“Meeting specifications is not enough” Dr. W. Edwards Deming

Dr. Deming was the father of the ‘plan, do, check, act’ cycle as a means of integrating quality into everyday manufacturing practices. Thinking of manufacturing as a holistic system and applying such an approach to quality is core to building a resilient practice.


Until recently, the medical device industry was ‘untouchable’ from a downturn perspective—as the population ages, more treatments and procedures are required to maintain good health. The industry’s traditional growth trajectory was in the 5% (pure devices) to 30% (Internet of Medical Things) range. The impact of Covid-19 is palpable: if companies don’t have technology designed to detect, treat or monitor the disease, their revenues are faltering.

However, this pause in ‘business as usual’ can be a benefit in disguise. In an article by McKinsey, they state “prioritizing innovation today is the key to unlocking post-crisis growth.” And that although 90% of executives agree with this statement, only 21% feel ready to meet the challenge.

So where does that leave us with quality management? For regulated industries, quality management is an integral part of their Good Manufacturing Practice (GMP). It ensures that the procedures designed to build compliant products are adhered to, documented and recallable.

Quality Management Systems (QMS) is the default for most companies in these regulated industries. The challenge with a QMS is that it is often a standalone system with a reactive approach to quality issues, whereas the manufacturing process requires a proactive approach to quality. Our argument is that a Manufacturing Execution System (MES) or Manufacturing Operations Management (MOM) solution is a necessity for your holistic approach to quality, and we offer you ten reasons why MES should be the backbone of your quality operations.

1. Quality is Everyone’s Daily Business

According to W. Edward Deming, “Quality is everyone’s responsibility,” meaning that every person in your enterprise needs to be focused on quality in the course of executing their job—it must be embedded in the general culture and manufacturing processes.

A proactive approach to quality operations is the future of medical device manufacturing. It’s time to stop issues before they occur.

Human errors in production are avoided via automated operator guidance with rule-based inputs. If deviation occurs, the MES detects this and can generate an Non-Conformance Report (NCR) and/or automatically trigger a quality protocol as part of the Corrective Action Preventive Action (CAPA) process.

Having the MES/MOM—the broader manufacturing system—as the primary platform maintains a holistic view and capture of activity to encompass manufacturing quality management operations.

2. Information Flow

Enforcing quality standards is a complicated process. As products become more complex and differentiated, the background processes need to maintain flexibility and robust to create a more agile operation. This process is necessarily multi-disciplinary, so there is cross-functional participation at maintaining quality levels, and with that comes multiple, non-cross functional sub-systems.

An example is where a manufacturing operator moves a product out of an operation; information collected includes engineering data from the equipment, calculating derived parameters in real-time; associating them with a lot in the electronic data collection, and posting the data into an SPC chart. If there is a deviation detected, the system holds the lot and triggers a CAPA activity.

These sub-systems of manufacturing and quality management need to work together, seamlessly, in order for everyone involved to have full visibility of the process. The leading manufacturers, according to a Cambashi research report, use MES/MOM as that information and unification platform.

3. Master Data

Master data may include flow, step, resources, states, parameters, or other information that manufacturing and quality need in order to be effective.

Master data is crucial for MES transactions (moving a lot into an operation for example) as well as for quality functions such as Corrective Action (CAPA), incoming material inspection or operator quality instructions.

If the systems are separated, you either have a duplication of master data (which is inefficient and prone to errors) or you have to maintain in a third master data management system, which adds to system complexity. If the master data is stored in the MES/MOM platform, you gain visibility, efficiencies from a single management console, and the elimination of potential errors caused by the wrong master data.

4. Electronic Device History Records (eDHR)

Device History Records are required by the Food and Drug Administration (FDA) (21 Code of Federal Regulation (CFR) Part 820) as part of their Quality System Regulations for each batch or lot, to demonstrate that it has been built in accordance with its device master record. The DHR must include all dates, quantities, acceptance records, labels and device identifiers along with the manufacturing steps taken throughout the process.

Traditionally, DHRs were paper-based and included production travelers and other documentation included in the final record.

eDHRs are now found within most modern MES/MOM platforms. The benefits are numerous: automatic generation of records, built in real-time from the process outcome; access to all information, DHRs, and decisions for every unit in the production line. 

With a modern MES, you don’t even need a separate ‘DHR’ as that is already represented in the history records kept by the MES system for quality-related purposes.

Additionally, beyond regulatory compliance, the MES allows you complete visibility and traceability into your manufacturing operations. Problem resolution practices can be implemented quickly, safely and effectively as the MES provides real-time information and guidance.

5. Additional Regulatory Compliance

In addition to DHR, there are other regulatory requirements such as ISO 13485:2016 and the Medical Device Regulation (MDR) compliance that can be supported by an integrated MES/MOM platform. These include:

  • Training conditions and requirements can be enforced through MES’s labor management functionality. Certifications can be enforced to allow qualified personnel to perform certain transactions at given steps for specific products
  • Task confirmation with electronic dual signature capture can be implemented with the associated electronic records and audit trails
  • Validity checks can be enforced to determine the legitimacy of the source data input or operational instructions
  • Labeling requirements can be implemented seamlessly, key to ensuring the right information is printed on the labels during production.
  • Traceability is captured automatically in the MES as the product moves through the manufacturing process
  • Test and measurement results are collected in the MES
  • Videos, CAD Images, and Worker instructions are available directly in the MES at the relevant process step
  • Ensure GMP compliance

6. Integrated CAPA

The time it takes to remediate a CAPA activity can be significantly shortened with an integrated CAPA system.

