be significantly less expensive. The cloud provides many models to store the data, and data generated by equipment is typically stored in a database for a short time and then moved to less expensive, highly redundant storage. It also gives us options to minimize the processing power that is needed to deal with the most recent data, further increasing savings and benefits.
How do you manage updates, patches, and change control in the cloud?
Wellington: Most updates are performed without our customers seeing any impact at all. Updates and patches to 42Q are handled using a stringent change control process, and we provide visibility to all our customers to ensure that they are prepared for updates. 42Q strives to eliminate downtime during updates. We also schedule those updates to be as friendly to most of our customers’ production schedules as possible.
As far as the underlying cloud environment, most of the updates are performed without our customers seeing any impact at all. We use a blue-green deployment model with most of our implementations, which allows us to replace individual instances while the system continues to run smoothly.
What is the role of MES with the advent of edge computing and increased shop floor capabilities from SCADA and ERP solutions?
Wellington: The capabilities of MES systems have evolved over the years in many ways. The 42Q difference is its cloud based architecture and connectivity. From the beginning we envisaged the system becoming a network that connects manufacturing and test equipment like SCADA. It utilizes many Industry 4.0 and IIoT and big data techniques to connect all of this equipment to the cloud. The manufacturing operation gains the benefits that edge computing and new SCADA technology offer, while being able to access all data provided by such advanced equipment in real-time. Within 42Q, we help to ensure that the products are built correctly, the data is tracked well, and that the engineers and customers have all of the data that they need to be better, faster and more profitable.
Did you audit AWS before selecting them as your Cloud provider?
Wellington: Sanmina and 42Q evaluated AWS (among other leading cloud-providers) before we began to use them. We examined their certifications and their shared responsibility model, and evaluated their performance. We also examined their change control process, certifications, and compliance levels, and this is a process that we continue to perform. AWS provided the policies, procedures, and certifications necessary to comply with our requirements including SOC II Type II. We also found their change management procedures to be more than adequate to allow us to make provisions to keep our system and our customers functional.
How do you manage CSV for Cloud MES?
Seán: There are some cloud-specific adjustments that have had to be made to the validation process compared to traditional on premises systems, but not as many as one might think. Most of the content of the CSV is about making sure the application meets our intended use. That still happens very much the same way it would for an on premise system, at least for the service provider. Some hardware related things end up being done by the cloud provider. However, the manufacturer has to assess the risk in light of the Cloud MES provider’s work such as an IQ and OQ certificate and build their protocol in light of that.
How do you address hesitation regarding storage of sensitive data in the Cloud?
Wellington: Today pretty much everybody uses the cloud to keep a lot of information that they wouldn’t have dared to put on the internet 10 years ago, but we do still get some pushback from some potential customers. AWS and 42Q are SOC II type II compliant, encrypt the data at rest and in motion, use several firewalls and has significantly more security and reliability than your average on-premises data center.
You can view the complete “Straight from the Source” webinar On-Demand here
This Brief was written by Axendia, Inc. and sponsored by 42Q and AWS. The opinions and analysis expressed in this Brief reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and should not be attributed as such.