Building the Device Master Records (DMR) Documentation for Medical Devices

As promised, I’ve laid out the groundwork for how to document your DMR for medical devices (or any device manufactured). This groundwork includes all the mainstream documents used in the industry of manufacturing and engineering technology. There are myriad document types that build up a standard DMR, for which I have included in the diagram below.

These documents are intended to show that quality and inspection of a device has been performed, documented, and verified. After verification, the device is released to manufacturing.

Checklist
(Use a word processing application for this document)

The first document type is a product or device checklist. (Commonly, this checklist is used as a way to screen a new product pending release to manufacturing). When you create or implement a checklist for a new device, include the documentation system information as follows:

• Database
  Include qualified drawings and schematics. Such quantifiers as parts/ components size, quantity, and weight must be verified in the checklist for accuracy. *To ensure the device and all its components are correctly verified, review the schematics for the device, and then ensure that the annotations in the drawing match the calculations in the database description fields.

The first thing that should be read on your product checklist is the title and subject—and possibly the location that the product is intended to be used. For example, one checklist may cover a product for use in Japan, and another for use in the United States (Example: Electrical devices do not use a universal current in all countries). 

A catalog or record number is commonly placed in the upper right hand side of the checklist. If the checklist is specific to a department—such as welding, laser trimming, or molding—then ensure that the database has a command to print that department’s name on the page every time a hard copy is produced (On a personal note, I’ve seen companies have the department name show up on the computer system, but the name of the department is omitted when the computer prints a hard copy).

• Labels
  This includes master label (organization or corporate identity, catalog number, description, quantity… and other information as required)

• DMR
  Include copies of all labels and master label, diagrams/ schematics, and work orders.

• Verification
  On the checklist, have the appropriate department check off and sign who inspected and proofed the diagrams, drawings, components, labels, and reference documentation (the directions for use), and work order. Include a signature for the manager who releases the product checklist. Ensure QA signs the checklist before releasing the documentation to manufacturing.

The completed checklist is saved in MS Word or Word Perfect format. An unalterable reference file can be placed on the system in portable document format (PDF).

All of these steps are intended to reduce error in manufacturing. The device checklist is a solid way of preparing documenting for devices, scientific developments or experiments, and academic research. Next, I’m going to introduce to you a document that is referred to in the engineering/ manufacturing industry as the Job Traveler.

Job Traveler
(Use a spread sheet application for this document or tables on a word processing application)

The job traveler, or manufacturing traveler as it is sometimes called, refers to the operation/ instructions and quality inspection for a number of processes and procedures in the building or manufacturing of a device. The document is best created from a printout directly from the database and/ or an Excel file. 

Header information

The document header must display the title of the document, the job number (an assigned number in the documentation system) followed by a bar code, the assembly number (commonly includes record number [indicated with a capital “R” plus a number, followed by the rest of the assembly’s filed number on the record]), a brief description (name of device or components; acronyms are commonly used), the quantity released, revision number, and due date. 

Body content – instructions & reference to process documents

Data is printed on to the page in sections—usually this body is divided into departmental columns (similar to how a matrix flowchart points to who does what in a process/ system). You will place the operation bar codes in one column, the operations in the next column, and the reference documents for quality assurance in another column, followed by a column for acceptance/ rejection. 

Examples of the content appropriate to the “Operations” column includes: pulling samples, dimensional inspection, weighing, labeling, and work order verification. In manufacturing, the operations column will probably include a section for warehouse operations. In a nutshell, the details on the job traveler are choppy instructions—short, to the point. For more detailed instructions, one must access the process or procedural documents (that’s why the reference documents are given a number that is traceable to the record on the documentation system). 

Most dynamic electronic DHR systems can track all of the documents, files, records in your system both forward and backward (i.e. when, where, and who created the file). More importantly, a smart documentation system will detect which records belong to which storage system. In short, data can be updated to another database without changing the original files on another record.

Reference documents

Documents of reference are given a prefix on the job traveler. Quality assurance will have QP (Quality Process) preceding the number of the reference document. Manufacturing will assign the acronym MP (Manufacturing Process) before the number of the reference document. 

Quite often there are multiple documents of reference declared by any single department or operation within the job traveler. Unfortunately, there simply isn’t ample space on the job traveler to give every reference a humanly recognizable name. To get around this, you’ll have to search through your organization’s network, pull PDF files for more intelligible descriptions of the MP/QP reference document. Another way around this is to open a master flowchart from a high-level (bird’s eye view) perspective, and then click your way to the appropriate process. 

If the system is mapped out well (processes interlinked to procedures and references), you should be able to locate the file of interest without too much haggling with other document format files. In short, everything should be accessible from the organization’s flowcharts, diagrams—but, this is unlikely to happen without a full time technical writer on staff. The reason is simple… computer’s

don’t update flowcharts or documents. They can only update fields, files, records, etc.

Bill of Materials

The bill of materials is your record of released/ unreleased materials for manufacturing the device(s). Include the item description, number, quantity released, revision number, required quantity, and the current status—material released or not. As with all documents in your system, please include the title and job number.

Quick note: The barcode is optional. The reason there’s a bar code on documents is to keep batching tidy. Although it’s an option, I highly recommend implementing barcodes

Parts List

The parts list will show all data regarding the parts, components, materials, and quantifiers for your device. A good practice is to include a diagram or drawing schematic of your device in the parts list document—at the top, on the first page. 

Header information

On the header section of the parts list, create a table of sections for the following:

· Item (# assigned to the device on record)

· Revision (Rev. followed by a two digit number. For example: Rev.01)

· Job number (Refers to the job traveler instructions for operations. Include a barcode if possible)

Place the diagram or drawing on the front page after the header.

Body content

Separate the contents of the document’s body into sections. This is typically done for you by the software running your documentation system. Databases like Oracle may have features to print this kind of document layout for you.

Each item gets a number, such as “1” or “2”, and so on. Next is the quantity column—which refers to a specific component (from here on referred to as “part”) contributing to the whole of the device. Adjacent to this column is where you will input your part number, which is the record and file number assigned to the part. Create a column with a brief description of the part. Usually, you’ll have some details for the number of parts trimmed, cut, or sized to a specified measurement.

This concludes the basic overview for documenting devices for building up the DMR record in your documentation.

I’ll be adding some resources over the week. So, please revisit for any updates to this post.

*This article originally posted on 10/20/09, by Thomas P. Walton