An integrated CAPA system features workflow real-time triggering from shop floor data, such as material parameters, yields or loss types; engineering parameters; Statistical Process Control (SPC) control violations; and equipment alarms or events.

It also provides the necessary data for affected products or equipment, reducing the time required to access the data and perform corrective actions. This activity is not trivial! For example, discovering that a piece of equipment is the cause of a quality breach, your first activity would be to contain the equipment by not allowing further processing, tracing all materials that may have passed through its station, determining if it was within a specific time period that the breach occurred, and quarantining or holding all products that may be affected. An integrated platform makes it easier and more reliable to execute these activities, ensuring ‘no data gets left behind.’

7. Process Control

An effective method of monitoring a manufacturing process is to use SPC employing control charts based on real time in-process data. An advantage of SPC over other methods of quality control is that it emphasizes early detection and prevention of problems, rather than the correction of problems after they have occurred.

The integration of MES and SPC allows you to successfully monitor and control process input variables, so you are able to control the process variability and proactively prevent quality issues.If deviations are detected, the MES can trigger several actions, such as the opening of a quality deviation protocol or workflow. Immediate containment actions can be to isolate, quarantine or hold the material; stop the equipment; or restrict the material to specific operations (preventing lot merges or shipments while isolating the cause of the breach).

A common platform of MES and SPC or quality management avoids lapses in corrective actions; gaps in recordkeeping; and can incorporate feedback or feed-forward variables in real time to strengthen the quality management process.

8. Manufacturing Document Control

Good documentation will greatly improve your organization’s effectiveness and efficiency by ensuring that your QMS has a strong foundation. Most manufacturing processes involve constant collaboration among multiple departments as products and related product documentation are created and written. 

Documentation can span training, work instructions, Standard Operating Procedures, corrective actions, maintenance procedures, or any documents that are manufacturing-oriented and contribute to the product lifecycle.

Documentation, in order to be relevant, needs to be maintained with version control, reviews, authorized changes, signoffs, publishing or deactivating. A typical means of control is to use a separate Document Management System (DMS).

However, integrating a DMS into a MES platform brings performance and capabilities to a new level. The MES can grasp the context by which the document is being used. From sourcing raw material to manufacturing execution and shipping, the display of work instructions or production plans at the right step and the right time can be a crucial part of your quality assurance practices. The documents become a living part of your manufacturing strategy, versus a passive storage for materials that may be unread and unnoticed.

9. Equipment Management

A QMS includes equipment management as one of the important organization components to document and manage. The control and calibration of equipment, and a policy for maintenance (using process control methods for preventative maintenance) are an integral part of the QMS.

Integrating these processes with an MES brings obvious advantages for overall equipment management and scheduling; easier scheduling, recording of all calibration procedures and maintenance activities (overall equipment management) as well as with any CAPA actions.

Integration with the MES allows preventative maintenance and calibration activities to be done on real usage, versus simple time-based methodology.

Procedures can be planned in conjunction with other production activities of the equipment, allowing immediate rescheduling in the case of deviations. Most importantly, the integrated system automatically will prevent equipment from being used if calibration or maintenance is past due.

The same MES can show or guide the user through detailed calibration or preventative maintenance instructions. In the background, the system can record all activities and actions performed, documenting and retaining for online access and auditing at any time.

10. Reporting & Analysis ‘Single Point of Truth’

LNS Research reported that 55% of executives say their quality metrics are not effectively measured, and 47% say that their organizations have too many disparate quality systems and data sources. An Accenture study indicates that only 25% of respondents feel they are prepared to make use of their data, and 74% feel ‘overwhelmed’ when working with data at all.

Both of these studies bring forth an important aspect of big data usage: that without context (in this case, manufacturing) disparate systems, disconnected from the enterprise, lose their opportunity to contribute to organizational improvements.

When a quality system is separated from the manufacturing operations software, it loses that ability to become the ‘single source of truth.’ This requires structuring information models in which every data element is stored exactly once. When the data is updated, the update propagates to the upper aggregated levels without duplication—reducing the possibility of errors and eliminating wasted time.

Structuring your data storage in a single architecture, optimized for reporting and analysis—online, offline (operational data store) and in a data warehouse—allow you to create that single point of truth with the MES as the point of entry. This is the one way that a full range of quality-related actions, from the shop floor to the upper level of management can be performed upon the same facts.


MES is the essential complement to an organization’s QMS, where together they can accelerate process development, improve production control, deliver regulatory compliance, and provide real time visibility to management.

We’ve provided you ten reasons why medical device manufacturers should consider using a MES/MOM as the primary platform for a proactive approach to quality management. It helps make quality everyone’s business, while making it more systematic. It helps consistent data and master data to flow where it’s needed, when it’s needed.

Integrated MES/QMS allows eDHR to be not only ready for regulators, but ready to analyze manufacturing improvements. Built-in integration facilitates and speeds CAPA, process control and equipment management as well as document control processes as you gain a holistic view of operations. 

This blog post is an excerpt from our whitepaper, “Quality is Everyone’s Business. Outlining 10 reasons why the MES/MOM platform is best for manufacturing quality management.” You can download it here.