A medical device engineer walks into a restaurant …
He is handed a controlled document. Most would call it a menu. What is the purpose of this document? How many elements of information does it contain? Is it the correct revision? Was line clearance performed? Does it include step-by-step instructions? Does it include a revision history? What about the model number of the oven used to prepare the meal? Does it show an approved list of ingredients and their suppliers? Oh, that’s no controlled document, that’s a menu. Or is it?
Many would chuckle at this story as a simplistic analogy. Yet, there are many lessons from this example that could apply to a medical device facility. No, it’s not a controlled document in the sense most understand it. But the owner would not want it to be this morning’s breakfast menu during dinner, or to display last year’s prices. Nor would she want it to show meal options that are not available.
What is this document and what is its function? Its purpose – or function - is to help the customer select the meal. It contains two elements: the description of the item, and the price. So far so good. Would it contain the ingredients, or instructions on how to prepare the meal? Well, no, because the customer is not there to prepare the meal, he is there to order and enjoy the meal. True, there are certain control elements that are missing. But most would agree that the ingredients and instructions belong on another document – the recipe - and not on the menu. This should be a self-evident truth, that is, until one walks into a medical device facility. Then and there, it seems that common sense is left at the lobby hanging in the coat closet. And, no, this is not about compliance to 21 CFR Part 820. That is not an option. However, common sense is still optional – if one chooses to bring it into the facility.
Over the last several decades, a tangled web and a never-ending mess has emerged based upon false notions and myths rather than practicality. An unwritten rule exists that each document must cross-reference all related documents, and that repetition and redundant information makes sense. A very tangled web has emerged:
|The Tangled Web of Cross-References
And this is just for one product family. It doesn’t yet include the higher-level documents of the Quality Management System (QMS).
How did this situation come into being? Did someone or something purposely make this difficult to follow?
It all began with good intentions. The same bricks that pave the road to a very bad place.
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. Non-lean apologists will often resist change by simply proclaiming that “they said …” it has to be done this way. Or, “we’ve always done it this way.”
So what is the definition of Lean Documents?
It is an approach to the process of creating and revising controlled documents that minimizes 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-Material (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.
There is an alternative to that tangled web of cross-references:
Looking at lean manufacturing, lean documents both in the context of eliminating the types of waste, there is a framework of commonality to work from:
Sources of Manufacturing Waste
Sources of Document Process Waste
- Defective product
- Processing time
- Waiting time
- Defective documents (errors; omissions)
- Too many documents
- Document handling time
- Too much repetition and unnecessary cross-referencing
- Processing of documents
- Document routing time
- Waiting for approval and processing
Looking at the main records of the Quality System Regulation, the peculiar wording 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 option of summarizing the contents. Yet, how many companies compile huge binders with the physical contents of these records?
Going back to the questions of the restaurant menu, the following questions come to mind when looking at these definitions of DHF, DMR, and DHR:
· Do they truly have different functions?
· Do they contain the same elements of information?
· Are they in reality the same, just viewed from different perspectives?
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. A first step is to challenge and question the current tangled mess. Compliance does not mean complexity, and quality does not mean redundancy. In fact, both contain the seeds that undermine quality and compliance.
Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, Jose served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.