A record: the general and simple interpretation of the word implies the evidence of an event, stored in the form of a paper-based or electronic document, which could be referred to at a later point in time to confirm the event took place as maintained in said document.

Records have a huge significance in our daily lives and in manufacturing it takes on a new meaning. Data is generated with every single transaction that happens on a production floor, in the R&D labs, in warehouses and even when material lies dormant on the floor. All of this data, when documented for the purposes of history, compliance, analysis and reporting, forms records.

The ability to design a product and then successfully manufacture and bring it to market relies heavily on the manufacturer’s ability to create records, communicate them effectively, and throughout the process, verify whether production followed the recorded operational methodology. Manufacturing records generally define the product’s specifications, exact bills of material, work and operator instructions, and other details that ensure compliance to design. The ideal production process includes qualification requirements of personnel, validation of the production routes and recipes, evidence of key transactions or production milestones with requisite labels, time stamps and signatures. Production KPIs and other parameters either related to the product’s quality or process’s validation are also critical

The more complex the manufacturing operation, the greater the need rather the MUST to document every single transaction. It also linear with more effort and cost must be spent pertaining to maintaining records which aligns that the manufactured product conforms to the master specifications. Modern manufacturing operations, irrespective of the industry segment, involve some degree of record keeping. However, it is the manufacturing of products which affect the health and welfare of people, like medical devices, pharmaceuticals and diagnostic devices, or industries where manufactured products which are extremely complex , that records are maintained for the entire product lifecycle and audited by a regulatory authority, a third party, or in some cases both.

In the medical device manufacturing industry for example, the FDA places well defined and clear regulations pertaining to the master record related to the production of the device, which are referred to as DHRs, Device History Records. Specifically, the Quality system regulation, 21CFR part 820 deals with what is known as an e-DHR or electronic Device History Record.

e-DHR, as the name suggests, is the electronic version of a device history record, which is basically a record of the production life cycle of a medical device from its inception to its distribution and beyond. It contains at a minimum details of the master record (DMR) which includes the designed specification of the device, the dates of manufacture and distribution, records of acceptance that the production is indeed compliant with the DMR. Also included are primary identification, labelling details, sub-components, and of course the barcodes and identification details of the product itself.

However, the e-DHR extends far beyond the minimum requirements detailed above, and irrespective of the name, may be useful in any industry where documentation and compliance play a major role.

Today, we will examine the role a modern MES with e-DHR functionality can play in not only meeting the record keeping needs placed by regulatory authorities or other bodies, but also in helping reducing cost and effort related to the whole quality assurance and compliance activity. Benefits include the containment and correction of detected errors, reduction of ‘just in case’ inventory and overall product cycle time, and faster response to changing market needs and trends.

The Industry 4.0 revolution is fundamentally different from the industrial revolutions of the past as it brings together a combination of technologies, but also relies heavily on information generated within and outside the value chain to create better business results. In this new revolution, the ability to acquire, analyze and apply the information collected, faster and better than your competitors is what gives you an advantage. The role data and IT applications play in this industrial revolution is greater than ever. For any manufacturing organization, Industry 4.0 basically mandates having a MES or MOM-based platform as the centerpiece to connect the entire value chain virtually through IT application integration and allows for shop floor data to turn into value-adding information.

The Cost of Paper in Manufacturing

In an environment where manufacturing is complex and every aspect of production of a batch, lot or individual SKU must be recorded, it is hard to imagine paper-based records being able to keep up with and deliver Industry 4.0 level insight and connectivity. In fact, paper-based systems of record and reporting are prone to errors (the manual data error rate is at least 1%) and makes the operation slow to respond. It is unfeasible to manually record every shop-floor transaction; compound with the need to be audited, need to be filed and need to be protected, makes paper records highly impractical for most large companies. Here are some of the costs of paper-based recordkeeping:

  • $14,000 worth of productivity is lost per worker per year due to their inability to find the proper data they require to do their job.
  • Professionals in a paper-based business workflow spend up to 35-50% of their time searching for information due to lack of a centralized repository or index.
  • The costs of using paper in the office can run at a rate of $.10 Cents/Page or 13 to 31 times the cost of purchasing the paper in the first place. The American office worker uses an average of 10,000 sheets of paper every year.
  • Businesses spend 5% of their budgets on filing, approximately $25,000 to fill a typical four-drawer file cabinet, and an additional $2,000 to maintain it every year.

