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You need automated document control, Mr. Skogen!

 

As most of you know, document control is critical in medical device development and manufacturing. This was also the case when I worked as an engineer in a medical device company.

  • Engineering records drive medical product development, and the company quality system and Standard Operating Procedures (SOPs) govern how business is conducted.
  • Organized, revision-controlled, and auditable records are fundamental to maintaining regulatory compliance.
  • Capturing changes to the DHF and the DMR is necessary in order to demonstrate the entire design history of your device to the regulatory bodies.

Document control, however, was often associated with manual, tedious work, and high risk of errors in my former company. The reason? We had to do everything manually

 

This is what we did

We created and updated company data in design programs, SOPs, memos, and spreadsheets. Changes were printed out and routed for signatures in colored folders. Product information was communicated to internal teams, outsourced manufacturers, and suppliers via email, phone, or disconnected chat tools.

Critical product records, including the design history file (DHF), device master record (DMR), and bill of materials (BOM) were kept in a combination of engineering vaults, spreadsheets, and paper files. Final BOMs were usually loaded into enterprise resource planning (ERP) systems.

  

Then this happened

You see, the problem with this approach is that you cannot accurately update large, complex and continually evolving product records like the DHF, DMR and BOMs. It is both inefficient and associated with high degrees of risk.

At the same time, these records are highly relational and include various associated data and files, like revisions, parts and drawings. And they must all be properly linked and tracked. Spreadsheets, servers and paper files alone do not provide integrated ways to aggregate all related item data.

Thirdly, maintaining a system of spreadsheets in a validated state is both time-consuming and challenging. Trust me on this one! Spreadsheets do not live up to the level of organization and accountability required in the medical device industry.

Spreadsheets are not cut out for this

When speaking of spreadsheets, they do not have integral processes for managing engineering change orders (ECOs) and cannot be used to control device master record changes, manage associated files or create proper documentation for the DHF. The FDA requires that ECOs are properly verified, validated, reviewed, and documented in the DHF of the product. Manual routing of paper ECOs in colored folders are just inefficient and creates bottlenecks.

The overall problem with this approach was that all design efforts are iterative processes with many changes and reworks along the way. Capturing the many changes that occur simply became a maintenance nightmare for the spreadsheet owner. That was me!

So, one day I was on the phone with a friend who was working in a similar position. Jokingly, I was complaining about my spreadsheet “situation”. Then he said: You need automated document control, Mr. Skogen!

He explained the ins and outs of that foreign concept to me. Then it dawned on me. And I realized, this would make my working life so much easier.

 

What we should have done

We should have had access to a system that allowed us to create as many regulatory structures as we wanted to manage and have them managed in the same way so that they are automatically created, tracked and baselined. Other document structures such as the Technical File could also benefit from being managed in the same way as the DHF and the DMR.

Quite frankly, such capability should be a standard requirement in the medical device industry, if you ask me. 

 


That is why we developed Minerva PLM

In Minerva PLM we have developed this feature. In this video, I will show you how you can handle these document structures in the same way with the same requirements for change management and traceability and achieve:

- Accurate project update status

- Faster documentation retrieval and more assured regulatory compliance by capturing product data as it happens, not as an afterthought—risk avoidance

- Efficient regulatory submission workflow that is futureproofed. Face an audit with confidence knowing that information is held or federated into a single knowledgebase, readily available

- Decreased risk of errors and improved product quality and support with the ability to rapidly respond to changing customer demands.

About the author

Thomas Skogen

Thomas is an expert in Supply Chain and Manufacturing Optimization with more than 10 years of experience originating from Medical Device and High-Tech & Electronic Industries. He comes with a background as an Electronics engineer, complemented with a Master in Technology Management. Thomas has held positions in multinational corporations such as Nilfisk, heading the internal optimization program as well as the supply chain organization.

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