Design Control Guidance - Food and Drug Administration

software in each machine. The contractor had subsequently withdrawn following acontractual dispute, leaving the manufacturer with no rights to the source code developedby the contractor, and no practical way to maintain the software. For this and otherreasons, the product was the subject of a mandatory recall and all known units werecollected and destroyed.This is admittedly an extreme case, but many similar cases have been documented in whichthe manufacturer lacked design information necessary to validate a design and maintain itthroughout the product life cycle. This occurs for the most innocent of reasons—contracts expire, companies reorganize, employees move on to new projects or new jobs.Even when the designer is available, he or she may forget why a particular decision wasmade years, months, or even weeks before. Since design decisions often directly affect thewell-being of device users and patients, it is to the manufacturer’s benefit to maintain theknowledge base which forms a basis for the product design.Except for small projects, it is unusual for all design history documents to be filed in asingle location. For example, many design engineers maintain laboratory notebooks whichare typically retained in the engineers’ personal files. In addition, the design history mayinclude memoranda and electronic mail correspondence which are stored at variousphysical locations. Quality system plans applicable to a development project may reside inthe quality assurance department, while the chief engineer may be responsible formaintaining design and development plans. These diverse records need not beconsolidated at a single location. The intent is simply that manufacturers have access tothe information when it is needed. If a manufacturer has established procedures formultiple filing systems which together satisfy that intent, there is no need to createadditional procedures or records.As an example of the level of detail which may be entailed, some manufacturers havepolicies covering laboratory notebooks. Manufacturers typically find that without suchwritten procedures, a breakdown in communications eventually occurs, resulting in a lossof control. These procedures might address the following points.• Laboratory notebooks are the property of the manufacturer, not the individual.• A separate notebook is to be maintained for each project, and surrendered to theengineering librarian at the conclusion of the engineer’s active participation in theproject.• Laboratory notebooks are to be surrendered if the employee leaves the company.• Product development supervisors shall review employees’ laboratory notebooks atspecified intervals to ensure that records are complete, accurate, and legible.There are no requirements on the location or organization of the design history file. Insome cases, especially for simple designs, the designer will assemble and maintain theentire design history file. For larger projects, a document control system will likely beestablished for design documents, and these files will likely be maintained in some centrallocation, usually within the product development department.Section J. Design History File 3/11/97 Page 44