In medical device development, document controls are the building blocks of an ISO and FDA compliant Quality Management System. They are the processes and tools you need in place to manage documents as they are created and used by your organisation. They include procedures for identifying, retrieving, approving, distributing, changing, and archiving information critical to your project.
If your document control procedures are badly defined and easy to ignore, they can lead to document anarchy. Messy and inconsistent file versioning, storage and handling can result in delays and mistakes. They can lead you to wrongly specify products and engineer your products incorrectly.
But if your document control procedures are over complicated and hard to work with, they can be equally inefficient and ineffective. Processes may grind to a halt as bureaucracy impedes progress. Worse, your team may end up circumventing process altogether to ‘get work done’, meaning vital checks are not made and required records are not kept.
Within a paper-based quality system, it’s hard to impose consistent document control procedures. A manual approach always risks human error, and a lack of automation makes it hard to scale up your operations. But using a mix of Google Docs and DocuSign won’t necessarily solve the problem either, as you still must manually update links between systems, maintain precise audit records and impose lots of workarounds to keep your documentation moving through the lifecycle.
And then there are the eQMS, the structured digital QMS that are often used by larger companies to build and manage their medical devices. These systems come preloaded with templates for SOPs (Standard Operating Procedures). They impose document workflows that dictate the way your processes ‘must’ work. Created for large organisations, they can be overly prescriptive for scaling operations. They may require you to adhere to document procedures that make no sense for your business and do not effectively answer the regulation anyway. You can end up spending months changing your operations to fit the way the eQMS works, retraining your staff, while undermining compliance by creating extra complexity and confusion amongst your team.
Lean document management draws on the principles of Lean manufacturing popularised in the 1990s by researchers Womack and Jones. As Western companies faced increased volatility and competition in global markets, Womack and Jones’ Lean methodologies showed how they could learn from the Japanese concept of Kaizen to improve both the speed and quality of their output.
Lean aims to systematically identify and remove layers of wasteful process to help companies focus more effectively on meeting the needs of their customers, rather than becoming tied up in their own bureaucracy.
But a Lean approach is not about ruthlessly sweeping away all procedure just to speed up delivery. After all, document procedures in medical device development are often about imposing deliberate ‘circuit breakers’ in development to allow proper review and validation of deliverables.
Instead, applied to medical device document management, a Lean approach looks to provide ‘just enough’ control over documents to deliver products that exactly meet your customer and regulatory requirements. It identifies and strips away what is unnecessary in a process to make it as frictionless but cost effective and controlled as possible.
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In the Lean approach ‘waiting’ is identified as one of the 7 ‘wastes’ that destroy productivity.
Waiting can be a big part of medical device development particularly if you’re working manually within a paper-based system or ‘hybrid digital QMS’. Waiting for meetings to secure ‘wet signatures’, waiting for documents from colleagues to collate and pass on to others for approval. All these delays are endemic in manual systems often resulting in serious omissions and mistakes.
A Lean DMS (Document Management System) looks to automate these document control procedures to increase the ‘velocity’ of operations.
Automated document control procedures ensure data and information move through your system in a timely and consistent way. Automation ensures documents are checked for accuracy and usefulness by default before they are published and in use. The right system ensures documents are:
A Lean DMS will use real time email and clear user dashboards to prompt action and reminders to ensure nothing is left undone and to keep documents moving through your system in a timely way.
But the document control procedures that can be required by a traditional eQMS are often ‘one-size fits all’. They can require steps in a document approval process that are unnecessary for your business. Their inflexibility can become a straitjacket for your operation and employees.
When you are choosing a document management system, make sure you can adopt the leanest approach possible. You need to be able build your own unique review and approval sequences. You need to be able to eliminate or combine steps if they are excessive for your purposes. You need to be able change and optimise document workflows to ensure they are always doing what they should in the most economical way.
Which brings us to overprocessing.
Overprocessing is another waste that a LEAN approach seeks to eradicate. Imposing more procedures than are necessary to achieve required results is a constant danger for a scaling business bound by complex regulation and working with inflexible digital tools.
For many medical device developers, the introduction of a digital sign-off process through e-signatures can add complexity and expense, rather than increase efficiencies.
Some medical device developers will be persuaded by their DMS supplier to use biometric approval methods (through fingertip or Iris scanning). But neither the FDA nor ISO 13485 insists on this method of authentication for digital signatures. While promising a more frictionless and secure access protocol, biometrics can impose new hardware requirements for a business and give your team a whole new set of administrative and data protection tasks that weigh them down.
Other systems will use third party digital signature integrations like HelloSign or DocuSign to deliver on e-signature requirements. Digital signatures like these, notarised by certifying authorities, may seem like the obvious solution to meet authentication requirements. But they will often need careful re-engineering to be made compliant with FDA 21 CFR Part 11.
A 21 CFR Part 11 checklist: 7 key FDA e-signature requirements
The effort and expense entailed in supporting and tailoring integrations - adding extra steps to meet medical device quality standards, can end up adding more cost and ‘friction’ to your process than they eliminate. A Lean document management system will have built in e-signatures designed to exactly meet the required regulation - and no more.
Defects in medical device products cost time and money in delays to launch and reengineering costs. In the worst-case scenarios, they will cost you even more in fines, recalls and regulatory sanction.
In a Lean approach, eliminating defects in medical devices is focused around the quality and effectiveness of your document control procedures.
ISO 13485 and FDA 21 Part 820 both specify that developers need to operate a stage-gated system where deliverables are continually reviewed and validated against plans and designs to minimise non-conformities. Critical cycles of ‘Plan, Do, Check, Act’ are enabled through rigorous cross checking of documentation, prototypes, and end products. They seek to eliminate defects through a process of continual review, correction, and optimisation.
Lean document management tools help you organise these sequences in the way that keep documents accurate while moving at maximum velocity. Unlike more ‘one size fits all’ eQMS they acknowledge that every medical device is different and will need a unique development approach to bring it to market effectively.
A Lean document control system, therefore, helps you define the design stage gates that meet the regulatory demands in ways that work for you. They will let you build ‘document holders’ for each stage of a project, populated with the files that you define and require to be completed.
They will fire off notifications to your team when that documentation is ready for approval. They will trigger actions and ‘next steps’ as previous stages of a project are checked and completed. This movement of documents through the system is like the movement of materials in a Lean, ‘Just-In-Time’ manufacturing cycle. Files are made available and reviewed only when they are ready, minimising the ‘noise’ of unnecessary information in our inboxes, preventing wasted time and effort.
Ultimately, these ‘document holders’ can also help you define and collate the contents of your technical files (the required DHF, DMR, and DHR) while you are designing and building your product.
Lean document control procedures are focused on doing ‘just enough’ to meet regulatory demands, while keeping projects always moving forward. A Lean document control system helps you automate and configure procedures in ways that work for you and your business, while making the right documentation available in the right place when it is needed. They help you automatically generate the audit trails and evidence you’ll need to prove compliance and ensure traceability.
In the true spirit of Lean, they can help you generate the technical documentation you’ll need for audit as you complete each phase of your project, rather than wasting time at the end pulling them all together.