DHF, DMR, DHR Process, Part 3

Posted by Bob Duffy on December 5, 2017 in Device Tips, Manufacturing

Design History File, Device History Records, Device Master Record, Device Tips, DHF, DHR, DMR

This is the 3^rd of the 4-part series around tips for leveraging the interrelationship between the Design History File (DHF), Device Master Record (DMR) and Device History Records (DHR’s). This tip is focused on completing the Device Master Record (DMR) with additional elements, typically from Manufacturing, Quality Assurance, Service and Marketing.

So here’s the tip:

Once the product concept has been defined and the DHF is started, start developing rest of the DMR.

In the previous Device Tip, I mentioned that the DMR is started from a portion of the Design History File that is transferred to formal Document Control. In this tip I’ll focus on completing the DMR that contains the following elements:

• Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
• Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
• Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
• Packaging and labeling specifications, including methods and processes used; and
• Installation, maintenance, and servicing procedures and methods.

In other words, identify those elements of the DMR that will be generated by people not typically on the design team, and start developing those elements in parallel with the design.

This will take another task away from the typical end-of-the-project crunch to “get the product into production”.

More Details

This will also allow Manufacturing, Quality Assurance and Marketing as to develop their elements throughout the design and development process. It is also likely that these groups will also begin the process of understanding the design and ultimately taking ownership of the product in product and in actual use by Customers.

Of the total content of a DMR, only Device specifications and Packaging and labeling specifications typically come from the DHF. Production process specifications are typically developed by manufacturing engineering staff, and Quality assurance procedures and specifications are typically developed by quality engineering staff. Installation, maintenance, and servicing procedures and methods are typically developed by the installation and service staff.

The following table shows the typical elements of Production process specifications, and the typical groups that create those elements.

The following table shows the typical elements of Quality assurance procedures and specifications, and the typical groups that create those elements.

Packaging and labeling specifications typically involve collaboration between Design Engineering, Regulatory, Legal and Manufacturing Engineering. The following table shows the typical elements of Packaging and labeling specifications, and the typical groups that create those elements.

The following table shows the typical elements of installation, maintenance, and servicing procedures and methods, and the typical groups that create those elements.

A complete DMR sets the stage for the final element, Device History Records (DHR’s), which will be covered in a future Device Tip.

Other Tips In This Series

DHF, DMR, DHR Part 1, Overview

DHF, DMR, DHR Process, Part 2 – DMR->DMR