MES as the foundation for eDHR

This is where MES comes in—to convert the paper-based DHRs into digital e-DHRs. Modern MES applications may not just replicate but also enhance the actual production process virtually, where each and every aspect of the real manufacturing process is visible and each transaction of importance is recorded in real-time.

From a device history perspective, the MES is the application upon which the DMR or the master specification would either be created or stored. The primary requirements of having the entire spec, route and performance data recorded is met for each and every variant. In plants where hundreds of variants exist today (which as customization becomes more prevalent may become thousands of variants) storing exact spec, route and functionality of each device on paper becomes impossible.

MES with e-DHR functionality allows for all specifications to be stored and retrieved seamlessly. As the actual production commences, MES can validate the BOM (bill of material) and can generate an alarm/notify an operator if a component does not match the specifications.

Furthermore, as the product moves along the shop floor, the MES automatically captures the stream of data coming from the process to include equipment and product-related KPIs. Reporting and recording the shop floor data in real-time allows any condition, such as out of stock, asset underperformance or other shortages to be viewed and managed. Production can be halted or re-routed, equipment can be repaired, and stock can be replenished or re-ordered. In short, a full ENFORCEMENT throughout the shop floor to build product as prescribed.

At each milestone where oversight and compliance are mandated by regulation, specification or design, the MES guides and informs the operators and records their tasks as they happen, in real-time. The MES includes version control and e-signature capture, mandatory for regulated operations, as well as other functionality such as creation/application of labels pertaining to lot, and expiration details (if any) pertaining to the product and sub-assemblies/components.

MES adds value to eDHR

From the time a device or product is designed, to the time it is assembled/produced and finally packed and shipped, the MES records every single instance needed for successful compliance from a DHR perspective. But a modern MES platform does much more than a ‘paper on glass’ recording; it actually adds value to the production activity itself.

Let’s clearly understand the areas where value is added: first, in the device history and second, in the process execution, which is done through the MES.

The first and most obvious benefit of having e-DHR is the elimination of countless man-hours spent in creating paper-based records; with MES everything is recorded as it happens and reported in near real-time. There is a direct impact on costs associated with elimination of paper, reducing additional workforce needed for record keeping and since the records are captured directly, errors stemming from manual recording are eliminated.

Next is the case of error detection, containment and CAPA (Corrective Action Preventive Action). The MES records errors as they happen and can be configured to contain the impact based on severity of error detected, which might range from an alarm in the case of an elevated KPI captured to an actual plant shut down in the case of major breakdown or reagent leak.

The MES enables operators to implement corrective actions as defined by the DMR by following instructions outlined by the application and records the compliance of the CAPA activities as they take place. The MES also provides fool proofing through the e-DHR where data/credentials have oversight to ensure compliance; for example, an operator may be rejected unless the correct value is entered the production process, or their certifications are updated to allow them to perform a specific task. The MES acts as the ‘ENFORCER’ of the specifications, provides qualification verification for personnel and self-audits the data captured or entered, thereby ensuring the e-DHR document is perfectly compliant and production follows the 100% right first time rule.

Inventory reduction

When device history and execution reside in the MES, the need to carry excess inventory on the shop floor (known as ‘safety stock’) can be minimized. This stock is kept as a precaution, in anticipation of a material issue (quality or performance) so that shop floor productivity isn’t reduced. Safety stock may be reduced or even eliminated, as the MES follows exact execution rules and production schedules. WIP inventory may be planned exactly to the products scheduled to go onto the floor that day, so the need to have any excess inventory on the shop floor is minimized.

With the MES executing and recording the device history, production cycle time reduces as the need to manually record, report and audit each and every aspect of the production is eliminated. Speed of reacting to market and value chain stimuli is a key to success in Industry 4.0 and the MES allows this responsiveness, as all documents and information is recorded in version controlled documents and are self-audited vis-à-vis the specification as a matter of e-DHR functionality.   

While the case for MES based e-DHRs is extremely clear for medical device, diagnostics and other highly regulated industries, the benefits that automated execution and documentation bring are just as useful to industries where regulations are not that complex or restrictive. Having information pertaining to specification compliance and product quality holds high importance for any industry.

For any manufacturer considering the pursuit of Industry 4.0, a MES is the centerpiece to your digital transformation initiative. The availability of electronic documentation and its implementation in your process might just be the use case which helps your organization realize the initial benefits of Industry 4.0. 

For more on eDHR and Critical Manufacturing MES, please visit https://criticalmanufacturing.com/en/industries/medical-device-manufacturing  

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