A medical device engineer walks into a restaurant. He’s handed a menu. It’s a simple listing of dishes with a brief description. However, if this were a controlled document, it would likely contain step-by-step instructions, the revision history, the model number of the oven used to prepare the meal, and more information a diner wouldn’t care about.
This menu isn’t what we would typically consider a controlled document. But it is a good example of a lean document. It contains only the information the diner is interested in and nothing more. There’s no reason for it to contain a complete list of ingredients or instructions — that belongs on the recipe, not the menu. Including excessive information on a document that doesn’t need it would be redundant. But medical device documentation tends to do just that.
To quote a famous poet: “Oh what a tangled web we weave when we include every cross-reference in our documents.” That might not be an exact quote, but it very clearly describes what most medical device facilities do with their documentation. In an attempt to comply with 21 CFR Part 820, these organizations have embraced a tangled web and never-ending mess of cross-references based on false notions and myths rather than practicality. An unwritten rule exists that each document must cross-reference all related documents. That rule results in the following:
How did this situation come into being? It all began with good intentions. The same bricks that pave the road to a very bad place. Coming back from that means bringing lean principles into documentation practices.
Lean manufacturing has been around for quite some time. Yet, for regulated industries in general and medical devices in particular, the benefits of lean cannot emerge while the system is burdened with very archaic and non-lean practices.
Applying the principles of lean to a document system requires the methodical elimination of waste. Each document is the product of a business process. Waste must be found and removed from that process. The document, however, carries with it the artifacts of that waste. Redundancy and waste are often confused and justified with compliance and quality. But companies can remain compliant while embracing lean documents.
So, what is the definition of lean documents? It is an approach to the process of creating and revising controlled documents that minimize waste by providing exactly the information that is needed, at the right time, to the right audience — and nothing more.
Documents such as drawings, bills of materials (BOMs), routers, work instructions, etc. once had an original intent and function. But somewhere along the way, these were burdened — along with their process — with baggage that now passes for established and required provisions.
Companies find themselves constantly revising documents and correcting obsolete information, creating incomprehensible mixes of types of information, and introducing complexity where none was intended or required.
Yet, by methodically applying the principles of lean, a path back to simplicity and logic emerges. Its end result may be a surprise. The above tangled web becomes clearer.
Looking at lean manufacturing and lean documents both in the context of eliminating the types of waste, there is a framework of commonality to work from:
Besides lean principles, the Quality System Regulation itself provides a clue to a lean option:
“The DHF shall contain or reference (emphasis added) the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.”
“The DHR shall include, or refer to the location of (emphasis added), the following information.”
“The DMR for each type of device shall include, or refer to the location of (emphasis added), the following information.”
The above italicized words give us the lean option of summarizing the contents. Yet, how many companies compile huge binders with the physical contents of these records? The key to trimming down documentation is to focus on future proofing documentation. Medical device firms need to be compliant, but regulations are constantly changing. Lean documents are flexible enough to adapt to those changes.
A good current example of this is the European Union (EU) Medical Device Regulation (MDR). The new regulation has a numbering system that is to be used for products and processes. If a medical device company immediately changed their numbering system to match, it would cause chaos in the company. According to lean principles, the company would keep their own numbering system, only adjusting it when the documents in question will be used outside of the organization.
Asking questions about the status quo in your organization is the first step toward implementing lean documents. Look at the purpose behind the document, the elements of information they actually need to contain, and if information needs to be repeated in multiple documents. These questions are essential to finding the path to a leaner structure. The obstacle is not technical but conceptual. There is an alternative and leaner way, and that begins with challenging the current tangled mess of documents that exists in most businesses.
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