Each and every device manufactured must have a unique identifier and must be traceable in every manner. It is paramount that each transaction before and during production which impacts the product and its end functionality be recorded. And this is far easier said than done. The records thus maintained to achieve this mandatory compliance are referred to as DHRs, or Device History Records.
A DHR is supposed to contain all details of a product, like:
- Spec/Design or DMR (Device Master Record)
- Where the parts are sourced from
- Whether or not the machines used for assembling the equipment are calibrated and operators who perform the assembling are qualified to do so
- Whether or not the right process was used to perform the assembly/production
- Whether or not any non-conformance to standards occurred, and if yes, how it was dealt with
- Unique identifier of the product including records related to individual parts both sourced and manufactured
- Final quality review or inspection report of the product before being released to the market.
Traditionally, a DHR is a set of paper based documents, compiled as a dossier or file to provide a record of all the above requirements. These documents are manually compiled and then recorded as per the standards mandated by the regulatory authorities.
To bring the complexity into perspective, imagine a medical device plant, which churns 20,000 products a day from one of its 5 plants, with a minimum of say 10 documents to be compiled manually to respective files. The organization as a whole is required to collect, sort, validate, analyze and then finally record at least 200,000 documents a day. And this is for just one plant.
Now, let’s see how errors in manual documentation would add to this complexity. Imagine that 99,9% of the times transactions are recorded flawlessly. This seems to be a pretty good rate right? Unfortunately it is not good enough. With 0,1% of the total transactions recorded with errors or flaws, the chances of the total number of flawed products reaching the market, in a month’s time, would reach a staggering 4,400 plus units (considering that the errors made are unique and unrelated, taking a 22 day work month, from just the one plant).
With the above example it would also be safe to say that when the DHR is maintained manually, the manufacturer stands the chance of facing irreversible damage not only to its financial wellbeing, but also to its reputation. Think about the potential product recalls, disgruntled customers, government sanctions, failed audits and spoilt relationships. Even for a well-established player, such costs can have crippling effects on future planning.
Moving from Paper to Electronic Records
To this end, the solution which most of the manufacturers in the Medical Device industry are leaning to is the eDHR, or Electronic Device History Records. The eDHR transforms the paper based recording process into a fully automated and electronic one. However, contrary to popular belief, eDHR is not simply an electronic record of the transaction recorded on paper, such as scanned images of quality reports or bills of entry from material suppliers. It is rather a mechanism to monitor, record, validate, analyze and control the entire operation associated with the manufacturing of a medical device.Modern MES applications house the eDHR within their overall functionality spectrum, allowing the automation of the documentation. MES applications not only help execute a production process, but also integrate the shop floor with other applications in the organization. They allow recording/reporting of all transactions in real-time while enforcing CAPA/containment strategies wherever an error or OOS (out of spec) event is detected.
>> Read more about Quality and Compliance in Medical Device Manufacturing
Let’s look at how an MES application with the eDHR functionality in-built can help Medical Device manufacturers reach compliance as per the standards imposed by the regulatory authorities. Say we consider the same manufacturing plant we had mentioned earlier.
MES applications help automate compliance activities
First of all the MES application would contain the Spec related to each product. Whenever a particular product needs to be manufactured, the application would ascertain that the right material is issued for the same. It can also check the inventory and alert the concerned personnel if it finds that the material required is not available or not proper. Once the correct material or parts are issued from the store, the application records the relevant label information and creates a record for the same. This is done in real-time and can be accessed by the authorized personnel at any given time after it’s recorded.
Once the application has ascertained that the material is compliant, it would move to the next stage - which is validating whether or not the process equipment and the operators in question are qualified to perform the requisite operations. The MES checks the current state of machinery, when it was calibrated/checked and reports if it finds that it is non-compliant. Also, the application checks the operators and whether the qualification of the concerned personnel is correct, only then allowing for the operation to begin.
During the operation, the application records every transaction and references it with the SOP to ascertain that the correct route/recipe is followed. If any error was detected, it triggers CAPA/containment plan automatically. Finally, once the product is ready, the MES records its unique code, which can be a UPC for a batch or an item number for an individual product, along with all the information related to that product/batch (material used, fitness of machine/operator, production related information etc.).
A key deliverable for the eDHR is to maintain the electronic records of all documents and authorizations given such as any e-Signature and that too in the requisite reporting format. As the eDHR functionality fully automates the documentation process and is self-auditing in nature, it allows for error free recording and reporting of data.
Seeing the advantages of the eDHR functionality, most Medical Device manufacturers are turning towards MES applications, which will help automate their compliance activities. But the question here is whether the manufacturers in the industry should focus solely on compliance when they go for an MES or do they have more to gain by going for an automated and advanced process execution application, such as the MES?
Next week we will explore the overall benefits offered by the MES application for the Medical Device industry and for the players of all sizes, right from start-ups to established stalwarts.
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